ACL TOP Family Operator's Manual

ACL TOP Family Operator's Manual Help ♦ Version 5.2 ♦ P/N 00027503450 R00 ♦ 2014 Manufacturer Instrumentation Laboratory 180 Hartwell Road Bedford, MA 01730-2443 USA Phone: 781-861-0710 Fax: 781-861-1908 www.ilus.com EU Authorized Representative Instrumentation Laboratory SpA Viale Monza 338 20128 Milan Italy Phone: +39-02-25-22-1 Fax: +39-02-25-75-250 Email: webitalia@itmil.ilww.com www.il-italia.it ®ACL TOP is a registered trademark of Instrumentation Laboratory Co. ACL TOP Family Operator's Manual © Copyright 2014 Instrumentation Laboratory All Rights Reserved This publication and any and all materials (including software) related to the products of IL are of a proprietary nature and are communicated on a strictly confidential basis; they may not be reproduced, recorded, stored in a retrieval system, transmitted or disclosed in any way or by any means whatsoever, whether electronic, mechanical through photocopying or otherwise, without IL’s prior written consent. Information contained herein is believed by IL to be accurate; in any event, no responsibility, whether expressed or implied, is assumed hereby by IL for or in connection with the use thereof, or for infringement of any third party rights that might arise therefrom, or from any representation or omissions contained therein. ii of 22 L0027503450 R00 ACL TOP Family Operator's Manual Table of Contents Table of Contents iii CHAPTER 1 About This Manual 1 Welcome to Help 1 Important Symbols 7 Hazards 8 CHAPTER 2 General Information 10 General Information Overview 10 Intended Use 11 Symbols 11 Measured Parameters 13 Operating Principles 13 Instrument Description 15 Modules ACL TOP 300 Model ACL TOP 500 CTS Model ACL TOP 700/ TOP 700 CTS Models ACL TOP 700 LAS Model Instrument Safety Covers Power Connector Emergency Stop Button Keypad Laboratory Automation System (LAS) LAS Arm and Probe LAS Probe Aspirating from Sample on the LAS Track Cuvette Loading Area Bar Code Reader Sample Area Diluent Area Reagent Area Probe Incubators Optical Reading Unit System Fluids – Rinse and Clean Fluid Waste Monitor and Volume Control 15 15 16 17 18 19 19 20 21 22 23 24 25 27 28 30 31 33 34 34 35 38 42 Calibrating the All-in-One CM Monitor Touch Screen All In One Monitor Diagrams Configuring Volume Control on the ELO Touchsystems Entuitive Monitor Manufacturer 42 43 45 46 iii of 22 L0027503450 R00 ACL TOP Family Operator's Manual Contents Certification 47 CE Certification CSA Certification Other Certification 47 47 48 System Specifications 49 ACL TOP 300 CTS Specifications 50 ACL TOP 500 CTS Specifications 52 ACL TOP 700 and 700 CTS Specifications 54 ACL TOP 700 LAS Specifications 57 Test Performance 60 Typical Precision Performance Interference 60 66 Analytical Limitations 67 Installing the ACL TOP Instrument 68 Site Requirements 68 Limited Warranty Spatial Requirements Electrical Requirements 68 69 71 Actions Upon Delivery 74 Bringing Into Operation 74 Training Requirements 75 Warranty 76 Limitations and Disclaimers 77 CHAPTER 3 User Interfaces 79 User Interfaces 79 Input Devices 79 Touch Screen Mouse Keyboard Bar Code Reader Two-Dimensional Bar Code Reader Push Buttons LIS CD-ROM Drive 79 80 80 80 80 80 80 80 Output Devices 81 Getting Started 82 Terminology 83 Calibration/NPP Cuvettes Incubators LAS Terminology Material 83 83 87 87 90 iv of 22 L0027503450 R00 ACL TOP Family Operator's Manual Contents Optical Reading Unit (ORU) 91 Visual Styles 92 Layout 92 Main Screen 93 ACL TOP Family Software Main Screen 93 Menu Bar 94 Toolbar 99 General Toolbar Operations Toolbar Navigation Toolbar Other Commonly Used Toolbar Icons Icon Tooltips Moving the Toolbars Toolbar Icon Drop-down Menu 99 100 101 102 102 103 103 Working Area 104 Navigation Toolbar Analysis Menu Scrolling Unique Identifiers 104 104 104 104 Status Bar 106 General Log Icon Analyzer Status LIS Status Auto Run Status LAS Status Alarm Buttons 106 106 107 107 107 108 Information Panel 109 Time To Completion User ID Security Level Number of Entries Current Date and Current Time 109 109 109 109 109 Common Functions Overview 110 Logging In 111 Placing Focus 112 Placing Focus on an Item Combinations of Select and Focus 112 113 Selecting Objects 114 Selecting All the Objects in a List 114 Adding an Item 115 Viewing an Item 115 Deleting an Item 116 Sorting Lists 116 v of 22 L0027503450 R00 ACL TOP Family Operator's Manual Contents Filtering Data 117 Find and Auto-Search 118 Save 119 Restore 119 Previous Screen 119 Print 120 Printing an Entire List Printing Selected Data 120 120 Print Screen 121 Run / Auto Run 122 Overview After Initiating a Test Running Tests on Manually Loaded Samples Enabling and Resuming Auto Run Exporting Data 122 123 123 124 125 Exporting an Entire List Exporting Selected Data 125 125 Cancel / Stop / Progress Bar 127 Exit 127 CHAPTER 4 Setup 128 Material List 128 Accessing the Material List Filtering the Material List Material List Toolbar Material List Actions Menu Material List Table 128 128 129 130 132 Material Definition 135 Viewing and Adding Material Definitions Configuring Reporting of INR Results Material Definition Actions Menu Material Definition – Toolbar 135 136 137 138 Assigned Values 155 Overview Viewing, Editing, Printing, Exporting Assigned Values Assigned Values for Calibration Assigned Values for QC Test List 155 155 156 157 158 Accessing the Test List Filtering the Test List Viewing a Test Definition Printing and Exporting a Test Definition Report – Single Test Printing and Exporting a Test Definition Report – Multiple Tests Adding/Creating a User-Defined Test vi of 22 158 158 158 159 159 160 L0027503450 R00 ACL TOP Family Operator's Manual Contents Copying a Test Deleting a Test Definition Enabling or Disabling a Test Finding a Test Test List Toolbar Test List Actions Menu Test List Screen 160 161 162 162 163 163 164 Test Definition 166 Viewing a Test Definition Printing and Exporting a Test Definition Report – Single Test Printing and Exporting a Test Definition Report – Multiple Tests Creating a User-Defined Test Test Definition Operations Toolbar General Information Screen 166 166 166 167 167 169 Accessing the General Information screen General Information Actions Menu General Information Assay Manual validation required Enable as Shadow Test Enable as Paired Test Consistency Check 169 170 171 172 172 173 174 175 Analytical Cycle Definition 176 Overview Adding a Material Load Cycle Definition – for user-defined tests Deleting a Material Load Cycle Definition – for user-defined tests Analytical Cycle Definition Screen Toolbar Analytical Cycle Definition Screen Material/Sample Load Cycle Definition Screen Sample Pre-Dilution 176 176 177 178 179 183 190 Overview Accessing the Sample Pre-Dilution Screen Sample Pre-dilution Screen General Tab Sample/Mixture Tab Diluent tab 190 190 190 191 193 197 Alternative Pre-Dilution 201 Overview Accessing the Alternative Pre-dilution Screen Alternative Pre-dilution Screen General Tab Data Reduction Parameters 201 201 201 203 212 Configuring Data Reduction Parameters for the Primary Wavelength Primary Wavelength Wavelength Definition 212 212 214 vii of 22 L0027503450 R00 ACL TOP Family Operator's Manual Contents Overview Accessing the Wavelength definition screen Wavelength Definition screen 214 214 215 Raw Data Checks 218 Overview Accessing the Raw Data Checks screen Raw Data Checks screen 218 218 219 Normalized Data Checks 225 Overview Accessing the Normalized Data Checks Screen Normalized Data Checks Screen Baseline Check Tab Endpoint Check tab Multiple Threshold Check Tab Primary Algorithm 225 225 226 228 229 230 232 Accessing Primary Algorithm Parameters Primary Algorithm Screen Enable Primary Algorithm Endpoint Algorithm Linear Kinetic Algorithm Linear Kinetic Algorithm Screen Threshold Algorithm First and Second Derivative Algorithms Delta Algorithm Delta Second Derivative Tab Final Minus Initial Algorithm Statistics Algorithm 232 232 233 233 234 235 240 243 254 255 256 259 Secondary Algorithm 261 Result Unit Definition 262 Accessing the Result Unit Definition screen Viewing and Editing Measured Units Deleting a Result Unit Result Unit Definition Result Unit Definition Screen 262 262 263 264 266 Calibration Setup 272 Accessing the Calibration Definition screen Accessing the Pre-diluted Calibrators screen Calibration Definition Screen Enable calibration General tab Frequency Tab DR Parameters Tab Math Model tab (or Math Model High) Math Model Low Tab Automatic Dilution Screen General Tab 272 273 274 274 275 278 279 280 283 284 285 viii of 22 L0027503450 R00 ACL TOP Family Operator's Manual Contents Calibrator Tab Diluent Tab Pre-diluted Calibrators Screen Column Headings 292 296 299 299 Configuring Factor Parallelism 301 Overview Factor Parallelism Testing Options Factor Parallelism Criteria IL Tests Default Criteria Determining Factor Activity Using Factor Parallelism (multiple sample dilutions) Examples of Factor Parallelism results Parallelism Setup 301 302 306 307 308 310 312 Overview Viewing and Editing the Parallelism Definition Screen Parallelism Definition Screen Analytical Cycle tab Data Reduction Tab Normal Pool Plasma Setup 312 312 313 314 315 320 Test Definition – Normal Pool Plasma Screen General Tab Frequency Tab Rerun Rules Setup 321 322 324 325 Overview 325 Consistency Check 332 Performing a Consistency Check Consistency Check Window 332 332 QC List 333 Accessing the QC List QC List Toolbar QC List screen 333 333 334 QC Setup Definition 335 Accessing the QC Setup Definition screen QC Setup Definition screen 335 336 Test Profiles List 342 Accessing the Test Profiles List Configuring the Standard Test Profile Test Profiles List Toolbar Test Profiles List Screen 342 344 344 345 QC Profiles List 346 Accessing the QC Profiles List QC Profiles List Toolbar QC Profiles List Column Descriptions 346 346 347 Defining QC Profiles 348 Creating a QC Profile 348 ix of 22 L0027503450 R00 ACL TOP Family Operator's Manual Contents Viewing a QC Profile Editing a QC Profile Deleting a QC Profile 349 349 349 Reflex Rules 351 Creating a Reflex Rule Viewing or Editing a Reflex Rule Reflex List Operations Toolbar Reflex List 351 351 352 352 Auto-Validation Setup 355 Configuring Auto-Validation 355 Revision History Report 359 Importing and Exporting Definitions 360 Overview Exporting Definitions Importing Definitions Field Descriptions 360 361 363 365 Global Definitions Setup 366 Setting Up Global Definitions Global Definitions Setup Screen 366 366 Bar Code Definitions Setup 373 Configuring Bar Code Reading Bar Code Definitions screen 373 374 Bar Code Label Placement 376 LIS Configuration 377 Overview Configuring Communication with an LIS Performing a Manual LIS Query Host Communications Configuration Tab ASTM-1394 Configuration Tab Communications Configuration Tab 377 377 377 378 380 381 Sender List 382 Accessing the Sender List Sender List 382 382 LAS Overview 383 Definition Sample Workflow Prioritization of Samples Communication Hazards and Warnings LAS Terminology 383 384 385 385 386 386 LAS Configuration 387 Accessing the LAS Configuration screen LAS Configuration tab LAS Interface Module Configuration tab 387 388 391 x of 22 L0027503450 R00 ACL TOP Family Operator's Manual Contents LAS Tube Types tab 391 System Security 392 User Security List 392 Accessing the User Security List User Security List screen 392 393 Adding and Editing Users 394 Adding a New User Unlocking a User Editing a User User Security Screen 394 395 395 397 Software Access Screen 399 Accessing the Software Access Screen 399 Formatting Reports 400 Configuring Reports Laboratory Header Tab Demographic Tab Footer Tab AutoPrint Setup Tab 400 401 402 402 403 Display Overview 404 Sample List Display Settings 405 Test Programming Window 406 Configuring the Test/Profiles Programming Window Material Programming Window 406 407 Configuring the Material Programming Window 407 Setup Language 408 CHAPTER 5 Preparing the System 409 Additional Preparation 409 Material Identification 410 Manually Identifying Offline Rack Material Manually Identifying Inserted Rack Material Automatic Material Identification – Using the Bar Code Reader Manual Material Identification – Using the Offline Rack Bar Code Reader 410 411 412 413 414 TOP 300 CTS Bar Code Reader TOP 500 CTS Bar Code Reader TOP 700 Bar Code Reader 415 415 416 2D Bar Code Scanner 417 Overview Setup Using the 2D Bar Code Scanner Verified Barcode Material Data dialog box 417 417 418 419 Reaction Cuvettes 422 xi of 22 L0027503450 R00 ACL TOP Family Operator's Manual Contents Rinse Fluid 423 Overview Changing the Rinse Fluid 423 424 Clean Fluid 425 Overview Changing the Clean Fluid 425 426 Fluid Waste 427 Reagents 430 Calibrators and NPP 431 Quality Controls 431 Samples 432 Sample Containers and Adapters 433 Sample Adapters for Open and Closed Tubes Sarstedt Closed Tube Sample (CTS) Racks Old Style Sarstedt Closed Tube Sample (CTS) Rack and Adapters Validated Uncapped Sample Containers Validated Uncapped Sample Containers for LAS – Track Only Validated Capped Sample Containers for CTS – Piercing Mode Enabled Validated Capped Sample Containers for CTS – Low-Fill Tubes Sample Containers Not Recommended for CTS 433 435 437 439 441 442 444 445 Diluents 447 Restriction Map 448 Overview Accessing the Restriction Map TOP 500 CTS Restriction Map TOP 700 Restriction Map TOP 700 LAS Restriction Map 448 448 450 451 452 Closed Tube Sampling 453 Overview Enabling/Disabling CTS Mode Closed Tube Sampling (CTS) Probe Sarstedt Closed Tube Sample (CTS) Rack and Adapters 453 454 455 457 Sample Area 458 Reagent Area 458 Accessing the Reagent Area and Rack Details Programming Non-Bar Coded Reagents Using the Offline Rack Viewing On-board Materials Reagent Area Operations Toolbar Reagent Rack Details Operations Toolbar Reagent Area Screen Reagent Rack Details Screen Offline or Virtual Rack Diluent Area 458 459 460 461 462 464 468 471 472 Accessing the Diluent Area 472 xii of 22 L0027503450 R00 ACL TOP Family Operator's Manual Contents Diluent Area Viewing On-board Materials Diluent Rack Details 473 476 476 Reagent/Diluent Area 477 Overview Accessing the Reagent/Diluent Area and Rack Details Programming Non-Bar Coded Reagents Using the Offline Rack Viewing On-board Materials Reagent/Diluent Area Operations Toolbar Reagent Rack Details Operations Toolbar Reagent/Diluent Area Screen Reagent Rack Details Screen Offline Racks Diluent Rack Details Screen Test Feasibility 477 477 478 478 479 480 481 486 489 490 492 Accessing The Test Feasibility List Test Feasibility List window Test Feasibility List Tab QC Feasibility List Tab Refresh/Close 492 492 493 497 498 CHAPTER 6 Starting and Stopping the Instrument 499 Starting and Stopping Overview 499 Starting the Instrument 499 Shutting Down the Instrument 501 Emergency Stop 502 Controlled Stop 503 Resume Auto Run 504 Recovery 505 Performing a Recovery Operation Performing a Forced Recovery 505 506 CHAPTER 7 Calibration 507 Calibration Details 507 Overview Reviewing and Validating Calibration Test Results Viewing Calibration Curves Deleting a Calibration Point Value Printing and Exporting a Calibration Report Calibration Details Screen Calibration Curve Tab 507 508 509 510 511 513 513 Calibration Status List 520 Performing a Calibration 522 CHAPTER 8 Normal Pool Plasma 525 NPP Status Details 525 xiii of 22 L0027503450 R00 ACL TOP Family Operator's Manual Contents Overview Reviewing NPP Results Recalculating NPP Test Results Printing an NPP List Report Printing an NPP Results Report Exporting a Report NPP Status List Screen 525 525 526 526 527 527 528 Performing a Normal Pool Plasma Measurement Programming an NPP in the NPP Details screen Programming an NPP from the Sample Rack Details screen Automatic NPP 531 531 532 532 CHAPTER 9 Quality Control 533 QC Overview 533 QC Performed on Alternate Lots Activating an Alternate Lot 533 533 QC Results List 534 Accessing the QC Results List QC Results List 534 535 QC Test Status List 537 Accessing the QC Test Status List QC Test Status List screen 537 537 Performing a Quality Control Test 538 Programming QC in the QC Test Status List Programming QC in the Sample Rack Details screen Enabling Automatic QC Programming a QC Profile Reviewing QC Results 538 542 543 543 545 Viewing and Filtering the QC Results Viewing QC Statistics in Chart and Grid View Adding or Viewing Comments Tracking QC Information Viewing Reaction Curves Omitting Points Restoring Points Purging Data Setting Statistics as Target Activating an Alternate Lot Uploading results to the LIS Filtering Results for Printing Reports Printing QC Test Status Reports Exporting Reports QC Statistics Screen Active Lot Tab Chart View Grid View xiv of 22 545 546 547 547 547 548 548 549 550 550 550 550 555 555 556 557 558 562 L0027503450 R00 ACL TOP Family Operator's Manual Contents Grid Plus Chart View Multi-Chart View 564 565 CHAPTER 10 Sample Analysis 566 Sample Collection and Storage 566 Plasma Collection Plasma Separation 566 566 Sample Area 567 Accessing the Sample Area Viewing On-board Materials Sample Area Operations Toolbar Sample List Toolbar Sample Area Screen Restriction Map Racks Track Control Panel Bar Code Reader Indicator 567 568 569 570 571 575 580 583 583 LAS Cuvette Holding Area 585 LAS Cuvette Holding Area Operations Toolbar 586 Sample Rack Details 590 Accessing Sample Rack Details Deselecting Tests Sample Area Toolbar Sample Rack Details Operations Toolbar Sample Rack Details screen Tests and Profiles Window Rack Summary Information 590 591 591 592 594 596 597 Programming Bar Coded Samples 598 Programming Bar Coded Samples Using an LIS (Host) Programming Bar Coded Samples After Loading the Rack, Without an LIS 598 599 Programming Non-Bar Coded Samples 600 Programming Non-Bar Coded Samples Using the Offline Rack and an LIS (Host) with Automatic Downloading Enabled Programming Non-Bar Coded Samples After Inserting the Rack, Using an LIS with Host Query Enabled Programming Non-Bar Coded Samples After Inserting the Rack, Without Using an LIS Programming Non-Bar Coded Samples Using the Offline Rack, Without Using an LIS 600 601 602 603 Reviewing Sample Status 604 Reviewing Test Results 605 Recalculating Test Results Validating a Single Completed Test Result Validating All Completed Test Results for a Sample Uploading a Single Completed Test Result to the LIS Uploading All Completed Test Results for a Sample to the LIS Deleting Results Printing Sample Results Reports xv of 22 605 606 606 607 608 608 609 L0027503450 R00 ACL TOP Family Operator's Manual Contents Printing Sample Results Detailed Reports Printing Patient Reports Exporting Reports 610 611 612 Sample List 613 Viewing Sample Details Selecting and Placing Focus on Samples Adding and Removing Tests Associated with a Sample Validating a Single Completed Test Result Validating All Completed Test Results for a Sample Uploading a Single Completed Test Result to the LIS Uploading All Completed Test Results for a Sample to the LIS Finding a Sample ID Filtering Selected Samples by Test Code Changing the Sample List Display Settings Configuring Sample List Display Settings Actions Menu Sample List Toolbar Sample List Screen Sample List Columns Test Information Columns Time to Completion Sample Details 613 613 615 615 615 616 617 617 618 619 620 622 625 626 628 631 633 634 Viewing Sample Details Viewing Parallelism Details Test Information Tab Patient Demographics Tab 634 634 635 636 Test Details 637 Viewing Test Details Printing and Exporting a Parallelism Report Printing the Clot Curve Test Details Screen Parallelism Test Details Screen 637 638 639 640 642 Clot Curve Analysis 643 Overview Configuring, Viewing and Analyzing Derivative Curves Clot Curve Analysis Conclusion Results Statistics 643 644 648 650 651 Viewing Results Statistics Results Statistics Window 651 653 Test Counters Statistics 654 Accessing the Test Counters Statistics Windows Simple Test Counter Statistics Detailed Test Counter Statistics Sample List Filter 654 655 656 658 xvi of 22 L0027503450 R00 ACL TOP Family Operator's Manual Contents Sample Filters 1 Tab Set of Filters 2 Tab Set of Filters 3 Tab Test Filters 1 Tab All Samples 659 661 662 663 664 CHAPTER 11 Analyzer Status 665 Analyzer Status Indicators 665 CHAPTER 12 Alarms and Troubleshooting 666 Alarm Messages 666 Accessing Alarm Messages 666 Material Alarms 668 Job Frequency Alarms 683 QC Alarms 684 Maintenance Alarms 685 Analyzer Alarms 687 External Communications Alarms 739 Setup Alarms 747 Other Alarms 751 Popup Alarms 754 Alarm Buttons 768 Warning Alarms Error Alarms No New Alarms Alarm Buttons in the Status Bar 768 768 768 769 Troubleshooting Other Problems 770 Data Flags 772 Data Flag Groups Data Flags List 773 774 Accessing Data Flags 792 Sample List Sample Details Screen Test Details Screen Calibration Details Screen QC Statistics Screen NPP Details Screen 792 792 793 793 794 794 CHAPTER 13 System 795 Maintenance Schedule 795 Daily Maintenance Weekly Maintenance Monthly and Quarterly Maintenance Annual and Semi-Annual Maintenance As Needed Maintenance By Number of Piercings Maintenance 795 796 796 796 797 797 xvii of 22 L0027503450 R00 ACL TOP Family Operator's Manual Contents Good Laboratory Practice 797 Maintenance List 799 Accessing Maintenance Activities Maintenance Actions Menu Operations Toolbar Maintenance Activity Table 799 801 804 805 Viewing and Configuring a Maintenance Activity 807 Viewing and Editing a Maintenance Activity Adding a Manual Maintenance Activity Configuring a Warning Threshold Maintenance Activity Configuration dialog box 807 807 808 809 Adding a New Maintenance Activity 812 Adding a Manual Maintenance Activity Maintenance Activity Configuration dialog box 812 813 Deleting a Maintenance Activity 813 Maintenance Definitions 815 Automatic Fluidic Line Priming Cycle Automatic Routine Clean for All Probes Clean Cuvette Waste Drawer Clean Deep Wash and Clean Cup Area Clean Rack Areas CTS Foot Cleaning Cuvette Evacuation Cycle Empty Cuvette Waste – Daily (Manual Activity) Empty Waste Fluid – Weekly (Manual Activity) Enhanced Clean for All Probes Enhanced Clean for LAS Probe Enhanced Clean for Reagent 1 and Reagent 2 Probes Enhanced Clean for Reagent 1 Probe Enhanced Clean for Reagent 2 Probe Enhanced Clean for Reagent Probe Enhanced Clean for Sample Probe Foot and Probe Inspection Replace CTS Filter and clean Clean Cup Area Replace CTS Piercer Replace LAS Syringe Replace LAS Syringe Tip Replace Reagent 1 and Reagent 2 Syringe Tips Replace Reagent 1 Syringe Replace Reagent 1 Syringe Tip Replace Reagent 2 Syringe Replace Reagent 2 Syringe Tip Replace Reagent Syringe Replace Reagent Syringe Tip Replace Sample Syringe Replace Sample Syringe Tip 815 816 816 817 817 817 818 818 818 819 820 821 822 823 824 825 825 826 826 826 827 827 827 827 828 828 828 828 829 829 xviii of 22 L0027503450 R00 ACL TOP Family Operator's Manual Contents Rinse/Clean Priming Cycle for All Probes Rinse/Clean Priming Cycle for LAS Probe Rinse/Clean Priming Cycle for Reagent 1 Probe Rinse/Clean Priming Cycle for Reagent 2 Probe Rinse/Clean Priming Cycle for Reagent Probe Rinse/Clean Priming Cycle for Sample Probe Routine Clean for All Probes Wipe Down All Probes Wipe Down LAS Probe Wipe Down Reagent Probes Wipe Down Sample Probe Performing Maintenance Activities 829 830 830 831 831 832 832 833 833 833 834 835 Maintenance Activities (listed alphabetically) 835 Automatic Fluidic Line Priming Cycle 835 Automatic Routine Clean for all Probes 836 Clean Deep Wash and Clean Cup Area – Weekly (Manual Activity) 837 Clean Rack Areas – As Needed (Manual Activity) 838 CTS Foot Cleaning – As Needed (Manual Activity) – CTS Models Only 839 Cuvette Evacuation Cycle – As Needed (Semi-automatic Activity) 840 Empty Cuvette Waste – Daily (Manual Activity) – 300 CTS Models Only 840 Empty Waste Fluid– Weekly (Manual Activity) – 300 CTS Models Only 841 Enhanced Clean for All Probes – Daily for all probes together (Semi-automatic Activity) 842 Enhanced Clean for LAS Probe – As Needed (Semi-automatic Activity) – LAS Models Only 844 Enhanced Clean for Reagent 1 and Reagent 2 Probes – As Needed (Semi-automatic Activity) – TOP 700 Models Only 845 Enhanced Clean for Reagent 1 Probe – As Needed (Semi-automatic Activity) 846 Enhanced Clean for Reagent 2 Probe – As Needed (Semi-automatic Activity) – TOP 700 Models Only 847 Enhanced Clean for Reagent Probe – As Needed (Semi-automatic Activity) – 300/500 CTS Models Only 848 Enhanced Clean for Sample Probe – Daily (Semi-automatic Activity) 849 Foot and Probe Inspection – As Needed (Manual Activity) – CTS Models Only 850 Replace CTS Filter and clean Clean Cup Area – 5000 Piercings (Manual Activity) – CTS Models Only 852 Replace CTS Piercer – Every 120,000 piercings (Manual Activity) – CTS Models Only 853 Replace LAS Syringe – As Needed (Semi-automatic Activity) 853 Replace LAS Syringe Tip – Every 6 months (Semi-automatic Activity) 853 Replace Reagent 1 and Reagent 2 Syringe Tips – Every 6 months (Semi-automatic Activity) 853 Replace Reagent 1 Syringe – As Needed (Semi-automatic Activity) 853 Replace Reagent 1 Syringe Tip – Every 6 months (Semi-automatic Activity) 854 Replace Reagent 2 Syringe – As Needed (Semi-automatic Activity) 854 Replace Reagent 2 Syringe Tip – Every 6 months (Semi-automatic Activity) 854 Replace Reagent Syringe – As Needed (Semi-automatic Activity) 854 Replace Reagent Syringe Tip – Every 6 months (Semi-automatic Activity) 854 Replace Sample Syringe – As Needed (Semi-automatic Activity) 854 Replace Sample Syringe Tip – Every 6 months (Semi-automatic Activity) 854 Rinse/Clean Priming Cycle for All Probes – As Needed (Semi-automatic Activity) 855 Rinse/Clean Priming Cycle for LAS Probe – As Needed (Semi-automatic Activity) 855 xix of 22 L0027503450 R00 ACL TOP Family Operator's Manual Contents Rinse/Clean Priming Cycle for Reagent 2 Probe – As Needed (Semi-automatic Activity) Rinse/Clean Priming Cycle for Reagent Probe – As Needed (Semi-automatic Activity) Rinse/Clean Priming Cycle for Sample Probe – As Needed (Semi-automatic Activity) Routine Clean for All Probes – As Needed (Semi-automatic Activity) Wipe Down All Probes – As Needed (Manual Activity) – Non-CTS Models Only Wipe Down LAS Probe – Weekly (Manual Activity) Wipe Down Reagent Probes – As Needed (Manual Activity) Wipe Down Sample Probe – Weekly (Manual Activity) – Non-CTS instruments Only Replacing the Syringe and Syringe Tip 856 856 857 857 858 859 860 861 862 Hamilton Syringe Procedures 862 CTS Piercer/Probe Replacement Procedure Overview 868 CTS Piercer/Probe Replacement Procedures 868 Probe and Seal Assembly Removal Procedure 869 Probe and Seal Assembly Installation Procedure 873 Piercer Probe Removal Procedure 875 Piercer Probe Installation Procedure 877 Warning Thresholds 880 System Decontamination 882 Cleaning the Monitor 884 Cleaning the Reagent Cooling Filter 885 Diagnostics Overview 886 Cuvettes 887 Viewing the Cuvettes Screen Cuvettes Tab 887 887 Optical Reading Unit 888 ORU Cleaning Procedure ORU Blanking Procedure ORU Tab 888 888 890 ORU Linearity Test 892 Viewing the ORU Linearity Test Screen ORU Linearity Test Tab 892 892 Controllers, Covers and Racks 893 Viewing the Controllers, Covers and Racks Screen Controllers, Covers and Racks Tab Fluids 893 893 894 Viewing the Fluids Screen Fluids Tab 894 894 Probes Coordinates Adjustment 895 Accessing the Probes tab Preparing for Adjusting Probe Coordinates Adjusting Probe Coordinates Setting the LAS Aspiration Point Manually 895 895 898 898 xx of 22 L0027503450 R00 ACL TOP Family Operator's Manual Contents Setting the LAS Aspiration Point Semi-Automatically Probes Tab Voltages 899 900 902 Viewing the Voltages Screen Voltages Tab 902 902 Universal Arm 903 Viewing the Universal Arm Screen Universal Arm Tab 903 903 Fluid Precision Test 904 Viewing the Fluid Precision Test screen Fluid Precision Test Tab 904 904 Instrument Status 905 Viewing Instrument Status Configuring the Alarms Grid and Alarms Chart tabs Filtering the Alarms Grid and Alarms Chart tabs Viewing Status Statistics Instrument Status Operations Toolbar Versions tab Alarms Chart Tab Alarms Display Settings Dialog Box Alarms Filter Dialog Box Status Statistics Screen Instrument Temperatures 906 906 907 907 907 908 911 912 915 917 919 Viewing Instrument Temperatures Instrument Temperatures Window 919 919 Analytical Versions 920 General Log List 921 Accessing the General Log List Printing a Report Exporting a Report Clearing the Log List General Log List Toolbar Icons General Log Entry Creation window 921 921 922 922 923 925 CHAPTER 14 Backup and Restore 926 Backup and Restore 926 Overview Full Backup of Database Full Restore of Database Burn Backup of Database to CD or DVD using Nero Express Essentials Backup and Restore screen 926 927 929 930 931 CHAPTER 15 Parts and Consumables 932 Parts and Consumables List 932 Most Frequently Ordered Items Less Frequently Ordered Items 933 934 xxi of 22 L0027503450 R00 ACL TOP Family Operator's Manual Contents Reagent Racks, Diluent Racks and Bottle Adapters 935 CHAPTER 16 Reference 939 Reference Section Overview 939 Toolbar Icons 940 Grid Icons 947 Graph Icons 950 Sample Status Color Codes 952 Reagent Status Color Codes 954 Reagent Placement Reagent Remaining Stability Reagent On-board Volume 954 954 955 LED Status Color Codes 956 Measured Units 957 Measured Units Calculated Units Parallelism Units Calibrated Units Calibration Units Statistical Units Derivative Units Paired Results Units 957 957 957 958 958 958 958 959 CHAPTER 17 IL Locations 960 Instrumentation Laboratory Worldwide Locations 960 Instrumentation Laboratory Headquarters Werfen Group Corporate Headquarters US, Canada, Latin America, and South America Pacific Region Europe, Middle East, Africa 960 960 961 963 965 Glossary 969 Index 973 xxii of 22 L0027503450 R00 ACL TOP Family Operator's Manual CHAPTER 1 ABOUT THIS MANUAL Welcome to Help This manual describes the some of the features of the ACL TOP Family Operator's Manual. The primary manual is an online help system that is readily available while using the instrument. NOTE: l l This manual is for use with all ACL TOP Family models. The screens displayed in this manual may vary slightly from what appears on the instrument. This is due to slight differences on those screens between various ACL TOP models. The online help uses drop-down text extensively to make it easier for you to locate areas of interest. Click the following drop-down text to view other descriptions of functionality deployed in the online help: Accessing the Help Manual To access the manual, perform one of the following procedures: l Press the <F1> key. l Select the Help l Select Help in the menu bar. icon in the toolbar. See Parts and Consumables List to order a CD containing this manual in PDF format. Locating Topics in the Table of Contents The TOC tab in the Navigation pane is dynamic. It always expands to and highlights the topic that is currently open. If the TOC tab is not displayed, simply open it to view where the open topic exists in the TOC structure. 1 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 1 – About This Manual Welcome to Help Managing Favorite Topics and Searches Favorite Topics To add a topic to Favorites: 1. Open a topic that you want to add to Favorites. 2. Select the Add topic to favorites icon in the toolbar. 3. Open the Favorites tab in the navigation pane to view the topic title under Favorite Topics. 4. To open a Favorite topic, select a topic title under Favorite Topics. 5. To remove the topic from Favorites, select the check box next to the topic title, then select the Delete selected favorite topics icon above the check boxes. Favorite Searches 1. Open the Search tab in the navigation pane and perform a search. The search results appear in the Search pane. 2. Select the Add search string to favorites icon next to the Search button in the Search pane. 3. Open the Favorites tab in the navigation pane to view the search string under Favorite Searches. 4. To perform a Favorite search, select a search string under Favorite Searches. 5. To remove the topic from Favorites, select the check box next to the search string, and select the Delete selected favorite searches above the check boxes. 2 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 1 – About This Manual Welcome to Help Online Help Toolbar – Show/Hide navigation – Toggle the Navigation pane in and out of view. – Expand all - Expand all the drop-down text in the open topic. – Collapse all - Collapse all the drop-down text in the open topic. – Print topic – Print all or part of the open topic. – Quick search – Search the current topic for the text entered in the Quick search text box to the left of the button. Single words only. Not case-sensitive. – Remove search highlighting – After a search, remove the highlighting from the search text found in the open topic. – Back – Open the previous topic. – Forward – After using the Back button to view previously opened topics, click the Forward button to retrace the sequence forward. – Refresh – Refresh the current screen. – Home – Open the Title page of the ACL TOP Operator's Manual. – Search – Open the Search tab in the Navigation pane. – Index – Open the Index tab in the Navigation pane. – Favorites – Open the Favorites tab in the Navigation pane. See Managing Favorite Topics and Searches. – TOC – Open the Table of Contents tab in the Navigation pane. See Locating Topics in the Table of Contents. Links Links are provided throughout this manual to allow you to quickly move to other topics that are related to the topic that is open. Links are blue and underlined. Click a link to jump to its target. 3 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 1 – About This Manual Welcome to Help Image Thumbnail Links Large pictures in the online help appear as expandable thumbnail images. To print a thumbnail image in full size, right-click the expanded image and select Print. Click the following thumbnail to expand the image. Expanding Text Click here This is expending text. to view the expending text. Also, click the colored text to view toolbar icons. For example, the Run icon. Printing Help Topics l l When printing topics that contain drop-down or expanding text, you must display all hidden text before printing. Content in text drop-downs does not print in the collapsed state. Large pictures in the online help appear as expandable thumbnail images. To print a thumbnail image in full size, right-click the expanded image and select Print. 4 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 1 – About This Manual Welcome to Help Commonly Used Terms The following terminology appears throughout this manual: l l l Analytical Module – Part of the instrument where sample processing and testing are performed. Also referred to as the AM and the Analyzer. Control Module – A Microsoft® Windows™ PC running the ACL TOP software developed by IL. Also referred to as the CM, it provides the User Interface and Data Management functionality. The CM connects to the Analytical Module and provides the high level controls. The CM includes the monitor, keyboard, and mouse. System/Instrument – Analytical Module + Control Module See Terminology and the Glossary for more terms. NOTE: The terms jobs and tests are used interchangeably both on the instrument and in this help manual. This is also true for bottles and vials. 5 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 1 – About This Manual Welcome to Help Tooltips Display Material and Test Information The instrument displays useful material and test information in tooltips when you hover the cursor over the various rack positions displayed in the Working Area. Some examples follow. Material Information Tooltip Hovering over a material in a reagent or diluent rack displays the Material Type, Expiration Date, Lot ID and Volume of material on-board. Test Information Tooltip Hovering over a position in a sample rack displays the Sample ID and the test status. In this case the tooltip displays the time remaining to complete the tests ordered on the sample. User-editable Fields Many screens contain fields that you can edit, especially those screens having to do with user-defined tests and materials. Other fields for IL-locked tests and materials, for example, are editable only by IL Test Developers and these are grayed out. Access to fields varies depending on login level and security setting. See Also l Terminology l General Information Overview 6 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 1 – About This Manual Important Symbols Important Symbols Only trained operators following the procedures described in this manual should use the ACL TOP Family of instruments. IL declines any responsibility otherwise. Good laboratory practices dictate that biohazard precautions be taken while operating the ACL TOP and when handling patient samples, controls, calibrators, or similar materials. Throughout this manual, you should pay particular attention to paragraphs marked WARNING, CAUTION, NOTE, and BIOHAZARD. These paragraphs are labeled with the following symbols and contain important information: WARNING: Warning statements provide information about electrical hazards CAUTION: Caution statements provide information about personal injury hazards and product damage hazards. NOTE: Note statements contain important user information. BIOHAZARD: Biohazard statements alert you to potentially biohazardous conditions. See Also l Hazards l Symbols 7 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 1 – About This Manual Hazards Hazards WARNING: On most ACL TOP instruments, the computer, monitor, keyboard and mouse are located on the left side of the instrument. On the ACL TOP 700 LAS model, these components are located on the right side of the instrument to facilitate the LAS Track operation. Use extreme caution when handling any liquid, liquid waste, cuvette waste, or bulk rinse or clean fluid on the instrument. Care must be taken to avoid spilling anything that can cause electrical shorts or other malfunctions related to spills or causing a biohazardous condition when using the keyboard, mouse, monitor or computer. Do not connect the analyzer to power before verifying correct voltage setting. The analyzer can be used with a power (main) voltage of 100-127 VAC or 135-264 VAC (50/60 Hz). Verify the voltage of the local power (main) to be used. Check the voltage select label located on the backplate of the analyzer. Listed are the nominal ranges of 115 (for 100-127 VAC input) and 240 (for 135-264 VAC input). Be sure the analyzer is correctly set for the power (main) being applied. Always plug the analyzer into a grounded outlet. Allow at least 6 inches (15.24 cm) of clearance on the sides, back, and top of the analyzer to ensure proper cooling. This equipment has been tested and found to comply with national and international EMC and RFI requirements. These requirements are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment. This equipment generates, uses, and can radiate radio frequency. If not installed and used in accordance with the manufacturer’s instructions, this equipment may cause harmful interference to radio communications. Operation of this equipment in a residential area may cause harmful interference. In this case you will be required to correct the interference at your own expense. WARNING: Operating technicians and maintenance personnel are urged to follow sound electrical safety practices at all times. Although all exposed metal parts of the analyzer are at ground potential (zero volts), never touch them with one hand while also touching a plumbing fixture, radiator, AC-operated device, or other grounded object with the other hand. Before opening the analyzer, remove the power cable from the power outlet. Do not replace components or attempt any repair with the analyzer switched on. Do not operate the analyzer in an atmosphere containing explosive gases; components of the analyzer could possibly generate sparks. CAUTION: Avoid spilling fluid on or into the analyzer at any time. Spills should be cleaned up promptly. 8 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 1 – About This Manual Hazards WARNING Piercing Hazard: Do not reach hands inside covers while instrument is on. Piercing probe can cause injury if probe arms are in motion. BIOHAZARD: When working with human blood products, all accessible parts of the analyzer must be considered biohazardous. The analyzer surface, racks, track area, and probes should be routinely disinfected. CAUTION Biohazard: While it is unlikely that spills or leaks will travel to the underside of the instrument or the table it is on, care should be taken to inspect both the underside of the system and table for possible leaks. Clean and disinfect any spills discovered. Report leaks to Service personnel for repair. System fluid waste is biohazardous. Use precautions when changing or emptying the fluid waste container. Always follow local regulations when disposing of liquid waste. See Also l Important Symbols 9 of 992 L0027503450 R00 ACL TOP Family Operator's Manual CHAPTER 2 GENERAL INFORMATION General Information Overview General information about the ACL TOP Family includes the following: l Intended Use l Symbols l Measured Parameters l Operating Principles l Instrument Description l Monitor and Volume Control l Manufacturer l Certification l System Specifications l Instrument Specifications l Test Performance l Analytical Limitations l Hazards l Installing the ACL TOP l Site Requirements l Actions Upon Delivery l Bringing into Operation l User Training Requirements l Warranty l Limitations and Disclaimers 10 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 2 – General Information Intended Use Intended Use The ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The system provides results for both direct hemostasis measurements and calculated parameters. NOTE: Installation and use of any additional software on the ACL TOP control module is not allowed as it could affect instrument performance. Addition of any software other than validated programs from the manufacturer would be considered a device modification as defined in the warranty section of this manual. See Warranty. See Also l Instrument Description l Warranty l Limitations and Disclaimers Symbols The following symbols appear on the labels of ACL TOP Family components. Symbol Description CE Mark CSA Mark Temperature Limitation Use by Manufacturer Batch Code Biological Risk Caution: Risk of Danger { IEC 61010.1 } Consult Accompanying Documents 11 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 2 – General Information Symbols Symbol Description Caution: Risk of Electric Shock Note: Important User Information Attention: Consult Instructions for Use Catalog Number Serial Number In Vitro Diagnostic Device Authorized Representative Contains sufficient for <n> tests Protective Conductor Terminal - Earth Earth Ground Off (supply) On (supply) Bar Code Reader Hazard Stop Action – Instrument stops all moving parts immediately See Also l Reference Section Overview l Important Symbols l Hazards 12 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 2 – General Information Measured Parameters Measured Parameters The ACL TOP instrument performs the following types of tests: l Coagulometric (Turbidimetric) Tests l Chromogenic (Absorbance) Tests l Immunological Tests See Also l General Information Overview l Measurement Units Operating Principles Coagulometric (Turbidimetric) Measurements The principle of coagulometric (turbidimetric) clot detection is used in the system to measure and record the amount of time required for a plasma specimen to clot. This technique assesses coagulation endpoint by measuring change in optical density. Clot detection is based on the principle that light passing through a medium in which fibrinogen is converted to fibrin is absorbed by the fibrin strands. Light (671 nm) is transmitted through a sample onto a photodetector, which is positioned 180° to the source. Light absorption increases as fibrin clot formation progresses. Consequently, light transmittance through the sample continuously decreases and is measured by the photodetector. The corresponding electrical signal output from the photodetector changes according to the detected light. The signal output is processed via software through a series of algorithms to determine the clot point. Chromogenic (Absorbance) Measurements Chromogenic tests can be either direct or indirect. l l Direct test – Test where the analyte of interest (e.g. protein C, plasminogen) acts directly on a specified synthetic substrate. Indirect test – Test where the analyte of interest (antithrombin, plasmin inhibitor) reacts with a fixed quantity of enzyme to form inactive complexes. Under optimized test conditions, residual enzyme activity is then measured using a specific synthetic substrate. In most cases, the reaction is monitored at 405 nm by the continuous release of paranitroaniline (pNA) from the synthetic substrate. The chromogenic channels use the colorimetric principle of measuring absorbance in the cuvette. An optical sensor reads light (405 nm) that passes through the cuvette. The light is absorbed by the fluid in the cuvette in direct proportion to the concentration of pNA. The amount of light reaching the photodetector is converted into an electrical signal that is proportional to the enzyme activity. 13 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 2 – General Information Operating Principles Immunological Measurements The principle of immunological measurement is used on the system to directly measure and record the amount of an analyte. This technique assesses the physical concentration of the analyte (and not its activity) by measuring change in optical density. Although similar to the turbidimetric method, the immunological method relies on the formation of antigenantibody complexes to affect light transmission. Immunological testing of the ACL TOP uses the 405 nm or the 671 nm channels depending on the test and the reagent formulation. Both the 405 nm and the 671 nm channels use the principle of measuring absorbance in the cuvette. An optical sensor reads the light (at 405 nm or 671 nm) that passes through the cuvette. The light is absorbed by the fluid in the cuvette in direct proportion to the concentration of antigen-antibody complexes. The amount of light reaching the photodetector is converted into an electrical signal that is proportional or inversely proportional to the analyte concentration. See Also l Instrument Description 14 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 2 – General Information Instrument Description Instrument Description Modules The ACL TOP instrument is composed of two modules: C ontrol Module (C M) The CM provides a user interface and operation control. It consists of a personal computer running Windows™ software, keyboard, touch screen display monitor, mouse, and communications interfaces to the AM and external devices/systems. The CM provides the major functionality associated with the user interface (UI) including data management, data reduction, LIS (Laboratory Information System) communications, sample identification, test materials management, fluid management, reporting, test tracking and QC management, and monitoring. A nalytical Module (A M) The AM consists primarily of sample and reagent handling hardware. It processes reagents and auxiliary materials. It can perform coagulometric (turbidimetric), chromogenic (absorbance), and immunological measurements. ACL TOP 300 Model The ACL TOP 300 is a low to medium volume (40 sample capacity) bench-top, fully automatic, randomaccess analyzer that is intended for analysis using both open and closed (capped) sample tubes and having cap piercing capability. 15 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 2 – General Information Instrument Description ACL TOP 500 CTS Model The ACL TOP 500 CTS is a mid to large volume (80 sample capacity) bench-top, fully automatic, randomaccess analyzer that is intended for analysis using both open and closed (capped) sample tubes and having cap piercing capability. 16 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 2 – General Information Instrument Description ACL TOP 700/ TOP 700 CTS Models The ACL TOP 700 (includes ACL TOP Base) instrument is a large volume analyzer (120 sample capacity) intended for open sample tube analysis. The ACL TOP 700 CTS (includes ACL TOP CTS) instrument is the same as the ACL TOP 700 (includes ACL TOP Base) but is intended for analysis using both open and closed (capped) sample tubes. Closed tube analysis is enabled using a cap-piercing capability. The major parts of the TOP 700 (includes TOP Base) are: l Control Module (CM) – User interface and operation control l Analytical Module (AM) – Primarily sample and reagent handling hardware including o AM Computer o Cuvette Handling o Sample Area o Diluent Area o Reagent Area o Bulk Fluids o Waste Handling o Sample Handling o Reagent Handling o Reaction and Detection o Interconnect and Power Supply o Access-restricting Cover with Safety Interlocks o Instrument-supporting Structure-chassis o Safety Interlock for Cuvette Waste Drawer 17 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 2 – General Information Instrument Description CAUTION: Care must be taken to avoid spilling any liquids and possibly causing electrical shorts or other malfunctions related to spills. ACL TOP 700 LAS Model The system is similar to the instruments described above, having the Control Module (CM) and the Analytical Module (AM), and also including communications interfaces on the CM with the external devices/systems of the laboratory automation system. The ACL TOP 700 LAS Laboratory Automation System (LAS) is a fully automated random access analyzer designed specifically for in-vitro diagnostic clinical use in the track-automated hemostasis laboratory. Intended for coagulation and fibrinolysis testing and in the assessment of thrombosis and hemostasis, the instrument provides results for both direct hemostasis measurements and calculated results. This instrument interfaces with LAS track in accordance with the CLSI guideline for point-of reference sampling. Primary sample tubes can be introduced to the analyzer via the laboratory automation track or by loading pre-spun open tubes or sample cups directly onto the instrument. The computer, monitor, keyboard and mouse are located on the right side of the instrument. NOTE: Capped, unspun samples must be spun and uncapped by the LAS system before moving them to the analyzer. The ACL TOP 700 LAS instrument does not centrifuge or uncap sample tubes. It cannot accept capped tubes. NOTE: Placing items on the cover could cause damage to the cover or LAS arm and probe. Do not place any items on the LAS arm cover. 18 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 2 – General Information Instrument Description Instrument Safety Covers The covers enhance operator safety and reduce the effect of the external environment on the instrument when operating at environmental extremes and minimize the evaporation from samples and reagents. They help to maintain temperature control and reduce the effect of stray light on sample data acquisition. The instrument will not operate with any of the access covers open. The LAS area, sample and reagent access covers are designed to provide increased operating safety. The LAS arm cover is on the far left, the sample area cover is the large cover in the middle, and the reagent area cover is the large cover on the right. These must remain closed during system operation. NOTE: Unlocking the instrument cover may take a few seconds. Power Connector The AM1 power switch is located on the right side of the analytical module, adjacent to the power cord connection. This switch is for the main power supply and controls all power to the AM. WARNING: This switch must be turned off and the power cord disconnected before performing service on the instrument. Leave sufficient room to quickly disconnect the power cord, if necessary. NOTE: l The power supply carries UL/CSA approvals. l Maximum power requirements for the AM do not exceed 1100 watts. l l The power supplies in both the AM and CM incorporate a power factor correction to prevent harmonic distortions in the power lines and to satisfy requirements for EMC/EMI Standard EN61326.1. The AM incorporates a standard AC input IEC 1010.1-92 connector. Leave sufficient room to quickly disconnect the power cord, if necessary. 1The part of the instrument where sample processing and testing are performed. Also called the Analyzer or the Analytical Module. 19 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 2 – General Information Instrument Description Emergency Stop Button The emergency stop button is located on the front of the AM. Use this button to immediately stop the instrument, when necessary. Tests that were in progress will need to be restarted. TOP 300 CTS Emergency Stop Button TOP 500 CTS Emergency Stop Button TOP 700 Emergency Stop Button 20 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 2 – General Information Instrument Description Keypad The physical keypad on the front of each instrument varies by model. It contains some or all of the following buttons and indicators: Status LEDs These instrument LEDs in some cases correspond to LEDs on the status bar. l System – Refers to the analyzer status. l Loader – Status of the cuvette loader. l Rinse – Status of the rinse solution. l Clean – Status of the clean solution. Sample Rack Buttons and LEDs Press a button to move the bar code reader to the corresponding sample rack position. The LEDs indicate the status of the sample rack positions. l Green – Rack position contains a sample rack, and is available to unload. It is NOT an indication that all samples in that rack have finished testing. l Amber – Rack position is unavailable, in use and locked. l No color – Rack position is available to load sample racks, or rack has been rejected. Diluent Rack Buttons and LEDs Press a button to move the bar code reader to the corresponding diluent rack position. The LEDs indicate the status of the diluent rack positions. l Green – Rack position contains a diluent rack, and is available to unload. l Amber – Rack position is unavailable, in use and locked. l No color – Rack position is available to load diluent racks, or the rack has been rejected. Reagent Rack Buttons and LEDs Press a button to move the bar code reader to the corresponding reagent rack position. The LEDs indicate the status of the reagent rack positions. l Green – Rack position contains a reagent rack, and is available to unload. l Amber – Rack position is unavailable, in use and locked. l No color – Rack position is available to load reagent racks, or the rack has been rejected. 21 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 2 – General Information Instrument Description Bar Code Reader Home Button The Bar Code Reader Home button appears on TOP 300 CTS and TOP 500 CTS models. It bypasses the bar code reader 30 second timeout before it returns to the home position. The bar code reader must be in the home position to perform reagent liquid level detecting, or to begin sampling. Pressing this button decreases the time for sample processing. The Home icon in the toolbar performs this same function. TOP 300 CTS Keypad TOP 500 CTS Keypad TOP 700 CTS Keypad Laboratory Automation System (LAS) The LAS consists of two modules, the LAS manager and an LAS track. The LAS Manager software determines which samples require testing by the ACL TOP 700 LAS instrument and routes those samples to it on the LAS track. The LAS track transports sample tubes to the LAS instrument for processing and consists of the main track and the sample tube queue. The instrument has an arm with an unheated probe and syringe, an aspiration area, a holding area, an enhanced clean area, and a cover with an access door for the placement and removal of the enhanced clean material, all on the exterior of the left side of the instrument. This module is positioned adjacent to the LAS track. Communication between the ACL TOP 700 LAS instrument and the LAS track uses an embedded interface module (IM). LAS configuration and communication is achieved by means of the LAS Configuration screen. CAUTION: To avoid contamination, Instrumentation Laboratory strongly recommends against using the ACL TOP instrument to perform analysis on Hepabsorb samples. 22 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 2 – General Information Instrument Description LAS Arm and Probe When the LAS Manager detects that a sample requires testing, the sample is moved via the LAS track to the sample tube queue. The LAS arm dispenses the sample material into cuvette cells in the holding area (cuvette slots 1-3 of the 14 slot holding area). The cuvettes are then moved to slots 6 - 12 in the holding area. The sample is processed the same way as in other ACL TOP instruments. The LAS Manager ensures the sample tube queue does not become backlogged. 23 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 2 – General Information Instrument Description LAS Probe Aspirating from Sample on the LAS Track NOTE: LAS sample priority is lower than stat1 samples but higher than any front-loaded, normal priority samples. Stat samples on-board the LAS are treated as LAS priority. See Laboratory Automation System (LAS) for additional information. NOTE: Capped, unspun samples must be spun and uncapped by the LAS system before moving them to the analyzer. The ACL TOP 700 LAS instrument does not centrifuge or uncap sample tubes. It cannot accept capped tubes. CAUTION: The computer, monitor, keyboard and mouse are located the right side of the instrument. Use extreme caution when handling any liquid, liquid waste, cuvette waste, or bulk rinse or clean fluid on the ACL TOP 700 LAS instrument. Care must be taken to avoid spilling any liquids and possibly causing electrical shorts or other malfunctions related to spills or causing a biohazardous condition when using the keyboard, mouse, monitor or computer. 1In medical terminology, immediate; with no delay. Stat samples have highest priority. 24 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 2 – General Information Instrument Description Cuvette Loading Area The cuvette loading area is on the left side of the AM. A conveyor belt moves the cuvette strips to the cuvette shuttle, which places them in position to be used by the AM for sample handling. Cuvette Loader The cuvette loader can be filled with up to 20 clips of 10 cuvette strips each, for a maximum of 200 cuvette strips (800 cuvette cells). l l l l A conveyor belt transports the cuvette clips to the front of the loading area. Electrical sensors detect when additional cuvette clips need to be loaded onto the system, and inform the operator by means of an indicator on the front right of the instrument. An amber LED for Cuvette Loader indicates the loader contains 3 or fewer clips. A red LED indicates the loader is empty. The indexer1 pushes the cuvette clip to the right to position it so one strip can be picked up by the cuvette shuttle. As the cuvette strips are used, new cuvette clips are brought forward and positioned for pickup. You can add more to the loading area while the analyzer is running. 1The part of the cuvette loader which prepares cuvettes for pick-up by the shuttle mechanism. 25 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 2 – General Information Instrument Description NOTE: Cuvettes are intended for single use only. IL does not support the use of previously used cuvettes on ACL TOP instruments. See Limitations and Disclaimers. Cuvette Shuttle The cuvette shuttle picks up a single cuvette strip from the cuvette clip and transports it from one position or slot to another. Cuvette Strip being picked up by Cuvette Shuttle 26 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 2 – General Information Instrument Description Bar Code Reader The bar code reader moves to each track position to allow for insertion of the sample, diluent or reagent racks. Bar coded information on sample tubes or diluent or reagent bottles is scanned into the instrument as the racks are inserted. Move the bar code reader to the desired track using the track buttons on the front of the AM or by clicking the virtual track buttons displayed on the reagent area screen on the CM. With the bar code reader positioned in front of the track position, insert the rack. A track guides the insertion of the rack into its correct position. After the bar code reader has been at a track position for 30 seconds, it moves to its home position. This also occurs when you select the Run icon in the toolbar. You can use the Home button on the touch screen when the Sample, Reagent, or Diluent screen is displayed to immediately move the bar code reader to its home position. NOTE: l l l When loading sample, diluent, or reagent racks, pull the rack out all the way before loading. Pulling a rack out partially while loading or changing bottles, tubes, or sample cups may result in misidentification of rack contents. Care should be taken when the bar code reader is moving so that your fingers do not get pinched. When you use the Home button, the Bar Code Reader warning light (located on the BCR cover) blinks three times to warn you to clear the path. A rack incompletely placed in a track causes the homing function to fail, and displays the BCR movement failure error. Bar Code Reader This example is the TOP 700 (includes ACL TOP Base), 700 CTS (includes ACL TOP CTS) and 700 LAS models. 27 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 2 – General Information Instrument Description Sample Area To the right of the cuvette loader is the sample area where manually placed patient samples are placed on the AM. The sample tubes or cups are placed on racks that are inserted through a bar code reader. The sample area is at ambient temperature and can hold 4-12 racks, depending on the model, each capable of holding 10 samples for a total of 40-120 samples. When the rack is in use (during aspiration of material) it is locked and an amber LED displays for the track position. When the rack is no longer in use the LED changes to green and the rack is released. The sample rack holds both capped and uncapped sample tubes and open sample cups. Sample racks identified as CTS are designed to hold capped sample tubes, while those without the CTS designation are for open sample tubes and cups. NOTE: When using sample cups they must be IL 2.0 mL sample cups. The use of non-IL sample cups may lead to improper sampling and incorrect results. See Parts and Consumables List. The wash station for the sample probe is located behind the sample rack area. See Also l Sample Area l Reagent Area l Parts and Consumables List Sample Area with Both LAS Arm (left) and Sample Arm (right) 28 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 2 – General Information Instrument Description Sample Rack – non CTS Sample Rack – CTS NOTE: For cleaning racks and adapters, IL recommends that you use any of the following: l 10% bleach l 0.1 N HCl l Mild soap After decontamination with bleach you should always rinse with tap water to remove excess bleach residue on the inner walls of the container. DO NOT SOAK RACKS IN ANY SOLUTION. Soaking may corrode racks or remove labels. Sample Arm The sample arm consists of a probe and syringe used for aspirating and dispensing samples. 29 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 2 – General Information Instrument Description Diluent Area Depending on the ACL TOP model, the diluent area can accommodate 1-3 diluent racks. Each diluent rack can hold up to eight vials of QC materials, calibration and NPP1 plasmas, sample diluents and clean materials. For more information, see Diluent Area. 1Normal Pool Plasma. A type of sample used as a standard of comparison when calculating the International Normalized Ratio (INR) and when calculating test results that use the normalized ratio. 30 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 2 – General Information Instrument Description Reagent Area The Reagent Area is on the right side of the AM1. There are 3-6 tracks each with six reagent positions, that hold 18-36 reagents. As with sample racks, reagent racks are inserted into reagent tracks by means of the bar code reader. This area is cooled to 15° C ± 3° C. Positions 1 and 2 on each rack allow for the use of magnetic stir bars. See Test Feasibility for proper placement of all reagents. Reagent Area Showing Intermediate (left) and Start (right) Reagent Arms Reagent Arms There are up to two reagent arms, depending on the model. The left reagent arm when present, is used for aspirating/dispensing materials placed in D3, and intermediate and start reagents in reagent racks placed in R1-R4. (An intermediate reagent is one that, when mixed with sample, activates certain constituents of the sample but is not enough to bring the reaction to completion.) On models with multiple reagent arms, the right reagent arm is used for aspirating/dispensing start reagents from tracks R3-R6 of the Reagent Area. (A start reagent is one that, when mixed with the sample or sample mixture, begins the reaction of interest. It must be the final reagent added to the cuvette cell.) On TOP 700 (includes ACL TOP Base), 700 CTS (includes ACL TOP CTS) and 700 LAS models, both reagent arms can access positions in tracks R3-R4 in the Reagent Area. On TOP 300/500 CTS models, the reagent arm may access all reagent racks. See Test Feasibility for proper placement of all reagents. CAUTION: When manually moving the probe arm, lift the arm to its highest position. To avoid damaging the probe arm during the move, grasp it from the back, as near to the back wall as possible. 1The part of the instrument where sample processing and testing are performed. Also called the Analyzer or the Analytical Module. 31 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 2 – General Information Instrument Description Grasping a probe arm from the front pushes it out of alignment. A misaligned probe arm causes inaccurate coordinates adjustment and other errors. The wash station for the left reagent probe is located in the back left side of the reagent area; the wash station for the right reagent arm is located in the back right side of the reagent area. See Also l Reagent Area Reagent Rack NOTE: For cleaning racks and adapters, IL recommends that you use any of the following: l 10% bleach l 0.1 N HCl l Mild soap After decontamination with bleach you should always rinse with tap water to remove excess bleach residue on the inner walls of the container. DO NOT SOAK RACKS IN ANY SOLUTION. Soaking may corrode racks or remove labels. 32 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 2 – General Information Instrument Description Probe The probe is the part of the instrument that makes contact with liquid material. Each probe has a sensor that recognizes the presence of liquids and stops at the optimized liquid level. A Teflon tube connects the sample or reagent probe to a syringe that is capable of delivering 4 to 250 µL. The LAS probe has a maximum volume of 1000 µL. The reagent probes are heated and heat liquids being pipetted to 37° C ± 1° C. If a probe appears to be damaged, bent, shows visible corrosion, or if you are experiencing frequent liquid level detection failures, the probe may need to be replaced. Contact Service. Whenever a probe is replaced, the arm coordinates must be adjusted. Probe (in foreground) and Syringe Probe Syringes There is a syringe pump for each probe to enable the separate movement of rinse, clean, sample or reagent through the probe. 33 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 2 – General Information Instrument Description Incubators Behind the rack areas are two incubators that are used for the sample and/or reagent incubation phase(s) of the test. The sample incubator can hold up to 8 cuvette strips (4 for TOP 300 CTS). The reagent incubator can hold up to 8 cuvette strips (4 for TOP 300 CTS). The incubator temperature is maintained at 37.0° C ± 0.5° C. In the sample incubator, sample material is pipetted into the cuvette cells. The cuvette strips are then moved into the reagent incubator where intermediate reagents are dispensed. Right Sample Probe and Incubator Slots Optical Reading Unit There are 2-4 optical reading units (ORUs), each with four reading stations, located to the right of the reagent incubator where start reagents are dispensed into the cuvette cells to start a reaction. Readings are taken of the reaction using wavelengths of 671 nm for coagulometric, 405 nm for chromogenic, and either 671 or 405 nm for immunologic measurements. Instrument Model # ORUs # Reading Channels TOP 300 CTS 2 8 TOP 500 CTS 3 12 TOP 700 (includes TOP Base) 4 16 TOP 700 CTS (includes TOP CTS) 4 16 TOP 700 LAS 4 16 34 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 2 – General Information Instrument Description System Fluids – Rinse and Clean The rinse fluid system and the clean fluid system remove contaminants from the system to reduce the risk of carryover1 affecting test results. These fluids clean not only the internal surfaces of the probe and the related tubing, but also the external surface of each probe tip, removing contaminants that may have contacted the probe during fluid aspiration. Rinse Fluid System The rinse fluid is used to rinse the probes after the aspiration and dispensation of a test fluid. Typically, the probe is rinsed after each syringe pump cycle. However, in instances where a common reagent is being dispensed into consecutive cells, the rinse pump may not be operated until after the final dispense. The amount of rinse fluid used is not test-dependent. The rinse fluid system is composed of the system rinse fluid bottle, the rinse fluid tubing, two rinse pumps, the rinse pump tubing, the rinse/clean stations in the sample and reagent areas, and the waste fluid. Each probe is connected to a dedicated rinse pump and has a dedicated rinse/clean station at which it is positioned during the operation of the rinse cycle. The probe is positioned above the rinse cup and rinse is dispensed through the probe into the rinse cup. Rinse dispensed from the probe enters the rinse cup, displacing any rinse that is in the rinse cup. Any excess fluid that overflows from the rinse cup drains into the accumulator through an opening in the bottom of the rinse/clean station. The rinse fluid is placed on the ACL TOP instrument in a 4L rinse bottle. A rinse fluid sensor located on the front of the AM2 monitors the level of rinse fluid. It displays an amber warning light (except for TOP 300 CTS) when the level drops below 1000 mL, and displays a red error light when the level drops below 600 mL. If the rinse fluid sensor changes to red during the BUSY state, the instrument performs a controlled stop to finish running the active tests. The remaining tests do not run until the operator replaces the rinse, and presses Start again. If the rinse fluid drops below 100 mL the system performs an emergency stop. CAUTION: Do not replace the rinse fluid when the instrument is Busy or in a Controlled Stop. l l l When replacing the rinse fluid, ensure the computer, monitor and keyboard are moved far enough out of the way to prevent any rinse spilling on them. The 4 liter rinse bottle is not designed to be refilled during instrument operation. We recommend periodic changing of the rinse bottles to prevent accumulation of particulates and other contaminants. Do not top off. Refilling (topping off) the 4 liter rinse bottle during operation of the instrument may cause the introduction of air bubbles into the tubing. This can happen if the bottle is almost empty or if the end of the tubing is raised above the liquid level. Bubbles created in the rinse fluid can enter the rinse tubing and cause improper rinsing of the probes. Extra care should be taken to ensure any manipulation of the contents of the rinse bottle doesn't create bubbles. 1Residual sample material left on the sample probe, after the probe has been rinsed, that carries over to another sample when the probe enters it. 2The part of the instrument where sample processing and testing are performed. Also called the Analyzer or the Analytical Module. 35 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 2 – General Information Instrument Description Clean Fluid system The clean fluid system is composed of the system clean fluid bottle, the clean fluid tubing, a pump, a manifold, three valves, clean cup tubing, the rinse/clean stations and fluid waste. A pump is used to transport clean fluid from the clean fluid bottle to the clean stations. Each rinse/clean station contains a clean cup that serves as a reservoir for the clean fluid. The clean cups are filled from the bottom. The probe enters the clean fluid and aspirates fluid from the clean cup, the pump is operated and the valve dedicated to the clean cup is opened. Clean fluid is pumped into the clean cup. The volume of clean fluid pumped into the clean cup is sufficient to not only fill the clean cup, but to also flush any contaminants from the clean cup. Any excess fluid that overflows from the clean cup drains into the accumulator through an opening in the bottom of the rinse/clean station. A cleaning cycle is used to clean the probe at specific times during the operation of the instrument. It cleans the probe more completely than the rinse system. The probe aspirates clean fluid from the clean cup in the rinse/clean station or from a bottle of clean material placed on a rack and dispenses the clean fluid into the rinse/clean station. A clean fluid sensor located on the front of the AM (except for TOP 300 CTS) monitors the level of clean fluid and displays an amber warning light when the level drops to 75 mL. It displays a red error light when the level drops to 25 mL. If the clean fluid sensor changes to red while the instrument is Busy, the instrument performs a controlled stop after running the active tests. Wait until the system comes to a complete stop, replace the bottle with a new one, then restart the testing. For the LAS probe only: If the instrument detects an insufficient volume of clean material during testing, an emergency stop is performed to prevent possible contamination. CAUTION: Do not replace the clean fluid during busy or controlled stop. When replacing the clean fluid ensure the computer, monitor and keyboard are moved far enough out of the way to prevent any clean fluid spilling on them. See Rinse Fluid and Clean Fluid. 36 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 2 – General Information Instrument Description Rinse (left) and Clean Bottles with Fluid Waste Container Underneath 37 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 2 – General Information Instrument Description Fluid Waste A fluid waste pump (except for TOP 300 CTS) removes fluid from the internal waste reservoirs located under the Clean and Rinse stations in the Sample and Reagent Areas. Sensors in each reservoir detect when the accumulator is full, and turn on the pump for a configured span of time to empty the waste into the waste container. NOTE: l l l The TOP 300 CTS uses gravity to empty waste fluid from the reservoirs. The TOP 300 CTS liquid waste line cannot rest in a horizontal position across the table or bench that holds the instrument. It must maintain a negative slope across the entire length of the tubing to minimize the backup of waste fluids. There must be no crimping in the tubing. For all instruments except the TOP 300, a sensor indicates when fluids fail to empty. If fluids back up, the system performs an emergency stop. Waste Container A 10 liter waste container holds the fluid waste pumped from the accumulators. A waste fluid sensor (except for TOP 300 CTS) on the front of the AM1 warns the operator when the waste container is nearly full by turning amber (warning), and turning red (error) when the waste container is full. When the sensor turns red, the instrument performs a controlled stop. If the waste container is not replaced with an empty one, the instrument eventually performs an emergency stop. You must empty or change the waste container before running more tests. See Empty Waste Fluid. 1The part of the instrument where sample processing and testing are performed. Also called the Analyzer or the Analytical Module. 38 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 2 – General Information Instrument Description CAUTION Biohazard: l l System fluid waste is biohazardous. Use precautions when changing or emptying the fluid waste container. Always follow local regulations when disposing of liquid waste. The TOP 300 CTS model does not have a waste fluid sensor. You must empty the waste container frequently. See Fluid Waste. See Also l Fluid Waste l Controlled Stop l Emergency Stop Cuvette Waste Container The cuvette waste container is located on the lower right side of the instrument behind the cuvette waste door (the TOP 300 CTS does not have a door). The cuvette waste module includes an accumulator that allows the cuvette waste drawer to empty without shutting down the instrument (the TOP 300 CTS does not have a cuvette waste accumulator). Six used cuvette strips are moved onto the accumulator as readings are finished, then deposited into the cuvette waste drawer. The cuvette waste liner has a capacity of 100-250 (+/- 10) used cuvettes, depending on the model. Cuvette waste liners are used in the cuvette waste drawer to contain used cuvette strips, keep the waste drawer clean and free of contaminants, and facilitate disposal of the waste cuvettes. CAUTION Biohazard: l l Cuvette waste is biohazardous. Use precautions when emptying the cuvette waste drawer. Refer to local and state regulations for disposal of potentially hazardous materials. The TOP 300 CTS model does not have a cuvette waste sensor. You must empty the cuvette waste container frequently. See Empty Cuvette Waste. 39 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 2 – General Information Instrument Description Cuvette Waste Door Open Cuvette Waste Container – TOP 300 CTS When the waste drawer is removed, the analyzer performs a controlled stop, and completes only the tests that are running, providing the cuvette accumulator is not full. If the drawer is re-inserted before the running tests are finished, the AM1 cancels the controlled stop and finishes running the tests on all the samples. If the active tests are completed before the drawer is reinserted, the AM enters the READY state. You must restart the remaining tests. If the cuvette waste drawer is not reinserted, the instrument does not restart. The following two status indicators appear on the front of the AM for the cuvette waste: 1The part of the instrument where sample processing and testing are performed. Also called the Analyzer or the Analytical Module. 40 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 2 – General Information Instrument Description l l Door open indicator – Turns green when the waste door is open. Cuvette waste indicator – Turns amber (warning) when the drawer is nearly full. Turns red (error) when the waste drawer is full or removed. Cuvette Waste Drawer See Also l Operating Principles l Intended Use l LED Status Color Codes 41 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 2 – General Information Monitor and Volume Control Monitor and Volume Control NOTE: Instrumentation Laboratory recommends the monitor volume be turned up to maximum volume. Consult the monitor manufacturer's user guide. Calibrating the All-in-One CM Monitor Touch Screen To calibrate the All-in-One monitor touch screen supplied with the ACL TOP 300 model. 1. Select the Microsoft® Windows™ Start button. 2. Select Programs > PenMount Universal Driver > PenMount Control Panel. 3. Select the PenMount icon, and select Configure. 4. Select Standard Calibration. 5. Follow the screen prompts to complete touch screen calibration. 42 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 2 – General Information Monitor and Volume Control All In One Monitor Diagrams The diagrams in this section apply to the All In One Monitor and CM1 supplied with the ACL TOP 300 model. Function/Control NOTE: Auto Adjust aligns the screen when it becomes misaligned. 1A Microsoft Windows™ PC running the ACL TOP software developed by IL. The CM provides the User Interface and data management functionality. The CM connects to the Analytical Module and provides the high level controls. 43 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 2 – General Information Monitor and Volume Control Connectors 44 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 2 – General Information Monitor and Volume Control Configuring Volume Control on the ELO Touchsystems Entuitive Monitor The ELO Touchsystems Entuitive monitor is configured with speakers. The volume of these speakers can be changed to accommodate laboratories with varying ambient noise. The Touchmonitor factory sound is configured to be very low. Use the following procedure to increase the sound of the speakers: 1. On the right side of the monitor are five push buttons. They are, from top to bottom, MENU, UP arrow, DOWN arrow, SELECT and POWER. 2. Select the menu button to display a menu window on the Touchmonitor. Using the up or down arrow buttons, navigate to the volume setting (symbol). Press the select button to choose the volume setting. 3. Using the up or down arrow buttons, configure the volume of the speakers. Press the select button to store the volume setting. 4. Select the menu button to exit the menu functionality. See Also l General Information Overview l System Specifications 45 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 2 – General Information Manufacturer Manufacturer The ACL TOP Family of instruments is manufactured by: Headquarters Instrumentation Laboratory 180 Hartwell Road Bedford, MA 01730-2443 USA Phone: 781-861-0710 Fax: 781-861-1908 www.ilus.com See Also l Worldwide Locations 46 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 2 – General Information Certification Certification CE Certification The CE label on the back of the instrument indicates that the ACL TOP instrument conforms to the European Directives as stated in IL's Declaration of Conformity. EU Directive: l IVD - 98/79/EC (27/10/1998) – Annex I and III Applicable standards: l CEI/IEC 61326-1: 1998 (Class A) l CEI/IEC 61010-2-04 CSA Certification The CSA label on the back of the instrument indicates that the Canadian Standards Association (CSA) has certified the ACL TOP instrument to the applicable standards. Applicable standards: l CAN/CSA C22.2 No. 1010.1-92 l UL Std. No. 61010-1, 2nd Edition 47 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 2 – General Information Certification Other Certification The ACL TOP instrument meets CEI/IEC 61010-1, 2001 Mod, Second Edition, for the following: l External surface temperature l Flame resistance l Fluid resistance l Internal air flow and temperature l Audible noise l Product labeling The ACL TOP instrument shipping crate complies with the International Safe Transit Packaging Testing Procedure 1B (June, 1999), ASTM 999. European Union Directive 2002/96/EC on Waste Electrical and Electrical Equipment (WEEE) Instrumentation Laboratory is committed to meeting or exceeding the conditions of the WEEE Directive and being a good environmental partner. In compliance with the WEEE Directive, beginning with product shipped after August 13, 2005, all instruments are labeled with the symbol shown above. Disposing of this product correctly helps prevent potential negative consequences for the environment and for human health. Recycling conserves natural resources. Penalties may be applicable for incorrect disposal of this waste, in accordance with national (European) legislation. Please call your local Instrumentation Laboratory distributor for information regarding the disposal of any end-of-life instruments. 48 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 2 – General Information System Specifications System Specifications l ACL TOP 300 CTS Specifications l ACL TOP 500 CTS Specifications l ACL TOP 700 and 700 CTS Specifications l ACL TOP 700 LAS Specifications See Also l Test Performance l Analytical Limitations l Hazards 49 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 2 – General Information ACL TOP 300 CTS Specifications ACL TOP 300 CTS Specifications The TOP 300 CTS is a bench top, fully automated, random access coagulation instrument characterized by its ability to analyze a medium volume of samples with excellent throughput and a extended walkaway time. The TOP 300 CTS model meets the needs of medium size routine and specialty laboratories. Most important for users are features that provide consistency of test results across ACL TOP family members, minimize the need for user interaction, and increase the efficiency and safety of laboratory procedures. TOP 300 CTS Specifications Test Menu Clotting tests (671 YES (standard) nm) Chromogenic tests YES (standard) (405 nm) Immunological tests (671 or 405 nm) YES (standard) System ACL TOP 300 Configurations CTS Compact design with coagulometric, chromogenic and immunologic tests; and open tube sampling and closed tube sampling with cap piercing. Throughput PT tests/hour Up to 110 APTT tests/hour Up to 110 PT & APTT tests/hour Up to 110 Random access YES Continuous sample loading YES Continuous reagent loading YES Continuous cuvettes loading YES Sample transport system Racks Samples on-board 40 (10 samples/rack) Sample containers Primary tubes and cups Sample bar code reader YES (integrated) Sample pipetting arms/probes Configurable CTS Sample liquid level detecting YES (capacitance probe) Sample area protection cover YES (with lock and sensor) Reagent transport system Racks Reagents on-board (refrigerated) 26 (18 positions in reagent racks + 8 positions in a diluent rack) Reagent containers Original bottles Reagent bar code reader YES (integrated) Bar coded reagents YES (bar code includes lot, exp. date and bottle size) Hand-held 2D bar code reader YES (optional) Reagent pipetting arms/probes 1 reagent probe is integrated on common arm Reagent liquid level detecting YES (capacitance probes) 50 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 2 – General Information ACL TOP 300 CTS Specifications TOP 300 CTS Specifications Reagent area protection cover YES (with lock and sensor) Cuvettes on-board 800 Cuvettes type Plastic disposable (4 cuvettes/strip) Applications on-board 500 User programmable applications 250 Tests per sample 30 Walkaway capability 400 tests (100 cuvette strip capacity of cuvette waste container) Sample pre-dilution YES Calibration curve pre dilution YES Factor parallelism YES STAT capability YES (at any time in any position) STAT time Time to PT result when the system is idle: ~ 3 minutes Rerun testing YES (configurable) Reflex testing YES (configurable) Reaction curves display YES Quality Control program YES (with configurable multi-rules) Results auto validation YES Patient samples results database 2,000 - 20,000 samples (configurable) QC results database 2,000 - 20,000 samples (configurable) Security system YES (configurable) Events log system YES Bi-directional interface YES Host Query function YES Integrated PC and monitor (Control Module) Intel processor. 17 inch color LCD touch screen (external). Portwell Model #286229-04. Ratings: 100-240 VAC, 2.5 A, 50/60 Hz. Operating System Windows XP Keyboard YES (external) Mouse YES (external) User Interface Windows based Dimensions (analyzer) Weight Width 81 cm (32 inches) Depth 84 cm (33 inches) Height 73 cm (29 inches) 91 kg (200 pounds) 51 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 2 – General Information ACL TOP 500 CTS Specifications ACL TOP 500 CTS Specifications The TOP 500 CTS is a bench top, fully automated, random access coagulation instrument characterized by its ability to analyze a medium-to-large volume of samples with high throughput and a long walkaway time. The ACL TOP 500 CTS meets the needs of medium to large size routine and specialty laboratories. Most important for users are features that provide consistency of test results across ACL TOP family members, minimize the need for user interaction, and increase the efficiency and safety of laboratory procedures. ACL TOP 500 CTS Specifications Test Menu Clotting tests (671 YES (standard) nm) Chromogenic tests YES (standard) (405 nm) Immunological tests (671 or 405 nm) YES (standard) System ACL TOP 500 Configurations CTS Compact design with coagulometric, chromogenic and immunologic tests; and open tube sampling and closed tube sampling with cap piercing. Throughput PT tests/hour Up to 240 APTT tests/hour Up to 180 PT & APTT tests/hour Up to 180 Random access YES Continuous sample loading YES Continuous reagent loading YES Continuous cuvettes loading YES Sample transport system Racks Samples on-board 80 (10 samples/rack) Sample containers Primary tubes and cups Sample bar code reader YES (integrated) Sample pipetting arms/probes Configurable CTS Sample liquid level detecting YES (capacitance probe) Sample area protection cover YES (with lock and sensor) Reagent transport system Racks Reagents on-board 40 (24 positions in reagent racks + 16 positions in diluent racks) Reagents on-board storage temperature 40 refrigerated (24 refrigerated positions in 4 reagent racks, 16 refrigerated positions in 2 diluent racks) Reagent containers Original bottles Reagent bar code reader YES (integrated) Bar coded reagents YES (bar code includes lot, exp. date and bottle size) Hand-held 2D bar code reader YES 52 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 2 – General Information ACL TOP 500 CTS Specifications ACL TOP 500 CTS Specifications Reagent pipetting arms/probes 1 Reagent liquid level detecting YES (capacitance probes) Reagent area protection cover YES (with lock and sensor) Cuvettes on-board 800 Cuvettes type Plastic disposable (4 cuvettes/strip) Applications on-board 500 User programmable applications 250 Tests per sample 30 Walkaway capability 2400 tests (max. 80 samples on-board X max. 30 tests per sample) Sample pre-dilution YES Calibration curve pre dilution YES Factor parallelism YES STAT capability YES (at any time in any position) STAT time Time to PT result when the system is idle: ~ 3 minutes Rerun testing YES (configurable) Reflex testing YES (configurable) Reaction curves display YES Quality Control program YES (with configurable multi-rules) Results auto validation YES Patient samples results database 2,000 - 20,000 samples (configurable) QC results database 2,000 - 20,000 samples (configurable) Security system YES (configurable) Events log system YES Bi-directional interface YES Host Query function YES PC (Control Module) External (Intel processor). Continental Resources Model #286229-06. Ratings: 100-120/200-240 VAC, 4/2 A, 50/60 Hz, Watts 230. Monitor 17 inch color LCD touch screen (external). Elo TouchSystems Model #ET1715L, Rating: 100-240 V, 1 A, 50-60 HZ Operating System Windows XP Keyboard YES (external) Mouse YES (external) User Interface Windows based Dimensions (analyzer) Weight Width 110 cm (43 inches) Depth 82 cm (32 inches) Height 73 cm (29 inches) 142 kg (312 pounds) 53 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 2 – General Information ACL TOP 700 and 700 CTS Specifications ACL TOP 700 and 700 CTS Specifications This topic describes specifications for the ACL TOP 700 (includes ACL TOP Base) and ACL TOP 700 CTS (includes ACL TOP CTS) instruments: These instruments are bench top, fully automated, random access coagulation instruments characterized by their ability to analyze a high volume of samples with high throughput and a long walkaway time. These instruments meet the needs of the large routine and specialty laboratories. Most important for users are features that provide consistency of test results across ACL TOP family members, minimize the need for user interaction, and increase the efficiency and safety of laboratory procedures. ACL TOP 700 and 700 CTS Specifications Test Menu Clotting tests (671 YES (standard) nm) Chromogenic tests YES (standard) (405 nm) Immunological tests (671 or 405 nm) System Configurations Base Throughput (base model) Throughput (CTS model) YES (standard) Coagulometric, chromogenic and immunologic tests; open tube sampling CTS Base configuration + Closed Tube Sampling (cap piercing) PT tests/hour Up to 360 APTT tests/hour Up to 320 PT&APTT tests/hour Up to 330 (165 samples of each test/hour) PT tests/hour Up to 270 APTT tests/hour Up to 270 PT & APTT tests/hour Up to 260 (130 samples of each test/hour) Random access YES Continuous sample loading YES Continuous reagent loading YES Continuous cuvettes loading YES Sample transport system Racks Samples on-board 120 (10 samples/rack) Sample containers Primary tubes and cups Sample bar code reader YES (integrated) Hand held 2D sample bar code reader YES Sample pipetting arms/probes 1 (standard) + 1 (optional cap-piercing) Sample liquid level detecting YES (capacitance probe) Sample area protection cover YES (with lock and sensor) 54 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 2 – General Information ACL TOP 700 and 700 CTS Specifications ACL TOP 700 and 700 CTS Specifications Reagent transport system Racks Reagents on-board 60 (36 positions in reagent racks + 24 positions in diluent racks) Reagents on-board storage temperature 44 refrigerated + 16 room temperature (36 refrigerated positions in 6 reagent racks, 8 refrigerated positions in 1 diluent rack, 16 room temperature positions in 2 diluent racks) Reagent containers Original bottles Reagent bar code reader YES (integrated) Bar coded reagents YES (bar code includes lot, exp. date and bottle size) Reagent pipetting arms/probes 2 Reagent liquid level detecting YES (capacitance probes) Reagent area protection cover YES (with lock and sensor) Cuvettes on-board 800 Cuvettes type Plastic disposable (4 cuvettes/strip) Applications on-board 500 User programmable applications 250 Tests per sample 30 Walkaway capability 120 samples Sample pre dilution YES Calibration curve pre dilution YES Factor parallelism YES STAT capability YES (at any time in any position) STAT time Time to PT result when the system is idle: ~ 3 minutes Rerun testing YES (configurable) Reflex testing YES (configurable) Analytical Reference YES Reaction curves display YES Quality Control program YES (with configurable multi-rules) Results auto validation YES Patient samples results database 2,000 - 20,000 samples (configurable) QC results database 2,000 - 20,000 samples (configurable) Security system YES (configurable) Events log system YES Bi-directional interface YES Host Query function YES PC (Control Module) External (Pentium IV). Continental Resources Model #28622906. Ratings: 100-120/200-240 VAC, 4/2 A, 50/60 Hz, Watts 230. Monitor 17 inch color LCD touch screen (external). Elo TouchSystems Model #ET1715L, Rating: 100-240 V, 1 A, 50-60 HZ 55 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 2 – General Information ACL TOP 700 and 700 CTS Specifications ACL TOP 700 and 700 CTS Specifications Operating System Windows XP Service Pack 2 Keyboard YES (external) Mouse YES (external) User Interface Windows based Dimensions (analyzer) Width 151 cm (59 inches) Depth 76 cm (30 inches) Height 73 cm (29 inches) Weight (Base TOP analyzer) 162 kg (356 pounds) Weight (CTS TOP analyzer) 166 kg (367 pounds) 56 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 2 – General Information ACL TOP 700 LAS Specifications ACL TOP 700 LAS Specifications The ACL TOP model is a fully automated random access analyzer designed specifically for in-vitro diagnostic clinical use in the track-automated hemostasis laboratory. Intended for coagulation and fibrinolysis testing and in the assessment of thrombosis and hemostasis, the LAS provides results for both direct hemostasis measurements and calculated results. The TOP 700 LAS model is designed to interface with laboratory automation track systems in accordance with the CLSI guideline for point-of-reference sampling. Primary sample tubes can be introduced to the analyzer via the laboratory automation track or by loading pre-spun open tubes or sample cups directly onto the instrument. The LAS instrument is mounted to a table. The TOP 700 LAS model meets the needs of large routine and specialty laboratories. Most important for users are features that provide consistency of test results across ACL TOP family members, minimize the need for user interaction, and increase the efficiency and safety of laboratory procedures. ACL TOP 700 LAS Specifications Test Menu Clotting tests (671 nm) YES (standard) Chromogenic YES (standard) tests (405 nm) Immunological YES (standard) tests (671 or 405 nm) System LAS Configurations Coagulometric, chromogenic and immunologic tests; open tube sampling + Laboratory Automation System compatibility Random access YES Continuous sample loading YES Continuous reagent loading YES Continuous cuvettes loading YES Sample transport system Racks Samples on-board 90 (10 samples/rack) Sample containers Primary tubes and cups Sample bar code reader YES (integrated) Hand held 2D sample bar code YES reader Sample pipetting arms/probes 1 (standard) + 1 (off-board) Sample liquid level detecting (for volume tracking) YES (capacitance probe) Sample area protection cover YES (with lock and sensor) LAS area protection cover YES (with sensor) Reagent transport system Racks Reagents on-board 60 (36 positions in reagent racks + 24 positions in diluent racks) Reagents on-board storage temperature 44 refrigerated + 16 room temperature (36 refrigerated positions in 6 reagent racks, 8 refrigerated positions in 1 diluent rack, 16 room 57 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 2 – General Information ACL TOP 700 LAS Specifications ACL TOP 700 LAS Specifications temperature positions in 2 diluent racks) Reagent containers Original bottles Reagent bar code reader YES (integrated) Bar coded reagents YES (bar code includes lot, exp. date and bottle size) Reagent pipetting arms/probes 2 Reagent liquid level detecting YES (capacitance probes) Reagent area protection cover YES (with lock and sensor) Cuvettes on-board 800 Cuvettes type Plastic disposable (4 cuvettes/strip) Applications on-board 500 User programmable applications 250 Tests per sample 30 Sample pre dilution YES Calibration curve pre dilution YES Factor parallelism YES Stat capability YES (for manually loaded samples at the front of the instrument, at any time in any position) Stat time Time to PT result when the system is idle: ~ 3 minutes Rerun testing YES (configurable) Reflex testing YES (configurable) Reaction curves display YES Quality Control program YES (with configurable multi-rules) Results auto validation YES Patient samples results database 2,000 - 20,000 samples (configurable) QC results database 2,000 - 20,000 samples (configurable) Security system YES (configurable) Events log system YES Bi-directional interface YES Host query function YES PC (Control Module) External (Pentium IV). Continental Resources Model #286229-06. Ratings: 100-120/200-240 VAC, 4/2 A, 50/60 Hz, Watts 230. Monitor 17 inch color LCD touch screen (external). Elo TouchSystems Model #ET1715L, Rating: 100-240 V, 1 A, 50-60 HZ Operating system Windows XP Keyboard YES (external) Mouse YES (external) User Interface Windows based Dimensions Width 188 cm (74 inches) 58 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 2 – General Information ACL TOP 700 LAS Specifications ACL TOP 700 LAS Specifications (analyzer) Depth 87 cm (34 inches) Height 162 cm (64 inches), includes integrated table. Weight (total) 319 kg (703 pounds) Analyzer 184 kg (406 pounds) Table 135 kg (297 pounds) 59 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 2 – General Information Test Performance Test Performance The data presented in this section is representative of all instruments in the ACL TOP Family. Typical Precision Performance The following are typical performance characteristics provided only as examples. Refer to product insert sheets to obtain specific information. Typical Precision Typical precision was performed using normal and abnormal controls. Precision is calculated following CLSI Document EP5-A. Within run and total precision assessed over multiple runs (n=80) using multiple levels of control plasma gave the following results: Reagent Type (Result Unit) Control Level Mean Within Run Total %CV %CV Antithrombin Normal 108.5 5.7 5.8 (%) Low Abnormal 53.5 5.6 6.8 High Abnormal 32.0 6.8 9.1 APTT Normal 30.3 1.2 1.6 (seconds) Low Abnormal 49.3 0.9 2.1 High Abnormal 59.0 0.9 1.4 D-Dimer Low Control 340 4.6 7.7 (ng/mL) High Control 729 2.5 4.5 Factor II Normal 110.7 4.2 5.2 (%) Low Abnormal 64.5 4.1 5.3 High Abnormal 37.5 3.8 5.6 Factor V Normal 124.7 4.0 4.7 (%) Low Abnormal 79.9 3.0 4.7 High Abnormal 43.4 3.6 4.8 Factor VII Normal 106.2 3.6 3.9 (%) Low Abnormal 61.3 2.1 3.7 High Abnormal 33.0 2.9 4.4 Factor X Normal 114.6 1.8 2.8 (%) Low Abnormal 64.6 2.2 3.4 High Abnormal 38.3 1.9 3.6 364.7 7.9 8.8 Low Fibrinogen 92.9 7.7 8.4 Protein C Normal 120.4 2.6 3.3 (%) Low Abnormal 30.9 3.0 4.3 High Abnormal 18.4 3.7 4.7 Normal 1.3 1.4 Fibrinogen-C (mg/dL) Normal Prothrombin (PT) 11.9 60 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 2 – General Information Test Performance Reagent Type (Result Unit) Control Level Mean Within Run Total %CV %CV (seconds) Low Abnormal 25.7 1.5 2.7 High Abnormal 37.3 1.8 3.0 PT-Based Fibrinogen Normal 302.6 3.7 4.1 (mg/dL) Low Fibrinogen 128.2 7.7 7.8 Typical Method Comparison Typical method comparison was performed using normal and abnormal patient samples. Method comparison is calculated following CLSI Document EP9-T. In method comparison studies evaluating citrated plasma samples, the ACL TOP Family member and the ACL Advance (predicate device) were shown to be statistically similar as shown below. Reagent Type (Result Unit) n Slope Intercept r Sample Range Antithrombin 123 1.03 -1.418 0.9660 25.0 to 121.7 205 1.076 -0.380 0.9943 24.2 to 236.7 120 1.12 -16.0 0.993 101 0.95 -0.551 0.9753 6.0 to 128.2 93 0.81 4.742 0.9822 2.1 to 149.3 96 0.882 3.153 0.9922 6.3 to 147.4 109 0.97 2.995 0.9954 5.0 to 142.3 98 1.00 -8.740 0.9759 121.6 to 695.0 123 1.15 -0.323 0.9902 9.4 to 129.7 150 0.990 1.46 0.9987 9.8 to 107.4 93 -9.93 0.9587 121.6 to 695.0 (%) APTT (seconds) D-Dimer 84 to 19809 (ng/mL) Factor II (%) Factor V (%) Factor VII (%) Factor X (%) Fibrinogen-C (mg/dL) Protein C (%) Prothrombin (PT) (seconds) PT-Based Fibrinogen 1.084 (mg/dL) 61 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 2 – General Information Test Performance A ntithrombin A PTT D -D imer 62 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 2 – General Information Test Performance Factor II Factor V Factor VII 63 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 2 – General Information Test Performance Factor X Fibrinogen-C (C lauss Method) 64 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 2 – General Information Test Performance Protein C (%) Prothrombin Time (PT) PT-B ased Fibrinogen 65 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 2 – General Information Test Performance Typical Linearity Linearity studies were performed using multiple sample levels with each level tested in replicates of four on an ACL TOP Family member. Results are shown in the table below. Reagent Type (Result Unit) No. of Levels Test Range Slope Antithrombin 9 Levels 0 to 152.7 0.9039 0.9991 9 Levels 143.7 to 1086.7 1.0000 0.9984 9 Levels 0.86 to 154.13 0.9946 0.9997 9 Levels 1.04 to 187.34 0.9540 0.9986 9 Levels 0.92 to 165.33 0.9411 0.9981 8 Levels 0.95 to 143.03 0.9322 0.9975 9 Levels 72.2 to 721.6 0.9164 0.9866 7 Levels 5.6 to 166.8 0.9237 0.9948 Prothrombin Time (PT) 9 Levels 12.3 to 160.3 1.0222 0.9992 58.3 to 777.8 0.9015 0.9978 r2 (%) D-Dimer (ng/mL) Factor II (%) Factor V (%) Factor VII (%) Factor X (%) Fibrinogen-C (mg/dL) Protein C (%) (%) PT-based Fibrinogen 10 Levels (mg/dL) Interference Refer to the product insert sheets. See Also l System Specifications l Analytical Limitations 66 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 2 – General Information Analytical Limitations Analytical Limitations On the ACL TOP instrument, sample carryover1 is negligible. In most situations inaccuracy attributed to carryover is within the normal imprecision of the method, and therefore not statistically or clinically significant. NOTE: Refer to the reagent label for test-specific interference and limitation information. See Also l Test Performance l System Specifications 1Residual sample material left on the sample probe, after the probe has been rinsed, that carries over to another sample when the probe enters it. 67 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 2 – General Information Installing the ACL TOP Instrument Installing the ACL TOP Instrument Review the following regarding the installation of your system: l Site Requirements l Actions Upon Delivery l Bringing Into Operation Site Requirements IL personnel or other person(s) duly authorized by IL must install the ACL TOP instrument. NOTE: l l l The control module (CM) is dedicated to a specific ACL TOP instrument. Any attempt to swap the CM with one from another ACL TOP Family instrument results in the following warning: CM is in use from a different ACL TOP model. Use of this CM will require Service intervention. The CM for the ACL TOP instrument is a dedicated computer. Do not install any other software application on it as this would qualify as a modification. Modifications to the programming or the instrument may affect instrument performance and may void IL's warranty. Do not use thumb drives (USB flash drives) that contain third-party software on the instrument. Do not plug or unplug any cables or drives without Service guidance. The ACL TOP instrument complies with all local, state and national regulations and requirements in the US for installation and site requirements. CAUTION: The ACL TOP instrument weighs from 200-365 pounds (91-166 kg) depending on the model. Use extreme care when moving the instrument. A total of four people should be used. Two people should lift using the two molded handles in the rear of the unit. The third and fourth persons should each take a front corner. Limited Warranty Instrumentation Laboratory is responsible for the safety and electrical performance of this equipment under the following mandatory conditions: l l Persons authorized by IL carry out assembly operations, extensions, adjustments, modifications or repairs. The electrical installation of the room complies with the local, state, or national requirements (including power supply circuit with independent grounding). l The equipment is used in accordance with these instructions. l IL brand products are used. Non-IL brands are not covered. 68 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 2 – General Information Site Requirements Spatial Requirements Maximum Dimensions for Analytical Module (AM) All measurements are in centimeters/inches and kilograms/pounds. Model Weight Height Depth Width TOP 300 CTS 91 kg 200 lbs 73 cm 29 in 84 cm 33 in 81 cm 32 in TOP 500 CTS 141 kg 312 lbs 73 cm 29 in 81 cm 32 in 110 cm 43 in TOP 700 162 kg 356 lbs 73 cm 29 in 76 cm 30 in 151 cm 59 in TOP 700 CTS 166 kg 367 lbs 73 cm 29 in 76 cm 30 in 151 cm 59 in TOP 700 LAS 184 kg 406 lbs 73 cm 29 in 76 cm 30 in 188 cm 74 in With integrated table 319 kg 703 lbs NOTE: In the LAS configuration the instrument is bolted to the table. The instrument must be positioned so that a waste tube can be connected to the right side of the unit without any kinks or bends that could cause an obstruction. The instrument must be positioned so that there is at least 15.2 cm (6 inches) clearance on all sides, back and top for proper air circulation. Maximum Dimensions for Stand-alone Control Module (CM) For all models except TOP 300 CTS. Weight 17 kg 37 lbs Height 45 cm 17.5 in Depth 49 cm 19 in Width 19 cm 7.5 in 69 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 2 – General Information Site Requirements Maximum Dimensions for the Touch Screen Monitor For all models except TOP 300 CTS. Height 37 cm 14.5 in Depth 8 cm 3 in Width 43 cm 17 in Maximum Dimensions for Integrated CM and Touch Screen Monitor For TOP 300 CTS model. Height 36 cm 14 in Depth 9 cm 3.5 in Width 43 cm 17 in 70 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 2 – General Information Site Requirements Electrical Requirements The instrument is designed to operate correctly with electrical variations to ±10% in an ambient temperature of 15° C to 32° C (59° F to 89° F) with a relative humidity of 5%-85% (non-condensing). The instrument should be placed in an area free from dust, fumes, vibrations and excessive variations of temperature. The instrument should not be used at an altitude greater than 2000 meters. The ACL TOP instrument is single phase, has current leakage of less than 500 µAmps, and produces 2,049 BTUs per hour. In accordance with safety standard IEC 1010, paragraph 1.4, there is no safety hazard in the temperature range 5-40° C. The instrument is designed to operate correctly with electrical variations of up to ±10% on the nominal supply and with supply frequencies between 47 and 63 Hz. WARNING: Ensure the supply voltage in the laboratory is compatible with the label on the rear of the AM1 as shown in the following table: Value of supply voltage Current for normal function (A) Value as shown on the label 240V AC ±10% 5A 100-240 VAC 115V AC ±10% 10 A 100-240 VAC 100V AC ±10% 10 A 100-240 VAC The CM2 requires an input voltage between 100-240V and an amperage of 3.5A. The monitor requires an input voltage between 100-240V and an amperage of 1.8-0.9A. The power cord provided with the instrument is a certified cord with a three-prong, double insulated, grounded (NEMA) receptacle and plug. 1The part of the instrument where sample processing and testing are performed. Also called the Analyzer or the Analytical Module. 2A Microsoft Windows™ PC running the ACL TOP software developed by IL. The CM provides the User Interface and data management functionality. The CM connects to the Analytical Module and provides the high level controls. 71 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 2 – General Information Site Requirements Instrument Volt-Amps Specifications ACL TOP Analytical Module Volts AC Amps Volts/Amp Watts Frequency 100 VAC 10A 1000 VA 600 W 50/60Hz 115VAC 10A 1150 VA 600 W 50/60Hz 240VAC 5A 1200 VA 300 W 50/60 Hz Watts Frequency ACL TOP Control Module Volts AC Amps Volts/Amp 100 VAC 6A 600 VA 600 W 50/60Hz 115VAC 6A 690 VA 600 W 50/60Hz 240VAC 3A 720 VA 300 W 50/60 Hz Monitor Volts AC Amps Volts/Amp Watts Frequency 12 VDC 4.16A 50 VA * 50 W 50/60Hz * DC voltage has no phase difference. Therefore VA = Watts. 72 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 2 – General Information Site Requirements Environmental Conditions The instrument functions correctly in an ambient temperature of 15° C to 32° C (59° F to 89° F) with a relative humidity of 5% to 85% (non-condensing). In accordance with the IEC regulations, no instrument failures occur in the presence of short-term ambient temperatures as low as 5° C or as high as 40° C. The instrument has been tested to IEC 60068-2-40 to 2000 meters. The instrument should not be used at an altitude greater than 2000 meters. The instrument should be placed in an area free from dust, fumes, vibrations and excessive variations of temperature. The heat generated by the instrument during normal operation is exhausted from the bottom, the front-right and the left side of the unit. Sufficient space (at least 6 inches) must be provided around the instrument to permit circulation of air for cooling. The instrument must be positioned so that a waste tube can be easily connected on its right side. Leave sufficient room to quickly disconnect the power cord, if necessary. The audible noise emission is a maximum of 55 dBA, which passes IEC/CEI 61010-1 :2001 Second Edition. Storage Conditions Store the instrument and startup kit at 10°C to 30°C, and 5% to 85% relative humidity, non-condensing. Shipping Conditions Ship the instrument and startup kit at -30°C to 60°C, and 5% to 85% relative humidity, non-condensing. Reagent Specifications Reagent specifications for the ACL TOP instrument are published separately and distributed in the reagent packaging. Non-IL Reagents The use of non-IL brand reagents or supplies for testing may cause a clinically significant degradation of performance and results. IL does not assume any obligation or warranty engagement concerning precision and/or accuracy of the measurements, nor for any damage to the instrument directly or indirectly resulting from the use of reagents, consumables and/or expendable supplies other than those produced by IL. See Also l Warranty l Limitations and Disclaimers 73 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 2 – General Information Actions Upon Delivery Actions Upon Delivery Only an IL-certified representative may perform the following actions upon delivery: l Uncrate the ACL TOP instrument. l Make sure that the shipping list is complete. l Make sure all materials are in proper condition. l Install the ACL TOP instrument. IL is not responsible for damages resulting from attempts by an employee or representative of your company to perform any of the above actions. Bringing Into Operation The entire ACL TOP instrument installation process is the responsibility of an IL-certified representative. CAUTION: The ACL TOP instrument weighs from 200-365 pounds (91-166 kg) depending on the model. Use extreme care when moving the instrument. A total of four people should be used. Two people should lift using the two molded handles in the rear of the unit. The third and fourth persons should each take a front corner. IL is not responsible for damages resulting from any attempt by any employee or representative of your company to install the ACL TOP instrument. See Also l Warranty l Limitations and Disclaimers l User Training Requirements l Site Requirements 74 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 2 – General Information Training Requirements Training Requirements The user will operate the instrument in accordance with instructions for use in this manual. Using the instrument improperly may result in impairment or injury. The operator will follow normal laboratory practices for handling biohazardous substances, including the use of lab coats, gloves, and shield, where required. Users who operate the ACL TOP instrument must be properly trained by Instrumentation Laboratory, or an IL representative. Contact your local IL representative for information about training programs and the training certification policy. IL is not responsible for damages caused by using, or attempting to use, the ACL TOP instrument by employees, or representatives of your company or laboratory. See Also l Warranty l Limitations and Disclaimers l Actions Upon Delivery l Bringing Into Operation l Site Requirements 75 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 2 – General Information Warranty Warranty IL warrants to Customer that the Products will be free from defects in material or workmanship for one year from date of delivery, in the case of instruments and ninety (90) days from date of delivery for other products (unless a different period is specified), or IL will repair or replace the product or provide credit, at its sole option, upon prompt notification and compliance with its instructions. IL makes no warranty and shall have no obligation with respect to expendable or consumable parts and supplies nor with respect to damage caused by or resulting from accident; misuse; neglect; use of parts, materials or products not furnished by IL; or unauthorized installation, alterations or repairs to the Products. IL EXPRESSLY DISCLAIMS ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING THE IMPLIED WARRANTY OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR OR AN INTENDED PURPOSE. IL's sole responsibility and the Customer's exclusive remedy for any claims arising out of the purchase of the Products is the repair, replacement, or credit as described above where applicable. In no event: 1. shall the cost of the exclusive remedy exceed the purchase price; 2. shall IL be liable for any claims, losses or damages of any third party or for lost profits or any special, indirect, incidental, consequential, or exemplary damages, irrespective of whether attributable to contract, warranty, negligence, strict liability, or otherwise, even if IL has been advised of the possibility of such damages. See Also l Limitations and Disclaimers l Actions Upon Delivery l Bringing Into Operation l User Training Requirements l Site Requirements 76 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 2 – General Information Limitations and Disclaimers Limitations and Disclaimers Warranty Claims Customer must inform IL of any defects found within 8 days from receipt or from discovery, in case of defects which may not be identified in the normal inspection or which may appear at a later time. Neglect and Misuse The warranty does not apply to those defective instruments or materials showing defects or damage from such as: l Insufficient or negligent care by the customer. l Use of the instrument by a user who has not been properly trained by IL or its representative. l Failure of customer to follow to the instructions contained in the Manuals prepared by IL for this purpose. l Tampering with or altering the instrument. l Repairs made by any person not duly authorized by IL. l Misuse due to carelessness, negligence or inexperience. l l Employment of materials under heavier conditions than those for which they had been designed and manufactured and use of the same in combination with incompatible or dangerous products. Failure to observe regulations relative to installation, power supply and operation of the instruments (with particular regard to the regulations for accident prevention). It is also understood that, following the purchase and delivery of the instrument, the customer shall be deemed liable for any losses, damages or complaints concerning persons or things incurred by the use or misuse of the instrument on behalf of the customer, his employees, co-operators or others. Damage during Transportation Damages caused by or connected to transport are excluded. Customer shall bear all risk and cost for transporting products to and from IL’s factory. Third Party Products Those instruments or accessories that are supplied by IL but are not of IL manufacture will only benefit from the warranty conditions offered by the manufacturer of such products. Safety Instrumentation Laboratory (IL) is responsible for the safety and electrical performance of this equipment if and only if: l l l Assembly operations, extensions, adjustments, modifications or repairs are carried out by persons authorized by IL, The electrical installation of the room complies with the local, state or national requirements (including a power supply circuit with independent grounding), The equipment is used in accordance with these instructions for use. 77 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 2 – General Information Limitations and Disclaimers “Washed” Cuvettes The IL ACL TOP instrument cuvette was designed and manufactured as a single use product. Instrumentation Laboratory and its authorized dealers shall not be responsible for instrument malfunction, invalid test values or damages of any kind resulting from use of washed cuvettes. Non-IL Brand Product IL does not test other manufacturer reagents to ascertain their suitability for the ACL's methodology or their level of performance on the IL ACL instruments. The use of non-IL brand reagents or supplies for testing may cause a clinically significant degradation of performance and results. IL does not assume any obligation or warranty engagement concerning precision and/or accuracy of the measurements, nor for any damage to the instrument directly or indirectly resulting from the use of reagents, consumables and/or expendable supplies other than those produced by IL. IL brand reagents, consumables and expendable supplies (including, for example, cuvettes) were developed specifically for the ACL TOP instrument’s detection systems. IL ACL TOP instrument products are tested to ensure proper performance when using plasma samples in accordance with the protocol. Each lot of IL brand ACL TOP instrument reagents is tested against these criteria. Verification of other brands of reagent or supplies to ascertain their suitability for the ACL TOP instrument methodology or their level of performance on the IL ACL TOP instruments is not performed. The use of non-IL brand reagents or supplies for testing that is not done in accordance with IL protocols may cause a clinically significant degradation of performance and results. IL does not assume any obligation or warranty engagement concerning precision and/or accuracy of the measurements or for any damage to the instrument directly or indirectly resulting from the use of reagents and/or consumables other than those produced by IL. User-Defined Tests A user with the appropriate security level can create a new test or copy an existing test. All responsibility for parameter development and validation of new or copied tests belongs to the user alone. NO AGENT OR EMPLOYEE OF IL IS AUTHORIZED TO EXTEND ANY OTHER WARRANTY OR TO ASSUME FOR IL ANY LIABILITY EXCEPT AS ABOVE SET FORTH. See Also l Warranty l Actions Upon Delivery l Bringing Into Operation l User Training Requirements l Site Requirements 78 of 992 L0027503450 R00 ACL TOP Family Operator's Manual CHAPTER 3 USER INTERFACES User Interfaces Click one of the following links to view the corresponding ACL TOP User Interface (UI) feature: l Input Devices l Output Devices l Software – Getting Started See Also l LIS Configuration l Global Definitions Setup l Visual Styles Input Devices Input devices include the following: l Touch Screen l Mouse l Keyboard l Bar Code reader l 2-dimensional bar code reader l Push Buttons l LIS l CD Read/Write Drive Touch Screen The screen is touch-sensitive. Pressing an icon or field selects it similar to selecting it with a mouse. 79 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 3 – User Interface Input Devices Mouse The ACL TOP instrument uses a standard two-button mouse and follows the standard Microsoft® conventions for its use. Keyboard The ACL TOP instrument uses a standard 105 key Windows keyboard and follows the standard Microsoft® conventions for its use. Bar Code Reader If the sample tubes and/or the reagent bottles have bar code labels, the system scans the labels as the racks are inserted into the AM. After the bar code reader moves away from the track where you inserted the rack, the scanned information displays. Two-Dimensional Bar Code Reader See 2D Bar Code Scanner. Push Buttons The AM1 has push buttons on the front that move the bar code reader to the sample and reagent rack areas. There is also a push button in the center front of the AM that initiates an Emergency Stop as soon as it is pressed. LIS The interface to the Laboratory Information System provides a means of downloading test requests remotely. See LIS Configuration. CD-ROM Drive The CD-ROM drive on the CM may be used for input. Typically it is used for software and parameters upgrades. 1The part of the instrument where sample processing and testing are performed. Also called the Analyzer or the Analytical Module. 80 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 3 – User Interface Output Devices Output Devices Output devices include the following: l Monitor – Primary output device to display test results. l Diskette drive – Where present, use to export configuration or data files. l CD read/write drive – Use to export configuration or data files. l Printer (optional) – Uses a standard interface for printing reports. l LIS – Use to output sample results. See Also l Input Devices l Software – Getting Started l LIS Configuration 81 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 3 – User Interface Getting Started Getting Started To use the ACL TOP software effectively, review the following topics: l Terminology l Layout l Common Functions See Also l Input Devices l Output Devices l Global Definitions Setup 82 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 3 – User Interface Terminology Terminology See the Glossary for more terms. Calibration/NPP An analytical material with a defined concentration or activity used to calibrate a test. A calibrator1 may be calibration plasma or NPP. An NPP, or Normal Pool Plasma, is made by combining plasma from a large number of people so that the pool acts as a representation of typical plasma. It is free of biases due to race, sex, age, etc. Cuvettes Cuvette A vessel, cell, chamber, or well in which sample and reagents are deposited, mixed, incubated and analyzed. The cuvette cell is also called the cuvette well. Each cuvette cell has an optical path of 0.67 cm and is designed to hold a minimum of 150 µL to a maximum of 600 µL of reaction mixture. NOTE: Cuvettes are intended for single use only. IL does not support the use of previously used cuvettes on ACL TOP instruments. See Limitations and Disclaimers. Cuvette Accumulator A holding area for used cuvettes. It collects cuvettes after they leave the shuttle, but before they are dumped into the cuvette waste drawer. Cuvette Box A cuvette box is a group of 10 cuvette clips packaged together for easy loading on the system (10 cuvette clips = 100 cuvette strips = 400 cuvette cells). Cuvettes are loaded by the box. 1A type of sample with an assigned value used to calibrate a test. 83 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 3 – User Interface Terminology Cuvette Clip A group of 10 cuvette strips joined together by features incorporated in the cuvette strips themselves. Cuvette Loader The cuvette loader is the left-most part of the instrument and is a defined area for cuvette loading that includes the pivot arm and the indexer. The cuvette loader can hold up to 20 cuvette clips of ten strips per clip for a total of 800 cuvette cells. The transport is a conveyor belt that transports the clips along the loader and onto the pivot arm, which, with the help of the indexer1, positions the cuvette strips for pickup by the cuvette shuttle. While the analysis is proceeding, the space on the indexer left by the cuvette clips that have been moved to the incubation/analysis areas is filled with new cuvette clips. A sensor detects when more cuvette clips need to be placed onto the loader and an LED on the front of the instrument displays yellow when there are 3 or fewer cuvette strips remaining, and red when the loader is empty. A message is also displayed in the Material Alarms screen. Cuvette Shuttle The cuvette shuttle includes the carriage, gripper and jaw. It can position a cuvette at any slot and move it to any other slot. To the right of the cuvette loader are slots for the cuvette strips. It is here that sample predilutions and calibration dilutions are performed at ambient temperature. C arriage The part of the shuttle that moves the cuvette strip from the loader to the various slots. Gripper Moves the cuvette strip into and out of the slots. The gripper includes the jaw. Jaw The part of the gripper that locks on to the cuvette strip. 1The part of the cuvette loader which prepares cuvettes for pick-up by the shuttle mechanism. 84 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 3 – User Interface Terminology Cuvette Slot Any valid drop-off and/or pick-up point for the cuvette strip. Examples of cuvette slots are incubator slots and ORU slots. Cuvette Strip Four cells molded together in a disposable plastic piece form the cuvette strip. A cuvette strip is used for the analysis. Each cuvette strip incorporates features to clip strips together to form cuvette clips and features to enhance handling capabilities. Cuvette Waste Container – TOP 300 CTS only This container holds the waste cuvette strips. Used cuvette strips are moved to the right side of the AM1 where they are deposited into a cuvette waste container. CAUTION Biohazard: Refer to local and state regulations for disposal of potentially hazardous materials. The cuvette waste container must be properly seated in the waste container area such that the cuvettes fall directly into the waste container. The waste container must sit securely against the inner wall of the waste area. Improper seating of the cuvette waste container may result in cuvettes falling onto the bench or floor. The cuvette waste area contains no sensor. It should be emptied once per day, when cuvettes reach the Max level printed on the container, or as needed to prevent overflow. Disposable gloves should be worn when handling waste cuvettes to avoid contact with potentially infectious material. 1The part of the instrument where sample processing and testing are performed. Also called the Analyzer or the Analytical Module. 85 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 3 – User Interface Terminology Cuvette Waste Drawer – Excludes TOP 300 CTS A leak-proof five-sided container designed to be used with a disposable liner. This container holds the waste cuvette strips. Used cuvette strips are moved to the right side of the AM and onto a cuvette accumulator which holds 6 used strips. When the sixth strip moves to the accumulator, it drops down and causes the strips to fall into the waste drawer. CAUTION Biohazard: Refer to local and state regulations for disposal of potentially hazardous materials. The cuvette waste drawer must be properly seated such that the cuvette exit path from the analyzer is open and waste cuvettes can fall freely. Improper seating of the cuvette waste drawer or use of improper waste containers may result in cuvettes jamming. Cuvette waste liners may be cleaned in an autoclave. However, sharp edges may result which could cause injury. Place the cuvette waste liner in an autoclave bag before putting it into an autoclave. Disposable gloves should be worn when handling waste cuvettes to avoid contact with potentially infectious material. Waste Cuvette A cuvette that contains a completed coagulation or chemical reaction, and is ready to discard. NOTE: Cuvettes are intended for single use only. IL does not support the use of previously used cuvettes on ACL TOP instruments. See Limitations and Disclaimers. 86 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 3 – User Interface Terminology Incubators Sample Incubator A heated area to the right of the dilution area contains slots for cuvette strips. Sample material is pipetted into the cuvette cells here. The temperature is maintained at 37.0° C ± 0.5° C. Reagent Incubator A heated area to the right of the sample incubator contains slots for cuvette strips. Intermediate reagents are pipetted into the cuvette cells here. The temperature is maintained at 37.0° C ± 0.5° C. LAS Terminology Adjustment Volume Percentage of extra liquid added to every LAS probe sample aspiration to account for volume loss due to LAS probe inaccuracy. The IL default is 2%. Aliquoting Area The cuvette slots where the LAS arm aliquots the LAS samples. Aliquoting Area Expiration Time Time used to determine whether a sample is moved to the LAS Cuvette Holding Area. If the time exceeds the configured setting, it is not moved. Aspiration Point Position on the sample tube queue where the LAS probe can access a sample tube. Interface Module (IM) Interface Module Embedded System. Communication between the LAS instrument and the LAS track is through an embedded interface module (IM) that is configured in the LAS Configuration screen. LAS Laboratory Automation System LAS Arm The LAS arm aspirates external samples and aliquots them into the system. LAS Cuvette Holding Area Cuvette slots where the LAS samples are placed in the system after the LAS arm has aspirated the samples from the LAS track. It is the same as the Base TOP holding area except for the slots that belong to the LAS aliquoting area. 87 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 3 – User Interface Terminology LAS Manager Software or application that coordinates all the modules (track, decapper, analyzer, etc.) integrated in an LAS. LAS Sample Sample provided by a Laboratory Automation System. Sample aspiration time A time out, specified in the Sample Aspiration Unit, used to determine whether to aspirate an accepted tube or release it to another instrument. Countdown starts when the tube is accepted. The default is 15 minutes. Sample expiration time The time used to determine whether or not the LAS sample is moved to the waste station. LAS Status Status of the LAS track and communications with the instrument. The statuses are as follows: R EA D Y LAS is ready and functioning. U N A VA ILA B LE LAS track is not able to provide samples automatically. D ISA B LED The LAS arm cannot be used and there is no communication with the LAS track. U N K N OW N (blank) LAS track is down or there is a communications error between the IM and the LAS track or the IM is not responding. R ESET QU EU E The instrument is resetting the track queue. During this time the instrument does not interact with the LAS track and Diagnostics is disabled. N OT C ON N EC TED The instrument is not an LAS instrument or there is a communication error between the CM and the IM or the IM is down. STOPPED Auto Run is temporarily deactivated or a controlled stop has been requested or interaction with the LAS track has stopped. The stopped state ends when you select Run Tests (the icon or the Actions menu item) from any screen. 88 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 3 – User Interface Terminology LAS Track The LAS Track transports LAS samples to the ACL TOP 700 LAS instrument. It includes the sample tube queue and the aspiration point. Preparation cuvettes The number of cuvette strips to use for preparing dilutions and predilutions. Query Point Position at the entrance to the sample tube queue. Sample Tube Queue A dedicated branch of the LAS track where LAS samples that are to be processed by the instrument are diverted from the main LAS track. Virtual Sample Tube Queue A software list that represents the LAS samples located at the sample tube queue. The list is maintained by the ACL TOP 700 LAS. 89 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 3 – User Interface Terminology Material Cleaning material A liquid used to reduce or remove unwanted substances from the probe surfaces. The material is typically acid or bleach-based. Clean B diluted A dilute cleaning solution used in many tests. To make: dilute 1 mL of Clean B with 7 mL of CLSI (formerly NCCLS) CLRW Type water or equivalent. This solution must be made up fresh each day. Deficient plasma A plasma-based material that is lacking certain factors necessary to complete the coagulation cascade. Diluent A liquid used to reduce the concentration of a sample or a reagent. See sample diluent, reagent diluent, below. Empty material Material that is present on the AM but the liquid level has been detected to be below the volume error threshold. Intermediate reagent Material that is added to the sample material to activate certain constituents of the sample but does not bring the reaction to completion. These materials are placed in diluent tracks and reagent tracks on-board the ACL TOP instrument. Known Material Material that is defined and used in at least one test, calibration or QC definition. Placed Material Material that is known and located in a defined position on the AM. You cannot change the material definition of any materials that are placed. QC Material A sample-like material typically having known amounts of analyte that is used to detect changes from stable system operation and eliminate reporting of results affected by system instability. Reagent A liquid material used as part of a test, that, when mixed with sample, provides the necessary constituents to either initiate or complete the desired biochemical reaction. 90 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 3 – User Interface Terminology Reagent Diluent A liquid material used to reduce the concentration of reagent materials or to reconstitute a lyophilized reagent. Sample Any material used for the sample component of a test. Typically, a sample is plasma-based material, either patient sample or control/calibrator. Sample Diluent A liquid material used to reduce the concentration of sample materials. Sample Type Refers to the different kinds of materials that can generate data (patient, QC or calibrator). Start Reagent Material added to the cuvette in the ORU that acts as a trigger to start acquisition. These materials are placed in reagent tracks R3 to R6. Unidentified Material Material that is defined but is not used in any test, calibration, or QC definition. Optical Reading Unit (ORU) ORU 1, 2, 3, 4 Slots with the optical reading units where start reagents such as APTT CaCl2 are pipetted into the cuvette cells. It is also here that the readings are taken of the reactions occurring in the cuvette cells. Each ORU has four reading stations. See Also l Welcome to Help l Glossary 91 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 3 – User Interface Visual Styles Visual Styles To configure the ACL TOP user interface style: 1. Select Setup > Visual Style in the menu bar. 2. Select a color in the submenu. See Also l User Interfaces l Getting Started l Layout Layout Each screen contains the following areas: l Main Screen l Menu Bar l Toolbar l Working Area l Status Bar l Information Panel 92 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 3 – User Interface Main Screen Main Screen ACL TOP Family Software Main Screen The ACL TOP Family user interface contains the following functional areas: l Title Bar – Displays the instrument name and the screen name. l Menu Bar l Toolbar l Working Area l Status Bar l Information Panel 93 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 3 – User Interface Menu Bar Menu Bar The ACL TOP instrument main menu bar contains the following menu options: Instrument Menu l Controlled Stop l Recovery l Resume Auto Run l Log Out l Exit NOTE: The choices on the Actions menu differ depending upon what is displayed in the working area. 94 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 3 – User Interface Menu Bar Sample List Actions Menu Configuration l Filter Results l Recalculate l Validate l Upload l Delete l Find Sample l Previous l Next l Select All l Unselect All l Filter Selection by Test Code l Download Tests Order l Add/Remove Tests l Run Tests Print Preview l Sample Results Report l Patient Report Print l Sample Results Report l Patient Report Export l Sample Results Report l Patient Report l Sample Results (EXCEL) Raw Data Report Patient Demographics l Save l Restore Print Screen Review 95 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 3 – User Interface Menu Bar l Previous Screen l Sample Details l Test Details l Results Statistics l Simple Test Counters Statistics l Detailed Test Counters Statistics Analysis Menu l Sample Area l Reagent Area l Diluent Area l Sample List QC Menu l Results List l Test Status List Calibration Menu l Status List NPP Menu l Status List 96 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 3 – User Interface Menu Bar Setup Menu l Vial Lists l Material List l Test List l QC List l Test Profiles List l QC Profiles List l Reflex List l Auto Validation l Revision History Report l Import/Export l Global Definitions l Bar Code Definitions l LIS l Communications l Sender List l LAS Configuration ( ACL TOP 700 LAS only) l Security l User Security List l Software Access Screen l Reports l Display l l Sample List Display Settings l Test Programming Window l Material Programming Window Languages System Menu l Maintenance l Diagnostics l Instrument Status l Status Statistics l General Log List 97 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 3 – User Interface Menu Bar Help Menu l Help Topics l About ACL TOP NOTE: After you print or export a report or a list, you may not be able to perform certain operations, such as shutting down the instrument. The system may seem to lock up. When you print or export, the Print/Export dialog box opens. If you click anywhere on the ACL TOP screen, or select a menu item before you select Confirm or Cancel in the dialog box, the dialog box moves behind the ACL TOP application window, preventing you from doing anything else. You must: 1) minimize the ACL TOP application window; 2) select Confirm or Cancel; 3) then maximize the ACL TOP window. You can also press ALT+Tab to display the Print or Export dialog box. See Also l Layout 98 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 3 – User Interface Toolbar Toolbar The toolbar that appears over the ACL TOP instrument Working Area is divided into three sections: General, Operations, and Navigation toolbars. The content of the toolbar is dynamic, depending on the context of the Working Area. In this topic, TOP 700 LAS Sample List toolbar is used as an example: General Toolbar Online help is accessible in all ACL TOP instrument screens. Help – Launches the online help. 99 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 3 – User Interface Toolbar Operations Toolbar The Sample List operations toolbar is used to perform operations on samples and the tests associated with them. It contains the following icons: Sample List Display Settings Validate Upload Filter Filter in Use Find Add/Remove Tests Print Sample Details Test Details Save Restore 100 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 3 – User Interface Toolbar Navigation Toolbar The Sample List navigation toolbar is used to navigate among the Sample, Reagent, and Diluent areas, as well as the QC Results List and Calibration Status List areas. It contains the following icons: Previous Screen QC Results List Calibration Status List LAS Cuvette Holding Area Sample Area Reagent Area Diluent Area 101 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 3 – User Interface Toolbar Other Commonly Used Toolbar Icons The following commonly used toolbar icons appear dynamically depending on the context in the Working Area. Toolbar icons remain disabled until the configuration in the Working Area is correct for the respective task. See Toolbar Icons. Add Add/Remove Material Scan (Bar code) Copy Test Delete Item/Delete Material Test Feasibility List Perform a Maintenance Activity Run Programmed Tests Restriction Map Save View Item/View Material Warning Thresholds Icon Tooltips When you hover the cursor over a toolbar icon, a tooltip displays the task it performs. 102 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 3 – User Interface Toolbar Moving the Toolbars At the left side of the operations and navigation sub-toolbars are vertical bars. When you select one of these bars, the position of the toolbar moves vertically to another position in the <screen> toolbar. Toolbar Icon Drop-down Menu Some toolbar icons have a small arrow on their right side. When you select the arrow, a drop down menu appears. This drop-down menu is typically configurable, and may also appear on the touch screen. See Also l Graph Icons l Grid Icons l Toolbar Icons l Layout 103 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 3 – User Interface Working Area Working Area The Working Area is below the toolbar. It typically contains a data table or a form. There are a number of different data tables and forms that appear in the working area. By default, the Sample List is shown at startup. Other lists (tables) may be viewed by selecting an icon in the navigation toolbar. Navigation Toolbar The navigation toolbar is dynamic. Its contents depend on the context in the Working Area. TOP 700 (includes ACL TOP Base), 700 CTS (includes ACL TOP CTS) and 700 LAS TOP 300 CTS TOP 500 CTS Analysis Menu You can select a data area from Analysis menu, as shown here (TOP 700 (includes ACL TOP Base), 700 CTS (includes ACL TOP CTS) and 700 LAS example): These are the most commonly used data areas. There are others not listed on this menu. Scrolling The working area often has arrow icons on its right side and below the table that let you scroll up and down or left and right through the table data. There are also arrow icons that go to the topmost or bottommost row or leftmost or rightmost column of data. Unique Identifiers Most tables that appear in the Working Area contain a unique identifier column (for example, test code). When you select a row, the cell in the unique identifier column appears with blue cell borders, indicating that object has focus. See Placing Focus. See Also l Layout l Sample Area 104 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 3 – User Interface Working Area l Reagent Area l Diluent Area l Reagent/Diluent Area l Sample List l Information Panel 105 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 3 – User Interface Status Bar Status Bar The status bar is located below the working area. General Log Icon The General Log icon opens a General Log List that displays the events that have occurred. Analyzer Status The Analyzer1 Status displays a short description and a color indicator of the current state of the analyzer, as follows: Description Color of Indicator Power-up Blue Initializing Blinking Blue Warming Up Blinking Blue Ready Green Busy Blue Controlled Stop Blue Error Amber Emergency Stop Amber Diagnostics Blinking Amber Maintenance Blinking Amber Connecting No indicator Not Connected No indicator The Connecting status indicator is used during startup. The status changes to Not Connected when the system times out without connecting to the Analytical Module. It typically takes up to 30 minutes for the analyzer to complete the power-up process and go to the Ready state. However, it can take up to 60 minutes at temperature extremes. 1The part of the instrument where sample processing and testing are performed. Also called the AM or the Analytical Module. 106 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 3 – User Interface Status Bar LIS Status The LIS Status displays the following states: l Amber – Rejected l Gray – Not connected l Green – Connected Auto Run Status The Auto Run Status displays the following states: l Amber – Stopped l Gray – Disabled l Green – Enabled l Red – Error To view a short error message, hover the cursor over the red LED. A tooltip displays the cause of the error. If the Auto Run status is both Stopped and Error, the Stopped status displays. If Auto Run leaves the Stopped state but remains in the Error state, the status displays Failed. LAS Status The LAS Status displays the following states: l Amber – Unavailable or Stopped l Gray – Disabled l Green – Ready 107 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 3 – User Interface Status Bar Alarm Buttons The following icons in the status area open a window with a table that lists alarm warnings and error messages. These are disabled until there is something to report. See Alarm Buttons. Material Alarms Job Frequency Alarms QC Alarms Maintenance Alarms Analyzer Alarms External Communications Alarms (LIS and LAS alarms) See Also l Layout l Alarm Messages l LED Status Color Codes 108 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 3 – User Interface Information Panel Information Panel The lowest area of the screen contains an information panel with the following: Time To Completion The Time To Completion area is located under the analyzer status LED. It displays the estimated time to complete all currently running tests. Not all tests are scheduled at once. As tests are added to the schedule, the time to completion updates. The blue progress bar visually represents the time to completion. User ID See Adding and Editing Users. Security Level See System Security. Number of Entries Number of entries on the open screen. For example, if the Material List is open, a Number of Entries value of 131 indicates there are 131 materials in the Material List. Current Date and Current Time Do not change the date and time in the Control Panel. Changing them may affect material stability and patient data. The instrument has an internal clock that resets the date and time when necessary. See Also l Layout l LED Status Color Codes 109 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 3 – User Interface Common Functions Overview Common Functions Overview The following functions are generally available in all areas of the instrument: l Log in l Focus l Select l Add Item l View Item l Delete Item l Sort l Filtering Data l Find and Auto-Search l Save l Restore l Previous Screen l Print l Print Screen l Run/Auto Run l Exporting Data l Cancel/Stop/Progress Bar l Log Out l Exit 110 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 3 – User Interface Logging In Logging In To start the ACL TOP instrument software you must log in with your user name and password. 1. Enter your user name and password. 2. Select OK to continue logging in or select the Shutdown button to shut down the ACL TOP instrument software. If your password has a defined duration and it goes into the warning period, you are alerted on-screen and you have the option of changing it. l l l If the password is not changed you can log on for the remainder of the valid period only. When the password expires you are given the option to change it. If No is selected you are no longer allowed to log on. If you select Yes, the change password screen displays, and you enter the new password, which is then valid for the period defined in the User security screen. If your password does not have a defined duration it will not expire. See Also l Log Out l Adding and Editing Users l Common Functions Overview 111 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 3 – User Interface Placing Focus Placing Focus Placing Focus on an Item To place focus on a list item: 1. Open the list in table format (for example, Material List, Test List, Sample List, QC List, Reflex List, etc.). 2. Click a cell in the column that contains the unique identifier. For example: l Material Name column l Test Code column l Sample ID column 3. A blue cell border indicates the row has focus. Only one row at a time can have focus. 4. You can perform an operation on the item that has focus. 112 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 3 – User Interface Placing Focus Combinations of Select and Focus NOTE: Do not edit the sample ID after an analytical session has started, unless you remove the rack first. N ot Selected / N o Focus Focus When a sample has focus you can obtain detailed information about the sample and its tests. Only one sample at a time may have focus. Selected Multi-selection is allowed. You can print, validate or upload the sample information for all selected samples. Selected with Focus Select and place focus to obtain detailed information about a sample and its tests. You can validate and upload in this configuration. U nderlined – H idden D ata An underlined sample ID indicates there are test results that are not displayed in the Sample List. See Sample List Display Settings to display hidden columns. See Also l Selecting Objects l Selecting and Placing Focus on Samples 113 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 3 – User Interface Selecting Objects Selecting Objects You can perform actions such as add, delete, edit, print, validate or upload on items displayed on a screen by selecting the objects, then performing the action. Selecting an Object To select an item: 1. Click in the left-most Select column in the row on which to perform an action. 2. A red check mark indicates the row is selected. 3. The unique identifier in the row also has focus1, indicated by a blue cell border around it. 4. You can now perform intended actions on the selected item. Selecting All the Objects in a List To select all the items in a list: 1. Click the Select icon in the column heading to place a red check mark in every row in the list. 2. You can now perform intended actions on all the items in the list. See Also l Placing Focus l Selecting and Placing Focus on Samples l Sorting Lists l Filtering Data l Find and Auto-Search 1To place focus on the unique identifier in a list, click a row in the table. A blue cell border indicates focus. Only one unique identifier in a list can have focus. 114 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 3 – User Interface Adding an Item Adding an Item To add an item: 1. Select the Add icon in the toolbar (when it is active). 2. The task that runs depends on the context in the Working Area. A new row is added to the table in the Working Area. See Also l Adding a New Maintenance Activity l Adding a New Material l Adding a Test Definition Viewing an Item The action triggered when you select the View icon in the toolbar depends on the context in the Working Area. It typically displays detailed information on the object1 that has focus2. See Also l Material Definition l Test Definition 1A data item in the Working Area of the ACL TOP application. For example, the unique identifier in a table, a maintenance activity, or function, etc. 2To place focus on the unique identifier in a list, click a row in the table. A blue cell border indicates focus. Only one unique identifier in a list can have focus. 115 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 3 – User Interface Deleting an Item Deleting an Item To delete an item: 1. Select1 one or more items in a list to delete. 2. Select the Delete icon in the toolbar. 3. Confirm the deletion when prompted. See Test Deletion Rules. NOTE: You may not delete IL-locked materials. Sorting Lists To sort a list: 1. Select a column heading. A small arrow appears in the column heading to indicate the column is sorted in ascending or descending order. 2. Select the same column heading again to resort in reverse order. 3. Select a second column heading to sort the list by that criteria. The first column you sorted now becomes the secondary sorting criteria. The sorting condition is retained when you exit and re-enter the screen. 1Click in the Selection column of a table. A red check mark indicates selection. You can typically select more than one object. 116 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 3 – User Interface Filtering Data Filtering Data To filter data in the Working Area: 1. Select the Filter bar. icon in the toolbar, or select Actions > Configuration > Filter in the menu 2. If the current view has been filtered, the icon displays in the toolbar. 3. <Optional> Select the Filter icon in the toolbar and change or remove the currently applied filter criteria. Filters are available for the following screens: l Material List l Test List l QC List l Sample List l Maintenance List l General Log List See Also l Sample List Filter l Find and Auto-Search l Sorting Lists l Placing Focus l Selecting Objects 117 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 3 – User Interface Find and Auto-Search Find and Auto-Search Find To find an item in the Working Area: 1. Open the screen that contains the table you want to search. 2. Select the Find icon in the toolbar, or select Actions > Results > Find in the menu bar. 3. Enter all or part of the search text in the Quick Search dialog box. 4. Select the Next or Previous button to locate items with similar names in the Working Area. Auto-Search Auto-Search is programmed for most tables in the ACL TOP interface. This means that you do not have to select Find in the menu bar or toolbar to begin the search. To find an object capable of having focus1 in a table: 1. Open the screen that contains the table you want to search. 2. <Optional> Sort the column you want to search in. 3. Start typing the text you want to search for. For example: SA1174 4. The focus automatically moves to the first object in the column that corresponds to the characters you have typed. See Also l Filtering Data l Sorting Lists l Placing Focus l Selecting Objects 1To place focus on the unique identifier in a list, click a row in the table. A blue cell border indicates focus. Only one unique identifier in a list can have focus. 118 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 3 – User Interface Save Save Select the Save icon in the toolbar, or select Actions >Save in the menu bar to save the following types of information: l Auto validation information l Bar code definitions l Calibration data l LIS communications configuration l LAS configuration l Interface Module configuration l Material definitions l Patient identification data l Profile data l QC data l Reflex definition l System configuration information l Test definitions l User security Restore Restore returns the system configuration to its previous saved state. Any changes made since that time are discarded. To restore the system to its previous configuration: l Select the Restore icon in the toolbar, or select Actions > Restore in the menu bar. Previous Screen To view the previously displayed screen (when available): l Select the Previous Screen menu bar. icon in the toolbar, or select Actions > Previous Screen in the See Also l Toolbar l Toolbar Icons 119 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 3 – User Interface Print Print Printing an Entire List To print an entire list: 1. Open the list to print (Material List, Test List, etc.). 2. Select Actions > Print > <submenu> in the menu bar. For example, select Print Material List or Print Test List. 3. In the Print dialog box, select OK. Printing Selected Data To print selected data: 1. Open a list (Material List, Test List, etc.). 2. Select1 one or more rows in the list that is open in the Working Area. 3. Select Actions > Print > <submenu> in the menu bar. 4. In the Print dialog box and select OK. NOTE: After you print or export a report or a list, you may not be able to perform certain operations, such as shutting down the instrument. The system may seem to lock up. When you print or export, the Print/Export dialog box opens. If you click anywhere on the ACL TOP screen, or select a menu item before you select Confirm or Cancel in the dialog box, the dialog box moves behind the ACL TOP application window, preventing you from doing anything else. You must: 1) minimize the ACL TOP application window; 2) select Confirm or Cancel; 3) then maximize the ACL TOP window. You can also press ALT+Tab to display the Print or Export dialog box. See Also l Formatting Reports l Exporting Data l Print Screen 1Click in the Selection column of a table. A red check mark indicates selection. You can typically select more than one object. 120 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 3 – User Interface Print Screen Print Screen To print the screen that is currently displayed: 1. Open the appropriate screen in the Working Area. 2. Select Actions > Print Screen in the menu bar. NOTE: Except for alarm screens, Print Screen is not available when a window or dialog box is open on top of the screen. See Also l Formatting Reports l Exporting Data l Print 121 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 3 – User Interface Run / Auto Run Run / Auto Run Overview When Auto Run is enabled, samples run automatically when PLACED. You do not have to select Run in the toolbar or the menu bar.Auto Run is enabled in the Global Definitions Setup screen. Auto Run cannot be disabled for LAS. The run starts automatically when all the following conditions are met: l The AM status is READY. l Sample status is PLACED. l Enhanced clean is not required. l Temperatures are in range. l At least one ORU is enabled. The instrument monitors these conditions at one-minute intervals. If the required conditions are not met, the instrument retries Auto Run after each monitoring interval. After Auto Run starts, the instrument status remains BUSY until testing is complete. A sample with tests that are not feasible remains in the LAS Cuvette Holding Area until all tests become feasible, or until the sample expiration time elapses. LAS alarms appear in the General Log as well as in External Communications Alarms area in the Status Bar. Auto Run has its own status line at the bottom of the screen. The LED statuses include the following: l Amber – Stopped l Gray – Disabled l Green – Ready l Red – Not Available See LED Status Color Codes. To determine why Auto Run is not available, hover your mouse over the red LED to display a tooltip stating cause of the error. If the Auto Run status is both STOPPED and NOT AVAILABLE, the STOPPED status displays. If Auto Run leaves the STOPPED state but remains in the ERROR state, the status displays NOT AVAILABLE. 122 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 3 – User Interface Run / Auto Run After Initiating a Test When you confirm the run, a progress bar appears while the system is processing the run command. It disappears when processing is finished. After the run starts, other jobs can be added and executed within the same analytical session. You are not forced to press the Run icon again after new tests are programmed within existing or new racks. The time to completion is displayed in the status bar during test execution. See Information Panel. The testing finishes when all feasible jobs programmed in the last started analytical session are completed. NOT FEASIBLE tests generate alarms for each missing material. If the job is not feasible because QC failed or there is no validated calibration, an alarm message appears. See Calibration Setup and QC Setup Definition to see how to set this feasibility check. When the analytical session finishes, NOT FEASIBLE tests are canceled and their status changes to PLACED. If, between the programming and the run, one or more tests become inconsistent or disabled, associated tests are canceled and their status changed from PLACED to TO DO when the run begins. An alarm is also generated. When the analytical cycle completes, the system performs a clean cycle for all probes and activates the waste accumulator peristaltic pump to empty the contents of both the sample and reagent waste accumulators. See Fluid Waste. Running Tests on Manually Loaded Samples You can only run tests when the analyzer status is READY. You can run tests programmed in one or more sample racks. To run tests on manually loaded samples: l Select the Run icon in the toolbar, or select Run in the Actions menu. NOTE: After selecting the run command, the following apply: l l l If an enhanced clean is required, the instrument prompts you to perform it. Press OK to abort running the test. You must perform the enhanced clean before running the test. See Enhanced Clean in Performing Maintenance Activities. If the temperature is out of range, the instrument prompts you to confirm the run command or cancel and wait until temperatures are in range. The instrument prompts you with a list of the disabled ORUs, if any, as a warning about throughput changes. Confirm or cancel the run. 123 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 3 – User Interface Run / Auto Run Enabling and Resuming Auto Run To enable Auto Run: 1. Make sure the instrument is in the READY state. 2. Select Setup > Global Definitions in the menu bar. 3. Select Auto Run in the Run area of the Global Definitions screen. 4. Select the Save icon in the toolbar to save your changes. 5. With Auto Run enabled, testing begins as soon you load the required materials onto the instrument. You do not have to select Run in the toolbar or the menu bar to start a test. 6. If any of the following conditions occur, the instrument disables Auto Run: l The AM status is not READY. l Sample status is not PLACED. l Enhanced clean is required. l Temperatures are out of range. l All ORUs are enabled. 7. If the instrument disables Auto Run, hover the cursor over the red LED on the screen to display a tooltip stating cause of the error. Correct the error. Then select Instrument > Resume Auto Run in the menu bar to resume Auto Run. See Also l LED Status Color Codes l Reference Section Overview l Resume Auto Run 124 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 3 – User Interface Exporting Data Exporting Data Exporting an Entire List To export an entire list to an external file: 1. Open a list to export (Material List, Test List, Sample List). 2. Select Actions > Export > <submenu> in the menu bar. For example, select Export Material List or Export Test List. 3. In the Export dialog box, select a file format and destination, then select OK. Exporting Selected Data To export selected to an external file: 1. Open a list to export (Material List, Test List, Sample List). 2. Select1 one or more rows in the list that is open in the Working Area. 3. Select Actions > Export > <submenu> in the menu bar. 4. In the Export dialog box, select a file format and destination, then select OK. Export File Formats l Acrobat l Crystal Reports l HTML 3.2 l HTML 4.0 l MS Excel 97-2000 l MS Excel 97-2000 (Data only) l MS Word l ODBC l Record Style (columns no spaces) l Record Style (columns with spaces) l Report Definition l Rich Text Format l Separated Value (CSV) l Tab-separated Text l Text l XML 1Click in the Selection column of a table. A red check mark indicates selection. You can typically select more than one object. 125 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 3 – User Interface Exporting Data NOTE: After you print or export a report or a list, you may not be able to perform certain operations, such as shutting down the instrument. The system may seem to lock up. When you print or export, the Print/Export dialog box opens. If you click anywhere on the ACL TOP screen, or select a menu item before you select Confirm or Cancel in the dialog box, the dialog box moves behind the ACL TOP application window, preventing you from doing anything else. You must: 1) minimize the ACL TOP application window; 2) select Confirm or Cancel; 3) then maximize the ACL TOP window. You can also press ALT+Tab to display the Print or Export dialog box. See Also l Importing and Exporting Definitions l Print 126 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 3 – User Interface Cancel / Stop / Progress Bar Cancel / Stop / Progress Bar The Cancel button cancels the operation currently in progress, and rolls back the changes that have occurred up to that point. The Stop button cancels the operation that is currently in progress. The Progress Bar graphically represents the execution of an operation that requires time to run, and can be canceled. See Also l Common Functions Overview Logging Out Use the Log Out command if you leave the system unattended and want to prevent access to it with your log on name. You can log out while the system is operating. 1. Select Instrument > Log Out. 2. Select OK in the confirmation dialog box. See Also l Login l Common Functions Overview Exit To close out of the ACL TOP software: l Select Instrument > Exit in the menu bar, or select the close box in the upper right corner of the screen. See Also l Starting the Instrument l Shutting Down the Instrument l Emergency Stop l Controlled Stop l Recovery 127 of 992 L0027503450 R00 ACL TOP Family Operator's Manual CHAPTER 4 SETUP Material List The Material List contains all the available defined materials used on the system. Before a material can be used it must be defined. The system contains a library of definitions for materials manufactured by IL for use on the instrument. Accessing the Material List To open the Material List screen: l Select Setup > Material List in the menu bar. Filtering the Material List To filter the Material List: 1. Select the down arrow to the right of the Filter icon in the toolbar. 2. Select one or more of the following options on the filter drop-down menu: l Show All l Cal1/NPP2 and QC l Diluents l Reagents l Clean l Enabled materials l Disabled materials 1Calibrator. A type of sample with an assigned value used to calibrate a test. 2Normal Pool Plasma. A type of sample used as a standard of comparison when calculating the International Normalized Ratio (INR) and when calculating test results that use the normalized ratio. 128 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Material List Material List Toolbar The operations toolbar includes the following: Select the following icons to perform the associated tasks: Add a New Material View Material Definition Delete a Material Filter Material Restriction Map Scan (2D bar code) Print the Material List 129 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Material List Material List Actions Menu C onfiguration Select Configuration > Filter to open a submenu of filters used to filter the materials displayed in the Material List Table. Material Select Material > Add to add a material definition. Select Material > Delete to delete a non-IL material definition. To delete, you must first place a check mark in the left column in the Material List Table next to the material name. A material used in a test definition cannot be deleted before the test definition is deleted. Either remove it from the test definition, or delete the test definition, then delete the material. Select Material > Scan to scan a 2D bar code to update lot information and other values. (for example, ISI value for reagents, or assigned value for calibrators). NOTE: You may not delete IL-locked materials. R esults Select Results > Find Material to open the Quick Search window. Enter the material name and select OK. Print Preview Select Print Preview > Print Preview Material List to preview a report containing the entire Material List before printing. Print Select Print > Print Material List to print a report containing the entire Material List. Select Print > Print Material Definitions to print a report containing the selected material definitions. 130 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Material List Export Select Export > Export Material List to export the Material List report. Specify the format and the destination in the popup Export dialog box. See: Exporting Data. Select Export > Export Material Definitions to export the selected1 material definitions. NOTE: After you print or export a report or a list, you may not be able to perform certain operations, such as shutting down the instrument. The system may seem to lock up. When you print or export, the Print/Export dialog box opens. If you click anywhere on the ACL TOP screen, or select a menu item before you select Confirm or Cancel in the dialog box, the dialog box moves behind the ACL TOP application window, preventing you from doing anything else. You must: 1) minimize the ACL TOP application window; 2) select Confirm or Cancel; 3) then maximize the ACL TOP window. You can also press ALT+Tab to display the Print or Export dialog box. Print Screen Select Print Screen to print the screen currently displayed. R eview Select Review >Previous Screen to return to the last screen displayed. Select Review > Material Definition to display the Material Definition screen for the material that has the focus. Select Review > Restriction Map to display the Restriction Map showing the types of material to place onto each track. It also shows the types of racks that may be placed and their corresponding track positions. 1Click in the Selection column of a table. A red check mark indicates selection. You can typically select more than one object. 131 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Material List Material List Table The Material List displays what is defined for each material. Column Heading Descriptions Select Click one or more cells in this column to place check marks, selecting rows to perform actions on. Click the Select icon in the column heading to select or deselect all the rows in the table. When you select one or more rows, the Delete toolbar icon is enabled (for non-IL materials only). N ame The name of the material. Type A material can be one of the following types: l Intermediate reagent l Start reagent l Sample Diluent l Quality Control l Calibrator/NPP l Clean l Deficient Plasma Start R eagent A check mark indicates the material is a start reagent. A start reagent is a material that, when mixed with a sample or a sample mixture (for example, a sample + diluent) begins the reaction. See Test Feasibility for proper placement of all reagents. 132 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Material List Material R eferenced A check mark indicates the material is used in at least one test definition. A material is also referenced if it is configured in the Material Programming Window. Referenced materials cannot be deleted. A material becomes non-referenced when it is no longer in the Material Programming window in a test definition, or when the test definition is deleted. Material On-board A check mark indicates the material is currently placed on the system. Placed materials cannot be deleted or edited. Material Manufactured by IL A check mark indicates the material was manufactured and approved by Instrumentation Laboratory. ILdefined materials cannot be deleted. Lot ID An alphanumeric code that identifies where and when the material was manufactured. Exp. D ate The date when the material no longer meets the manufacturer’s specifications. R efrigeration A check mark indicates the material requires refrigeration. Stirring A check mark indicates the material requires stirring. Stirring is available only in rack positions 1 and 2 on all reagent racks. Index The following values indicate: l 1-500 – Material manufactured by Instrumentation Laboratory. l 501-999 – User-defined material. Unique for each material. A lternate Lot A check mark indicates the material has an alternate lot defined. An alternate lot can be used to evaluate a new material lot before the current lot expires. 133 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Material List Enabled Material A check mark indicates the material is referenced by an enabled test. An unchecked box indicates the material is included in a test definition for a test that has been disabled. See Test List . See Also l Material Definition l Reagents l Restriction Map l Test Feasibility l Reagent Area 134 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Material Definition Material Definition Viewing and Adding Material Definitions To view material definition information: 1. Select Setup > Material List in the menu bar. 2. Select the View icon in the toolbar, or double-click a material on the Material List to display the Material Definition screen. 3. View settings on the following tabs: l General Information tab l Stir, Rinse & Clean Information tab l Lot Specific Information tab 4. Select the Add icon in the toolbar to define a new material. 5. Select the Save icon in the toolbar to save your changes. 6. Select the Previous Screen icon in the toolbar to return to the Material List. 135 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Material Definition Configuring Reporting of INR Results To report INR1, you must enable NPP2 and define a valid NPP value in the test definition. The NPP default value is 0.0. Enter the ISI3 value into the Material definition for the PT reagents as follows: 1. Select Setup > Material List in the menu bar. 2. Place focus4 on the PT reagent, and select the View icon in the toolbar. 3. On the Lot Specific Information tab select Enable lot management. 4. Select the ISI Value option and enter the ISI value from the PT reagent package insert. 5. Select the Save icon in the toolbar to save your changes. 6. Select Setup > Test List in the menu bar. 7. In the Test List, place focus on the PT test code and select the View icon in the toolbar. 8. In the Test Definition screen, select Normal Pool Plasma in the navigational tree. 9. In the Normal Pool Plasma screen, select the Enable NPP option (if not selected) and edit the NPP information as appropriate for your laboratory. 10. Select the Save icon in the toolbar to save your changes. 11. The ACL TOP instrument is now properly set up to report INRs. See ISI Value. NOTE: l If the product lot number changes, the new ISI value from the package insert must be entered. l If the measured result is 0, the Ratio and INR results fail. 1International Normalized Ratio. This value is used to standardize the reporting of Prothrombin Time (PT) worldwide. 2Normal Pool Plasma. A type of sample used as a standard of comparison when calculating the International Normalized Ratio (INR) and when calculating test results that use the normalized ratio. 3International Sensitivity Index. This value is provided by each Prothrombin Time (PT) reagent and used to calculate the International Normalized Ratio (INR). 4To place focus on the unique identifier in a list, click a row in the table. A blue cell border indicates focus. Only one unique identifier in a list can have focus. 136 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Material Definition Material Definition Actions Menu Material Select Material > Save to save the changes to the material definition. Select Material >Restore to restore the screen to its previous values. Select Material >Activate Lot to activate the alternate lot. Print Preview Select Print Preview to display a preview of the Material Definition Report before printing. Print Select Print to print the Material Definition Report. The report displays the same information as the Material Definition screen, with the fields labeled as Enabled or Disabled. Export Select Export to export the Material Definition Report. See Exporting Data. NOTE: After you print or export a report or a list, you may not be able to perform certain operations, such as shutting down the instrument. The system may seem to lock up. When you print or export, the Print/Export dialog box opens. If you click anywhere on the ACL TOP screen, or select a menu item before you select Confirm or Cancel in the dialog box, the dialog box moves behind the ACL TOP application window, preventing you from doing anything else. You must: 1) minimize the ACL TOP application window; 2) select Confirm or Cancel; 3) then maximize the ACL TOP window. You can also press ALT+Tab to display the Print or Export dialog box. Print Screen Select Print Screen to print the screen that is currently displayed. Review l Select Review > Previous Screen to view the previous screen. l Select Review > Assigned Values to view the Assigned Values window. See Assigned Values. 137 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Material Definition Material Definition – Toolbar The operations toolbar for this screen includes the following: Select the following icons to perform the associated tasks: Assigned Values (only for a material defined as a calibrator1). Save – Saves the Material Definition. Restore. Activate Lot. Print – Prints Material Definition Report. 1A type of sample with an assigned value used to calibrate a test. 138 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Material Definition Material Definition – General Information Tab Material Index Unique number for each material. The analyzer uses the material index value internally, as follows: l 1-500 – IL materials l 501-999 – User-defined materials Material Name Enter a name for a new material, or edit an existing name. Accepts a maximum of 20 alphanumeric characters. NOTE: Changing the name of a material, invalidates its calibration. If you change the material name, you must recalibrate the tests that use the material. Manufacturer Defaults to IL, but may be edited if the material is from another manufacturer. Accepts a maximum of 15 alphanumeric characters. 139 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Material Definition Category Type / Material Type These fields define the material type. They cannot be changed for an existing material. For a new material, select options from the category drop down list. Then select the material type from the drop down list. C al/N PP and QC l Calibrator/NPP1 l Quality Control C lean l Clean D iluents l Sample Diluent l Reagent Diluent R eagents l l l Deficient Plasma Intermediate Reagent – A material that, when mixed with sample, activates certain components of the sample, but is not enough to bring the reaction to the desired completion. These reagents are always be followed by a start reagent. See Test Feasibility for proper placement of all reagents. Start Reagent – A start reagent is a material that, when mixed with a sample or a sample mixture (for example, a sample + diluent) begins the reaction. See Assigned Values. 1Normal Pool Plasma. A type of sample used as a standard of comparison when calculating the International Normalized Ratio (INR) and when calculating test results that use the normalized ratio. 140 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Material Definition Bottle Type Use to specify the bottle size. The system calculates the actual volume of material available in the bottle when the probe senses the presence of the liquid. For IL materials, the bottle volume is obtained from the bar code on the bottle. When a new material is defined, the correct volume must be selected from a drop down list. NOTE: When materials are loaded and identified via the bar code, the system recognizes the bottle type, and automatically updates the material definition. When manually identifying a material, make sure the bottle size matches the defined bottle type. Mismatch of bottle size and bottle type may result in erroneous volume tracking and handling. The following graphic depicts the bottles and shows their volumes and maximum fill lines. Smallest Volume/D ead Volume The ACL TOP instrument indicates when a bottle of material can no longer be used. The liquid remaining in the bottle when the bottle is no longer valid is defined as the throwaway material. The throwaway material depends on both 1) the smallest volume for a material; and 2) the dead volume of a material bottle. l Smallest Volume – For each enabled material definition in the system that is referenced by an enabled test definition, the system automatically computes the smallest volume defined for it. The smallest volume equals the smallest pipetting volume for a single pipetting step in any test where the material is used. This volume is used by the system to compute the zero bottle volume. The system 141 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Material Definition considers as EMPTY all bottles that contain less than the smallest volume for that bottle. For example, if the volume of liquid in a bottle is too low to perform a test: 1) the status of that material is changed to EMPTY; 2) the on-board volume changes to 0; and 3) the bottle status changes to a red color (status = PLACED, ERROR). The smallest volume may be modified: 1) each time any related test definition is changed; and 2) when you change system parameters that could affect test definition volumes (for example, dilution parameters). Important: Material smallest volume affects only the display of the material status (the on-board volume and the material bottle status [color]). l Dead Volume – The unusable volume that triggers the <Material name> insufficient volume alarm. For example: 1) there are no more bottles of the same material available on the instrument; 2) it is the last available bottle; or 3) there is not enough material to execute the test. The dead volume depends on the material bottle. Dead volume is based on the physical geometry of the bottle, mechanical tolerances, etc. Aspirating from a bottle beyond its dead volume creates a risk of performing partial aspirations, which may affect analytical results, or risk the probe striking the bottom of the bottle. Dead volumes have been optimized for reagent bottles located in stirred positions. The following table lists dead volumes, including volume measurement accuracies that depend on instrument-to-instrument variability. NOTE: Values shown here represent estimates. Since material properties differ, actual values may vary due to inherent differences in the physical properties of the sample or reagent within them. Bottle Size Max. Dead Volume NonStirred Max. Dead Volume Stirred Volume Measurement Accuracy 2 mL sample cup 0.15 mL N/A N/A 4 mL 0.4 mL N/A ± 0.2 mL 7.5 mL 0.8 mL N/A ± 0.3 mL 10 mL 0.8 mL 2.0 mL ± 0.3 mL 15 mL 1.3 mL 2.8 mL ± 0.5 mL 20 mL 1.3 mL 2.8 mL ± 0.5 mL 30 mL 3.5 mL N/A ± 0.7 mL Aliquot tube (Fisherbrand) N/A* N/A Aliquot tube (Corning) N/A* N/A Cuvette 65 μL N/A * Dead volumes for aliquot tubes cannot be determined due to variability of tube geometry, tolerance, sample characteristics, and tube material. 142 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Material Definition l l Throwaway Material – This depends on both the material smallest volume and the bottle dead volume. Usable Volume – The total volume of liquid in a specific material bottle minus the dead (unusable) volume of that bottle. Volume Tracking The system uses the fill volume to track the available volume of material in real-time, and generates a warning when the volume reaches the defined warning threshold. Enable Volume Threshold Specifies the volume of material remaining that triggers low volume. The minimum allowed value is 0.3 mL (to eliminate the possibility of having insufficient material to complete a run. The low volume warning threshold should be established for every material based on the laboratory workload and workflow to allow enough time to replace the material. Enable Expiration Tracking Option to generate a warning when the material approaches its expiration date. The expiration date is defined in the Lot Specific Information tab. This option also is available when Lot Management is disabled. For IL materials, the expiration date is read from the bar code on the bottle. NOTE: Expiration tracking is linked to the data contained in the bar code on the reagent vial. When Lot Management is disabled, expiration tracking for the reagent vial remains enabled. Expired material generates a material expiration warning. To enable extended expiration time, select the Enable lot management and Enable extended expiration date options on the Lot Specific Informationtab. Enable W arning Threshold Specifies the number of days before the material expiration date to generate a warning. The Expiration Tracking warning threshold should be established for every material, based on laboratory needs. 143 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Material Definition On-board stability Enable On-board Stability Tracking Option to automatically track the stability of a material placed in the reagent area. On-board Stability Specifies the number of minutes, hours or days that the material remains stable while it is on the Analyzer1 in the Diluent or Reagent area. The system generates an error and stops using that material when the defined onboard stability time elapses. This field is available only for user-defined materials. Enable warning threshold Specifies the number of minutes, hours or days before reaching the on-board stability limit to issue a warning. The low on-board stability warning threshold should be established for every material, based on laboratory needs. NOTE: Do not change the date and time on the host computer. This can affect material stability and patient data. The instrument has an internal clock that resets the date/time when necessary. Test not feasible when stability is expired When this option is selected, the following events occur when the reagent material exceeds the on-board stability: l Tests in the TO DO state will not run. l Tests that are PLACED but not scheduled will not run. l l l l Tests that are PLACED and scheduled, but NOT FEASIBLE (required materials are not on-board) will not run. Tests that are PLACED and ACTIVE (required materials are on-board) will run, and the results are flagged. Tests that are NOT FEASIBLE (required materials are not on-board) will not run. Exception: If an onboard material expires while a test is ACTIVE, the test will run but the results will be flagged. Tests that are COMPLETE remain complete. NOTE: Rerun and Reflex tests are created and executed (if feasible) during the run session, so they have PLACED status, and run based on the above rules. Comments Enter notes about the material, if desired. 1The part of the instrument where sample processing and testing are performed. Also called the AM or the Analytical Module. 144 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Material Definition Location Information Location information is provided only when the material is on-board. This consists of a table with the following data columns: l Track identifier – ID for a track l Rack identifier – ID for a rack l Rack position identifier – ID for a rack position l Lot identifier – ID for a lot number l Stirring indicator – Check mark means position has stirring l Refrigeration indicator – Check mark means position has cooling 145 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Material Definition Material Definition – Stir, Rinse & Clean Information Tab On this tab, define: 1) how the instrument performs rinse and clean after a material has been pipetted; and 2) whether stirring is necessary. Select Rinse or Clean and Rinse for reagent, diluent and sample materials. 146 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Material Definition Rinse Option to perform probe rinse operations. This option is disabled if you select the Clean & Rinse option. Frequency Specifies when to perform probe rinsing. Options are: l l Between changes in material only – Default option. Rinsing is not performed between multiple, successive dispensations of this material, but is performed between changes of material. After each dispensation of same material – Rinsing is performed between each dispensation of the same material. R inse time Time allocated for the probe rinsing operation. l Minimum: 1 sec. l Maximum: 5 sec. l Default: 1 sec. See Analytical Cycle Definition Screen. Option to scrub the internal probe walls (during each rinse cycle) by moving the rinse material up and down inside the probe. Configure the number of times to agitate in the field provided. Stirring required Option to stir the material. You must place a magnetic stir bar (IL Part Number 09746610) in the bottle with the fluid. The bottle must be placed in reagent rack positions R1 or R2. If the bottle is placed into a rack position that does not support stirring, the instrument issues a warning. 147 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Material Definition Clean & Rinse Option to perform probe clean and rinse operations. This option is disabled if you select the Rinse option. N umber of clean & rinse cycles Configure the number of clean and rinse cycles to perform. Clean Cycle C lean material Select a system clean material in the drop down list. NOTE: l l IMPORTANT: Many IL-defined tests use Clean B diluted as the clean material. If the Clean B diluted bottle becomes empty, the instrument performs an emergency stop, and all work in progress is lost. To avoid loss of work, place multiple bottles of Clean B diluted on-board the instrument. See Test Feasibility for proper placement of all reagents. The absence of the selected clean material from on-board the instrument makes the test that uses the material for which the clean is defined NOT FEASIBLE. N umber of aspiration cycles Configure the number of times to run the clean and rinse cycle. C lean airgap Amount of air the probe aspirates before aspirating the clean material. This prevents contaminating the clean material and ensures accurate volume delivery. l Minimum: 0 µL l Maximum: 250 µL l Default: 15 µL C lean volume Volume of clean material in microliters that the probe aspirates during the clean and rinse cycle. l Minimum: 0 µL l Maximum: 190 µL l Default: 130 µL 148 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Material Definition C lean transport airgap Volume of air aspirated after the clean volume. This prevents material loss during probe movement, and ensures accurate volume delivery. This is not selectable for system clean. l Minimum: 0 µL l Maximum: 250 µL l Default: 0 µL (Zero indicates not used.) C lean total volume Sum of the clean volume, clean airgap and clean transport airgap. The clean total volume must not exceed the maximum probe volume, or 250 µL. H old time Period of time the clean material is held in the probe before it is agitated or dispensed to waste. l Minimum: 0 sec. l Maximum: 60 sec. l Default: 0 sec. Enable agitation Option to scrub the internal probe walls (during each rinse cycle) by moving the rinse material up and down inside the probe. Configure the number of times to agitate in the field provided. C lean material volume for all cycles Volume of clean material required for the configured number of aspiration cycles. 149 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Material Definition Rinse cycle Frequency Specifies when to perform probe rinsing. Options are: l l Between changes in material only (default) – Rinsing is not performed between multiple, successive dispensations of this material, but is performed between changes of material. After each dispensation of same material – Rinsing is performed between each dispensation of the same material. R inse after clean time Time allocated for the probe rinsing operation. l Minimum: 1 sec. l Maximum: 5 sec. l Default: 1 sec. See Analytical Cycle Definition Screen. Option to scrub the internal probe walls (during each rinse cycle) by moving the rinse material up and down inside the probe. Configure the number of times to agitate in the field provided. 150 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Material Definition Material Definition – Lot Specific Information Tab Enable Lot Management Check this option to enable the fields on this tab. You can define two different lots of a material: an active lot and an alternate lot. If lot management is enabled, the material is identified by both name and lot number. This option must be enabled if an ISI value is used with a reagent. When this option is not selected, the material is identified by name only, and either lot may be placed on the system. Both lots are considered the same, and can be used for either an active lot study or an alternate lot study. Lot specific data located in this screen can be viewed and edited only when lot management is enabled. The system tracks the materials used with their corresponding lot tracking information for every test performed on the system, including calibration, QC, and patient sample tests. See Enable Alternate Lot. 151 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Material Definition Active Lot Lot ID A Lot ID is mandatory if lot management is enabled. The material identification appears on the bar code label. When using bar coded materials, if the lot ID on the bar code label does not match the lot number specified in this field, the system does not use the bar code information, and the bottle position on the CM displays a question mark to indicate MATERIAL PLACED BUT UNIDENTIFIED. Expiration D ate The expiration date of a material is printed on its label. When using bar coded materials, if the expiration date on the bar code does not match the expiration date specified in this field, the system will not use the bar coded information, and the bottle position on the CM will display a question mark to indicate MATERIAL PLACED BUT UNIDENTIFIED. Enable Extended Expiration D ate If IL extends a material expiration date, select this option and enter the new expiration date. If the extended expiration date is earlier than the original expiration date, the system issues an error, and the new date is not saved. ISI Value Available only if the material type is reagent. If you select this option, enter the manufacturer's ISI value from the reagent insert sheet to calculate the INR value. By default, this field is blank. ISI Value ISI (International Sensitivity Index) specific to the lot of thromboplastin reagent used by Prothrombin Time (PT) tests. The ISI value compares the behavior of a specific lot of PT reagent with the International Reference Thromboplastin. The ISI value must be entered in the material definition of the PT reagent in order to obtain correct INR (International Normalized Ratio) values. Failure to edit the ISI default value causes incorrect INR results. A warning is generated when the ISI value is missing. If the corresponding lot number is changed, this value becomes blank, and you must enter the ISI value for the new lot number found in the new package insert. INR Formula l INR = (PT Patient / PT Normal)ISI value l PT PATIENT = Patient’s PT in seconds l PT Normal = PT Normal Pool Plasma value, dependent on user-specified NPP mode l ISI Value = International Sensitivity Index from the current lot number of the PT reagent used CAUTION: Important Warning l If the INR calculation is not properly set up, erroneous patient results may be reported. l If the product lot number changes, insert the new ISI value from the package. 152 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Material Definition See Configuring Reporting of INR Results. Lot Specific C omment Enter a comment for this lot. Last Modification D ate/Time Date and time the lot information was last changed. Enable Alternate Lot An alternate lot is used to perform parallel studies. The results of an alternate lot study are not used by the system. You cannot validate patient results generated by the alternate lot. Select this option to use another lot of the same material. The fields for alternate lot are the same as for active lot. The lot ID must be different than the active lot ID. If the last 4 digits of the ID are the same for both lots, the expiration dates must be different or an error is issued. Tests that require a calibration allow an active lot calibration and an alternate lot calibration to be valid at the same time. This allows the results from the new lot of material to be compared to its own calibration curve. You can automatically activate the alternate lot if the material is not on-board and if both the active and alternate lots have been enabled and defined for the material. When the alternate lot has been automatically activated, the lot information is copied from the alternate lot to the active lot, the existing active lot data is archived, the alternate lot fields are set to their default values and the alternate lot is disabled. Use the Actions menu or the Activate Lot alternate lot. icon to activate the If the material that is being activated is a calibrator, the calibrations obtained with an active lot of calibrator always remain active and can always be validated (even when that lot does not exist any more). Calibrations obtained with an alternate lot of calibrator become active when the alternate lot becomes active. All other existing active and validated tests that were run with the previous active lot of calibrator, but were not run with the alternate lot of that calibrator, are not affected. They remain active and validated, although obtained with an active lot that is no longer active. NOTE: l l Only active calibrations can have a calibration lot that is no longer in the system. Validated alternative lot calibrations become unvalidated when any of the lots of the calibrator or reagents used for them are removed from the system. The recalculation function is not available for calibrations performed using an old calibrator lot or an old reagent lot. l To manually switch from alternate lot to active lot, you must first disable the alternate lot. l The active and alternate lots cannot have the same lot number. l When you manually disable the alternate lot of QC material, all QC data associated with that lot is lost. 153 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Material Definition Test not feasible when lot is expired Option to cancel tests that use this material after the lot expires. See Also l Review and Validation l Reviewing QC Results l Reviewing Test Results 154 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Assigned Values Assigned Values Overview The Assigned Values window for a material is accessible only when the following conditions are met: l l Calibration – The material is used in a test definition for calibration/NPP1. The assigned value field for a calibration material is also available in Test Definition – Calibration. QC – The material is used in a Quality Control definition in the QC List. The assigned value for a quality control material is also available in QC Definition. Viewing, Editing, Printing, Exporting Assigned Values To view assigned values: 1. Select Setup > Material List in the menu bar. 2. In the Material List, double-click a material of type Quality Control or Calibrator/NPP to open the Material Definition screen. 3. Select the Assigned Values the selected material. icon in the toolbar to open the Assigned Values dialog box for NOTE: If you enable lot management, you must enter and save the lot number and expiration date on the Lot Specific Information tab. Failure to do this disables the Assigned Values icon. 4. To edit assigned values, double-click a cell in the appropriate column, edit the value, and select the OK button. 5. To print assigned values, select the Print button and follow the prompts. 6. To preview assigned values before printing, select the Preview button. 7. To export assigned values, select the Export button and follow the prompts. NOTE: NOTE: After you print or export a report or a list, you may not be able to perform certain operations, such as shutting down the instrument. The system may seem to lock up. When you print or export, the Print/Export dialog box opens. If you click anywhere on the ACL TOP screen, or select a menu item before you select Confirm or Cancel in the dialog box, the dialog box moves behind the ACL TOP application window, preventing you from doing anything else. You must: 1) minimize the ACL TOP application window; 2) select Confirm or Cancel; 3) then maximize the ACL TOP window. You can also press ALT+Tab to display the Print or Export dialog box. 1Normal Pool Plasma. A type of sample used as a standard of comparison when calculating the International Normalized Ratio (INR) and when calculating test results that use the normalized ratio. 155 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Assigned Values Assigned Values for Calibration Assigned values for the active lot of a calibrator1 are edited in the Active Lot column. Assigned values for the alternate lot of a calibrator are edited in the Alternate Lot column. 1A type of sample with an assigned value used to calibrate a test. 156 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Assigned Values Assigned Values for QC Target mean values for the active lot of control are edited in the Active Lot – Mean column. The SD values are edited in the corresponding Active Lot – SD column. Target mean values for the alternate lot of control are edited in the Alternate Lot – Mean column. The SD values are edited in the corresponding Alternate Lot – SD column. See Also l Material Definition l QC Setup Definition 157 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Test List Test List This screen contains a list of tests that are performed on the ACL TOP instrument. The information displayed in the Test List table is imported from the Test Definition screens. Accessing the Test List To open the Test List: l Select Setup > Test List in the menu bar. Filtering the Test List To filter the Test List: 1. Select Setup > Test List in the menu bar. 2. Do one of the following: l l Select Actions > Configuration > Filter > Enabled Tests and/or Disabled Tests in the menu bar to toggle those filters on and off. Select the arrow on the Filter icon in the toolbar, and select Enabled Tests and/or Disabled Tests to toggle those filters on and off. 3. The filter configuration persists. Viewing a Test Definition To view a test definition: 1. Select Setup > Test List in the menu bar. 2. Double-click a test in the Test List. 3. Select an item in the Test Definition navigation tree to view the test settings in the respective screen. 4. Select the Previous Screen icon in the toolbar to return to the Test List. 158 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Test List Printing and Exporting a Test Definition Report – Single Test A test definition report contains all the test settings defined in the test definition. To print or export a test definition report for a single test: 1. Select Setup > Test List in the menu bar. 2. Double-click a test in the Test List. 3. In the ACL TOP menu bar, select Actions > Print or Actions > Export...Or select the Print Export or icon in the toolbar. 4. <Export> Choose the export Format and file Destination in the Export dialog box, then select Save. Printing and Exporting a Test Definition Report – Multiple Tests A test definition report contains all the test settings defined in the test definition. To print or export a test definition report for multiple tests: 1. Select Setup > Test List in the menu bar. 2. In the Test List, select1 the tests to print or export. 3. In the ACL TOP menu bar, select Actions > Print > Print Tests Definition or Actions > Export > Export Tests Definition. 4. <Export> Choose the export Format and file Destination in the Export dialog box, then select Save. NOTE: Test definitions can be from several to forty pages long. Printing or exporting multiple test definitions may result in a long processing time. These operations perform in the background. 1Click in the Selection column of a table. A red check mark indicates selection. You can typically select more than one object. 159 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Test List Adding/Creating a User-Defined Test To create a new user-defined test: 1. <Optional> Select Setup > Security > Software Access Screen and check that you have proper security level to perform the required actions. 2. Select Setup > Test List in the menu bar. 3. In the Test List, select the Add bar. icon in the toolbar, or select Actions > Test > Add in the menu 4. Enter a unique Test code and Test name in the Non-IL Test Definition – General Information screen. 5. Select the required test definition items in the navigation tree and configure the required fields in the respective screens. 6. Select the Save icon in the toolbar to save your changes. 7. Select the Previous Screen in the list. icon in the toolbar to return to the Test List. The new test appears NOTE: A user with the appropriate security level can create a new test or copy an existing test. All responsibility for parameter development and validation of new or copied tests belongs to the user alone. Copying a Test To copy a test: 1. <Optional> Select Setup > Security > Software Access Screen and check that you have proper security level to perform the required actions. 2. Select Setup > Test List in the menu bar. 3. Select1 a test in the Test List. 4. Select the Copy icon in the toolbar, or select Actions > Test > Copy in the menu bar. 5. The copied test opens in the Test Definition screen. All test definition information except the Test Code, Test Name and LIS number is copied to the new test definition. NOTE: A user with the appropriate security level can create a new test or copy an existing test. All responsibility for parameter development and validation of new or copied tests belongs to the user alone. 1Click in the Selection column of a table. A red check mark indicates selection. You can typically select more than one object. 160 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Test List Deleting a Test Definition To delete a test: 1. Select Setup > Test List in the menu bar. 2. Select1 a user-defined test in the Test List. 3. Select the Delete icon in the toolbar, or select Actions > Test > Delete in the menu bar. 4. Confirm the deletion in the Deleting Test Definition dialog box. This dialog box lists all the references associated with that test that will also be deleted. 5. See Test Deletion Rules. NOTE: A user with the appropriate security level can create a new test or copy an existing test. All responsibility for parameter development and validation of new or copied tests belongs to the user alone. About Deleting Test Definitions Tests referenced elsewhere in the system cannot be deleted unless the references are also deleted (for example, parent/shadow, paired test, imported test, reflex rules, QC, test profile, Test Programming window, and Sample List). You may manually delete references to tests, or allow the instrument to delete them automatically. If tests are referenced in other locations, the system displays a message listing the references to delete. Test Deletion Rules The rules for deleting a test from the system are as follows: l IL-locked tests cannot be deleted in the Test List. l A parent test cannot be deleted until all of its shadow tests are deleted. l A test whose calibration results are imported by another test cannot be deleted until all tests that import the test are deleted. 1Click in the Selection column of a table. A red check mark indicates selection. You can typically select more than one object. 161 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Test List l l l l l l The master test in a paired test definition cannot be deleted until the paired test partner is deleted. A test referenced in one or more QC definitions cannot be deleted until the QC definitions referencing the test are deleted. A test referenced in one or more test profile definitions cannot be deleted until the references or profiles are deleted. A test referenced in one or more reflex rules cannot be deleted until the references or rules are deleted. A test referenced in the Test/Profiles Programming window cannot be deleted until it is removed from the programming window. A test referenced in the Sample List Display Settings cannot be deleted until it is removed from the display settings. Enabling or Disabling a Test To enable or disable a test: 1. Select Setup > Test List in the menu bar. 2. <Optional> Filter the Test List by Enabled Tests or Disabled Tests, or both 3. Select one or more tests in the Test List. 4. Select the Enable/Disable Test in the menu bar. icon in the toolbar, or select Actions > Test > Enable/Disable 5. If a test is enabled, it becomes disabled. If disabled, it becomes enabled. A check mark in the Test Status column in the Test List indicates the test is enabled. NOTE: l l A test referenced elsewhere cannot be enabled/disabled until the references are disabled/enabled (for example: parent/shadow, paired test, imported test, reflex rules, test profile, Profiles Programming screen, or Sample List Display Settings). References must be manually enabled or disabled. The Promote function on the Actions > Test menu is available only to IL test developers. Finding a Test To find a test in the Test List: 1. Select Setup > Test List in the menu bar. 2. Select Actions > Results > Find Test in the menu bar. 3. Enter all or part of the test code in the Quick Search window. 4. Select Next or Previous to find and place focus1 on the test code in the Test List. 1To place focus on the unique identifier in a list, click a row in the table. A blue cell border indicates focus. Only one unique identifier in a list can have focus. 162 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Test List Test List Toolbar The operations toolbar for the test list screen includes the following: Select the following icons to perform the associated tasks: Add a new test View a test definition Delete a test Copy a test Enable/Disable test Filter the Test List Print the Test List Test List Actions Menu The Actions menu for the test list is as follows: 163 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Test List Test List Screen Select Click one or more cells in this column to place check marks, selecting rows to perform actions on. Click the Select icon in the column heading to select or deselect all the rows in the table. Selecting one row enables the Copy, Delete and Enable/Disable Test toolbar icons. C ode Unique identifier for the test. The maximum length is 8 characters. N ame Full name of the test. The maximum length is 20 characters. IL Test A checkmark indicates a test developed by Instrumentation Laboratory. LIS Laboratory Information System test identifier used to communicate between a host computer and the ACL TOP instrument. Tests with an extended acquisition mode enabled have a unique LIS number for the test run in this mode. Tests with parallelism enabled have a unique LIS number for the test run in the parallelism mode. The maximum number of LIS numbers per test definition is four: 1) standard acquisition mode; 2) extended acquisition mode; 3) parallelism mode; and 4) alternative pre-dilution. A cq. Time Standard Acquisition Time = The number of seconds the instrument spends acquiring data during a test. N o. R eps Number of replicates the test performs on patient and/or QC samples. The default value is 1. 164 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Test List U nit Primary unit for the measured result in the test. N ormal R ange Range of values the user has defined as the normal range of test results for patients in their population. The default range is -999999.9 to 999999.9. C onsistency A check mark indicates the test definition is consistent. Inconsistencies must be corrected before a test can run. Test Enabled/D isabled A check mark indicates the test is enabled to run on the instrument. A test referenced elsewhere cannot be enabled/disabled until the references are disabled/enabled (for example: parent/shadow, paired test, imported test, reflex rules, test profile, Profiles Programming screen, or Sample List Display Settings). References must be manually enabled or disabled. See Also l Test Definition 165 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Test Definition Test Definition Viewing a Test Definition To view a test definition: 1. Select Setup > Test List in the menu bar. 2. Double-click a test in the Test List. 3. Select an item in the Test Definition navigation tree to view the test settings in the respective screen. 4. Select the Previous Screen icon in the toolbar to return to the Test List. Printing and Exporting a Test Definition Report – Single Test A test definition report contains all the test settings defined in the test definition. To print or export a test definition report for a single test: 1. Select Setup > Test List in the menu bar. 2. Double-click a test in the Test List. 3. In the ACL TOP menu bar, select Actions > Print or Actions > Export...Or select the Print Export or icon in the toolbar. 4. <Export> Choose the export Format and file Destination in the Export dialog box, then select Save. Printing and Exporting a Test Definition Report – Multiple Tests A test definition report contains all the test settings defined in the test definition. To print or export a test definition report for multiple tests: 1. Select Setup > Test List in the menu bar. 2. In the Test List, select1 the tests to print or export. 3. In the ACL TOP menu bar, select Actions > Print > Print Tests Definition or Actions > Export > Export Tests Definition. 4. <Export> Choose the export Format and file Destination in the Export dialog box, then select Save. NOTE: Test definitions can be from several to forty pages long. Printing or exporting multiple test definitions may result in a long processing time. These operations perform in the background. 1Click in the Selection column of a table. A red check mark indicates selection. You can typically select more than one object. 166 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Test Definition Creating a User-Defined Test To create a new user-defined test: 1. <Optional> Select Setup > Security > Software Access Screen and check that you have proper security level to perform the required actions. 2. Select Setup > Test List in the menu bar. 3. In the Test List, select the Add bar. icon in the toolbar, or select Actions > Test > Add in the menu 4. Enter a unique Test code and Test name in the Non-IL Test Definition – General Information screen. 5. Select the required test definition items in the navigation tree and configure the required fields in the respective screens. 6. Select the Save icon in the toolbar to save your changes. 7. Select the Previous Screen in the list. icon in the toolbar to return to the Test List. The new test appears NOTE: A user with the appropriate security level can create a new test or copy an existing test. All responsibility for parameter development and validation of new or copied tests belongs to the user alone. Test Definition Operations Toolbar The Test Definition toolbar consist of, but is not limited to, the following: Select the following icons to perform the associated tasks: Apply Consistency Checks to determine whether the current test definition information is consistent. Save the test definition. Restore the previously saved information. 167 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Test Definition NOTE: l l If you change the parameters of a user-defined test such that the analytical performance of that test is affected, you must recalibrate that test. See User-Defined Tests disclaimer. You cannot edit the test definition of a test with a status of PLACED. See Also l Test List l General Information l Analytical Cycle Definition l Data Reduction Parameters l Result Unit Definition l Calibration l Parallelism l Normal Pool Plasma l Rerun Rules 168 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup General Information Screen General Information Screen Accessing the General Information screen To open the General Information screen for a test: 1. Select Setup > Test List in the menu bar. 2. Do one of the following in the Test List to open the Test Definition screen for a test: l Double-click a test. l Place focus1 on a test code, and select the Test Definition l Select2 a test, and select Actions > Review > Test Definition in the menu bar. icon in the toolbar. 3. Select General Information in the navigation tree to view the General Information screen. 4. <Optional> Edit the General Information screen. 5. Select the Save icon in the toolbar to save your changes. 6. Select the Previous Screen icon in the toolbar to return to the Test List. 1To place focus on the unique identifier in a list, click a row in the table. A blue cell border indicates focus. Only one unique identifier in a list can have focus. 2Click in the Selection column of a table. A red check mark indicates selection. You can typically select more than one object. 169 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup General Information Screen General Information Actions Menu Test l Select Test > Apply Checks to apply consistency checks to the test definition. l Select Test > Save to save the test definition. l Select Test > Restore to restore the test definition to the previously saved version. Print Preview Previews the Test Definition report containing the data displayed on the General Information screen before printing. Print Prints a Test Definition report containing the data displayed on the General Information screen. Export Exports the test definition data displayed on the General Information screen. Print Screen Prints the General Information screen. R eview Select Actions > Review > Previous Screen in the ACL TOP menu bar to return to the Test List. 170 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup General Information Screen General Information Test code Unique mnemonic for the test. The maximum length is 8 alphanumeric characters. Test name Complete name of the test. The maximum length is 20 alphanumeric characters. The test name is printed on the Patient report. LIS number Laboratory Information System identifier (used in host communication) for a test when using the standard acquisition time. The following extensions are appended to the test code for the LIS number: l 1 – Standard tests l 2 – Extended tests l 3 – Parallelism tests l 4 – Alternative Pre-dilution For example, PT-RP has a test number of 13, a standard test LIS Number of 131, an extended test LIS number of 132, a parallelism test LIS number of 133, and a Diluted LIS number of 134. NOTE: The LIS code must be programmed before analyzing samples that require test results to be uploaded to the host. Samples run before programming the LIS codes are not uploaded. Test number Unique numeric identifier for the test. Consistency requires all user-defined and IL locked tests to have a value in this field. Values are as follows: l 1-250 – IL locked tests l 251-500 – User-defined tests l 501-750 – IL locked tests for investigation only. When creating a new test or copying an existing test, the next available test number is automatically assigned to the test. IL test Read-only. If checked, the test is an IL-defined and locked. For investigation only Read-only. If checked, the test is for investigational use only. 171 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup General Information Screen Assay A ssay release number Indicates whether the assay has been modified from the last parameter release. The maximum length is 50 alphanumeric characters. Test modification number Automatically increments by a value is one each time this test definition is saved. U ser revision comment Comment stating the reason a change was made to the test definition. The maximum length is 50 alphanumeric characters. IL revision comment For IL use only. Comment stating the reason a change was made to the test definition. The maximum length is 50 alphanumeric characters. Manual validation required Option to force manual validation of test results before results can upload to the LIS. 172 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup General Information Screen Enable as Shadow Test Shadow tests are used when multiple test results are derived using the same raw data. Example Prothrombin Time (PT – the Parent Test) and Fibrinogen (FIB – the Shadow Test) where the same coagulation curve can be used to give two different results: 1) the clotting time; and 2) the amount of fibrinogen in the sample. Parent test Test that generates the raw data from which multiple results are obtained (using different algorithms to compute the results). When enabled, the Parent test drop down list becomes active. Inherit LIS numbers from parent test A checkmark indicates the LIS number from this test is identical to the parent test. Shadow Test Rules l l l A shadow test must have a parent test assigned to it. A parent test may have more than one shadow test associated with it. The maximum number of shadow tests is 5. A parent test definition cannot be deleted until after all of its shadow test definitions are disassociated from the parent test (Disable the Enable as shadow test option and deselect the parent test. Or delete the shadow test). NOTE: If you enable a test as a shadow test, you can configure a delay time for the shadow test. See Analytical Cycle Screen. 173 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup General Information Screen Enable as Paired Test Paired tests are used when a meaningful result can be generated only by comparing the results of two different tests, such as an activated form of a test against a non-activated form. Example Activated Protein C Resistance (aPCR) ratio result that compares the activated aPCR measured result against the non-activated aPCR measured result. Master paired test Option to select a test whose results are required to generate the reported result. A paired test uses the measured results from two tests and their corresponding NPP1 values to compute the result. When enabled, the Master Paired Test drop down list becomes active. Enable Paired Test D ependency When this option is enabled both tests of the pair run simultaneously, and both results are used to generate the reported result. The second test of the pair must start while the first test is active. When this option is disabled the paired test results are computed only when the master test runs and there is a result for the partner test on the patient sample. Example Lupus anticoagulant Screen (LAC-S) and Lupus anticoagulant Confirm (LAC-C) paired test. These tests do not need to be ordered together. LAC-C may only be required if there is a questionable LAC-S result. You could request LAC-C later and the result is used with the previously run LAC-S to calculate a ratio. Paired Test Rules The master test of a paired test definition: l l l l Must be enabled in order for the paired test partner to be enabled. Cannot be disabled until the paired test partner is disabled, regardless of whether it is an independent or dependent paired test. Can be enabled regardless of whether the paired test partner is enabled. Can be deleted while the paired test partner remains present, regardless of whether it is an independent or dependent paired test. 1Normal Pool Plasma. A type of sample used as a standard of comparison when calculating the International Normalized Ratio (INR) and when calculating test results that use the normalized ratio. 174 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup General Information Screen Consistency Check Indicates whether the test definition is consistent, meaning the test can run as defined. If a test is not consistent, the inconsistency must be corrected before the test can run. See Consistency Check. NOTE: If you change the parameters for your user-defined tests so the analytical performance of that test is affected, you must recalibrate that test. See User-Defined Tests disclaimer. See Also l Analytical Cycle Definition l Data Reduction Parameters l Result Unit Definition l Calibration l Parallelism l Normal Pool Plasma l Rerun Rules 175 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Analytical Cycle Definition Analytical Cycle Definition Overview The Analytical Cycle Definition screen allows the test developer to do the following: l Select the primary wavelength that produces measured results. l Select the acquisition time used to acquire data. l Set up the loading cycles required to obtain a reaction curve. l Enable the extended mode. l Select the number of replicates. Adding a Material Load Cycle Definition – for user-defined tests To add a material in a user-defined test: 1. Select Setup > Test List in the menu bar. 2. Do one of the following in the Test List to open the Test Definition screen for a test: l l l Double-click a user-defined test. Place focus1 on a user-defined test code, and select the Test Definition the toolbar. icon in Select2 a user-defined test, and select Actions > Review > Test Definition in the menu bar. NOTE: A user with the appropriate security level can create a new test or copy an existing test. All responsibility for parameter development and validation of new or copied tests belongs to the user alone. 3. In the Test Definition screen, select Analytical cycle definition in the navigation tree. 4. Select the Add icon in the toolbar. The Material/Sample Load Cycle Definition window opens. 5. Select materials in the Material list in the same order they are to be used. 6. Select the Save icon in the toolbar to save your changes. 7. Select the Previous Screen icon in the toolbar to return to the Test List. See Creating a user-defined test. 1To place focus on the unique identifier in a list, click a row in the table. A blue cell border indicates focus. Only one unique identifier in a list can have focus. 2Click in the Selection column of a table. A red check mark indicates selection. You can typically select more than one object. 176 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Analytical Cycle Definition Deleting a Material Load Cycle Definition – for user-defined tests To delete a material from the analytical cycle: 1. Select Setup > Test List in the menu bar. 2. Double-click a user-defined test in the Test List. 3. In the Test Definition screen, select Analytical cycle definition in the navigation tree. 4. In the Load cycle table, select1 the material to delete. 5. Select the Delete icon in the toolbar. 6. Select the Save icon in the toolbar to save your changes. 7. Select the Previous Screen icon in the toolbar to return to the Test List. NOTE: A user with the appropriate security level can create a new test or copy an existing test. All responsibility for parameter development and validation of new or copied tests belongs to the user alone. 1Click in the Selection column of a table. A red check mark indicates selection. You can typically select more than one object. 177 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Analytical Cycle Definition Analytical Cycle Definition Screen Toolbar The operations toolbar includes the following: Select the following icons to perform the associated tasks: Apply Consistency Checks to determine whether the current test definition information is consistent. Save the test definition. Restore the previously saved information. Add a material to a user-defined test. Opens the Material/Sample Load Cycle Definition window. See User-Defined Tests disclaimer. View the Material/Sample Load Cycle Definition window for the material with focus1 in the Test List. Applies to the load cycle. Delete a material from the load cycle. See Deleting a Material Load Cycle Definition. 1To place focus on the unique identifier in a list, click a row in the table. A blue cell border indicates focus. Only one unique identifier in a list can have focus. 178 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Analytical Cycle Definition Analytical Cycle Definition Screen Acquisition – wavelength Primary wavelength The primary wavelength determines the optical wavelength that is used to monitor the reaction and to produce a result. The options are: l 405 nm – Typically used for chromogenic tests. l 671 nm – Typically used for coagulometric tests. The default option when creating a test is 671 nm. 179 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Analytical Cycle Definition Acquisition – time Standard time Acquisition time during which enough data points are collected to determine the clotting point or reaction rate for the majority of samples. The acquisition time is expressed in seconds. The raw data may store a maximum of 6000 data points, which corresponds to 600 seconds of data read every 1/10th of a second. For acquisition times greater than 600 seconds, the sample rate (the amount of time between each data point) will increase. l Minimum: 20 seconds l Maximum: 1800 seconds l Default: 30 seconds NOTE: For user-defined tests, if a test imports the raw calibration data from another test, you can configure the standard time for the test that is importing the calibration, with the restriction that the standard time must be less than or equal to either the standard time or the extended time, if enabled, of the test whose calibration is being imported. See User-Defined Tests disclaimer. D elay time The delay time specifies the interval of data to be ignored by data reduction when calculating the result. The delay time is part of the acquisition time. l Minimum: 0 seconds l Maximum: 750 seconds l Default: 3 seconds NOTE: For user-defined tests: l l l l If you enable a test as a shadow test, you can configure the delay time for the shadow test independently of the parent test. If a test imports the raw calibration data from another test, you can configure the delay time for the test that is importing the calibration. Delay time is not displayed in reaction graphs. A user with the appropriate security level can create a new test or copy an existing test. All responsibility for parameter development and validation of new or copied tests belongs to the user alone. 180 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Analytical Cycle Definition Enable extended test mode Option to collect data for a longer time period. Extended time When configured for extended acquisition, data is collected for a longer period of time compared to the standard acquisition, to be able to determine the clotting point for samples that have prolonged clotting times. If the extended test mode is enabled, the extended time must be greater than the standard time. The default is 30 seconds The extended test mode must be enabled for a calibration to run using extended acquisition time. The extended test mode must be enabled for parallelism to run using extended acquisition time. NOTE: For user-defined tests, if a test imports the raw calibration data from another test, you can configure the extended time for the test that is importing the calibration, with the restriction that the extended time cannot be greater than the extended time, if enabled, of the test whose calibration is being imported. See User-Defined Tests disclaimer. LIS number This field displays the extended mode LIS number of the test. The LIS number for an extended test must be unique. 181 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Analytical Cycle Definition Test code This field displays the extended mode test code of the test. The extended test code is the test code appended by the character defined in the test mode extension area of the Global Definitions screen. Load cycle N umber of replicates This allows for selection of the number of times the test is to be repeated on a sample. The default value is 1; the maximum value is 2. Load Cycle Table The Load Cycle table contains read-only information populated from the Material/Sample Load Cycle Definition screen. (See Adding a Material Load Cycle Definition.) The display order is the order materials are added to the reaction cuvette. Double-click the material name to access detailed material information, or click select1 the material and select the View Load Cycle Definition window. icon in the toolbar, which opens the Material/Sample NOTE: If you enable a test as a shadow test, you can view the Analytical cycle fields for the shadow test but you cannot edit them. Total cuvette volume Total Cuvette Volume indicates the total volume of reaction mix as defined in the Load Cycle table. The minimum volume required is 150 μL. The maximum volume is 600 μL. l l The total of all liquid volumes cannot be less than 150 μL, the volume of liquid required to fill the optical window on the cuvette cell. If you change the parameters for a user-defined test, so that the analytical performance of that test is affected, you must recalibrate that test. See User-Defined Tests disclaimer. 1Click in the Selection column of a table. A red check mark indicates selection. You can typically select more than one object. 182 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Analytical Cycle Definition Material/Sample Load Cycle Definition Screen Material List of materials that have been defined for use on the system. Select materials from the drop-down list. 183 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Analytical Cycle Definition NOTE: l l l The intermediate and start reagents of a test that imports the raw calibration data from another test must be the same as the intermediate and start reagents of the test that is imported. When defining the first load cycle, the material must be either sample or a sample diluent. When defining the last load cycle, the material must be a start reagent. IMPORTANT – Many IL-defined tests use Clean B diluted as the clean material. If the Clean B diluted bottle becomes empty, the instrument performs an emergency stop, with the consequent loss of all work that was in progress. Hint: To avoid loss of work, place multiple bottles of Clean B diluted on-board the instrument. See Test Feasibility for proper placement of all reagents. Aspiration information This area defines the arrangement of volumes in the probe is as follows: H ead volume Sample volume aspirated to wet the probe before aspirating the sample volume required to run the test. This volume is not delivered to the cuvette. 184 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Analytical Cycle Definition l Minimum: 0 μL l Maximum: 250 μL l Default: 0 μL NOTE: When creating a user-defined test, the head volume for the sample defined in Material/Sample Load Cycle Definition must equal the calibrator head volume defined in the Automatic Dilution section of the Test Definition. See User-Defined Tests disclaimer. A irgap Volume of air to aspirate immediately before aspirating the sample, separating the sample and rinse. If a head volume is used, it is the volume of air separating the sample and head volume to prevent rinse contamination and ensure accurate volume delivery. l Minimum: 0 μL l Maximum: 250 μL l Default: 15 μL H ead volume airgap Volume of air (0-250 µL) to aspirate before the head volume. This field defaults to the Airgap value if the head volume is greater than zero. Otherwise this value is zero. Material/Sample volume Volume of material or sample in microliters (0 – 250 µL) that is delivered to the cuvette. Transport airgap Volume of air to aspirate after the sample volume. It prevents material loss during probe movement and ensures accurate volume delivery. l Minimum: 0 μL l Maximum: 250 μL l Default: 15 μL Total volume Sum of the volumes and airgaps for the specified material. This field is read-only and is computed by the system based on the total of the load volumes. Dispensation information Enhanced dispense Option to improve reagent mixing in the reaction cuvette when a material is added. This dispense option is key to the optimal development of test parameters where a fast mix is required. 185 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Analytical Cycle Definition Enable mix Option to mix the contents of the cuvette cell. Mixing is done by re-aspirating and dispensing a quantity of material in the same cell. Mix The mix volume percentage is used to calculate the volume of material that is aspirated from the cuvette cell and redispensed into the same cuvette cell to facilitate a mix. The mix volume is calculated as: l Mix volume = (total cuvette volume – cuvette dead volume) mix % l Minimum: 25% l Maximum: 100% l Default: 50% Rinse time after mix Amount of time to rinse the probe after mixing is completed. l Minimum: 1 sec l Maximum: 5 sec l Default: 1 sec Number of cycles This is the number of mix/rinse cycles to be performed. l Minimum: 1 cycle l Maximum: 3 cycles l Default: 1 cycle NOTE: To perform a mix, a minimum of 100 μL of liquid must be in the cuvette cell. Enable incubation time Select to enable incubation of the material. Incubation may be required for warming the cuvette contents or to allow sufficient time for a reaction to occur. Incubation range The incubation range is the minimum and maximum amount of time in seconds (20-1800) the material should remain in the cuvette before another material is added. The instrument automatically applies a 20-90 second incubation range to sample or reagent loading steps that do not have incubation enabled. Rinse Time Length of time to rinse the probe after material delivery when the Enable mix option is disabled. 186 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Analytical Cycle Definition l Minimum: 1 second l Maximum: 5 seconds l Default: 1 second Enable agitation Option to scrub the internal probe walls (during each rinse cycle) by moving the rinse material up and down inside the probe. Configure the number of times to agitate in the field provided. l Minimum: 1 sec l Maximum: 5 sec l Default: 1 sec Before Aspiration Rinse / Clean & Rinse Enable rinse / clean & rinse before aspiration Option to enable rinse and clean operations before the probe aspirates sample. R inse Select this option to perform rinse cycles. l Rinse cycles – Configure the number of rinse cycles to perform. l Time – Configure the number of seconds for each rinse cycle to run. l o Minimum: 1 sec o Maximum: 5 sec o Default: 1 sec Enable agitation – Option to scrub the internal probe walls (during each rinse cycle) by moving the rinse material up and down inside the probe. Configure the number of times to agitate in the field provided. C lean & rinse Option to define a clean and rinse cycle for a sample or a defined reagent. For IL-locked tests, this is a userdefined field when the default for that test has Rinse enabled (sample load cycle only). This option allows you to configure sample probe cleaning when sample materials known to have carryover1 issues are in use. Option to scrub the internal probe walls (during each rinse cycle) by moving the rinse material up and down inside the probe. Configure the number of times to agitate in the field provided. l Clean & rinse cycles – Configure the number of clean and rinse cycles to perform. l Aspiration cycles – Configure the number of times to run the clean and rinse cycle. 1Residual sample material left on the sample probe, after the probe has been rinsed, that carries over to another sample when the probe enters it. 187 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Analytical Cycle Definition l l Clean airgap – Amount of air the probe aspirates before aspirating the clean material. This prevents contaminating the clean material and ensures accurate volume delivery. Clean volume – Volume of clean material that the probe aspirates during the clean and rinse cycle. NOTE: l l l l l o IMPORTANT: Many IL-defined tests use Clean B diluted as the clean material. If the Clean B diluted bottle becomes empty, the instrument performs an emergency stop. To avoid this, place multiple bottles of Clean B diluted on-board the instrument. See Test Feasibility for proper placement of all reagents. o The clean total volume must not exceed the maximum probe volume, or 250 µL. o When using a clean material other than system clean, the clean material must be placed in the same area as the load cycle material. Thus, if the rinse and clean is enabled for a sample, the clean material must be placed in a diluent rack in the Sample Area. If it is enabled for a reagent, you must place the clean material in a diluent rack in the Reagent Area. Clean transport airgap – Volume of air aspirated after the clean volume. This prevents material loss during probe movement, and ensures accurate volume delivery. This is not selectable for system clean. Clean total volume – Sum of the clean volume, clean airgap and clean transport airgap. The clean total volume cannot exceed the maximum probe volume, or 250 μL. Clean volume (all cycles) – Volume of clean material required for the configured number of aspiration cycles. Clean material – Select a system clean material in the drop down list. Hold time – Period of time the clean material is held in the probe before it is agitated or dispensed to waste. o l Enable agitation – Option to scrub the internal probe walls (during each rinse cycle) by moving the rinse material up and down inside the probe. Configure the number of times to agitate in the field provided. Rinse time – Time allocated for the probe rinsing operation. o Enable agitation – Option to scrub the internal probe walls (during each rinse cycle) by moving the rinse material up and down inside the probe. Configure the number of times to agitate in the field provided. After Dispensation Rinse / Clean & Rinse The fields on this tab are similar to those on the Before Aspiration Rinse / Clean & Rinse tab, above. See Also l General Information l Data Reduction Parameters l Result Unit Definition l Calibration 188 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Analytical Cycle Definition l Parallelism l Normal Pool Plasma l Rerun Rules 189 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Sample Pre-Dilution Sample Pre-Dilution Overview There are two pre-dilution options: l Sample pre-dilution – Dilution typically used to run a test l Alternative pre-dilution – Atypical dilution used to eliminate certain effects Accessing the Sample Pre-Dilution Screen To access the Sample pre-dilution screen: 1. Select Setup > Test List in the menu bar. 2. Double-click a test in the Test List. 3. In the Test Definition navigational tree, expand Analytical cycle definition and select Sample predilution. 4. <Optional> Edit the Sample pre-dilution screen. 5. Select the Save icon in the toolbar to save your changes. 6. Select the Previous Screen icon in the toolbar to return to the Test List. Sample Pre-dilution Screen Enable sample pre-dilution Option to activate pre-dilution parameters. Enables the fields on the General, Sample/Mixture and Diluent tabs. 190 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Sample Pre-Dilution General Tab Dilution definition N umber of parts sample Specifies the number of parts of sample to use in sample dilutions. Example: The number of parts of sample is 1. The number of parts of diluent is 9. In this example nine parts of diluent are added for every one part of sample. This dilution ratio is 1:10. N umber of parts diluent Specifies the number of parts of diluent to use in diluent dilutions. Example: The number of parts of sample is 1. The number of parts of diluent is 9. In this example nine parts of diluent are added for every one part of sample. This dilution ratio is 1:10. Minimum aspiratable volume Minimum volume of material used in dilutions. By default, the instrument attempts to use the smallest possible volume (4 µL) when performing calculations. The value in this field overrides the default volume and forces the system to use the volume of material specified in this field when preparing dilutions. l Minimum: 4 μL l Maximum: 50 μL l Default: 4 μL 191 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Sample Pre-Dilution Pre-dilution Table This read-only table lists the volumes that are used to dilute the sample. Enable Mix Option to activate the mix parameters. Enables the fields in this section. Mix Volume Percentage of material in the cuvette cell that is aspirated from the cuvette cell and redispensed into the same cuvette cell to mix the material. The mix volume is calculated as: l l Mix volume = (total cuvette volume - cuvette dead volume) * mix % o Minimum: 25 μL o Maximum: 250 μL Cuvette dead volume is 65 μL. Cuvette maximum volume is 600 μL. N umber of C ycles Number of mix cycles to perform. l Minimum: 1 cycle l Maximum: 3 cycles l Default: 1 cycle R inse after Mix Number of seconds to rinse the probe after a mix is performed. l Maximum: 1 sec l Maximum: 5 sec l Default: 1 sec NOTE: To perform a mix, the cuvette cell must contain a minimum of 100 μL of liquid. 192 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Sample Pre-Dilution Sample/Mixture Tab Use this tab to define sample and mixture1 loading parameters. Volumes NOTE: The sum of all volumes cannot exceed 250 μL. H ead volume Sample volume aspirated to wet the probe before aspirating the sample volume required to run the test. This volume is not delivered to the cuvette. l Minimum: 0 μL l Maximum: 250 μL l Default: 0 μL NOTE: When creating a user-defined test, the head volume for the sample defined in Material/Sample Load Cycle Definition must equal the calibrator head volume defined in the Automatic Dilution section of the Test Definition. See User-Defined Tests disclaimer. 1A dilution that requires a two-step dilution process to achieve the required dilution ratio. 193 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Sample Pre-Dilution A irgap Volume of air to aspirate immediately before aspirating the sample, separating the sample and rinse. If a head volume is used, it is the volume of air separating the sample and head volume to prevent rinse contamination and ensure accurate volume delivery. The airgap prevents rinse contamination and ensures accurate volume delivery. l Minimum: 0 μL l Maximum: 250 μL l Default: 15 μL Transport airgap Volume of air to aspirate after the sample volume. It prevents material loss during probe movement and ensures accurate volume delivery. l Minimum: 0 μL l Maximum: 250 μL l Default: 15 μL H ead volume airgap Volume of air (0-250 µL) to aspirate before the head volume. This field defaults to the Airgap value if the head volume is greater than zero. Otherwise this value is zero. Before Aspiration Rinse / Clean & Rinse Enable rinse / clean & rinse before aspiration Option to enable rinse and clean operations before the probe aspirates sample. R inse Select this option to perform rinse cycles. l Rinse cycles – Configure the number of rinse cycles to perform. l Time – Configure the number of seconds for each rinse cycle to run. l o Minimum: 1 sec o Maximum: 5 sec o Default: 1 sec Enable agitation – Option to scrub the internal probe walls (during each rinse cycle) by moving the rinse material up and down inside the probe. Configure the number of times to agitate in the field provided. C lean & rinse Option to define a clean and rinse cycle for a sample or a defined reagent. For IL-locked tests, this is a userdefined field when the default for that test has Rinse enabled (sample load cycle only). This option allows 194 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Sample Pre-Dilution you to configure sample probe cleaning when sample materials known to have carryover1 issues are in use. Option to scrub the internal probe walls (during each rinse cycle) by moving the rinse material up and down inside the probe. Configure the number of times to agitate in the field provided. l Clean & rinse cycles – Configure the number of clean and rinse cycles to perform. l Aspiration cycles – Configure the number of times to run the clean and rinse cycle. l l Clean airgap – Amount of air the probe aspirates before aspirating the clean material. This prevents contaminating the clean material and ensures accurate volume delivery. Clean volume – Volume of clean material that the probe aspirates during the clean and rinse cycle. NOTE: l l l l l o IMPORTANT: Many IL-defined tests use Clean B diluted as the clean material. If the Clean B diluted bottle becomes empty, the instrument performs an emergency stop. To avoid this, place multiple bottles of Clean B diluted on-board the instrument. See Test Feasibility for proper placement of all reagents. o The clean total volume must not exceed the maximum probe volume, or 250 µL. o When using a clean material other than system clean, the clean material must be placed in the same area as the load cycle material. Thus, if the rinse and clean is enabled for a sample, the clean material must be placed in a diluent rack in the Sample Area. If it is enabled for a reagent, you must place the clean material in a diluent rack in the Reagent Area. Clean transport airgap – Volume of air aspirated after the clean volume. This prevents material loss during probe movement, and ensures accurate volume delivery. This is not selectable for system clean. Clean total volume – Sum of the clean volume, clean airgap and clean transport airgap. The clean total volume cannot exceed the maximum probe volume, or 250 μL. Clean volume (all cycles) – Volume of clean material required for the configured number of aspiration cycles. Clean material – Select a system clean material in the drop down list. Hold time – Period of time the clean material is held in the probe before it is agitated or dispensed to waste. o l Enable agitation – Option to scrub the internal probe walls (during each rinse cycle) by moving the rinse material up and down inside the probe. Configure the number of times to agitate in the field provided. Rinse time – Time allocated for the probe rinsing operation. o Enable agitation – Option to scrub the internal probe walls (during each rinse cycle) by moving the rinse material up and down inside the probe. Configure the number of times to agitate in the field provided. 1Residual sample material left on the sample probe, after the probe has been rinsed, that carries over to another sample when the probe enters it. 195 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Sample Pre-Dilution After Dispensation Rinse / Clean & Rinse The fields on this tab are similar to those on the Before Aspiration Rinse / Clean & Rinse tab, above. 196 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Sample Pre-Dilution Diluent tab Use this tab to define the loading parameters for diluent material. The Head volume, Airgap, Transport airgap and Head volume airgap fields on the Diluent tab are identical to those on the Sample/Mixture tab. Volumes NOTE: The sum of all volumes cannot exceed 250 μL. Material Select a sample diluent material in the list. The material must be defined as a Diluent type in the Material Definition. H ead volume The diluent volume aspirated to wet the probe before aspirating the diluent volume required to run the test. This volume is not delivered to the cuvette. l Minimum: 0 μL l Maximum: 250 μL l Default: 0 μL NOTE: When creating a user-defined test, the head volume for the sample defined in Material/Sample Load Cycle Definition must equal the calibrator head volume defined in the Automatic Dilution section of the Test Definition. See User-Defined Tests disclaimer. 197 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Sample Pre-Dilution A irgap Volume of air to aspirate immediately before aspirating the diluent, separating the sample and rinse. If a head volume is used, it is the volume of air separating the diluent and head volume. The airgap prevents rinse contamination and ensures accurate volume delivery. l Minimum: 0 μL l Maximum: 250 μL l Default: 15 μL Transport airgap Volume of air to aspirate after the diluent volume. It prevents material loss during probe movement and ensures accurate volume delivery. l Minimum: 0 μL l Maximum: 250 μL l Default: 15 μL H ead volume airgap Volume of air (0-250 µL) to aspirate before the head volume. This field defaults to the Airgap value if the head volume is greater than zero. Otherwise this value is zero. Before Aspiration Rinse / Clean & Rinse Enable rinse / clean & rinse before aspiration Option to enable rinse and clean operations before the probe aspirates sample. R inse Select this option to perform rinse cycles. l Rinse cycles – Configure the number of rinse cycles to perform. l Time – Configure the number of seconds for each rinse cycle to run. l o Minimum: 1 sec o Maximum: 5 sec o Default: 1 sec Enable agitation – Option to scrub the internal probe walls (during each rinse cycle) by moving the rinse material up and down inside the probe. Configure the number of times to agitate in the field provided. C lean & rinse Option to define a clean and rinse cycle for a sample or a defined reagent. For IL-locked tests, this is a userdefined field when the default for that test has Rinse enabled (sample load cycle only). This option allows 198 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Sample Pre-Dilution you to configure sample probe cleaning when sample materials known to have carryover1 issues are in use. Option to scrub the internal probe walls (during each rinse cycle) by moving the rinse material up and down inside the probe. Configure the number of times to agitate in the field provided. l Clean & rinse cycles – Configure the number of clean and rinse cycles to perform. l Aspiration cycles – Configure the number of times to run the clean and rinse cycle. l l Clean airgap – Amount of air the probe aspirates before aspirating the clean material. This prevents contaminating the clean material and ensures accurate volume delivery. Clean volume – Volume of clean material that the probe aspirates during the clean and rinse cycle. NOTE: l l l l l o IMPORTANT: Many IL-defined tests use Clean B diluted as the clean material. If the Clean B diluted bottle becomes empty, the instrument performs an emergency stop. To avoid this, place multiple bottles of Clean B diluted on-board the instrument. See Test Feasibility for proper placement of all reagents. o The clean total volume must not exceed the maximum probe volume, or 250 µL. o When using a clean material other than system clean, the clean material must be placed in the same area as the load cycle material. Thus, if the rinse and clean is enabled for a sample, the clean material must be placed in a diluent rack in the Sample Area. If it is enabled for a reagent, you must place the clean material in a diluent rack in the Reagent Area. Clean transport airgap – Volume of air aspirated after the clean volume. This prevents material loss during probe movement, and ensures accurate volume delivery. This is not selectable for system clean. Clean total volume – Sum of the clean volume, clean airgap and clean transport airgap. The clean total volume cannot exceed the maximum probe volume, or 250 μL. Clean volume (all cycles) – Volume of clean material required for the configured number of aspiration cycles. Clean material – Select a system clean material in the drop down list. Hold time – Period of time the clean material is held in the probe before it is agitated or dispensed to waste. o l Enable agitation – Option to scrub the internal probe walls (during each rinse cycle) by moving the rinse material up and down inside the probe. Configure the number of times to agitate in the field provided. Rinse time – Time allocated for the probe rinsing operation. o Enable agitation – Option to scrub the internal probe walls (during each rinse cycle) by moving the rinse material up and down inside the probe. Configure the number of times to agitate in the field provided. 1Residual sample material left on the sample probe, after the probe has been rinsed, that carries over to another sample when the probe enters it. 199 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Sample Pre-Dilution After Dispensation Rinse / Clean & Rinse The fields on this tab are similar to those on the Before Aspiration Rinse / Clean & Rinse tab, above. See Also l Test Definition l Analytical Cycle Definition l Material Definition 200 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Alternative Pre-Dilution Alternative Pre-Dilution Overview Alternative pre-dilution means using a different sample dilution. For example, a D-Dimer HS test may require a higher dilution ratio to eliminate prozone effects. An alternative pre-dilution may be ordered for samples where concentration effects may be a known issue. An alternative pre-dilution may be triggered via a rerun test if the test is so configured. Alternative predilution must be enabled and defined before it can be used in test reruns. See Rerun Rule Setup. Accessing the Alternative Pre-dilution Screen To open the Alternative Pre-dilution screen: 1. Select Setup > Test List in the menu bar. 2. Double-click a test in the Test List. Or if you are creating a new user-defined test, select the Add icon in the toolbar. NOTE: A user with the appropriate security level can create a new test or copy an existing test. All responsibility for parameter development and validation of new or copied tests belongs to the user alone. 3. In the Test Definition navigation tree, expand Analytical cycle definition, and select Alternative predilution. 4. Edit the Alternative pre-dilution screen. 5. Select the Save icon in the toolbar to save your changes. 6. Select the Previous Screen icon in the toolbar to return to the Test List.. Alternative Pre-dilution Screen Enable alternative pre-dilution Option to enable an alternative pre-dilution for a test. Some IL locked tests have alternative pre-dilution enabled and defined. For user-defined tests, this option allows you to define an additional pre-dilution. When this option is enabled, you can run the pre-diluted test as a separate test. See User-Defined Tests disclaimer. When a diluted test is ordered either directly or as a rerun, the dilutions settings defined here are used. 201 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Alternative Pre-Dilution Use extended acquisition time Option to use an extended acquisition time1 (for acquiring data). Select this option when the alternative pre-dilution requires a more diluted sample than is defined in the standard reaction or sample pre-dilution parameters. Diluted LIS number The diluted LIS test ID number may be the same as the parent test or it may be unique. When it is the same as the parent test, validated results are transmitted to the LIS using the parent LIS test ID number and test name. When the diluted LIS number is unique, the diluted format of the test may be ordered from the LIS directly, and runs using the alternative pre-dilution settings. Diluted tests with validated results and unique LIS numbers are transmitted to the LIS using the diluted LIS number. When the LIS number is unique, the LIS can directly order a diluted version of the test. Diluted versions can also be ordered manually, or as a result of reflex or rerun settings. Test code Unique test code for the alternative pre-dilution test. The alternative pre-dilution test code is the test code plus an automatically added one character extension. You can define the one character extension in Global Definitions. 1The amount of time that optical data is collected by the system. Acquisition Time can be either Standard or Extended. Standard Acquisition Time is the time spent collecting the required number of data points to determine the clotting point or reaction rate for the majority of samples. With Extended Acquisition Time, data is collected for a longer period of time to determine the clotting point for samples which have prolonged clotting times. 202 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Alternative Pre-Dilution General Tab Dilution definition N umber of parts sample Specifies the number of parts of sample to use in sample dilutions. Example: The number of parts of sample is 1. The number of parts of diluent is 9. In this example nine parts of diluent are added for every one part of sample. This dilution ratio is 1:10. N umber of parts diluent Specifies the number of parts of diluent to use in diluent dilutions. Example: The number of parts of sample is 1. The number of parts of diluent is 9. In this example nine parts of diluent are added for every one part of sample. This dilution ratio is 1:10. Minimum aspiratable volume Minimum volume of material used in dilutions. By default, the instrument attempts to use the smallest possible volume (4 µL) when performing calculations. The value in this field overrides the default volume and forces the system to use the volume of material specified in this field when preparing dilutions. l Minimum: 4 μL l Maximum: 50 μL l Default: 4 μL 203 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Alternative Pre-Dilution Pre-dilution Table This read-only table lists the volumes that are used to dilute the sample. Enable Mix Option to activate the mix parameters. Enables the fields in this section. Mix Volume Percentage of material in the cuvette cell that is aspirated from the cuvette cell and redispensed into the same cuvette cell to mix the material. The mix volume is calculated as: l l Mix volume = (total cuvette volume - cuvette dead volume) * mix % o Minimum: 25 μL o Maximum: 250 μL Cuvette dead volume is 65 μL. Cuvette maximum volume is 600 μL. N umber of C ycles Number of mix cycles to perform. l Minimum: 1 cycle l Maximum: 3 cycles l Default: 1 cycle R inse after Mix Number of seconds to rinse the probe after a mix is performed. l Maximum: 1 sec l Maximum: 5 sec l Default: 1 sec NOTE: To perform a mix, the cuvette cell must contain a minimum of 100 μL of liquid. 204 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Alternative Pre-Dilution Sample/Mixture Tab Volumes NOTE: The sum of all volumes cannot exceed 250 μL. H ead volume Sample volume aspirated to wet the probe before aspirating the sample volume required to run the test. This volume is not delivered to the cuvette. l Minimum: 0 μL l Maximum: 250 μL l Default: 0 μL NOTE: When creating a user-defined test, the head volume for the sample defined in Material/Sample Load Cycle Definition must equal the calibrator head volume defined in the Automatic Dilution section of the Test Definition. See User-Defined Tests disclaimer. A irgap Volume of air to aspirate immediately before aspirating the sample, separating the sample and rinse. If a head volume is used, it is the volume of air separating the sample and head volume to prevent rinse contamination and ensure accurate volume delivery. 205 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Alternative Pre-Dilution The airgap prevents rinse contamination and ensures accurate volume delivery. l Minimum: 0 μL l Maximum: 250 μL l Default: 15 μL Transport airgap Volume of air to aspirate after the sample volume. It prevents material loss during probe movement and ensures accurate volume delivery. l Minimum: 0 μL l Maximum: 250 μL l Default: 15 μL H ead volume airgap Volume of air (0-250 µL) to aspirate before the head volume. This field defaults to the Airgap value if the head volume is greater than zero. Otherwise this value is zero. Before Aspiration Rinse / Clean & Rinse Enable rinse / clean & rinse before aspiration Option to enable rinse and clean operations before the probe aspirates sample. R inse Select this option to perform rinse cycles. l Rinse cycles – Configure the number of rinse cycles to perform. l Time – Configure the number of seconds for each rinse cycle to run. l o Minimum: 1 sec o Maximum: 5 sec o Default: 1 sec Enable agitation – Option to scrub the internal probe walls (during each rinse cycle) by moving the rinse material up and down inside the probe. Configure the number of times to agitate in the field provided. C lean & rinse Option to define a clean and rinse cycle for a sample or a defined reagent. For IL-locked tests, this is a userdefined field when the default for that test has Rinse enabled (sample load cycle only). This option allows you to configure sample probe cleaning when sample materials known to have carryover1 issues are in use. 1Residual sample material left on the sample probe, after the probe has been rinsed, that carries over to another sample when the probe enters it. 206 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Alternative Pre-Dilution Option to scrub the internal probe walls (during each rinse cycle) by moving the rinse material up and down inside the probe. Configure the number of times to agitate in the field provided. l Clean & rinse cycles – Configure the number of clean and rinse cycles to perform. l Aspiration cycles – Configure the number of times to run the clean and rinse cycle. l l Clean airgap – Amount of air the probe aspirates before aspirating the clean material. This prevents contaminating the clean material and ensures accurate volume delivery. Clean volume – Volume of clean material that the probe aspirates during the clean and rinse cycle. NOTE: l l l l l o IMPORTANT: Many IL-defined tests use Clean B diluted as the clean material. If the Clean B diluted bottle becomes empty, the instrument performs an emergency stop. To avoid this, place multiple bottles of Clean B diluted on-board the instrument. See Test Feasibility for proper placement of all reagents. o The clean total volume must not exceed the maximum probe volume, or 250 µL. o When using a clean material other than system clean, the clean material must be placed in the same area as the load cycle material. Thus, if the rinse and clean is enabled for a sample, the clean material must be placed in a diluent rack in the Sample Area. If it is enabled for a reagent, you must place the clean material in a diluent rack in the Reagent Area. Clean transport airgap – Volume of air aspirated after the clean volume. This prevents material loss during probe movement, and ensures accurate volume delivery. This is not selectable for system clean. Clean total volume – Sum of the clean volume, clean airgap and clean transport airgap. The clean total volume cannot exceed the maximum probe volume, or 250 μL. Clean volume (all cycles) – Volume of clean material required for the configured number of aspiration cycles. Clean material – Select a system clean material in the drop down list. Hold time – Period of time the clean material is held in the probe before it is agitated or dispensed to waste. o l Enable agitation – Option to scrub the internal probe walls (during each rinse cycle) by moving the rinse material up and down inside the probe. Configure the number of times to agitate in the field provided. Rinse time – Time allocated for the probe rinsing operation. o Enable agitation – Option to scrub the internal probe walls (during each rinse cycle) by moving the rinse material up and down inside the probe. Configure the number of times to agitate in the field provided. After Dispensation Rinse / Clean & Rinse The fields on this tab are similar to those on the Before Aspiration Rinse / Clean & Rinse tab, above. 207 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Alternative Pre-Dilution Diluent Tab Volumes NOTE: The sum of all volumes cannot exceed 250 μL. Material Select a sample diluent material in the list. The material must be defined as a Diluent type in the Material Definition. H ead volume The diluent volume aspirated to wet the probe before aspirating the diluent volume required to run the test. This volume is not delivered to the cuvette. l Minimum: 0 μL l Maximum: 250 μL l Default: 0 μL NOTE: When creating a user-defined test, the head volume for the sample defined in Material/Sample Load Cycle Definition must equal the calibrator head volume defined in the Automatic Dilution section of the Test Definition. See User-Defined Tests disclaimer. 208 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Alternative Pre-Dilution A irgap Volume of air to aspirate immediately before aspirating the diluent, separating the sample and rinse. If a head volume is used, it is the volume of air separating the diluent and head volume. The airgap prevents rinse contamination and ensures accurate volume delivery. l Minimum: 0 μL l Maximum: 250 μL l Default: 15 μL Transport airgap Volume of air to aspirate after the diluent volume. It prevents material loss during probe movement and ensures accurate volume delivery. l Minimum: 0 μL l Maximum: 250 μL l Default: 15 μL H ead volume airgap Volume of air (0-250 µL) to aspirate before the head volume. This field defaults to the Airgap value if the head volume is greater than zero. Otherwise this value is zero. Before Aspiration Rinse / Clean & Rinse Enable rinse / clean & rinse before aspiration Option to enable rinse and clean operations before the probe aspirates sample. R inse Select this option to perform rinse cycles. l Rinse cycles – Configure the number of rinse cycles to perform. l Time – Configure the number of seconds for each rinse cycle to run. l o Minimum: 1 sec o Maximum: 5 sec o Default: 1 sec Enable agitation – Option to scrub the internal probe walls (during each rinse cycle) by moving the rinse material up and down inside the probe. Configure the number of times to agitate in the field provided. C lean & rinse Option to define a clean and rinse cycle for a sample or a defined reagent. For IL-locked tests, this is a userdefined field when the default for that test has Rinse enabled (sample load cycle only). This option allows 209 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Alternative Pre-Dilution you to configure sample probe cleaning when sample materials known to have carryover1 issues are in use. Option to scrub the internal probe walls (during each rinse cycle) by moving the rinse material up and down inside the probe. Configure the number of times to agitate in the field provided. l Clean & rinse cycles – Configure the number of clean and rinse cycles to perform. l Aspiration cycles – Configure the number of times to run the clean and rinse cycle. l l Clean airgap – Amount of air the probe aspirates before aspirating the clean material. This prevents contaminating the clean material and ensures accurate volume delivery. Clean volume – Volume of clean material that the probe aspirates during the clean and rinse cycle. NOTE: l l l l l o IMPORTANT: Many IL-defined tests use Clean B diluted as the clean material. If the Clean B diluted bottle becomes empty, the instrument performs an emergency stop. To avoid this, place multiple bottles of Clean B diluted on-board the instrument. See Test Feasibility for proper placement of all reagents. o The clean total volume must not exceed the maximum probe volume, or 250 µL. o When using a clean material other than system clean, the clean material must be placed in the same area as the load cycle material. Thus, if the rinse and clean is enabled for a sample, the clean material must be placed in a diluent rack in the Sample Area. If it is enabled for a reagent, you must place the clean material in a diluent rack in the Reagent Area. Clean transport airgap – Volume of air aspirated after the clean volume. This prevents material loss during probe movement, and ensures accurate volume delivery. This is not selectable for system clean. Clean total volume – Sum of the clean volume, clean airgap and clean transport airgap. The clean total volume cannot exceed the maximum probe volume, or 250 μL. Clean volume (all cycles) – Volume of clean material required for the configured number of aspiration cycles. Clean material – Select a system clean material in the drop down list. Hold time – Period of time the clean material is held in the probe before it is agitated or dispensed to waste. o l Enable agitation – Option to scrub the internal probe walls (during each rinse cycle) by moving the rinse material up and down inside the probe. Configure the number of times to agitate in the field provided. Rinse time – Time allocated for the probe rinsing operation. o Enable agitation – Option to scrub the internal probe walls (during each rinse cycle) by moving the rinse material up and down inside the probe. Configure the number of times to agitate in the field provided. 1Residual sample material left on the sample probe, after the probe has been rinsed, that carries over to another sample when the probe enters it. 210 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Alternative Pre-Dilution After Dispensation Rinse / Clean & Rinse The fields on this tab are similar to those on the Before Aspiration Rinse / Clean & Rinse tab, above. See Also l Test Definition l Analytical Cycle Definition l Sample Pre-Dilution 211 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Data Reduction Parameters Data Reduction Parameters Data reduction parameters are configurable for the Primary Wavelength of user-defined tests. See UserDefined Tests disclaimer. Configuring Data Reduction Parameters for the Primary Wavelength To configure the data reduction parameters for the Primary Wavelength: 1. Select Setup > Test List in the menu bar. 2. In the Test List, double-click a user-defined test, or select the Add new user-defined test. icon in the toolbar to create a NOTE: A user with the appropriate security level can create a new test or copy an existing test. All responsibility for parameter development and validation of new or copied tests belongs to the user alone. 3. In the Test Definition navigation pane, expand DR Parameters, Primary wavelength. 4. Select an item under Primary wavelength to open the respective screen. 5. Configure parameters on each screen. 6. Select the Save icon in the toolbar to save your changes. 7. Select the Previous Screen icon in the toolbar to return to the Test List. Primary Wavelength The selections under Primary Wavelength in the navigational tree allow you to configure the following primary wavelength settings: l Wavelength Definition l Raw Data Checks l Normalized Data Checks l Primary Algorithm l Secondary Algorithm NOTE: If you change the data reduction parameters for your user-defined tests such that the analytical performance of that test is affected, recalculate the calibrations and samples. See Reviewing Test Results for information on recalculation. See User-Defined Tests disclaimer. See Also l General Information l Analytical Cycle Definition 212 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Data Reduction Parameters l Result Unit Definition l Calibration l Parallelism l Normal Pool Plasma l Rerun Rules 213 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Wavelength Definition Wavelength Definition Overview The Wavelength Definition screen is used to setup the Reference and Normalization methods used in Data Reduction as well as in error and warning reporting. All data acquired by the Analyzer1 is reported in terms of its initial value multiplied by 1,000,000. To convert the data back to its original value, each raw data point is divided by 1,000,000. l Raw data value = raw data value from analytical module/1,000,000 All raw data points are adjusted by their corresponding ORU blanking value. The ORU blanking value is determined through Diagnostics and each ORU unit. Each position in the ORU and each wavelength has its own value. See Optical Reading Unit. l Raw data value = <raw data value>/<ORU blank value> NOTE: If the ORU blank value is less than the raw data value, the resulting raw data value will be greater than 1.0. This results in negative values if the data is normalized by absorbance. Accessing the Wavelength definition screen To access the Wavelength definition screen: 1. Select Setup > Test List in the menu bar. 2. Double-click a test in the Test List. 3. In the Test Definition navigational tree, expand DR Parameters > Primary wavelength, and select Wavelength definition. 4. <Optional> Edit the parameters on the Primary wavelength screen. 5. Select the Save icon in the toolbar to save your changes. 6. Select the Previous Screen icon in the toolbar to return to the Test List. 1The part of the instrument where sample processing and testing are performed. Also called the AM or the Analytical Module. 214 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Wavelength Definition Wavelength Definition screen Primary Wavelength Read-only value extracted from the Analytical Cycle screen. Data generated at this wavelength is used to calculate results. Enable Warnings and Enable Errors Options to issue warning and error messages. Error reporting is enabled by default. Enable Reference Method Option to enable curve referencing, which shifts the normalized data curve towards a baseline value of zero (or near zero). Data curves are referenced so the curves of a particular test have the same starting point (reference point) across all samples. This feature is useful with algorithms such as the Threshold algorithm (when searching for an absolute value) and the Endpoint algorithm. N umber of Seconds Time interval used to compute the average of the raw data points. This average is subtracted from each raw data point in the curve, shifting the entire curve closer to zero. 215 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Wavelength Definition Enable Normalization Method Option to enable the normalization method, which converts the data values from the optical reading unit into Intensity or Absorbance values, as selected here. The resulting data is used to generate the normalized curve. The default method is Absorbance. A bsorbance To normalize using absorbance, each data point in the raw data is converted to mAbs using the following formula: l Value = -log (data) * 1000 Intensity To normalize using intensity, each data point in the raw data is converted to %Transmittance using the following formula: l Value = data * 1000 Smoothing The process of modifying the normalized data curve to reduce the noise and give it a smoother appearance. This helps identify the true clot point. The normalized curve may be smoothed up to three times using a moving average method. For each smooth, the limits are 1-20 data points. Smoothing uses a moving average algorithm where the number of points specified (the degree) on either side of each point are averaged. The averaged value replaces the specific point. This process continues for all points in the data curve. NOTE: When averaging the data points, the original (not the replaced value) is used. The original data points are the input. The averaged data point is the output. Example In the following example, the normalized data is smoothed three times. Each smoothing operation uses 9 points. 216 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Wavelength Definition In the transition from normalized to Smooth 1, 9 points on either side of a particular point are averaged to produce the new point value, as represented in Smooth 1. In the transition from Smooth 1 to Smooth 2, smoothing of the beginning of the data is demonstrated. The first point is always an exact copy. The second smoothed point is the average of the first three points (one point on either side of the second point). The third smoothed point is the average of the first five points (two points on either side of the third point), and so on, until there are enough points to average the specified number of points. The end of the data curve is processed the same way, as demonstrated in the transition from Smooth 2 to Smooth 3. The number of points used for smoothing determines the coarseness of the smoothing action. The greater the number of points specified, the greater the number of points averaged and the smoother the curve. NOTE: For sensitive reactions, a large smoothing degree may erase much of the signal change of the reaction, and may greatly reduce the ability of the data reduction to locate the clot point. Conversely, a smoothing degree that is too small may not smooth the curve sufficiently so that the clot point can be distinguished from the noise. See Also l Optical Reading Unit l Data Reduction Parameters 217 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Raw Data Checks Raw Data Checks Overview Use the Raw Data Checks screen to configure the checks to perform on the raw data collected by the Analytical Module1. The data checks you configure are performed before the data is processed (normalized, smoothed or referenced) by the instrument. The settings on the Raw Data Checks screen are locked for all tests defined by Instrumentation Laboratory. These fields are editable only for user-defined tests. See User-Defined Tests disclaimer. Raw data – Values and Delta Raw data values typically range from 0 to 1.2. Some data points acquired by the analyzer may be marked with ORU flags (noise, calculation errors, etc.). These points, and other erroneous data points (those significantly different than their surrounding points) may be omitted from the data through the Signal Check. Data checks identify raw data curves with patterns that do not match expected (or classical) data curves. NOTE: Many raw data checks use the delta of the curve (signal change across the curve). The delta of the raw data curve is not always computed as the signal difference between the last point in the curve and the first point in the curve (as for classic curves). The delta of the data curve is computed as the difference between the minima and the maxima of the data curve, where the minima and maxima follow a particular curve sequence. For example, if a data curve starts at a high value, then drops to a smaller value, then goes back up to a high value, the delta is computed as the difference between the lowest value and the highest value. Accessing the Raw Data Checks screen To access the Raw Data Checks screen: 1. Select Setup > Test List in the menu bar. 2. Double-click a test in the Test List. 3. In the Test Definition navigation tree, expand DR Parameters, Primary wavelength and select Raw data checks. 4. <User-defined test> Configure the data check parameters in the Raw Data Checks screen. See UserDefined Tests disclaimer. 5. Select the Save icon in the toolbar to save your changes. 6. Select the Previous Screen icon in the toolbar to return to the Test List. 1The part of the instrument where sample processing and testing are performed. Also called the AM or the Analyzer. 218 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Raw Data Checks Raw Data Checks screen The fields on the Raw Data Checks screen are editable only for user-defined tests. They are not editable for IL-defined tests. See User-Defined Tests disclaimer. Enable Raw Data Checks Option to configure one or more data checks to run on the raw data collected by the Analytical Module1. The data checks are performed on the data before it is processed by the instrument. Enable First Point Check Option to perform the first data point check on the first point after the end of the delay period in the raw data. Compares the value of the first point in the data curve against some percentage of the delta of the data curve. The result is flagged or fails when an unacceptable amount of noise is detected at the beginning of the cycle. 1The part of the instrument where sample processing and testing are performed. Also called the AM or the Analyzer. 219 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Raw Data Checks Error and W arning thresholds Maximum percentage of the delta of the data curve allowed before a warning or error is issued. Example – CE 5050 (Data) Start point out of range Enable Last Point Check Option to compare the value of the last point in the data curve against some percentage of the delta of the data curve. The result is flagged or fails when the curve drifts at the end of the reaction. Error and W arning thresholds Maximum percentage of the delta of the data curve allowed before a warning or error is issued. Example –CE 5058 (Data) Endpoint range Enable Signal Check Option to perform a signal check on all data points in the raw data curve. The signal check performs both of the following tasks: l Checks the value of each data point. l Marks bad data points with ORU flags. 220 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Raw Data Checks Signal minimum an d Signal maximum Set the acceptable signal range in these fields. If a data point occurs outside the specified range or is marked with an ORU flag, it may be replaced with a calculated data point that is within the range and is not marked with an ORU. Configure an acceptable number of bad data points for substitution in the Maximum illegal values field. Maximum illegal values Maximum number of bad data points to allow for substitution, expressed as a percentage of the total number of points in the data curve. Configure the percentage in this field. If the number of bad points found in the data curve exceeds this value (%), the result fails. Enable Substitution Method Data point substitution methods to use with signal check, allowing data processing to continue. Options include: l l Replace with previous value – The preceding data point replaces the one that is outside the expected range or marked with an ORU flag. Extrapolate – A bad data point is replaced with one extrapolated by computing the average value of the preceding data point and the next valid data point in the raw data curve. Enable Curve Sequence Check Option to perform a curve sequence check on all data points in the raw data curve. Determines the sequence of data points in terms of value, from smaller to larger, or from larger to smaller. Most tests have an expected curve. This check ensures the data set follows expected behavior. Results that do not follow expected behavior fail. Options are: l Min follows max – Data values decrease in value over time. l Max follows min – Data values increase in value over time. Example –CE 5057 (Data) Curve min. and max. not in correct sequence 221 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Raw Data Checks Example –CE 5057 (Data) Curve min. and max. not in correct sequence Enable Spike Removal Option to remove data spikes in the raw data curve. Compares the difference between two consecutive data points to a value computed as a percentage of the delta of the raw data curve specified in the Max. % of curve delta field. If the difference between the two data points exceeds the maximum difference allowed, the second point may be replaced with a point within the allowable range. Configure an acceptable number of bad data points for substitution in the Max. % of illegal points field. Max. % of curve delta Maximum allowable percentage of the delta of the raw data curve between consecutive data points. Configure the percentage in this field. If the difference between two consecutive data points exceeds this percentage, the second point may be replaced with a point within the allowable range. 222 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Raw Data Checks Max. % of illegal points Maximum number of bad data points to allow for substitution, expressed as a percentage of the total number of points in the data curve. Configure the percentage in this field. If the number of bad points found in the data curve exceeds this value (%), the result fails. Enable Substitution Method Data point substitution methods used with spike removal, allowing data processing to continue. Options include: l l Replace with previous value – The preceding data point replaces the one that is outside the expected range. Extrapolate – A bad data point is replaced with one extrapolated by computing the average value of the preceding data point and the next valid data point in the raw data curve. Maximum number of bad data points to allow for substitution, expressed as a percentage of the total number of points in the data curve. Configure the percentage in this field. If the number of bad points found in the data curve exceeds this value (%), the result fails. Enable Baseline by Moving SD Option to truncate noisy data in the baseline area of a reaction curve. A stable baseline of the raw data curve is established by locating the section of the data curve with the smallest standard deviation (SD) followed by truncation of all data points that occur before the point in time where the smallest SD was found. This bypasses noise at the beginning of a data curve (for example, noise caused by mixing reagents or the presence of a bubble). Enable percentage of time Option to use the specified percentage of the reaction curve time to locate the smallest SD calculated as follows: l (Total acquisition time – delay) * percentage Specify the percentage in the Percentage field. The SD calculation begins at the end of the delay time and continues for the time corresponding to the percentage of time specified. Enable absolute time Option to use an absolute amount of time in the reaction curve, specified in the Time field, over which to locate the smallest SD. The SD calculation begins at the end of the delay time and continues for the specified time. This option should be selected if Enable baseline by moving SD is selected and the test uses an extended acquisition mode. l Minimum: 0.100 seconds l Maximum: 1800.00 seconds Siz e of window Indicates the data points to use (over the specified period of time) to compute the SD. For faster reactions, the size of the window should be fairly small. 223 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Raw Data Checks See Also l Data Reduction Parameters l Data Flags l Alarm Messages 224 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Normalized Data Checks Normalized Data Checks Overview The Normalized data checks screen allows you to select which normalized data checks you want to perform and the limits to apply to each of those checks. The normalized data is the data that has been acquired from the analyzer and is subsequently normalized, then smoothed and finally referenced, providing these data checks have been enabled. For many of the normalized data checks, the delta (signal change across the curve) of the normalized data curve is used. It is important to note that the delta of the normalized data curve is not necessarily computed as the signal difference between the last point in the curve and the first point in the curve (although for classic curves, this is the case). The delta of the data curve is computed as the difference between the minima and the maxima of the data curve, where the minima and maxima follow a particular curve sequence. So, for example, if a data curve starts at a high value, then drops to a lower value, then goes back up to a high value, the delta is computed as the difference between the lowest value and the highest value. Accessing the Normalized Data Checks Screen To access the Normalized Data Checks screen: 1. Select Setup > Test List in the menu bar. 2. Double-click a test in the Test List. 3. In the Test Definition navigational tree, expand DR Parameters, Primary wavelength and select Normalized data checks. 4. <User-defined tests> Configure the Normalized data checks screen. See User-Defined Tests disclaimer. 5. Select the Save icon in the toolbar to save your changes. 6. Select the Previous Screen icon in the toolbar to return to the Test List. 225 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Normalized Data Checks Normalized Data Checks Screen Enable Normalized Data Checks Check to enable any or all normalized data checks. The normalized data checks are checks that are performed on the normalized and smoothed data curve. N ormalized Signal C heck Aids in choosing the correct derivative peak for algorithms based on derivative methods (first derivative, second derivative, and delta). When enabled, derivative peaks found in an area of the normalized curve where the signal is trending in a negative direction are not considered valid and are ignored. Enable N ormaliz ed C urve D elta U pper Limit Determines if the magnitude of the reaction curve is too high. Computes the delta of the normalized data curve and compares the actual delta value against the allowed delta value. Results obtained from curves where the delta is greater than the maximum delta expected fail. When enabled, the following fields are also enabled: l Error limit (Upper) l Warning limit (Upper) 226 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Normalized Data Checks Enable N ormaliz ed C urve D elta Lower Limit Determines if the magnitude of the reaction curve is too low. Computes the delta of the normalized data curve and compare the actual delta value against the allowed delta value. Results obtained from curves where the delta is less than the minimum delta expected fail. If this field is enabled, the following fields are also enabled: l Error limit (Lower) l Warning limit (Lower) Example – CE 5060 (Data) Minima delta not found Enable C alibrated R esult D elta C heck Compares the normalized curve delta of a sample to that of the lowest calibrator1 dilution. If the normalized curve delta of the sample is not within the tolerance range of the lowest calibrator dilution normalized curve delta, the result is either failed or flagged. This check is only applicable to tests that have a validated calibration. Max Tolerance Defines the allowable variation (%) around the lowest calibrator dilution delta. If this range is violated, the result is failed. Max Tolerance warning Defines the allowable variation (%) around the lowest calibrator dilution delta. If this range is violated, the result is flagged. 1A type of sample with an assigned value used to calibrate a test. 227 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Normalized Data Checks Baseline Check Tab Enable Baseline Check Verifies that the baseline (beginning) of the reaction is stable. If the data curve has been referenced, you can establish an expected mean and tolerance for the baseline of the curve. Regardless of whether the data curve has been referenced or not, you can establish an expected maximum standard deviation (SD). Not all data curves have a signature that allows for a stable baseline. N umber of Seconds Number of seconds over which the baseline average of the normalized data is computed. Enable Mean C heck Verifies that the mean computed for the baseline is within the expected range. Enable SD C heck Ensures the beginning of the data curve is stable. Results obtained from curves that do not meet the SD check error criterion fail. Example – CE 5052 (Data) Baseline SD out of range 228 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Normalized Data Checks Endpoint Check tab Enable Endpoint Check Verifies that the end of the reaction curve is stable and is not drifting. If the data curve has been referenced and the test has predictable curves, you can establish an expected mean and tolerance for the endpoint of the curve. Regardless of whether the data curve has been referenced or not, you can establish an expected maximum standard deviation. Not all data curves have a signature that allows for a stable endpoint. N umber of Seconds Number of seconds over which the endpoint average of the normalized data is computed. Enable Mean C heck Verifies that the mean computed for the endpoint is within the expected range. Enable SD C heck Fails samples that exceed the variation determined during test method development. Ensures the end of the data curve is stable. Curves that do not meet the SD check error criterion fail. 229 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Normalized Data Checks Multiple Threshold Check Tab Enable Multiple Threshold Check Searches the normalized data, starting at the beginning of the data, for multiple occurrences of a defined threshold value. Only considers data that is moving in a positive direction. The threshold value is defined as either an absolute value or a percentage of the normalized curve delta. Method If the method is Absolute value of referenced curve, the curve must be referenced. If the method is Percentage of curve, the threshold limit value is calculated as follows: Threshold Limit Value (Error or Warning) = Curve Minimum + (Curve Delta * Limit Value/100) 230 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Normalized Data Checks The Multiple Threshold Check can fail or flag samples that present with this type of abnormal curve characteristic. Error Limit The Error Limit is calculated using the Threshold Limit Value calculation above where the limit value is the value defined in the Error Limit field. If the Threshold Limit Error Value is found two times and the time between each occurrence of the located threshold value is greater than the defined time span, the result fails with the error, CE 5092 Normalized data contains multiple thresholds. W arning Limit The Warning Limit is calculated using the Threshold Limit Value calculation above where the limit value is the value defined in the Warning Limit field. If the Threshold Limit Warning Value is found twice and the time between each occurrence of the located threshold value is greater than the defined time span, the result is reported with the warning: CW 5232 “Normalized data contains multiple thresholds. NOTE: If the warning limit is set to the same value as the error limit, only the error is generated. Time Span Distinguishes between true reaction curve anomalies and baseline noise and is the time between two occurrences of the threshold limit value. To produce an error or warning, the time between two occurrences of the threshold limit value must be greater than the limit defined in the Time Span field; otherwise the two values are considered noise. See Also l Data Reduction Parameters 231 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Primary Algorithm Primary Algorithm The primary algorithm used to determine the end point of a reaction. The settings on the Primary Algorithm screen are locked for all tests defined by Instrumentation Laboratory. These fields are editable only for user-defined tests. See User-Defined Tests disclaimer. Accessing Primary Algorithm Parameters To view the primary algorithm for a test: 1. Select Setup > Test List in the menu bar. 2. Double-click a test in the Test List. 3. In the Test Definition navigation pane, expand DR Parameters, Primary wavelength and select Primary algorithm. 4. <User-defined tests> Configure the primary algorithm parameters in the Primary algorithm screen. Note: A user with the appropriate security level can create a new test or copy an existing test. All responsibility for parameter development and validation of new or copied tests belongs to the user alone. 5. Select the Save icon in the toolbar to save your changes. 6. Select the Previous Screen icon in the toolbar to return to the Test List. Primary Algorithm Screen 232 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Primary Algorithm Enable Primary Algorithm Option to enable the fields on the Primary Algorithm screen. Endpoint Algorithm The average of a specified number of data points at the end of the curve is calculated to produce a result in terms of milliabsorbance or % transmittance. l l indicates region defined by endpoint time (2 sec) The red dot indicates average of data points defined by endpoint time Endpoint time Time span at the end of the curve over which to compute the average of the normalized data points. 233 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Primary Algorithm Linear Kinetic Algorithm The change in optical signal over a given amount of time is calculated. Valid results are %Transmittance/min, Transmittance/min, or Milliabsorbance/min. 234 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Primary Algorithm Linear Kinetic Algorithm Screen Slope of curve Option to compute the change in optical signal as the slope of the normalized data curve beginning at the start time and continuing for the total time indicated by Time. The slope calculation is a simple linear regression calculation. At the end of the calculation, the computed slope is adjusted for the length of time of the calculation and for the rate at which the data was acquired. Start time Point in time in the reaction data where computing the slope begins. Time Total amount of time used to calculate the slope. Delta of curve The difference between the reaction signal at the specified starting time and that at the specified end time is calculated. At the conclusion of the calculation, the computed delta is adjusted for the length of time of the calculation and for the rate at which the data was acquired. 235 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Primary Algorithm Method Select the method used to calculate the change in optical signal over a given amount of time. Options are: l l Baseline/Endpoint averages – The instrument calculates the averages of the data over the specified baseline and endpoint times, then calculates the difference. Exact start/end Time – The system calculates the difference between the data values of a point at the specified start time and end time. Start time Enabled only when the method is Exact start/end time. The start time is the point in time in the reaction data to begin computing the slope of the normalized data. End time Editable only when the method is Exact start/end time. Time is the total amount of time over which to calculate the slope. B aseline time Editable only when the method is Baseline/Endpoint averages. Baseline time is the amount of time at the beginning of the curve over which to compute the average of the normalized data points. Endpoint time Editable only when the method is Baseline/Endpoint averages. Endpoint time is the amount of time at the end of the curve over which to compute the average of the normalized data points. 236 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Primary Algorithm Example – 5060 CE (Data) Minima delta not found: Enable linear regression SD error check Verifies whether the standard deviation of the calculated slope is less than the specified error limit. If greater than the error limit, the result fails. SD error limit Maximum standard deviation allowed before the data is considered to be in error. Enable linear regression SD warning check Verifies whether the standard deviation of the slope is less than the specified warning limit. If greater than the warning limit, the result returns with a warning flag. SD warning limit Maximum standard deviation allowed before a warning flag is associated with the result. 237 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Primary Algorithm Example – 5066 CE (Reaction) Linear Regression SD out of range: Enable negative calculation When selected, difference calculations within the slope or delta methods are not computed using the absolute value. As a result, negative measured values may be produced. If enabled, the initial slope check is also calculated without considering absolute values. If disabled, the absolute value is used for difference calculations within the slope or delta methods as well as in the initial slope check computation. Enable initial slope check When enabled, the slope of the normalized data is calculated starting at the beginning of the data curve, after the end of any delay period and for the total time as indicated by the parameter Time. The initial slope calculation is a simple linear regression. At the conclusion of the calculation, the computed slope is adjusted for the length of time of the calculation and for the rate at which the data was acquired. Time Amount of time used to calculate the initial slope. The valid range is 0 seconds to the standard acquisition time. Maximum Error Limit If the computed initial slope is greater than the maximum error limit, all processing ceases and the result fails. The valid range is 0.0 to the maximum displayable value. 238 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Primary Algorithm Maximum W arning Limit If the computed initial slope is less than the maximum error limit but greater than the warning limit, processing continues, but the result is flagged. Valid range is 0.0 to the maximum displayable value. Example – 5076 CE (Reaction) Initial slope error: 239 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Primary Algorithm Threshold Algorithm Determines the measured result by locating a threshold limit value within the data curve. The limit value may be determined as a percentage of the delta of the normalized data curve, or it may be an absolute value within the data curve. If the limit value to search for is an absolute value, the data curve must first be referenced. When locating values in the data curve as a percentage of the data curve, the threshold limit value (and check value, if enabled) is always be located (because the computed value is guaranteed to be within the delta of the data curve). Method The following methods can be used to compute (or assign) the value located in the data curve. l Percentage of curve – The system calculates the threshold search value using the following relationship: o l Threshold value = Normalized curve baseline + ((Normalized curve maximum – Normalized curve baseline) * Limit value) Absolute value of referenced curve – The system tries to locate the point with the value closest to this value. Reference must be enabled if searching for absolute values. See Enable reference method. 240 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Primary Algorithm Search Direction The following search directions can be used to move through the curve when locating the threshold value. l l Forward – Starts searching at the beginning of the reaction curve when trying to locate the threshold value. Stops searching at the last instance of the sought-after value. Backward – Starts searching at the end of the reaction curve when trying to locate the threshold value. Stops searching at the first instance of the sought-after value. Limit Value Value to search in the data curve. The value depends upon the method. l l If method is Percentage of curve, enter a value in terms of percent ranging from 0-100%. If method is Absolute value of referenced curve, enter an absolute value ranging from 0 to the maximum displayable value. Enable Threshold Check Option for the threshold algorithm to search the data curve for an additional value. Ensures the data curve has enough magnitude (if using absolute values); or ensures the reaction has occurred in an expected amount of time for the test. C heck Value Additional value to locate in the data curve. l l If method is Percentage of curve, enter a value in terms of percent ranging from 0-100%. If method is Absolute value of referenced curve, enter an absolute value ranging from 0 to the maximum displayable value. Enable Threshold C heck Error Option to flag the data with an error when the threshold check value is not found in the data curve. It is impossible to get this error if the threshold method is Percentage of the curve. Enable Time Span C heck Option to calculate the difference in time between the location of the threshold value and the threshold check value and generate a warning or an error if the difference is outside the specified range. Method l l Greater than – An error is generated when the time at which the limit and check values are located is greater than the specified error limit. Less than – An error is generated when the time between the time at which the limit and check values are located is less than the specified error limit. Error Limit Difference in time between thresholds used to generate an error. 241 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Primary Algorithm W arning Limit Difference in time between thresholds used to generate a warning. Example In the example below, the data curve has not been referenced. The red line indicates the time when the threshold limit value was located. The green line indicates the time when the threshold check value was located. The time span is the time (8 seconds) between when the limit value was found (31 seconds) and the check value was found (39 seconds). The measured result is the time when the limit value was found in the data curve. 242 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Primary Algorithm First and Second Derivative Algorithms First Derivative The first derivative algorithm locates the clotting time by finding the point of maximum inflection in the normalized curve. 243 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Primary Algorithm Second Derivative The second derivative algorithm locates the clotting time by finding the point of maximum inflection in the second derivative curve. 244 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Primary Algorithm 245 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Primary Algorithm Method l Slope – Uses slope to plot the clot curve. l Least squares – Uses the least squares method to plot the clot curve. l Points – Number of data points to the left and right of each data point to use in the slope and least squares methods of calculating the clot curve. Peak Search Method (1st and 2nd D erivative) l l l l l Greatest maxima peak – (1st and 2nd Derivative) Searches the derivative curve for the peak with the greatest positive value. The peak maxima must be greater than the value established by the Maxima Peak Check, if enabled. If not enabled, the value must be greater than zero to be recognized as a peak. A maximum of one peak is located. Last maxima peak – (1st and 2nd Derivative) Searches the derivative curve for all peaks that satisfy the maxima peak criteria. The peak maxima must be greater than the value established by the Maxima Peak Check, if enabled. If not enabled, the value must be greater than zero to be recognized as a peak. The first point in the data curve cannot be considered a maxima peak, nor can the time of a maxima peak be after what is considered the end of the curve (maximum value of absorbance-normalized curve). A maximum of 100 peaks are located. The last maxima peak found is used for calculating results, if it passes all peak check criteria. If the last max peak fails the peak check criteria, the next to last peak is used, and so on, until a result is determined, or until the list of peaks is exhausted. Greatest Max/Min Couplet – (2nd Derivative) A minima peak (<0) must immediately follow the maxima peak. For this reason, this check can only be used with second derivative curves. The peak maxima must be greater than the value established by the Maxima Peak Check value and the absolute value of the peak minima must be greater than the Minima Peak Check value, if enabled. The first point in the data curve cannot be considered a maxima peak, nor can the time of a maxima or minima peak be after what is considered the end of the curve (maximum value of absorbance-normalized curve). A maximum of 100 couplets are located. The couplet with the greatest signal difference between the minima and the maxima is considered first. If this couplet fails the peak check criteria, the couplet with the next greatest difference between minima and maxima is used, and so on, until a valid couplet is found or the list of peaks is exhausted. Last Max/Min Couplet – (2nd Derivative) A minima peak (<0) must immediately follow the maxima peak. For this reason, this check can only be used with second derivative curves. The peak maxima must be greater than the value established by the Maxima Peak Check value and the absolute value of the peak minima must be greater than the Minima Peak Check value, if enabled. The first point in the data curve cannot be considered a maxima peak, nor can the time of a maxima or minima peak be after what is considered the end of the curve (maximum value of absorbance-normalized curve). A maximum of 100 couplets are located. The last couplet located is considered first. If this couplet fails the peak check criteria, the couplet with the next greatest difference between minima and maxima is used, and so on, until a valid couplet is found or the list of peaks is exhausted. Greatest Max/Min to Zero Couplet – (2nd Derivative) This search method is identical to the Greatest Max/Min Couplet with the following exception: o l After the couplet is located, the search continues through the 2nd derivative minima to find the first point greater than zero. Last Max/Min to Zero Couplet – (2nd Derivative) This search method is identical to the Last Max/Min Couplet with the following exception: 246 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Primary Algorithm o After the couplet is located, the search continues through the 2nd derivative minima to find the first point greater than zero. Smoothing (1st and 2nd D erivative) Process of adjusting data points to remove noise artifacts. Select the best option. Up to three smooths can be applied to each derivative function. Delta Checks Max. Peak D elta C heck (1st and 2nd D erivative) l l Calculates the delta of the normalized data at the location within the normalized data for each maxima peak found in the derivative data. This is computed by taking the difference of the value of the point in the normalized data at the time indicated by the maxima peak value and the point in the normalized data at the time that is considered the baseline of the curve. Verifies the calculated delta is greater than the user-specified absolute value. Max. Peak D elta % C heck (1st and 2nd D erivative) l l Calculates the delta of the normalized data at the location within the normalized data for each maxima peak found in the derivative data. This is computed by taking the difference of the value of the point in the normalized data at the time indicated by the maxima peak maximum value and the point in the normalized data at the time that is considered the baseline of the curve. Verifies the calculated delta is greater than the user-specified percentage of the delta of the normalized curve. 247 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Primary Algorithm D erivative Max. Type (1st derivative) Enable one of the following: Max to the normalized endpoint – The first derivative maximum is computed by calculating the difference between the first derivative signal maxima and the first derivative signal corresponding to the time of the normalized curve endpoint. l Max to the normalized baseline – The first derivative maximum is computed by calculating the difference between the first derivative signal maxima and the first derivative signal corresponding to the time of the normalized curve baseline. l Peak D elta C heck (2nd D erivative) Calculates the delta of the normalized data at the location within the normalized data for each maxima/minima peak found in the derivative data. This is computed by taking the difference between the value of the point in the normalized data at the time indicated by the maxima peak value and the minima peak value. l Verifies the calculated delta is greater than the user-specified absolute value. l Peak D elta % C heck (2nd D erivative) l l Calculates the delta of the normalized data at the location within the normalized data for each maxima peak found in the derivative data. This is computed by taking the difference between the value of the point in the normalized data at the time indicated by the maxima peak maximum value and the minima peak minimum value. Verifies that the calculated delta is greater than the user-specified percentage of the delta of the normalized curve. 248 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Primary Algorithm For the data shown above, assume the following warning and error limits are set: l Peak Delta Check Warning: 8 mAbs l Peak Delta Check Error: 4 mAbs l Peak Delta % Check Warning: 40% l Peak Delta % Check Error: 20% NOTE: In this example: l The Total Curve Δ is 21.8 mAbs. l ΔMax2 - Min 2 = 11.6 mAbs (indicated by Xs on normalized curve) or 53.2% of curve l ΔMax 1 - Min 1 = 1 mAbs (indicated by an X with a vertical line through it on normalized curve) or 4.5% of curve In the example above, all search methods would use the peak checks as follows: l ΔMax 1- Min 1 is less than the Peak Delta Warning and Error l ΔMax 2- Min 2 is greater than the Peak Delta Warning l ΔMax 1- Min 1 is less than the Peak Delta % Warning and Error l ΔMax 2- Min 2 is greater than the Peak Delta % Warning Depending on the search method, Max 2 or couplet 2 would be used to calculate the result. 249 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Primary Algorithm Peak Checks Peak checks are used to help identify the correct peaks. If a peak or couplet passes the peak check criteria (warning and error) a result returns. If a peak or couplet exceeds the warning limit but not the error limit, a result returns with a warning. If a peak or couplet exceeds the error limit, the result returns as failed. Peak checks may be useful in removing 2nd derivative maxima and minima which are the result of rises in the baseline or bumps in the clot curve after the clotting has slowed. Max. Peak C heck (1st and 2nd D erivative) Verifies the maxima peak occurs earlier than the last valid point in the derivative curve. Verifies the value of the maxima peak is greater than the user-specified warning/error limits established for the maxima peak. Min. Peak C heck (2nd D erivative only) Verifies the minima peak occurs earlier than the last valid point in the derivative curve. Verifies the absolute value of the minima peak is greater than the user-specified warning/error limits established for the minima peak. 250 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Primary Algorithm Enable 1st D erivative B ound C heck (2nd D erivative only) Ensures the second derivative maxima peak selected occurs before the first derivative maxima peak. If the peak search method used is a couplet method, it ensures the minima peak selected occurs after the first derivative maxima peak. For example: If the Peak Search Method is: Greatest Max Peak l Max1 is less than Max Peak Check warning limit, but is considered. l Max2 is greater than Max Peak Check warning limit and is considered. l Max3 is greater than Max Peak Check warning limit and is considered. l Max2 is chosen to calculate result as Max2 is greater than Max3. If Max1 was the only Max to be found, the system would return a result using this peak with a warning (Maxima of 2nd derivative is low). 251 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Primary Algorithm Greatest Max/Min Couplet l Max/Min1 does not meet Max (warning) or Min (error) Peak Check criteria and is not considered. l Max/Min2 meets all Peak Check criteria and is considered. l Max/Min3 meets all Peak Check criteria and is considered. l l Max/Min2 is used to calculate result as this couplet has the largest difference between the max and min of all the couplets that were considered. If Min1 and Max1 were the only min/max pair to be found, the system would return an error (min/max peak criteria not met). l Max/Min1 does not meet Max (warning) or Min (error) Peak Check criteria and is not considered. l Max/Min2 meets all Peak Check criteria and is considered. l Max/Min3 meets all Peak Check criteria and is considered. l l Max/Min2 is used to calculate result as this couplet has the largest difference between the max and min of all the couplets that were considered. If Min1 and Max1 were the only min/max pair to be found, the system would return an error (min/max peak criteria not met). Last Max Peak l Max1 does not meet Max Peak warning limit, but is considered. l Max2 meets Max Peak Check criteria and is considered. l Max3 meets Max Peak Check criteria and is considered. l Max3 is the last max found which meets criteria and is used to calculate result. l If Max1 were the only max to be found, the system would return a warning (Maxima of 2nd derivative is low). Last Max/Min Couplet l Max/Min1 does not meet Max (warning) or Min (error) Peak Check criteria and is not considered. l Max/Min2 meets all Peak Check criteria and is considered. l Max/Min3 meets all Peak Check criteria and is considered. l Max/Min3 is used to calculate result as it is the last couplet found which passes all criteria. l If Min1 and Max1 were the only couplet to be found, the system would return an error (Min/Max peak criteria not met). Peak C ount C heck (1st and 2nd derivatives) This check counts the number of maxima peaks (either as a maxima alone or as part of a peak couplet) within the specified window size. Starting at the first maxima peak, the window size is determined by adding the time corresponding to the maxima peak to the window size value. The number of maxima peaks are counted, and if the number exceeds the number allowed (error or warning limits), the result is flagged (warning) or failed (error) with an error ERR MAX PEAK COUNT EXCEEDED. 252 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Primary Algorithm First Peak B oundary (1st and 2nd D erivative) Check used to distinguish a true peak from noise at the beginning of the data curve. The ascent value is the increase in intensity of the peak after the first data point. If the curve does not ascend to the defined limit (calculated as Percent Limit x Max Peak Delta) the peak is not considered a valid peak. D efinition B oundary (1st and 2nd D erivative) When the Definition Boundary (percent) check is enabled, data reduction uses the maximum value of all the data within this peak as the peak maxima. You can choose the following three options to determine which of the local maxima peaks are selected: l First peak l Greatest peak l Last peak Post Processing Checks (Second Derivative) Time Span Compares the difference in time between the minima and maxima peak when a couplet peak search method is used. Depending on the chosen method, if the difference in time is less than or greater than the error limit, the result is FAILED. Depending on the chosen method, if the difference in time is less than or greater than the warning limit, a numeric result with a warning is generated. See: Data Flags, CE 5064. 253 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Primary Algorithm Delta Algorithm Uses the 2nd derivative algorithm. The 2nd derivative minima and maxima are located. The time when these points occur is referenced back to the normalized curve. The difference between the values of the normalized curve at these times is computed to obtain the delta value. The chart below shows how the delta is computed when the peak search method is either Greatest Max/Min to Zero Couplet or Last Max/Min to Zero Couplet. The location of the first point in the 2nd derivative curve that is greater than zero (after it has gone through the minima) is used. If the Greatest Max/Min Couplet or Last Max/Min Couplet method is used, the minimum of the 2nd derivative references back to the normalized curve. 254 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Primary Algorithm Delta Second Derivative Tab The Delta algorithm setup is similar to the Second Derivative algorithm setup with the following exception: l Because the Delta Algorithm must use a couplet peak search method, the Last Maxima Peak and Greatest Maxima Peak methods are not available as peak search options. 255 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Primary Algorithm Final Minus Initial Algorithm The Final Minus Initial Algorithm calculates a measured result using one of the following methods: l l Computes the difference between two points (Exact start/end time). Computes the difference of the averages of several points obtained at the beginning and end of the curve (Baseline/Endpoint averages). Method Select one of the following options in the drop-down list: l Baseline/Endpoint averages – The system calculates the averages of the data over the specified baseline and endpoint times, and calculates the difference. l l Baseline Time – Length of time over which to compute the average of the normalized data, starting from the beginning of the curve. Editable only if the method is Baseline/Endpoint averages. Endpoint Time – Length of time at the end of the curve over which to compute the average. Editable only if the method is Baseline/Endpoint averages. 256 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Primary Algorithm indicates region defined by Baseline/Endpoint time Red dots indicate average of data points defined by Baseline/Endpoint time. l Exact Start/End Time – If selected, the system calculates the difference between the data values corresponding to the exact points specified in Start time and End time. l l Start Time – This is only editable if the method is Exact Start/End time. This is the point in time in the reaction to begin computing the slope of the normalized data. End Time – This is only editable if the method is Exact Start/End time. This is the total amount of time used to calculate the slope of the normalized data. 257 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Primary Algorithm Enable Linear Regression SD Error Check Option to verify that the standard deviation of the slope is less than the specified error limit. A value greater than the warning limit returns a FAILED result. l SD Error Limit – Maximum standard deviation allowed before the data is considered in error. Enable Linear Regression SD Warning Check Option to verify that the standard deviation of the slope is less than the specified warning limit. A value greater than the error limit returns a result with a warning flag. l SD Warning Limit – Maximum standard deviation allowed before results are flagged with a warning. Enable Negative Calculation With the negative calculation option enabled, the Final minus initial algorithm is no longer computed using the absolute value of the difference. As a result, negative measured values may be produced. If it is enabled, the Initial slope check is also calculated without considering absolute values. If disabled, the absolute value is used for the difference calculation within the final minus initial algorithm, as well as in the initial slope check computation. Enable Initial Slope Check The slope of the normalized data is calculated starting at the beginning of the data curve (after the end of any delay period) and for the total time indicated by the Time parameter. The initial slope calculation is a simple linear regression. After the slope is calculated, it is adjusted for the length of time of the calculation and for the rate at which the data was acquired. Time Total amount of time used to calculate the initial slope. The valid range is 0 seconds to the standard acquisition time. Maximum Error Limit If the computed initial slope is greater than the maximum error limit, all processing ceases, and the result fails. The valid range is 0 to the maximum displayable value. Maximum W arning Limit If the computed initial slope is less than the maximum error limit but greater than the warning limit, processing continues, but the result is flagged. The valid range is 0 to the maximum displayable value. 258 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Primary Algorithm Statistics Algorithm The Statistics algorithm performs a linear regression calculation on the range of data between the statistics start time and statistics time values. It calculates the mean of the linear regression data. Statistics Statistics Start Time Time in the data to begin performing calculations. Statistics Time Total amount of time over which to perform calculations. 259 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Primary Algorithm Enable Optical Interference Check Option to apply error and warning checks to the data. Error Limit an d Tolerance Parameters used to define the range of acceptable mean values. An error message is generated when the limit is exceeded. ER ange Range of acceptable mean values computed using the error limit and tolerance values. W arning Limit an d Tolerance Parameters used to define the range of acceptable mean values. A warning flag associated with the sample when the limit is exceeded. W R ange Range of acceptable mean values computed using the warning limit and tolerance values. See Also l Data Reduction Parameters l Clot Curve Analysis 260 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Secondary Algorithm Secondary Algorithm The system uses the secondary algorithm if the primary algorithm fails any of its curve checks. NOTE: l l The secondary algorithm must be enabled by clicking the Enable range for secondary algorithm option in Calibration Setup. The secondary algorithm must use the same measured result unit (for example, seconds) as the primary algorithm. If any of the raw data checks or normalized data checks fail, neither the primary algorithm nor the secondary algorithm is used, and an error results. The secondary algorithm options are similar to those of the primary algorithm. See Also l Data Reduction Parameters 261 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Result Unit Definition Result Unit Definition Use the Result Unit Definition screen to define sample result units and select them for sample result display. Accessing the Result Unit Definition screen To open the Result Unit Definition screen: 1. Select Setup > Test List in the menu bar. 2. Double-click a test in the Test List. 3. In the Test Definition navigation tree, select Result units. Viewing and Editing Measured Units To view or edit a measured unit: 1. Open the Result Unit Definition screen. 2. Place focus1 on a unit of measurement in the Unit column. 3. Select the View icon in the toolbar. 4. Configure editable fields in the Result Unit Definition dialog box. 5. Select OK to close the window. 6. Select the Save icon in the toolbar to save your changes. 7. Select the Previous Screen icon in the toolbar to return to the Test List. NOTE: l l A test must always have a measured unit defined. The default measured unit is seconds. The measured result unit and ranges of the test that imports results calibration data from another test must be the same as the measured result unit and ranges of the imported test. 1To place focus on the unique identifier in a list, click a row in the table. A blue cell border indicates focus. Only one unique identifier in a list can have focus. 262 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Result Unit Definition Adding Result Units To add a result unit: 1. Open the Result Unit Definition screen. 2. Select the Add icon in the toolbar to open the Non-IL Result Unit Definition window. 3. Configure the new result unit in the Non-IL Result Unit Definition window. 4. Select OK to close the window. 5. Select the Save icon in the toolbar to save your changes. 6. Select the Previous Screen icon in the toolbar to return to the Test List. NOTE: If the measured result is 0, the Ratio and INR results fail. Deleting a Result Unit To delete a result unit: 1. Open the Result Unit Definition screen. 2. Select1 the result unit in the table to delete. 3. Select the Delete icon and confirm. 4. Select the Save icon in the toolbar to save your changes. 5. Select the Previous Screen icon in the toolbar to return to the Test List. NOTE: Measured result units cannot be deleted. 1Click in the Selection column of a table. A red check mark indicates selection. You can typically select more than one object. 263 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Result Unit Definition Result Unit Definition From this screen you can do the following: l Add a result unit. l View result unit details. l Delete a result unit. Result Unit Definition Columns Selection C olumn Click one or more cells in this column to place check marks, selecting rows to perform actions on. Click the Select icon in the column heading to select or deselect all the rows in the table. U nit The unit that is measured in the test. U nit Type The type of unit measured in the test. Available unit types are Measured, Calibrated, Calculated, Paired, Statistical and Derivative. Label Abbreviated form of the unit. Indicates how the unit appears in the sample list. 264 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Result Unit Definition A check mark indicates the material is an IL-defined material. dec. Number of decimal places the reported result contains. NOTE: - Numeric values are calculated using precise values. However, when displayed, these values are rounded to a specified number (n) of decimal places. Due to this rounding, a value displayed on-screen may appear to be within the defined range limit when it is actually out of range. Such values are flagged to indicate that they are out of the range. N ormal, Therapeutic, Linear a n d Test R ange Normal, Therapeutic, Linear and Test Range columns display the established minimum and maximum values for each of these ranges. Patient Result Selection Select up to four predefined result unit types per sample to display in the Sample List. Primary Unit Configuration Primary U nit Select the predefined result unit used to check the maximum difference between replicate results. NOTE: You should define only one primary calibrated unit. Enable Max D ifference If this option is enabled, and the number of replicates is 2, the maximum difference between each of the replicates is computed. If the percent difference between either of the results and the mean of the results is greater than the maximum difference allowed, the mean of the result is flagged with a warning. Max D ifference Specifies the maximum difference between an individual result and the mean result as a percentage that cannot be exceeded or the mean result is flagged as an error or warning. Measured Result Curve Display Settings Use these fields to configure the graphical display settings for the measured result curve. 265 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Result Unit Definition Result Unit Definition Screen Unit selection U nit type Select one of the following result unit types: l Calculated – Some tests require more than one result or the use of a conversion factor to compute a result. An example of such a test is the Prothrombin Time test, where an ISI value is required to compute the INR result. The following options are available for calculated units: o Ratio o INR If the measured result is 0, the Ratio and INR results fail. l Calibrated – If a test requires calibration, it must always have a calibrated unit defined to report a calibrated result. 266 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Result Unit Definition NOTE: You should define one primary calibrated unit (one unit with no conversion). The following options are available for calibrated units: l l l o % o User-Defined o μg/L o μg/mL o μmol/L o AU/mL o g/L o IU/dL o IU/mL o mg/dL o mg/L o mU/mL o ng/mL o nmol/L o U/mL Derivative – The following options are available for derivative units: o 1st der = Maximum peak height of first derivative curve o 2nd der - = Maximum negative peak height of second derivative curve o 2nd der + = Maximum positive peak height of second derivative curve Paired – Tests that are configured as paired tests require the use of a paired unit. An example of such a test is the APCR test, where results from both the activated and non-activated forms of the test are required to compute a Ratio result. The following options are available for paired units: o % Correction = ((Measured Result 1 - Measured Result 2) / (Measured Result 1 - NPP1)) * 100 o PiCi% = ((ThP-B - ThP-A) / ThP-B )*100=PiCi% o Rosner Index = (Measured Result 1 - NPP2) / Measured Result 2) * 100 o Test Delta = (S1 - S2) o Test Delta % = ((S1 - S2) / S1) * 100 o Test Delta-N = ((S1 - S2) / (NPP1 - NPP2)) o Test Delta-N% = ((S1/S2) / (NPP1/NPP2)) * 100 o Test Ratio = (S1/S2) o Test Ratio-N = ((S1/S2) / (NPP1/NPP2)) o Test Ratio-N% = ((S1 - S2) / (NPP1 - NPP2)) * 100 Statistical – A statistical unit is required when the statistic algorithm is chosen as the primary algorithm. The options available for statistical units are: o %CV o SD o Slope 267 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Result Unit Definition U nit Select the unit specific to the unit type. U ser-defined label The user-defined label allows you to input the user-defined calibration unit. It is used when you want to define your own calibrated unit. You can create one user-defined unit per test. D ecimals Select the number of decimal places to be reported for the result. NOTE: - Numeric values are calculated using precise values. However, when displayed, these values are rounded to a specified number (n) of decimal places. Due to this rounding, a value displayed on-screen may appear to be within the defined range limit when it is actually out of range. Such values are flagged to indicate that they are out of the range. Calibrated unit data This is editable only if the selected unit type is calibrated. Enable conversion Option to enable conversion. Select an option in the Conversion unit list. C onversion factor Linear multiplication factor applied to the result unit for converting results (e.g. from g/L to mg/dL). Paired result data This is editable only if the selected unit type is paired. Paired unit Tests that are configured as paired tests require the use of a paired unit. An example of such a test is the APCR test, where results from both the activated and non-activated form of the test are required to compute a ratio result. INR unit data Read-only information extracted from the material definition. It displays material to which the ISI value is specific, as well as the ISI value itself, provided that the unit type is calculated and the unit is INR. Minimum limits A llow negative results (QC jobs excluded) Option to enter a limit for acceptable negative values. If a negative result is obtained and the value is less than zero but more positive than the negative value limit, the value is reported as a true negative value. If a negative result is obtained that is less than zero and more negative than the negative value limit, the value 268 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Result Unit Definition fails. For Linear Kinetic and Final minus initial algorithms, negative values for measured results are only reported if negative calculation is enabled from within the Primary algorithm setup for these algorithms and Allow negative results is enabled for the measured result unit. This option applies to all unit types. Enable negative limit Option to allow negative results. N egative value limit The negative limit below which the result fails. Enable transform negative results to z ero This option is available only for calibrated units. Option to define a limit for acceptable negative calibrated values. If a negative calibrated result is obtained with a value that is less than zero but more positive than the negative value limit, the result is reported as zero. If a negative calibrated result is obtained with a value that is less than zero and more negative than the negative value limit, the result fails. NOTE: Calibration results are automatically reported as 0 in the following situations: l l When measured result values (any sample type) are less than the mean of the measured result of the 0% calibration dilution for assays employing a 0% dilution that have a positive calibration slope; or When measured result values (any sample type) are greater than the mean of the measured result of the 0% calibration dilution for assays employing a 0% dilution that have a negative calibration slope. Transform to Field where you configure a number to convert a negative result. Enable result correlation When this option is enabled and the result is found to be within the specified correlation range, a correlation factor and offset are applied to the result to obtain better agreement with results obtained by another method. The result correlation default is disabled. Result Correlation Formula y = a*x + b Where: y = Calculated new result x = Original result a = Factor b = Offset 269 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Result Unit Definition NOTE: In a linear regression, results from the ACL TOP are the x set of values. Correlation Range C orrelation range Minimum a n d Maximum Range in which the result must fall in order to apply correlation factor and offset. Method Specifies the use of the linear method when applying factor and offset. Factor Value to multiply by each result to shift the slope of the curve. The default value is 1.000. Offset Value to add to each result to shift the curve on the y-axis. The offset value is applied before the factor value is applied. The default value is 0.000. Ranges Enable normal range Option to flag results that fall outside the established limits. l Minimum/Maximum – Enter minimum and maximum values to define the normal range for the test. NOTE: For calibrated results employing a conversion factor, the normal range minimum and maximum values are automatically calculated from the range of the primary calibrated unit and the conversion factor. Enable therapeutic range Option to flag results that fall outside the established limits. l Minimum/Maximum – Enter minimum and maximum values to define the therapeutic range for the test. Enable linear range Option to flag results that fall outside the established limits. l l l Minimum/Maximum – Enter minimum and maximum values to define the linear range for the test. Extended Time Minimum and Maximum – Enter minimum and maximum values to define the linear range for the result unit when extended acquisition analysis is performed. Alternative Pre-dilution Minimum and Maximum – Enter minimum and maximum values to define the linear range for the result unit when alternative pre-dilution is performed. 270 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Result Unit Definition NOTE: For calibrated results employing a conversion factor, all linear range minimum and maximum values are automatically calculated from the range of the primary calibrated unit and the conversion factor. Enable test range Option to flag results that fall outside the established limits. l l Minimum/Maximum – Enter minimum and maximum values to define the test range for the result unit. Extended time/alternative pre-dilution – Enter minimum and maximum values to define the test range for the result unit when extended acquisition analysis is performed. NOTE: For calibrated results employing a conversion factor, all test range minimum and maximum values are automatically calculated from the range of the primary calibrated unit and the conversion factor. See Also l General Information l Analytical Cycle Definition l Data Reduction Parameters l Calibration l Parallelism l Normal Pool Plasma l Rerun Rules 271 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Calibration Setup Calibration Setup Overview You can define the following calibration items: l Calibration method, dilution volumes and pipetting parameters for calibrator1 and diluent materials used to prepare automatic dilutions l Calibrator materials used in manual calibrations l Calibration frequency tests l Data reduction parameters for the calibration math model and related checks. Calibration can be defined using automatic dilution or pre-diluted calibrators. NOTE: A calibration will become an alternate lot if any of the material lots (other than the calibrator) used to generate the active calibration are no longer on-board the system. When a calibration changes from active to alternate, the calibration status changes from validated to unvalidated. Accessing the Calibration Definition screen To access the Calibration Definition screen: 1. Select Setup > Test List in the menu bar. 2. Double-click a test in the Test List. 3. Select Calibration in the Test Definition navigational tree. 4. Click the General, Frequency and DR Parameters tabs to access the respective calibration fields. 5. <Optional> Perform edits in the calibration fields. 6. Select the Save icon in the toolbar to save your changes. 7. Select the Previous Screen icon in the toolbar to return to the Test List. 1A type of sample with an assigned value used to calibrate a test. 272 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Calibration Setup Accessing the Automatic Dilution screen To access the Automatic Dilution screen: 1. Select Setup > Test List in the menu bar. 2. Double-click a test in the Test List. 3. In the Test Definition navigation tree, expand Calibration and select Automatic Dilution. 4. <Optional> Perform edits in the General, Calibrator and Diluent tabs. 5. Select the Save icon in the toolbar to save your changes. 6. Select the Previous Screen icon in the toolbar to return to the Test List. Accessing the Pre-diluted Calibrators screen To access the Pre-diluted Calibrators screen: 1. Select Setup > Test List in the menu bar. 2. Double-click a test in the Test List. 3. In the Test Definition navigation tree, expand Calibration and select Pre-diluted calibrators. 4. <Optional> Edit the calibration points. 5. Select the Save icon in the toolbar to save your changes. 6. Select the Previous Screen icon in the toolbar to return to the Test List. See Pre-diluted Calibrators Screen. 273 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Calibration Setup Calibration Definition Screen Enable calibration Option to activate calibration parameters for editing. 274 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Calibration Setup General tab General N umber of R eplicates Number of repeat measurements to perform on each dilution. l Minimum: 1 l Maximum: 6 l Default: 3 C alibration U nit Select the unit from the drop down list. Only a primary calibration unit may be selected. A primary calibration unit is a calibrated unit that does not employ a conversion factor. C alibration Mode You can enable Automatic dilutions process or Prediluted calibrators. These are not selectable if import calibration is enabled. When the Prediluted calibrators option is enabled, the following columns in the Prediluted Calibrators table become user-definable: l l l l Calibrator Material – A type of sample with an assigned value used to calibrate a test. Target Value – The value that has been defined for the calibrator by its manufacturer. It represents the expected value at 100% dilution. If a calibrator material has not been selected or the assigned value defined, the Target Value column displays 0.00 for each concentration. The target value is automatically updated after the missing information is entered and saved. Min. Replic. – The minimum number of valid replicates per calibration point to validate a calibration result. %CV Max – Maximum %CV for each calibrator concentration that is allowed. If the %CV is greater than the maximum specified here, that calibration point fails. Enable Import Calibration Option to import calibration data from another test to calculate calibrated results. If Imported type field is set to Results Data, the Imported unit field will match the calibration unit from the imported test. If Imported type is set to Raw Data, the Imported unit field is blank. Calibration data reduction fields from the imported test are automatically copied into the calibration data reduction fields of the test that is importing the calibration. If a test uses an imported calibration, the validated imported calibration must use the same validated calibration as the master test. If it does not, the calibrated results of the test using the imported calibration are flagged. If the master calibration is not validated or no longer exists, calibration results of the test using the imported calibration are flagged. 275 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Calibration Setup A llow define parallelism / clean & rinse Option to force an additional clean and rinse cycle before aspiration begins on parallelism jobs. Imported Test From this list, select a test from which to import calibration data. Imported Type Select one of the following: l l Raw Data – Data as it is acquired from the analyzer. Results Data – Values such as the slope, intercept and r2 values calculated for the calibration that is being imported. When you import results data, the calibration is automatically validated. However, if you import an unvalidated master calibration, the calibration in the importing test is unvalidated. Selecting this option enables the Correction Factor field. C orrection Factor Multiplier applied to an imported calibration when the Enable Import Calibration option is enabled and the Imported Type is set to Results Data. This option is only available for copied (open) tests. This field is disabled for IL tests. Imported U nit This displays the calibration unit to import from the calibration. NOTE: l l l If a test imports the raw calibration data from another test, you can configure the delay time for the importing test. The intermediate and start reagents of a test that imports the raw calibration data from another test must be the same as the intermediate and start reagents of the test that is imported. When you import calibration results data into a test, the results correlation setup (including the measured result unit and result unit ranges) of the test are overwritten by the imported data. Import Validation Status Option to import the calibration from a master test. When the calibration to import is validated, the imported calibration is automatically validated. Test Feasibility Test not feasible when no validated calibration Option to make a test not feasible when there is no validated calibration for that test and the on-board lot of reagent it uses. This condition is reflected in the Test Feasibility screen and applies to patient tests and associated QC tests. 276 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Calibration Setup NOTE: When creating an open test that uses a calibration that is imported from another test, the calibration for the imported test must be performed after the new test definition has been created in order to obtain calibrated results. The same applies if an existing open test definition is modified to use an imported calibration. Calibration Execution Force mode with reduced clean Option to force a selected test to calibrate without running any other jobs. When this option is selected, the only operation you can perform is to calibrate the selected test. This option decreases calibration time for assays that require extra rinsing between dispensing reagents. When a calibration test has the this option enabled and the dilution process is configured to run in batch mode, the calibration must be programmed in the Calibration Details screen on a calibrator placed in a diluent rack. Extra rinsing is not required because multiple reagents are not dispensed. This feature is locked for all IL tests. 277 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Calibration Setup Frequency Tab Use this screen to define the calibration frequency. Enable Frequency Option to define the frequency parameters and to display a warning when calibration is due. Frequency Option (in number of tests or hours or days) between calibrations. NOTE: Only patient jobs are considered when counting the frequency by tests. QC jobs, calibration points, and NPP points are excluded. Enable W arning Threshold Option to configure a warning to issue when calibration is due. Warning Threshold Establishes the time to notify you that a calibration is due. If the frequency is set to tests, the warning threshold must be in terms of tests. Likewise, if the frequency is set to hours, the warning threshold must be in terms of hours. If the frequency is in terms of days, select the warning threshold in terms of hours or days. 278 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Calibration Setup DR Parameters Tab Enable Extrapolation Option to specify to what extent extrapolation of the calibration curve is allowed. The result unit for these limits is the same as that specified for the calibration unit on the General tab. Calibration results outside these limits fail, but the measured result is reported. (The error codes are 5508 for Out of calibration range high, and 5509 for Out of calibration range low.) NOTE: The out of calibration range high and low checks are done before the result is multiplied by the pre-dilution factor. Enable range for secondary algorithm Check to set a range for the secondary algorithm so that, if the secondary algorithm is used, a result value that falls below the minimum limit allowed or exceeds the maximum limit allowed fails. Enable %C V C heck If this field is enabled, the %CV between the replicates for each dilution point is calculated. If the %CV of the replicates exceeds the corresponding value shown in the %CV Max. column in the Calibration Points table for any dilution point, the calibration curve is flagged and fails. This check can only be enabled if the number of replicates is two or more. (See Pre-diluted Calibrators for a screen shot displaying the Calibration Point table.) Enable Outlier R emoval If checked and there are at least three good replicate results for a concentration, the replicate with the value furthest from the mean is discarded. After the outlier is removed, the mean of the replicates is recalculated. 279 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Calibration Setup Enable 0% D ilution Target Value Check to override the automatic target value concentration for a 0% calibration dilution with a manually entered non-zero value, provided the new value is less than the target value of the next dilution. This ensures calibrations with transformations for which zero is illegal produce failed results for the 0% dilution. The ability to configure this value on a test-by-test basis preserves the true zero value for those tests for which there is no transformation conflict, such as D-Dimer HS. Measured R esult on X A xis If checked, calibration measured results are plotted on the X axis. Enable Math Model Low Some factor tests require multiple math models applied to different areas of the calibration curve to obtain the best fit. If checked, you can define an additional math model in the Math Model Low tab. NOTE: If both math model high and math model low are used, the first math model must include the highest concentration but not the lowest; the second math model must include the lowest concentration but not the highest. Math Model tab (or Math Model High) Math Model Select a linear curve fit, spline curve fit, or Polynomial order 2 through Polynomial order 6 for the math model. This field is locked for IL tests. NOTE: If both math model high and math model low are used, the first math model must include the highest concentration but not the lowest; the second math model must include the lowest concentration but not the highest. Spline Enables a Monotonic check to ensure within a given range of values there is only one result possible. Spline curves that move both up and down, and hence could have more than one calibrated result for a single measured value, are failed. Linear R egression Enables the lower part of the screen to allow selection of Enable slope check and Enable Yintercept check. l Enable Slope Check – Verifies the slope of the calibration curve is within the specified tolerance of the expected slope. o Expected Slope – Target slope value for the test. The default is 1.000. o Tolerance – Acceptable deviation around the expected slope in percent. The default is 10. 280 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Calibration Setup o l Range – Acceptable range for slope automatically calculated from the expected slope and tolerance values. Enable Y-intercept Check – Verifies that the y-intercept of the calibration curve is within the expected tolerance. o Expected Y-Intercept – Target y-intercept value for the test. The default is 0.000. o Tolerance – Acceptable deviation around the expected y-intercept in percent. The default is 10. o Range – Acceptable range for y-intercept automatically calculated from the Expected Y-Intercept and Tolerance values. Polynomial Order 2-6 These math models are available to improve curve fit. If a polynomial fit is selected, you can enable the Monotonic check to ensure within a given range of values there is only one result possible. Curves that move both up and down, and hence could have more than one calibrated result for a single measured value, are failed. Transformations Read-only fields for IL locked tests that display the mathematical transformations applied to the measured results and the calibration dilution target values, to aid in making the calibration curve more linear. For user-defined tests, transformations can be enabled for any of the math models. See User-Defined Tests disclaimer. X-A xis transformation Converts the X data into a value that produces a linear curve fit. The available transformations are: l No transformation l 10x l x2 l 1/x l x1/2 l x =x/x(0) l Log10(x) l x2.5 l Log10(Log10(x)) l 1/x1/2 l Ln(x) l (Ln(x))2 l ex 281 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Calibration Setup Y-A xis transformation Converts the Y data in order to obtain a linear curve fit. The available transformations are: l No transformation l 10y l y2 l 1/y l y1/2 l y = y/y(0) l Log10(y) l y2.5 l Log10(Log10(y)) l (Ln(y))2 l Ln(y) l 1/y1/2 l ey Enable Trend Check Verifies that all of the measured results generated for the calibration curve follow a trend in measured result signal. This means that all data points increase in value as the concentrations decrease, or all data points decrease in value as the concentrations increase. (Calibration curves with data that do not follow a trend are failed.) See Data Flags, CA 5566. Enable Monotonic Check Checks each segment (interval) of the curve (a segment is between two calibration points) to ensure there are no local maxima or minima within that segment. Curves that move up and down within calibration points are failed. See Data Flags, CA 5567. This check is disabled for the linear regression math model. Enable R2 Check Verifies that the coefficient of determination (R2 ) is greater than or equal to the specified value. The minimum R2 is the minimum acceptable value for R2 . The default is 0.985. NOTE: - The R2 value is calculated using precise values. However, when displayed they are rounded to 3 decimal places. Due to this rounding, a failed R2 value may appear onscreen as within the defined range limit. Such values are flagged to indicate that they are out of the range. First Concentration Defines the first point to use for this calibration segment. Last Concentration Defines the last point to use for this calibration segment. 282 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Calibration Setup Enable Reverse Slope Check Option to perform a reverse slope check when the Math Model High selected is Polynomial order 2-6. This option generates an error when all of the following conditions are met: l l l The measured values are decreasing for lower concentrations; and The measured value is higher or lower than the measured mean for highest calibration concentration; and The corresponding target value is lower than the target value for the highest concentration. The following curve shows the failed results. Math Model Low Tab Some factor tests require the use of two different math models at different calibration dilutions to provide the best fit in the specific dilution ranges. Two curve segments, high and low, are used, with each segment having a different math model. The setup of the low math model is identical to that described for the high math model, with the exception that a cutoff point can be defined. Cut-off Defines which calibration segment to use for calculating calibrated results from measured results. Value Measured results that are less than the specified value are converted to calibrated results using the high math model segment. Measured results greater than the specified value are converted to calibrated results using the low math model segment. B y concentration Measured results less than the value corresponding to the selected calibration dilution are converted to calibrated results using the high math model segment. Measured results greater than the value corresponding to the selected calibration dilution are converted to calibrated results using the low math model segment. 283 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Calibration Setup The curve is displayed in the Calibration Status List screen. See Reviewing and Validating Calibration Test Results. Automatic Dilution Screen Use the Automatic Dilution screen to obtain the calibration points from one calibrator material. 284 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Calibration Setup General Tab Dilution Points D efine Points by % D ilution If selected, for each dilution point the concentration field is enabled for editing and defines a calibration point. The calibration point target value field is disabled for editing and is calculated from the calibrator assigned value and the corresponding calibration dilution concentration. D efine Points by Target C oncentration For user-defined tests, if selected, for each dilution point the calibration point target value field is enabled for editing and defines a calibration point. The calibration dilution concentration field is disabled for editing and is calculated from the calibrator assigned value and the corresponding calibration point target value. The resulting calibration curves have concentration points (X-axis) that are always the same regardless of the calibrator lot. Define points by target concentration can only be used if sample pre-dilution is enabled for the test. If sample predilution is not enabled and the target value entered is greater than the calibrator target value, the screen displays blank volumes. If you save, an inconsistency message is displayed: Calibration: Dilution point definition mode by target is only available with Sample Pre-dilution enabled. See UserDefined Tests disclaimer. The Define points by target concentration option is used when the calibration is based on the assigned value, which may change from lot to lot. (Refer to the calibrator insert sheet. ) Example If you use this option to calibrate a factor test with a calibrator having a value of 80% activity, the dilutions are adjusted so that the 100%, 50%, 20%, 10% and 5% target concentrations are maintained. This could also work for an insert sheet value of 120% activity where the calibrator dilutions would be adjusted so that the 100%, 50%, 20%, 10% and 5% activities are maintained. In this instance, no matter what the calibrator assignment value is, the calibration target values for the particular test would always be 100%, 50%, 20%, 10% and 5% activities. C alibrator Target Value a n d U n it Calibrator assigned value for the active lot of the calibrator. The calibration unit is the unit used when defining the assigned value. Dilution Process D irect Calibrator level is prepared directly from the calibrator vial instead of from the previous serial dilution, reducing the number of material transfer steps and minimizing unwanted dilution. 285 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Calibration Setup Serial With serial dilution, neat calibrator1 is first transferred to an aliquot cuvette before being transferred to the reaction cuvette. Each successive dilution is prepared from the dilution preceding it. The transfer of calibrator to cuvette during calibration introduces a slight dilution of the calibrator, which is intrinsic to any syringe-driven fluidic system. This dilution is the reason for a slight discrepancy in measured results between the calibrator run as part of the calibration cycle and the same calibrator run as a sample. 1Undiluted calibration plasma (100% strength). 286 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Calibration Setup 287 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Calibration Setup Single D ilution If you select Single dilution, the dilution sequence (calibration plus sample pre-dilution) for a particular calibrator level is prepared and sent to a reaction cuvette before preparing the next dilution level. NOTE: l l All replicates of a particular dilution are processed in the same cuvette strip. Preparation of the next dilution does not begin until all the dilution steps of the previous dilution are complete. B atch If you select Batch, all dilutions (calibration plus sample predilution) for all dilution levels are prepared before the reaction processing starts. Replicates of different dilutions can be mixed in a cuvette strip. Calibration Definition Table Calibration Points Definition For each dilution point the following fields are defined: C oncentration To enter a concentration: 1. Double-click the first cell in the column. 2. Enter the concentration in terms of percent (i.e., enter 100 for 100%). The system accepts concentrations up to 200%. NOTE: For concentrations greater than 100%, sample pre-dilution must be enabled and defined. Because the system automatically calculates the volumes required to make the calibration dilutions, you must enter concentrations in the order highest to lowest. At least three (3) concentrations are required in order to perform a calibration and up to eight (8) concentrations are allowed. Target Value After you select the calibrator material and define the assigned value, each concentration target value is automatically calculated. If a calibrator material has not been selected or the assigned value defined, the 288 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Calibration Setup Target Value column displays 0.00 for each concentration. The target value is automatically updated after the missing information is entered and saved. NOTE: The following volumes are not computed until you define the Test Definition Load Cycle, and, if using concentrations greater than 100%, until Sample Predilution has been enabled and defined. Min. R eplicates The minimum number of valid replicates per calibration point to validate a calibration result. % C V Max. Maximum %CV for each calibrator concentration that is allowed. If the %CV is greater than the maximum specified here, that calibration point fails. % Max. mean an d % Min. mean The mean check within a dilution verifies that the measured mean is inside a tolerance range compared with the 100% dilution. The tolerance range for a concentration using the 100% concentration measured mean is calculated as follows: Min = (mean100 * (<Minimum mean value %>/100.0)) Max = (mean100 * (<Maximum mean value %>/100.0)) The concentration is flagged when the concentration measured mean is outside tolerance range. This check is not available for 100% and 0% dilutions. If the check fails and the autovalidation is configured with DR warnings on measured results, the autovalidation fails. C alibrator Volume Read-only display of the total amount of calibrator, in μL, that is required to prepare the dilution. NOTE: All replicates (max of 6) of every dilution (max of 8) that are run for calibration of a test must use calibrator from the same bottle placed on-board. (6 replicates X 8 dilutions = 48 tests.) Factor tests require more calibrator than is available in a 1 mL bottle. You must pool 2 bottles and place it on-board before starting the calibration tests. Mixture Volume Read-only display of the total amount of the previous concentration, in μL, that is required to prepare the dilution. D iluent Volume Read-only display of the total amount of diluent, in μL, that is required to prepare the dilution. 289 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Calibration Setup Calibration Data Point Checks Select the View focus. icon to display the DR Checks Configuration window for the concentration having Use this window to apply some, all, or none of the data checks to specific concentrations. To select a data check to apply to a specific dilution, the data check must be enabled and defined for the test within the test setup. DR check is only available for Automatic dilution. It is not available for pre-diluted calibrators. Enable Mix Activates the mix parameters for editing. Mix Uses the mix volume percentage to calculate the volume of material that is aspirated from the cuvette cell and re-dispensed into the same cuvette cell to facilitate a mix. The mix volume is calculated as follows: l Mix Volume = (Total cuvette volume – Cuvette dead volume) * Mix % N umber of C ycles Number of mix cycles to be performed. l Minimum: 1 l Maximum: 3 l Default: 1 290 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Calibration Setup R inse A fter Mix Amount of time, in seconds, to rinse the probe after a mix has been performed. l Minimum: 1 sec l Maximum: 5 sec l Default: 1 sec Minimum A spiratable Volume Specifies the minimum volume of calibrator to use when making a dilution. Because the system automatically performs dilution calculations, it tries to use the smallest possible volume (4µL) when performing calculations. By entering a value greater than 4µL, the system is forced to use volumes no less than the entered volume when making dilutions. l Minimum: 4 μL l Maximum: 50 μL l Default: 4 μL Pre-Dilution volumes When sample pre-dilution is enabled, the system computes the number of steps needed to generate enough volume of diluted calibrator for each calibration dilution point. The chart shows the calibration point predilution sample volume, mixture volume, and diluent volume for the indicated dilution point. See Sample Pre-dilution. D ilution Point To prepare concentrations greater than 100%, the system alters the sample predilution parameters to use a larger volume of calibrator and a smaller volume of diluent. When entering a concentration greater than 100% in the Calibrator Volumes table, the only volume displayed is the total calibrator volume required to prepare all replicates. In the Calibration Definition table, the 150% dilution point is selected and its corresponding altered sample predilution volumes are displayed in the Predilution volumes area. Note that volumes in cells with a blue background are delivered directly to the reaction cuvette, or if predilution is enabled for the test, to the predilution cuvette. 291 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Calibration Setup Calibrator Tab Volumes The calibrator liquid volume is the same as the one defined for the sample material in the load cycle. Material Name of the material to use as calibrator. The calibration material may be adjusted on copied (open) tests only. Material must be defined as a Calibrator/NPP type. You can access available materials using the drop down list. NOTE: The sum of all volumes cannot exceed 250 μL. H ead volume Sample volume aspirated to wet the probe before aspirating the sample volume required to run the test. This volume is not delivered to the cuvette. l Minimum: 0 μL l Maximum: 250 μL l Default: 0 μL 292 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Calibration Setup NOTE: When creating a user-defined test, the head volume for the sample defined in Material/Sample Load Cycle Definition must equal the calibrator head volume defined in the Automatic Dilution section of the Test Definition. See User-Defined Tests disclaimer. A irgap Volume of air to aspirate immediately before aspirating the sample, separating the sample and rinse. If a head volume is used, it is the volume of air separating the sample and head volume to prevent rinse contamination and ensure accurate volume delivery. The airgap prevents rinse contamination and ensures accurate volume delivery. l Minimum: 0 μL l Maximum: 250 μL l Default: 15 μL Transport airgap Volume of air to aspirate after the sample volume. It prevents material loss during probe movement and ensures accurate volume delivery. l Minimum: 0 μL l Maximum: 250 μL l Default: 15 μL H ead volume airgap Volume of air (0-250 µL) to aspirate before the head volume. This field defaults to the Airgap value if the head volume is greater than zero. Otherwise this value is zero. Before Aspiration Rinse / Clean & Rinse Enable rinse / clean & rinse before aspiration Option to enable rinse and clean operations before the probe aspirates sample. R inse Select this option to perform rinse cycles. l Rinse cycles – Configure the number of rinse cycles to perform. l Time – Configure the number of seconds for each rinse cycle to run. o Minimum: 1 sec o Maximum: 5 sec o Default: 1 sec 293 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Calibration Setup l Enable agitation – Option to scrub the internal probe walls (during each rinse cycle) by moving the rinse material up and down inside the probe. Configure the number of times to agitate in the field provided. C lean & rinse Option to define a clean and rinse cycle for a sample or a defined reagent. For IL-locked tests, this is a userdefined field when the default for that test has Rinse enabled (sample load cycle only). This option allows you to configure sample probe cleaning when sample materials known to have carryover1 issues are in use. Option to scrub the internal probe walls (during each rinse cycle) by moving the rinse material up and down inside the probe. Configure the number of times to agitate in the field provided. l Clean & rinse cycles – Configure the number of clean and rinse cycles to perform. l Aspiration cycles – Configure the number of times to run the clean and rinse cycle. l l Clean airgap – Amount of air the probe aspirates before aspirating the clean material. This prevents contaminating the clean material and ensures accurate volume delivery. Clean volume – Volume of clean material that the probe aspirates during the clean and rinse cycle. NOTE: l l l l l o IMPORTANT: Many IL-defined tests use Clean B diluted as the clean material. If the Clean B diluted bottle becomes empty, the instrument performs an emergency stop. To avoid this, place multiple bottles of Clean B diluted on-board the instrument. See Test Feasibility for proper placement of all reagents. o The clean total volume must not exceed the maximum probe volume, or 250 µL. o When using a clean material other than system clean, the clean material must be placed in the same area as the load cycle material. Thus, if the rinse and clean is enabled for a sample, the clean material must be placed in a diluent rack in the Sample Area. If it is enabled for a reagent, you must place the clean material in a diluent rack in the Reagent Area. Clean transport airgap – Volume of air aspirated after the clean volume. This prevents material loss during probe movement, and ensures accurate volume delivery. This is not selectable for system clean. Clean total volume – Sum of the clean volume, clean airgap and clean transport airgap. The clean total volume cannot exceed the maximum probe volume, or 250 μL. Clean volume (all cycles) – Volume of clean material required for the configured number of aspiration cycles. Clean material – Select a system clean material in the drop down list. Hold time – Period of time the clean material is held in the probe before it is agitated or dispensed to waste. 1Residual sample material left on the sample probe, after the probe has been rinsed, that carries over to another sample when the probe enters it. 294 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Calibration Setup o l Enable agitation – Option to scrub the internal probe walls (during each rinse cycle) by moving the rinse material up and down inside the probe. Configure the number of times to agitate in the field provided. Rinse time – Time allocated for the probe rinsing operation. o Enable agitation – Option to scrub the internal probe walls (during each rinse cycle) by moving the rinse material up and down inside the probe. Configure the number of times to agitate in the field provided. After Dispensation Rinse / Clean & Rinse The fields on this tab are similar to those on the Before Aspiration Rinse / Clean & Rinse tab, above. 295 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Calibration Setup Diluent Tab Volumes NOTE: The sum of all volumes cannot exceed 250 μL. Material Select a sample diluent material in the list. The material must be defined as a Diluent type in the Material Definition. H ead volume The diluent volume aspirated to wet the probe before aspirating the diluent volume required to run the test. This volume is not delivered to the cuvette. l Minimum: 0 μL l Maximum: 250 μL l Default: 0 μL NOTE: When creating a user-defined test, the head volume for the sample defined in Material/Sample Load Cycle Definition must equal the calibrator head volume defined in the Automatic Dilution section of the Test Definition. See User-Defined Tests disclaimer. 296 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Calibration Setup A irgap Volume of air to aspirate immediately before aspirating the diluent, separating the sample and rinse. If a head volume is used, it is the volume of air separating the diluent and head volume. The airgap prevents rinse contamination and ensures accurate volume delivery. l Minimum: 0 μL l Maximum: 250 μL l Default: 15 μL Transport airgap Volume of air to aspirate after the diluent volume. It prevents material loss during probe movement and ensures accurate volume delivery. l Minimum: 0 μL l Maximum: 250 μL l Default: 15 μL H ead volume airgap Volume of air (0-250 µL) to aspirate before the head volume. This field defaults to the Airgap value if the head volume is greater than zero. Otherwise this value is zero. Before Aspiration Rinse / Clean & Rinse Enable rinse / clean & rinse before aspiration Option to enable rinse and clean operations before the probe aspirates sample. R inse Select this option to perform rinse cycles. l Rinse cycles – Configure the number of rinse cycles to perform. l Time – Configure the number of seconds for each rinse cycle to run. l o Minimum: 1 sec o Maximum: 5 sec o Default: 1 sec Enable agitation – Option to scrub the internal probe walls (during each rinse cycle) by moving the rinse material up and down inside the probe. Configure the number of times to agitate in the field provided. C lean & rinse Option to define a clean and rinse cycle for a sample or a defined reagent. For IL-locked tests, this is a userdefined field when the default for that test has Rinse enabled (sample load cycle only). This option allows 297 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Calibration Setup you to configure sample probe cleaning when sample materials known to have carryover1 issues are in use. Option to scrub the internal probe walls (during each rinse cycle) by moving the rinse material up and down inside the probe. Configure the number of times to agitate in the field provided. l Clean & rinse cycles – Configure the number of clean and rinse cycles to perform. l Aspiration cycles – Configure the number of times to run the clean and rinse cycle. l l Clean airgap – Amount of air the probe aspirates before aspirating the clean material. This prevents contaminating the clean material and ensures accurate volume delivery. Clean volume – Volume of clean material that the probe aspirates during the clean and rinse cycle. NOTE: l l l l l o IMPORTANT: Many IL-defined tests use Clean B diluted as the clean material. If the Clean B diluted bottle becomes empty, the instrument performs an emergency stop. To avoid this, place multiple bottles of Clean B diluted on-board the instrument. See Test Feasibility for proper placement of all reagents. o The clean total volume must not exceed the maximum probe volume, or 250 µL. o When using a clean material other than system clean, the clean material must be placed in the same area as the load cycle material. Thus, if the rinse and clean is enabled for a sample, the clean material must be placed in a diluent rack in the Sample Area. If it is enabled for a reagent, you must place the clean material in a diluent rack in the Reagent Area. Clean transport airgap – Volume of air aspirated after the clean volume. This prevents material loss during probe movement, and ensures accurate volume delivery. This is not selectable for system clean. Clean total volume – Sum of the clean volume, clean airgap and clean transport airgap. The clean total volume cannot exceed the maximum probe volume, or 250 μL. Clean volume (all cycles) – Volume of clean material required for the configured number of aspiration cycles. Clean material – Select a system clean material in the drop down list. Hold time – Period of time the clean material is held in the probe before it is agitated or dispensed to waste. o l Enable agitation – Option to scrub the internal probe walls (during each rinse cycle) by moving the rinse material up and down inside the probe. Configure the number of times to agitate in the field provided. Rinse time – Time allocated for the probe rinsing operation. o Enable agitation – Option to scrub the internal probe walls (during each rinse cycle) by moving the rinse material up and down inside the probe. Configure the number of times to agitate in the field provided. 1Residual sample material left on the sample probe, after the probe has been rinsed, that carries over to another sample when the probe enters it. 298 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Calibration Setup After Dispensation Rinse / Clean & Rinse The fields on this tab are similar to those on the Before Aspiration Rinse / Clean & Rinse tab, above. Pre-diluted Calibrators Screen If the calibration mode is set to Prediluted calibrators, you can use the Pre-diluted Calibrators screen to set up the list of calibrators to define the pre-diluted calibration points. See Accessing the Pre-diluted Calibrators screen. Column Headings C alibrator Material For each dilution point, click the Calibrator Material table cell, then select the calibrator material from a drop down list. NOTE: l l l Calibrators must be previously defined in the Material List before you can select them from the Calibrator Material drop down list. Each pre-diluted calibrator material can only be selected once in the same list of pre-diluted calibrators. All pre-diluted calibrators must have the same lot management configuration as defined in lot management and alternate lot in material definitions. Target Value The target value is the known concentration of the calibrator. The advantage of entering target values instead of dilution percentages is that calibration dilutions have the same value regardless of the assigned value of the calibrator. 299 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Calibration Setup Min. R eplicates The minimum number of valid replicates per calibration point required to produce a valid calibration. Minimum = 1. Maximum = 6. %C V Max The maximum %CV for each calibration dilution that is allowed. If the %CV is greater than this value, that calibration point fails. Min. Replicates and % CV Max. are calculated by the instrument, and the fields are automatically populated after you select the calibrator material. If Enable %CV check is enabled on the Calibration – DR Parameters tab, both of these settings are user-definable. See Also l Calibration Details l Calibration Status List l Performing a Calibration l General Information l Global Definitions Setup l Analytical Cycle Definition l Data Reduction Parameters l Result Unit Definition l Parallelism l Normal Pool Plasma l Rerun Rules 300 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Configuring Factor Parallelism Configuring Factor Parallelism This topic describes how to set up parallelism testing on the Parallelism screens. Overview Factor parallelism increases the quality of test results and identifies causes of interference that may affect those results. Regulatory bodies recommend a minimum of 2-3 different dilutions of plasma for factor tests. A reportable dilution should fall within the working range of the test. Ideally, dilutions of test plasma should be the same as those of the calibrator1. The test results of the various plasma dilutions should parallel the calibration curve. The criteria to define ”parallelism” are based on statistical or mathematical analysis that might employ, for example, a comparison of the slopes of the curve obtained with the test plasma dilutions versus the slope of the calibration curve, a check of the r2 of the parallelism curve or a check of the variance between the recalculated results of the first sample dilution (100%) and the subsequent dilutions. The ACL TOP instrument offers a wide range of mathematical data-checks which, if enabled by the operator, allow the determination of parallelism. The system also displays default-criteria for each data-check that can be customized. Since there are no official guidelines that establish these criteria, they can be defined according to the discretion and needs of the individual laboratory. As mentioned above, the factor parallelism feature allows the detection of interference to the test. In particular, the presence of heparin, lupus anticoagulants or specific factor inhibitors may affect the results of the single factor tests; therefore, performing the testing with different dilutions of the test plasma may assist in a diagnosis. Lupus anticoagulants may prolong APTT and PT clotting times, depending on the sensitivity of the reagent used. In these cases, plasma test dilutions could have the effect of increasing the calculated % activity of the increasingly diluted replicates. Unfractionated heparin usually prolongs the APTT clotting times. Therefore, when testing a single heparinized sample for factor activity in the standard test, the presence of heparin may interfere and cause falsely low factor activity. When tested in the parallelism mode, the multiple sample dilutions can serve to dilute the heparin effect with each increasing dilution, and as a consequence result in higher % factor activities with subsequent dilution. Factor inhibitors, on the other hand, may or may not be detected with the parallelism function. The ACL TOP instrument provides a unique competitive advantage for testing of factors. Although most of the major competitors offer the ability to test multiple factor dilutions, only the ACL TOP instrument provides a sophisticated and comprehensive array of options to automatically assess the results. 1A type of sample with an assigned value used to calibrate a test. 301 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Configuring Factor Parallelism Factor Parallelism Testing Options For each factor test the ACL TOP instrument provides two testing modes: l l Standard Factor (single dilution) – The sample is measured at a pre-defined dilution ratio. Results are provided in seconds and % activity. Factor Parallelism (up to four dilutions) – The sample is measured at different dilution levels (typically three, up to four). The system can also detect whether the sample dilutions curve is parallel to the calibration curve. Nonparallelism can indicate interference in the patient sample, possibly due to heparin, lupus anticoagulants or factor inhibitors. Testing Options The following sections and examples describe the factor parallelism testing options available on the ACL TOP instrument: l Factor Parallelism Reporting Units l Factor Parallelism Criteria l IL Tests Default Criteria l Definition and Use of Factor Parallelism l Examples of Factor Parallelism Results Factor Parallelism Reporting Units When defining a factor parallelism test, you may select up to four units to display on the screen and include in the results printout. The following test definition screen shows where the selection of the units is made (drop-down options from unit 1 to 4): 302 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Configuring Factor Parallelism All selected units are always displayed in the parallelism result details screen. The following parallelism units are available for selection: Mean of 100% The system calculates the % activity of the 100% dilution. If more than one replicate is defined (up to three), the mean is provided. While all the available units are specifically intended to aid in the determination of the parallelism, this particular unit provides information only about the 100% dilution. Mean of Corrected Results (CR) The system calculates the % activity of each sample plasma dilution (excluding the 100% dilution) and corrects each corresponding % activity result to compensate for the dilution factor (Corrected Results). It then calculates the mean of these corrected results. Example Dilution (%) % Activity CR % 100 96 96 50 47 94 25 23 92 The Mean of Corrected Results (CR) in this example is 93% (mean of 94% and 92%). 303 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Configuring Factor Parallelism %CV of Corrected Results (CR) The system calculates the % activity of each sample plasma dilution (excluding the 100% dilution) and corrects each corresponding % activity result to compensate for the dilution factor (Corrected Results). It then calculates the %CV of these CR results. Example Dilution (%) % Activity CR % 100 96 96 50 47 94 25 23 92 The %CV of Corrected Results (CR) in this example is 1.5% (CV % of 94% and 92%). Mean of Corrected Results (CR) 100% This is the same as the Mean of Corrected Results but this calculation includes the 100% dilution result in the mean calculation. Example Dilution (%) % Activity CR % 100 96 96 50 47 94 25 23 92 The Mean of Corrected Results (CR) 100% in this example is 94% (mean of 96%, 94% and 92%). %CV of Corrected Results (CR) 100% This is the same as % CV of Corrected Results but this calculation includes the 100% dilution in the CV calculation. Example Dilution (%) % Activity CR % 100 96 96 50 47 94 25 23 92 The %CV of Corrected Results (CR) 100% in this example is 2.1% (CV % of 96%, 94% and 92%). 304 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Configuring Factor Parallelism Slope The system computes the slope of the sample dilution results which make up the parallelism curve. The slope is calculated using the math model defined in the parallelism Transformation fields. Example NOTE: The following examples are not test-specific and are given for information only. FVIII Calibration [X = sec; Y = ln(% FVIII)] Dilution% Target % FVIII ln(% FVIII) sec 130 140.4 4.94 45.3 100 108 4.68 48.1 40 43.2 3.77 57.4 5 5.4 1.69 81.3 1 1.1 0.10 95.4 -10.508 Slope Intercept 97.39 r2 0.998 Parallelism dilutions [X = sec; Y = ln(% Dilution)] dilution% ln(% FVIII)) sec % CR% 100 4.61 45.8 135.8 135.8 50 3.91 52.8 69.6 139.2 25 3.22 59.2 37.8 151.2 Slope -9.666 Intercept 90.414 r2 0.999 The reported parallelism slope in this example is -9.666. r2 The system computes the r2 of the parallelism curve. The r2 is calculated using the math model defined in the parallelism Transformations fields. See example in slope unit: the reported parallelism r2 is 0.999. 305 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Configuring Factor Parallelism NOTE: - The R2 value is calculated using precise values. However, when displayed they are rounded to 3 decimal places. Due to this rounding, a failed R2 value may appear on-screen as within the defined range limit. Such values are flagged to indicate that they are out of the range. y-Intercept The system computes the y-intercept of the parallelism curve. The y-intercept is calculated using the math model defined in the parallelism Transformations fields. See example in slope unit: the reported y-intercept in this example is 90.414. Factor Parallelism Criteria The system provides a number of criteria to evaluate the factor parallelism data. These criteria are enabled and configured in the same screen where the parallelism units are defined. For your convenience the screen is included again below: 306 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Configuring Factor Parallelism IL Tests Default Criteria The following criteria are available: Slope Check If this check is enabled, the system compares the slope of the parallelism curve to the slope of the calibration curve. The acceptable slope range is definable by means of acceptable % deviation around the calibration slope (tolerance). After the tolerance is defined, the system displays the acceptable range. If the parallelism slope falls outside the acceptable range, the following flag is generated: Code Flag Message W/E 5254 RW Slope out of range W r2 Check If this check is enabled, the system verifies that the r2 of the parallelism curve is greater than or equal to the specified value (Min r2 ). If not, the following flag is generated: Code Flag Message W/E 5255 RW Parallelism r2 out of range W NOTE: - The R2 value is calculated using precise values. However, when displayed they are rounded to 3 decimal places. Due to this rounding, a failed R2 value may appear on-screen as within the defined range limit. Such values are flagged to indicate that they are out of the range. Variance Check If this check is enabled, the system computes the percent difference between the average corrected result at each concentration and the average result at 100%. If any of the dilutions have a percent difference that exceeds the Max. Variance, the following flag is generated: Code Flag Message W/E 5253 RW Max. variance of parallelism dilution out of range W %CV of Corrected Result (CR) If this check is enabled, the system calculates the %CV of the corrected primary results excluding the 100% dilution, and compares it against the maximum %CV defined (Max %CV). If the maximum %CV is exceeded, the following flag is generated: Code Flag Message W/E 5259 RW %CV of the CR is greater than the maximum %CV allowed W 307 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Configuring Factor Parallelism %CV of Corrected Result (CR) and 100% If this check is enabled, the system calculates the %CV of the corrected primary results, including the 100% dilution, and compares it against the maximum %CV defined (“Max %CV”). If the maximum %CV is exceeded, the following flag is generated: Code Flag 5260 Message W/E RW %CV of the CR and the 100% dilution is greater than the maximum %CV allowed. W Determining Factor Activity Using Factor Parallelism (multiple sample dilutions) Factor parallelism is configured in the Parallelism screen. Number of dilutions For user-defined tests, up to four dilutions can be defined, with the 100% dilution point being mandatory. IL tests that use factor parallelism have three dilutions defined. See User-Defined Tests disclaimer. Primary U nit The primary unit is the calibrations unit used to display the parallelism results. Default options for IL locked tests are % and U/mL. Units from 1 to 4 are user selectable for results display and printing. See: Factor Parallelism Reporting Units, above. U nit 1 Select Mean of 100%. This provides the average % activity obtained at the different dilution levels (usually three dilutions are selected). U nit 2 Mean Corrected Results 100%. U nit 3 %CV of Corrected Results 100%. U nit 4 Can be left blank. 308 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Configuring Factor Parallelism Selecting the Criteria Enable the Variance check option to flag those results with significant discrepancies among different sample dilutions. The sample should undergo further analysis before factor activity results are reported. In addition to variance check, other parallelism criteria may be enabled. The following checks can be enabled: Slope Check This check is used to establish a proper tolerance value between the slope of the parallelism curve compared to the slope of the calibration curve. Measurement of some known samples (with and without factor inhibitor) starting with a tolerance value of 15% can help define the desired tolerance to discriminate between normal samples and abnormal samples. Observe the flagging and eventually modify this threshold as needed (sample results re-calculation can be used to test the effect of the changes without having to re-run the samples). r2 Check This is the same as for the check above; start testing with a min r2 value of 0.980. NOTE: - The R2 value is calculated using precise values. However, when displayed they are rounded to 3 decimal places. Due to this rounding, a failed R2 value may appear on-screen as within the defined range limit. Such values are flagged to indicate that they are out of the range. Variance Check This is the same as for the check above; start testing with a max variance value of 20%. %CV of CR This is the same as for the check above; start testing with a max %CV value of 15%. %CV of CR and 100% This criterion is very similar to the %CV of CR; if it is used in the definition of the max CV%, consider that the inclusion of the 100% usually leads to lower CV%. Reporting Factor Activity Results If an inhibitory pattern is not found, then report the first dilution whose uncorrected % activity result falls within the linearity of the test. If an inhibitory pattern is determined to be present, more dilutions may be required to determine accurate factor level. 309 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Configuring Factor Parallelism Examples of Factor Parallelism results Normal Sample Sample with inhibitors 310 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Configuring Factor Parallelism NOTE: l l The College of American Pathologists (CAP) guidelines require at least 2 dilutions be tested before a factor test is reported. This requirement was instituted as a tool for identification of inhibitors and/or activators. In conjunction with these guidelines, IL suggests making three (3) dilutions per sample to be tested for factors. The dilutions should be chosen according to an individual facility's protocol. Additional dilutions are not made to guarantee precision of recovery After the dilutions are tested, the results should be reviewed. Two consecutive values with laboratorydefined maximum variance (for example, less than or equal to ± 20%) indicate acceptable results. Be certain to use only values within the calibrated range for this assessment. Average the two (2) acceptable results and report. Example Dilutions: Values: Calibration Plasma Test Factor VIII Laboratory Maximum Variance 1:10 1:20 1:40 98% 92% 106% 100% ± 20% The 98% and 92% pair meets the criteria for within the calibrated range and within ± 20% of each other. The 92% and 106% pair does not meet the criteria. Report 95%, the average of 98% and 92%. See Also l Parallelism 311 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Parallelism Setup Parallelism Setup Overview Use the Parallelism Definition screen to: l l Enable or disable parallelism for the current test. Configure the analytical cycle and data reduction parameters used when performing factor parallelism studies. You cannot enable parallelism if any of the following conditions apply: l The test is a paired test. l The test is a shadow test. l Calibration is not enabled. Viewing and Editing the Parallelism Definition Screen To open and edit the Parallelism Definition screen: 1. Select Setup > Test List in the menu bar. 2. Double-click a test in the Test List. 3. In the Test Definition screen, select Parallelism in the navigational tree. 4. <Optional> Edit the parallelism fields on the Analytical Cycle and Data Reduction tabs. 5. Select the Save icon in the toolbar to save your changes. 6. Select the Previous Screen icon in the toolbar to return to the Test List.. 312 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Parallelism Setup Parallelism Definition Screen Enable parallelism Option to run parallelism tests. Enables the fields on the Parallelism screen. Parallelism LIS number Unique parallelism mode test ID number for the Laboratory Information System (LIS). Test code Unique parallelism test identifier appended by the character defined in the Parallelism mode extension option in Global Definitions. 313 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Parallelism Setup Analytical Cycle tab Number of Replicates Number of repeat measurements to perform on a parallelism dilution. l Minimum: 1 l Maximum: 3 l Default: 1 Diluent Material Diluent material name extracted from the Calibration Definition – Diluent tab. Read-only for IL locked tests. Dilution Process Dilution process used for this test. It is read-only for IL locked tests. D irect Option to make all parallelism dilutions directly from the sample cup. Serial Option to transfer the sample to an aliquot cuvette before transferring it to the reaction cuvette. Successive dilutions are made from the previous dilution mixture. Single dilution Option to prepare the dilution sequence (parallelism plus sample pre-dilution) for a particular parallelism level and transfer it to a reaction cuvette before starting the preparation of the next dilution level. NOTE: l l All replicates of a particular dilution are processed in the same cuvette strip. Preparation of the next dilution does not begin until all dilution steps of the previous dilution are complete. B atch Option to prepare all dilutions (parallelism plus sample pre-dilution) for all dilution levels before the reaction processing starts. Replicates of different dilutions may be mixed in a cuvette strip. Dilutions Table This table lists the dilutions. For user-defined tests, up to four dilutions can be defined, with the 100% dilution point being mandatory. IL Tests that use factor parallelism have three dilutions defined. See UserDefined Tests disclaimer. 314 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Parallelism Setup Data Reduction Tab Parallelism Point Units Primary U nit Calibrated unit used to display parallelism results. You can select any defined calibration unit. Options for IL locked tests are % and U/mL. If the unit is changed from the default value, parallelism results must be recalculated to update the patient information with the new unit and its respective values. The parallelism graph is still displayed using the unit defined for the calibration. NOTE: l l You must have a validated calibration for the test before running the parallelism test. Statistical results based on the corrected results (mean CR, %CV of CR, etc.) displayed in both the Parallelism Detail screen and the Sample List screen are in terms of the primary calibrated unit. 315 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Parallelism Setup Units Select up to four result units for parallelism from the following list for results display and printing: l Mean of 100% l Mean CR l Mean CR 100% l Slope l r2 l y-intercept l %CV of CR l %CV of CR 100%. See Determining Factor Activity for an example of configuring this setting. Enable Slope Check Option to generate an error message when the slope of the parallelism curve falls outside the expected range. See Determining Factor Activity for an example of configuring this setting. Target Slope Read-only value of the slope of the validated calibration curve calculated using linear regression and the parallelism transformations. Tolerance Acceptable deviation from the target slope in percent. l Minimum: 0 l Maximum: 100 l Default: 10 R ange Acceptable range for the slope, calculated automatically from the target slope and tolerance values. 316 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Parallelism Setup Transformations Read-only values for IL locked tests. They display the transformations, if any, that are used for the current test. For user-defined tests, transformations can be enabled for any of the math models. See User-Defined Tests disclaimer. X A xis Transformation Selections are: l No transformation l Log10(Log10(X)) l 1/X l 10X l X2 l eX l X1/2 l l 1/X1/2 l X=X/X(0) X2.5 l In(X) l (1n(x))2 l Log10(X) Y A xis Transformation Selections are: l No transformation l Log10(Log10(Y)) l 1/Y l 10Y l Y2 l eY l Y1/2 l l 1/Y1/2 l Y=Y/Y(0) Y2.5 l In(Y) l (1n(Y))2 l Log10(Y) NOTE: For user-defined tests: l l l l If parallelism is defined after a calibration for that test has been validated, the calibration must be recalculated to apply the correct parallelism transformation to the calibration to use in the parallelism display. See Review and Validation for information on recalculation. If parallelism transformations are modified after parallelism results are obtained, both the calibration and parallelism sample for that test must be recalculated to update the parallelism display. Failure to perform either of the above actions triggers a results warning 5568: Calibration and parallelism transformations do not match. A user with the appropriate security level can create a new test or copy an existing test. All responsibility for parameter development and validation of new or copied tests belongs to the user alone. 317 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Parallelism Setup Enable r2 Check Option to system-verify whether the coefficient of determination (r2 ) is greater than or equal to the specified value. If not, an error is generated. See Determining Factor Activity for an example of configuring this setting. NOTE: - The R2 value is calculated using precise values. However, when displayed they are rounded to 3 decimal places. Due to this rounding, a failed R2 value may appear on-screen as within the defined range limit. Such values are flagged to indicate that they are out of the range. Min r 2 Minimum acceptable value for parallelism r2. The default value is 0.980. Variance Check When selected, the system calculates the difference between the corrected primary result at 100% and each of the means of corrected results at the other concentrations, and verifies that the computed % difference of the concentration is less than the maximum % difference allowed. If the maximum variance is exceeded, an error is generated. See Determining Factor Activity for an example of configuring this setting. Max. Variance This is the maximum acceptable percent difference allowed. The default is 15. %CV of CR (corrected result) When selected, the system calculates the %CV of the corrected primary results (excluding the 100% and 0% dilutions) and compares it against the maximum %CV allowed. If the maximum %CV is exceeded, an error is generated. See Determining Factor Activity for an example of configuring this setting. Max. %C V Maximum acceptable %CV allowed. The default is 15. %CV of CR (corrected result) and 100% When selected, the system calculates the %CV of the corrected primary results (excluding 0% dilutions) and compares it against the maximum %CV allowed. If the maximum %CV is exceeded, an error is generated. See Determining Factor Activity for an example of configuring this setting. Max. %C V Maximum acceptable %CV allowed. The default is 15. See Also l Configuring Factor Parallelism l General Information l Analytical Cycle Definition 318 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Parallelism Setup l Data Reduction Parameters l Result Unit Definition l Calibration l Normal Pool Plasma l Rerun Rules 319 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Normal Pool Plasma Setup Normal Pool Plasma Setup The NPP1 test definition screen allows you to define the NPP mode, material and frequency for a test. Viewing and Editing the Normal Pool Plasma screen To view and edit the Normal Pool Plasma screen: 1. Select Setup > Test List in the menu bar. 2. Double-click a test in the Test List. 3. In the Test Definition navigation tree, select Normal Pool Plasma. 4. <Optional> Edit the fields on the NPP General and Frequency tabs. 5. Select the Save icon in the toolbar to save your changes. 6. Select the Previous Screen icon in the toolbar to return to the Test List. NOTE: Before using a new NPP definition to recalculate patient test results, the calibration must be recalculated, saved and validated. Perform the following steps in sequence: 1. Change the NPP definition as desired and save the changes. 2. Select the desired calibration, recalculate, save the changes and validate. See Calibration Details. 3. Recalculate the patient results. See Recalculating Test Results. 1Normal Pool Plasma. A type of sample used as a standard of comparison when calculating the International Normalized Ratio (INR) and when calculating test results that use the normalized ratio. 320 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Normal Pool Plasma Setup Test Definition – Normal Pool Plasma Screen Enable NPP Option to configure the Normal Pool Plasma parameters. Enables the fields on the General and Frequency tabs. 321 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Normal Pool Plasma Setup General Tab NPP Mode Select a mode in the NPP mode drop-down list. D erived from C alibration Enables the following options on the Method drop-down list: l Mean of calibration point replicates – Uses the Mean of a specified calibration point to obtain the NPP value. Enables the Calibration point list: o l Calibration point – List of calibration standards whose mean is used as the NPP value. After you select the standard option in this list, the concentration and target value for the standard displays to the right of the Calibration point list. Compute value from calibration curve equation – The NPP value used to calculate results is computed from the calibration curve at the concentration/activity level you specify. Enables theNPP value list. o NPP value – Allows you to input the concentration/activity level used to compute the NPP value. Midpoint of N ormal R ange Uses the midpoint of the normal range defined in result units to obtain the NPP value. R un as Sample An NPP material placed on board runs each time an NPP is ordered. Enables the NPP material list. l NPP material – List of materials to use as NPP. The material must be defined as type Calibrator/NPP. U ser Input N PP Value Option to manually enter an NPP value. Enables the NPP field. l NPP – Allows input of measured result values to use for calculations involving NPP. Enable Adjust Calibration to NPP Available for NPP values only when the calibrated result unit is percentage (%). Intended primarily for PT tests. It can be used only for calibrations that use a linear regression math model. When enabled, the Calibration Details screen shows the original calibration curve (green) as well as the adjusted calibration curve (purple). 322 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Normal Pool Plasma Setup NPP Calibration Curve Screen 323 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Normal Pool Plasma Setup Frequency Tab Enable Frequency This option must be selected to edit frequency parameters and automatically run NPP calibration or to prompt when calibration is due. This is only enabled if the NPP mode is Run as Sample. Frequency Enter the frequency to prompt for NPP calibration or run NPP calibration in terms of number of tests, hours or days. Next, select the appropriate interval (tests, hours or days) from the drop down list. NOTE: Only patient jobs are considered when counting the frequency by tests. QC jobs, calibration points, and NPP points are excluded. Enable Warning Threshold Option to generate a warning when an NPP is due. W arning Threshold This establishes when to notify you that an NPP is due. If the frequency is set to Tests, the warning threshold must also be in terms of Tests. Likewise, if the frequency is set to Hours, the warning threshold must also be in terms of Hours. If the frequency is in terms of days, select the warning threshold in terms of either hours or days. Enable Automatic Execution Option to automatically execute NPP when the frequency threshold is reached. Automatic execution can be performed only if all the necessary materials are available on-board with sufficient volumes, adequate stability, and valid expiration dates. See Also l General Information l Calibration l Analytical Cycle Definition l Parallelism l Data Reduction Parameters l Rerun Rules l Result Unit Definition 324 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Rerun Rules Setup Rerun Rules Setup Overview You can configure the ACL TOP instrument to automatically rerun a test based on result range violations or data reduction conditions. If Rerun is enabled, and a defined test result is obtained, the test runs again on that sample. You can configure rerun to do the following: l Run same test. l Run the same test using an extended acquisition time. l Run the same test using an alternative pre-dilution on the sample. NOTE: Parallelism, QC, and calibration cannot trigger a rerun. Configuring Rerun Rules To configure the rerun rules: 1. Select Setup > Test List in the menu bar. 2. Double-click a test in the Test List. 3. In the Test Definition navigation tree, select Rerun - Rules. 4. Configure the rerun rules on the Result Ranges and DR Errors tabs. 5. Select the Save icon in the toolbar to save your changes. 6. Select the Previous Screen icon in the toolbar to return to the Test List. 325 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Rerun Rules Setup Rerun Rules Screen This screen contains two tabs – Result Ranges and DR Errors. Enable Rerun Option to rerun tests based on the rules configures in the Rerun Rules screen. Activates the rerun parameters for editing. 326 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Rerun Rules Setup Result Ranges Tab Result Unit to Test Select a result unit in the list to configure in the rerun rules. Table columns R ule The available range result rules include: l Above Normal Range l Below Normal Range l Above Therapeutic Range l Below Therapeutic Range l Above Linear Range l Below Linear Range l Above Test Range l Below Test Range l Above Extrapolation Range l Below Extrapolation Range l Above Secondary Algorithm Range l Below Secondary Algorithm Range l (Range) Above Measured Result Test Range l (Range) Below Measured Result Test Range. Same Test / Extended Test / A lternative pre-dilution To select a rerun rule, select Same Test, Extended Test, or Alternative Pre-Dilution. NOTE: l l l To use a range rule, the test result ranges must have been pre-configured in the Result Unit Definition screen. To use extended test, Extended Test Mode must be enabled and defined in the Analytical Cycle screen. To use alternative pre-dilution, it must be enabled and defined in Alternative Pre-Dilution. For example: l If a sample returns a result with an Above Linear Range flag, and the rerun action is set to Alternative pre-dilution, the sample is diluted according to the alternative pre-dilution setup, and the same test is repeated. 327 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Rerun Rules Setup l l l If the sample returns a result with an Above Test Range flag, and the rerun action is set to Extended Test, that sample reruns using the Extended acquisition time. If a sample returns a result with an Above Normal Range flag, and the rerun action is set to Same Test, the same test is run again. If you have enabled Extended Acquisition Time configured in the Alternative Pre-dilution, and Extended acquisition has been enabled in the Analytical cycle definition for that test, an alternative pre-dilution rerun occurs using the extended acquisition mode. See Alternative Pre-Dilution. 328 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Rerun Rules Setup DR Errors Tab Generic failure on measured result Options to select all the rerun rules in the corresponding column (only one column) for the test selected in the Test List. Table columns R ule This allows you to select some of the available DR Rules without having to select them all. They include: l (Data) First point out of range l (Data) Last point out of range l (Data) Curve min. and max. not in correct sequence l (Data) Curve sequence unknown l (Data) Incorrect number of raw data points l (Data) Too many invalid raw data points l (Data) Number of spikes exceeds error limit l (Data) Insufficient points remaining for calculation l (Data) Normalized curve delta too high l (Data) Normalized curve delta too low 329 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Rerun Rules Setup l (Data) Normalized curve delta less than lowest calibrator1 delta l (Data) Baseline average high l (Data) Baseline average low l (Data) Baseline SD exceeds error limit l (Data) Endpoint average high l (Data) Endpoint average low l (Data) Endpoint SD exceeds error limit l (Coag) First derivative peak not found l (Coag) First derivative negative check failed l (Coag) Second derivative peak not found l (Coag) Too many first derivative peaks l (Coag) Too many second derivative peaks l (Coag) First threshold limit not found l (Coag) Second threshold limit not found l (Coag) Max (min) time span violation l (Reaction) Initial slope exceeds error limit l (Reaction) Linear regression SD exceeds error limit l (Data) Result exceeds negative value limit l (Data) Result check failed l (Data) Calculation error l (Data) Interference error l (Prep) Aspiration baseline error l (Prep) Unexpected LLD error l %Max difference of replicates exceeded l (Data) Normalized data contains multiple thresholds Same Test / Extended Test / A lternative pre-dilution To create a rerun rule, select Same Test, Extended Test, or Alternative Pre-Dilution run. You must enable and define extended test mode (Analytical Cycle Definition) and alternative pre-dilution (Alternative PreDilution) to use those rerun rules. R erun Priority If multiple rules are configured with different rerun responses, and multiple rules trigger a test rerun, only one rerun occurs, according to the following priority: 1A type of sample with an assigned value used to calibrate a test. 330 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Rerun Rules Setup l l l First priority: Alternative pre-dilution – Rules configured to rerun Alternative pre-dilution tests override the Extended Test and Same Test reruns. Second priority: Extended Test – Rules configured to rerun Extended Tests override Same Test reruns. Third priority: Same Test – Rules configured to rerun the Same Test activate only when there are no rule violations configured for Alternative pre-dilution or Extended Test reruns. See Also l General Information l Analytical Cycle Definition l Data Reduction Parameters l Result Unit Definition l Calibration l Parallelism l Normal Pool Plasma 331 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Consistency Check Consistency Check All parameter information for the test definition is verified for consistency and relationships between different areas by means of a consistency check. After the consistency check is performed, the area of the Test Definition screen located at the bottom of the screen provides information to help identify problems within the test definition. On the navigational tree inconsistent areas are highlighted in red, starting with the first inconsistent area, to facilitate correcting the inconsistency. As each area becomes consistent, the next inconsistent area is highlighted in red. Performing a Consistency Check To perform a consistency check: 1. Select Setup > Test List in the menu bar. 2. Place focus1 on a test in the Test List, and select the Apply Checks select Actions > Test > Apply Checks in the menu bar. icon in the toolbar, or 3. Locate and select the inconsistency in the navigational tree (red text) to open the respective screen. 4. Correct the inconsistent settings. 5. Select the Save icon in the toolbar to save your changes. Consistency Check Window Double-click an inconsistency message to open the screen with the inconsistent configuration. The inconsistent screen is identified in red text in the navigational tree. See Also l Test Definition 1To place focus on the unique identifier in a list, click a row in the table. A blue cell border indicates focus. Only one unique identifier in a list can have focus. 332 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup QC List QC List The read only QC List displays information from the QC Definition for QC materials and test pairings. Accessing the QC List To access the QC List: 1. Select Setup > QC List in the menu bar. 2. To filter the QC list, select the down arrow beside the Filter icon in the toolbar, then select Enabled QC Definitions or Disabled QC Definitions in the submenu. 3. To view or edit a QC setup definition, double-click a test in the list, or place focus on a test code and select the QC Definition icon in the toolbar. 4. To add a new QC definition, click the Add icon in the toolbar. 5. After creating or editing a definition in the QC Setup Definition screen, do one of the following: l Select the Save l Select the Restore 6. Select the Previous Screen icon in the toolbar to save your changes. icon in the toolbar to restore the original configuration. icon in the toolbar to return to the QC List. QC List Toolbar The operations toolbar includes the following: Select the following icons to perform the associated tasks: Add a new QC definition. Opens the QC Setup Definition screen. View QC Definition details. Opens the QC Setup Definition screen for the test in focus. Delete a QC Test. Deletes the selected test from the QC List screen. A test that is referenced in one or more QC definitions cannot be deleted until these QC definitions are deleted. Filter. Select Enabled QC Definitions, Disabled QC Definitions, or both from a drop down list. 333 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup QC List QC List screen Selection C olumn Click one or more rows to place check marks in this column, indicating selection of one or more tests. Test C ode Unique name of the test that is paired with the QC material in the Material Name column. Material N ame Name of the control material, a sample-like material typically having known amounts of analyte, which is used to detect changes from stable system operation. U nit Result unit for the test using the selected QC material. Target Mean Expected mean for the test using the selected QC material. Target SD Expected standard deviation for the test using the selected QC material. Test Enabled/D isabled Indicates whether a test is enabled for use on the instrument. See Also l Quality Controls l QC Setup Definition l QC Overview l QC Test Status List l QC Profiles List l Reviewing QC Results l QC Results List 334 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup QC Setup Definition QC Setup Definition Accessing the QC Setup Definition screen To access the QC Setup Definition screen: 1. Select Setup > QC List in the menu bar. 2. To filter the QC list, select the down arrow beside the Filter icon in the toolbar, then select Enabled QC Definitions or Disabled QC Definitions in the submenu. 3. To view or edit a QC setup definition, double-click a test in the list, or place focus on a test code and select the QC Definition icon in the toolbar. 4. To add a new QC definition, click the Add icon in the toolbar. 5. After creating or editing a definition in the QC Setup Definition screen, do one of the following: l Select the Save l Select the Restore 6. Select the Previous Screen icon in the toolbar to save your changes. icon in the toolbar to restore the original configuration. icon in the toolbar to return to the QC List. 335 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup QC Setup Definition QC Setup Definition screen Material Name Drop down list where you select the control material for the QC being defined. Material must be defined as a QC type. An alternate lot of a material is used for QC studies whose information does not affect the QC system status and whose results are not able to flag patient samples. After you save the definition, the material name cannot be changed. Comments Read-only field containing user-defined text imported from the Comments field in the Material Definition. Test Code In the drop down list, select the test code for which QC is being defined. After you save the definition for this material, you cannot change the test code. You can select the same test code for a maximum of 20 different quality control materials. Thereafter the test code is no longer available for selection. Unit This field is enabled after the test code has been selected. Use the drop down list to select a result unit defined for that test. If you define a QC test with a calibrated result unit, the QC test is not feasible if there is no validated calibration. 336 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup QC Setup Definition Target (Active Lot) Mean Enter the expected mean for the test using the selected QC material. SD Enter the expected standard deviation for the test using the selected QC material. Enable Rules Option to apply rules to check QC results. Select a rule to apply in the Rules are available: l 1-2S l 1-2.5S l 1-3S l 1-3.5S l 2-2S l 2 of 3-2S l R-4S l 3-1S l 4-1S l 7x l 7T l 10x l % Rule Selection column. The following Patient Flags QC failed Option to flag all patient results for this test when QC fails. QC Expired Option to flag all patient results for this test when QC becomes overdue. Test Feasibility Test not feasible when QC failed. Option to make a test Not Feasible when the QC status changes from Passed to Failed. If this transition occurs while the system is busy, active tests complete and the results are flagged. All other tests (pending, not feasible) are not performed. When QC changes from Failed to Passed, these other tests become Feasible. 337 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup QC Setup Definition User Defined Deviation Rule The allowed percent deviation from the mean, which enables compliance with RiLiBÄK standards. NOTE: When the % Rule is selected in the Enabled Rules table in this screen, the User Defined Deviation Rule/Allowed Variance field is enabled for editing. When this rule is selected, the Allowed Variance field must contain a numeric value. NOTE: - Numeric values are calculated using precise values. However, when displayed, these values are rounded to a specified number (n) of decimal places. Due to this rounding, a value displayed on-screen may appear to be within the defined range limit when it is actually out of range. Such values are flagged to indicate that they are out of the range. RiLiBÄK Conformance Enable R iLiB Ä K root of means square calculation Option to use RiLiBÄK rules for calculating the root of means square when defining the acceptable percent variation from the root of means square for a defined interval of points identified in the interval state setting (for example, a date range or number of points) in the QC Results List filter. A llowed variance Defines the value for acceptable percent variation as described in the previous paragraph. Frequency In this section, configure the instrument to run QC or to generate a warning message based on the number of tests, number of hours, absolute time of day and at a reagent vial change. QC is performed automatically when all of the following conditions are met: l Automatic execution is enabled. l The configured thresholds or events are reached. l The QC is feasible (materials on-board with sufficient volume and not expired). l You have ordered a specific test related to the QC. If any of the above conditions are not met, the system generates a warning and sets the QC status to Overdue. NOTE: When Auto Run is configured in Global Definitions Setup, it only auto-executes a QC job when By Absolute Time is configured. B y tests Option to configure the instrument to: 1) run QC (automatically, if enabled); or 2) generate a warning after the specified number of tests have been performed (specify the frequency in the Number of tests field. 338 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup QC Setup Definition l l Enable warning threshold – Option to generate a message to run QC when the warning threshold is reached. Enter the number of hours/tests in the field beside this option. Automatic execution – Option to run QC automatically when the threshold number of Tests/Hours is reached. Automatic execution can be performed only if all the necessary materials are on-board in sufficient volumes, adequate stability, and valid expiration dates. NOTE: l l l l l After a QC job has finished running, the frequency timer for Tests/Hours resets to the starting point. This is true whether the QC job is manually or automatically generated. A manually executed QC job that runs at the same time as a frequency-initiated QC job, does not cause a duplicate QC test to run. The execution of QC frequency jobs initiated By Tests or By Hours has no impact on jobs initiated By Absolute Time. The execution of QC frequency jobs initiated By Tests or By Hours has no impact on jobs initiated By Absolute Time. Only patient jobs are considered when counting the frequency by tests. QC jobs, calibration points, and NPP points are excluded. NOTE: Automatic execution of a QC job By tests or By hours occurs when all the following conditions are met: o Automatic execution is enabled. o All the required materials for the QC test are on board. o The QC test is feasible. o An order has been created to run the test related to the QC. For example, to run a QC job for Routine Control X for the test APTT, an APTT test must be ordered. If Automatic execution is enabled By tests or By hours in the QC Setup Definition, and the above conditions are not met when the frequency is due, the system generates an alarm indicating that QC is not feasible, or QC is overdue. B y hours Option to configure the instrument to: 1) run QC (automatically, if enabled); or 2) generate a warning after the specified number of hours have passed (specify the frequency in the Number of hours field. l l Enable warning threshold – Option to generate a message to run QC when the warning threshold is reached. Enter the number of hours/tests in the field beside this option. Automatic execution – Option to run QC automatically when the threshold number of Tests/Hours is reached. Automatic execution can be performed only if all the necessary materials are on-board in sufficient volumes, adequate stability, and valid expiration dates. NOTE: 339 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup QC Setup Definition l l l l After a QC job has finished running, the frequency timer for Tests/Hours resets to the starting point. This is true whether the QC job is manually or automatically generated. A manually executed QC job that runs at the same time as a frequency-initiated QC job, does not cause a duplicate QC test to run. The execution of QC frequency jobs initiated By Tests or By Hours has no impact on jobs initiated By Absolute Time. The execution of QC frequency jobs initiated By Tests or By Hours has no impact on jobs initiated By Absolute Time. NOTE: Automatic execution of a QC job By tests or By hours occurs when all the following conditions are met: o Automatic execution is enabled. o All the required materials for the QC test are on board. o The QC test is feasible. o An order has been created to run the test related to the QC. For example, to run a QC job for Routine Control X for the test APTT, an APTT test must be ordered. If Automatic execution is enabled By tests or By hours in the QC Setup Definition, and the above conditions are not met when the frequency is due, the system generates an alarm indicating that QC is not feasible, or QC is overdue. B y A bsolute Time Option to configure the instrument to run QC at a specified time of day or generate a warning. Select one or more of the following options and enter a time of day. This option sets the starting time for the By Hours option if selected in this screen. l First time – Check option and configure the time in the adjacent field. l Second time – Check option and configure the time in the adjacent field. l Third time – Check option and configure the time in the adjacent field. l Fourth time – Check option and configure the time in the adjacent field. Example If First time is configured as 07:00, and Number of hours configured as 8, the instrument runs QC or generates a warning message at local times: 15:00, 23:00, and 07:00. Automatic execution Option to run QC automatically at the times specified in this parameter. Automatic execution can be performed only when all the following conditions are met: l All required materials are on-board in sufficient volumes l The on-board stability parameters in Material Definition have not been exceeded. l If you have enabled Auto Run in Global Definitions Setup, or have manually ordered a test associated with the QC. 340 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup QC Setup Definition NOTE: l l A QC job triggered by a By Absolute Time setting resets the frequency timer for By Test and/or By Hours. The execution of QC frequency jobs initiated By Tests or By Hours has no impact on jobs initiated By Absolute Time. NOTE: If Automatic execution of a QC job By Absolute Time is selected in the QC Setup Definition, and Auto Run is selected in Global Definitions Setup, QC automatically executes the QCs at the defined times if the following conditions are met: o All the required materials for the QC test are on board. o The QC test is feasible. B efore vial use Option to run automatic QC if any of the vials used for the specific assay (start or intermediate reagents) have changed. This is not recommended if you are using more than one reagent, because a vial change of an intermediate or start reagent forces a QC, even if one has just been performed. NOTE: l l l This frequency option is independent (and in addition to) the By Tests, By Hours and By Absolute Time frequency options. When this frequency option is selected, automatic QC executes (in addition to other frequencyinitiated QC jobs). If a QC job is triggered by the Before vial use option, the By tests and By hours frequency timer resets to the starting point. See Also l Quality Controls l QC Overview l QC List l QC Profiles List l QC Results List l QC Test Status List l Reviewing QC Results 341 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Test Profiles List Test Profiles List The Test Profiles List contains a list of all test profiles1 currently defined on the system. The ACL TOP instrument can store up to 100 test profiles, each containing up to 15 individual tests. Accessing the Test Profiles List To access the Test Profiles List: 1. Select Setup > Test Profiles List in the menu bar. 2. To view a test profile, place focus2 on a profile in the Test Profiles List, and select the Profile icon in the toolbar. View the test profile in the Profile Definition screen. 3. To delete a test profile, select3 one or more profiles in the Test Profiles List and select the Delete icon in the toolbar. Confirm the deletion. 1A test profile is a grouping of tests. When you associate the test profile with a sample, all the tests in the profile run on sample. 2To place focus on the unique identifier in a list, click a row in the table. A blue cell border indicates focus. Only one unique identifier in a list can have focus. 3Click in the Selection column of a table. A red check mark indicates selection. You can typically select more than one object. 342 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Test Profiles List Defining a New Test Profile To define a new test profile: 1. Select Setup > Test Profiles List in the menu bar to open the Test Profiles List. 2. Select the Add icon in the toolbar. 3. In the Profile Definition screen, enter a name and description for the new test profile. 4. Use the arrow buttons to move selected test codes from the Available tests window to the Selected tests window. NOTE: l l The Available tests window contains only enabled test definitions. The Selected tests window contains the test definitions to add to the test profile. You cannot duplicate tests within a single profile. 5. Select the Save icon in the toolbar to save your changes. 6. Select the Previous Screen icon in the toolbar to return to the Test Profiles List. 343 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Test Profiles List Configuring the Standard Test Profile To configure the Standard Profile: 1. Select Setup > Test Profiles List in the menu bar to open the Test Profiles List. 2. Select1 a profile in the Test Profiles List. 3. Select the Toggle Standard Profile column in the Test Profiles List. icon in the toolbar. A check mark appears in the Standard Tests contained in the standard profile are automatically programmed on every sample that has a sample ID but does not have a test programmed through the LIS. There can be only one standard test profile on the system. Test Profiles List Toolbar The Test Profiles List operations toolbar includes the following: Select the following icons to perform the associated tasks: Add – Opens the Profile Definition screen where you can define a new test profile. View – Opens the Profile Definition screen for the profile having focus2. Delete – Deletes the selected profiles. Toggle Standard Profile. Enables/disables the standard profile. 1Click in the Selection column of a table. A red check mark indicates selection. You can typically select more than one object. 2To place focus on the unique identifier in a list, click a row in the table. A blue cell border indicates focus. Only one unique identifier in a list can have focus. 344 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Test Profiles List Test Profiles List Screen Selection C olumn Click one or more cells in this column to place check marks, selecting rows to perform actions on. Click the Select icon in the column heading to select or deselect all the rows in the table. N ame Unique test profile name. Maximum 10 characters. D escription User-created description of the test profile. Maximum 50 characters Standard A check mark indicates the standard profile. Tests contained in the standard profile are automatically programmed on every sample that has a sample ID but does not have a test programmed through the LIS. There can be only one standard test profile on the system. If the LIS orders a test that is contained in the standard profile, the system does not run a duplicate test. See Configuring the standard profile. NOTE: l The Available tests window contains only enabled test definitions. l You cannot duplicate tests within a single profile. l You cannot delete a test definition that is referenced in any test profile. l You cannot disable a test definition that is referenced in any test profile. See Also l Test Definition 345 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup QC Profiles List QC Profiles List The QC Profiles List contains all QC profiles currently defined on the system. Accessing the QC Profiles List To access the QC Profiles List: 1. Select Setup > QC Profiles List in the menu bar. 2. To view a QC profile, double-click a profile in the table. 3. To add a new QC profile, click the Add 4. Select the Save icon in the toolbar. icon in the toolbar to save your changes. 5. Select the Previous Screen icon in the toolbar to return to the QC Profiles List. QC Profiles List Toolbar The operations toolbar includes the following: Select the following icons to perform the associated tasks: Add a new QC profile. Opens the Profile Definition screen. View Profile Definition details. Opens the Profile Definition screen for the profile in focus. Delete a Profile. Deletes the selected profiles. 346 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup QC Profiles List QC Profiles List Column Descriptions Selection C olumn Click one or more rows to place check marks in this column, indicating selection of one or more QC profiles. Maximum 10 characters. N ame Name of the QC profile. D escription User-created description of the QC profile. Maximum 50 characters. The following requirements apply: l Duplicate profile names are not allowed. l The Available QCs List contains only enabled QC definitions. See QC List. l The selected QCs list contains only QC definitions you selected from the available QCs list. l You cannot duplicate QCs within a single profile. l You cannot delete a QC definition that is referenced in any QC profile. l You cannot disable a QC definition that is referenced in any QC Profile. See Also l Quality Controls l QC Overview l QC List l QC Results List l QC Setup Definition l QC Test Status List l Reviewing QC Results 347 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Defining QC Profiles Defining QC Profiles A QC Profile is a group of QC tests under one heading or name that you can select to run without needing to individually select each of the QC tests. The ACL TOP instrument is capable of storing up to 100 QC profiles, each containing up to 15 individual tests. Creating a QC Profile To create a QC Profile: 1. Select Setup > QC Profiles List in the menu bar. 2. Select the Add icon in the toolbar, or select Actions > QC Profile > Add in the menu bar. The QC Profile Definition screen appears. A maximum of 100 QC profiles may be defined. 3. Enter a unique name (maximum of 10 characters) and a description (maximum of 50 characters) in the appropriate fields. 4. Select the tests in the Available QCs field to included in the new QC profile, and select the right arrow to move them into the Selected QCs field. 5. Select the Save icon in the toolbar to save your changes. 6. Select the Previous Screen icon in the toolbar to return to the QC Profiles List. 348 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Defining QC Profiles Viewing a QC Profile To view a QC profile: 1. Select Setup > QC Profiles List in the menu bar. 2. In the QC Profiles List, do one of the following to open the QC Profile Definition screen: l Double-click a profile. l Select a profile and select the View l Select a profile and select Actions > Review > QC Profile Definition in the menu bar. icon in the toolbar. 3. In the QC Profile Definition screen, the tests listed in the Selected QCs field are the tests in the QC profile that has focus1 in the QC Profiles List. 4. Select the Previous Screen icon in the toolbar to return to the QC Profiles List. Editing a QC Profile To edit a QC profile: 1. Open a QC profile in the QC Profile Definition screen. See Viewing a QC profile. 2. Select tests in the Available QCs and Selected QCs fields, and use the arrow buttons to move them to and from the Selected QCs field. The tests in the Selected QCs field are the tests that are included in the QC profile after you save. 3. Select the Save icon in the toolbar to save your changes. 4. Select the Previous Screen icon in the toolbar to return to the QC Profiles List. Deleting a QC Profile To delete a QC profile: 1. Select Setup > QC Profiles List in the menu bar. 2. Select one or more QC profiles in the QC Profiles List and select the Delete toolbar. icon in the 3. Click OK in the confirmation dialog box. 1To place focus on the unique identifier in a list, click a row in the table. A blue cell border indicates focus. Only one unique identifier in a list can have focus. 349 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Defining QC Profiles See Also l Quality Controls l QC Overview l QC List l QC Profiles List l QC Results List l QC Setup Definition l QC Test Status List l Reviewing QC Results 350 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Reflex Rules Reflex Rules Reflex rules allow you to program and automatically execute a test generated by a condition of another test's results. The ACL TOP instrument can store up to 100 reflex rules, each containing up to 10 conditions. Creating a Reflex Rule To create a reflex rule: 1. Select Setup > Reflex List in the menu bar. 2. Select the Add icon in the toolbar. 3. In the Reflex Definition screen, enter a unique name for the reflex rule in the Rule name field. The name can be 1-10 characters. 4. Enter a description of the rule in the Description field. The description can be 1-80 characters. 5. Click in the Test Code column, then select a test code in the drop down list. 6. Click in the Result Unit column, then select the result unit in the drop down list. 7. Click in the Rule column, then select a rule in the drop down list. 8. If the rule contains an operator (<, >, =), enter a numeric value for the rule in the Value column. 9. If multiple rules are used in the reflex test, select either the AND or OR operator from the Op. (operator) drop down list. This is available only if two or more rules are selected. 10. Use the arrow buttons to move one or more tests to execute in response to the reflex rule violation from the Available window to the Selected window. You cannot select the same test code you selected in the earlier step. 11. Select the Save icon in the toolbar to save your changes. Viewing or Editing a Reflex Rule To view or edit an existing reflex rule: 1. Select Setup > Reflex List in the menu bar. 2. Double-click a rule in the Reflex List to view the rule settings in the Reflex Definition screen. 3. Follow the steps in the Creating a Reflex Rule procedure to edit the rule. 351 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Reflex Rules Reflex List Operations Toolbar Select the following icons to perform the associated tasks: Add Reflex Rule – Opens the Reflex Definition screen. View Reflex Rule – Opens the Reflex Definition screen for the Reflex Rule having focus. Delete Reflex Rule – Deletes the selected Reflex Rule. Reflex List The Reflex List screen contains a list of all reflex rules currently defined on the instrument. Selection C olumn Click in the column to select. Select one or more reflex rules to delete. N ame Name of the reflex rule. Must be a unique name with a maximum of ten characters. IL Locked C olumn A check mark indicates a locked reflex rule, which cannot be edited or deleted. D escription Description of the reflex rule. Cannot exceed 80 characters. NOTE: After a reflex triggers, the reflex test does not execute if it has already been performed on a sample. For example, the FXIII Ag test is run and a reflex rule causes the FXIII High test to run. Later, FXIII Ag is requested for the same sample again and again meets the criteria to reflex. The reflex test does not execute because it has already been performed. 352 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Reflex Rules Reflex Definition Screen Rule name Name of the reflex rule. Enter a unique name with a maximum of 10 characters. IL Locked A check mark indicates a locked reflex rule, which cannot be edited or deleted. Description Description of the reflex rule. Enter a description with a maximum of 80 characters. Conditions Test C ode Unique identifier of a test in the reflex rule. Click in the table cell, then select a test code in the drop down list. R esult U nit Test result unit for a test in the reflex rule. Click in the table cell, then select a result unit in the drop down list. 353 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Reflex Rules R ule List of rules to apply to the reflex rule. Click in the table cell, then select a rule in the drop down list. Value Numeric value to apply to the reflex rule. If the rule contains an operator (<, >, =), enter a numeric value in this table cell. NOTE: - Numeric values are calculated using precise values. However, when displayed, these values are rounded to a specified number (n) of decimal places. Due to this rounding, a value displayed on-screen may appear to be within the defined range limit when it is actually out of range. Such values are flagged to indicate that they are out of the range. Op. Operator to use if multiple rules are used in the reflex test. Click in the table cell, then select the AND or OR operator in the drop down list. This is available only if two or more rules are selected. Tests to be executed Use the arrow buttons to move the selected tests to execute in the reflex rule from the Available window to the Selected window. A vailable List of available tests. Selected List of tests to run if the reflex rules trigger an event. See Also l Alternative Pre-Dilution 354 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Auto-Validation Setup Auto-Validation Setup Use the Auto-Validation Setup screen to configure the instrument to automatically validate test results based on the criteria you select. Configuring Auto-Validation To configure auto-validation: 1. Select Setup > Auto Validation in the menu bar. 2. In the Auto Validation screen, select the Enable auto-validation option. 3. Select the Patient result, Parallelism result and/or Calibration result options to enable selection of the auto-validation exception criteria in the Patient, Parallelism and Calibration columns. If you do not select any of these options, auto-validation is performed for every test result. 4. Select the Auto-Validation Exception criteria in the Patient, Parallelism and/or Calibration columns. Auto-validation of test results does not occur for the criteria you select. 5. Select the Save icon in the toolbar to save your changes. 355 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Auto-Validation Setup Auto-Validation Setup screen Enable auto-validation Option to auto-validate test results. Enables the controls on this screen. Data reduction tests each mean result against the established result range flags. Patient result Option to auto-validate patient test results. Enables the selection of exception criteria in the Patient column. Parallelism result Option to auto-validate parallelism test results. Enables the selection of exception criteria in the Parallelism column. C alibration result Option to auto-validate calibration test results. Enables the selection of exception criteria in the Calibration column. Auto-Validation Exceptions Auto-validation exceptions are organized by the following criteria: 356 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Auto-Validation Setup Failures Test failed – Option to block auto-validation when a test fails. Errors l l l l l l DR error on measured results – Option to block auto-validation when a data reduction error occurs on a measured result. Max. difference on primary test result – Option to block auto-validation when the Max. difference value for a test result exceeds the value defined in the respective test definition. See Result Unit Definition. Parallelism error – Option to block auto-validation when any of the parallelism data reduction parameters have been exceeded. (See Parallelism Setup - Data Reduction Tab.) Parallelism must be enabled. QC errors – Option to block auto-validation when any QC rule has been violated, as defined in the respective QC setup definition. Temperature error – Option to block auto-validation when the analyzer temperature drifts from nominal during a test. Errors on test results – Option to block auto-validation when any error occurs on test results. W arnings l l DR warning on measured results – Option to block auto-validation when a data reduction error occurs on a measured result (as defined, and if enabled) in a test definition under Raw Data Checks, Normalized Data Checks, or Primary/Secondary Algorithm. (See Data Reduction Parameters.) Parallelism warning – Option to block auto-validation when a parallelism error occurs on a parallelism result. R esults outside range These four options are automatically selected when the DR error on measured results option in the Errors criteria group is selected. They can also can be selected independently. l l l l Results outside test range – Option to block auto-validation when test results are outside the test range. Results outside therapeutic range – Option to block auto-validation when test results are outside the therapeutic range. Results outside linear range – Option to block auto-validation when test results are outside the linear range. Results outside normal range – Option to block auto-validation when test results are outside the normal range. Expirations l LAS Sample expired during processing – Option to block auto-validation when the LAS sample expiration time has been exceeded before the Sample results are obtained. 357 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Auto-Validation Setup l l Material expiration – Option to block auto-validation when a material used for a specific test has expired before the Sample results are obtained. The Enable lot management option must be selected. See Material Definition – Lot Specific Information Tab. Material stability expired – Option to block auto-validation when a material used for a specific test has exceeded the on-board stability value, as defined in the Material Definition before the Sample results are obtained. The On-board stability tracking option must be selected. See Material Definition – General Information Tab. Overdues l l l l Calibration overdue – Option to block auto-validation when a calibration related to an ordered test becomes overdue before the test results are final. Maintenance overdue – Option to block auto-validation when any maintenance operation becomes overdue. NPP overdue – Option to block auto-validation when an NPP1 related to an ordered test becomes overdue before the test results are final. QC overdue – Option to block auto-validation when a QC related to an ordered test becomes overdue before the test results are final. See Also l Data Reduction Parameters 1Normal Pool Plasma. A type of sample used as a standard of comparison when calculating the International Normalized Ratio (INR) and when calculating test results that use the normalized ratio. 358 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Revision History Report Revision History Report Available only to IL personnel. 359 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Importing and Exporting Definitions Importing and Exporting Definitions Overview The Import/Export feature allows you to transfer a copy of any or all of the following data: l Materials l Tests l QCs l Vials l Profiles o Test o QC l Reflex l Sample display settings l Programming window o Tests o Materials l Maintenance activities l Bar code definitions l LIS definitions l Global definitions l Security definitions l LAS definitions l Report configuration l Validation rules Use the import/export function to transfer test and material definitions from one instrument to another. Data transfer can occur between all ACL TOP Family instruments. For example: l From one ACL TOP 700 instrument to another ACL TOP 700 instrument l From an ACL TOP 500 CTS instrument to an ACL TOP 700 instrument NOTE: All ACL TOP models contain some unique Test, Material and QC definitions that are not compatible with other ACL TOP models, and therefore cannot be imported/exported between instrument models. 360 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Importing and Exporting Definitions Exporting Definitions To export data from the Import/Export screen: 1. Select Setup > Import/Export to open the Import/Export screen. 2. Select the Export tab. 3. In the Destination file field enter a file name with extension .XML after the displayed path. Use the Browse button to change the file path. The Export in the following example: icon is enabled only for XML files, as 4. Select the tab that corresponds to type of data to export. 5. In the Available window, select one or more items to export. Use the Shift/CTRL keys to multi-select. 6. Select the upper right arrow to move selected items to the Selected definitions to Export window. The system automatically moves other related definitions. For example: If you select the PT-RP test on the Tests tab, all materials associated with the PT-RP test are automatically moved to the Selected definitions to Export window on the Materials tab. 7. <Optional> Check the Select All option to move everything in the Available window to the Selected definitions to Export window. 8. <Optional> Place a check mark in the box to the left of an item in the Selected definitions to Export window to force that definition to be imported during a subsequent import process. A check mark 361 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Importing and Exporting Definitions here prevents deselection of that definition when performing the subsequent import. All dependent definitions are also be imported. For example: If you select the PT-RP assay for forced subsequent import during the creation of the export file, all materials required to perform the test (Factor Diluent, HemosIL Cal Plasma, PT RecombiPlastin, Clean B Diluted) are also imported. Materials that are not required to run the test (QC materials) are not imported. Enable the selection of dependencies on the Others tab. By default, the system forces import of everything used in the exported definition. 9. To delete definitions, use the lower right arrow to move them to the Selected (definitions) to delete window. The system does not automatically move related definitions. You must move related definitions manually. To force the deletion of a definition on import, check the item in the Selected to Delete window. 10. Select the Export location. icon in the toolbar to move a copy of the definitions to the selected file 362 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Importing and Exporting Definitions Importing Definitions NOTE: An import operation cannot be performed while the system status is BUSY or in a CONTROLLED STOP. To import data: 1. Select Setup > Import/Export to open the Import/Export screen. 2. Select the Import tab. 3. In the Source Data area use the Browse button to locate the source file to import. Files for import must have an .XML extension. After selecting the file, the definitions contained in the file appear in the Available and Available Definitions Marked to be deleted windows in each tab of the Import screen. Definitions selected for mandatory import or deletion are displayed in the Selected definitions to add/import and Selected definitions to delete windows, respectively. 4. Select the tab for the type of data you are importing. 5. Select one or more definitions in the Available window, and select the upper right arrow to move them to the Selected definitions to add/import window. Use the Shift/CTRL keys to multi-select. Select the Select All option to move everything to the Selected definitions to add/import window. 6. By default, all available definitions are selected for import. To deselect a definition for import, use the left arrow to move it from the Selected definitions to add/import window to the Available window. Select the Select All option to move everything from the Selected definitions to add/import window to the Available window. 363 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Importing and Exporting Definitions NOTE: l l Importing data overwrites all IL-Locked fields. It does not overwrite most user-defined fields. An exception is user-defined fields in the QC definition. To avoid overwriting QC definitions, move QC definitions from the Selected definitions to add/import window to the Available window before import. Importing items with check boxes is mandatory. Importing items without check boxes is not mandatory. To avoid importing unchecked items, move them to the Available window. To import non-mandatory items, move them to the Selected definitions to add/import window. 7. Select the Import user defined fields option to import user-defined fields. 8. To delete definitions, use the lower right arrow to move them to the Selected (definitions) to delete window. The system does not automatically move related definitions. You must move related definitions manually. 9. Select the Import icon to transfer the definitions to the instrument. CAUTION: l l When you import results data from a calibration, the Result Correlation setup in Result Units is not protected from editing. Changing the correlation factor or the offset for IL locked tests can compromise calibration results. After importing a test over an existing test in the database, you must recalibrate the imported test before running any type of sample. NOTE: l l l A definition with a broken underline indicates the definition exists on the system, and will be overwritten during the import. If two materials or tests have different ID numbers but the same name, the system imports all the parameters except the one with the duplicate name code. A message displays information about the definition with the duplicate name code. When importing a maintenance activity, the Frequency field is overwritten if the imported activity is more frequent than the one set by the system. Frequency is not overwritten if the imported activity is less frequent than the one set by the system. 364 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Importing and Exporting Definitions Field Descriptions Major Version Number assigned to the major version of the test parameters. Minor Version Two fields indicating the minor version of the test parameters. Others Tab Select the dependencies to force the instrument to import for each definition being imported. By default, the instrument imports everything used in the definition. Dependencies imported include the following: l Maintenance activities l Barcode definitions l LIS definitions l Global definitions l Security definitions l LAS definitions l Report configuration l Validation rules The settings in this tab are exportable to assist in the transfer of user-defined settings from one instrument to another of the same model. 365 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Global Definitions Setup Global Definitions Setup Global Definitions is the area of configuration that allows you to select options that define default values used by the system when configuring other areas of the system. Setting Up Global Definitions To set up global definitions: 1. Make sure the instrument is in the READY state. 2. Select Setup > Global Definitions in the menu bar. 3. In the Global Definitions screen, configure the global parameters. 4. Select the Save icon in the toolbar to save your changes. Global Definitions Setup Screen 366 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Global Definitions Setup Run Patient Priority Option to pipette all test requests for one patient sample before starting the next patient sample. For example, if PT and APTT tests were ordered for four samples, the processing order would be: Sample 1: PT Sample 1: APTT Sample 2: PT Sample 2: APTT Sample 3: PT Sample 3: APTT Sample 4: PT Sample 4: APTT Throughput Option to schedule the test to run starting with the 8 tests that complete the quickest. Then the scheduler processes the next 8 quickest tests, and so on. In the example used above the processing order would be: Sample 1: PT Sample 2: PT Sample 3: PT Sample 4: PT Sample 1: APTT Sample 2: APTT Sample 3: APTT Sample 4: APTT A uto R un Option to run tests automatically after a sample is PLACED. The run starts automatically when all the following conditions are met: l A sample is placed (sample status is PLACED). l An enhanced clean is not currently required. l Temperatures are not out of range. l All ORUs are enabled. 367 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Global Definitions Setup The instrument monitors these conditions at 1 minute intervals. If the above conditions are not met, the instrument retries Auto Run after each monitoring interval. After Auto Run starts, the instrument status remains BUSY until testing completes. A sample with tests that are not feasible remains in the LAS Cuvette Holding Area until all tests become feasible, or until the sample expiration time elapses. Test Definition Features D isplay D erivative C urves Option to enable/disable displaying the first and second derivative curves in the reaction graph on the Test Details screen. In the Test Details screen you can toggle derivative curves on and off. This option defines the default global setting. Enable Global R erun Option to enable/disable all rerun rules for all tests that have Rerun parameters defined and enabled. Enable Global R eflex Option to enable/disable all reflex rules for all tests that have Reflex parameters defined and enabled. 368 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Global Definitions Setup Sample Life Sample life specifies a time frame, in days or hours, that is used to determine whether new test requests, coming from the LIS or programmed by you, are assigned to a sample ID that is already in the system. In other words, if a sample/test request is received by the ACL TOP within the time specified in the sample life field, and the same sample/test request (with identical patient demographics) is already in the system, the new test request is appended to the sample already in the system. For example, if the sample life field is set to 24 hours and a sample ID 123 with test APTT (having blank patient demographics) is received by the TOP at 10:00 a.m. Oct 1, then another sample ID 123 with test APTT (having blank patient demographics) is received by the system at 8:00 a.m. Oct. 2, the second APTT test is appended to the first sample ID 123. In this example, the results for the two tests are displayed as follows: Sample ID Test APTT 123 APTT If a sample ID 123 with test APTT (having blank patient demographics) is received by the TOP at 10:00 a.m. Oct 1, then another sample ID 123 with test APTT (having blank patient demographics) is received by the system at 11:00 a.m. Oct. 2, the second sample ID/APTT test is run as a completely separate test from the first sample ID. In this example, the results for the two tests are displayed as follows: Sample ID Test 123 APTT Sample ID Test 123 APTT . If sample life is disabled, sample IDs are reused. The range is 1-99, the unit is hours or days. The default is 24 hours. Default File Path Location where data logs are stored, if enabled. The system must be configured by an IL representative to save data reduction reports. To change the default file path, select the browse button and enter a new location. 369 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Global Definitions Setup Test Mode Extensions Extended A cquisition Mode Extension Extension added to the test code for tests run in extended acquisition mode. Any keyboard character may be used. The default value is E. Parallelism Mode Extension Extension added to the test code for parallelism tests. Any keyboard character may be used. The default value is P. D iluted Mode Extension Extension added to the test code for diluted tests. Any keyboard character may be used. The default value is D. Editing Options Enable K eypad Option for a numeric keypad to popup anytime you click in a field that contains a numeric value. Disabled by default. Enable K eypad for Sample ID Option for a numeric keypad to popup anytime you click in a sample ID field that contains a numeric value. Disabled by default. 370 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Global Definitions Setup Sample/Reagent Probe Dilution Parameters Max. Syringe Volume Maximum volume of fluid able to be aspirated or dispensed. Limited by the physical characteristics of the syringe pump. The default value is 250 μL. Min. Syringe Volume Minimum volume of fluid able to be aspirated or dispensed accurately. Limited by the performance characteristics of the syringe pump. The default value is 4 μL. Max. C onsecutive D ispensations Number of dispenses of the same material that can be injected into the same cuvette well without rinsing when preparing dilutions. The default value is 3. Cuvette Dilution Parameters C uvette Overflow Volume Maximum volume capacity of a cuvette well. The default value is 600 μL. C uvette B lind Volume Volume of fluid, in microliters, that cannot be removed from the cuvette well by a probe aspiration. The default value is 65 μL. Min. C uvette Volume for Mix Minimum volume of fluid, in microliters, required to be present in a cuvette well in order to mix the cuvette well contents. The default value is 100 μL. Min. C uvette Volume for Test Minimum volume of fluid, in microliters, required to be present in a cuvette well before it can be sent to the optical reading unit (ORU). The default value is 150 μL. Max. C uvettes per D ilution Maximum number of cuvettes to use when making dilutions. Select a number between 1 and 8. 371 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Global Definitions Setup CTS Parameters Enable Piercing Mode Option to enable cap piercing on the ACL TOP CTS instrument. Cap piercing is required when running tests on closed tube samples. This option enables the Low-Fill Tubes Handling option. Low-Fill Tubes H andling Select the Enable Lower z-depth option to enable the ACL TOP CTS instrument to run tests on low fill closed tube samples. This option addresses sample tube types where a small fill volume (e.g. 1.8 mL) is paired with a tube inner diameter typical of tubes designed to accommodate larger fill volumes (e.g. 2.7 mL). In these tubes, the plasma fill line sits very low (near the bottom of the tube, and far from the tube cap), at a distance that is barely reachable by the sample probe. Contact Service to enable this option. Enable deep wash when rinsing before aspirating Enables the deep wash cycle that is generally used when CTS mode is enabled. For IL test development use only. System Identification Serial N o. AM serial number identifier. Model Type of configuration that defines the instrument. For example: l ACL TOP 300 l ACL TOP 500 CTS l ACL TOP 700 (includes ACL TOP Base) l ACL TOP 700 CTS (includes ACL TOP CTS) l TOP 700 LAS System Capacities Patient Samples You can configure up to 20,000. You are prompted to confirm if the change causes a large amount of data to be deleted. QC Jobs You can configure up to 20,000. You are prompted to confirm if the change causes a large amount of data to be deleted. 372 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Bar Code Definitions Setup Bar Code Definitions Setup Configuring Bar Code Reading To configure the bar code reading in the Sample and Reagent Areas: 1. Select Setup > Bar Code Definitions in the menu bar. 2. Configure the bar code settings in the Bar Code Definitions screen. 3. Select the Save icon in the toolbar to save your changes. 373 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Bar Code Definitions Setup Bar Code Definitions screen Enable Reagent Area Bar Code Reading Option to enable the reading of bar code labels on the reagent bottles placed on racks in the Reagent Area. When this option is disabled, the instrument does not read the bar code labels on the bottles it detects in the reagent racks. NOTE: When this option is disabled, the materials on the rack must be manually defined. Each instance of an unknown reagent in a rack position triggers an alarm code 3004 error when reagent racks are inserted into the instrument. l Alarm 3004 Non-identified Material in rack <rack ID> position <rack position #>, track # <rack track #>. Enable Sample Area Bar Code Reading Option to enable the reading of bar code labels on the sample cups and tubes placed on racks in the Sample Area. When this option is disabled, the instrument does not read the bar code labels on the sample cups and tubes it detects in the sample racks. Available Bar Code Formats The bar code formats in this area of the screen are available for selection. 374 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Bar Code Definitions Setup Enable code 128 This option is always enabled. Code 128 format is used for 1) all reagent bar codes; and 2) sample and reagent rack information bar codes. Enable interleaved 2 of 5 Option to use the Interleaved 2 of 5 barcode format. NOTE: l l l l This value must be set to 6, 8, 10, 12, 14 or 16 characters (minimum 6 characters, maximum 16, even number of digits). When an odd number of barcode digits is configured, the system appends a zero to the beginning when the label is scanned to convert the number of digits to an even number. The Checksum option adds a character to the barcode value. When using the Checksum option, set the Max. Number of digits value to 14 or fewer. For safety reasons set both the minimum number of digits and the maximum number of digits to your commonly used size. For example, if you commonly use a 12 digit bar code, set both the Min. and Max. Number of digits fields to 12. Enable C ode 39 Option to use the Code 39 barcode format. The following options are available: l l Enable Checksum – Option to use a checksum. Select the checksum type from the drop down list. Disabled by default. Enable Large Intercharacter Gap – Option to use a Large Intercharacter Gap. Enables the scanner to read symbols with gaps between the bar code characters that exceed three times the narrow element width. This is useful for reading symbols that are printed out of specification. Enable C odabar N W (7) Japan Option to use the Codabar NW(7) barcode format. The following options are available: l l Enable Checksum – Option to use a checksum. Select the checksum type from the drop down list. Disabled by default. Enable Large Intercharacter Gap – Option to use a Large Intercharacter Gap. Enables the scanner to read symbols with gaps between the bar code characters that exceed three times the narrow element width. This is useful for reading symbols that are printed out of specification. NOTE: An alarm is triggered when the bar code reader encounters a label longer than 16 characters. See Also l Material Identification 375 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Bar Code Label Placement Bar Code Label Placement To ensure accurate bar code scanning, do not place the label too low or too high on the tube. Use the following diagram to determine correct placement of the label. NOTE: Place the label inside the Symbol Placement Zone. See Also l Material Identification l Bar Code Definitions Setup l Bar Code Reader 376 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup LIS Configuration LIS Configuration Overview The ACL TOP instrument can interface to an LIS (Laboratory Information System). There are two types of communication between the ACL TOP instrument and the LIS (host). The communication from the LIS to the ACL TOP instrument is known as Host downloads and the communication from the ACL TOP instrument to the LIS is known as Host uploads. In a host downloading process, the information that travels from the LIS to the ACL TOP instrument is a set of test orders. A test order can be described as a test request to be performed on a sample. In a host uploading process, the information that travels from the ACL TOP instrument to the LIS is a set of test results. A test result can be briefly described as the numeric analytical values (measured or calculated) and/or associated error status, flags, and warnings, produced by the execution of the test. NOTE: The ACL TOP instrument does not run duplicate tests, whether ordered through the LIS or ordered manually. Only one test is performed per test code, per sample. To run duplicate tests on a sample, you must either 1) configure the test definition to run a replicate; or 2) wait until a test has generated test results. You configure the method of communication with the LIS on the LIS setup screen. Configuring Communication with an LIS NOTE: An LIS Administrator should supervise LIS configuration. To configure communication with an LIS: 1. Select Setup > LIS > Communications in the menu bar. 2. In the LIS Setup screen, complete the information on the Host Communications Configuration, ASTM-1394 Configuration, and Communications Configuration tabs according to your LIS requirements. Performing a Manual LIS Query To manually request test orders from the LIS: 1. Select Analysis > Sample List in the menu bar. 2. In the Sample List, select Actions > Results > Download Tests Order in the menu bar. Alternatively, see Programming Non-Bar Coded Samples After Inserting the Rack, Using an LIS without Host Query Enabled. 377 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup LIS Configuration Host Communications Configuration Tab Use this tab to enable the ACL TOP instrument to work with an LIS and configure the following modes and identifiers. Enable Host Communication Option to enable the ACL TOP instrument to work with an LIS system. Host Configuration Instrument ID ID of the ACL TOP instrument to send and receive messages. H ost ID ID of the LIS host to send and receive messages. 378 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup LIS Configuration Futura C ompatible Protocol Option to set the ACL TOP instrument communications protocol to be compatible with LIS drivers developed for communications with the ACL Futura or the ACL Advance. This protocol is not fully ASTM1394 compatible and has modifications that make it unique. If you select this protocol, the full ASTM-1394 Compatible Mode is automatically deselected. If you select the Futura Compatible Protocol, only Upload Quality Controls and Trace communications protocols can be selected. Full A STM-1394 C ompatible Mode (aka TOP-C ompatible mode) Option to set the ACL TOP instrument communications protocol to be compatible with the LIS drivers developed for ACL TOP instrument communications that are fully ASTM-1394 compatible. If you select this protocol, the Futura Compatible Protocol is automatically deselected. If you select Full ASTM-1394 Compatible Mode, the following four LIS options can be selected: l Use internal instrument sample ID – Option to provide the LIS with the sample ID assigned by the system. l Upload quality controls – Option to upload quality control results to the LIS. l Report errors to host – Option to report any LIS communications errors it encounters to the LIS. l Trace communications protocols – Option to add trace information to the Operating System Event Log. Automatic Host Operation H ost D ownloading The following modes are configurable. l Automatic Downloading – Option to perform an automatic download request each minute. l Host Query – Option to query the LIS for test requests after a sample is placed on the instrument. H ost U ploading Selecting the Enable automatic uploading option enables you to select one of the following Automatic patient uploading modes: l Upload results per test – Option to upload each test result individually as the result is available. l Upload results per sample – Option to upload all results for a specific sample ID. Storage When the laboratory LIS communication status is Disconnected, and ACL TOP LIS communications are enabled, the instrument stores up to a maximum of 7200 messages. R eset button Resets the contents of storage so that messages pending to be uploaded are not sent when connections are reestablished. 379 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup LIS Configuration ASTM-1394 Configuration Tab Use this tab to configure LIS protocol delimiters. The delimiters cannot be used more than once. Duplicate delimiters are not ASTM compatible. Field D elimiter List of characters to use to delimit (or separate) consecutive fields. Select one from the list. R epeat D elimiter List of characters to use to separate several occurrences of a given field. Select one from the list. C omponent D elimiter List of characters to use to differentiate several parts within a given field. Select one from the list. Escape D elimiter List of characters to use to signal special uses of several characters. Select one from the list. C ode pages Select the appropriate code page set (for character encoding) from the list. 380 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup LIS Configuration Communications Configuration Tab Use this tab to configure either Serial Port LIS communications or Network LIS communications protocol. Serial Port C onfiguration Only the COM port can be set. The selections are from a drop down list that contains COM1, COM2, COM3 or COM4. NOTE: All the other RS232 configuration parameters, such as baud rate, parity, stop bits, etc., can be configured through the Windows control panel and are not part of the ACL TOP instrument application. Select the appropriate COM port from the drop down list. Network If you select Network configuration, the setting of the Network TCP/IP configuration can be performed. TC P/IP C onfiguration If the connection mode is Server, the IP address is not editable. It is the responsibility of the Host to know the IP address of the instrument. If the connection mode is Client, enter the IP address and Port for the LIS host. See Also l Reviewing Test Results l Reviewing QC Results l Sender List 381 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Sender List Sender List The Sender represents the location from which a sample has been received. The Sender List displays a summary of currently defined senders. Accessing the Sender List To access the Sender List: 1. Select Setup > LIS > Sender List. 2. To add a sender to the list, select the Add icon in the toolbar. 3. Fill out the form fields. 4. Select the Save icon in the toolbar to save your changes. 5. To delete a sender in the list, select1 the sender in the Sender List and select the Delete the toolbar. Confirm the deletion. icon in Sender List Each sender is identified by the following information: l Code – Unique identifier for sender l Name l Department l Street l City l State/Country l Contact l Phone See Also l LIS Configuration 1Click in the Selection column of a table. A red check mark indicates selection. You can typically select more than one object. 382 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup LAS Overview LAS Overview Definition Laboratory automation systems are large automated laboratories that use a track to route primary sample tubes requiring analysis through pre-analytical, analytical and post-analytical stations positioned throughout the track. See Sample Containers and Adapters for a list of approved primary sample containers for use on the LAS track. The ACL TOP 700 LAS is a laboratory track automation-compatible hemostasis analyzer with the same features and functionality as the ACL TOP. It is designed for point-of-reference sampling following standards referenced in the following CLSI documents: l AUTO1: Specimen Container/Specimen Carrier l AUTO2: Bar Codes for Specimen Container Identification l l l AUTO3: Communications with Automated Clinical Laboratory Systems, Instruments, Devices, and Information Systems AUTO4: Systems Operational Requirements, Characteristics, and Information Elements AUTO5: Electromechanical Interfaces (from the automated track positioned adjacent to the instrument, or sampling from samples manually loaded at the front of the analyzer) 383 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup LAS Overview Sample Workflow Sampling from the LAS track is performed by the LAS sampling module located on the left side of the instrument. The LAS module consists of an LAS sampling arm with dedicated sample probe syringe, vial position and LAS cuvette holding area. The LAS area includes an enhanced clean station with an access door. The LAS arm accesses a bottle of clean material in the clean station to perform daily enhanced cleans. The access door allows you to place and remove clean material. See Enhanced Clean for LAS Probe. NOTE: l l l Do not place any items on the LAS arm cover. If the door on the LAS sampling module is opened when it is unsafe, the instrument performs an emergency stop. If the door is opened during power-up, the system stays in Power Up status until the door is closed. Capped, unspun samples must be spun and uncapped by the LAS system before moving them to the analyzer. The ACL TOP 700 LAS instrument does not centrifuge or uncap sample tubes. It cannot accept capped tubes. When the LAS automation track is enabled in the LAS Configuration screen and the LAS automation track is functioning, primary sample tubes are scanned at the LAS query point before entering the LAS sample tube queue. If the LAS Manager software determines that the sample requires testing by the TOP LAS analyzer, the LAS track diverts primary sample tube from the main track to the sample tube queue. Primary sample tubes that do not require testing bypass the TOP LAS and remain on the main LAS automation track. Sample aliquots are drawn from the primary sample tube and placed on-board in a cuvette cell. The maximum volume for an aliquot from the LAS track is 600 μL. The maximum sample volume that can be removed from the sample tube is 1200 μL. The aspirated sample remains accessible in the LAS holding area for rerun and reflex tests until the sample expiration time has elapsed. Auto Run When the LAS Track option is enabled, Auto Run is automatically enabled and cannot be disabled. Exception: LAS Controlled Stop. The instrument begins processing tests automatically after all of the following conditions are met: l A sample is placed (sample status is PLACED). l No enhanced clean is currently required. l Temperatures are not out of range. l All ORUs are enabled. l Test is feasible (reagents on-board). The instrument monitors these conditions at one minute intervals. If a condition is not met, it tries to initiate Auto Run after each monitoring interval. 384 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup LAS Overview After Autorun starts, the instrument status remain Busy until testing is complete. A sample with tests that are not feasible remains in the LAS Cuvette Holding Area until all tests become feasible, or until the sample expiration time elapses. Prioritization of Samples You can place samples in the front of the instrument at any time using the sample racks in the sample tracks. Sample tracks S1-S3 are blocked and cannot accept sample racks. Run priority is based on sample status and position placed on the instrument according to the following: l Highest Priority – STAT samples front-loaded in sample racks l Middle Priority – Samples aspirated from the LAS track l Lowest Priority – Non-priority samples front-loaded in sample racks NOTE: l l Samples aspirated from the LAS track do not receive priority status. The fastest way to process a test is to assign priority status (STAT) and front load the sample on a sample rack. Test orders for samples provided by the LAS track are received from the LIS. Manually entered test requests can only run on samples that are manually loaded in the sample area. Communication The LAS Manager runs on an external computer and manages the primary sample tubes traveling on an LAS automation track. Communication between the LAS instrument and the LAS track is through an embedded interface module (IM) that is configured in the LAS Configuration screen. 385 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup LAS Overview Hazards and Warnings CAUTION Biohazard: Check the underside of the instrument and table on that it sits for leaks. Clean and disinfect any spills discovered. Report leaks to Service personnel for repair. NOTE: LAS alarms are displayed in the General Log as well as in External Communications Alarms in the Status Bar at the bottom of the screen. See External Communications Alarms. CAUTION: To avoid contamination, Instrumentation Laboratory strongly recommends against using the ACL TOP instrument to perform analysis on Hepabsorb samples. LAS Terminology See Terminology. See Also l LAS Configuration l LAS Cuvette Holding Area l ACL TOP 700 LAS Specifications 386 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup LAS Configuration LAS Configuration The LAS Configuration screen is used to configure the ACL TOP instrument for operation and network communication. Most of the fields on the three tabs contain read-only values defined by IL and the system installer. You can enable or disable the Laboratory Automation System (LAS) on the LAS Configuration tab. When LAS is enabled, communications with the LAS track are initiated. Accessing the LAS Configuration screen To access the LAS Configuration screen: l Select Setup > LAS Configuration in the menu bar. 387 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup LAS Configuration LAS Configuration tab The parameters defined in the LAS Configuration tab do not affect the following configurations defined elsewhere: l Sample and reagent dilution parameters defined in Global Definitions. l Load cycle parameters defined in Test Definitions. Enable LAS Track Option to enable the Laboratory Automation System (LAS). If unchecked, the connection to the LAS track is disabled and the LAS arm moves to the rinse station. When disabled the LAS track remains available for Diagnostics and Maintenance. NOTE: l l Capped, unspun samples must be spun and uncapped by the LAS system before moving them to the analyzer. The ACL TOP 700 LAS instrument does not centrifuge or uncap sample tubes. It cannot accept capped tubes. If the instrument detects insufficient volume of clean material for the LAS probe to perform a required clean cycle during testing, it performs an emergency stop to prevent contamination. C onnection The connection settings are read-only, configured at initial set up, and should not be altered. 388 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup LAS Configuration LAS Parameters Most of the fields on this tab are for test developers only. # Slots for dilution preparation Number of slots reserved for calibrations and sample pre-dilutions. You can select values from 2-8. The default value is 2 which ensures maximum throughput. Increasing the number of preparation cuvettes in this field lowers the number of slots available for cuvette strips on-board, and lowers system throughput. See LAS Cuvette Holding Area. NOTE: l l l The system status must be Ready to adjust this setting. When the LAS arm is disabled, the TOP instrument ignores the value in this field and operates by front loading with 8 slots for predilutions. When the LAS arm is re-enabled (in this screen or in Diagnostics), this field is enabled and the instrument sets the number of predilutions to the value in this field. Adjustments for Calibration You may need to adjust this setting during calibration. If the current setting is insufficient to run calibration, an error message states: Number of preparation cuvette slots is insufficient to execute a calibration or parallelism job. When performing multiple calibrations, IL recommends setting this value to 8 for maximum efficiency. When performing a single calibration, you may run normal samples, but throughput is reduced. For this reason, IL recommends running calibrations independently of sample processing. When calibrating a single test, the required setting is 3-8 slots. When calibration is complete reset this value to 2 for maximum throughput. If the value is not reset to 2, throughput is reduced, and a back up of primary sample tubes may occur in the LAS track sample queue. 389 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup LAS Configuration Sample aspiration time Maximum time a sample tube sits in the LAS Sample queue on the LAS track before the system removes it from the aspiration position. The default value is 15 minutes. The cause for delay may include the following: l The LAS system performs a controlled stop. l Maintenance is performed. l The instrument is processing a large number of samples. NOTE: l l You can adjust the sample aspiration time to avoid sample tubes getting stuck for a long time. The aspiration time starts when the instrument accepts a tube from the LAS track. When the aspiration time expires, the tube is released without aspiration. The acceptable range for this value is 5-99 minutes or 1-99 hours. If it becomes necessary to adjust this setting, take optimization measures to meet your turnaround requirements. Consider load balancing adjustments using existing TOP 700 LAS units connected to the LAS track, or connect additional TOP 700 LAS units. A liquoting area expiration time Amount of time after which the LAS instrument discards the aliquotted sample. The default time is five minutes. The System Administrator may change this setting in minimum increments of one minute. Sample expiration time This value cannot be modified. Time used to determine when a sample that has been aliquotted from the LAS track to a cuvette in the holding area moves to waste. The LAS sample expiration time starts when the LAS sample is fully aliquotted into the first cuvette cell in the aliquotting area. If the time expires while a test is in the active state, the test executes and is flagged. Tests (including reflex and reruns) become not feasible when the LAS Sample expiration time has elapsed. If a test has not entered the active state when the Sample expiration time elapses, the test does not execute, and the sample must be reinserted into the instrument. 390 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup LAS Configuration LAS Interface Module Configuration tab Enable Interface Module This option is set by the system installer and cannot be modified. The TCP/IP configuration settings apply to the interface module computer. LAS Tube Types tab This tab is a read only reference for the system installer. See Also l LAS Overview l LAS Cuvette Holding Area l ACL TOP 700 LAS Specifications 391 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup System Security System Security The ACL TOP instrument user interface has four security levels. These are listed below from highest to lowest access level for: 1) IL locked tests and materials; and 2) non-IL tests and materials: l Administrator l Supervisor l Senior operator l Operator Setting up your system security is a three-step process. You need to: 1. Decide the tasks that you want each security level to be able to perform. 2. Configure the Software Access screen accordingly. 3. Define the users. NOTE: l Instrumentation Laboratory recommends that certain critical operations (for example, ISI value, calibrator values, etc.) be reserved for lab supervisor or lab administrator roles. l Only the lab administrator should have access to Diagnostics. l You cannot modify or delete IL pre-defined users/levels. See Also l Software Access screen l Adding and Editing Users l User Security List User Security List The User Security List screen lists the users configured on the system. Accessing the User Security List To access the User Security List: 1. Select Setup > Security > User Security List in the menu bar to open the User Security List. 2. See Adding and Editing Users. 392 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup User Security List User Security List screen Depending on your security level, you can add a new user, delete a user, or edit an existing user by clicking the appropriate icons in the toolbar. Selection C olumn Click one or more cells in this column to place check marks, selecting rows to perform actions on. Click the Select icon in the column heading to select or deselect all the rows in the table. Locked Status C olumn A check mark indicates the user ID is locked, and cannot log into the ACL TOP application. A user ID becomes locked when any of the following occurs: l The account expires. l After three unsuccessful login attempts. l A system administrator selects the User Locked option for a user in the User Security screen. Only a system administrator can unlock an account. See Also l Adding and Editing Users l Software Access Screen l System Security 393 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Adding and Editing Users Adding and Editing Users Only users with Supervisor or Administrator access rights can add, delete or modify users (user names). You can define up to a maximum of 100 users. The Supervisor and Administrator level can delete all users except the last Administrator. The current user cannot delete his/her own entry in the User Security List, and cannot delete users with a higher level of access than his/her own. Adding a New User To add a new user: 1. Select Setup > Security > User Security List in the menu bar to open the User Security List. 2. Select the Add icon in the toolbar. 3. In the User security screen, enter a unique user name in the Log on name field. 4. Enter the new user’s first name and last name in the appropriate fields. 5. Select a user security level in the Security level drop down list. 6. <Optional> Enter a comment in the Comments field. 7. Enter the login password in the Password field. 8. Reenter the password in the Confirm Password field. 9. <Optional> Select the Allow expiration option and configure the Valid period and Warning period as necessary. 10. <Optional> Select the User Locked option lock a user out of the system. 11. Select the Save icon in the toolbar to save your changes. 12. Select the Previous Screen icon in the toolbar to return to the User Security List. 13. The new user appears in the User Security List. 394 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Adding and Editing Users Unlocking a User To unlock a user: 1. <Optional> Select Setup > Security > Software Access Screen and check that you have proper security level to perform the required actions. 2. Select Setup > Security > User Security List in the menu bar to open the User Security List. 3. Select1 the user in the User Security List. 4. Select the User Definition icon in the toolbar. 5. In the User security screen, remove the check mark in the User Locked setting. 6. Select the Save icon in the toolbar to save your changes. Editing a User To edit a user: 1. <Optional> Select Setup > Security > Software Access Screen and check that you have proper security level to perform the required actions. 2. Select Setup > Security > User Security List in the menu bar to open the User Security List. 3. Select2 the user in the User Security List. 4. Select the User Definition icon in the toolbar. 5. In the User security screen, make the necessary edits. 6. Select the Save icon in the toolbar to save your changes. 1Click in the Selection column of a table. A red check mark indicates selection. You can typically select more than one object. 2Click in the Selection column of a table. A red check mark indicates selection. You can typically select more than one object. 395 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Adding and Editing Users Deleting a User To delete a user: 1. <Optional> Select Setup > Security > Software Access Screen and check that you have proper security level to perform the required actions. 2. Select Setup > Security > User Security List in the menu bar to open the User Security List. 3. Select1 one or more users in the User Security List. 4. Select the Delete icon in the toolbar. 5. Confirm the deletion. 1Click in the Selection column of a table. A red check mark indicates selection. You can typically select more than one object. 396 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Adding and Editing Users User Security Screen User Log on name Unique user name. Used to log onto the ACL TOP instrument. Must be 1-20 case-sensitive characters. First name User’s first name (maximum 20 characters). Last name User’s last name (maximum 20 characters). Security level List of user security levels. Options are Administrator, Supervisor, Senior operator, and Operator. C omment Enter a comment with a maximum 80 characters. 397 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Adding and Editing Users Password Password an d C onfirm password User's login password (maximum 14 case-sensitive characters). A llow expiration Option to allow the password to expire after a configured number of days. If this option is not selected, the password never expires. If selected, the following fields are enabled: l l Valid period – The period a password remains valid, after which the password becomes invalid. Options are 1-365 days. Warning period – The period of time before password expiration when a system generated warning is issued to the user. Options are 1-30 days. Last modification Date and time the user configuration was last changed. U ser Locked Option to lock a user out of the system. A check mark indicates the user is locked out of the system. A user becomes locked when any of the following occurs: l The account expires. l After three unsuccessful login attempts. l A system administrator selects this option. See Unlocking a user. See Also l User Security List l Software Access Screen l System Security 398 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Software Access Screen Software Access Screen The Software Access screen contains a table of operations that can be performed on the ACL TOP instrument, and the user access level required to perform them. Any user can view the Software Access screen. Accessing the Software Access Screen To open the Software Access screen: 1. Select Setup > Security > Software Access Screen in the menu bar. 2. Click the expand/collapse icon in the left column to show and hide additional rows for a screen. 3. To update user access levels, click an entry in the Access Level column and select a new access level in the drop down list. 4. Select the Save icon in the toolbar to save your changes. NOTE: You can edit the Software Access screen only if you are logged on with the appropriate access rights. The lab administrator is always allowed to edit this screen. See Also l User Security List l Adding and Editing Users 399 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Formatting Reports Formatting Reports Configuring Reports To configure reports: 1. Select Setup > Reports in the menu bar. 2. Configure settings in the Report Configuration dialog box in the following tabs. Click a link for details: l Laboratory Header l Demographic l Footer l AutoPrint Setup 3. To edit a table cell on the Laboratory Header and Footer tabs, double-click the cell and begin typing. 4. Select OK. NOTE: Patient results and calibration results must be validated before printing. See Reviewing Test Results and Calibration Details. 400 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Formatting Reports Laboratory Header Tab This section is used to identify the laboratory that performed the analysis. Alignment Select one of the following options: l Left – Left justifies the entire header at the top of the report. l Middle – Centers the entire header at the top of the report. l Right – Right justifies the entire header at the top of the report. Column Headings Field N ame User-defined text field. The value entered identifies the data type to display in the report header. For example: Laboratory. Maximum 15 characters. The actual text in this column does not appear in the report header. Field Value Enter the text to display in the report header. This text corresponds to the Field Name cell to the left. For example: Hemostasis Lab NOTE: l l Defining a report header is optional. If you define a field name, the Field Value cell to the right of it must have an entry. For example, to display the name of your laboratory, double-click the first empty cell in the Field Name column and type Laboratory. Then double-click the Field Value cell to its right and type in your laboratory name. The text in the Field Value column appears in the header of each report. 401 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Formatting Reports l l l If you leave a Field Name/Field Value pair empty, a blank line appears at that location in the header. The maximum number of lines in a report header is 20, including blank lines. Unused Field Name/Field Value pairs beneath the last pair that you define are ignored. They do not produce blank lines. Click a column heading to sort up or down. Demographic Tab Check or uncheck the data to appear on the Patient Report and Sample Results Report. Footer Tab This data appears on the report footer. Configuring this tab is similar to configuring the Laboratory Header tab. 402 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Formatting Reports AutoPrint Setup Tab You can autoprint patient samples by sample, test or rack. Printing starts when one of the following occurs: l As soon as the configured number of samples or tests completes. l When the rack, if selected, is completed. l When the configured number of minutes has elapsed. Printing does not occur while the AM1 is Busy or in a Controlled Stop. If you select autoprint By sample, all unprinted tests for a specific sample are printed. If all tests for a given sample have already printed, auto print is not initiated for that sample. If you select autoprint By test, completed tests that have not yet printed will autoprint. If you select auto print By rack, all programmed tests of the selected test types are printed when the sample track status for that rack changes from In use to Present or Empty. NOTE: If autoprint is enabled for patient samples, a page is used for each individual sample or test (depending on the mode enabled). See Also l Reviewing Test Results l Reviewing QC Results l Sample List Area 1The part of the instrument where sample processing and testing are performed. Also called the Analyzer or the Analytical Module. 403 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Display Overview Display Overview You can configure the display settings for the Sample List, the Test Programming window, and the Material Programming window: To configure display settings: 1. Select Setup > Display in the menu bar. 2. In the Display submenu, select one options: l Sample List Display Settings l Test Programming Window l Material Programming Window See Also l Sample List Area l Test Programming Window l Material Programming Window 404 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Sample List Display Settings Sample List Display Settings See Configuring Sample List Display Settings in Sample List. 405 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Test Programming Window Test Programming Window Use the Test Programming window to do the following: l l Make various tests and profiles accessible for programming in the Sample Details screen. Add and remove test orders to and from a sample rack position on the Rack Details screen in the sample area. Configuring the Test/Profiles Programming Window To configure the Test/Profiles Programming Window: 1. Select Setup > Display > Test Programming Window in the menu bar. The Program Tests and Profiles Placement Window first opens with blank programmable buttons. 2. To create a new tab, select the Add Tab button. In the Program tab name dialog box, enter a unique tab name with a maximum 16 characters, and select OK. The new tab is added to the right of the currently selected tab. Each tab contains twelve test or profile buttons. You can create up to 30 tabs. 3. To sort tabs, drag and drop tabs one at a time. 4. To remove a tab, select the tab and click the Remove Tab button. Confirm the deletion. 5. To program a button, drag a test or profile from the Available tests or Available profiles list to a blank button on the tab. The test or profile name appears on the button, and the material is removed from the respective list (for that tab only). 6. To remove a test or profile, drag the test or profile name from the button to the respective list. The test or profile name is removed from the button and added to the respective list. 7. Select OK to save the configuration. NOTE: Test and profile names can be added to only one button per tab, but can be added to multiple tabs. See Also l Sample Rack Details l Sample List Area l Sample Details 406 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Material Programming Window Material Programming Window Use the Material Programming Window to do the following: l l Add or remove materials used for testing samples, QC, calibration, etc. Add or remove materials to or from a reagent or diluent rack position on the Rack Details screen in the Reagent and Diluent Areas. Configuring the Material Programming Window To configure program materials: 1. Select Setup > Display > Material Programming Window in the menu bar. The Program Materials Placement Window first opens with blank programmable buttons. 2. If the programming controls do not appear in the Program Materials Placement Window, select the Show Programming Controls Controls button to display them. Select the Hide Programming button to toggle these controls out of view. 3. To create a new tab, select the Add Tab button. In the Program tab name dialog box, enter a unique tab name with a maximum 16 characters, and select OK. The new tab is added to the right of the currently selected tab. Each tab contains twelve material buttons. You can create up to 30 tabs. 4. To sort tabs, drag and drop tabs one at a time. 5. To remove a tab, select the tab and click the Remove Tab button. Confirm the deletion. 6. To program a button, drag a material from the Available materials list to a blank button on the tab. The material name appears on the button, and the material is removed from the Available materials list (for that tab only). 7. To remove a material, drag the material name from the button to the Available materials list. The material name is removed from the button and added to the Available materials list. 8. Select OK to save the configuration. NOTE: Material names can be added to only one button per tab, but can be added to multiple tabs. 407 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 4 – Setup Setup Language See Also l Reagent Area l Material List Setup Language To select the language to use on the ACL TOP instrument: 1. Select Setup > Language to open the list of available languages. 2. Select a language to use on the instrument. NOTE: You must install the language files for this option to be available. Contact Service. 408 of 992 L0027503450 R00 ACL TOP Family Operator's Manual CHAPTER 5 PREPARING THE SYSTEM Additional Preparation The system can stay on 24 hours a day. Automatic maintenance procedures such as fluidic priming cycles and routine cleaning of the probes ensure the system is ready for analysis at any time. If the system stays on, there is no need to perform any startup procedure before operating the system. If the system is turned off, follow the Starting the Instrument instructions to start the system. In addition, the following may require some preparation: l Material Identification l Bar Code Reader l 2D Bar Code Scanner l Reaction Cuvettes l Rinse Fluid l Clean Fluid l Fluid Waste l Reagents l Calibrators and NPP l Quality Controls l Sample Containers and Adapters l Diluents l Restriction Map l Sample Area l Reagent Area l Diluent Area l Test Feasibility See Also l Managing Materials 409 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 5 – Preparing the System Material Identification Material Identification To ensure automatic material identification, make sure the bottle bar code labels are properly aligned in the rack before placing them on the instrument. See Bar Code Label Placement. An active material is defined as one that is placed and required to complete an ACTIVE test. Manually Identifying Offline Rack Material To manually identify offline rack material: 1. Select the menu option Analysis > <material area> (Diluent or Reagent Area). 2. Double-click a position on the offline rack (located on the left hand side of the screen) to display the Rack Details screen. 3. Select the position where the material is located. 4. Select the Add/Remove Material Material name field. icon in the toolbar, or select the ellipsis next to the 5. Select the material from the Materials window. 6. Select the Insert Rack icon from the toolbar. 7. Insert the rack. NOTE: l l l l If you manually identify a material placed on the offline rack (sample, diluent, or reagent) and a tube or bottle with a bar code label is on the same rack, the system attempts to match the information manually entered with the bar code label. If it does not match, the system displays an error message. If you manually identify the presence of a material (tube, bottle, or sample cup) placed on the offline rack (sample, diluent or reagent rack) and upon insertion, the bar code reader does not detect the presence of that material, an error message displays for that position. If you fail to manually identify the presence of a material (tube, bottle or sample cup) placed on the offline rack (sample, diluent, or reagent rack) and upon insertion, the bar code reader detects the presence of a material, an error message displays for each detected position the system was not expecting. When loading sample, diluent, or reagent racks, pull the rack out all the way before loading. Pulling a rack out partially while loading or changing bottles, tubes, or sample cups may result in misidentification of rack contents. 410 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 5 – Preparing the System Material Identification Manually Identifying Inserted Rack Material To manually identify inserted rack material: 1. Insert the rack with the material to identify manually (non-bar coded material). The system generates an alarm. 2. In the Diluent or Reagent Area screen, double-click the rack containing the unidentified material (displayed with a question mark) to access the Rack Details screen. 3. Select the position to identify. 4. Select the Add/Remove Material icon in the toolbar. 5. Select the material from the Materials window. NOTE: l l When the material is in use, manual identification is disabled until the rack is removed. When loading sample, diluent, or reagent racks, pull the rack out all the way before loading. Pulling a rack out partially while loading or changing bottles, tubes, or sample cups may result in misidentification of rack contents. There are two ways to identify a material on board the ACL TOP instrument: l Automatic Material Identification l Manual Material Identification 411 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 5 – Preparing the System Material Identification Automatic Material Identification – Using the Bar Code Reader The ACL TOP instrument performs automatic material identification using a 1D bar code reader. 1D B ar C ode R eader The 1D bar code reader is built into the ACL TOP instrument and is configured in Setup/Bar code Definitions Setup. 1D B ar C odes A material rack containing 1D bar coded material is inserted into the instrument. The the built-in bar code reader reads the bar coded label looking for a match in the Materials database. If found, the information (material name, type, lot number, expiration date, stability, etc) is displayed. Inserting a rack or scanning material disables manual identification for bar coded materials. If the bar code label is not readable, does not match the material definition information, or is otherwise unusable, manual identification may be used to identify the material. Update of Material Information 2D B ar C ode R eader (Sold as an option for some models.) The 2D bar code reader is external to the ACL TOP instrument and is hand held. See 2D Bar Code Scanner. Bi-dimensional (2D) bar codes have been added to the boxes of those products with value assignment (PT reagents, calibrators and controls) to provide a means of importing lot specific information and assigned values into the system. In a single operation, the bi-dimensional bar code scanner provides a way for you to scan the 2D bar codes to update lot information and related values such as ISI values for reagents, and assigned values for calibrators and QC controls. 2D B ar C odes An external hand held 2D bar code reader is used to scan 2D bar coded materials looking for a match in its Materials database. If a match is found, the information for lot number, ISI values for reagents, and assigned values for calibrators and QCs is updated. If the matching information is not found, you must manually define it before it can be used. See Material Definition. 412 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 5 – Preparing the System Material Identification Manual Material Identification – Using the Offline Rack Use the offline (virtual) rack to program a rack that has not been inserted into the instrument. The programmed information is preserved while the rack is not placed. (Do not exit the application.) The information moves with the rack as it is inserted into the instrument. The information is removed from the offline rack when either of the following occurs: l The information read by the bar code reader matches what you have manually identified on the rack l If the bar code reader is disabled. If the bar code reader is enabled but the scanned information does not match your offline rack information, the offline rack information is not used. See Also l Bar Code Definitions Setup l Bar Code Label Placement l Reagents l Reagent/Diluent Area l Sample Area 413 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 5 – Preparing the System Bar Code Reader Bar Code Reader The bar code reader moves to each track position to allow for insertion of sample, diluent or reagent racks. Bar coded information on sample tubes or diluent or reagent bottles is scanned into the instrument as the racks are inserted. Move the bar code reader to the desired track using the track buttons on the front of the AM or by clicking the virtual track buttons displayed on the Reagent area screen on the CM. With the bar code reader positioned in front of the track position, insert the rack. A track guides the insertion of the rack into its correct position. After the bar code reader has been at a track position for 30 seconds, or if the Run bar code reader moves back to its home position. icon is selected, the You can select the Home button displayed on the touch screen when the sample or reagent screen is displayed to move the bar code reader (BCR) to its home position without having to wait for the BCR timeout. If the bar code reader is disabled, it will still scan the rack to detect vial presence. The material status becomes Unknown. CAUTION: l l l Care should be taken when the bar code reader is moving so that your fingers do not get pinched. When you use the Home button, the Bar Code Reader warning light (located on the BCR cover) blinks three times to warn you to clear the path. A rack incompletely placed in a track causes the homing function to fail, and displays the BCR movement failure error. When loading sample, diluent, or reagent racks, pull the rack out all the way before loading. Pulling a rack out partially while loading or changing bottles, tubes, or sample cups may result in misidentification of rack contents. 414 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 5 – Preparing the System Bar Code Reader TOP 300 CTS Bar Code Reader TOP 500 CTS Bar Code Reader 415 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 5 – Preparing the System Bar Code Reader TOP 700 Bar Code Reader Includes the TOP 700 (includes ACL TOP Base), 700 CTS (includes ACL TOP CTS) and 700 LAS instruments. See Also l Bar Code Definitions Setup l Bar Code Label Placement l Instrument Description 416 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 5 – Preparing the System 2D Bar Code Scanner 2D Bar Code Scanner (Sold as an option on some ACL TOP models.) Overview Bi-dimensional (2D) bar codes 2D bar code labels appear on boxes of products with value assignment (PT reagents, calibrators and controls). This allows you to scan, import and update the following types of material information on the system: l Material lot information l Assigned values for calibrators and QC controls l Related values (such as ISI values for PT reagents) Setup Refer to the Plug and Play Program Guide that accompanies the 2D bar code scanner for setup information. 417 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 5 – Preparing the System 2D Bar Code Scanner Using the 2D Bar Code Scanner To use the 2D bar code scanner: 1. Select Setup > Material List on the menu bar. 2. In the Material List, select the Scan icon in the toolbar. 3. Pull the trigger on the scanner to activate it. If communication with the device is successful, you are prompted to scan the bar code. If communication is unsuccessful the Material List screen displays. 4. Scan the bar code label. 5. The bar coded information displays in the Verified barcode material data dialog box. 6. The system considers the newly scanned material as the alternate lot. Select the Toggle Lot button to use the alternate lot (newly scanned material) on the system instead of the current active lot. NOTE: Activating the alternative lot may necessitate calibration and validation. Refer to your own laboratory procedures to determine the appropriate action. 7. To rescan the material, select the Retry button to clear the imported data, and scan the bar code label again. 8. Select the Save button to update the Material List with the new scanned values for each material. 9. The new values do not replace the active lots when the scanned values are saved. 418 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 5 – Preparing the System 2D Bar Code Scanner Verified Barcode Material Data dialog box A status message appears below the table. Generally, all scanned information is displayed for each material. A blank field indicates unknown, unmatched or not applicable information. Material Information N ame Name of the scanned material. Index Material identifier. Values are as follows: l 1-500 – Material manufactured by Instrumentation Laboratory. l 501-999 – User-defined material. Unique for each material. 419 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 5 – Preparing the System 2D Bar Code Scanner Type A material can be one of the following types: l Intermediate reagent l Start reagent l Sample Diluent l Quality Control l Calibrator/NPP l Clean l Deficient Plasma Import data The scanned data area displays in the following two columns for comparison: l l New scanned data – Values of the newly scanned material. The system considers this the alternate lot. (See Toggle Lot button.) Current Data (Active Lot) – Values of the same material that currently exists on the system. The scanned values for each material are compared with the active lot information for the corresponding material definition in the system. Lot ID An alphanumeric code that identifies where and when the material was manufactured. Expiration date The date when the material no longer meets the manufacturer’s specifications. ISI value yes/no Defines whether an ISI1 value is defined for the material. ISI value ISI value for the material. B ottle type Type of bottle that contains the material. 1International Sensitivity Index. This value is provided by each Prothrombin Time (PT) reagent and used to calculate the International Normalized Ratio (INR). 420 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 5 – Preparing the System 2D Bar Code Scanner Column Descriptions Errors A check mark in this column indicates that additional information is available. Click a check mark to access this information. An error does not necessarily mean a problem exists. In the example above, the error indicates that the source of the assigned value available for import has units that are not defined for that test on this instrument. This is a notification rather than a problem. Buttons Toggle Lot Changes from active lot to alternate lot. R etry After a valid bar code is scanned and the results displayed, you can ignore them and scan again. Select the Retry button to clear the screen data and re-enable the scan operation. Save A status message displays for each material shown. If all the scanned material definitions are available for import, the Save button is enabled. Select the Save button to update the Material List with the new scanned values for each material. The new values do not replace the active lots when the scanned values are saved. You must still do calibrations, validations, etc. C ancel Cancels the scan operation. You may cancel at any point during the scan procedure. See Also l Material Identification l Bar Code Definitions Setup l Bar Code Label Placement l Bar Code Reader 421 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 5 – Preparing the System Reaction Cuvettes Reaction Cuvettes Cuvettes are packaged in boxes that contain 400 cuvettes. Each box contains 10 clips, each clip consisting of 10 strips of 4 cuvette cells. The instructions for opening the box and loading the cuvettes are printed on the top of the box. The cuvette loader can hold up to 20 clips – a total of 800 cuvettes. Cuvettes may be loaded at any time, regardless of the state of the ACL TOP instrument. Cuvette Warning The ACL TOP instrument generates a warning when the number of cuvettes falls below 3 clips (120 cells). When the warning is generated, the cuvette loader LED in the auxiliary material status area of the Reagent or Diluent Area screen becomes amber. In addition, the status light on the front of the AM1 turns amber, and a yellow exclamation point appears on the Material Alarms button on the CM2. . Cuvette Error When there are no cuvette strips in the cuvette loader, an error is generated. The Analytical Module stops processing new samples and performs a controlled stop. The cuvette loader LED changes to red, and the AM status light changes to red. A red exclamation point appears on the Material Alarms button on the Control Module, and a message informs you that there are no more cuvettes available. If you add more cuvette strips to the cuvette loader before the instrument performs a controlled stop, the instrument continues performing whatever tests remain. CAUTION Biohazard: Cuvette waste is biohazardous. Use precautions when emptying the cuvette waste drawer. Refer to local and state regulations for disposal of potentially hazardous materials. NOTE: Cuvettes are intended for single use only. IL does not support the use of previously used cuvettes on ACL TOP instruments. See Limitations and Disclaimers. See Also l Additional Preparation 1The part of the instrument where sample processing and testing are performed. Also called the Analyzer or the Analytical Module. 2A Microsoft Windows™ PC running the ACL TOP software developed by IL. The CM provides the User Interface and data management functionality. The CM connects to the Analytical Module and provides the high level controls. 422 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 5 – Preparing the System Rinse Fluid Rinse Fluid Rinse fluid is used to rinse the probes during analysis. Overview Rinse fluid is packaged in a 4-liter bottle that is placed on the right side of the analyzer. A tube connecting the bottle to the system allows the rinse to be drawn into the analyzer. The ACL TOP instrument has a sensor that automatically detects the presence and volume of rinse fluid. All models except the ACL TOP 300 generate a warning when the volume is below 1000 mL, and an error when the volume is less than 600 mL. The warning sensor is not included on the ACL TOP 300. Material Alarm Warning When the warning is generated, the Rinse fluid LED on the Auxiliary Material Status area of the Reagent Area and Diluent Area screens turns amber, and a yellow exclamation point appears on the Material Alarm Warning button on the CM1. The Rinse status light on the front of the analyzer turns amber. Error Alarm Warning When an error is generated, the analyzer stops processing new samples and performs a controlled stop. The Rinse fluid LED changes to red, and a red exclamation point appears on the Material Alarm Error button on the CM. In addition, the Rinse status light on the front of the AM2 turns red. When the level of the rinse fluid drops below 100 mL, the instrument performs an emergency stop. 1A Microsoft Windows™ PC running the ACL TOP software developed by IL. The CM provides the User Interface and data management functionality. The CM connects to the Analytical Module and provides the high level controls. 2The part of the instrument where sample processing and testing are performed. Also called the Analyzer or the Analytical Module. 423 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 5 – Preparing the System Rinse Fluid Changing the Rinse Fluid To change the rinse fluid: 1. Remove and discard the cap and foil from the new bottle. 2. Remove the cap with the tubing from the old bottle and discard the bottle. 3. Screw the old cap onto the new bottle. 4. Place the new bottle into its receptacle. 5. Check the tubing for large air bubbles, blockages, or kinks and remove if necessary. The instrument detects when a new bottle of rinse is placed and performs an automatic priming cycle to remove air bubbles from the rinse lines. NOTE: In step 3, the old cap has a siphon and tubing attached. Steps 3 and 4 can be reversed, but doing them in order minimizes the amount of time the siphon is in the air, and minimizes the risk of air entering the tubing. If the cap assembly is damaged, remove the assembly. Unclip the tubing from the side of the AM, remove the cap from the bottle and discard it. Replace it with a new assembly. CAUTION: l l l l l When replacing the rinse fluid, move computer, monitor and keyboard out of the way to prevent rinse from spilling on them. The rinse bottle must be replaced when the instrument is not busy or in a controlled stop. Removing the rinse bottle while the instrument is running causes an emergency stop. The 4 liter rinse bottle is not designed to refill during instrument operation. IL recommends periodic changing of the rinse bottles to prevent accumulation of particulates and other contaminants. Do not top off. Refilling (topping off) the 4 liter rinse bottle during operation may cause air bubbles in the tubing. This can happen when the bottle is close to empty, or if the end of the tubing is raised above the liquid level. Bubbles in the rinse fluid can enter the rinse tubing and cause improper rinsing of the probes. Take extra care to prevent bubbles when manipulating the contents of the rinse bottle. Allow the rinse sensor to turn to red before replacing the bottle. This ensures the system performs an autoprime when the new bottle of rinse is detected and the sensor turns off. See Also l Parts and Consumables List l LED Status Color Codes 424 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 5 – Preparing the System Clean Fluid Clean Fluid Clean fluid is used to clean the probes during analysis. This occurs when specified in a test parameter, or through a maintenance activity. Overview The clean fluid is packaged in a 500 mL bottle that is placed on the right side of the analyzer. A tube connecting the bottle to the system allows the cleaning solution to be drawn into the analyzer. The ACL TOP instrument has a sensor that automatically detects the presence and volume of the clean fluid. The warning sensor is not included on the ACL TOP 300. It generates a warning when the volume is below 75 mL and an error when the volume is less than 25 mL. When the warning is generated, the Clean fluid LED on the Auxiliary Material Status area on the Reagent Area and Diluent Area screens turns amber and a yellow exclamation point appears on the Material Alarm Warning button on the CM1. In addition, the Clean status light on the front of the AM turns amber. When the error is generated, the analyzer stops processing new samples and performs a controlled stop. The Clean fluid LED changes to red, a red exclamation point appears on the Material Alarm Error button and a message informs you that there is no more clean fluid available. In addition, the Clean status light on the front of the AM turns red. If no clean fluid is detected in the clean well the instrument performs an emergency stop. CAUTION: l l Clean fluid contains hydrochloric acid and must be handled carefully. DO NOT ALLOW CLEAN FLUID TO COME IN CONTACT WITH SKIN OR EYES. When handling or changing clean solution bottles, wear protective eyewear, protective gloves and protective garments. When replacing the clean fluid, move the computer, monitor and keyboard to prevent clean fluid from spilling on them. NOTE: l l l The clean bottle must be replaced when the instrument is not in the BUSY or CONTROLLED STOP state. If the system detects a lack of clean fluid in the clean well (for example, caused by an air bubble in the tubing reaching the clean well) an alarm is generated and the instrument performs an emergency stop. A Rinse/Clean Priming Cycle for each probe can be performed in Maintenance to remove air bubbles from the clean line. 1A Microsoft Windows™ PC running the ACL TOP software developed by IL. The CM provides the User Interface and data management functionality. The CM connects to the Analytical Module and provides the high level controls. 425 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 5 – Preparing the System Clean Fluid Changing the Clean Fluid To change the clean fluid: 1. Remove the cap from the new bottle and discard it. 2. Remove the cap from the old bottle. 3. Screw the old cap onto the new bottle. 4. Place the new bottle into its receptacle. 5. Check the tubing for large air bubbles, blockages, or kinks and remove if necessary. NOTE: l l In step 3, the old cap has a siphon and tubing attached. Steps 3 and 4 can be reversed, but doing them in order minimizes the amount of time the siphon is in the air, and minimizes the risk of air entering the tubing. If the cap assembly is damaged, remove the assembly. Unclip the tubing from the side of the AM, remove the cap from the bottle and discard it. Replace it with a new assembly. The instrument detects when a new bottle of clean fluid is placed, and performs a priming cycle to remove air bubbles from the clean lines. See Also l Parts and Consumables List l Performing Maintenance Activities l LED Status Color Codes 426 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 5 – Preparing the System Fluid Waste Fluid Waste System fluid waste consists of the clean and rinse fluids used by the instrument during analysis and maintenance operations. Overview Waste Pump System fluid waste is discharged at the waste position located in the rinse/clean station for each probe. Internal waste reservoirs located under the rinse/clean stations hold the waste fluid until enough fluid builds up to trip the waste accumulator sensor which in turn starts the waste pump. NOTE: l l l The TOP 300 CTS uses gravity to empty waste fluid from the reservoirs. The TOP 300 CTS liquid waste line cannot rest in a horizontal position across the table or bench that holds the instrument. It must maintain a negative slope across the entire length of the tubing to minimize the backup of waste fluids. There must be no crimping in the tubing. For all instruments except the TOP 300, a sensor indicates when fluids fail to empty. If fluids back up, the system performs an emergency stop. Waste Container – Excludes the TOP 300 CTS The waste pump empties the internal waste reservoirs through tubing into a waste container that is located below the AM1. This container has its own sensor that detects when the container is nearly full. This causes a warning message to display in Material Alarms, and the Fluid Waste LED on the front of the analyzer 1The part of the instrument where sample processing and testing are performed. Also called the Analyzer or the Analytical Module. 427 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 5 – Preparing the System Fluid Waste changes to amber. If the nearly full waste container is not replaced with an empty one, the system generates an error message after a predefined interval. The TOP 300 CTS does not have a waste sensor. You must visually inspect the level of the liquid waste container on a regular basis and empty it as necessary. Material Alarm Warning When an error is generated, the AM stops processing new samples and performs a controlled stop. The Fluid Waste LED changes to red, a red exclamation point appears on the Material Alarms button, and a message states that the waste container is full. At the conclusion of the controlled stop, an error displays on the CM1 instrument status. Material Alarm Error If the waste container continues to fill, an emergency stop is performed and an error message is generated in the Materials Alarm window that states: Unable to empty the internal waste reservoir. 1A Microsoft Windows™ PC running the ACL TOP software developed by IL. The CM provides the User Interface and data management functionality. The CM connects to the Analytical Module and provides the high level controls. 428 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 5 – Preparing the System Fluid Waste Changing the Fluid Waste Container NOTE: The fluid waste container is not disposable. It is reusable. Changing the waste container is not a common occurrence. For the common maintenance activity, see Empty Waste Fluid. To change the fluid waste container: 1. Remove the cap from the new container and discard it. 2. Remove the cap from the old container. 3. Screw the old cap onto the new container. 4. Place the new container into its receptacle. 5. Check the tubing for large air bubbles, blockages, or kinks and remove if necessary. NOTE: l In Step 2 the old cap has tubing attached to it. Steps 3 and 4 can be reversed, but doing them in order minimizes the amount of time the tubing is in the air and the risk of fluid waste dripping outside the waste container. If the cap assembly is damaged, remove the assembly. Unclip the tubing from the side of the AM, remove the cap from the container, and discard it. Replace it with a new assembly. l If bleach is used, rinse the waste bottle with distilled water. l Do not fill the bottle with bleach after you empty it. l Make sure the lollipop sensor is secure against the side of the waste bottle. (The ACL TOP 300 does not contain the lollipop sensor.) CAUTION Biohazard: System fluid waste is biohazardous. Use precautions when changing or emptying the fluid waste container. Always follow local regulations when disposing of liquid waste. See Also l Performing Maintenance Activities l Controlled Stop l Emergency Stop l Parts and Consumables List l LED Status Color Codes l System Decontamination 429 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 5 – Preparing the System Reagents Reagents The term reagents includes both chemical reagents and deficient plasmas. Reagents are classified as intermediate reagents and start reagents. Depending on the instrument model, the reagent type may require a specific placement location on the instrument. The instrument prompts with the proper placement. Start Reagent A start reagent is a reagent that, when mixed with sample or a sample mixture1, activates the reaction in the optical reading unit (ORU). It is the last material added to the cuvette. Intermediate Reagent An intermediate reagent is a reagent that, when mixed with sample, activates certain ingredients of the sample but is not enough to bring the reaction to the desired completion. The reagent rack positions hold the 15 mL and 20 mL bottles. In addition, 4 mL and 10 mL bottles can be used with the proper adapters (see Material Definition). There is an adapter for each of these bottles that allows these smaller bottles to be seated correctly in the rack position while allowing the bar code label on the bottle to be read. Bottle Adapters Reagents are placed in reagent racks inserted into reagent tracks, but can also be placed in a diluent rack. Placing a reagent in the wrong position in the Reagent Area results in a warning message. See Test Feasibility for proper placement of all reagents. A warning message appears if the volume of a reagent falls below the limit defined as the warning threshold. An error message appears when the bottle is empty. When multiple bottles of the same reagent are placed onboard the instrument, after the volume in the bottle with a priority of 1 changes to 0, the probe moves to the bottle with the priority of 2, then 3, etc. No further aspirations occur on bottles with a volume of 0. See Also l Managing Materials l Test Feasibility 1A dilution that requires a two-step dilution process to achieve the required dilution ratio. 430 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 5 – Preparing the System Calibrators and NPP Calibrators and NPP Calibrator (Cal) Calibrator is a type of sample with an assigned value used to calibrate a test. Normal Pool Plasma (NPP) Normal Pool Plasma is a type of sample used as a standard of comparison. It is used in the calculation of the INR1 and in the calculation of test results that use the normalized ratio. Quality Controls Quality control (QC) materials can be placed in the ACL TOP instrument as follows: l On diluent racks accessible by the sample arm. l On sample racks in the Sample Area. See Test Feasibility for proper placement of all reagents. When you use sample cups in the sample racks, you cannot use bar codes, and therefore ACL TOP material tracking features such as volume warning, on-board stability tracking, and expiration date tracking cannot be used. See Also l QC Overview l QC List l QC Profiles List l QC Results List l QC Setup Definition l QC Test Status List l Reviewing QC Results 1International Normalized Ratio. This value is used to standardize the reporting of Prothrombin Time (PT) worldwide. 431 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 5 – Preparing the System Samples Samples A sample is an aliquot1 of patient plasma from a primary sample tube or aliquot cuvette. Sample can also refer to the material on which the test is being performed, including calibrators, controls, and NPP2 materials. Samples are placed on sample racks that are inserted into tracks in the Sample Area of the ACL TOP instrument. See Restriction Map. You may use either primary tubes or sample cups. NOTE: l l If sample cups are used, they must be IL 2.0 mL sample cups. Using non-IL sample cups may lead to improper sampling and incorrect results. See Parts and Consumables List. The amount of plasma in a sample tube must be sufficient to complete the tests and also avoid the probe syringe tip entering the red blood cell level, which would contaminate the probe and compromise patient results. Bar coded sample tubes provide the ACL TOP instrument with the required sample ID information. If the sample tubes are not bar coded, you must provide the sample ID. NOTE: You cannot change a sample ID if the test status for that sample is ACTIVE. 1A known fraction of a whole, constituting a sample. 2Normal Pool Plasma. A type of sample used as a standard of comparison when calculating the International Normalized Ratio (INR) and when calculating test results that use the normalized ratio. 432 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 5 – Preparing the System Sample Containers and Adapters Sample Containers and Adapters Sample Adapters for Open and Closed Tubes CAUTION: Fill sample tubes with enough plasma to complete the tests and to avoid entering the red blood cell level, which would contaminate the probe and compromise patient results. Open sample racks are designed to work with a variety of sample tubes and associated adapters to ensure the tubes are held firmly in place during aspiration and the maximum amount of plasma is available for use. CTS sample racks are designed to accommodate a variety of different tubes. The use of specially designed adapters is needed to ensure the tubes are held firmly in place during the piercing and aspiration routines, and to ensure the maximum amount of plasma is available for use. If the surface of the liquid is below the bottom level of the sample cup (which represents the maximum depth the sample probe can reach) the sample cannot be aspirated. The following types of adapters are available to address this risk: l l l l l l Aliquot sample tube adapter – Raises the bottom of the aliquot tube to the same height as the bottom of the sample cup. Aliquot tube adapters are black. Pediatric sample tube adapter – Similar to the aliquot sample tube adapter, but with a smaller diameter to hold these thin tubes centered in the sample position. It has been validated to work with 1.8 mL and 2.7 mL tubes. Pediatric tube adapters are blue. Microtube adapter– Use exclusively with the Sarstedt 1.3 mL Microtube. Microtube adapters are green. CTS adapter – Red adapter used with the standard CTS sample rack—one adapter per rack position. CTS rack adapter – Blue adapter that fits on top of all ten sample rack positions in the standard CTS rack—one adapter per ten rack positions. Sarstedt CTS adapter – Red adapter used with the red Sarstedt CTS rack. To avoid aspiration errors, probe errors, and probe contamination, use the correct adapter with the correct tube type. CAUTION: You must use only closed tubes on CTS sample racks. Use regular, uncapped, sample tubes and sample cups on open tube sample racks. Failure to use the proper rack (standard rack for open tubes; closed rack for closed tubes) may result in probe damage. 433 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 5 – Preparing the System Sample Containers and Adapters Sample Tube Adapter Adapter in Sample Rack CTS Rack Adapter on Standard CTS Rack 434 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 5 – Preparing the System Sample Containers and Adapters Sarstedt Closed Tube Sample (CTS) Racks 10 position Sarstedt CTS Racks 435 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 5 – Preparing the System Sample Containers and Adapters These racks increase the cap piercing reliability of the closed Sarstedt primary sample tubes on ACL TOP CTS instruments. The following two rack styles are designed to accommodate different sized Sarstedt tubes: l l One type securely holds Sarstedt tubes with cap diameters of 16.3 mm (for example, Sarstedt part number 04.1902.100, 2.9 mL fill volume). The other type accepts and securely holds Sarstedt tubes with cap diameters of 14.0 mm (for example Sarstedt part number 05.1165.100 or 05.1071.100 with 3.0 mL or 5 mL fill). CAUTION: Monovette tubes with NEW Sarstedt racks and Adapters When using the Sarstedt Monovette tubes on a ACL TOP CTS instrument, you must use the Sarstedt CTS rack. In addition, you must do one of the following: l Leave the sample track to the right of the Sarstedt rack empty; or l Insert only a Sarstedt CTS rack in the track to the right of a Sarstedt rack. This requirement prevents the protrusion on the left side of the CTS foot from contacting a Sarstedt CTS rack when the piercer probe accesses non-Sarstedt tubes in a track to the right of a Sarstedt rack. Cleaning NOTE: For cleaning racks and adapters, IL recommends that you use any of the following: l 10% bleach l 0.1 N HCl l Mild soap After decontamination with bleach you should always rinse with tap water to remove excess bleach residue on the inner walls of the container. DO NOT SOAK RACKS IN ANY SOLUTION. Soaking may corrode racks or remove labels. 436 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 5 – Preparing the System Sample Containers and Adapters Old Style Sarstedt Closed Tube Sample (CTS) Rack and Adapters 10 position Sarstedt CTS Rack These racks and adapters increase the cap piercing reliability of the closed Sarstedt primary sample tubes on ACL TOP CTS instruments. 2-sided Sarstedt Tube Adapter Sarstedt Tube Adapter This tube adapter accepts all sizes of Sarstedt coagulation tubes by changing the orientation of the adapter in the Sarstedt CTS rack. One side of the adapters have an opening that accepts larger diameter caps. Proper orientation is essential for reliable cap piercing of Sarstedt tubes. 437 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 5 – Preparing the System Sample Containers and Adapters Adapter Orientation 1 – Indicator (hole) up With the indicator side up, the adapter accepts and securely holds Sarstedt tubes with cap diameters of 16.3 mm. (for example, Sarstedt part number 04.1902.100, 2.9 mL fill volume). Adapter Orientation 2 – Indicator (hole) down With the indicator side down, the adapter accepts and securely holds Sarstedt tubes with cap diameters of 14.0 mm (for example Sarstedt part number 05.1165.100 or 05.1071.100 with 3.0 mL or 5 mL fill). CAUTION: Monovette tubes with OLD-STYLE Sarstedt racks and Adapters When using Sarstedt 5 mL Monovette tubes on a CTS instrument, always leave the sample tracks to the right of these tall tubes empty unless the rack to the right also contains Sarstedt 5 mL Monovette tubes. Do not place shorter tubes with these 5 mL tall tubes on the same rack. With the exception of the 5 mL tubes, all other tubes can be mixed and matched in the same rack, and do not require empty rack positions on the right side. This requirement ensures the foot does not hit the tall Sarstedt tube while it is trying to reach the shorter (i.e., 1.8 mL Pedi) tube. Cleaning NOTE: For cleaning racks and adapters, IL recommends that you use any of the following: l 10% bleach l 0.1 N HCl l Mild soap After decontamination with bleach you should always rinse with tap water to remove excess bleach residue on the inner walls of the container. DO NOT SOAK RACKS IN ANY SOLUTION. Soaking may corrode racks or remove labels. 438 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 5 – Preparing the System Sample Containers and Adapters Validated Uncapped Sample Containers The containers in the following table are valid for all ACL TOP models with uncapped tubes loaded in open tube sample racks. For a list of validated uncapped primary sample tubes that can be directly sampled from an LAS track, see Validated Uncapped Sample Containers – LAS Track. CAUTION: Use extra caution when using glass tubes which are prone to breakage. Validated Uncapped Sample Containers Sample Container Type Source/Available Adapter Needed Part No. 2.0 mL Cup IL P/N 55751-00 N/A 1.8 mL Pediatric Vacutainer® Becton Dickinson 366392 Pedi (IL P/N 285246-00) (IL P/N 285335-00) set of 10 1.8 mL Plastic Vacutainer® Becton Dickinson 363080 N/A 1.8 mL Vacutainer® Becton Dickinson 368273 N/A 2.7 mL Pediatric Vacutainer® Becton Dickinson 366393 Pedi (IL P/N 285246-00) (IL P/N 285335-00) set of 10 2.7 mL Plastic Vacutainer® Becton Dickinson 363083 N/A 4.5 mL Vacutainer® Becton Dickinson 369714 N/A 4.5 mL Vacutainer® Becton Dickinson 366415 N/A 4.5 mL Vacutainer® Becton Dickinson 367714 N/A 1.8 mL Greiner Bio-One Greiner Bio-One Vacuette® * 454321 Aliquot (IL P/N 285245-00) (IL P/N 285334-00) set of 10 3.15 mL Greiner BioOne Vacuette® Greiner Bio-One 454327 N/A 5.0 mL Vacuette Greiner Bio-One 454330 N/A 5.0 mL Vacuette Greiner Bio-One 456323 CTS Adapter 1.8 mL Greiner Bio-One Greiner Bio-One Vacuette® 454322 Aliquot (IL P/N 285245-00) (IL P/N 285334-00) set of 10 3.15 mL Greiner BioOne Vacuette® Greiner Bio-One 454332 N/A 2.7 mL Greiner Bio-One Greiner Bio-One Vacuette® 454334 N/A 439 of 992 Why Adapter Needed Small OD, Low fill volume Small OD, Low fill volume Low fill volume Low fill volume L0027503450 R00 ACL TOP Family Operator's Manual Chapter 5 – Preparing the System Sample Containers and Adapters Validated Uncapped Sample Containers Sample Container Type Source/Available Adapter Needed Part No. Why Adapter Needed 1.3 mL Micro Tube * Sarstedt 41.1506.005 Micro (IL P/N 285296-00) (IL P/N 285337-00) set of 10 Small OD, Low fill volume 2.9 mL S-Monovette® Sarstedt 04.1902.100 N/A 3 mL S-Monovette® Sarstedt 05.1165.100 N/A 5 mL S-Monovette® Sarstedt 05.1071.100 N/A 1.8 mL Venosafe® Terumo VF052SBCS07 Aliquot (IL P/N 285245-00) (IL P/N 285334-00) set of 10 Low fill volume 2.7 mL Venosafe® Terumo VF053SBCS07 Aliquot (IL P/N 285245-00) (IL P/N 285334-00) set of 10 Low fill volume 3.6 mL Venosafe® Terumo VF054SBCS07 N/A 1.8 mL Venoject II® Terumo VPC052K Aliquot (IL P/N 285245-00) (IL P/N 285334-00) set of 10 Low fill volume 2.7 mL Venoject II® Terumo VPCW053K Aliquot (IL P/N 285245-00) (IL P/N 285334-00) set of 10 Low fill volume 4.5 mL Venoject II® Terumo VPCW050K N/A 1.8 mL Nipro sample tube Nipro NP-CD0185 Aliquot (IL P/N 285245-00) (IL P/N NP-CS0185 285334-00) set of 10 Low fill volume 2.7 mL Nipro sample tube Nipro NP-CD0275 Aliquot (IL P/N 285245-00) (IL P/N NP-CS0275 285334-00) set of 10 Hold tube in rack 3.6 mL Nipro sample tube Nipro NP-CD0365 N/A NP-CS0365 1.8 mL Sekisui sample tube Sekisui SPMK0502S Aliquot (IL P/N 285245-00) (IL P/N 285334-00) set of 10 Low fill volume 1.8 mL Sekisui sample tube Sekisui ST-518SC Aliquot (IL P/N 285245-00) (IL P/N 285334-00) set of 10 Low fill volume Aliquot Tube Fisherbrand P/N 14-956 3D Aliquot (IL P/N 285245-00) (IL P/N 285334-00) set of 10 Low fill volume Aliquot Tube Corning® P/N 430662 Aliquot (IL P/N 285245-00) (IL P/N 285334-00) set of 10 Low fill volume * Tubes are usable when filled to nominal levels. However, the amount of usable plasma will be lower than 500uL. 440 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 5 – Preparing the System Sample Containers and Adapters Validated Uncapped Sample Containers for LAS – Track Only Only the following tubes may be used on the LAS track. Validated Uncapped Sample Containers for LAS - Track Only Sample Container Type Source/Available Part No. 1.8 mL Plastic Vacutainer® Becton Dickinson 363080 2.7 mL Plastic Vacutainer® Becton Dickinson 363083 4.5 mL Vacutainer® Becton Dickinson 369714 4.5 mL Vacutainer® Becton Dickinson 366415 1.8 mL Greiner Bio-One Vacuette® Greiner Bio-One 454321 3.15 mL Greiner Bio-One Vacuette® Greiner Bio-One 454327 1.8 mL Greiner Bio-One Vacuette® Greiner Bio-One 454322 3.15 mL Greiner Bio-One Vacuette® Greiner Bio-One 454332 2.7 mL Greiner Bio-One Vacuette® Greiner Bio-One 454334 2.9 mL S-Monovette® Sarstedt 04.1902.100 3 mL S-Monovette® Sarstedt 05.1165.100 5 mL S-Monovette® Sarstedt 05.1071.100 1.8 mL Venosafe® Terumo VF-052SBCS07 2.7 mL Venosafe® Terumo VF-053SBCS07 3.6 mL Venosafe® Terumo VF-054SBCS07 1.8 mL Venoject II® Terumo VP-C052K 2.7 mL Venoject II® Terumo VP-CW053K 4.5 mL Venoject II® Terumo VP-CW050K 1.8 mL Nipro sample tube Nipro NP-CD0185, NP-CS0185 2.7 mL Nipro sample tube Nipro NP-CD0275, NP-CS0275 3.6 mL Nipro sample tube Nipro NP-CD0365, NP-CS0365 1.8 mL Sekisui sample tube Sekisui SPM-K0502S 1.8 mL Sekisui sample tube Sekisui ST-518SC 441 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 5 – Preparing the System Sample Containers and Adapters Validated Capped Sample Containers for CTS – Piercing Mode Enabled These containers are valid for use on all ACL TOP CTS models. Piercing mode must be enabled. Validated Capped Sample Containers for CTS – Piercing Mode Enabled Sample Container Type Source/Available Adapter needed Rack needed Part No. 1.8 mL Pediatric Vacutainer® Becton Dickinson 366392 Pedi (IL P/N CTS sample 285246-00) rack (IL P/N (IL P/N 285335- 294008) 00) set of 10 1.8 mL Plastic Vacutainer® Becton Dickinson 363080 N/A 2.7 mL Pediatric Vacutainer® Becton Dickinson 366393 Pedi (IL P/N CTS sample 285246-00) rack (IL P/N (IL P/N 285335- 294008) 00) set of 10 2.7 mL Plastic Vacutainer® Becton Dickinson 363083 N/A CTS sample rack (IL P/N 294008) 4.5 mL Vacutainer® Becton Dickinson 369714 N/A CTS sample rack (IL P/N 294008) 4.5 mL Vacutainer® Becton Dickinson 366415 CTS (IL P/N CTS sample 285288-00) rack (IL P/N (IL P/N 285336- 294008) 00) set of 10 CTS sample rack (IL P/N 294008) 3.15 mL Greiner Bio-One Vacuette® Greiner Bio-One 454327 N/A CTS sample rack (IL P/N 294008) 1.8 mL Greiner Bio-One Vacuette® Aliquot (IL P/N 285245-00) (IL P/N 285334-00) set of 10 Low fill volume Greiner Bio-One 454322 3.15 mL Greiner Bio-One Vacuette® Greiner Bio-One 454332 N/A 2.7 mL Greiner Bio-One Vacuette® Greiner Bio-One 454334 N/A 2.9 mL S-Monovette®*° Sarstedt 04.1902.100 Sarstedt (IL P/N Sarstedt sample 285821-00) rack (IL P/N (IL P/N 294127- 285831) 00 set of 10) 442 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 5 – Preparing the System Sample Containers and Adapters Validated Capped Sample Containers for CTS – Piercing Mode Enabled Sample Container Type Source/Available Adapter needed Rack needed Part No. 3 mL S-Monovette®*° Sarstedt 05.1165.100 Sarstedt (IL P/N Sarstedt sample 285821-00) rack (IL P/N (IL P/N 294127- 285831) 00 set of 10) 5 mL S-Monovette®*° Sarstedt 05.1071.100 Sarstedt (IL P/N Sarstedt sample 285821-00) rack (IL P/N (IL P/N 294127- 285831) 00 set of 10) 2.7 mL Venosafe® Terumo VF053SBCS07 Aliquot (IL P/N 285245-00) (IL P/N 285334-00) set of 10 CTS sample rack (IL P/N 294008) 2.7 mL Venoject II® Terumo VPCW053K Aliquot (IL P/N 285245-00) (IL P/N 285334-00) set of 10 CTS sample rack (IL P/N 294008) 1.8 mL Vacutainer® Becton Dickinson 368273 N/A 4.5 mL Vacutainer® Becton Dickinson 367714 N/A 5.0 mL Vacuette Greiner Bio-One 456323 CTS Adapter ° Sarstedt sample rack (IL P/N 285831) is needed to run in closed tube mode. See Sarstedt Sample Rack. * See old style Sarstedt CTS rack and adapter note. 443 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 5 – Preparing the System Sample Containers and Adapters Validated Capped Sample Containers for CTS – Low-Fill Tubes Use the following tubes when the Low-Fill Tubes Handling CTS option is enabled. Validated Capped Sample Containers for CTS – Lower Z Piercing Mode Enabled Sample Container Type Source/Available Part No. Adapter Needed Why Adapter Needed 1.8 mL Sekisui sample tube * ST-518SC-J2 (IL P/N 285334-00) set CTS sample rack (IL P/N of 10 294008) * Validated for use in CTS mode without Lower Z piercing mode enabled. However the usable volume1 will be 200 uL or less. 1The total volume of liquid in a specific material bottle minus the dead (unusable) volume of that bottle. 444 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 5 – Preparing the System Sample Containers and Adapters Sample Containers Not Recommended for CTS These containers are not recommended for use on ACL TOP when capped. Sample Containers Not Recommended for CTS Sample Container Type Source/Available Why NOT RECOMMENDED for CTS Part No. (Piercing mode enabled) 2.0 mL Cup IL P/N 55751-00 Uncapped sample containers are not to be used with CTS sample racks. Sampling from open tube when CTS is in pierce mode (sample may not be collected correctly). Aliquot Tube Fisherbrand P/N 14-956 3D Uncapped sample containers are not to be used with CTS sample racks. Sampling from open tube when CTS is in pierce mode (sample may not be collected correctly). Aliquot Tube Corning® P/N 430662 Uncapped sample containers are not to be used with CTS sample racks. Sampling from open tube when CTS is in pierce mode (sample may not be collected correctly). 1.3 mL MicroTube (capped) Sarstedt 41.1506.005 Push cap material cannot be pierced. Use in OPEN mode only Remove flip cap. Maximum usable volume1 is 200 uL. Contains an anticoagulant in the tube and a flip top—it is not a vacutainer tube nor is it an aliquot tube. Draw blood with a syringe, then fill the tube and mix the blood with the anticoagulant. 1.8 mL Sekisui SPMSekisui K0502S (change sample tube in cap material) (capped) * Cap of SPM-U0502S has indented core (diameter close to that of piercing probe). May be problematic for CTS. The piercer may not be able to center on the indented core correctly and pierce. 1.8 mL Sekisui SPMSekisui K0502S sample tube (capped) This tube does not meet the requirement that a sample tube (excludes aliquot tubes) must have a minimum usable volume2 of 500 uL (10 PT assays) to be used on the system. Currently, an average of only 250 uL can be aspirated from this tube. This is because the distance from the cap to the fill line is 52.50 mm and the CTS probe can only travel 54 mm from the top of the cap into the tube. If the tube is not filled to the fill line, a test cannot be performed. 4.5 mL Terumo VPVenoject CW050K II® (capped) This tube has a high fill volume; there is not enough clearance between the top of the plasma and the bottom of the cap during sample probe aspiration. Using this capped sample tube in a CTS sample rack results in the probe diving into the fluid during aspiration and possibly contaminating the probe or resulting in fluidic imprecision. 3.6 mL Venosafe® (capped) This tube has a high fill volume; there is not enough clearance between the top of the plasma and the bottom of the cap during sample probe aspiration. Using this capped sample tube in a CTS sample rack results in the probe diving into the fluid during aspiration and possibly Terumo VF054SBCS07 1The total volume of liquid in a specific material bottle minus the dead (unusable) volume of that bottle. 2The total volume of liquid in a specific material bottle minus the dead (unusable) volume of that bottle. 445 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 5 – Preparing the System Sample Containers and Adapters Sample Containers Not Recommended for CTS Sample Container Type Source/Available Why NOT RECOMMENDED for CTS Part No. (Piercing mode enabled) contaminating the probe or resulting in fluidic imprecision. 1.8 mL Nipro NPNipro CD0185, NPsample tube CS0185 (capped) Tests revealed that the caps appear to be more elastic then other manufactures and that this cap produces larger pieces of coring compared to other brands. The analytical precision of these tubes, does not meet acceptance criteria for precision. This tube functions well only in NONCTS mode. 2.7 mL Nipro NPNipro CD0275, NPsample tube CS0275 (capped) Tests revealed that the caps appear to be more elastic then other manufactures and that this cap produces larger pieces of coring compared to other brands. The analytical precision of these tubes, does not meet acceptance criteria for precision. This tube functions well only in NONCTS mode. 3.6 mL Nipro NPNipro CD0365, NPsample tube CS0365 (capped) Tests revealed that the caps appear to be more elastic then other manufactures and that this cap produces larger pieces of coring compared to other brands. The analytical precision of these tubes, does not meet acceptance criteria for precision. This tube functions well only in NONCTS mode. SARSTEDT Sarstedt 06.1668.001 Monovette® 1.4 mL sample tubes Carrier with tube above ZMax1. Needs adapter to fit on sample racks. Can only aspirate 80 uL without an adapter. Greiner pediatric tube 1 mL This tube cannot be pierced. Also because the inside of this tube is tapered there is a possibility of coming out of liquid for some test on our list. Greiner P/N 450413 See Also l Parts and Consumables List 1Maximum travel distance of a probe in the Z (vertical) direction, measured at the lowest possible aspiration point of the probe. 446 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 5 – Preparing the System Diluents Diluents A diluent is a liquid used to reduce the concentration of another liquid. A sample diluent reduces the concentration of sample material; a reagent diluent reduces the concentration of reagent material. Sample diluents must be placed in a diluent rack. Placing a sample diluent in the wrong position causes a warning message. See Test Feasibility for proper placement of all reagents. The first two positions on the diluent rack hold 30 mL bottles, but can be used for 4 mL, 10 mL, and 20 mL bottles providing the correct adapter is inserted into the position on the rack. There is an adapter for each of these smaller bottles that allows them to be seated correctly in the rack position while allowing the bar code label on the bottle to be read. These adapters are red to distinguish them from the reagent rack adapters. Bottle Adapters A warning message is displayed if the volume of a diluent falls below the limit defined as the warning threshold. See Material Definition. An error message is displayed when the bottle is determined to be empty. See Also l Restriction Map l Test Feasibility l Material Definition l Reagent/Diluent Area 447 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 5 – Preparing the System Restriction Map Restriction Map NOTE: See Test Feasibility for proper placement of all reagents. Overview The Restriction Map shows which types of materials may be placed onto which tracks. It also the shows the types of racks that may be placed and their corresponding track positions. Important Considerations l l Place sample tubes and reagent/diluent bottles on the rack carefully to avoid damaging the bar code labels. Make sure the labels can be read by the bar code reader. Use the tracks to guide the racks into the correct position. Improper seating of the rack can cause spillage. Accessing the Restriction Map To open the Restriction Map: 1. Select one of the following icons in the toolbar to open the corresponding area: Sample Area Reagent Area Diluent Area LAS Cuvette Holding Area 2. Select the Restriction Map in the menu bar. icon in the toolbar, or select Actions > Review > Restriction Map 448 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 5 – Preparing the System Restriction Map TOP 300 CTS Restriction Map A bottle in a cell means that the material can be placed in the corresponding track position. For example: l A patient sample may be placed in any track from S1 to S4. l A calibrator1 sample may be placed in Sample tracks S1 - S4 plus diluent track D1. l Sample diluents are restricted to tracks D1, reagent diluents to tracks D1 and R1-R3. NOTE: l l If you define a sample clean material and select the Clean and Rinse option requiring a non-system clean material such as Clean B diluted, that clean material must be placed in track D1. Non-system clean materials used by the reagent probes must be placed in tracks D1, or R1-R3. 1A type of sample with an assigned value used to calibrate a test. 449 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 5 – Preparing the System Restriction Map TOP 500 CTS Restriction Map A bottle in a cell means that the material can be placed in the corresponding track position. For example: l A Patient sample may be placed in any track from S1 to S8. l A Calibrator sample may be placed in Sample tracks S1 - S8 plus diluent track D1. l Sample diluents are restricted to tracks D1, reagent diluents to tracks D2 and R1 - R4. NOTE: l l If you define a sample clean material and select the Clean and Rinse option requiring a non-system clean material such as Clean B diluted, that clean material must be placed in track D1. Non-system clean materials used by the reagent probes must be placed in tracks D2, or R1-R4. 450 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 5 – Preparing the System Restriction Map TOP 700 Restriction Map The following is the restriction map on ACL TOP 700 (includes ACL TOP Base) and ACL TOP 700 CTS (includes ACL TOP CTS) instruments: A bottle in a cell means that the material can be placed in the corresponding track position. For example: l A Patient sample may be placed in any track from S1 to S12. l A Calibrator sample may be placed in Sample tracks S1 - S12 plus diluent tracks D1 and D2. l Sample diluents are restricted to tracks D1 and D2, reagent diluents to tracks D3 and R1 - R4. NOTE: l l If you define a sample clean material and select the Clean and Rinse option requiring a non-system clean material such as Clean B diluted, that clean material must be placed in track D1 or D2. Non-system clean materials used by the reagent probes must be placed in tracks D3, R1, R2, R5, and/or R6. Do not place non-system clean materials in tracks R3 or R4. 451 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 5 – Preparing the System Restriction Map TOP 700 LAS Restriction Map A bottle in a cell means that the material can be placed in the corresponding track position. For example: l A Patient sample may be placed in any track from S4 to S12. l A Calibrator sample may be placed in Sample tracks S4 - S12 plus diluent tracks D1 and D2. l Sample diluents are restricted to tracks D1 and D2, reagent diluents to tracks D3, and R1 - R4. NOTE: l l l Tracks S1 - S3 are unavailable on the LAS. If you define a sample clean material and select the Clean and Rinse option requiring a non-system clean material such as Clean B diluted, that clean material must be placed in track D1 or D2. Non-system clean materials used by the reagent probes must be placed in tracks D3, R1, R2, R5, and/or R6. Do not place non-system clean materials in tracks R3 or R4. See Also l Test Feasibility l Reagent Area l Diluent Area l Reagent/Diluent Area 452 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 5 – Preparing the System Closed Tube Sampling Closed Tube Sampling WARNING Piercing Hazard: Do not put hand inside instrument while sample arm is in motion. CAUTION Biohazard: In the unlikely event that the CTS piercer probe gets stuck or jammed in the cap of a primary sample tube, do not attempt to remove the cap. Call Service for assistance. The CTS piercer probe assembly is delicate, very sharp, and biohazardous. The removal of a stuck cap from the piercer probe could cause personal injury or damage to the instrument. Overview In Closed Tube Sampling (CTS) mode, the instrument accepts both CTS sample racks and open tube sample racks. CAUTION: You must use only closed tubes on CTS sample racks. Use regular, uncapped, sample tubes and sample cups on open tube sample racks. Failure to use the proper rack (standard rack for open tubes; closed rack for closed tubes) may result in probe damage. Sample tube adapters used with the CTS sample racks are listed in CTS Capped and Uncapped Sample Containers and Adapters. With CTS mode disabled, the instrument does not accept CTS sample racks. If a CTS sample rack is inserted an error message displays: CTS rack rejected. When CTS is disabled, the instrument runs only uncapped tubes and sample cups on open tube sample racks. If you try to disable the CTS mode while CTS racks are on the instrument, a message displays: Unable to disable CTS mode. CTS racks currently in use. The following diagram shows the piercer/probe in the piercing mode (on left) and in the sample probe mode (on right). 453 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 5 – Preparing the System Closed Tube Sampling Enabling/Disabling CTS Mode To enable/disable CTS mode: 1. Make sure the instrument is in the READY state. 2. Select Setup > Global Definitions in the menu bar. 3. In the Global Definitions screen, select or clear the Enable piercing mode option in the CTS parameters section. 4. Select the Save icon in the toolbar to save your changes. 454 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 5 – Preparing the System Closed Tube Sampling Closed Tube Sampling (CTS) Probe The piercer probe assembly consists of both a piercer and a sample probe located in a piercer assembly. This assembly is designed for sampling from capped primary sample tubes. The CTS piercer probe assembly has a foot to hold the sample tube in place, allowing the piercer to cut through the cap. After the piercer cuts through, the foot remains on the cap long enough to allow the probe to move down into the tube to aspirate material. The debris from piercing the cap is collected by the piercer and deposited into a filter at the sample arm rinse station. Sample Arm CTS Probe Sample Tube Cap Piercing 455 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 5 – Preparing the System Closed Tube Sampling After aspirating the sample, the CTS/Sample arm moves to the wash station and performs a deep wash. Pressurized air is released through the piercer/probe to blow out any material that might remain following a wash or rinse. Special CTS racks are used for cap piercing. These racks are labeled CTS on the front of the rack. CAUTION: If a cap is not detected on a sample tube placed in a CTS rack, an alarm displays. In this case, remove the tube from the CTS rack and load it onto an open-tube sample rack. Use only capped sample tubes on CTS racks. Use sample cups and uncapped sample containers on open-tube sample racks. CTS Sample Rack 456 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 5 – Preparing the System Closed Tube Sampling NOTE: For cleaning racks and adapters, IL recommends that you use any of the following: l 10% bleach l 0.1 N HCl l Mild soap After decontamination with bleach you should always rinse with tap water to remove excess bleach residue on the inner walls of the container. DO NOT SOAK RACKS IN ANY SOLUTION. Soaking may corrode racks or remove labels. Sarstedt Closed Tube Sample (CTS) Rack and Adapters See Sample Containers and Adapters. See Also l CTS Capped and Uncapped Sample Containers and Adapters 457 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 5 – Preparing the System Sample Area Sample Area See Sample Area under Sample Analysis. Reagent Area This topic applies to the following models: l TOP 700 (includes TOP Base) l TOP 700 CTS (includes TOP CTS) l TOP 700 LAS For TOP 500 CTS and TOP 300 CTS models, see Reagent/Diluent Area. Overview Each reagent rack in the reagent area holds up to six 20 mL or 15 mL bottles, but can also be used for the 4 mL and 10 mL bottles providing the correct adapter is inserted into the position on the rack. (See Reagents and Restriction Map.) When placed on-board the analyzer, the first two positions (#1 and #2) in each reagent rack provide stirring capability if a stir bar has been placed in the reagent bottle. When the rack is in use (during aspiration of material) it is locked and an amber LED displays for the track position. When the rack is no longer in use the LED changes to green and the rack is released. Accessing the Reagent Area and Rack Details To access the Reagent Area and Rack Details: 1. Select the Reagent Area bar to open the Reagent Area. icon in the toolbar, or select Analysis > Reagent Area in the menu 2. Double-click a position on the offline rack (located on the left side of the screen) to open the Reagent Rack Details screen. 458 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 5 – Preparing the System Reagent Area Programming Non-Bar Coded Reagents Using the Offline Rack 1. Select the Reagent Area icon, or select Analysis > Reagent Area in the menu bar. 2. Double-click a rack to open the Rack Details screen. 3. Select a position in the rack, then select the Add/Remove Material window with that rack position in focus. icon to open the Materials 4. Select a reagent button to place that reagent in the reagent rack position. (See Material Programming Window for configuring this window with reagents to select.) 5. To program additional reagents on the rack, select a position and repeat the previous step. 6. When you have programmed all the materials on the rack, select the Insert Rack toolbar. icon in the 7. Insert the rack into the instrument. NOTE: If for any reason a sample, diluent or reagent material that you manually program on an offline rack (through the Control Module1) does not match the bar code on the tube or bottle, an error is issued. This includes failing to program a material the instrument detects. CAUTION: When loading sample, diluent, or reagent racks, pull the rack out all the way before loading. Pulling a rack out partially while loading or changing bottles, tubes, or sample cups may result in misidentification of rack contents. 1A Microsoft Windows™ PC running the ACL TOP software developed by IL. The CM provides the User Interface and data management functionality. The CM connects to the Analytical Module and provides the high level controls. 459 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 5 – Preparing the System Reagent Area Viewing On-board Materials The Reagent & Diluent Map displays on-board materials in table format. To view on-board materials: 1. Select the Sample Area , Diluent Area open the Sample, Diluent or Reagent Area. or Reagent Area icon in the toolbar to 2. Select Actions > Review > Reagent & Diluent Map in the menu bar. 3. In the Reagent & Diluent Map, select the Diluent Area tab to view the on-board diluent materials by position in each rack. 4. Select the Reagent Area tab to view the on-board reagents by position in each rack. 5. Select the right and left arrows below the table to display more racks. 460 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 5 – Preparing the System Reagent Area Reagent Area Operations Toolbar Select the following icons to perform the associated tasks: Run Tests – Starts the analytical session. Disabled if the analyzer is not in Ready status. Same as Actions > Map > Run Tests in the menu bar. Test Feasibility List – Opens the Test Feasibility List which indicates the following: l Whether the test is feasible. A red X indicates the test is not feasible. l Whether the materials have been correctly placed. l Number of tests that can run based on the volume of materials on-board. You can add and run tests while the analyzer is running. Restriction Map – Opens the Restriction Map. Also select Actions > Review > Restriction Map in the menu bar. Rack Details – Opens the Rack Details screen for the rack that has focus in the Reagent Area screen. Bar Code Home Position – Moves the bar code reader to its home position. Print – Prints a report that contains the following: l State of all inserted racks with material placed on-board. l State of on-board materials. This report is useful when a maintenance activity is performed requiring removal of material racks. 461 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 5 – Preparing the System Reagent Area Reagent Rack Details Operations Toolbar Select the following icons to perform the associated tasks: Run Tests – Starts the analytical session. Disabled if the analyzer is not in Ready status. Same as Actions > Map > Run Tests in the menu bar. Add/Remove Materials – Opens the Materials window where you select a reagent to add to the reagent rack position in focus. Clear rack information – Clears all reagents from the rack in focus. Bar Code and Comments – Opens the Bar Code Edition dialog box where you can review comments about the selected reagent (comments entered in the Material Definition – General Information tab). Insert Rack – Inserts the rack into the instrument. Test Feasibility List – Opens the Test Feasibility List which indicates the following: l Whether the test is feasible. A red X indicates the test is not feasible. l Whether the materials have been correctly placed. l Number of tests that can run based on the volume of materials on-board. You can add and run tests while the analyzer is running. Bar Code Home Position – Moves the bar code reader to its home position. Print – Prints the rack details report for the rack displayed. NOTE: After selecting Run: l l The instrument issues a warning if an enhanced clean is required. You must perform the enhanced clean before running any other operations. See Enhanced Clean in Performing Maintenance Activities. The instrument issues a warning if temperatures are out of range. You can confirm to run the current operation, or cancel and wait until the temperatures are in range. 462 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 5 – Preparing the System Reagent Area l The instrument issues a message with the list of the disabled ORUs, if applicable, to warn of any throughput changes. You can confirm to run the current operation, or cancel it. 463 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 5 – Preparing the System Reagent Area Reagent Area Screen The reagent area includes the tracks on the right side of the AM. It is cooled to 15° C ± 3°. This screen is functionally similar to the Sample Area screen. Rack Representation The reagent rack representation on the screen is: 464 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 5 – Preparing the System Reagent Area NOTE: l You may notice a slight resistance when inserting or removing racks. This is normal. l Material #1 is at the top. Material #6 is at the bottom. Reagent & Diluent Map Displays the materials that are on-board. Columns in the screen represent the tracks where racks are inserted on the instrument. Rows in the screen represent the positions in the rack. R eagent A rea tab Display on-board reagents. D iluent A rea tab Display on-board diluent materials. A rrow buttons Select the right and left arrows below the map to display more racks. 465 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 5 – Preparing the System Reagent Area Rack Warnings and Errors The Reagent Area of the Control Module1 has a boxed area to the right that contains rack warning and error messages and status indicators. D escription field Displays the errors and warnings issued for the materials placed on-board. 1A Microsoft Windows™ PC running the ACL TOP software developed by IL. The CM provides the User Interface and data management functionality. The CM connects to the Analytical Module and provides the high level controls. 466 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 5 – Preparing the System Reagent Area A uxiliary material status Green – Cuvette waste door is open Gray – Waste fluid status is OK – Clean fluid status is OK – Rinse fluid status is OK – Cuvette waste status is OK – Cuvette waste door is closed Yellow – Waste fluid status is warning – Clean fluid status is warning – Rinse fluid status is warning – Cuvette waste status is warning – Cuvette loader status is warning Red – Waste fluid status is full – Clean fluid status is empty – Rinse fluid status is empty – Cuvette waste status is full or removed – Cuvette loader status is empty NOTE: l l l l IL recommends daily visual monitoring of the rinse and clean solutions. For all models except the ACL TOP 300, when rinse or clean solutions reach a low level, a warning is issued. When the ACL TOP 300 rinse or clean bottle become empty, the instrument performs a controlled stop, issues a warning, and the LED on the front of the instrument turns red. The ACL TOP 300 model does not have a status indicator for the waste fluid, cuvette door or cuvette waste. 467 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 5 – Preparing the System Reagent Area Reagent Rack Details Screen This screen contains information for each placed bottle of reagent. Double-click the reagent rack to open the Rack Details screen. Material N ame Select browse ellipsis next to this field, or select the Add/Remove Material to open the Materials window. 468 of 992 icon in the toolbar L0027503450 R00 ACL TOP Family Operator's Manual Chapter 5 – Preparing the System Reagent Area The first tab of the Materials window opens with the reagents that have been configured for selection. (See Material Programming Window for configuring this window with reagents to select.) Additional tabs contain additional material names from which you can select. Select one material name per rack position. A reagent definition can be changed when the reagent is not placed. Lot ID Material lot ID. By default, the active lot ID is selected. If defined, you may select the alternate lot ID instead. Priority The default priority is zero. Priorities are automatically assigned by the system. Typically, first bottle placed is assigned priority 1, the second bottle placed priority 2, and so on. An exception is made for QC reagents (see QC Reagents). You may also assign a numeric priority value. Material positions with the highest priority are used first (for example, priority 1). You cannot change priority when a warning or error condition is displayed. NOTE: If you remove a reagent or diluent rack, you may lose priority settings upon reentry of the rack into the instrument. See Working Information. QC Reagents When new vials of QC reagent are added to a rack that contains existing vials of the same QC reagent, and the rack is reinserted within one hour, the instrument uses all the reagent in the older vials before using the QC reagent in new vial. Separate Priority with Same Material Placed On Two Sides of the Analyzer Vial priority is set based on the ability of the reagent to be transported. For example, if four vials of Material A are placed on the system (two on the Sample side, and two on the Reagent side) the two vials on the Sample side are assigned priority 1 and 2, and the two vials on the Reagent side are also assigned priority 1 and 2. 469 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 5 – Preparing the System Reagent Area For TOP 300 CTS, the diluent rack is accessible by the sample probe and reagent probe. However, priority for reagents in the diluent rack is assigned to the sample probe. Reagents for the sample probe in the diluent rack receive separate priority as identical reagents in reagent racks. When reagents in the reagent racks are used up or expired, the reagent probe accesses the reagent in the diluent rack regardless of priority. Expiration date The reagent lot’s expiration date as established by the manufacturer. W arnings and errors List of warning and error message issued against the reagent in that rack position. Double-click this field to display a window with the complete text of the message. Some possible messages are: l Low material volume l Empty material l Lot not defined l Material placement error l Inconsistent bottle size l Stability expired l Material expiration l Material not stirred R emaining stability The number of days, hours and minutes the reagent remains stable on-board the analyzer. On-board volume The current volume of reagent (in mL) on-board the analyzer. R eagent color codes On the far left of each reagent position is a colored circle that conveys additional information concerning the reagent in that position, as follows: Not placed Gray Placed, not identified Green with a question mark Placed, identified Green Placed, warning Amber Placed, error Red In use Green surrounded by a heavy black circle In use, warning Amber surrounded by a heavy black circle In use, error Red surrounded by a heavy black circle See Reagent Color Codes and LED Status Color Codes. 470 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 5 – Preparing the System Reagent Area W orking information The working information refers to the attributes of a bar coded reagent vial on-board. It is used by the system to determine test feasibility and reagent on-board stability. The vial bar code contains the material name, expiration date, lot number, and vial size. If the reagent or diluent rack is removed from the instrument and replaced, the bar code scan determines whether the reagent vial is the same as the vial that was removed. The working information of a vial (onboard stability) is retained under the following conditions: l The vial must be reinserted into the same position from which it was removed. l The vial must be reinserted within one hour after removal. l The volume of fluid in the reagent vial cannot change by more than 30%. Offline or Virtual Rack The rack to the far left in the Reagent Area represents an offline rack on your workbench. It is used to preprogram reagents for a rack before inserting it into the analyzer. You can also program a rack after it has been inserted, but it is often preferable to do it beforehand. CAUTION: When loading sample, diluent, or reagent racks, pull the rack out all the way before loading. Pulling a rack out partially while loading or changing bottles, tubes, or sample cups may result in misidentification of rack contents. NOTE: If for any reason a sample, diluent or reagent material that you manually program on an offline rack (through the Control Module1) does not match the bar code on the tube or bottle, an error is issued. This includes failing to program a material the instrument detects. See Also l Material Programming Window l Reagent Color Codes l Test Feasibility l Restriction Maps l LED Status Color Codes 1A Microsoft Windows™ PC running the ACL TOP software developed by IL. The CM provides the User Interface and data management functionality. The CM connects to the Analytical Module and provides the high level controls. 471 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 5 – Preparing the System Diluent Area Diluent Area Accessing the Diluent Area To access the Diluent Area: l l Select the Diluent Area bar. icon in the toolbar, or select Analysis > Diluent Area in the menu <300/500 CTS> Select the Reagent Area Area in the menu bar. icon in the toolbar, or select Analysis > Diluent 472 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 5 – Preparing the System Diluent Area Diluent Area TOP 300 CTS Diluent Area The diluent area in the TOP 300 CTS model includes the one diluent rack position located in the reagent area. This diluent rack holds up to 8 calibration plasmas, QC materials, and dilution materials in original bottles placed on diluent racks. 500 CTS Diluent Area The diluent area in the 500 CTS model includes the two diluent rack positions in the reagent area. These diluent racks hold up to 16 calibration plasmas, QC materials, and dilution materials in original bottles placed on diluent racks. TOP 700 Diluent Area The diluent area in the TOP 700 models includes the three diluent rack positions. Two in the sample area and one in the reagent area. These diluent racks hold up to 24 calibration plasmas, QC materials, and dilution materials in original bottles placed on diluent racks. When the rack is in use (during aspiration of material) it is locked and an amber LED displays for the track position. When the rack is no longer in use the LED changes to green and the rack is released. See Test Feasibility for proper placement of all reagents. The sample arm aspirates and dispenses materials from diluent racks placed in the sample area. The reagent arm aspirates and dispenses materials from the diluent rack placed in the reagent area. The Diluent Area screen is functionally similar to the Reagent Area screen. The diluent area can accommodate three diluent racks (two tracks in the sample area and one in the reagent area). Each diluent rack can hold two large bottles and six smaller bottles. The first two positions of the diluent rack can also be used for 4 mL, 10 mL, and 20 mL bottles, providing the correct adapter is inserted into the position on the rack. (See Diluents.) The diluent rack representation on the screen is: 473 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 5 – Preparing the System Diluent Area Diluent Area with Sample Probe 474 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 5 – Preparing the System Diluent Area Diluent Rack NOTE: l Material #1 is at the top; material #8 is at the bottom. l You may notice a slight resistance when you are inserting or removing racks. This is normal. NOTE: For cleaning racks and adapters, IL recommends that you use any of the following: l 10% bleach l 0.1 N HCl l Mild soap After decontamination with bleach you should always rinse with tap water to remove excess bleach residue on the inner walls of the container. DO NOT SOAK RACKS IN ANY SOLUTION. Soaking may corrode racks or remove labels. 475 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 5 – Preparing the System Diluent Area Viewing On-board Materials The Reagent & Diluent Map displays on-board materials in table format. To view on-board materials: 1. Select the Sample Area , Diluent Area open the Sample, Diluent or Reagent Area. or Reagent Area icon in the toolbar to 2. Select Actions > Review > Reagent & Diluent Map in the menu bar. 3. In the Reagent & Diluent Map, select the Diluent Area tab to view the on-board diluent materials by position in each rack. 4. Select the Reagent Area tab to view the on-board reagents by position in each rack. 5. Select the right and left arrows below the table to display more racks. Diluent Rack Details This screen is identical to the Reagent Details screen. It contains information for each placed bottle of material. Double-click the diluent rack in the Diluent Area screen that has focus to open the Rack Details screen. See Also l Reagent Area l Test Feasibility l Sample Status Color Codes l Restriction Map l Reagent Color Codes 476 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 5 – Preparing the System Reagent/Diluent Area Reagent/Diluent Area This topic applies to TOP 500 CTS and TOP 300 CTS models. For TOP 700 (includes TOP Base), TOP 700 CTS (includes TOP CTS) and TOP 700 LAS models, see Reagent Area. Overview The Reagent/Diluent Area has diluent (D) tracks and reagent (R) tracks. The screen also displays an offline rack for diluents on the left side, and an offline rack for reagents on the right side. The Reagent/Diluent Area is cooled to 15° C ± 3°. Each reagent rack holds up to six 20 mL or 15 mL bottles. You can also use 4 mL and 10 mL bottles with adapters. (See Sample Area and Reagents.) Positions #1 and #2 in each reagent rack provide stirring if you place a stir bar in the reagent1 bottle. See Test Feasibility for proper placement of all reagents.See Restriction Map for general placement of samples and reagents. A clear cover placed over the area helps to reduce condensation. Accessing the Reagent/Diluent Area and Rack Details To access the Reagent/Diluent Area and Rack Details: 1. Select the Reagent Area icon in the toolbar, or select Analysis > Reagent Area in the menu bar to open the Reagent/Diluent Area. 2. Double-click a position on the offline rack (located on the left side of the screen) to open the Reagent Rack Details screen. 1A liquid material used as part of a test. When mixed with sample, a reagent provides the necessary constituents to initiate or complete the desired biochemical reaction. For example: test reagents, diluents, QC/NPP materials, calibrator materials, clean materials, etc. 477 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 5 – Preparing the System Reagent/Diluent Area Programming Non-Bar Coded Reagents Using the Offline Rack 1. Select the Reagent Area icon, or select Analysis > Reagent Area in the menu bar. 2. Double-click a rack to open the Rack Details screen. 3. Select a position in the rack, then select the Add/Remove Material window with that rack position in focus. icon to open the Materials 4. Select a reagent button to place that reagent in the reagent rack position. (See Material Programming Window for configuring this window with reagents to select.) 5. To program additional reagents on the rack, select a position and repeat the previous step. 6. When you have programmed all the materials on the rack, select the Insert Rack toolbar. icon in the 7. Insert the rack into the instrument. NOTE: If for any reason a sample, diluent or reagent material that you manually program on an offline rack (through the Control Module1) does not match the bar code on the tube or bottle, an error is issued. This includes failing to program a material the instrument detects. CAUTION: When loading sample, diluent, or reagent racks, pull the rack out all the way before loading. Pulling a rack out partially while loading or changing bottles, tubes, or sample cups may result in misidentification of rack contents. Viewing On-board Materials To view on-board materials: 1. Select the Sample Area or the Reagent/Diluent Area Sample or Reagent/Diluent Area. icon in the toolbar to open the 2. Select Actions >Review > Reagent & Diluent Map in the menu bar. 3. In the Reagent & Diluent Map, select the Diluent Area tab to view the on-board diluent materials. 4. Select the Reagent Area tab to view the on-board reagents. 5. Select the right and left arrows below the map to display more racks. 1A Microsoft Windows™ PC running the ACL TOP software developed by IL. The CM provides the User Interface and data management functionality. The CM connects to the Analytical Module and provides the high level controls. 478 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 5 – Preparing the System Reagent/Diluent Area Reagent/Diluent Area Operations Toolbar Select the following icons to perform the associated tasks: Run Tests – Starts the analytical session. Disabled if the analyzer is not in Ready status. Same as Actions > Map > Run Tests in the menu bar. Test Feasibility List – Opens the Test Feasibility List which indicates the following: l Whether the test is feasible. A red X indicates the test is not feasible. l Whether the materials have been correctly placed. l Number of tests that can run based on the volume of materials on-board. You can add and run tests while the analyzer is running. Restriction Map – Opens the Restriction Map. Also select Actions > Review > Restriction Map in the menu bar. Rack Details – Opens the Rack Details screen for the rack that has focus in the Reagent Area screen. Bar Code Home Position – Moves the bar code reader to its home position. Print – Prints a report that contains the following: l State of all inserted racks with material placed on-board. l State of on-board materials. This report is useful when a maintenance activity is performed requiring removal of material racks. 479 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 5 – Preparing the System Reagent/Diluent Area Reagent Rack Details Operations Toolbar Select the following icons to perform the associated tasks: Run Tests – Starts the analytical session. Disabled if the analyzer is not in Ready status. Same as Actions > Map > Run Tests in the menu bar. Add/Remove Materials – Opens the Materials window where you select a reagent to add to the reagent rack position in focus. Clear rack information – Clears all reagents from the rack in focus. Bar Code and Comments – Opens the Bar Code Edition dialog box where you can review comments about the selected reagent (comments entered in the Material Definition – General Information tab). Insert Rack – Inserts the rack into the instrument. Test Feasibility List – Opens the Test Feasibility List which indicates the following: l Whether the test is feasible. A red X indicates the test is not feasible. l Whether the materials have been correctly placed. l Number of tests that can run based on the volume of materials on-board. You can add and run tests while the analyzer is running. Bar Code Home Position – Moves the bar code reader to its home position. Print – Prints the rack details report for the rack displayed. NOTE: After executing an operation: l l The instrument prompts you to abort and install a CTS filter if one is not detected. See Replace CTS Filter and clean Clean Cup Area. The instrument issues a warning if an enhanced clean is required. You must perform the enhanced clean before running any other operations. See Enhanced Clean in Performing Maintenance Activities. 480 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 5 – Preparing the System Reagent/Diluent Area l l The instrument issues a warning if temperatures are out of range. You can confirm to run the current operation, or cancel and wait until the temperatures are in range. The instrument issues a message with the list of the disabled ORUs, if applicable, to warn of any throughput changes. You can confirm to run the current operation, or cancel it. Reagent/Diluent Area Screen TOP 300 CTS 481 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 5 – Preparing the System Reagent/Diluent Area ACL TOP 500 CTS When the rack is in use (during aspiration of material) it is locked and an amber LED displays for the track position. When the rack is no longer in use the LED changes to green and the rack is released. Rack Representation The reagent rack representation on the screen is: 482 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 5 – Preparing the System Reagent/Diluent Area NOTE: l You may notice a slight resistance when inserting or removing racks. This is normal. l Material #1 is at the top. Material #6 is at the bottom. Reagent & Diluent Map Displays the materials that are on-board. Columns in the screen represent the tracks where racks are inserted on the instrument. Rows in the screen represent the positions in the rack. R eagent A rea tab Display on-board reagents. D iluent A rea tab Display on-board diluent materials. A rrow buttons Select the right and left arrows below the map to display more racks. 483 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 5 – Preparing the System Reagent/Diluent Area Rack Warnings and Errors The Reagent/Diluent Area has a boxed area to the right that contains rack warning and error messages and status indicators: D escription field Displays the errors and warnings issued for the materials placed on-board. A uxiliary material status Green - Waste fluid status is OK - Clean fluid status is OK - Rinse fluid status is OK - Cuvette waste status is OK 484 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 5 – Preparing the System Reagent/Diluent Area - Cuvette waste door is open Yellow - Waste fluid status is warning - Clean fluid status is warning - Rinse fluid status is warning - Cuvette waste status is warning - Cuvette loader status is warning Red - Waste fluid status is full - Clean fluid status is empty - Rinse fluid status is empty - Cuvette waste status is full or removed - Cuvette loader status is empty Status Indicator on Physical Instrument NOTE: l l l l IL recommends daily visual monitoring of the rinse and clean solutions. For all models except the ACL TOP 300, when rinse or clean solutions reach a low level, a warning is issued. When the ACL TOP 300 rinse or clean bottle become empty, the instrument performs a controlled stop, issues a warning, and the LED on the front of the instrument turns red. The ACL TOP 300 model does not have a status indicator for the waste fluid, cuvette door or cuvette waste. 485 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 5 – Preparing the System Reagent/Diluent Area Reagent Rack Details Screen This screen contains information for each placed bottle of reagent. Double-click the reagent rack to open the Rack Details screen. Material N ame Select browse ellipsis next to this field, or select the Add/Remove Material to open the Materials window. 486 of 992 icon in the toolbar L0027503450 R00 ACL TOP Family Operator's Manual Chapter 5 – Preparing the System Reagent/Diluent Area The first tab of the Materials window opens with the reagents that have been configured for selection. (See Material Programming Window for configuring this window with reagents to select.) Additional tabs contain additional material names from which you can select. Select one material name per rack position. A reagent definition can be changed when the reagent is not placed. Lot ID Material lot ID. By default, the active lot ID is selected. If defined, you may select the alternate lot ID instead. Priority The default priority is zero. Priorities are automatically assigned by the system. Typically, first bottle placed is assigned priority 1, the second bottle placed priority 2, and so on. An exception is made for QC reagents (see QC Reagents). You may also assign a numeric priority value. Material positions with the highest priority are used first (for example, priority 1). You cannot change priority when a warning or error condition is displayed. NOTE: If you remove a reagent or diluent rack, you may lose priority settings upon reentry of the rack into the instrument. See Working Information. QC Reagents When new vials of QC reagent are added to a rack that contains existing vials of the same QC reagent, and the rack is reinserted within one hour, the instrument uses all the reagent in the older vials before using the QC reagent in new vial. Separate Priority with Same Material Placed On Two Sides of the Analyzer Vial priority is set based on the ability of the reagent to be transported. For example, if four vials of Material A are placed on the system (two on the Sample side, and two on the Reagent side) the two vials on the Sample side are assigned priority 1 and 2, and the two vials on the Reagent side are also assigned priority 1 and 2. 487 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 5 – Preparing the System Reagent/Diluent Area For TOP 300 CTS, the diluent rack is accessible by the sample probe and reagent probe. However, priority for reagents in the diluent rack is assigned to the sample probe. Reagents for the sample probe in the diluent rack receive separate priority as identical reagents in reagent racks. When reagents in the reagent racks are used up or expired, the reagent probe accesses the reagent in the diluent rack regardless of priority. Expiration date The reagent lot’s expiration date as established by the manufacturer. W arnings and errors List of warning and error message issued against the reagent in that rack position. Double-click this field to display a window with the complete text of the message. Some possible messages are: l Low material volume l Empty material l Lot not defined l Material placement error l Inconsistent bottle size l Stability expired l Material expiration l Material not stirred R emaining stability The number of days, hours and minutes the reagent remains stable on-board the analyzer. On-board volume The current volume of reagent (in mL) on-board the analyzer. R eagent color codes On the far left of each reagent position is a colored circle that conveys additional information concerning the reagent in that position, as follows: Not placed Gray Placed, not identified Green with a question mark Placed, identified Green Placed, warning Amber Placed, error Red In use Green surrounded by a heavy black circle In use, warning Amber surrounded by a heavy black circle In use, error Red surrounded by a heavy black circle See Reagent Color Codes and LED Status Color Codes. 488 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 5 – Preparing the System Reagent/Diluent Area W orking information The working information refers to the attributes of a bar coded reagent vial on-board. It is used by the system to determine test feasibility and reagent on-board stability. The vial bar code contains the material name, expiration date, lot number, and vial size. If the reagent or diluent rack is removed from the instrument and replaced, the bar code scan determines whether the reagent vial is the same as the vial that was removed. The working information of a vial (onboard stability) is retained under the following conditions: l The vial must be reinserted into the same position from which it was removed. l The vial must be reinserted within one hour after removal. l The volume of fluid in the reagent vial cannot change by more than 30%. Offline Racks The racks to the far left and far right represent offline racks on your workbench. You can pre-program the diluents on the left offline rack, or the reagents on the right offline rack before inserting them into the analyzer. You can also program a rack after it has been inserted, but it is often preferable to do it beforehand. See Material Identification. NOTE: If for any reason a sample, diluent or reagent material that you manually program on an offline rack (through the Control Module1) does not match the bar code on the tube or bottle, an error is issued. This includes failing to program a material the instrument detects. NOTE: When loading sample, diluent, or reagent racks, pull the rack out all the way before loading. Pulling a rack out partially while loading or changing bottles, tubes, or sample cups may result in misidentification of rack contents. 1A Microsoft Windows™ PC running the ACL TOP software developed by IL. The CM provides the User Interface and data management functionality. The CM connects to the Analytical Module and provides the high level controls. 489 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 5 – Preparing the System Reagent/Diluent Area Diluent Rack Details Screen This screen is functionally similar to the reagent Rack Details screen described in this topic. The Diluent Area includes the 1-3 tracks, depending on the model. The diluent rack holds up to 8 calibration/NPP plasmas, QC materials, and sample dilution materials in original bottles placed on the racks, or up to 8 intermediate reagents, deficient plasmas, reagent dilution materials. See Test Feasibility for proper placement of all reagents. Each diluent rack can hold two large bottles and six small bottles. The first two positions of the diluent rack can be used for 4 mL, 10 mL, and 20 mL bottles when the correct adapter is inserted into the position on the rack. (See Diluents.) Rack Representation The diluent rack representation on the screen is: NOTE: l Material #1 is at the top; material #8 is at the bottom. l You may notice a slight resistance when you are inserting or removing racks. This is normal. 490 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 5 – Preparing the System Reagent/Diluent Area LED When the rack is in use (during aspiration of material) it is locked and an amber LED displays for the track position. When the rack is no longer in use the LED changes to green and the rack is released. See Also l Material Programming Window l Reagent Color Codes l Test Feasibility l Restriction Maps l LED Status Color Codes 491 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 5 – Preparing the System Test Feasibility Test Feasibility Test Feasibility checks whether all the materials a selected test needs are available and usable. It answers the question: Why won't my test run? The Test Feasibility window identifies the reagents required to run the test, and where to place them on the instrument (rack and position). NOTE: See Restriction Map for general placement of samples and reagents. Accessing The Test Feasibility List To access the Test Feasibility List: 1. Select the Sample Area , Diluent Area open the Sample, Diluent or Reagent Area. or Reagent Area icon in the toolbar to 2. Select Actions > Review > Test Feasibility List in the menu bar, or select the Test Feasibility List icon in the toolbar. 3. The Test Feasibility List window opens, where you can view information on the Test Feasibility List and QC Feasibility List tabs. Test Feasibility List window 492 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 5 – Preparing the System Test Feasibility Test Feasibility List Tab Test C ode Tests defined on the system. General C onsistency If checked, the test is set up correctly and can run. General Feasibility Feasibility status of normal and extended tests. The following values can appear in this column: l l X – One or more materials are not placed on-board, or are placed in the wrong position, or are placed with insufficient volume. Black number – The test is feasible, and the materials are correctly placed. The value indicates the approximate number of tests that can run based on the usable volume1 of materials on-board. l Black zero – An insufficient volume of material is placed on-board. l Yellow number – The test is feasible, but there is no valid calibration for the on-board lot. Clicking a cell in this column displays a window with the following information: l List of the materials required to run the test. l Material types. l Positions where the materials should be placed on-board. l Number of tests that can run with the volumes of material on-board. l A red X in the # Tests column indicates: 1) An insufficient volume of material on-board; or 2) The materials may not be in the correct rack position. The following message appears in the Status bar: Job not feasible: Needed materials not placed, incorrect placement or empty volume. NOTE: The numbers displaying how many tests are feasible are approximate, and should be used only as a guide. 1The total volume of liquid in a specific material bottle minus the dead (unusable) volume of that bottle. 493 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 5 – Preparing the System Test Feasibility Required materials may include some or all of the following, depending on what has been defined: l Load cycle reagents l Load cycle sample diluents l Load cycle reagent diluents l Clean materials for load cycle materials l Predilution diluent l Predilution diluent clean l Rerun predilution diluent l Rerun predilution diluent clean. Parallelism Feasibility All tests for which parallelism has been defined have either a red X or a number. The following values can appear in this column: l l X – One or more materials are not placed on-board, or are placed in the wrong position, or are placed with insufficient volume. Black number – The test is feasible, and the materials are correctly placed. The value indicates the approximate number of tests that can run based on the usable volume1 of materials on-board. l Black zero – An insufficient volume of material is placed on-board. l Yellow number – The test is feasible, but there is no valid calibration for the on-board lot. Clicking a cell in this column displays a window with the following information: l List of the materials required to run the test. l Material types. l Positions where the materials should be placed on-board. 1The total volume of liquid in a specific material bottle minus the dead (unusable) volume of that bottle. 494 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 5 – Preparing the System Test Feasibility l l Number of tests that can run with the volumes of material on-board. A red X in the # Tests column indicates: 1) An insufficient volume of material on-board; or 2) The materials may not be in the correct rack position. The following message appears in the Status bar: Job not feasible: Needed materials not placed, incorrect placement or empty volume. C alibration Feasibility All tests for which calibration has been defined and do not use an imported calibration have either a red X or a number. The following values can appear in this column: l l l X – The required materials are not placed in the correct positions, or there is no validated calibration for the on-board lot. Black number – The test is feasible and the materials have been correctly placed. The number indicates the approximate number of tests that can run with the usable volume1 of materials on-board. Black zero – An insufficient volume of material is placed on-board. Clicking a cell in this column displays a window with the following information: l List of the materials required to run the test. l Material types. l Positions where the materials should be placed on-board. l Number of tests that can run with the volumes of material on-board. l A red X in the # Tests column indicates: 1) An insufficient volume of material on-board; or 2) The materials may not be in the correct rack position. The following message appears in the Status bar: Job not feasible: Needed materials not placed, incorrect placement or empty volume. QC Feasibility See QC Feasibility List tab. The following values can appear in this column: l l l Black Check Mark – QC for the test is feasible. All materials (reagents and controls) are correctly placed and have sufficient volume. Gray Check Mark – Some of the materials do not have sufficient volume to run the test. QC can run using the controls that are present in sufficient volume. See Grid Icons. X – QC is not feasible. 1The total volume of liquid in a specific material bottle minus the dead (unusable) volume of that bottle. 495 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 5 – Preparing the System Test Feasibility N PP Feasibility All tests for which NPP1 has been defined have either a red X or a number. The following values can appear in this column: l l X – One or more materials are not placed on-board, or are placed in the wrong position, or are placed with insufficient volume. Black number – The test is feasible, and the materials are correctly placed. The value indicates the approximate number of tests that can run based on the usable volume2 of materials on-board. l Black zero – An insufficient volume of material is placed on-board. l Yellow number – The test is feasible, but there is no valid calibration for the on-board lot. Clicking a cell in this column displays a window with the following information: l List of the materials required to run the test. l Material types. l Positions where the materials should be placed on-board. l Number of tests that can run with the volumes of material on-board. l A red X in the # Tests column indicates: 1) An insufficient volume of material on-board; or 2) The materials may not be in the correct rack position. The following message appears in the Status bar: Job not feasible: Needed materials not placed, incorrect placement or empty volume. 1Normal Pool Plasma. A type of sample used as a standard of comparison when calculating the International Normalized Ratio (INR) and when calculating test results that use the normalized ratio. 2The total volume of liquid in a specific material bottle minus the dead (unusable) volume of that bottle. 496 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 5 – Preparing the System Test Feasibility QC Feasibility List Tab Test C ode Lists all tests for which QC has been defined. Material name Lists all the QC controls defined for the test. QC Feasibility Number of QC tests that can run with the usable volume1 on-board. Clicking a cell in this column displays a window with the following information: l List of the materials required to run the test. l Material types. l Positions where the materials should be placed on-board. l Number of tests that can run with the volumes of material on-board. 1The total volume of liquid in a specific material bottle minus the dead (unusable) volume of that bottle. 497 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 5 – Preparing the System Test Feasibility l A red X in the # Tests column indicates: 1) An insufficient volume of material on-board; or 2) The materials may not be in the correct rack position. The following message appears in the Status bar: Job not feasible: Needed materials not placed, incorrect placement or empty volume. Refresh/Close Select Refresh to refresh the contents of the window. Select Close to close the window. LAS Test Feasibility A sample with tests that are not feasible remains in the LAS Cuvette Holding Area until all tests become feasible, or until the sample expiration time elapses. See Also l Material Definition – Smallest Volume 498 of 992 L0027503450 R00 ACL TOP Family Operator's Manual CHAPTER 6 STARTING AND STOPPING THE INSTRUMENT Starting and Stopping Overview To start or stop the instrument, select one of the following: l Starting the Instrument l Shutting Down the Instrument l Emergency Stop l Controlled Stop l Recovery l Resume Auto Run Starting the Instrument To start the instrument: 1. Make sure the access cover is closed. 2. Power on the CM1. 3. Power on the AM2 using the On/Off switch on the right side of the analyzer. 4. Double-click the ACL TOP icon on the desktop. 5. Log onto the ACL TOP instrument. See Recovery for starting the instrument after an emergency stop. The analyzer mechanical initialization process takes about three minutes. After initialization, the AM enters the Adjusting Thermal state to regulate all thermally controlled devices. The time for the AM to reach specified temperature (Power-Up to Ready) with empty sample and reagent modules takes approximately 30 minutes at a nominal operating temperature of 25° C. At the extreme 1A Microsoft Windows™ PC running the ACL TOP software developed by IL. The CM provides the User Interface and data management functionality. The CM connects to the Analytical Module and provides the high level controls. 2The part of the instrument where sample processing and testing are performed. Also called the Analyzer or the Analytical Module. 499 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 6 – Starting and Stopping the Instrument Starting the Instrument operating temperatures of 15° C and 32° C, it takes approximately 60 minutes with empty sample and reagent modules. NOTE: l l A rinse flow verification test is performed automatically by the instrument at the end of mechanical initialization. However, it does not start if the cuvette loader is Empty or if there is a Rinse Bottle Empty error or Low warning. If a probe fails this test (each probe can retry one additional time), a Rinse Flow Test Failure message appears. If any probe coordinates files are missing, the instrument status changes from Initializing to Error, and you must select System > Diagnostics > Probes and perform the coordinates adjustment for the affected arm(s) before the instrument can complete initialization. When you exit Diagnostics, mechanical initialization is performed automatically by the instrument. See Probes/Coordinates Adjustment. The time required to stabilize depends on the ambient temperature and initial conditions of the system. The system is ready to use when the status LED is green and the CM displays Ready. Normally, the instrument is kept running continuously. Automatic maintenance procedures such as periodic fluidic priming cycles ensure the system is Ready for analysis at all times. See Also l Starting and Stopping Overview 500 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 6 – Starting and Stopping the Instrument Shutting Down the Instrument Shutting Down the Instrument To shut down the instrument: 1. Make sure the AM1 in the Ready state. 2. Select Instrument > Exit in the menu bar. 3. Select OK in the confirmation dialog box. The AM begins an abbreviated mechanical initialization to place the analyzer into a known safe state. 4. At the conclusion of the mechanical initialization, turn off the AM. The switch is located on the right side of the analyzer. 5. Shut down the CM2 according to standard Windows procedures. NOTE: After you print or export a report or a list, you may not be able to perform certain operations, such as shutting down the instrument. The system may seem to lock up. When you print or export, the Print/Export dialog box opens. If you click anywhere on the ACL TOP screen, or select a menu item before you select Confirm or Cancel in the dialog box, the dialog box moves behind the ACL TOP application window, preventing you from doing anything else. You must: 1) minimize the ACL TOP application window; 2) select Confirm or Cancel; 3) then maximize the ACL TOP window. You can also press ALT+Tab to display the Print or Export dialog box. See Also l Starting the Instrument l Starting and Stopping Overview l Emergency Stop l Controlled Stop l Recovery 1The part of the instrument where sample processing and testing are performed. Also called the Analyzer or the Analytical Module. 2A Microsoft Windows™ PC running the ACL TOP software developed by IL. The CM provides the User Interface and data management functionality. The CM connects to the Analytical Module and provides the high level controls. 501 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 6 – Starting and Stopping the Instrument Emergency Stop Emergency Stop An emergency stop immediately terminates all operations and motion on the Analyzer1. An emergency stop can be performed when the instrument is in any state except Not Connected, even when no user is logged on. To perform an emergency stop l Press the red emergency stop button on the front of the Analyzer. See Also l Starting the Instrument l Starting and Stopping Overview l Emergency Stop l Controlled Stop l Recovery 1The part of the instrument where sample processing and testing are performed. Also called the AM or the Analytical Module. 502 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 6 – Starting and Stopping the Instrument Controlled Stop Controlled Stop The Instrument > Controlled Stop menu command stops the ACL TOP instrument from processing new samples. This is a user-initiated controlled stop as opposed to the instrument-initiated controlled stop. These two operations are the same. They complete samples that have started testing, then return the Analytical Module1 to the READY state. Tests that had not started when the controlled stop initiated return to the PLACED state. Performing a Controlled Stop To perform a controlled stop: 1. Select Instrument > Controlled Stop in the menu bar. 2. Select OK on the confirmation dialog box. NOTE: If you select Cancel or close the confirmation dialog box without selecting OK, the controlled stop request is canceled. TOP 700 LAS Controlled Stop Since the ACL TOP 700 LAS system has Auto Run always enabled, you need the ability to stop processing samples at any time. The LAS Controlled Stop choice on the Instrument menu stops processing new samples. This is a user-initiated controlled stop. If selected while the instrument is in the BUSY state, it allows the tests that have already started to complete. Tests that had not started when the LAS Controlled Stop was initiated return to the PLACED state. When the ACL TOP 700 LAS status is Stopped the following applies: l New tubes from the LAS track are rejected. l No new aspirations are performed. l The sample tube currently in use is held at the track aspiration point. 1The part of the instrument where sample processing and testing are performed. Also called the AM or the Analyzer. 503 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 6 – Starting and Stopping the Instrument Resume Auto Run Performing a Controlled Stop on an ACL TOP 700 LAS Instrument To perform an LAS Controlled Stop: 1. Select Instrument > LAS Controlled Stop in the menu bar. 2. Select OK on the confirmation dialog box. NOTE: If you select Cancel or close the confirmation dialog box without selecting OK, the controlled stop request is canceled. 3. After the LAS controlled stop completes, do one of the following to start a new analytical session. The instrument status changes from Stopped to Ready. l Select Instrument > Resume Auto Run in the menu bar. l Select the Run l Select Actions > Map > Run Tests in the menu bar. icon in the toolbar. See Also l Starting and Stopping Overview l Resume Auto Run Resume Auto Run If any of the following conditions occur, the instrument disables Auto Run: l The AM status is not READY. l Sample status is not PLACED. l Enhanced clean is required. l Temperatures are out of range. l All ORUs are disabled. To re-start Auto Run: 1. Hover the cursor over the red LED on the screen to display a tooltip stating cause of the error. 2. Correct the error. 3. Select Instrument > Resume Auto Run in the menu bar. 4. The Auto Run status changes to Ready and the Auto Run function starts again. See Also l Run / Auto Run 504 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 6 – Starting and Stopping the Instrument Recovery Recovery Recovery initializes the system and returns the instrument to the Ready state after an emergency stop. Overview After an emergency stop occurs and recovery is performed, the sample and reagent rack information is retained when both of the following conditions are met: l The bar code reader is not moved. l The covers are not opened during the emergency stop. After recovery, select the Run icon in the toolbar to run tests on samples in the TO DO state. LA S On the TOP 700 LAS model, after an emergency stop has occurred and recovery is initiated, the Analytical Module1 notifies the Control Module2 of all cuvettes detected in the LAS aspiration area, the LAS holding area, and in the shuttle. Only cuvettes with successfully aspirated sample and tests programmed are restored. Cuvettes that are empty or have partially aspirated samples are not restored and are eventually moved to the cuvette waste. Performing a Recovery Operation To perform recovery: 1. <Optional> To retain sample and reagent rack information, do not move the bar code reader or open the instrument covers while the instrument is in the emergency stop. 2. Select Instrument > Recovery in the menu bar. 3. If the bar code reader was moved or the covers opened during the emergency stop, remove the racks and reinsert them into the instrument to restore sample and reagent rack information that was lost during recovery. 1The part of the instrument where sample processing and testing are performed. Also called the AM or the Analyzer. 2A Microsoft Windows™ PC running the ACL TOP software developed by IL. The CM provides the User Interface and data management functionality. The CM connects to the Analytical Module and provides the high level controls. 505 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 6 – Starting and Stopping the Instrument Recovery Performing a Forced Recovery Use this procedure if the instrument stalls. To perform a forced recovery: 1. <Optional> To retain sample and reagent rack information, do not move the bar code reader or open the instrument covers while the instrument is in the emergency stop. 2. Press the emergency stop button on the front of the instrument. 3. Select Instrument > Recovery in the menu bar. 4. If the bar code reader was moved or the covers opened during the emergency stop, remove the racks and reinsert them into the instrument to restore sample and reagent rack information that was lost during recovery. See Also l Starting and Stopping Overview 506 of 992 L0027503450 R00 ACL TOP Family Operator's Manual CHAPTER 7 CALIBRATION Calibration Details Overview Calibration allows for the conversion of a measured value (raw data) to a value expressing units of concentration or activity of the analyte. The analyzer makes dilutions, adds reagents, and takes readings, then generates a calibration curve. After a calibration is complete, you can review the calibration results and manually validate them so they can be used to calculate sample results. When you validate a calibration, you confirm that the calibration results are valid for a particular lot of calibrator1 and reagent. You can also autovalidate the calibration results. See Auto Validation Setup The ACL TOP instrument can store the ten most recent calibrations, but only one calibration can be validated at any time. After the 11th calibration runs, the oldest calibration is removed from the Calibration Details screen. The validated calibration is never removed. NOTE: If you change the parameters of a user-defined test so the analytical performance of that test is affected, you must recalibrate that test. See User-Defined Tests disclaimer. NOTE: A calibration will become an alternate lot if any of the material lots (other than the calibrator) used to generate the active calibration are no longer on-board the system. When a calibration changes from active to alternate, the calibration status changes from validated to unvalidated. 1A type of sample with an assigned value used to calibrate a test. 507 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 7 – Calibration Calibration Details Reviewing and Validating Calibration Test Results To review and validate calibration test results: 1. Select Calibration > Status List in the menu bar. 2. In the Calibration Status List, double-click a test code, or select a test code and select the Calibration Details icon to open the Coagulation Calibration Details screen. By default, the Calibration Details screen opens displaying the validated calibration. If a test has no validated calibration, the Calibration Details screen displays Calibration 1. 3. Select the Calibration Curve tab to view the calibration curve and results for the various dilutions. 4. Select the Calibration Information tab to view calibration status information. 5. Select the Reactions Information tab to view the reaction curves for each point on the calibration curve as well as errors and warnings for specific data points. 6. Select the Tracking Information tab to view lot specific information for the materials used and a log of all comments related to the calibration. 7. To add or edit a comment in the Tracking Information tab, select the Comments icon in the toolbar. The system also prompts you for comments after you make any edits in the Coagulation Calibration Details screen. 8. To validate a calibration, select the tab with the calibration to validate (e.g., Calibration 1, 2, etc.), and select the Validate icon in the toolbar. The calibration data is stored in the system and is used to calculate calibrated results for future tests. Validation is not possible if any calibration check fails. 9. To recalculate a calibration, select the Recalculate Calibration icon. This replots the calibration curve according to the current test and material definitions. When recalculating calibration results, the system uses the calibrator lot number used during execution. If the lot number does not exist or the proper assigned values are not accessible, the recalculation fails. See Reviewing Test Results. 10. Select the Save icon in the toolbar to save your changes. 11. Select the Previous Screen icon in the toolbar to return to the Calibration Status List. NOTE: l l If the calibration result has a warning and you validate the result despite the warning, that warning is not posted to the sample results. You are responsible for acknowledging the warning and ignoring it. Failed calibrations may not be validated. 508 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 7 – Calibration Calibration Details l A calibration will become an alternate lot if any of the material lots (other than the calibrator) used to generate the active calibration are no longer on-board the system. When a calibration changes from active to alternate, the calibration status changes from validated to unvalidated. Viewing Calibration Curves To view a curve in the Calibration Curve tab: 1. Open a test in the Coagulation Calibration Details screen. 2. Select the Calibration Curve tab. 3. Double-click the curve to enlarge the window. 4. Select Actions > Configuration > Multiple Math Model View in the menu bar to display a calibration curve that is a combination of two curve segments. A solid vertical line shows the point in the curve at which the math model segments meet. 5. To view each segment individually, select Actions > Configuration > Math Model High View or Math Model Low View in the menu bar. 6. Select the Previous Screen icon in the toolbar to return to the Calibration Status List. HINT: If the scale makes the curve unreadable, clear the Enable Display Transformed Axes option and reselect it to display the points properly. The Multiple Math Model View is the default view. The selected view is named in the title bar. 509 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 7 – Calibration Calibration Details Deleting a Calibration Point Value To delete a calibration point value: 1. Open a test in the Coagulation Calibration Details screen. 2. Select the Calibration Curve tab. 3. In the table of data point values, double-click the point value to delete in the Replicate column. 4. Select the point value in the table again to highlight it. 5. Press the Delete key on the keyboard. 6. Click elsewhere on the tab screen to see the curve with the deleted value. A deleted point value appears in the table as parentheses, and in the calibration curve as an X. 7. To restore the deleted point value before saving, select Actions > Calibration > Restore in the menu bar. 8. Select the Save icon in the toolbar to save your changes. 9. To restore the deleted point value after saving, select the Recalculate Calibration icon. This replots the calibration curve according to the current test and material definitions. When recalculating calibration results, the system uses the calibrator lot number used during execution. If the lot number does not exist or the proper assigned values are not accessible, the recalculation fails. See Reviewing Test Results. 10. Select the Previous Screen icon in the toolbar to return to the Calibration Status List. 510 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 7 – Calibration Calibration Details Printing and Exporting a Calibration Report To print or export a calibration report for a completed test: 1. Open a test in the Coagulation Calibration Details screen. 2. Select the Print icon in the toolbar, or select Actions > Print in the menu bar. 3. To export the calibration report, select Actions > Export in the menu bar. See Exporting Data. C alibration R eport A calibration report includes the following information: l Test code l Calibration unit l Date and time performed l Date and time validated l Calibrator materials (up to eight are listed) l In case of manually diluted calibrations, all calibrator materials are listed including: l l l o Diluent name o Validation status o Calibration status o Master calibration test code Result information including: o Regression type o X-Axis transformation o Y-Axis transformation Calibration factors including: o Y Intercept o Slope o r2 o Errors and warnings For each concentration the following is printed: o Concentration if automatic pre-dilution is used o Calibrator material if manual pre-dilution is used o Concentration – assigned value o Concentration – CV% o Concentration – mean value 511 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 7 – Calibration Calibration Details o Replicate value (printed once for each replicate up to a maximum of 6) – If a replicate value is a detected value, it is displayed in brackets [ ]. If it is an edited value, it appears on the report in bold characters. If it is an omitted value it is displayed in braces { }. NOTE: After you print or export a report or a list, you may not be able to perform certain operations, such as shutting down the instrument. The system may seem to lock up. When you print or export, the Print/Export dialog box opens. If you click anywhere on the ACL TOP screen, or select a menu item before you select Confirm or Cancel in the dialog box, the dialog box moves behind the ACL TOP application window, preventing you from doing anything else. You must: 1) minimize the ACL TOP application window; 2) select Confirm or Cancel; 3) then maximize the ACL TOP window. You can also press ALT+Tab to display the Print or Export dialog box. 512 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 7 – Calibration Calibration Details Calibration Details Screen Calibration Curve Tab This tab contains important information to help you decide which calibration to validate. NOTE: The X-axis is calibrated from the smallest measured value, not from zero. Calibration Statistics Slope If the Slope Check option is enabled for the test, this value is checked to verify that the curve falls within the acceptable slope range. R 2 Value If the R2 Check is enabled for the test, this value is checked to verify that the curve falls within the acceptable R2 range. Y-Intercept If the Y-Intercept Check has been enabled for the test, this value is checked to verify that it falls within the acceptable y-intercept range. 513 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 7 – Calibration Calibration Details A djusted Y Part of the calibration slope calculation for the linear regression math model only. If the slope cannot be calculated, the Y-Intercept field is blank. N PP If NPP mode is enabled and the mode is Derived from Calibration, the NPP measured result is displayed (mean value of replicates of the selected calibration dilution). N PP Value If NPP mode is enabled, and the mode is Derived from Calibration, the NPP1 calibrated result is displayed (target value of the selected calibration dilution). Enable Display Transformed Axes Option to enable toggling between the current calibration graph display mode (no axis transformation, x = time and y = measured unit) and the transformed axes mode. See Viewing Calibration Curves. HINT: If the scale makes the curve unreadable, clear the Enable Display Transformed Axes option and reselect it to display the points properly. Point Value Table Column Headings C alc. Value Calculated value for the mean of each calibration dilution. %C V CV calculated for the replicates of a dilution. If the Enable %CV Check option is enabled, this value is checked to verify that it is less than the maximum %CV allowed. %CVs greater than the maximum allowed CV are displayed in red text. This value is not reported if the level has less than 3 replicate values. Mean Value Mean of the replicates for a dilution. 1Normal Pool Plasma. A type of sample used as a standard of comparison when calculating the International Normalized Ratio (INR) and when calculating test results that use the normalized ratio. 514 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 7 – Calibration Calibration Details Multiple Math Model For factor tests having multiple math models using polynomial equations defined for the calibration, the Calibration Curve tab screen shows the polynomial coefficients as exponents. See Viewing Calibration Curves. C alibration R esult with Math Model H igh 515 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 7 – Calibration Calibration Details Calibration Information Tab Displays important status information about the calibration, including the following: l Test execution date/time l Validation status l Validation date/time l Errors and warnings – QC overdue or failed, Maintenance overdue or failed, Results recalculated l Other general information. 516 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 7 – Calibration Calibration Details Reactions Information Tab Displays the following: l l Reaction curves for each point in the calibration curve Errors and warnings specific to that data point. (Temperature errors and warnings are flagged only on replicates, not on the test as a whole.) To view the reaction curve for a particular dilution replicate: 1. Double-click the value in the Replicate column. 2. Double-click the reaction curve to enlarge the window. No reaction curve is displayed for points that are manually edited. 517 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 7 – Calibration Calibration Details Tracking Information Tab Displays the following for the active or alternate lot material used for the test selected in the Calibration Status List: l Material name l Lot number l Expiration date l Comments log for the calibration 518 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 7 – Calibration Calibration Details Comments You can view and enter comments in the Comments field. Comments contain Time, Date, and User ID. See Viewing Calibration Curves. See Also l Calibration Status List l Calibration Setup l Performing a Calibration l Reviewing Test Results l Auto Validation Setup 519 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 7 – Calibration Calibration Status List Calibration Status List Accessing the Calibration Status List To view the Calibration Status List: 1. Select Calibration > Status List in the menu bar. 2. To print a Calibration Status List, select the Print icon in the toolbar. 3. To export the Calibration Status List Report, select Actions > Export in the menu bar. 4. See Calibration Details. NOTE: After you print or export a report or a list, you may not be able to perform certain operations, such as shutting down the instrument. The system may seem to lock up. When you print or export, the Print/Export dialog box opens. If you click anywhere on the ACL TOP screen, or select a menu item before you select Confirm or Cancel in the dialog box, the dialog box moves behind the ACL TOP application window, preventing you from doing anything else. You must: 1) minimize the ACL TOP application window; 2) select Confirm or Cancel; 3) then maximize the ACL TOP window. You can also press ALT+Tab to display the Print or Export dialog box. NOTE: A calibration will become an alternate lot if any of the material lots (other than the calibrator) used to generate the active calibration are no longer on-board the system. When a calibration changes from active to alternate, the calibration status changes from validated to unvalidated. 520 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 7 – Calibration Calibration Status List Calibration Status List screen This screen contains the following status information for tests with calibration enabled and defined: l Test Code l Calibrator l Job Status l Unit l Frequency Status l Overdue Date and Time l Last Validated l Frequency l Last Completed See Also l Calibration Details l Calibration Setup l Performing a Calibration 521 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 7 – Calibration Performing a Calibration Performing a Calibration Before Programming a Calibration The following conditions must be met before programming a calibration. 1. Define the calibration materials. See Calibration Setup. 2. In the Test Definition screen, define the calibration units. See Result Unit Definition. 3. Place all reagents, diluents and calibrators in the appropriate positions on the instrument. See Test Feasibility for proper placement of all reagents. 522 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 7 – Calibration Performing a Calibration Programming a Calibration in the Calibration Details screen Use this procedure when working with calibrator1 material placed in the original bottle on a diluent rack inserted into a diluent track. NOTE: When a calibration is programmed in the Calibration Details screen and the test is not feasible because the calibration plasma has expired, the instrument uses calibration plasma from other placed bottles, taking first from an active lot placed in track D1, then from an alternate lot placed in track D1. 1. Make sure the required conditions are met. 2. Select Calibration > Status List in the menu bar. 3. In the Calibration Status List double-click a test, or select a text and select the View the toolbar. icon in By default, the Calibration Details screen opens displaying the validated calibration. If a test has no validated calibration, the Calibration Details screen displays Calibration 1. 4. Select the Program menu bar. icon in the toolbar, or select Action > Calibration > Program in the NOTE: After selecting the run command, the following apply: l l l l l If an enhanced clean is required, the instrument prompts you to perform it. Press OK to abort running the test. You must perform the enhanced clean before running the test. See Enhanced Clean in Performing Maintenance Activities. If the temperature is out of range, the instrument prompts you to confirm the run command or cancel and wait until temperatures are in range. The instrument prompts you with a list of the disabled ORUs, if any, as a warning about throughput changes. Confirm or cancel the run. A new calibration test cannot be programmed if it is running or scheduled to run. A calibration will become an alternate lot if any of the material lots (other than the calibrator) used to generate the active calibration are no longer on-board the system. When a calibration changes from active to alternate, the calibration status changes from validated to unvalidated. 1A type of sample with an assigned value used to calibrate a test. 523 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 7 – Calibration Performing a Calibration Programming a Calibration in the Sample Rack Details screen Use this procedure when working with calibrator material placed in a sample container on a sample rack. 1. Select the Sample Area bar. icon in the toolbar, or select Analysis > Sample Area in the menu 2. Select the Rack Details rack. icon in the toolbar to open the Rack Details screen for the appropriate 3. Select Cal/NPP in the Sample Type drop down list. 4. Select a material in the Sample ID drop down list. 5. Select the Cal1 option beside the Sample ID list. 6. If lot management is enabled, select the Active Lot or Alternate Lot button. 7. Select the Add/Remove Tests icon to open the Tests and Profiles dialog box. 8. Double-click one or more test cells on the right side of the screen and select tests in the Test Programming Window to add to the Rack Details screen. 9. Select the Run icon in the toolbar. NOTE: After selecting the run command, the following apply: l l l l If an enhanced clean is required, the instrument prompts you to perform it. Press OK to abort running the test. You must perform the enhanced clean before running the test. See Enhanced Clean in Performing Maintenance Activities. If the temperature is out of range, the instrument prompts you to confirm the run command or cancel and wait until temperatures are in range. The instrument prompts you with a list of the disabled ORUs, if any, as a warning about throughput changes. Confirm or cancel the run. A calibration will become an alternate lot if any of the material lots (other than the calibrator) used to generate the active calibration are no longer on-board the system. When a calibration changes from active to alternate, the calibration status changes from validated to unvalidated. You can now Review and Validate calibration results. See Also l Calibration Details l Calibration Status List l Calibration Setup 1Calibrator. A type of sample with an assigned value used to calibrate a test. 524 of 992 L0027503450 R00 ACL TOP Family Operator's Manual CHAPTER 8 NORMAL POOL PLASMA NPP Status Details Overview Normal Pool Plasma (NPP) is a type of sample used to generate a standard value that is used to calculate ratio and INR1 results. The ACL TOP instruments use calibration data, normal range data, or NPP sample data to generate an NPP value. NOTE: If the measured result is 0, the Ratio and INR results fail. The ACL TOP instrument stores the five most recent NPP results per test. After the sixth NPP sample is run, the oldest NPP data is removed from the NPP Details screen. Reviewing NPP Results To review status and NPP test results: 1. Select NPP > Status List in the menu bar. 2. <Optional> Click a column to sort the NPP Status List by ascending or descending order. 3. Do one of the following to open the NPP Details screen. l Double-click a test in the list. l Place focus on the test code and select the NPP Details l Select Actions > Review > NPP Details in the menu bar. icon. 4. Select the General Information tab to view important status information about the NPP. 5. Select the Reaction Information tab to view the reaction curves, result values, and errors and warnings for each NPP replicate. 6. Select the Tracking Information tab to view lot information for the NPP material and the comments log. 1International Normalized Ratio. This value is used to standardize the reporting of Prothrombin Time (PT) worldwide. 525 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 8 – Normal Pool Plasma NPP Status Details Recalculating NPP Test Results To recalculate the results of the NPP test displayed in the active tab: 1. Make sure the NPP test has completed. 2. Open the test in the NPP Details screen. 3. Select the Recalculate Results icon, or select Actions > NPP > Recalculate in the menu bar. The NPP test results update after the operation completes. This operation uses the current validated calibration with the same lot number. NOTE: When recalculating results, the system uses the ISI value from the lot that matches the material used during the test. If the lot used during test execution is no longer in the system, or the current material with ISI value was not used during the execution, the INR result fails. See Reviewing Test Results for information on recalculation. Printing an NPP List Report To print an NPP List report: 1. Select NPP > Status List. 2. Select Actions > Print in the menu bar, or select the Print icon. An NPP List report includes the following information: l Test code l NPP material l NPP unit l Frequency status l Overdue date and time l Frequency, including: o Automatic execution enabled o Last executed date and time 526 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 8 – Normal Pool Plasma NPP Status Details Printing an NPP Results Report To print an NPP Results report: 1. Select NPP > Status List. 2. Double-click a test in the NPP Status List, or select Actions > Review > NPP Details in the menu bar to open the NPP Details screen. 3. Select Actions > Print Screen in the menu bar, or select the Print icon. An NPP Results report includes the following information: l Test code l NPP material l Frequency status l Rack ID l Position l Date and time performed l Errors and warnings l For each replicate the following information is included: l o Measured value + Measured unit o Calibrated value + Calibrated unit o Replicate errors o Reaction curve Test tracking information Exporting a Report To export a report: 1. Select NPP > Status List in the menu bar. 2. Double-click a test in the NPP Status List to open the NPP Details screen. 3. Select Export to export the NPP List report or the NPP Results report. 4. In the Export dialog box, select the format and destination in the respective fields. 5. Click OK. See Exporting Data. NOTE: After you print or export a report or a list, you may not be able to perform certain operations, such as shutting down the instrument. The system may seem to lock up. When you print or export, the Print/Export dialog box opens. If you click anywhere on the ACL TOP screen, or select a menu item before 527 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 8 – Normal Pool Plasma NPP Status Details you select Confirm or Cancel in the dialog box, the dialog box moves behind the ACL TOP application window, preventing you from doing anything else. You must: 1) minimize the ACL TOP application window; 2) select Confirm or Cancel; 3) then maximize the ACL TOP window. You can also press ALT+Tab to display the Print or Export dialog box. NPP Status List Screen The NPP Status List contains current status information for tests that are NPP-enabled and defined exclusively as NPP Run as Sample. The table contains the following columns: l Test Code l Material l Job Status l Unit l Frequency Status l Overdue Date and Time l Frequency l l Auto Execution Mode Last Completed 528 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 8 – Normal Pool Plasma NPP Status Details NPP Details Screen General Information Tab Displays the following NPP status information: l Test execution date/time l Validation status l Validation date/time l Errors and warnings l Other general information Reaction Information Tab Displays the reaction curves, result values, and errors and warnings for each NPP replicate. Tracking Information Tab Displays the following NPP material information: l Material name l Lot number l Expiration date l Comments log See Also l Normal Pool Plasma Setup l Performing a Normal Pool Plasma Measurement 529 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 8 – Normal Pool Plasma NPP Status Details l Accessing Data Flags 530 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 8 – Normal Pool Plasma Performing a Normal Pool Plasma Measurement Performing a Normal Pool Plasma Measurement An NPP test can run as follows: l In the Sample Rack Details screen l In the NPP Details screen l Automatically by the system if the NPP mode is set to Run as sample. Before You Begin NPP 1. Define the NPP materials for the test. See Normal Pool Plasma Setup. 2. In the test definition, set the NPP mode to Run as Sample. See Normal Pool Plasma Setup. 3. Place the NPP materials in the appropriate positions on the analyzer. See Test Feasibility for proper placement of all reagents. Programming an NPP in the NPP Details screen Use the NPP method when working with NPP material placed in its original bottle on a diluent rack inserted into a diluent track. NOTE: If the NPP material has expired, and the NPP is run from the NPP Details screen, the instrument uses NPP material from other placed bottles, taking first from an active lot placed in track D1 or D2, then from an alternate lot placed in track D1 or D2. 1. Make sure the required conditions are met. 2. Select NPP > Status List in the menu bar. 3. Double-click a test. 4. Select the Program icon. NOTE: After selecting the run command, the following apply: l l l l If an enhanced clean is required, the instrument prompts you to perform it. Press OK to abort running the test. You must perform the enhanced clean before running the test. See Enhanced Clean in Performing Maintenance Activities. If the temperature is out of range, the instrument prompts you to confirm the run command or cancel and wait until temperatures are in range. The instrument prompts you with a list of the disabled ORUs, if any, as a warning about throughput changes. Confirm or cancel the run. A new NPP test cannot be programmed if it is running or scheduled to run. 531 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 8 – Normal Pool Plasma Performing a Normal Pool Plasma Measurement Programming an NPP from the Sample Rack Details screen Use the NPP method when working with NPP material placed in a sample container on a sample rack. 1. Select the Sample Area bar. icon in the toolbar, or select Analysis > Sample Area in the menu 2. Select the Rack Details rack. icon in the toolbar to open the Rack Details screen for the appropriate 3. Select Cal/NPP in the Sample Type drop down list. 4. Select a material in the Sample ID drop down list. 5. Select the NPP1 button beside the Sample ID list. 6. If lot management is enabled, select the Active Lot or Alternate Lot button. 7. Select the Add/Remove Tests icon in the toolbar to open the Tests and Profiles dialog box. 8. Double-click one or more test cells on the right side of the screen and select tests in the Test Programming Window to add to the Rack Details screen. 9. Select the Run icon in the toolbar. NOTE: After selecting the run command, the following apply: l l l If an enhanced clean is required, the instrument prompts you to perform it. Press OK to abort running the test. You must perform the enhanced clean before running the test. See Enhanced Clean in Performing Maintenance Activities. If the temperature is out of range, the instrument prompts you to confirm the run command or cancel and wait until temperatures are in range. The instrument prompts you with a list of the disabled ORUs, if any, as a warning about throughput changes. Confirm or cancel the run. Automatic NPP If Automatic NPP is enabled for the test, the system automatically performs an NPP measurement when the user-defined frequency interval expires. To enable Automatic NPP, see Normal Pool Plasma Setup. NOTE: Automatic NPP can only be performed using NPP material placed on a diluent rack inserted into a diluent track. 1Normal Pool Plasma. A type of sample used as a standard of comparison when calculating the International Normalized Ratio (INR) and when calculating test results that use the normalized ratio. 532 of 992 L0027503450 R00 ACL TOP Family Operator's Manual CHAPTER 9 QUALITY CONTROL QC Overview The ACL TOP instrument provides a quality control (QC) program that allows you to monitor performance characteristics of an analytical system for precision and accuracy as well as alert you to sources of unacceptable analytical performance. QC definitions must be set up before performing QC. See QC Setup Definition. QC Performed on Alternate Lots QC may be performed on alternate lots of QC materials to establish a new control range while the original material is processed. After a sufficient number of control determinations has been performed, the alternate lot can be activated. Alternate lot results are not used to flag patient sample results. The result data points may be displayed on the Levey-Jennings chart in a different color than the active lot result data points. See Reviewing QC Results. When the alternate lot has been automatically activated the following occurs: l The lot information is copied from the alternate lot to the active lot. l The existing active lot data is archived. l The alternate lot fields are set to their default values. l The alternate lot is disabled. Activating an Alternate Lot To activate an alternate lot: 1. Select QC > Results List in the menu bar. 2. Double-click a material name or test code in the results list. 3. Select the Activate Lot bar. icon in the toolbar, or select Actions > QC > Activate Lot in the menu See Also l Quality Controls l QC List 533 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 9 – Quality Control QC Results List l QC Profiles List l QC Results List l QC Setup Definition l QC Test Status List l Reviewing QC Results QC Results List The QC Results List screen displays the results obtained from the most recent QC measurement. Accessing the QC Results List To access the QC Results List: 1. Select QC > Results List in the menu bar. 2. Double-click a test code in the QC Results List to view the associated QC statistics. 3. See Reviewing QC Results. 534 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 9 – Quality Control QC Results List QC Results List The QC Results List displays the results obtained from the most recent QC measurement. It contains the following information for tests that have QC enabled and defined: l Test Code – Unique test code for the test. l Material Name – Name of material as defined in the Material Definition. l Last QC Results – Numeric result of the last QC run. l Unit – Unit for the last QC run. l Last QC Job Status – Status of the last QC job run for that point. Status can be PASSED, FAILED or OMITTED. l Target Mean – Expected mean as defined in the Material Definition. See Assigned Values. l Target SD – Expected standard deviation as defined in the Material Definition. See Assigned Values. l Cumulative Statistic Mean – Mean value of all QC points for the active lot. l Cumulative Statistic SD – Standard deviation for the active lot. l Cumulative Statistic N – Number of points used to determine the mean and standard deviation of the active lot. NOTE: To change the cumulative statistics for the QC results list, change the active lot or perform a QC purge. l l l l Frequency Status – Frequency status of the QC test as defined in the QC Setup Definition. Status can be OVERDUE, DUE or no status. If frequency is not configured, this field is blank. This column is different from the Frequency Status column in the QC Test Status List screen. It is used to display the last QC status for this test. Time to Overdue – The time when a QC is expected to become overdue, as defined in the QC Setup Definition. Tests to Overdue – The number of tests at which a QC is expected to become overdue, as defined in the QC Setup Definition. You must have frequency By tests enabled to have a value in this column. Auto Execution Mode – A check mark indicates automatic execution is enabled in the QC Setup Definition. NOTE: Automatic execution of a QC job By tests or By hours occurs when all the following conditions are met: o Automatic execution is enabled. o All the required materials for the QC test are on board. o The QC test is feasible. o An order has been created to run the test related to the QC. For example, to run a QC job for Routine Control X for the test APTT, an APTT test must be ordered. 535 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 9 – Quality Control QC Results List If Automatic execution is enabled By tests or By hours in the QC Setup Definition, and the above conditions are not met when the frequency is due, the system generates an alarm indicating that QC is not feasible, or QC is overdue. NOTE: If Automatic execution of a QC job By Absolute Time is selected in the QC Setup Definition, and Auto Run is selected in Global Definitions Setup, QC automatically executes the QCs at the defined times if the following conditions are met: o All the required materials for the QC test are on board. o The QC test is feasible. l Active Lot/Lot ID – Lot ID of the active lot. l Active Lot/Expiration Date – Expiration Date of the active lot. l Enabled Alternate Lot – A check mark indicates the alternate lot is enabled in the Material Definition. NOTE: o Running a QC on an alternate lot does not reset the frequency status. o Running a QC on an alternate lot results in a blank QC status. Results are not evaluated for alternate lots. See Also l Quality Controls l QC Overview l QC List l QC Profiles List l QC Setup Definition l QC Test Status List l Reviewing QC Results 536 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 9 – Quality Control QC Test Status List QC Test Status List Accessing the QC Test Status List To access the QC Test Status List. 1. Select QC > Test Status List in the menu bar. 2. See Reviewing QC Results. QC Test Status List screen The QC Test Status List screen contains the following status information for tests that have QC enabled and defined. Test Code – Unique test code for the test. Active QC Lot Status – Overall status of the active QC lot. Frequency Status – Frequency status of the QC test as defined in the QC Setup Definition. Status can be OVERDUE, DUE or no status. If frequency is not configured, this field is blank. Applies to an active QC lot only. Does not apply to alternate QC lots. NOTE: The frequency status in the QC Test Status List screen is different from the QC Results List screen frequency status as follows: o If all defined QCs are OK, the test frequency status is OK. o If any QC test has an overdue status, the test frequency status is Overdue. o If no QC test is overdue and there is at least one QC test that is due, the test frequency status is Due. Time to Overdue – The time when a QC is expected to become overdue, as defined in the QC Setup Definition. Tests to Overdue – The number of tests at which a QC is expected to become overdue, as defined in the QC Setup Definition. You must have frequency By tests enabled to have a value in this column. Last QC Material – Lot number of the last QC material result for the test code. Last Completed QC – Date and time stamp at completion of the last QC result for the test code. See Also l Performing a Quality Control Test l QC List l Reviewing QC Results l QC Profiles List l Quality Controls l QC Results List l QC Overview l QC Setup Definition 537 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 9 – Quality Control Performing a Quality Control Test Performing a Quality Control Test Before You Begin A Quality Control Task 1. Define and enable the quality control materials for the test. See QC Setup Definition. 2. Place the QC materials correctly on the instrument. See Test Feasibility for proper placement of all reagents. Programming QC in the QC Test Status List Use this procedure when working with QC materials placed in the original bottles on a diluent rack inserted into a diluent track. NOTE: When QC is programmed in the QC Statistics screen and the test is not feasible because the QC material has expired, the instrument uses QC material from other placed bottles. To program QC in the QC Test Status List: 1. Make sure the required conditions are met, as described in Before You Begin A QC Task (in this topic). 2. Select QC > Test Status List in the menu bar. 3. In the QC Test Status List, double-click a test, or select1 a test and select the QC Statistics icon in the toolbar. The QC Statistics screen opens. 4. Select the Material/Test View icon in the toolbar to toggle the view in the Material/Tests Definition Tree between Tests > Material and Material > Tests mode. 1Click in the Selection column of a table. A red check mark indicates selection. You can typically select more than one object. 538 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 9 – Quality Control Performing a Quality Control Test Material/Tests Definition Tree 5. Select the Material/Test View configuration. l icon in the toolbar to toggle the tree view to the desired If the tree is organized by Material > Tests, when you check a material, all the QC tests related to that material are added to the Program QC list. Click the check box again to deselect it, or select the Clear QC Selection everything. l icon to deselect If the tree is organized by Tests > Material, when you check a test, all the QC materials related to that test are added to the Program QC list. Click the check box again to deselect it, or select the Clear QC Selection everything. icon to deselect 6. <Paired Tests> Make sure both tests (master and paired) are feasible. l If the master test is not feasible, and the paired test is feasible, the master test does not run and the paired test fails. 539 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 9 – Quality Control Performing a Quality Control Test l If the master test is feasible, and the paired test is not feasible, the master test runs and produces results, but the paired test does not run. 7. Select one or more tests or materials in the Tests/Material Definition tree. 8. To select one or more QC profiles to run, select the Select QC Profiles icon in the toolbar. Then select the QC profiles in the Select multiple QC profiles dialog box, and click OK. The tests in those profiles appear selected in the tree. 9. Select the Program icon in the toolbar to run the QC tests . See Reviewing QC Results. NOTE: After selecting the run command, the following apply: l l l l l If an enhanced clean is required, the instrument prompts you to perform it. Press OK to abort running the test. You must perform the enhanced clean before running the test. See Enhanced Clean in Performing Maintenance Activities. If the temperature is out of range, the instrument prompts you to confirm the run command or cancel and wait until temperatures are in range. The instrument prompts you with a list of the disabled ORUs, if any, as a warning about throughput changes. Confirm or cancel the run. A new QC test cannot be programmed if it is running or scheduled to run. If QC is not feasible, a message prompts you to view feasibility detailed information. See Test Feasibility. 540 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 9 – Quality Control Performing a Quality Control Test 10. When the QC tests are complete, the QC Statistics screen for each material/test combination updates with the result information. See Reviewing QC Results. 541 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 9 – Quality Control Performing a Quality Control Test Programming QC in the Sample Rack Details screen Use this procedure when working with a QC material placed in a sample container in a Sample Rack. NOTE: This method does not use bar codes. Therefore, volume warning, on-board stability tracking, and expiration date tracking cannot be used. To program QC in the Sample Rack Details screen: 1. Select the Sample Area bar. icon in the toolbar, or select Analysis > Sample Area in the menu 2. Place the QC controls into sample cups on a sample rack. 3. Insert the sample rack onto the analyzer. 4. Place focus on the rack with the QC controls and select the Rack Details open the Rack Details screen. icon in the toolbar to 5. Select the rack position. 6. In the Sample Type drop down list, select Quality Control. 7. In the Sample ID drop down list, select the material. 8. If lot management is enabled, select the Active lot or Alternate lot button. 9. Select the Add/Remove Tests icon in the toolbar to open the Tests and Profiles dialog box. 10. Click the appropriate tests to populate the Rack Detail screen. 11. Select the Run icon in the toolbar. NOTE: After selecting the program command: l l l l If an enhanced clean is required, the instrument prompts you to perform it. Press OK to abort running the test. You must perform the enhanced clean before running the test. See Enhanced Clean in Performing Maintenance Activities. If the temperature is out of range, the instrument prompts you to confirm the run command or cancel and wait until temperatures are in range.. The instrument prompts you with a list of the disabled ORUs, if any, as a warning about throughput changes. Confirm or cancel the run. You can place active and alternative lots of QC materials on-board the instrument at the same time. 542 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 9 – Quality Control Performing a Quality Control Test CAUTION: When loading sample, diluent, or reagent racks, pull the rack out all the way before loading. Pulling a rack out partially while loading or changing bottles, tubes, or sample cups may result in misidentification of rack contents. Enabling Automatic QC If Automatic QC is enabled for a test, the system automatically performs QC when the user-defined frequency expires. To enable automatic QC: l See QC Setup Definition. NOTE: Automatic QC can only be performed using QC materials placed on a diluent rack inserted into a diluent track. Programming a QC Profile To program a QC profile: 1. Define one or more QC profiles before programming a QC profile. See Defining QC Profiles. 2. Make sure the required conditions are met, as described in Before You Begin A QC Task (in this topic). 3. Select QC > Test Status List in the menu bar. 4. In the QC Test Status List, double-click a test to open the QC Statistics screen. 5. <Optional> Select the Material/Test View the appropriate view. icon in the toolbar to toggle the navigation tree to 6. <Optional> Select the Clear QC Selection navigation tree. icon in the toolbar to remove all selections in the 7. Click the Select QC Profiles icon in the toolbar. 8. In the Select Multiple QC Profiles dialog box, select one or more QC profiles. 9. Select OK. See Also l QC Setup Definition l Restriction Map l Reviewing QC Results l Performing Maintenance Activities 543 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 9 – Quality Control Performing a Quality Control Test l Test Feasibility l Defining QC Profiles 544 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 9 – Quality Control Reviewing QC Results Reviewing QC Results The QC Results List provides a statistical summary of QC results for all material/test combinations. The instrument typically uses rounded values1 when displaying results. Viewing and Filtering the QC Results To view the QC Results List: 1. Select QC > Results List in the menu bar. 2. Select a column heading in the QC Results List to sort the results data by that criteria. 3. To filter the QC Results List, select the Filter Configuration > Filter in the menu bar. icon in the toolbar, or select Actions > 4. Select filter options in the QC Result List Filter dialog box. Select All QCs to display all the result data. 5. Click OK. 1Values are calculated using full precision values. However, when displayed, these values are rounded to a specified number (n) of decimal places. When rounding of an out-of-range value results in a false in-range displayed value, the displayed value is flagged to indicate that it is out-of-range. 545 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 9 – Quality Control Reviewing QC Results Viewing QC Statistics for a Specific Result To view statistics for a specific QC result: 1. Open the QC Results List. 2. Do one of the following: l Double-click a material name or test code in the results list. l Select a material name or test code and select the QC Statistics 3. In the QC Statistics screen, select the Filter Configuration > Filter in the menu bar. icon. icon in the toolbar, or select Actions > 4. Select filter options in the QC Statistics – Date Interval dialog box. Select Apply to all the QCs to display all the statistics. 5. Click OK. Viewing QC Statistics in Chart and Grid View To view QC information in Chart or Grid View: 1. Open a QC result in the QC Statistics screen. 2. Do one of the following: l In the toolbar, select the Switch View icon, which appears dynamically as the Grid View sequence. l icon, the Switch View icon or the Chart View icon in In the menu bar, select a view option on the Actions > Configuration > Switch View submenu. 3. <Chart View> To view both the active and alternate lot points on the same chart, in either the Active Lot or Alternate Lot tab, select the Display active/alternate lot option. 546 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 9 – Quality Control Reviewing QC Results Using Multi-Chart View To use Multi-Chart View: 1. In the QC Statistics screen, select the Material/Test View Definitions tree to one of the following views: l l icon to toggle the Material/Test Test > Materials – Graphically displays the different QC materials used for a specific test. Material > Tests – Graphically displays the same QC material used for different tests. 2. Select Actions > Configuration > Multi-Chart View in the menu bar. See Multi-Chart View. Adding or Viewing Comments To view or add comments: 1. Open a QC result in Grid or Chart View. 2. <Grid View> Place a check mark in the left column next to the QC result. 3. <Chart View> Place the focus on the result (data point). 4. Select the Comments bar. icon in the toolbar, or select Actions > Review > Comment in the menu 5. Add comments and select OK. Tracking QC Information To track QC information: 1. Open a QC result in the QC Statistics screen. 2. In the Active Lot or Alternate Lot tab, click to place a check mark next to a test. 3. Select Actions > Review > Tracking information in the menu bar. The window displays the material name, lot number, and expiration date of the materials used for this test. Viewing Reaction Curves To view a reaction curve: 1. Open a QC result in the QC Statistics screen. 2. Select the Reaction Curve the menu bar. icon in the toolbar, or select Actions > Review > Reaction Curve in 547 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 9 – Quality Control Reviewing QC Results Omitting Points You can omit selected points from QC statistics. Omitted points appear on the graph as an X. To omit points: 1. Open QC results in a Chart View. 2. In the chart, click the result (chart point) to omit. 3. Select the Omit Point icon, or select Actions > Results > Omit Point in the menu bar. 4. Select OK to confirm the omission. A Comments dialog box opens. 5. Enter a comment and select Save. See Recalculating Interval Statistics. Restoring Points To restore omitted data points: 1. Open QC results in a Chart View. 2. In the chart, click the result (chart point) to omit. 3. Select Actions > Results > Restore Point in the menu bar. 4. Select OK to confirm the restoration. A Comments dialog box opens. 5. Enter a comment and select Save. NOTE: Only a result arrived at after the last QC event (such as QC definition change) can be omitted or restored. See Recalculating Interval Statistics. 548 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 9 – Quality Control Reviewing QC Results Recalculating Interval Statistics To recalculate interval statistics: 1. Place a check mark next to the test you want to recalculate interval statistics for. 2. Select Actions > Results > Recalculate in the menu bar. 3. The QC recalculation follows the same rules as a patient result recalculation and omit/restore points. 4. After recalculation, the results are saved and statistics are recalculated. If the recalculation cannot be performed or there is an event after the QC result execution date and time, the operation fails and an error message appears. NOTE: When recalculating results, the system uses the ISI value from the lot that matches the material used during the test. If the lot used during test execution is no longer in the system, or the current material with ISI value was not used during the execution, the INR result fails. See Reviewing Test Results for information on recalculation. Purging Data Results from a test up to a certain date can be purged. The purge function can be used with 1) all results; 2) active lot results only; or 3) alternate lot results only. This operation is intended to remove obsolete data points. It recalculates the cumulative statistics with the remaining points. Data cannot be recovered after it has been purged. NOTE: Purge data is not available if the instrument is running tests. To purge data: 1. Open a QC result in the QC Statistics screen. 2. Select Actions > QC > QCPurge in the menu bar. The Purge Data dialog box opens with the following choices: l Purge All l Purge Active Lot l Purge Alternate Lot 3. Select a date in the Purge Data dialog box and select OK. 4. The data up to this date is removed from the chart. 549 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 9 – Quality Control Reviewing QC Results Setting Statistics as Target The target mean and SD can be replaced with the statistics mean and SD values. To set statistic as target: 1. Open a result in the QC Statistics screen. 2. Select the Set Statistics Target Target in the menu bar. icon in the toolbar, or select Actions > QC > Set Statistic as 3. Select OK to confirm your choice. The statistics values for the active lot are copied to the active target values and the statistics values for the alternate lot are copied to the alternate target values. Activating an Alternate Lot An alternate lot can be activated at any time. To activate the alternate lot: 1. Open a result in the QC Statistics screen. 2. Select the Activate Lot bar. icon in the toolbar, or select Actions > QC > Activate lot in the menu Uploading results to the LIS To upload a result to the LIS: 1. Make sure the LIS is enabled. 2. Open a QC result in Grid View. 3. Place a check mark next to the result to be uploaded. 4. Select Actions > Results > Upload in the menu bar. Filtering Results for Printing Reports To filter results for printing reports: 1. Select the Filter bar. icon in the toolbar, or select Actions > Configuration > Filter in the menu 2. Select filter options in the QC Result List Filter. 3. Select OK. Only displayed results are included in reports. Printing QC Statistics Reports To print a QC Statistics Report: 550 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 9 – Quality Control Reviewing QC Results 1. Open the QC Statistics screen. 2. <Optional> Filter the results data. 3. Select Actions > Print > Print Compact Report or Print Comprehensive Report in the menu bar. NOTE: After you print or export a report or a list, you may not be able to perform certain operations, such as shutting down the instrument. The system may seem to lock up. When you print or export, the Print/Export dialog box opens. If you click anywhere on the ACL TOP screen, or select a menu item before you select Confirm or Cancel in the dialog box, the dialog box moves behind the ACL TOP application window, preventing you from doing anything else. You must: 1) minimize the ACL TOP application window; 2) select Confirm or Cancel; 3) then maximize the ACL TOP window. You can also press ALT+Tab to display the Print or Export dialog box. C ompact R eport 551 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 9 – Quality Control Reviewing QC Results C omprehensive R eport A QC Statistics Report includes the following information: l Date and time report generated l Name of hospital or laboratory l ACL TOP Instrument l ACL TOP Instrument Serial Number l Test code l QC Material l Data Interval 552 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 9 – Quality Control Reviewing QC Results l l Target o Mean o SD Statistic o Mean o SD o CV o N o Omitted o Total Data l Levey-Jennings chart l Tracking Information l o Material Name o Lot Number o Expiration Date o User Name Sample Result Information o Point No. o Result o SD Value o Unit o Omitted o Errors o Comment o Date/Time (data interval) o Target Mean (for the control material when test was completed) o Target SD (for the control material when test was completed) o Delta o CV o QC Status o Freq. Status o Lot ID (for this lot) o Exp. Date (for this lot) o Manufacturer (of the control material) 553 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 9 – Quality Control Reviewing QC Results Printing QC Results Status List Reports To print a QC Results Status List Report: 1. Open the QC Results List screen. 2. Select Actions > Print in the menu bar, or select the Print icon in the toolbar. QC R esults Status List R eport A QC Results Status List Report includes the following information: l Test Code l Material Name l Result Unit l Frequency Status l QC Test Status l Lot Number (for the active lot) l Expiration Date (for the active lot) l Alternate Lot - enabled check l Target Mean l Target SD l Cumulative Mean l Cumulative SD l Number of Results (for the active lot) l For each QC test the following is displayed for each QC data point of the current day and the active lot: o Point Index o Completion Date o Result Value o Result Unit o SD Value o DR Flags o QC Status (after this result was added) o Frequency Status o Omitted o Lot Number o Expiration Date (for this lot) 554 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 9 – Quality Control Reviewing QC Results o Manufacturer (of the control material) o Target Mean (for the control material when test was completed) o Target SD (for the control material when test was completed) o Delta o CV o Comment Printing QC Test Status Reports To print a QC Test Status Report: 1. Open the QC Tests Status List. 2. Select Actions > Print in the menu bar, or select the Print icon in the toolbar. A QC Tests Status Report contains the same information displayed on the QC Tests Status screen. Exporting Reports To export a report: 1. Select Export. 2. In the window that opens specify the format and select the destination. See Exporting Data. 555 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 9 – Quality Control Reviewing QC Results QC Statistics Screen The QC Statistics screen contains information for both the active and alternate material lots located on the Active Lot and Alternative Lot tabs. NOTE: Only active lots are used to monitor quality control. The alternate lot tab provides information about QC materials before they are used as an active lot. The QC Statistics screen can display QC data points in a Grid View, Chart View or Grid Plus Chart View. NOTE: Failed or omitted results are not provided in QC statistics. Material/Test Definitions Tree The Material/Test Definitions tree on the left side of the QC Statistics screen is used to perform the following tasks: l Select QCs to run. l Select material/tests to display in Multi-Chart view. 556 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 9 – Quality Control Reviewing QC Results Active Lot Tab The Active Lot tab contains the results for a particular material/test combination over a certain data interval. The Data Interval is user-configurable by means of the QC Statistics filter and can be set in terms of the following: l l l Last days – The period between the current date and the defined number of days before the current date. Valid range is 1 to 365. From/To – The period between the specified dates. Last Points – The last defined number of results received for this test and this control. Valid range is 1 to 999,999. Select the following icons to perform the associated tasks: Select QC Profiles Clear Tree Selection Program QC – Starts one or all QCs defined for the selected test. You can also select Actions > QC > Program QC in the menu bar. Material/Test View – Toggles sorting the Material/Test Definitions tree between Test view and Material view. Select the relevant tree view before displaying data in Multi-Chart View. Also use this icon to sort QC tests before Performing a quality control test. Switch View – Toggles the current view to Grid View. Appears dynamically in the toolbar, in sequence with the Chart View icon and the Switch View icon. See Viewing QC Statistics in Chart and Grid View. Switch View – Toggles current view to Chart View. Appears dynamically in the toolbar, in sequence with the Switch View icon and the Grid View icon. See Viewing QC Statistics in Chart and Grid View. Switch View – Toggles the current view to Grid Plus Chart View. Appears dynamically in the toolbar, in sequence with the Grid View icon and the Chart View icon. See Viewing QC Statistics in Chart and Grid View. Omit Point Set Statistic as Target 557 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 9 – Quality Control Reviewing QC Results Activate Alternate lot Comment Test Feasibility List – Checks whether all the materials a selected QC test needs are available for use. You can also select Actions > Review > Test Feasibility List in the menu bar. See Test Feasibility for complete information. QC Statistics Filter Print Chart View In the QC Statistics screen, the Switch View icon appears in the toolbar dynamically, and in sequence, as the Grid View icon, the Chart View icon, and the Switch View icon. The chart view includes a Levey-Jennings chart. The chart shows the variability of the result, in terms of standard deviations from the mean, over the defined data interval. 558 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 9 – Quality Control Reviewing QC Results Double-click the chart to expand to full screen view. A legend pops up when you hover the cursor over a chart. For example: 559 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 9 – Quality Control Reviewing QC Results The vertical colored lines on the chart indicate that certain events have taken place. Click the vertical line for a description and date and time of the event. Red Active Lot Changed – The active lot for the related QC material changed due to: l Enable or disable lot management l Active lot definition change. Yellow Target Values Updated – Target values were updated due to: Green Blue l Active lot assigned values change in QC definition l Active lot assigned values change in related QC material l Alternate lot assigned values change in QC material. QC Definition Changed – The QC definition changed due to: l Rules change in QC definition l Unit change in QC definition l Frequency configuration change in QC definition l Patient flags change in QC definition l Alternate lot definition change for related QC material l Enable or disable of test definition. Related Reagent Lot Changed – The QC test related reagent lot changed due to: l Enable or disable of lot management l Active lot definition change l Alternate lot definition change. NOTE: You cannot omit a QC point from QC statistics after one of the above events has occurred. Chart View Display Settings l Scale +/- – To change the Y-axis display scale, enter a value in the Scale +/- field. l Display Alternate Lot – To view the Alternate Lot QC data, select this field. 560 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 9 – Quality Control Reviewing QC Results l l Statistic Mean – If selected, a red horizontal line is added to the chart to indicate the Statistic Mean value. Trend Line – If selected, a green linear regression line is added to the chart to indicate the trending of the data. 561 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 9 – Quality Control Reviewing QC Results Grid View In the QC Statistics screen, the Switch View icon appears in the toolbar dynamically, and in sequence, as the Grid View icon, the Chart View icon, and the Switch View icon. Column Headings l Select – Click one or more cells in this column to place check marks, selecting rows to perform actions on. Click the Select table. icon in the column heading to select or deselect all the rows in the l No. – QC point number from the defined interval. See Filtering the Results List. l Completed D&T – Completion date and time for the QC result. l Result – Numerical value of the QC test result. l Unit – QC result unit as defined in the QC Setup Definition. l SD Value – A calculated number that tells how many standard deviations a control result is from its mean value and is the Z-Score value for Levey-Jennings chart. Calculated as: (Result Value - Target Mean)/Target SD. 562 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 9 – Quality Control Reviewing QC Results l l l l l Check box – A check mark indicates an error or warning is associated with the QC test result. Click the check mark to view details. QC Status – Indicates whether the individual QC result has PASSED, FAILED or been OMITTED. When QC fails, click this field to open a window that displays which rules failed. When the status is OMITTED, the point is not included in the QC statistics. Frequency Status – If QC Frequency is enabled, indicates the status of the test – either Overdue, Due or OK, and represents the status at the time QC was executed. Omitted Point – If checked, indicates that a QC result has been removed from the statistical calculations. Upload Status – If checked, indicates that the QC test has been uploaded to the Host. l Lot ID – The lot ID for the control material. l Exp. Date – The expiration date for the control material lot. l Manufacturer – Manufacturer of the control material. l l l l l l Target Mean – Expected mean value for the control material as defined in the product insert, or as defined by the user. See Assigned Values. Target SD – Expected standard deviation for the control material as defined in the product insert, or as defined by the user. See Assigned Values. Delta – The difference between the target and the measured result CV – CV of the QC point as compared to the initial target mean defined for an active lot. See Assigned Values. If the target mean changes, this CV value represents the CV compared to target mean before any changes. Comment – If checked, indicates that a user has entered a comment for this result. Ordered by – User ID of the person logged on when the QC test was performed. 563 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 9 – Quality Control Reviewing QC Results Grid Plus Chart View In the QC Statistics screen, the Switch View icon appears in the toolbar dynamically, and in sequence, as the Grid View icon, the Chart View icon, and the Switch View icon. The Grid Plus Chart View combines both the Grid and Chart Views, including functionality, into one view. 564 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 9 – Quality Control Reviewing QC Results Multi-Chart View Use Multi-Chart View to graphically compare QC results for: l Different tests using the same QC material; or l Different QC materials within the same test. This view shows all the available chart information for 1) the test; and 2) the materials for the test selected in the tree. The maximum number of graphs displayed per tab is four. The maximum number of tabs is six. Only graphs that contain values for at least one not-failed test are displayed. In Multi-Chart view, you can drag and drop charts within or between tabs. See Using Multi-Chart View. See Also l Quality Controls l QC List l QC Overview l QC Profiles List l QC Results List l QC Setup Definition l QC Test Status List 565 of 992 L0027503450 R00 ACL TOP Family Operator's Manual CHAPTER 10 SAMPLE ANALYSIS Sample Collection and Storage A detailed procedure for collection, transport, and preparation of plasma for coagulation testing is necessary since important diagnostic and therapeutic decisions are based on the results of these tests. Many variables are important because they affect the analytical results (for example: type of anticoagulant, storage of the sample, and the collection container for the blood sample. The following procedures are considered standard for any coagulation test. Plasma Collection Perform the following procedures when collecting plasma: 1. Draw blood with minimum stasis using a plastic syringe. 2. Transfer the drawn blood into a graduated polystyrene (or similar plastic material) test tube to avoid activation of the contact phase of coagulation. Alternatively, use an evacuated siliconized glass tube or an evacuated glass in plastic. 3. Immediately after drawing blood, anti-coagulate the plasma with one volume 3.2% trisodium citrate mixed with nine volumes of freshly drawn venous blood. Mix thoroughly. The correct concentration of the anticoagulant is fundamentally important to the precision of the results. References to the CLSI (formerly NCCLS) guideline may be followed when adjustments to the citrate concentration are required due to sample hematocrit variations. Plasma Separation Avoid hemolysis during collection and centrifugation of the sample. The breakage of red cells whose phospholipid surfaces have thromboplastin activity causes a change in coagulation times. Therefore, centrifuge samples as soon as possible according to the latest CLSI guideline. See Also l Sample Containers and Adapters 566 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Sample Area Sample Area The left side of the Analytical Module1 is the Sample Area where patient samples are manually loaded onto the AM. Place sample material on racks and insert the racks through the bar code reader. The Sample Area screen shows the status of all the racks in the sample area. Use the Sample Area screen to program tests for each sample. Accessing the Sample Area To access the Sample area: 1. Select the Sample Area bar. icon in the toolbar, or select Analysis > Sample Area in the menu 2. Use the Sample Area screen to program tests for each sample. 1The part of the instrument where sample processing and testing are performed. Also called the AM or the Analyzer. 567 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Sample Area Viewing On-board Materials The Reagent & Diluent Map displays on-board materials in table format. To view on-board materials: 1. Select the Sample Area , Diluent Area open the Sample, Diluent or Reagent Area. or Reagent Area icon in the toolbar to 2. Select Actions > Review > Reagent & Diluent Map in the menu bar. 3. In the Reagent & Diluent Map, select the Diluent Area tab to view the on-board diluent materials by position in each rack. 4. Select the Reagent Area tab to view the on-board reagents by position in each rack. 5. Select the right and left arrows below the table to display more racks. 568 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Sample Area Sample Area Operations Toolbar The Sample Area operations toolbar includes the following: Select the following icons to perform the associated tasks: Run Tests – Starts an analytical session. Disabled if the analyzer is running or is in any status other than Ready. You can also select Actions > Map > Run Tests in the menu bar. Also available on the Sample Rack Details screen. Test Feasibility List – Opens the Test Feasibility and QC Feasibility Lists. See Test Feasibility. Restriction Map – Opens the Restriction Map. Rack Details – Opens the Sample Rack Details screen for the rack that has focus1 in the Sample Area screen. Bar Code Home Position – Moves the bar code reader to its home position. Print – Prints a report showing the status of all inserted racks that have at least one material placed on-board, and the status of these materials. Useful when a maintenance activity is performed that requires the removal of material racks. 1To place focus on the unique identifier in a list, click a row in the table. A blue cell border indicates focus. Only one unique identifier in a list can have focus. 569 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Sample Area Sample List Toolbar The following icons can appear in the Sample List toolbar depending on the instrument model: Use the following icons to navigate in the Sample List, Reagent Area and Diluent Area. Returns to the Previous screen. Displays the QC Results List. Displays the Calibration Status List. Display the LAS Cuvette Holding Area for TOP 700 LAS. Displays the Reagent Area (Reagent/Diluent Area for TOP 300 CTS and 500 CTS ). Displays the Diluent Area. 570 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Sample Area Sample Area Screen The Sample Area is at ambient temperature and holds up to 12 racks, depending on the instrument model. Each rack can hold 10 samples. When the rack is in use (during aspiration of material) it is locked and an amber LED displays for the track position. When the rack is no longer in use the LED changes to green and the rack is released. When a rack is inserted with samples, and one or more sample tests are PLACED, NOT FEASIBLE, or ACTIVE, that rack displays in the Sample Area screen as light blue. See Racks. The non-CTS sample rack holds both open sample tubes and sample cups. The CTS sample rack holds closed sample tubes. See Closed Tube Sampling and Global Definitions. TOP 300 CTS Sample Area Screen 571 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Sample Area TOP 500 CTS Sample Area Screen 572 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Sample Area TOP 700 Sample Area Screen 573 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Sample Area TOP 700 LAS Sample Area Screen TOP 700 LAS Cuvette Holding Area See LAS Cuvette Holding Area. 574 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Sample Area Restriction Map The Restriction Map shows which tracks you can insert various types of materials. See Restriction Map. CAUTION: l l l l l l l IMPORTANT – Many IL-defined tests use Clean B diluted as the clean material. If the Clean B diluted bottle becomes empty, the instrument performs an emergency stop, with the consequent loss of all work that was in progress. Hint: To avoid loss of work, place multiple bottles of Clean B diluted on-board the instrument. See Test Feasibility for proper placement of all reagents. When loading sample, diluent or reagent racks, the racks must be pulled all the way out before loading. Pulling out racks partially while loading or changing bottles, tubes, or sample cups may result in incorrect identification of the rack contents. TOP 300 CTS – Clean materials used by the sample probe must be placed in track D1. Those used by the reagent probe must be placed in track R1 - R3. TOP 500 CTS – Clean materials used by the sample probe must be placed in track D1. Those used by the reagent probe must be placed in track D2 - R4. TOP 500 CTS – If you define a sample diluent material and select the Rinse and Clean option requiring a non-system clean material such as Clean B, that clean material must be placed in track D1. TOP 700 (includes ACL TOP Base), 700 CTS (includes ACL TOP CTS) and 700 LAS – If you define a sample diluent material and select the Rinse and Clean option requiring a non-system clean material such as Clean B, that clean material must be placed in track D1 or D2. TOP 700 (includes ACL TOP Base), 700 CTS (includes ACL TOP CTS) and 700 LAS – Clean materials used by the reagent probes must be placed in tracks D3 - R2, R5 - R6. 575 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Sample Area Restriction Map – TOP 300 CTS 576 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Sample Area Restriction Map – TOP 500 CTS 577 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Sample Area Restriction Map – TOP 700 For ACL TOP 700 (includes ACL TOP Base) and ACL TOP 700 CTS (includes ACL TOP CTS) instruments. 578 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Sample Area Restriction Map – TOP 700 LAS 579 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Sample Area Racks A non-CTS sample rack is represented on the left, a CTS sample rack is in the middle, and Sample rack present with test PLACED, NOT FEASIBLE or ACTIVE is on the right. 580 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Sample Area NOTE: l The CTS sample rack is identified with CTS on-screen. l Sample #1 is at the top of the rack. Sample #10 is at the bottom. l l l l l A sample rack may hold cups of calibrator1, controls, and patient samples as well as tubes of patient samples. The color-coded circles in the rack representation correspond to the 10 sample positions in the sample rack. When you hover the mouse pointer over a colored sample, its sample ID appears in a tooltip. When you single-click a sample, you get information about the sample such as the sample ID, the tests to be performed on the sample, and time to completion for a test in progress. For example: When a rack is inserted with samples, and one or more sample tests are PLACED, NOT FEASIBLE, or ACTIVE, that rack displays in the Sample Area screen as light blue. Offline Racks The rack to the far left in the Sample Area screen represents an offline rack that is on your workbench and not inside the analyzer. You can pre-program the samples for that rack before inserting it into the analyzer. You can program the rack after it has been inserted, but it is often preferable to do it beforehand. See Material Identification. 1A type of sample with an assigned value used to calibrate a test. 581 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Sample Area On-board Racks You can access a rack by pressing the buttons in the instrument or touching or clicking the on-screen buttons on the track control panel. The bar code indicator on the CM and the bar code reader on the AM both move. As the selected rack is placed on the instrument it is also displayed on the screen. NOTE: l An ambulance on the sample rack circle l A red cross symbol indicates a priority (stat) sample. indicates a stat1 sample. A question mark indicates an unidentified sample. This happens when the sample does not have a bar code label and it has been inserted without having been manually programmed. For a full listing of the color codes, see Sample Status Color Codes. 1In medical terminology, immediate; with no delay. Stat samples have highest priority. 582 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Sample Area Track Control Panel Below the rack area on the screen is the Track Control Panel. Each track is identified by the abbreviations S <sample>, D <diluent> and R <reagent>. TOP 300 CTS Track Control Panel TOP 500 CTS Track Control Panel TOP 700 Track Control Panel TOP 700 LAS Track Control Panel Each track access button can be used to insert and remove a rack from the analyzer. It is functionally identical to the physical buttons on the analyzer. Pressing the physical buttons or touching or clicking the on-screen buttons all move the bar code reader to that track position to allow the rack to be inserted. Each track position button has an LED indicator below it. l Gray – No rack is on-board. l Green – Rack is not in use, is accessible. l Orange – Rack is in use, not accessible. l Button grayed out (S1-S3) – Rack is not available – for use by LAS only. Bar Code Reader Indicator Just above the Track Control Panel is an indicator for the location of the bar code reader: Bar code reader movements are simulated on the computer screen. When you press a track access button, the bar code reader indicator appears above the button after the bar code reader reaches this position. 583 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Sample Area See Also l Sample List l Sample Details l Sample List Filter l Sample Rack Details 584 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis LAS Cuvette Holding Area LAS Cuvette Holding Area The LAS Cuvette Holding Area screen is a graphical representation of samples that have begun aliquotting from the LAS track and are scheduled for testing, or are in the process of testing. You can delete tests from samples in the holding area, but you cannot add tests. Accessing the LAS Cuvette Holding Area To open the LAS Cuvette Holding Area screen: l Select Analysis > LAS Cuvette Holding Area in the menu bar. Or 1. Select the Sample Area icon in the toolbar. 2. Select the LAS Cuvette Holding Area icon in the toolbar. Deleting a Test To delete a test from a cuvette in the LAS Cuvette Holding Area: 1. Open the LAS Cuvette Holding Area. 2. Click a Test cell to place focus1 on the test to delete. 3. Select the Delete Test icon in the toolbar. 4. In the Test and Profiles dialog box, deselect one or more tests to delete. NOTE: l You cannot add a test to a cuvette in the LAS Cuvette Holding Area. l If the test has started, you cannot delete it. 1To place focus on the unique identifier in a list, click a row in the table. A blue cell border indicates focus. Only one unique identifier in a list can have focus. 585 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis LAS Cuvette Holding Area LAS Cuvette Holding Area Operations Toolbar The LAS Cuvette Holding Area operations toolbar includes the following: Select the following icons to perform the associated tasks: Run Tests – Starts an analytical session. Disabled if the analyzer is already running or is in any status other than Ready. You can also select Actions > Map > Run Tests in the menu bar. Also available on the Sample Rack Details screen. See Sample Rack Details. Test Feasibility List – Runs Test Feasibility. Delete Tests – Deletes the test selected in the cuvette cell. A cuvette cell must have focus1 in the LAS Cuvette Holding Area screen. Restriction Map – See Restriction Map. Sample Details – Displays the Sample Details screen. Patient Demographics – Displays patient information, such as name, gender, DOB, patient ID, etc. Bar Code Home Position – Allows you to move the bar code reader to its home position without having to wait. Print – Prints a report showing the state of all inserted racks that have at least one material placed on-board, and the state of these materials. Useful when a maintenance activity is performed that requires the removal of material racks. 1To place focus on the unique identifier in a list, click a row in the table. A blue cell border indicates focus. Only one unique identifier in a list can have focus. 586 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis LAS Cuvette Holding Area LAS Cuvette Holding Area Screen 587 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis LAS Cuvette Holding Area C uvette Strip Graphical representation of a cuvette strip1 containing four cuvette wells. Each cell contains a separate aliquot2 taken from a sample on the LAS track. When displayed, it indicates the presence of a cuvette strip in the LAS Cuvette Holding Area. Click here for color indicators descriptions. Hover the cursor over a cuvette well to display a tooltip with the status of the sample. When the cuvette strip is in focus, the Sample ID and Test cells populate with the values associated with that sample. LA S C uvette H olding A rea A vailability Indicator Represents an available position for sample analysis. A maximum of 7 indicators can display. The number of available positions is inversely related to the # Slots for dilution preparation value configured in the LAS Configuration screen. When the # Slots for dilution preparation value is 2, seven indicators are present. Use this configuration for maximum throughput when testing samples. You can adjust the configuration to optimize sample or calibration throughput. See Adjustments for Calibration. Sample ID Obtained through communication with the LAS track. You may not manually enter a value into this field. 1Four cells molded together in a disposable plastic piece. Used for testing samples. Multiple cuvette strips clip together to form cuvette clips. 2A known fraction of a whole, constituting a sample. 588 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis LAS Cuvette Holding Area Test C ells To the right of each row are Test cells in two rows and several columns for each sample. More columns are available as needed – up to 30 tests for each sample. When you select a test cell an ellipsis the right of the cell. displays to See Also l LAS Overview l LAS Configuration l ACL TOP 700 LAS Specifications 589 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Sample Rack Details Sample Rack Details The Rack Details screen contains information for each sample placed on a rack. Accessing Sample Rack Details To access sample rack details: 1. Select the Sample Area bar. icon in the toolbar, or select Analysis > Sample Area in the menu 2. In the Sample Area screen, do one of the following: l Double-click a sample rack representation or a sample position on the rack. l Select Actions > Review > Rack Details in the menu bar. l Select the Rack Details icon in the toolbar. Programming Sample Tests To select one or more tests to run on a sample: 1. Open the Rack Details screen. 2. Select the sample type in the Sample type list. Select Patient for medical tests. 3. Select the sample ID in the Sample ID list. If you selected a Cal/NPP or Quality Control sample type, this field becomes a drop down list of available materials to use for calibration, NPP1, or quality control. 4. Select the Stat option if the test is high priority. 5. <Optional> If the sample type is Quality Control or Cal/NPP, and lot management is enabled for the sample, select to use the active or alternate lot. 6. Click a test cell on the right side of the Rack Details screen. 7. Select the dynamic ellipsis Add/Remove Tests that appears on the right side of the test cell, or select the icon in the toolbar to open the Tests and Profiles window. 8. Select a test or profile in the Tests and Profiles window, and select OK. 9. Repeat these steps for each test to run on the sample. 10. IMPORTANT – See Tests and Profiles window for important information about tests. 1Normal Pool Plasma. A type of sample used as a standard of comparison when calculating the International Normalized Ratio (INR) and when calculating test results that use the normalized ratio. 590 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Sample Rack Details Deselecting Tests When you click a named cell in the Tests and Profiles window, that test name is copied to the test list on the Rack Details screen and the test button on the Tests and Profiles window is depressed. Clicking a button a second time removes the test name from the Rack Details screen and deletes the test order. You can also deselect a test that has been ordered in the Sample List screen if the test has a TO DO status. After an ordered test has become active, it cannot be deselected. To remove a test with TO DO status from a sample: 1. Select the Sample List icon in the toolbar, or select Analysis > Sample List in the menu bar. 2. In the Sample List, select the sample ID with a test with TO DO status. 3. Select the Sample Details icon in the toolbar to open the Sample Details screen. 4. On the Test Information tab, place focus1 on the TO DO test and press the <Delete> on the keyboard before the test executes. Sample Area Toolbar The Sample Area toolbar includes the following: Select the following icons to perform the associated tasks: Run tests. Display Test Feasibility List. Display the Restriction Map. Display Rack Details. Move Bar Code Reader to home position. 1To place focus on the unique identifier in a list, click a row in the table. A blue cell border indicates focus. Only one unique identifier in a list can have focus. 591 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Sample Rack Details Sample Rack Details Operations Toolbar The Sample Rack Details screen toolbar includes the following: Select the following icons to perform the associated tasks: Run Tests – Starts an analytical session. Disabled if the analyzer is running or not Ready. You can also select Actions > Map > Run Tests in the menu bar. Auto List – Automatically programs a set of patient tests (for those in the TO DO state) that exist on the system. Applies only to patient tests and is only available for the off-line rack in the sample area (also see Reagent Area). The sample programming information is automatically loaded and displayed based on the priority of each sample. See Programming Non-Bar Coded Samples (Using an LIS). Add/Remove Tests and Profiles. Clear Rack – Clears all the material information. Available only for the off-line rack and disabled for all other racks. Insert Rack – Inserts a rack carrying the information and materials you defined on the offline rack. Disabled for all other racks. Test Feasibility List – Opens the Test Feasibility List. Display Patient Demographics. Open Sample Details to view detailed rack information. Bar Code Home Position – Moves the bar code reader to its home position. 592 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Sample Rack Details NOTE: After selecting the run command, the following apply: l l l l If an enhanced clean is required, the instrument prompts you to perform it. Press OK to abort running the test. You must perform the enhanced clean before running the test. See Enhanced Clean in Performing Maintenance Activities. If the temperature is out of range, the instrument prompts you to confirm the run command or cancel and wait until temperatures are in range. The instrument prompts you with a list of the disabled ORUs, if any, as a warning about throughput changes. Confirm or cancel the run. When loading sample, diluent, or reagent racks, pull the rack out all the way before loading. Pulling a rack out partially while loading or changing bottles, tubes, or sample cups may result in misidentification of rack contents. See Run and Auto Run. 593 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Sample Rack Details Sample Rack Details screen The picture below shows 2 rows of the test list displayed in the Rack Details screen. All the rows are similar, with one row for each sample. Select a row to configure by clicking the sample position at the left side of the screen. The selected sample has a ring around it to indicate it has focus. When you hover the cursor over a test, a tooltip displays the result for that test. Click the following icons on the right side of the toolbar to display the sample Rack Details screen for the rack to the left or right of the currently displayed rack. and 594 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Sample Rack Details Sample Type The default sample type is Patient. The following sample types appear in the list: l Patient – A sample being analyzed for medical purposes. l Cal/NPP – A grouping that allows a single material to be used for multiple sample types. l o Cal (Calibrator) – A sample with an assigned value used to calibrate a test. o NPP (Normal Pool Plasma) – A sample used as a standard of comparison for calculating: 1) INR; and 2) test results that use the normalized ratio. Quality Control – A sample having known amounts of analyte that is used to monitor system performance. Sample ID Unique identifier of the sample. This value is normally obtained by scanning a bar code label on a sample tube. You can also manually enter a value into this field. It must be an alphanumeric value with fewer than 16 characters. You cannot change the sample ID while the sample is in use. This field can be edited only when the sample type is Patient. For Cal/NPP and Quality Control samples, this field becomes a drop down list of available materials to use for calibration, NPP1, or quality control. Stat The Stat option specifies a high-priority patient sample. The priority codes for samples and tests are: l Normal – Regular priority l LAS – Higher priority (for all samples from the LAS track) l Stat – Highest priority (available for front-loaded samples only) l Partial – One or more, but not all tests for the sample are stat CAUTION: Continuously adding stat2 samples delays testing on non-stat samples, possibly indefinitely. Lot Selection If the sample type is Quality Control or Cal/NPP and lot management is enabled for the material, a pair of buttons is displayed to the right of the stat indicator. These buttons allow you to select either the active lot or the alternate lot. 1Normal Pool Plasma. A type of sample used as a standard of comparison when calculating the International Normalized Ratio (INR) and when calculating test results that use the normalized ratio. 2In medical terminology, immediate; with no delay. Stat samples have highest priority. 595 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Sample Rack Details Test Selection To the right of each row are Test cells in two rows and several columns for each sample. More columns are available as needed – up to 30 tests for each sample. When you select a test cell an ellipsis the right of the cell. displays to After you click the ellipsis, the Test and Profiles window opens, allowing you to select from the available tests and profiles. You can also double-click the test list cell or use the Add/Remove Tests the toolbar to open the Tests and Profiles window. icon in The Tests and Profiles window is also available from the Sample List screen menu item Actions > Results > Add/Remove Tests when a sample is selected (has a check mark in the Select column). Tests and Profiles Window Use the Tests and Profiles window to program tests to run on samples. Programming the Tests and Profiles window is similar to programming the Material Programming Window. NOTE: l l l l A profile is a set of tests. Up to 15 tests may be in a profile. Profiles are underlined to distinguish them from individual tests. When a profile is selected, all the buttons for the tests in that profile are depressed on the Tests and Profiles window. You cannot type a test name into the cell. Tests must be selected through the Tests and Profiles window. You cannot select tests for a sample that does not have a sample ID. When you click a named cell in the Tests and Profiles window, that test name is copied to the test list on the Rack Detail screen, and the test button on the Tests and Profiles window is depressed. You may select more than one test. 596 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Sample Rack Details l l l l Tests in a profile must be deselected individually. Pressing a profile button a second time does not deselect the tests in that profile. The ACL TOP instrument does not run duplicate tests, whether ordered through the LIS or ordered manually. Only one test is performed per test code, per sample. To run duplicate tests on a sample, you must either 1) configure the test definition to run a replicate; or 2) wait until a test has generated test results. If you select the Apply to each Sample ID option at the bottom of the Test and Profiles window before selecting a test, each test you select is assigned to all sample IDs in the rack. If you assign more than 10 tests to the sample, you can use the scroll arrows at the right side of the test list to view the cells containing the test names. Rack Summary Information After you request a test, a summary information table appears below and to the left of the test table with the following information: l Track ID value – Identifies the track number where the rack is placed. l Rack ID – Displays the rack ID that is read on the rack bar code label. l Number of samples l Number of tests See Also l Sample Status Color Codes l Sample List 597 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Programming Bar Coded Samples Programming Bar Coded Samples NOTE: l l To perform these procedures, the Enable Bar Codes option must be pre-configured in the Bar Code Definitions setup screen. Feasible tests programmed for samples placed on-board while the instrument is performing analysis are immediately scheduled when you perform the operations in this topic. It is not necessary to re-select the Run icon for these tests when the instrument is already running. Programming Bar Coded Samples Using an LIS (Host) 1. Select the Sample Area icon or select Analysis > Sample Area in the menu bar. 2. Select an available track position from the track control panel. 3. Insert a rack containing bar coded samples into the ACL TOP instrument. See Restriction Map for general placement of samples and reagents. The system reads the bar codes and programs the Sample IDs automatically into the Rack Detail screen. The programming of the tests is obtained from the LIS, according to the LIS communication configuration (host query or batch downloading). 4. Select the Run icon to start the analysis. 598 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Programming Bar Coded Samples Programming Bar Coded Samples After Loading the Rack, Without an LIS 1. Select the Sample Area icon or select Analysis > Sample Area in the menu bar. 2. Select an available track position from the track control panel. 3. Insert a rack containing bar coded samples into the ACL TOP instrument. See Restriction Map for general placement of samples and reagents. The system reads the bar codes and programs the Sample IDs automatically into the Rack Detail screen. 4. Select the Rack Details icon to open the Rack Detail screen. 5. Select the Stat option if the sample requires immediate action. NOTE: Continuously adding stat1 samples delays testing on non-stat samples, possibly indefinitely. 6. Select the Add/Remove Tests icon to open the Tests and Profiles window. Program the appropriate tests by selecting the test and/or profile buttons (profiles are underscored). 7. Select the Run icon to start the analysis. See Also l Laboratory Information Systems l Bar Code Definition l Manually Programming Non-Bar Coded Samples 1In medical terminology, immediate; with no delay. Stat samples have highest priority. 599 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Programming Non-Bar Coded Samples Programming Non-Bar Coded Samples Programming Non-Bar Coded Samples Using the Offline Rack and an LIS (Host) with Automatic Downloading Enabled You can use this method if your laboratory is connected to an LIS after the information regarding the samples to be programmed has been downloaded from the LIS to the analyzer. 1. Select the Sample Area icon or select Analysis > Sample Area in the menu bar. 2. Double-click a sample on the offline rack (located on the left side of the screen) to open the Rack Details screen. 3. Select the Auto List icon. The LIS orders populate the screen. 4. Load the rack in the sample ID order shown on the screen. 5. Select the Insert Rack icon. 6. Insert the rack into the ACL TOP instrument. 7. Select the Run icon to start the analysis. NOTE: l l l If you manually identify a material placed on the off line rack (sample, diluent, or reagent) and a tube or bottle containing a bar code is on the rack, the system attempts to match the information manually entered with the information on the bar code in that position. If the bar coded information fails to match the manually entered information, the system generates an error message. If you manually identify the presence of a material (tube, bottle, or sample cup) placed on the off line rack (sample, diluent, or reagent) and, upon insertion, the bar code reader does not detect the presence of that material, an error message displays for that position that the system was expecting to detect the material's presence. If you fail to manually identify the presence of a material (tube, bottle, or sample cup) placed on the off line rack (sample, diluent, or reagent) and, upon insertion, the bar code reader does detect the presence of a material, an error message displays for each detected position that the system was not expecting to detect. CAUTION: When loading sample, diluent, or reagent racks, pull the rack out all the way before loading. Pulling a rack out partially while loading or changing bottles, tubes, or sample cups may result in misidentification of rack contents. 600 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Programming Non-Bar Coded Samples Programming Non-Bar Coded Samples After Inserting the Rack, Using an LIS with Host Query Enabled 1. Select the Sample Area icon or select Analysis > Sample Area in the menu bar. 2. Select an available track position from the track control panel. 3. Insert the rack into the ACL TOP instrument. See Restriction Map for general placement of samples and reagents. The samples positions are displayed with question marks, indicating the system detects their presence but has no sample ID information (unknown samples). If Host Query is enabled, the instrument automatically queries the LIS when a rack is inserted. 4. Select the Rack Details icon to open the Rack Details screen. 5. Enter the sample ID in the Sample ID field. 6. Select the Stat option if the sample requires immediate action. NOTE: Continuously adding stat1 samples delays testing on non-stat samples, possibly indefinitely. 7. The LIS is queried for test requests and if it finds any for the sample ID, enters them in the test list field to the right of the sample ID. 8. Select the Run icon to start the analysis. 1In medical terminology, immediate; with no delay. Stat samples have highest priority. 601 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Programming Non-Bar Coded Samples Programming Non-Bar Coded Samples After Inserting the Rack, Without Using an LIS 1. Select the Sample Area or select Analysis > Sample Area in the menu bar. 2. Select an available track position from the track control panel. 3. Insert the rack into the ACL TOP instrument. See Restriction Map for general placement of samples and reagents. Notice the samples positions are displayed with a question mark, indicating that the system identified their presence but had no Sample ID information (unknown samples). NOTE: When a rack is inserted, the instrument automatically queries the LIS only when Host Query is enabled. 4. Select the Rack Details icon to open the Rack Details screen. 5. Enter the sample ID in the Sample ID field. NOTE: You cannot change a sample ID if the test status for that sample is ACTIVE. 6. Select the Stat option if the sample requires immediate action. NOTE: Continuously adding stat1 samples delays testing on non-stat samples, possibly indefinitely. 7. Select the Add/Remove Tests icon to open the Tests and Profiles window. Program the appropriate tests by pressing Test and/or Profile buttons (profiles are underscored). 8. Select the Run icon to start the analysis. CAUTION: When loading sample, diluent, or reagent racks, pull the rack out all the way before loading. Pulling a rack out partially while loading or changing bottles, tubes, or sample cups may result in misidentification of rack contents. 1In medical terminology, immediate; with no delay. Stat samples have highest priority. 602 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Programming Non-Bar Coded Samples Programming Non-Bar Coded Samples Using the Offline Rack, Without Using an LIS 1. Select the Sample Area icon or select Analysis > Sample Area in the menu bar. 2. Double-click a sample on the off line rack (located on the left side of the screen) to open the Rack Details screen. 3. Enter the sample ID in the Sample ID field. NOTE: You cannot change a sample ID if the test status for that sample is ACTIVE. 4. Select the Stat option if the sample requires immediate action. NOTE: Continuously adding stat1 samples delays testing on non-stat samples, possibly indefinitely. 5. Select the Add/Remove Tests icon to open the Tests and Profiles window. 6. Program the appropriate tests by pressing Test and/or Profile buttons (profiles are underscored). 7. Select the Insert Rack icon. 8. Insert rack into the ACL TOP instrument. 9. Select the Run icon to start the analysis. NOTE: Feasible tests that are programmed for samples placed on-board while the instrument is performing analysis are immediately scheduled. Pressing the Run instrument is running. icon again is not required when the See Also l Laboratory Information Systems l Bar Code Definition l Programming Bar Coded Samples 1In medical terminology, immediate; with no delay. Stat samples have highest priority. 603 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Reviewing Sample Status Reviewing Sample Status To review the status of an on-board sample: 1. Select Analysis > Sample List in the menu bar. 2. View the test fields at the right side of the Sample List for the results of individual tests performed on the sample. See Sample Details. See Also l Sample Details l Sample List l Test Details l Sample Status Color Codes 604 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Reviewing Test Results Reviewing Test Results Test result values are shown in a data table at the right side of the Sample List. Recalculating Test Results To recalculate test results: 1. Select Analysis > Sample List in the menu bar. 2. Select1 one or more samples in the Sample List. 3. Select Actions > Results > Recalculate in the menu bar. 4. <Optional> Select Stop in the window with a progress bar to interrupt the recalculation if it takes too long. Results recalculated remain recalculated, and additional recalculations do not process. This causes the values to recalculate after you have made a change to any of the following: l Delay time – You cannot change the delay time to be shorter than that used in the original analysis. l Acquisition time – You cannot change the acquisition time to be longer than that used in the original. l Test definition data reduction fields l Calibration l Parallelism data reduction fields 1Click in the Selection column of a table. A red check mark indicates selection. You can typically select more than one object. 605 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Reviewing Test Results NOTE: l l l When recalculating results, the system uses the ISI value from the lot that matches the material used during the test. If the lot used during test execution is no longer in the system, or the current material with ISI value was not used during the execution, the INR result fails. See Reviewing Test Results for information on recalculation. You can recalculate results only for tests having editable fields. You can recalculate results for all tests, or for only the tests that are filtered to display in the list. See Sample List. Validating a Single Completed Test Result To validate1 a single completed test result: 1. Select Analysis > Sample List in the menu bar. 2. Place focus2 on the sample ID. 3. Select the Sample Details icon in the toolbar to open the Sample Details screen. 4. In the Sample Details screen, select3 the test to validate. 5. Select the Validate icon in the toolbar. Validating All Completed Test Results for a Sample To validate4 all the completed test results for a sample ID: 1. Select Analysis > Sample List in the menu bar. 2. Select5 one or more sample IDs in the Sample List. 3. Select the Validate icon in the toolbar, or select Actions > Results > Validate in the menu bar. 4. When the operation completes a black check mark appears in the Validation Status column. See Sample List Display Settings to display hidden columns. 1The acceptance of test results by the user. 2To place focus on the unique identifier in a list, click a row in the table. A blue cell border indicates focus. Only one unique identifier in a list can have focus. 3Click in the Selection column of a table. A red check mark indicates selection. You can typically select more than one object. 4The acceptance of test results by the user. 5Click in the Selection column of a table. A red check mark indicates selection. You can typically select more than one object. 606 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Reviewing Test Results Uploading a Single Completed Test Result to the LIS You can upload validated1 sample results from the Sample List or from the Test Details screen. The LIS must be enabled before uploading can occur. See Laboratory Information Systems (LIS). To upload a single completed test result: 1. Select Analysis > Sample List in the menu bar. 2. In the Sample List, place focus2 on a sample ID with test results to upload. 3. Select the Sample Details icon in the toolbar to open the Sample Details screen. 4. In the Sample Details screen, select3 the test with results to upload. 5. Click the Upload icon in the toolbar, or select Actions > Results > Upload in the menu bar. See Upload Status. Test U pload A test upload sends the following information to the host: l Test ID l Test Status l Test Order Date l Test Results 1Test results accepted by the user. 2To place focus on the unique identifier in a list, click a row in the table. A blue cell border indicates focus. Only one unique identifier in a list can have focus. 3Click in the Selection column of a table. A red check mark indicates selection. You can typically select more than one object. 607 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Reviewing Test Results Uploading All Completed Test Results for a Sample to the LIS You can upload validated1 sample results from the Sample List or from the Test Details screen. The LIS must be enabled before uploading can occur. See Laboratory Information Systems (LIS). To upload all the completed test results for a sample: 1. Select Analysis > Sample List in the menu bar. 2. In the Sample List, place focus2 on a sample ID with test results to upload. 3. Select the Upload icon in the toolbar, or select Actions > Results > Upload in the menu bar. 4. When the operation is complete, a black check mark appears in the Upload Status column. See Sample List Display Settings to display hidden columns. See Upload Status. Sample U pload A sample upload sends the following information to the host: l Print Status l Priority l Sample Status l Upload Status l Validation Status Deleting Results To delete results or tests: 1. Select Analysis > Sample List in the menu bar. 2. Select a result or test. 3. Select Actions > Results > Delete in the menu bar. 1Test results accepted by the user. 2To place focus on the unique identifier in a list, click a row in the table. A blue cell border indicates focus. Only one unique identifier in a list can have focus. 608 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Reviewing Test Results Printing Sample Results Reports To print a Sample Results Report: 1. Select Analysis > Sample List in the menu bar. 2. In the Sample List select1 one or more sample IDs. 3. Select the Print menu bar. icon in the toolbar, or select Actions > Print > Sample Results Report in the NOTE: After you print or export a report or a list, you may not be able to perform certain operations, such as shutting down the instrument. The system may seem to lock up. When you print or export, the Print/Export dialog box opens. If you click anywhere on the ACL TOP screen, or select a menu item before you select Confirm or Cancel in the dialog box, the dialog box moves behind the ACL TOP application window, preventing you from doing anything else. You must: 1) minimize the ACL TOP application window; 2) select Confirm or Cancel; 3) then maximize the ACL TOP window. You can also press ALT+Tab to display the Print or Export dialog box. Sample R esults R eport If the test triggered a rerun test, an * appears in the first result cell in the report. The & sign appears for a result with a rerun test. See Rerun Rules Setup. A Sample Results report includes the following information: l Report Date and Time l Report Header (user configurable) with o Hospital o Laboratory o System (instrument name; for example ACL TOP 700) o Serial Number (of the instrument) l Sample ID l Sample Type l First Name (user configurable) l Last Name (user configurable) l Rack ID l Position ID 1Click in the Selection column of a table. A red check mark indicates selection. You can typically select more than one object. 609 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Reviewing Test Results l Test Code l Results (including the unit) or status of test if not successfully completed including: o UNDEFINED o COMPLETE o FAILED o PENDING o ACTIVE o TO DO l Flag l Performed Date and Time l Validated Printing Sample Results Detailed Reports To generate and print a Sample Results Detailed Report: 1. Select Analysis > Sample List in the menu bar. 2. In the Sample List, place focus1 a on sample ID. 3. Select the Test Details icon in the toolbar to open the Test Details screen. 4. Select Actions > Sample Results Detailed Report > Print in the menu bar. See Formatting Reports. Sample R esults D etailed R eport This report is available only if the test has completed. The Sample Results Detailed Report contains the same information as the Sample Results Report with the following additions: l Result for each replicate l Replicate errors l Reaction curve graph l Tracking information 1To place focus on the unique identifier in a list, click a row in the table. A blue cell border indicates focus. Only one unique identifier in a list can have focus. 610 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Reviewing Test Results Printing Patient Reports NOTE: Patient Result Reports are only available for validated results. To print a Patient Report: 1. Select Analysis > Sample List in the menu bar. 2. In the Sample List, select1 one or more sample IDs. 3. Select Actions > Print > Patient Report. Patient R eport If the test triggers a rerun test, an * appears in the first result cell. If the test triggered a diluted rerun, an & appears in the first result cell. A Patient report includes the following information: l Report Date and Time l Report Header (user configurable) with the following information: o Hospital or Laboratory Name o Serial Number (of the instrument) o System ID number l Sample ID l Sample Type l First Name l Last Name l Rack ID l Position ID l Test Code l Results (including the unit) or the status of the test if not successfully completed, including: o UNDEFINED o COMPLETE o FAILED o PENDING o ACTIVE 1Click in the Selection column of a table. A red check mark indicates selection. You can typically select more than one object. 611 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Reviewing Test Results o TO DO l Flag l Performed Date and Time l Validated Exporting Reports To export a Sample Results report: 1. Select Analysis > Sample List in the menu bar. 2. In the Sample List, select1 one or more sample IDs. 3. Select Actions > Export in the menu bar. 4. Specify the format and select the destination on the Export window. See Exporting Data. See Also l Sample List l Sample Details l Test Details 1Click in the Selection column of a table. A red check mark indicates selection. You can typically select more than one object. 612 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Sample List Sample List The Sample List contains information on samples. Only patient samples appear in the Sample List, including parallelism, extended and diluted tests. Sample information appears on the left side of the Sample List, and test information appears on the right. All tests associated with a sample ID appear in the Sample Details screen which, when open, appears under the Sample List. See Sample List Display Settings. Viewing Sample Details To view sample details: 1. Select Analysis > Sample List in the menu bar. 2. In the Sample List, place focus1 on a sample ID and select the Sample Details toolbar to open the Sample Details screen below the Sample List. icon in the 3. Select the Test Information tab in the Sample Details screen to view the tests associated with the sample in focus in the Sample List. 4. Select the Patient Demographics tab to view Sample and Patient information for the sample in focus in the Sample List. Selecting and Placing Focus on Samples To select and place focus on samples: 1. Select Analysis > Sample List in the menu bar. 2. To select one or more samples, click to place a check mark in the Select samples. column of those 3. To place focus on a sample ID, perform one of the following actions. You can place focus on only one sample ID. As you move focus to a different sample in the Sample List, the information in the Sample Details screen changes. l Press the Up and Down arrow keys on the keyboard to move the blue focus rectangle up and down the list of sample IDs. l Select a row in the Sample List to place focus on the sample ID in that row. l Touch the sample ID cell on the screen. l Use the Find tool to locate a sample ID in the Sample List. 4. Perform an action on the selected samples. Actions may be performed on multi-selected samples. For example, you can validate or upload the multi-selected samples, or filter the selected samples by test code. Multi-selected sample IDs do not have to be in focus. 1To place focus on the unique identifier in a list, click a row in the table. A blue cell border indicates focus. Only one unique identifier in a list can have focus. 613 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Sample List Combinations of Select and Focus NOTE: Do not edit the sample ID after an analytical session has started, unless you remove the rack first. N ot Selected / N o Focus Focus When a sample has focus you can obtain detailed information about the sample and its tests. Only one sample at a time may have focus. Selected Multi-selection is allowed. You can print, validate or upload the sample information for all selected samples. Selected with Focus Select and place focus to obtain detailed information about a sample and its tests. You can validate and upload in this configuration. U nderlined – H idden D ata An underlined sample ID indicates there are test results that are not displayed in the Sample List. See Sample List Display Settings to display hidden columns. 614 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Sample List Adding and Removing Tests Associated with a Sample To add or remove tests associated with a sample: 1. Select Analysis > Sample List in the menu bar. 2. Select1 one or more samples in the Sample List. 3. Select the Add/Remove Tests icon in the toolbar. 4. In the Test and Profiles dialog box, select or deselect the tests to add or remove from the selected samples. Select the Apply to all samples option to perform this action on all samples. See Test Programming Window for configuring this dialog box. Validating a Single Completed Test Result To validate2 a single completed test result: 1. Select Analysis > Sample List in the menu bar. 2. Place focus3 on the sample ID. 3. Select the Sample Details icon in the toolbar to open the Sample Details screen. 4. In the Sample Details screen, select4 the test to validate. 5. Select the Validate icon in the toolbar. Validating All Completed Test Results for a Sample To validate5 all the completed test results for a sample ID: 1. Select Analysis > Sample List in the menu bar. 2. Select6 one or more sample IDs in the Sample List. 3. Select the Validate icon in the toolbar, or select Actions > Results > Validate in the menu bar. 4. When the operation completes a black check mark appears in the Validation Status column. See Sample List Display Settings to display hidden columns. 1Click in the Selection column of a table. A red check mark indicates selection. You can typically select more than one object. 2The acceptance of test results by the user. 3To place focus on the unique identifier in a list, click a row in the table. A blue cell border indicates focus. Only one unique identifier in a list can have focus. 4Click in the Selection column of a table. A red check mark indicates selection. You can typically select more than one object. 5The acceptance of test results by the user. 6Click in the Selection column of a table. A red check mark indicates selection. You can typically select more than one object. 615 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Sample List Uploading a Single Completed Test Result to the LIS You can upload validated1 sample results from the Sample List or from the Test Details screen. The LIS must be enabled before uploading can occur. See Laboratory Information Systems (LIS). To upload a single completed test result: 1. Select Analysis > Sample List in the menu bar. 2. In the Sample List, place focus2 on a sample ID with test results to upload. 3. Select the Sample Details icon in the toolbar to open the Sample Details screen. 4. In the Sample Details screen, select3 the test with results to upload. 5. Click the Upload icon in the toolbar, or select Actions > Results > Upload in the menu bar. See Upload Status. Test U pload A test upload sends the following information to the host: l Test ID l Test Status l Test Order Date l Test Results 1Test results accepted by the user. 2To place focus on the unique identifier in a list, click a row in the table. A blue cell border indicates focus. Only one unique identifier in a list can have focus. 3Click in the Selection column of a table. A red check mark indicates selection. You can typically select more than one object. 616 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Sample List Uploading All Completed Test Results for a Sample to the LIS You can upload validated1 sample results from the Sample List or from the Test Details screen. The LIS must be enabled before uploading can occur. See Laboratory Information Systems (LIS). To upload all the completed test results for a sample: 1. Select Analysis > Sample List in the menu bar. 2. In the Sample List, place focus2 on a sample ID with test results to upload. 3. Select the Upload icon in the toolbar, or select Actions > Results > Upload in the menu bar. 4. When the operation is complete, a black check mark appears in the Upload Status column. See Sample List Display Settings to display hidden columns. See Upload Status. Sample U pload A sample upload sends the following information to the host: l Print Status l Priority l Sample Status l Upload Status l Validation Status Finding a Sample ID To find a sample ID: 1. Select Analysis > Sample List in the menu bar. 2. Select the Find icon in the toolbar, or select Actions > Results > Find Sample in the menu bar to open the Quick Search window. 3. Enter all or the first part of the sample ID and select Previous to search up, or Next to search down in the Sample List. You can also filter the Sample List to find a sample ID. 1Test results accepted by the user. 2To place focus on the unique identifier in a list, click a row in the table. A blue cell border indicates focus. Only one unique identifier in a list can have focus. 617 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Sample List Filtering Selected Samples by Test Code To select sample IDs associated with a test code: 1. Select Analysis > Sample List in the menu bar. 2. Select1 one or more sample IDs in the Sample List. 3. <Optional> Click the Select Sample List. column icon in the column heading to select all sample IDs in the 4. Select Actions > Results > Filter Selection by Test Code in the menu bar to open the Test Code Selection Filter. 5. Select2 one or more test codes in the Available column and click the right arrow to move them to the Selected column. 6. <Optional> Select one or more test codes in the Selected column and click the left arrow to move them to the Available column. 7. Select OK to filter the Sample List selection by the test codes in the Selected column. 8. The sample IDs associated with the filtered test codes now appear selected in the Sample List. 1Click in the Selection column of a table. A red check mark indicates selection. You can typically select more than one object. 2Click in the Selection column of a table. A red check mark indicates selection. You can typically select more than one object. 618 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Sample List Changing the Sample List Display Settings To change the Sample List to another saved configuration: 1. Select Analysis > Sample List in the menu bar. 2. Do one of the following: l l l Select the Sample List Display Settings default setting. icon in the toolbar to display the Select the down arrow to the right of the Sample List Display Settings and select a setting from the in menu. icon, Select Setup > Display > Sample List Settings in the menu bar, and select a defined setting in the submenu. 3. See Sample List Display Settings to display hidden columns. 619 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Sample List Configuring Sample List Display Settings Use this procedure to create and save up to eight configurations of fixed and scrollable columns in the Sample List table. Also use this procedure to edit an existing configuration. To configure a new Sample List display setting: 1. Select Analysis > Sample List in the menu bar. 2. Select Setup > Display > Sample List Settings > View in the menu bar. 3. In the Sample List Display Settings dialog box, select a Setting tab to configure with new display settings. 4. In the Configuration name field, enter a name for the new configuration to appear on this tab and the submenu. 5. <Optional> Select the Default option to make this configuration the default display. 6. Select the Non Scrollable Columns tab. Use the Left and Right arrows to populate the Selected columns list with the fixed columns to appear on the left side of the Sample List. 7. Select the Scrollable Columns tab. Use the upper Left and Right arrows to populate the Selected columns list with the test names to appear in the large scrollable header column to right of the fixed columns in the Sample List. 620 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Sample List 8. Use the lower Left and Right arrows on the Scrollable Columns tab to populate the Selected test unit columns list with the test units to appear in the scrollable columns under the test name heading column to right of the fixed columns in the Sample List. 9. Select OK to save the configuration. 621 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Sample List Actions Menu C onfiguration Opens the Sample List Filter submenu. R esults Opens a submenu with the following options: l Recalculate l Validate l Upload l Delete l Find Sample l Select All l Unselect All l Filter Selection by Test Code l Download Tests Order l Add/Remove Tests – Opens the Tests and Profiles window where you can manually add or delete a test for a sample selected in the Sample List. See Reviewing Test Results. Print Preview Opens a submenu with the following options: l Sample Results Report l Patient Report Pre-select one or more sample IDs or test codes to preview before printing. 622 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Sample List Print Opens a submenu with the following options: l Sample Results Report l Patient Report Pre-select one or more sample IDs or test codes to print. Export Opens a submenu with the following options: l Sample Results Report l Patient Report l Sample Results (EXCEL) – Exports the filtered list created with Filter Selection by Test Code. Pre-select one or more sample IDs or test codes to export. NOTE: After you print or export a report or a list, you may not be able to perform certain operations, such as shutting down the instrument. The system may seem to lock up. When you print or export, the Print/Export dialog box opens. If you click anywhere on the ACL TOP screen, or select a menu item before you select Confirm or Cancel in the dialog box, the dialog box moves behind the ACL TOP application window, preventing you from doing anything else. You must: 1) minimize the ACL TOP application window; 2) select Confirm or Cancel; 3) then maximize the ACL TOP window. You can also press ALT+Tab to display the Print or Export dialog box. R aw D ata R eport Includes measured results and results stored within the test (results that were not recalculated). Pre-select one or more samples or tests for a sample. Only completed tests can generate a report. The report is a text file placed into the folder specified in Global Definitions/Default File Path. Patient D emographics Opens a submenu with the following options: l Save l Restore Print Screen Prints the open screen. R eview Opens a submenu with the following options: l Previous screen l Sample details 623 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Sample List l l l Test details Results statistics – All results within a time interval, or results inside the normal range within that time interval, display for each Test Code/Unit. Results include Mean, Number of results, SD, Min and Max. See Results Statistics. Test Counters Statistics – Displays a table with the number of tests (active and alternate) executed for a test definition since the last reset of this screen. See Test Counters Statistics. 624 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Sample List Sample List Toolbar Select the following icons to perform the associated tasks: Sample List Display Settings – Changes the view settings. See Sample List Display Settings to display hidden columns. Validate – Use to validate1 selected test results. Upload – Upload selected test results to the LIS. Filter – Filters the Sample List. See Sample List Filter. Find – Search for a sample ID. Add/Delete Tests. Sample Details – Opens the Sample Details screen under the Sample List. Displays test information for the sample in focus2. Test Details – Opens the Test Details screen for the sample test in focus3. NOTE: Only patient samples are displayed in the Sample List. See Sample Area, Sample Details and Test Details. 1The acceptance of test results by the user. 2To place focus on the unique identifier in a list, click a row in the table. A blue cell border indicates focus. Only one unique identifier in a list can have focus. 3To place focus on the unique identifier in a list, click a row in the table. A blue cell border indicates focus. Only one unique identifier in a list can have focus. 625 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Sample List Sample List Screen Sample List Screen Displaying the Data Area Each row in the Sample List corresponds to a sample that has been programmed. Sample List To sort the Sample List: 1. Click a column heading. 2. Click the same column heading again to sort in reverse order. 3. Click a 2nd column to resort the list. This column becomes the primary sorting criterion, and the first column sorted becomes the secondary sorting criterion. 626 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Sample List Sample List with Tests and Profiles Window 627 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Sample List Sample List Columns See Sample List Display Settings to display hidden columns. Selection C olumn Click in this column to place a check mark there. This selects a sample. You can multi-select samples in this column. Sample ID Sample unique identifier. Click a row place focus1 on the sample ID in that row. Only one sample ID can have focus. When the sample has focus, the tests associated with it appear in the Sample Details screen. Sample Status Displays the color-coded status of each sample. See Sample Status Color Codes. Print Status Status of print jobs associated with the sample. AutoPrint must be enabled to activate this column. A black check mark indicates all actions are complete for all of the tests in the sample. A gray check mark indicates one or more actions are incomplete. Priority Status A check mark indicates the sample is a stat, which processes with the highest priority. CAUTION: Continuously adding stat2 samples delays testing on non-stat samples, possibly indefinitely. Validation Status Validation status of the sample. A black check mark indicates all actions are complete for all of the tests in the sample. A gray check mark indicates one or more actions are incomplete. Sample H ighest Error Code for the highest priority error associated with the sample. If the cell is empty, no error or warning exists for the sample. If a code is underlined, additional errors or warnings exist for this sample. See Sample List Display Settings to display hidden columns. See Data Flags for error descriptions. 1To place focus on the unique identifier in a list, click a row in the table. A blue cell border indicates focus. Only one unique identifier in a list can have focus. 2In medical terminology, immediate; with no delay. Stat samples have highest priority. 628 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Sample List D ate & Time Date and time the sample was entered into the system. R ack ID Track where the sample rack containing the sample is placed. An LAS value indicates the sample came from the LAS track. A sample aliquotted from the LAS track is assigned a rack ID of 999. This value is not displayed but is transmitted to the LIS. Position Position of the sample on the sample rack. An LAS value indicates the sample came from the LAS track. A sample aliquotted from the LAS track is assigned a rack position of 99. This value is not displayed but is transmitted to the LIS. U pload Status Upload status of sample results to the LIS. A black check mark indicates all actions are complete for all of the tests in the sample. A gray check mark indicates one or more actions are incomplete. A sample upload sends the following information to the host: l Print Status l Priority l Sample Status l Upload Status l Validation Status A test upload sends the following information to the host: l Test ID l Test Status l Test Order Date l Test Results On B oard Status A black check mark indicates the sample is on board. A dditional C olumn H eadings See Sample List Display Settings to display the following additional columns: l First Name of patient l Last Name of patient l Patient ID l Birth date 629 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Sample List l Gender l Status of sample l Ordered date & time – Date/time of the first test order l Last test completed date & time – Blank if no test has been completed for the sample. l First test completed date & time – Blank if no test has been completed for the sample. l Sender ID 630 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Sample List Test Information Columns <test> Columns On the right side of the Sample List are the Test Results columns. There is one large test results column (with sub-columns) for each test performed on a sample. The large <test> column contains the test name in the column heading. Under the <test> are sub-columns that contain the units used for the results and two columns with icon headings to identify the job type and rerun mode. The cells in the Test Results column can contain the following information for the sample: l l If the test is complete, the Test Result numeric value is displayed. (FAILED is displayed if the result failed.) If the test is not complete the status appears in the first result column for each test. Status can be: TO DO, PLACED, NOT FEASIBLE and ACTIVE. Job Type Displays a letter to indicate the type or mode of the test performed. The letter for each test type is defined in Global Definitions in Test Mode Extensions. The most commonly used letters are: E – Extended mode, P – Parallelism mode, and D – Dilution mode, although you can use any letter you choose for each of these modes. R erun Mode This column displays the following: o – Rerun test triggered by a previous test. o – This test triggered a rerun. 631 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Sample List R esult U nit C olumns l If the test completed successfully, the mean result for each unit displays. l If the test completed but the results failed, the word FAILED displays. l If the test is incomplete, its status displays in the first result column. l l If the result is underlined – There are more results for this test that cannot display. See Sample List Display Settings to change the display. If the result is italicized – There is at least one warning against it. The only exception to this is the Second Algorithm used flag. l If the result is purple and bold – The result is out of test range. l If the result is red and bold– The result is out of linear range but within test range. l If the result is orange and bold – The result is out of therapeutic range. l If the result is blue and not bold – The result is out of normal range but within linear range. l If the result is black and not bold – The result is within normal range. l An exclamation point displays on the sample status circle to indicate failed results. It appears based on the last result for each test run, or for a given sample. Example If a PT result fails, an exclamation point appears: l l If the test repeats and the result is good (for example: PT=80 seconds) the exclamation point disappears. If the test repeats in the extended mode and the result of the PT-E test is good (for example: PTE=105 seconds) the exclamation point still appears for the PT result, but not for the PT-E result because these are two different tests. In parallelism, if any of the parallelism indices fail (for example, slope, CV) an exclamation point appears. 632 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Sample List Time to Completion At the bottom of the screen, below the instrument status field, the time required to complete running tests displays dynamically, along with the number of tests completed and ordered. See Also l Exporting Data l Sample Details l Test Details l Sample Area l Sample List Filter l Reviewing Test Results l Results Statistics l Test Counters Statistics l Clot Curve Analysis 633 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Sample Details Sample Details Viewing Sample Details To view sample details: 1. Select Analysis > Sample List in the menu bar. 2. In the Sample List, place focus1 on a sample ID and select the Sample Details toolbar to open the Sample Details screen below the Sample List. icon in the 3. Select the Test Information tab in the Sample Details screen to view the tests associated with the sample in focus in the Sample List. 4. Select the Patient Demographics tab to view Sample and Patient information for the sample in focus in the Sample List. Viewing Parallelism Details To open the Parallelism Detail screen: 1. Select Analysis > Sample List in the menu bar. 2. In the Sample List, place focus2 on a sample ID with a parallelism test. 3. Select the Sample Details icon in the toolbar. 4. Select the parallelism test in the Sample Details screen. 5. Select the Test Details icon, or select Actions > Review > Test Details in the menu bar to open the Test Details screen. 1To place focus on the unique identifier in a list, click a row in the table. A blue cell border indicates focus. Only one unique identifier in a list can have focus. 2To place focus on the unique identifier in a list, click a row in the table. A blue cell border indicates focus. Only one unique identifier in a list can have focus. 634 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Sample Details Test Information Tab Column Headings Job Type Displays a letter to indicate the type or mode of the test performed. The letter for each test type is defined in Global Definitions in Test Mode Extensions. The most commonly used letters are: E – Extended mode, P – Parallelism mode, and D – Dilution mode, although you can use any letter you choose for each of these modes. R erun Mode This column displays the following: o – Rerun test triggered by a previous test. o – This test triggered a rerun. R esult U nit C olumns l If the test completed successfully, the mean result for each unit displays. l If the test completed but the results failed, the word FAILED displays. l If the test is incomplete, its status displays in the first result column. l l If the result is underlined – There are more results for this test that cannot display. See Sample List Display Settings to change the display. If the result is italicized – There is at least one warning against it. The only exception to this is the Second Algorithm used flag. l If the result is purple and bold – The result is out of test range. l If the result is red and bold– The result is out of linear range but within test range. l If the result is orange and bold – The result is out of therapeutic range. l If the result is blue and not bold – The result is out of normal range but within linear range. l If the result is black and not bold – The result is within normal range. l An exclamation point displays on the sample status circle to indicate failed results. It appears based on the last result for each test run, or for a given sample. Example If a PT result fails, an exclamation point appears: l l If the test repeats and the result is good (for example: PT=80 seconds) the exclamation point disappears. If the test repeats in the extended mode and the result of the PT-E test is good (for example: PTE=105 seconds) the exclamation point still appears for the PT result, but not for the PT-E result because these are two different tests. 635 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Sample Details In parallelism, if any of the parallelism indices fail (for example, slope, CV) an exclamation point appears. Patient Demographics Tab Displays information such as Patient ID, Name and Date of birth for the patient from whom the sample was obtained. See Also l Test Details l Sample Area l Sample List l Sample List Filter 636 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Test Details Test Details Viewing Test Details To view test details: 1. Select Analysis > Sample List in the menu bar. 2. In the Sample List, place focus1 on a sample ID and select the Sample Details toolbar to open the Sample Details screen below the Sample List. icon in the 3. In the Sample Details screen select the Test Information tab. 4. In the Test Information tab place focus on a test and select the Test Details to view the Test details screen. icon in the toolbar 5. Select the Previous Job and Next Job icons in the toolbar to scroll through the test results for the sample ID in focus in the Sample List. 1To place focus on the unique identifier in a list, click a row in the table. A blue cell border indicates focus. Only one unique identifier in a list can have focus. 637 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Test Details Printing and Exporting a Parallelism Report To print or export a Parallelism Report for a completed test: 1. Select Analysis > Sample List in the menu bar. 2. In the Sample List, select one or more patient sample IDs with parallelism results. 3. To print a Parallelism Report, select Actions > Print > Print Parallelism Report in the menu bar. 4. To export a Parallelism Report, select Actions > Export > Export Parallelism Report in the menu bar. NOTE: After you print or export a report or a list, you may not be able to perform certain operations, such as shutting down the instrument. The system may seem to lock up. When you print or export, the Print/Export dialog box opens. If you click anywhere on the ACL TOP screen, or select a menu item before you select Confirm or Cancel in the dialog box, the dialog box moves behind the ACL TOP application window, preventing you from doing anything else. You must: 1) minimize the ACL TOP application window; 2) select Confirm or Cancel; 3) then maximize the ACL TOP window. You can also press ALT+Tab to display the Print or Export dialog box. Parallelism Result report A Parallelism Result report includes the following information: l Test code l Sample ID l Sample type l Rack ID l Sample rack position ID l Execution date & time l Validation status l Validation date & time l Primary unit at 100% l Parallelism curve slope l Calibration curve slope l Parallelism Y-intercept l %CV-CR l Parallelism r2 l Average of correction result l Parallelism curve l Parallelism errors 638 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Test Details l Concentration l Mean primary value l Corrected result l Result l Replicates l For each concentration the following is printed: l o Concentration o Mean (mean value + measured unit) o Primary (primary value + primary unit) o Corrected result o Replicate value (printed once for each replicate up to a maximum of 3) o Replicate errors and warnings Test tracking information Printing the Clot Curve To print the clot curve: 1. Display the test details. 2. Select the Print icon in the toolbar. 639 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Test Details Test Details Screen Use the Test Details screen to access detailed information on each test for a sample ID. Test Information l l l Test code– Test code as defined in Test Definition. Test type – Type of test. For example: Patient, Calibrator, QC, NPP1, Patient parallel, Extended, etc. Defined in Test Definition. Sample ID– Unique sample identifier as defined on the sample bar code or as manually entered in the Sample Rack Details. l Rack ID – Rack identifier of the rack used to run the sample. l Status – Status of the result. l Upload status – Status of the result. Uploaded indicates the results were uploaded to the LIS. l Validation status – The sample validation status. l Sample position – Position on the rack where the sample was loaded when run. l l Ordered date/time – Date and time the test was ordered (manually or through the LIS). This does not represent the time the test executed. Completed date/time – Date and time the test completed execution. 1Normal Pool Plasma. A type of sample used as a standard of comparison when calculating the International Normalized Ratio (INR) and when calculating test results that use the normalized ratio. 640 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Test Details Check Boxes The check boxes on the left side of the Test Information section indicate the status of the sample ID when tests were performed. l l l CTS – Closed tube sample Reflex – A test that orders one or more secondary tests based on preset criteria applied to the initial test results. Rerun – A test that runs again based on preset criteria applied to the initial test results. Errors and warnings Table listing the Group, Code and Description of the errors and warnings generated when the sample was tested. See Data Flags. Measured Measured results for replicates. If applicable, additional reported results are also listed in the Unit 1-4 fields. Reaction graphs Graphical representation of the reaction curve. Select the Display derivative curves option to display the derivative curves. The default for this option is configured in Global Definitions. Tracking Information Tab Displays the Material name, Lot number, and Expiration date of the materials used in the test. 641 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Test Details Parallelism Test Details Screen The following screen displays parallelism results: Tabs exist for General Information, Tracking Information and one for each dilution (for example, Dilution 100.00%, Dilution 50.00%, etc.) Enable Display Transformed Axes On the General Information tab you can select how to display the curve – with or without the transformed axes – whether X and/or Y axis transformation is enabled in Parallelism Setup. In the screen above, the curve is displayed with transformed axes. See Also l Configuring Factor Parallelism l Parallelism Setup l Sample Details l Sample Rack Details l Exporting Data l Global Definitions l Data Flags l Test Definition l Clot Curve Analysis 642 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Clot Curve Analysis Clot Curve Analysis The PT and APTT tests are used as examples in this topic. Overview The ACL TOP instrument provides high quality results from both an accuracy and precision perspective. The instrument incorporates optical-based reading systems with the means to precisely monitor clotting, chromogenic, and immuno-turbidimetric reactions in the cuvette during the data acquisition cycle. The optical data is processed by means of sophisticated algorithms as well as data checks designed to ensure minimum acceptance criteria are met, and also ensuring that results are not reported from significantly abnormal reaction curves. In the case of clotting reactions, significantly abnormal conditions may be found, for example, in samples from patients with liver function impairments. These pathologic conditions are known to cause coagulation factor deficiencies as well as low fibrinogen levels.Samples from patients with these conditions can be difficult to analyze. They may result in non-optimal readings especially from mechanical based clotting analyzers which do not allow the clot to form undisturbed. Samples of this nature should be flagged on all systems and the reaction visually evaluated. This evaluation can be performed on the ACL TOP systems to establish a clot time. 643 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Clot Curve Analysis Configuring, Viewing and Analyzing Derivative Curves The PT and APTT tests are used as examples in this procedure and analyses. To configure, view and analyze derivative curves: 1. Select Setup > Global Definitions in the menu bar. 2. In the Global Definitions screen, under Test definition features, select the Display derivative curves option to enable the display of clot curves on the Test Details screen. 3. Select Analysis > Sample List in the menu bar. 4. In the Sample List, place focus1 on a sample ID and select the Sample Details toolbar to open the Sample Details screen below the Sample List. icon in the 5. In the Sample Details screen select the Test Information tab. 6. In the Test Information tab place focus on a PT or APTT test (the examples in this procedure/analysis) and select the Test Details screen. icon in the toolbar to view the Test details 7. On a Replicate tab, select Display derivative curves to view the clot curves for the test in focus. 8. Review the following sections for viewing PT and APTT clot curve examples. The First Derivative is plotted as a pink line. The Second Derivative is plotted in light blue. The dark blue line is the standard sample reaction plotted. For the PT reaction, the clot time is noted at the peak of the First Derivative. For the APTT, the clot time is noted at the peak of the Second Derivative. These selections correspond to the settings found in the test definition for these test examples. To view the settings for the test: 1. Select Setup > Test List in the menu bar. 2. Double-click the test in the Test List. 3. In the Test Details navigation tree, expand DR Parameters, Primary wavelength and select Primary algorithm. When a sample does not meet the criteria defined within the test definition, no result value are displayed. For these samples the clot curve, with the derivatives curves enabled, can be a useful tool to establish a clot time for the sample visually. The display of a clotting reaction is a dynamic display. You can utilize the mouse cursor to view the time by placing the cursor anywhere along the entire acquisition interval for the standard curve, First Derivative (pink line), or Second Derivative (light blue line). Positioning the cursor at the peak of the respective curve 1To place focus on the unique identifier in a list, click a row in the table. A blue cell border indicates focus. Only one unique identifier in a list can have focus. 644 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Clot Curve Analysis (i.e. Second Derivative for APTT) would provide the clot time for that sample, had it met all of the data check criteria. The APTT sample below is an example of how to read the curve value. Example 1 – Low Fibrinogen APTT Sample This reaction resulted in a Failed result with the error 5071 (Coag) First derivative peak not found. 645 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Clot Curve Analysis Double click the reaction graph on the ACL TOP interface to enlarge it. This is a reaction for an APTT processed using HemosILSynthASil. This assay uses the Second Derivative to establish a clotting time. This reaction shows a standard-looking clot curve with the characteristic S shape. The S shape indicates the reaction has a baseline, acceleration, and plateau phase. You can also notice a distinct peak for the Second Derivative (light blue) plot. The Y axis for the graph however has a limited scale. The readings range from 89 to 106 (curve delta of 17) which is much smaller than what you would normally obtain processing a sample with a normal fibrinogen value. For a sample such as this, if you place the cursor at the peak of the Second Derivative you get a reading of 107.7 seconds. This would correspond to the reading obtained if all data check criteria had passed. The clot curve can be a useful tool to establish what a clot time would be for a sample if the quality data checks were not enabled in the test definition. NOTE: Things to keep in mind when using this tool: l The standard clot curve (dark blue line) should have the characteristic S shape l A distinct peak for the First Derivative (pink line) should be present for assays using this algorithm. l A distinct peak for both the First Derivative (pink line) and Second Derivative (light blue line) should be present for assays using the Second Derivative algorithm. 646 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Clot Curve Analysis Example 2 – Extended APTT Sample – Failed Result This reaction resulted in a Failed result with the error 5071 (Coag) First derivative peak not found. Double click the reaction graph on the ACL TOP interface to enlarge it. For this example, the standard clot curve (dark blue line) does not present the classic S shape. The curve has a baseline and acceleration phase but lacks the plateau phase. In addition there is no distinct peak for the Second Derivative (light blue line). This particular clot curve cannot be used to manually establish a clotting time. This example presents a sample with an extremely long clotting time. This type of sample would need to be analyzed on a test/system that does not limit the data acquisition phase in order to establish the APTT clot time. 647 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Clot Curve Analysis Clot Curve Analysis On ACL TOP instrument, the monitored clotting reaction is plotted as a clot curve. A clot curve is generated for all processed samples. Samples with low fibrinogen often produce a normal looking clotting reaction. However, if the reaction does not meet the minimum delta specification, the system does not provide a result. On the ACL TOP systems the clot curve display may be reviewed the following ways: l Clot Curve reaction solely (no curves) l Clot Curve reaction plus derivative curves. An example of each of these is shown below for a PT and APTT reaction: PT Curve without Derivative Curves 648 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Clot Curve Analysis PT Curve with Derivative Curves APTT Curve without Derivative Curves 649 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Clot Curve Analysis APTT Curve with Derivative Curves The PT and APTT appear different due to the algorithm used to identify the clot point of the sample: l l The PT using HemosIL™ RecombiPlasTin 2G reagent is resulted using the First Derivative algorithm; therefore a single derivative curve is overlaid on the clot curve. The APTT using HemosIL SynthASil or APTT SP is resulted using a Second Derivative algorithm; therefore two Derivative curves are overlaid on the APTT clot curve. Conclusion You can use the clot curve evaluate results from compromised samples. In many situations, samples that present a Failed value (for example, due to very low fibrinogen content [fragile clot]) can be assessed via the clot curve and a visual result obtained. It is always important to first ensure a clot has formed by reviewing the clot curve for a baseline, acceleration and plateau phase before reading the result off the appropriate derivative curve for the particular assay. See Also l Global Definitions Setup l Primary Algorithm 650 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Results Statistics Results Statistics The Results Statistics window displays test result information grouped by test code and unit. Viewing Results Statistics To view results statistics: 1. Select Analysis > Sample List in the menu bar. 2. With the Sample List open, select Actions >Review > Result Statistics in the menu bar. 3. In the Results Statistics Filter window, configure the date constraints and the results to display. 4. Select OK to display the test results in the Results Statistics window. 5. To print a Results Statistics report, select the Print button on the Results Statistics window. All the information displayed in the window appears in the report. 6. Select the Preview or Export button on the Results Statistics window to preview or export a Results Statistics report. See Exporting Data. 651 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Results Statistics NOTE: After you print or export a report or a list, you may not be able to perform certain operations, such as shutting down the instrument. The system may seem to lock up. When you print or export, the Print/Export dialog box opens. If you click anywhere on the ACL TOP screen, or select a menu item before you select Confirm or Cancel in the dialog box, the dialog box moves behind the ACL TOP application window, preventing you from doing anything else. You must: 1) minimize the ACL TOP application window; 2) select Confirm or Cancel; 3) then maximize the ACL TOP window. You can also press ALT+Tab to display the Print or Export dialog box. Results Statistics Filter Filters the results to display in the Results Statistics window. Enable filter by date/time interval Option to filter by a date range. Enables the From and To fields. From and To Select the date range parameters for results to view in these fields. Results R esults Inside N ormal R ange Displays all non-failed results without the DR flags Normal Range Low or Normal Range High. A ll R esults Displays all non-failed results. 652 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Results Statistics R esults from Selected Jobs Displays non-failed results from jobs you have selected in the Sample List. See: Data Flags.) Results Statistics Window The title bar displays the filtering options you chose. The following columns are displayed: l Test & Unit – Displays the name of the test and the result unit. Each of the following are calculated using results that match the test code/test result unit: l Mean l Number of Results l SD l Min l Max l %CV See Also l Sample List Area 653 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Test Counters Statistics Test Counters Statistics There are two Test Counters Statistics windows: l l Simple Test Counters Statistics – Displays only the test code and the total number of determinations for each test. Detailed Test Counters Statistics – Displays more details for each test. By default, these are only available to Test Specialist/Service level (non-customer) users. However, service can change the access level for either to a customer level. Accessing the Test Counters Statistics Windows To open a Test Counters Statistics window: 1. Select Analysis > Sample List in the menu bar. 2. In the Sample List, select Actions > Review > Simple Test Counters Statistics or Detailed Test Counters Statistics in the menu bar. 3. The title bar displays the date of the last reset of the counters. 4. To sort the data in the table, select a column. See Sorting Lists. 5. To reset the counters, select the Reset Counters button in the window and confirm when prompted. All counters reset to 0 and the current date displays in the title bar. 6. To print a Test Counters List or Detailed Test Counters List report, select the Print button in the window. All the information displayed in the window prints in the report. 7. To preview a report, select the Preview button in the window. 8. Select OK to exit the window. 654 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Test Counters Statistics Simple Test Counter Statistics Displays the Test Code and the total number of Determinations for all test types. 655 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Test Counters Statistics Detailed Test Counter Statistics Displays a table containing the number of tests executed for a test definition since the last reset of this screen. The number of Standard, Rerun and Reflex tests run for both number of tests and number of determinations is displayed. Columns Descriptions Icon Test Code Normal Jobs Counter Extended Jobs Counter Parallel Jobs Counter Alternative Predilution Jobs Counter 656 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Test Counters Statistics Icon Test Code Calibration Jobs Counter – Number of calibrations (not tests) included in the calibration. The total values are displayed in bold text. Calibration points are counted as individual determinations. NPP Jobs Counter – Value is displayed in bold. QC Jobs Counter – Value is displayed in bold. # Total – The total number of jobs equals the sum of the patient calibration, NPP, and QC tests. This value displays in bold text. The totals displayed in bold are used to calculate the total number of tests. Values that display in plain text represent subtotals. For calibration, NPP1 and QC tests, rerun and reflex do not apply. Those cells are blank. For parallelism, rerun does not apply. Those cells are blank. If a test is canceled before its completion, the counters are not updated. See Also l Test Details l Sample List l Reviewing Test Results l Results Statistics 1Normal Pool Plasma. A type of sample used as a standard of comparison when calculating the International Normalized Ratio (INR) and when calculating test results that use the normalized ratio. 657 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Sample List Filter Sample List Filter By default, all known samples are displayed in the Sample List. Use the up to three filter options to reduce the selection in the Sample List. Filtering the Sample List To filter the Sample List: 1. Select Analysis > Sample List in the menu bar. 2. Select the Filter bar. icon in the toolbar, or select Actions > Configuration > Filter in the menu 3. In the Sample List Filter dialog box, select a maximum of three filters on the Sample Filters and Test Filters tabs. 4. Configure the filter criteria for the filters enabled in the previous step. See the descriptions of Sample List Filters and Test Filters tabs in this topic. 5. Select OK. The filtered results appear in the Sample List. 6. See Sample List to view sample and test details. 658 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Sample List Filter Sample Filters 1 Tab Enable filter by sample ID Option to filter the Sample List by a range of sample IDs. To use this filter, select this option and configure the sample ID range in the From and To fields. When the same sample ID is entered in both fields, one sample ID displays. Enable filter by sample priority Option to filter the Sample List by sample priority. To use this filter, select this option and choose one of the following in the Sample priority drop-down list: l Normal – Displays normal priority samples. l LAS – Displays samples on the LAS1 track. l Stat – Displays the highest priority samples. Enable filter by sample upload status Option to filter the Sample List by sample upload status. To use this filter, select this option and choose one of the following in the Upload status drop-down list: l Not uploaded – Displays sample IDs with test results that have not been uploaded to the LIS. l Uploaded – Displays sample IDs that have had all test results uploaded to the LIS. l Partial – Displays sample IDs that have uploaded some, but not all, test results to the LIS. Enable filter by ordered date/time Option to filter the Sample List by tests ordered within a date range or by the current date. To use this filter, select this option, then do one of the following: 1Laboratory Automation System 659 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Sample List Filter l Select the Filter by current date option. l Configure the date range in the From and To fields. Enable filter by sample validation status Option to filter the Sample List by sample validation status. To use this filter, select this option and choose one of the following in the Validation status drop-down list: l Not validated – Displays sample IDs with results that have not been validated. l Validated – Displays sample IDs that have had all results validated. l Partial – Displays sample IDs that have had some, but not all results validated. l Not validated or partial – Displays 1) sample IDs with results that have not been validated; and 2) sample IDs that have had some, but not all results validated. Enable filter by sample print status Option to filter the Sample List by sample print status. To use this filter, select this option and choose one of the following in the Print status drop-down list: l Not printed – Displays sample IDs that have test results that have not printed. l Printed – Displays sample IDs that have test results that have all printed. l Partial – Displays sample IDs that have printed some, but not all test results. 660 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Sample List Filter Set of Filters 2 Tab Enable filter by patient ID Option to filter the Sample List by a range of patient IDs. To use this filter, select this option and configure the patient ID range in the From and To fields. When the same patient ID is entered in both fields, one patient ID displays. Enable filter by sample highest error Option to filter the Sample List by sample highest error. To use this filter, select this option and choose a sample error code in the Sample error drop-down list. Only samples having the selected error are displayed in the Sample List. Selecting Any group displays sample IDs the highest error among all the errors or warnings. Underlined samples in the Sample List have multiple errors. See Alarms and Troubleshooting/Data Flags for a list of the error codes. Enable filter by failed jobs Option to filter the Sample List by failed jobs. To use this filter, select this option and choose one of the following in the Failed Jobs drop-down list: l Samples with failed jobs – Displays only samples with failed jobs . l Samples with no failed jobs – Displays only samples with no failed jobs . Enable filter by patient last name Option to filter the Sample List by a range of patient last names. To use this filter, select this option and configure the alphabetical range in the From and To fields (For example, enter A-Z or spell out full or partial last names). Enable filter by sample status Option to filter the Sample List by sample status. To use this filter, select this option and choose one of the following in the Sample status drop-down list: 661 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Sample List Filter l TO DO – Displays samples with TO DO status. l PLACED – Displays samples with PLACED status. l IN USE – Displays samples with IN USE status. l COMPLETED – Displays samples with COMPLETED status. l PENDING – Displays samples with PENDING status. l NOT FEASIBLE – Displays samples with NOT FEASIBLE status. Enable filter by sample on board Option to filter the Sample List by sample on board. To use this filter, select this option and choose one of the following in the Sample status drop-down list: l Not on board – Displays samples that are on board. l On board – Displays only samples that are not on board. Set of Filters 3 Tab Enable filter by first test completed date/time Option to filter the Sample List by first test completed within a date range or by the current date. To use this filter, select this option, then select the Filter by current date option, or configure the date range in the From and To fields. Enable filter by last test completed date/time Option to filter the Sample List by last test completed within a date range or by the current date. To use this filter, select this option, then select the Filter by current date option, or configure the date range in the From and To fields. 662 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Sample List Filter Test Filters 1 Tab Enable filter by test code Option to filter the Sample List by test code. To use this filter, select this option and select a Test code in the Test code drop-down list. Test code List of enabled tests, including parallel and extended tests. Type one or two letters of the test code, then expand the list to jump to that text string in the list. You can select a test code in the list, or enter the first letters of the test code in this field. The filter displays all the sample IDs with tests that exactly or partially match the text string in this field. R erun Option to filter the Sample List by rerun. To filter by rerun only, select the Rerun option and leave the Test code field empty. This configuration displays all sample IDs with a test that triggered a rerun. Filter by both Test C ode and R erun To filter by both Test Code and Rerun, enter the test code and select the Rerun option. This configuration displays sample IDs that ran the selected test and triggered a rerun. Enable filter by job type Option to filter the Sample List by job type. To use this filter, select this option and choose one of the following in the Sample status drop-down list: l Patient – Displays patient jobs in the Sample List. l Alt. Predilution – Displays alternative predilution jobs in the Sample List. l Parallelism – Displays parallelism jobs in the Sample List. l Extended – Displays extended jobs in the Sample List. 663 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 10 – Sample Analysis Sample List Filter Enable filter by job error Option to filter the Sample List by job error. To use this filter, select this option and choose an error code in the Job error drop-down list. Samples having the selected error display. Selecting Any group displays jobs with any error or warning. Underlined samples in the Sample List have multiple errors. See Data Flags for a list of the error codes. All Samples The All Samples option applies to all tabs. It cancels all filter criteria and displays all sample IDs in the Sample List. See Also l Sample List l Sample Details l Sample Area l Data Flags l Alarm Messages 664 of 992 L0027503450 R00 ACL TOP Family Operator's Manual CHAPTER 11 ANALYZER STATUS Analyzer Status Indicators To the right of the General Log the analyzer. on the Status Bar is a color-coded indicator of the current status of The LED indicates the status of the instrument as follows: Power-up Blue Startup initialization Blinking blue Shutdown initialization Blinking blue Adjusting thermal Blinking blue Ready Green Busy Blue Controlled stop Blue Error Amber Emergency Stop Amber Maintenance Blinking amber Diagnostics Blinking amber Connecting No LED Not connected No LED It typically takes up to 30 minutes for the analyzer to complete the power-up process from a cold start. It can take up to 60 minutes at extreme temperatures. See Also l Starting and Stopping Overview 665 of 992 L0027503450 R00 ACL TOP Family Operator's Manual CHAPTER 12 ALARMS AND TROUBLESHOOTING Alarm Messages You are notified of alarm messages through the alarm buttons on the instrument status bar. Alarm warning1 and error2 popup messages communicate important information as needed, such as when operator intervention is required. NOTE: Data flags do not appear in the General Log List or as popup alarms. For more information, see Accessing Data Flags. Accessing Alarm Messages To view an alarm message do one of the following: l Select the specific alarm button at the bottom of the screen to open that alarm window. l Select System > General Log in the menu bar to view a list of all archived alarm messages. l Select the General Log button on the left side of the status bar. See Alarm Buttons for a complete description of all alarm buttons. 1A warning message indicates that some user action may be required. Warnings do not affect the operation of the instrument. However, an error condition may eventually occur if the operator does not perform the required action. 2An error message indicates that a condition has been detected that requires immediate action. Failure to act may result in the instrument performing an emergency stop. 666 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Alarm Messages New alarm messages are displayed in bold text. When you close this window, the message text returns to normal font. The window can contain up to 200 messages. All messages that occur can be found in the General Log. Warning and Error Messages Select a link to view alarms by category: l Material Alarms l Job Frequency Alarms l QC Alarms l Maintenance Alarms l Analyzer Alarms l External Communications Alarms l Setup Alarms l Other Alarms l Popup Alarms See Also l Data Flags l Alarm Buttons l General Log List l Troubleshooting Other Problems 667 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Material Alarms Material Alarms Back to Alarm Messages. The alarms in this section are sorted by code number. CAUTION: When manually moving the probe arm, lift the arm to its highest position. To avoid damaging the probe arm during the move, grasp it from the back, as near to the back wall as possible. Grasping a probe arm from the front pushes it out of alignment. A misaligned probe arm causes inaccurate coordinates adjustment and other errors. Material Alarms – Warnings and Errors Code Message Alarm Description Operator Action 1210 Cuvette waste level sensor failure. Cuvette Waste Level Sensor Not Responding. The system performed a controlled stop: the run has to be re-started. If the problem persists, call Service. 1215 Unable to empty internal waste reservoir. Waste Accumulator Full Sensor remains in ON state. Verify that the waste container is not full, and that the indicator is not red. If the problem persists, call Service. Notes: l TOP 500/700/700 CTS/700 LAS: After 90 seconds running the Waste Pump. TOP 300: After five seconds. 1220 Reagent stirring failure. A check on the power required for stirring returned an error Call Service. 1239 Cuvette Loader failure. Failure during cuvette indexing detected. The system performed a controlled stop: the run has to be re-started. If the problem persists, call Service. 1240 Cleaning solution low in clean well. Validate LLD height in Clean well. If too low, short sipping may occur. Perform a Clean prime cycle (Maintenance). If the problem persists call Service. 1241 <Probe> Clean priming Clean priming failure. Inspect tubing for kinks and/or leaks. 668 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Material Alarms Material Alarms – Warnings and Errors Code Message Alarm Description Operator Action failure. Check clean solution bottle. If the problem persists, call Service. 1282 Probe <Probe> Rinse Flow Test Failure Rinse flow verification procedure failure Inspect probe tip for blockage and clear if blocked. Inspect tubing for kinks and/or leaks. Check rinse solution bottle. Call Service. 1285 Probe <Probe> Liquid Level Detection error in rack position <X>, track <YY>. LLD error occurred during pipetting operation. Check probe conditions. If the problem persists, call Service. 1286 Probe <Probe> missing post dispense error/clean detected. Missing post dispense rinse/clean detected Check probe conditions. If the problem persists, call Service. 1292 Probe <Probe> Liquid Level Detection error in LAS Track. LLD error in LAS Track Check probe conditions. If the problem persists, call Service. 1293 Probe <Probe> Liquid Level Detection error in cuvette position <X>, slot <YY>. LLD error in cuvette Check probe conditions. If the problem persists, call Service. 1294 Probe <Probe> Liquid Level Detection error in well position <well pos>. LLD error in well Check probe conditions. If the problem persists, call Service. 1336 Probe <Arm> Liquid Level Detection error in LAS Arm cover aspiration point. LLD error in LAS Arm Check probe conditions. If the problem cover aspiration point. persists, call Service. 1419 Probe <Probe> unexpected liquid level in rack position <X>, track <YY>. The probe detects liquid but the measured position of the liquid is unexpected. 669 of 992 Check probe conditions. If the problem persists, call Service. L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Material Alarms Material Alarms – Warnings and Errors Code Message Alarm Description 1420 Probe <Probe> unexpected liquid level in cuvette position <X>, slot <YY>. The probe detects liquid but the measured position of the liquid is unexpected. Check probe conditions. If the problem persists, call Service. 1421 Probe <Probe> unexpected liquid level in well position <well pos>. The probe detects liquid but the measured position of the liquid is unexpected. Check probe conditions. If the problem persists, call Service. 1422 Probe <Probe> Pre Aspiration Baseline Check Failure in rack position <X>, track <YY>. Invalid liquid detection: difference in baseline values read before and after liquid detection is too low. Check probe conditions. If the problem persists, call Service. 1423 Probe <Probe> Pre Aspiration Baseline Check Failure in cuvette position <X>, slot <YY>. Invalid liquid detection: difference in baseline values read before and after liquid detection is too low. Check probe conditions. If the problem persists, call Service. 1424 Probe <Probe> Pre Aspiration Baseline Check Failure in well position <well pos>. Invalid liquid detection: difference in baseline values read before and after liquid detection is too low. Check probe conditions. If the problem persists, call Service. 1425 Probe <Probe> aspiration baseline check failure in rack position <X>, track <YY>. Invalid liquid detection: difference in baseline values read before and after aspiration is too high. Check probe conditions. If the problem persists, call Service. 1426 Probe <Probe> aspiration baseline check failure in cuvette position <X>, slot <YY>. Invalid liquid detection: difference in baseline values read before and after aspiration is too high. Check probe conditions. If the problem persists, call Service. 1427 Probe <Probe> aspiration baseline check failure in well position <well pos>. Invalid liquid detection: difference in baseline values read before and after aspiration is too high. Check probe conditions. If the problem persists, call Service. 670 of 992 Operator Action L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Material Alarms Material Alarms – Warnings and Errors Code Message Alarm Description 1428 Probe <Probe> Post Aspiration Baseline Check Failure in rack position <X>, track <YY>. Invalid liquid aspiration. LLD Baseline read after liquid level detection and after liquid aspiration is too high: the probe did not stay submerged. Check probe conditions. If the problem persists, call Service. 1429 Probe <Probe> Post Aspiration Baseline Check Failure in cuvette position <X>, slot <YY>. Invalid liquid aspiration. LLD Baseline read after liquid level detection and after liquid aspiration is too high: the probe did not stay submerged. Check probe conditions. If the problem persists, call Service. 1430 Probe <Probe> Post Aspiration Baseline Check Failure in well position <well pos>. Invalid liquid aspiration. LLD Baseline read after liquid level detection and after liquid aspiration is too high: the probe did not stay submerged. Check probe conditions. If the problem persists, call Service. 1431 Probe <Probe> unexpected liquid level in LAS Track. The probe detects liquid but the measured position of the liquid is unexpected. Check probe conditions. If the problem persists, call Service. 1432 Probe <Probe> Pre Aspiration Baseline Check Failure in LAS Track. The probe detects liquid but the measured position of the liquid is unexpected. Check probe conditions. If the problem persists, call Service. 1433 Probe <Probe> aspiration baseline check failure in LAS Track. Invalid liquid detection: difference in baseline values read before and after aspiration is too high. Check probe conditions. If the problem persists, call Service. 1434 Probe <Probe> Post Invalid liquid Check probe conditions. If the problem 671 of 992 Operator Action L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Material Alarms Material Alarms – Warnings and Errors Code Message Alarm Description Aspiration Baseline Check Failure in LAS Track. aspiration. LLD Baseline read after liquid level detection and after liquid aspiration is too high: the probe did not stay submerged. persists, call Service. 1435 Probe <Probe> unexpected liquid level in LAS arm cover aspiration point. Unexpected liquid level in LAS arm cover aspiration point. Check probe conditions. If the problem persists, call Service. 1436 Probe <Arm> Pre Aspiration Baseline Check Failure in LAS Arm cover aspiration point. Invalid liquid detection: difference in baseline values read before and after liquid detection is too low. Check probe conditions. If the problem persists, call Service. 1437 Probe <Arm> aspiration baseline check failure in LAS Arm cover aspiration point. Invalid liquid detection: difference in baseline values read before and after aspiration is too high. Check probe conditions. If the problem persists, call Service. 1438 Probe <Arm> Post Aspiration Baseline Check Failure in LAS Arm cover aspiration point. Invalid liquid aspiration. LLD Baseline read after liquid level detection and after liquid aspiration is too high: the probe did not stay submerged. Check probe conditions. If the problem persists, call Service. 1440 Probe <Probe> unexpected clean level in rack position <X>, track <YY>. The probe detects clean but the measured position of the liquid is unexpected. Check probe conditions. If the problem persists, call Service. 1449 Clean aspiration error for probe <Probe>. There was an error during the aspiration of a clean liquid. Perform an enhanced clean maintenance activity. 2000 Rinse solution bottle empty. Rinse fluid system liquid EMPTY sensor detected. Replace the current Rinse bottle with a new one. DO NOT TOP OFF the Rinse bottle. It must be replaced when the instrument is not 672 of 992 Operator Action L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Material Alarms Material Alarms – Warnings and Errors Code Message Alarm Description Operator Action running. The system will automatically detect the presence of a new bottle. A prime cycle will be automatically performed. If the rinse fluid level drops below 600 mL during a run, the system will perform a controlled stop. In this case, wait until the analysis completes and the system comes to a complete stop, then replace the Rinse bottle. If the rinse fluid level drops below 100 mL, the system will perform an emergency stop. 2005 Waste tank full. Waste Fluid Container FULL sensor detected. Empty and replace the waste tank. Note: The TOP 300 CTS liquid waste line cannot rest in a horizontal position across the table or bench that holds the instrument. It must maintain a negative slope across the entire length of the tubing to minimize the backup of waste fluids. There must be no crimping in the tubing. 2006 Unable to empty internal waste reservoir. Cannot Empty Waste into Container Replace the waste tank. 2015 Clean solution bottle empty. Clean fluid system liquid EMPTY sensor detected. Replace the current Clean bottle with a new one. The Clean bottle must be replaced when the instrument is not running. If the Clean bottle emptied during a run, the system performs a controlled stop: wait until the system comes to a complete stop, replace the bottle with a new one, then restart the analysis. 2020 Cuvette load area empty. No cuvette strips detected at EMPTY sensor in load area. Load cuvettes. The system performed a controlled stop and two situations can occur when loading new cuvettes: - The cuvettes are loaded while the system is in controlled stop. In this case the run is automatically recovered (if there are tests pending to be performed). - The cuvettes are loaded when the system already completed the analysis and went from controlled stop to error. In this case the run has to be restarted (if there are tests pending 673 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Material Alarms Material Alarms – Warnings and Errors Code Message Alarm Description Operator Action to be performed). 2025 Cuvettes waste drawer missing. Cuvette waste drawer sensor defines waste drawer not present Insert cuvette waste drawer or make sure that it is properly inserted. If the drawer is removed while the system is running, a controlled stop is performed and two situations can occur when re-inserting the drawer: - The drawer is re-inserted when the system is in controlled stop. In this case the run is automatically recovered (if there are tests pending to be performed). - The drawer is re-inserted when the system already completed the analysis and went from controlled stop to error. In this case the run has to be restarted (if there are tests pending to be performed). If the system needs to dispose used cuvettes when the drawer is missing, an Emergency Stop is performed. In this case perform a Recovery after the cuvette drawer is reinserted. 2030 Cuvette waste full. Cuvette waste drawer FULL sensor detected. Empty cuvette waste drawer. The system performed a controlled stop and two situations can occur when re-inserting the drawer: 1.The drawer is re-inserted when the system is in controlled stop. In this case the run is automatically recovered (if there are tests pending to be performed). 2.- The drawer is reinserted when the system already completed the analysis and went from controlled stop to error. In this case the run has to be restarted (if there are tests pending to be performed). If the system needs to dispose used cuvettes when the drawer is missing, an Emergency Stop is performed. In this case perform a Recovery after the cuvette drawer is re-inserted. 2035 Cuvettes strip dropoff failure in position <Cuvette Slot ID>. Unable to Drop Off Cuvette in the requested position. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. 674 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Material Alarms Material Alarms – Warnings and Errors Code Message Alarm Description Operator Action 2040 Cuvettes strip positioning failure. The requested Cuvette move is not allowed The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. 2045 Cuvettes strip pickup failure in position <Cuvette Slot ID>. Unable to Pickup Cuvette in the requested position. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. 2046 Insufficient Clean volume in track #<Track ID>, position #<rack position>. Clean volume in vial detected to be at error threshold. Load additional clean material. 2055 Insufficient volume in track #<Track ID>, position #<rack position>. Insufficient liquid for the aspirate (sample or reagent) Make sure that there is enough material for the analysis and that it is presented in an appropriate container. 2074 Insufficient volume for sample <SampleID> at Aspiration Point. Insufficient liquid for the sample aspiration (LAS Track) Check probe conditions. Make sure that there is enough sample for the analysis. 2075 Insufficient liquid in cuvette <Cuvette Slot ID> well <well position>. Insufficient Liquid detected when mixing is performed in a cuvette. Call Service. 2076 Probe <Probe>: Insufficient volume in clean cup. Insufficient liquid for the aspirate (sample or reagent) Perform a Clean prime cycle (Maintenance). If the problem persists call Service. 2077 Insufficient volume in LAS Arm cover aspiration point. Insufficient liquid for the aspirate (LAS Arm Cover) Make sure that there is a vial at the aspiration point containing the appropriate volume of material. 2083 <Material Name> insufficient material to run additional calibration / test. Volume for last vial detected to be at error threshold. The volume of liquid on-board for a specific material is not enough to run a single job, so a new vial should be placed. Load additional material. 675 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Material Alarms Material Alarms – Warnings and Errors Code Message Alarm Description Operator Action 3001 <Material Name> volume low. Volume for last vial detected to be at warning threshold. Load additional material before the currently used vial gets empty. 3002 <Material Name> onboard stability low. Remaining stability for last vial detected to be at warning threshold. Load fresh material before the stability elapses for the currently used vial. 3003 <Material Name> close to expiration. Remaining expiration time for last vial/lot detected to be at warning threshold. Load a new lot of material with later expiration date before the currently used lot expires. 3004 Non-identified Material in rack <rack ID> position <rack position #>, track # <rack track #>. A material has been inserted without a BarCodeID Label. Manually define the material or remove rack, re-position the vial barcode and re-insert the rack. 3005 Unknown material in rack <rack ID> position <rack position #>, track # <rack track #>. A material has been inserted with a BarCodeID label whose Material Index does not correspond to any material definition in the material list. In this case the <Lot not defined> alarm shall not be triggered. Follow Link to Data Dictionary for further information about Barcode ID contents. Remove the material and verify. Define material prior to use in the system. Non-IL material should be used without barcodes. If the bottle type contained in the Bar Code is not defined or is disabled, this alarms will be also displayed. 3006 New Bottle Type (<Material Name> in rack <rack ID> position <rack position #>, track The Bottle Type contained in the Bar Code is different than the Bottle Type 676 of 992 The vial size has been automatically updated. Make sure that the fill volume defined in Material Definition is consistent with the new vial size. Also the on-board stability L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Material Alarms Material Alarms – Warnings and Errors Code Message Alarm Description # <rack track #>). defined in the material definition. definition may change. 3007 Unknown lot (<Material Name> in rack <rack ID> position <rack position #>, track # <rack track #>). A material has been loaded on-board whose lot is not defined in the system. In this case the Material ID contained in the Barcode Label is known but the Lot Id is not. Therefore the alarm <NonReferenced Material> shall not be generated. Follow link to Data Dictionary for further information about the contents of the Barcode ID. Remove material from the system. Verify that the material is a defined lot in the system prior to loading. 3009 Placement error (<Material Name> in rack <rack ID>, position <rack position #>, track #<rack track#>). A material has been placed in a wrong rack position. Remove the CAL/NPP and load it in a suitable position. See Test Feasibility for proper placement of all reagents. 3010 Placement error (<Material Name> in rack <rack ID>, position <rack position #>, track #<rack track#>). A material has been placed in a wrong rack position. Remove the QC and load it in a suitable position. See Test Feasibility for proper placement of all reagents. 3011 Placement error (<Material Name> in rack <rack ID>, position <rack position #>, track #<rack track#>). A material has been placed in a wrong rack position. Remove the Sample Diluent and load it in a suitable position. See Test Feasibility for proper placement of all reagents. 3012 Placement error (<Material Name> in rack <rack ID>, position <rack position #>, track #<rack track#>). A material has been placed in a wrong rack position. Remove the Reagent Diluent and load it in a suitable position. See Test Feasibility for proper placement of all reagents. 3013 Placement error A material has been Remove the Intermediate Reagent and load it 677 of 992 Operator Action L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Material Alarms Material Alarms – Warnings and Errors Code Message Alarm Description Operator Action (<Material Name> in rack <rack ID>, position <rack position #>, track #<rack track#>). placed in a wrong rack position. in a suitable position. See Test Feasibility for proper placement of all reagents. 3014 Placement error (<Material Name> in rack <rack ID>, position <rack position #>, track #<rack track#>). A material has been placed in a wrong rack position. Remove the Start Reagent and load it in a suitable position. See Test Feasibility for proper placement of all reagents. 3015 Placement error (<Material Name> in rack <rack ID>, position <rack position #>, track #<rack track#>). A material has been placed in a wrong rack position. Remove the Deficient Plasma and load it in a suitable position. See Test Feasibility for proper placement of all reagents. 3016 Placement error (<Material Name> in rack <rack ID>, position <rack position #>, track #<rack track#>). A material has been placed in a wrong rack position. Remove the Clean Material and load it in a suitable position. See Test Feasibility for proper placement of all reagents. 3017 Placement error (<Material Name> in rack <rack ID>, position <rack position #>, track #<rack track#>). A material has been placed in a wrong rack position. Remove the rack and load it in a suitable position. Start Reagents are always placed to the right of Intermediate Reagents and Deficient Plasma. See Test Feasibility for proper placement of all reagents. 3018 Placement error (<Material Name> in rack <rack ID>, position <rack position #>, track #<rack track#>). A material has been placed in a wrong rack position. Remove the rack and load it in a suitable position. Intermediate Reagents and Deficient Plasma are always placed to the left of Start Reagents. See Test Feasibility for proper placement of all reagents. 3019 Placement error (<Material Name> in rack <rack ID>, position <rack position #>, track #<rack track#>). A material has been placed in a wrong rack position. Remove the Start Reagent and load it on another rack. Do not mix on the same rack Start Reagents with Intermediate Reagents or the Deficient Plasma. See Test Feasibility for proper placement of all reagents. 3020 Placement error (<Material Name> in rack <rack ID>, position <rack position #>, track #<rack track#>). A material has been placed in a wrong rack position. Remove the Intermediate Reagent or Deficient Plasma and load it on another rack. Do not mix on the same rack Start Reagents with Intermediate Reagents or Deficient Plasma. See Test Feasibility for proper placement of all reagents. 678 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Material Alarms Material Alarms – Warnings and Errors Code Message Alarm Description Operator Action 3021 Placement error (<Material Name> in rack <rack ID>, position <rack position #>, track #<rack track#>). Two lots of the same material have been placed on-board at the same time. Remove the lot that you do not want to use. See Test Feasibility for proper placement of all reagents. 3024 <TestCode> <JobType> job not feasible. Waiting for <material name>. A job has been sent to AM and there is no enough volume for some of the reagents or a reagent is not placed. Clean Materials are not included in this alarm. Check the materials required for the assay or place more reagents. 3025 <TestCode> Automatic <JobType> job not feasible. Waiting for <material name>. An automatic job Check the materials required for the assay or created by the AM not place more reagents. have enough volume for some of the reagents or a reagent is not placed. Clean Materials are not included in this alarm. 3055 Placement error (<Material Name> in rack <rack ID>, position <rack position #>, track #<rack track#>). Material with vial profile different than 4mL placed in a Diluent rack Pos 3 to 8. Review bottle type for possible bar code label/bottle type inconsistency. Use another position for bottle placement. Material with vial profile equal to 30mL placed in a non Diluent rack or in Pos 3 to 8 of a diluent rack. 3084 <Material Name> onboard stability expired for last available vial. Remaining stability for last vial expired. Load fresh material. 3085 <Material Name> expired. The present date is greater than the expiration date of the Define a new active lot of material. 679 of 992 Depending on the material, calibration, QC L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Material Alarms Material Alarms – Warnings and Errors Code Message Alarm Description Operator Action last available vial/lot. or NPP measurements may be required prior to running patient samples. 3086 <Material Name> requires stirring (rack <rack ID> position <rack position #>, track # <rack track #>) A material requiring stirring is placed in a position not having stirring capability Remove material and load it in a stirringenabled position (reagent rack positions 1 or 2, inserted in track with stirring enabled). 3096 <Test Code> is inconsistent/disable/lock manual ordering. There was a programmed test inconsistent/disabled or locked for manual ordering and the test was removed. Check for test consistency, whether the test is enabled, or if it is locked for manual ordering. 3097 <TestCode> <JobType> job cannot be executed and was removed from sample/material <Sample ID/Material Name>. Number of predilution cuvette slots is insufficient. Number of predilution cuvette slots is insufficient to execute a calibration or a parallelism job. Increase the number of predilution cuvette slots defined in the LAS Configuration Screen. Please refer to the Operator's Manual for more guidance. 3182 <Test Code> is inconsistent/disabled. There was a programmed test for an LAS sample. The test definition is inconsistent/disabled and the test was removed. Check for test consistency and check if it is enabled. 3183 Sample volume for <Test Code> <JobType> job exceeds the limit of a cuvette cell. The LAS sample volume required to complete a single test cannot exceed 535 uL Retrieve the LAS sample and introduce the sample to the instrument via a sample rack. 3184 <TestCode> <JobType> job not feasible. Sample <SampleID> has expired. A job cannot start because the LAS sample expired Load fresh sample. 3185 <TestCode> <JobType> job not feasible. Waiting for sample A job has been sent to AM and there is not enough sample Load fresh sample. 680 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Material Alarms Material Alarms – Warnings and Errors Code Message Alarm Description Operator Action <SampleId>. volume. 3187 <TestCode> <JobType> Required Clean Material shortage has been estimated. Monitor <material name> availability. A job has been sent to AM and there is not enough volume for a required clean material or the clean is not placed. Check the clean material volume periodically and replenish as needed. 3088 Volume check not performed (<Material Name> in rack <rack ID>, position <rack position #>, track #<rack track #>). Volume check not performed because enhanced clean is required Perform an enhanced clean for the required probes. 3215 LAS sample expiration time exceeded for <Data Dictionary - SampleID>. The time that an LAS sample can remain on board has been exceeded. Load more sample. 4025 Clean solution level low. Clean fluid system liquid WARN sensor detected. Replace Clean solution bottle before it empties. The Clean bottle must be replaced when the instrument is not running. Removing the Clean bottle while the instrument is running will cause an Emergency Stop. 4030 Rinse solution level low. Rinse fluid system liquid WARN sensor detected. Replace rinse solution bottle before it empties. The Rinse bottle must be replaced when the instrument is not running. Removing the Rinse bottle while the instrument is running will cause an Emergency Stop. 4035 Cuvettes low in the load area. No cuvette strips detected at WARN sensor in load area. Load new cuvettes. 4040 Cuvette waste almost full. The level of cuvettes in the waste drawer is close to maximum height Empty cuvette waste drawer before it gets full. 4050 Waste tank almost full. Waste fluid container WARN sensor detected Empty waste tank before it gets full. 681 of 992 Note: The TOP 300 CTS liquid waste line cannot rest in a horizontal position across the L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Material Alarms Material Alarms – Warnings and Errors Code Message Alarm Description Operator Action table or bench that holds the instrument. It must maintain a negative slope across the entire length of the tubing to minimize the backup of waste fluids. There must be no crimping in the tubing. 4056 Waste tank not present. Waste tank is not present. Replace waste container. Back to Alarm Messages. 682 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Job Frequency Alarms Job Frequency Alarms Back to Alarm Messages. The alarms in this section are sorted by code number. Job Frequency Alarms – Warnings and Errors Code Message Alarm Description Operator Action 3053 Calibration due for <TestCode>. Calibration frequency in the warning threshold. Perform a calibration before it becomes overdue. 3054 Normal Pool Plasma due for <TestCode>. NPP frequency in the warning threshold. Run a Normal Pool Plasma before it becomes overdue. 3056 Calibration of <Test Code> completed: please review and validate. A calibration has been executed and requires validation from the user. Review and validate calibration if required. 3057 Calibration of <Test Code> recalculated. A calibration has been recalculated or edited. 3058 Calibration of <Test Code> validated. A calibration has been manually validated. 3059 Calibration of <Test Code> completed and autovalidated. A calibration has been completed and autovalidated. 3090 Calibration Overdue for <TestCode>. Frequency expired for the active validated calibration. Perform a calibration job using active lots and validate it. 3091 Normal Pool Plasma Overdue for <TestCode>. The NPP frequency has expired. Perform a Normal Pool Plasma job. 3094 Calibration for <Test Code> interrupted. A Calibration was active and it was manually or automatically interrupted. Recalibrate (even if frequency is OK). 3095 Autovalidation of completed calibration for <Test Code> failed. A calibration has been completed and the autovalidation failed. Review and validate calibration if required. 3098 <TestCode> <JobType> job not feasible. Calibration not available. A patient job has been sent to AM and there is no validated calibration for the on board lots. Validate a calibration for the on-board lots. 3099 <TestCode> <JobType> job not feasible. QC Failed for <material name>. A patient job has been sent to AM and there is a QC failed for that test. Run QC jobs. 683 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting QC Alarms QC Alarms Back to Alarm Messages. The alarms in this section are sorted by code number. QC Alarms – Warnings and Errors Code Message Alarm Description Operator Action 3026 QC Due : <TestCode><MaterialName> The expiration time to perform a QC job has entered in its threshold period. Run QC before it becomes overdue. 3027 QC Frequency OK : <TestCode><MaterialName> Transition from QC frequency Overdue/Due to OK 3028 QC Omitted point: <TestCode><MaterialName> QC result omitted 3029 QC Point restored:<TestCode><MaterialName> An omitted QC result has been re-enabled. 3030 QC Results purged until QC results have been purged. <limitDate> : <TestCode><MaterialName>. 3087 QC Overdue: <TestCode><MaterialName> The expiration date for a QC has been reached. 3088 QC Failed: <TestCode><MaterialName> QC rules have failed. It is a Review QC results, statistics and hint to detect problems in the graphs. Based on the situation, take measurement. proper corrective actions. 684 of 992 Perform QC. L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Maintenance Alarms Maintenance Alarms Back to Alarm Messages. The alarms in this section are sorted by code number. Maintenance Alarms – Warnings and Errors Code Message Alarm Description Operator Action 2086 Maintenance activity interrupted: <Maintenance Activity> A semi-Automatic or automatic Maintenance Activity's Execution has been interrupted due to an error. The activity has not been completed. Remove the cause of the error and re-select the activity. 3047 Maintenance activity due: An indicated maintenance activity shall be executed by the user. The expiration time to perform the activity has entered in its threshold period. Perform maintenance activity before it becomes overdue. <Maintenance Activity>. 3048 Manual maintenance activity <Maintenance Activity Name> has been added. A new manual maintenance activity has been defined and added by the user. 3049 Manual maintenance activity <Maintenance Activity Name> has been deleted. A manual maintenance Activity has been deleted by the user. 3050 Maintenance activity <Maintenance Activity Name> has been configured. A maintenance activity has been reconfigured. Their values might be changed. 3051 Frequency status for manual maintenance activity <Maintenance Activity Name> has changed to OK. The frequency status of a maintenance activity has changed to OK. 3052 Manual maintenance activity <Maintenance Activity Name> has been executed. A maintenance activity has been executed either manually by the user or automatically by the system. 3089 Maintenance activity overdue: An indicated Maintenance Activity should already have been executed by the user. The expiration date for a 685 of 992 Perform the maintenance activity. L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Maintenance Alarms Maintenance Alarms – Warnings and Errors Code Message Alarm Description <Maintenance Activity>. Maintenance Activity has been reached. 3216 Semiautomatic maintenance activity <Maintenance Activity Name> has been executed. A maintenance activity has been executed either manually by the user or automatically by the system. 3217 Automatic maintenance activity <Maintenance Activity Name> has been executed. A maintenance activity has been executed either manually by the user or automatically by the system. Operator Action Back to Alarm Messages. 686 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Analyzer Alarms Analyzer Alarms Back to Alarm Messages. The alarms in this section are sorted by code number. CAUTION: When manually moving the probe arm, lift the arm to its highest position. To avoid damaging the probe arm during the move, grasp it from the back, as near to the back wall as possible. Grasping a probe arm from the front pushes it out of alignment. A misaligned probe arm causes inaccurate coordinates adjustment and other errors. Analyzer Alarms – Warnings and Errors Code Message Alarm Description Cause Operator Action 0000 Analyzer / Control Module loss of communication. A non-recoverable error occurred in the CM/AM Communications Manager (e.g. loss of connection). Communication cable disconnection. Software or electronic failure. Check communication cable. Power off and restart the instrument. If the problem persists, call Service. If the instrument is in Emergency Stop this alarm is not reported. 0005 Master controller failure. Failure of LRC or CRC check. Master controller board malfunction. Power off and restart the instrument. If the problem persists, call Service. 0007 0010 0011 <Arm> Arm controller initialization failure. One of the AM Arm controller board did not processors failed to pass initialization tests. initialize, due to an Invalid Controller ID. Power off and restart the instrument. Rack-Cuvette controller initialization failure. One of the AM Rack-Cuvette controller processors failed to board did not pass initialize, due to an initialization tests. Invalid Controller ID. Power off and restart the instrument. Cuvettes controller initialization failure. One of the AM Cuvettes controller board did processors failed to not pass initialization tests. initialize, due to an Invalid Controller ID. Power off and restart the instrument. 687 of 992 If the problem persists, call Service. If the problem persists, call Service. If the problem persists, L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Analyzer Alarms Analyzer Alarms – Warnings and Errors Code Message Alarm Description Cause Operator Action call Service. 0012 0013 0014 0015 0016 0017 Racks controller initialization failure. One of the AM Racks controller board did processors failed to not pass initialization tests. initialize, due to an Invalid Controller ID. Power off and restart the instrument. Optical Reading Units controller initialization failure. One of the AM Optical Reading Units processors failed to controller board did not pass initialize, due to an initialization tests. Invalid Controller ID. Power off and restart the instrument. <Arm> Arm Controller software error. Invalid parameter provided in a function call, message queue or inter-task communication mechanism. Built-in checks in the software detected an unrecoverable error. Power off and restart the instrument. Invalid parameter provided in a function call, message queue or inter-task communication mechanism. Built-in checks in the software detected an unrecoverable error. Invalid parameter provided in a function call, message queue or inter-task communication mechanism. Built-in checks in the software detected an unrecoverable error. Invalid parameter provided in a function call, message queue or inter-task communication mechanism. Built-in checks in the software detected an unrecoverable error. Master Controller software error. Cuvettes Controller software error. Racks Controller software error. If the problem persists, call Service. If the problem persists, call Service. If the problem persists, call Service. Power off and restart the instrument. If the problem persists, call Service. Power off and restart the instrument. If the problem persists, call Service. Power off and restart the instrument. If the problem persists, call Service. 688 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Analyzer Alarms Analyzer Alarms – Warnings and Errors Code Message 0018 Optical Reading Units Controller software error. 0019 0020 0025 Rack-Cuvette Controller software error. Analyzer internal communication error. Master Controller software error. Alarm Description Cause Invalid parameter provided in a function call, message queue or inter-task communication mechanism. Built-in checks in the software detected an unrecoverable error. Invalid parameter provided in a function call, message queue or inter-task communication mechanism. Built-in checks in the software detected an unrecoverable error. A non-recoverable error occurred in the Controller Communications Manager or the low level CAN bus driver (master or controller side. Built-in checks in the software detected an unrecoverable error. Memory allocation failed or stack usage exceeds limit. Built-in checks in the software detected an unrecoverable error. Operator Action Power off and restart the instrument. If the problem persists, call Service. Power off and restart the instrument. If the problem persists, call Service. Power off and restart the instrument. If the problem persists, call Service. Power off and restart the instrument. If the problem persists, call Service. 0030 Master Controller software error. Error detected when calling kernel facilities. Built-in checks in the software detected an unrecoverable error. Power off and restart the instrument. If the problem persists, call Service. 0031 Cuvettes Controller software error. Error detected when calling kernel facilities. Built-in checks in the software detected an unrecoverable error. Power off and restart the instrument. If the problem persists, call Service. 0032 Racks Controller software error. Error detected when calling kernel facilities. Built-in checks in the software detected an unrecoverable error. 689 of 992 Power off and restart the instrument. L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Analyzer Alarms Analyzer Alarms – Warnings and Errors Code Message Alarm Description Cause Operator Action If the problem persists, call Service. 0033 Optical Reading Units Controller software error. Error detected when calling kernel facilities. Built-in checks in the software detected an unrecoverable error. Power off and restart the instrument. If the problem persists, call Service. 0034 Rack-Cuvette Controller software error. Error detected when calling kernel facilities. Built-in checks in the software detected an unrecoverable error. Power off and restart the instrument. If the problem persists, call Service. 0035 0036 0037 0038 0039 0040 Master Controller software error. Cuvettes Controller software error. Racks Controller software error. Optical Reading Units Controller software error. Rack-Cuvette Controller software error. Master Controller software error. Software logic error such as an invalid path in a switch statement or if.else branch. Built-in checks in the software detected an unrecoverable error. Software logic error such as an invalid path in a switch statement or if.else branch. Built-in checks in the software detected an unrecoverable error. Software logic error such as an invalid path in a switch statement or if.else branch. Built-in checks in the software detected an unrecoverable error. Software logic error such as an invalid path in a switch statement or if.else branch. Built-in checks in the software detected an unrecoverable error. Software logic error such as an invalid path in a switch statement or if.else branch. Built-in checks in the software detected an unrecoverable error. Invalid state for an event, function call, Built-in checks in the software detected an Power off and restart the instrument. If the problem persists, call Service. Power off and restart the instrument. If the problem persists, call Service. Power off and restart the instrument. If the problem persists, call Service. Power off and restart the instrument. If the problem persists, call Service. Power off and restart the instrument. If the problem persists, call Service. 690 of 992 Power off and restart the instrument. L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Analyzer Alarms Analyzer Alarms – Warnings and Errors Code Message Alarm Description message, etc Cause Operator Action unrecoverable error. If the problem persists, call Service. 0041 Cuvettes Controller software error. Invalid state for an event, function call, message, etc Built-in checks in the software detected an unrecoverable error. Power off and restart the instrument. If the problem persists, call Service. 0042 Racks Controller software error. Invalid state for an event, function call, message, etc Built-in checks in the software detected an unrecoverable error. Power off and restart the instrument. If the problem persists, call Service. 0043 Optical Reading Units Controller software error. Invalid state for an event, function call, message, etc Built-in checks in the software detected an unrecoverable error. Power off and restart the instrument. If the problem persists, call Service. 0044 Rack-Cuvette Controller software error. Invalid state for an event, function call, message, etc Built-in checks in the software detected an unrecoverable error. Power off and restart the instrument. If the problem persists, call Service. 0045 Master Controller software error. It was detected that there is a potential for a stack problem. Built-in checks in the software detected an unrecoverable error. Power off and restart the instrument. If the problem persists, call Service. 0046 Cuvettes Controller software error. It was detected that there is a potential for a stack problem. Built-in checks in the software detected an unrecoverable error. Power off and restart the instrument. If the problem persists, call Service. 0047 Racks Controller software error. It was detected that there is a potential for a stack problem. Built-in checks in the software detected an unrecoverable error. Power off and restart the instrument. If the problem persists, call Service. 0048 Optical Reading It was detected that Built-in checks in the 691 of 992 Power off and restart L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Analyzer Alarms Analyzer Alarms – Warnings and Errors Code Message Alarm Description Units Controller software error. there is a potential for a stack problem. Cause software detected an unrecoverable error. Operator Action the instrument. If the problem persists, call Service. 0049 Rack-Cuvette Controller software error. It was detected that there is a potential for a stack problem. Built-in checks in the software detected an unrecoverable error. Power off and restart the instrument. If the problem persists, call Service. 0050 Master Controller software error. The command received is not supported. Built-in checks in the software detected an unrecoverable error. Power off and restart the instrument. If the problem persists, call Service. 0051 Cuvettes Controller software error. The command received is not supported. Built-in checks in the software detected an unrecoverable error. Power off and restart the instrument. If the problem persists, call Service. 0052 Racks Controller software error. The command received is not supported. Built-in checks in the software detected an unrecoverable error. Power off and restart the instrument. If the problem persists, call Service. 0053 Optical Reading Units Controller software error. The command received is not supported. Built-in checks in the software detected an unrecoverable error. Power off and restart the instrument. If the problem persists, call Service. 0054 Rack-Cuvette Controller software error. The command received is not supported. Built-in checks in the software detected an unrecoverable error. Power off and restart the instrument. If the problem persists, call Service. 0056 Interrupted communication between the Analyzer and the Control Module. The CM has lost the connection with the AM module. Communication cable disconnected. Analyzer powered off. Other hardware/software communication problems. 692 of 992 Check communication cable connection. Verify that the Analyzer is powered on. Restart the system (both Analyzer and L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Analyzer Alarms Analyzer Alarms – Warnings and Errors Code Message Alarm Description Cause Operator Action Control Module); if the problem persist call Service. 0057 Optical Reading Units Controller software error. One of the wavelengths not used in ORU acquisitions. Built-in checks in the software detected an unrecoverable error. Power off and restart the instrument. If the problem persists, call Service. 0058 Controller <Controller Name> upgrade failure. Controller Upgrade has failed since downloaded SW version does not match SW version actually used. The AM reported an exception during the upgrade process. Controller Upgrade has failed. Call Service. Built-in checks in the software detected an unrecoverable error. Power off and restart the instrument. The AM not responding during controllers upgrade. There is a 1 min timeout. AM/CM loss of communications during upgrade process. 0061 <Arm> Arm Controller software error. Error detected when calling kernel facilities. If the problem persists, call Service. 0065 0070 <Arm> Arm Controller software error. <Arm> Arm Controller software error. Software logic error such as an invalid path in a switch statement or if.else branch. Built-in checks in the software detected an unrecoverable error. Invalid state for an event, function call, message, etc Built-in checks in the software detected an unrecoverable error. Power off and restart the instrument. If the problem persists, call Service. 693 of 992 Power off and restart the instrument. L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Analyzer Alarms Analyzer Alarms – Warnings and Errors Code Message Alarm Description Cause Operator Action If the problem persists, call Service. 0075 <Arm> Arm Controller software error. It was detected that there is a potential for a stack problem. Built-in checks in the software detected an unrecoverable error. Power off and restart the instrument. If the problem persists, call Service. 0080 <Arm> Arm Controller software error. The command received is not supported. Built-in checks in the software detected an unrecoverable error. Power off and restart the instrument. If the problem persists, call Service. 0084 Incompatible AM Master software version. Detected interface version <Interface Version> and expected <Interface Version>. Incompatible interface version between AM/CM AM Master version is incompatible with current CM software. Call Service. 0085 Incompatible <Controller Name> controller version. Incompatible interface version between a controller and the AM Master software A controller version is incompatible with current AM Master software. Call Service. 0086 Material <Material Name> not dispensed. SW detected a material that was not dispensed There was a software scheduling conflict. If the problem persists, call Service. 1001 <Arm> Arm failure. The arm is inoperable. Software or mechanical error. Initialization error. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. 1002 <Arm> Arm failure. The arm is inoperable. Software or mechanical error. The system performed an Emergency stop. Perform a Recovery. If the problem persists, Invalid Command. 694 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Analyzer Alarms Analyzer Alarms – Warnings and Errors Code Message Alarm Description Cause Operator Action call Service. 1003 <Arm> Arm failure. The arm is inoperable. Software or mechanical error. Invalid Operand. 1004 <Arm> Arm failure. The arm is inoperable. Software or mechanical error. Invalid command sequence. 1005 <Arm> Arm failure. The arm is inoperable. Software or mechanical error. Device not implemented. 1006 <Arm> Arm failure. The arm is inoperable. Software or mechanical error. Timeout error. 1007 <Arm> Arm failure. The arm is inoperable. Software or mechanical error. Device not initialized. 1008 <Arm> Arm failure. The arm is inoperable. Software or mechanical error. Command overflow. 1009 <Arm> Arm failure. The arm is inoperable. Software or mechanical error. No liquid detected with ZX command. 695 of 992 The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. The system performed an Emergency stop. Perform a Recovery. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Analyzer Alarms Analyzer Alarms – Warnings and Errors Code Message 1010 <Arm> Arm failure. Alarm Description The arm is inoperable. Cause Operator Action Software or mechanical error. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. Entered move for Z-axis out of range. 1011 <Arm> Arm failure. The arm is inoperable. Software or mechanical error. Not enough liquid detected with ZX command. 1012 <Arm> Arm failure. The arm is inoperable. Software or mechanical error. No liquid detected with ZZ command. 1013 <Arm> Arm failure. The arm is inoperable. Software or mechanical error. Not enough liquid detected with ZZ command. 1017 <Arm> Arm failure. The arm is inoperable. Software or mechanical error. Arm collision avoided. 1020 <Arm> Arm failure. The arm is inoperable. Software or mechanical error. Step loss on X axis. 1021 <Arm> Arm failure. The arm is inoperable. Software or mechanical error. Step loss on Y axis. 1022 <Arm> Arm failure. The arm is inoperable. Software or mechanical error. Step loss on Z axis. 696 of 992 The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Analyzer Alarms Analyzer Alarms – Warnings and Errors Code Message 1023 <Arm> Arm failure. Alarm Description The arm is inoperable. Cause Operator Action Software or mechanical error. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. Step loss detected on X-axis of opposing arm. 1024 <Arm> Arm failure. The arm is inoperable. Software or mechanical error. ALDIUM pulse time out. 1025 <Arm> Arm failure. The arm is inoperable. Software or mechanical error. Tip not fetched. 1026 <Arm> Arm failure. The arm is inoperable. Software or mechanical error. Tip crash. 1027 <Arm> Arm failure. The arm is inoperable. Software or mechanical error. Tip not clean. 1028 <Arm> Arm failure. The arm is inoperable. Software or mechanical error. Undefined error code reported. 1029 <Arm> Arm failure. The arm is inoperable. Software or mechanical error. Communication timeout. 1031 <Syringe> Syringe failure. The pump used to aspirate/dispense fluids is inoperable. Software or mechanical error. Initialization error. 697 of 992 The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Analyzer Alarms Analyzer Alarms – Warnings and Errors Code Message Alarm Description Cause Operator Action 1032 <Syringe> Syringe failure. The pump used to aspirate/dispense fluids is inoperable. Software or mechanical error. Invalid command. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. 1033 <Syringe> Syringe failure. The pump used to aspirate/dispense fluids is inoperable. Software or mechanical error. Invalid operand. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. 1034 <Syringe> Syringe failure. The pump used to aspirate/dispense fluids is inoperable. Software or mechanical error. Invalid command sequence. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. 1035 <Syringe> Syringe failure. Fluid Detection Error. This error occurs when the sensor board detects fluid, which is caused by leaking out the back of the valve. The sensor board detects fluid, which is caused by leaking out the back of the valve. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. 1036 <Syringe> Syringe failure. EEPROM Failure. This error occurs when the EEPROM is faulty. EEPROM is faulty. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. 1037 <Syringe> Syringe failure. The pump used to aspirate/dispense fluids is inoperable. Software or mechanical error. Device not initialized. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. 1038 <Syringe> Syringe failure. The pump used to aspirate/dispense fluids is inoperable. Software or mechanical error. Command overflow. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. 1039 <Syringe> Asynchronous dispensation in Syringe Pump and ORU controller communications Asynchronous dispensation in ORU failure. The system performed an Emergency stop. Perform a Recovery. 698 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Analyzer Alarms Analyzer Alarms – Warnings and Errors Code Message Alarm Description Cause Operator Action ORU. failure. If the problem persists, call Service. 1040 <Syringe> Syringe failure. The pump used to aspirate/dispense fluids is inoperable. Software or mechanical error. Communication timeout. 1041 The Optical Reading Unit <ORU ID> has been disabled. The ORU Head has been disabled. The ORU has been disabled. User request. 1042 The Optical Reading Unit <ORU ID> has been disabled. The ORU Head has been disabled due to low air limit. The ORU has been disabled. Air reading out of range (low). Call Service. 1043 The Optical Reading Unit <ORU ID> has been disabled. The ORU Head has been disabled due to due to a high air limit. The ORU has been disabled. Air reading out of range (high). Call Service. 1044 The Optical Reading Unit <ORU ID> has been disabled. The ORU Head has been disabled due to air drift low limit. The ORU has been disabled. Air reading drift (low) detected. Call Service. 1045 The Optical Reading Unit <ORU ID> has been disabled. The ORU Head has been disabled due to air drift high limit. The ORU has been disabled. Air reading drift (high) detected. Call Service. 1046 The Optical Reading Unit <ORU ID> has been disabled. The ORU Head has been disabled due to an ORU voltage problem. The ORU has been disabled. Detector voltage error detected. Call Service. 1047 <Syringe> Syringe failure. Plunger Overload. Movement of the syringe This error occurs plunger was blocked by when movement of excessive pressure. the syringe plunger is blocked by excessive pressure. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. 1048 <Syringe> Valve Overload. This The system performed Valve drive loses steps by 699 of 992 The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Analyzer Alarms Analyzer Alarms – Warnings and Errors Code Message Alarm Description Cause Syringe failure. error occurs when the valve drive loses steps by blockage or excess back pressure. Continual valve overload errors are an indication the valve should be replaced. blockage or excess back pressure. an Emergency stop. Perform a Recovery. If the problem persists, call Service. 1049 <Syringe> Syringe failure. Plunger Move Not Allowed. When the valve is in bypass or throughput position plunger movement commands are not allowed. Plunger Move Not Allowed. When the valve is in bypass or throughput position plunger movement commands are not allowed. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. 1050 <Syringe> Syringe failure. Command Overflow. This error occurs when the command buffer contains too many characters. Command Overflow. This error occurs when the command buffer contains too many characters. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. 1100 Optical reading units voltage control failure. Voltage out-of-range fault detected. Voltage out of range in optical reading units. Call Service. 1105 Arm communication error. RS232 communications error with arms Software or Hardware failure. Call Service. 1110 Cuvettes incubator No. 1 temperature control failure. Incubator temperature Temperature out of range in defined to be out of cuvette incubator. range for a period exceeding the fatal error limits. Call Service. 1111 Cuvettes incubator No. 2 temperature control failure. Incubator temperature Temperature out of range in defined to be out of cuvette incubator. range for a period exceeding the fatal error limits. Call Service. 1115 Optical reading unit No. 1 temperature control failure. ORU temperature defined to be out of range for a period exceeding the fatal Call Service. Temperature out of range in optical reading unit. 700 of 992 Operator Action L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Analyzer Alarms Analyzer Alarms – Warnings and Errors Code Message Alarm Description Cause Operator Action error limits. 1116 Optical reading unit No. 2 temperature control failure. ORU temperature defined to be out of range for a period exceeding the fatal error limits. Temperature out of range in optical reading unit. Call Service. 1117 Optical reading unit No. 3 temperature control failure. ORU temperature defined to be out of range for a period exceeding the fatal error limits. Temperature out of range in optical reading unit. Call Service. 1118 Optical reading unit No. 4 temperature control failure. ORU temperature defined to be out of range for a period exceeding the fatal error limits. Temperature out of range in optical reading unit. Call Service. 1120 Cuvette shuttle temperature control failure. Cuvette Shuttle temperature defined to be out of range for a period exceeding the fatal error limits. Cuvette shuttle temperature out of range. The system performed a controlled stop: the run has to be restarted. If the problem persists, call Service. 1125 Reagent area temperature control failure. Reagent Area temperature defined to be out of range for a period exceeding the fatal error limits. Reagent area temperature out of range. The system performed a controlled stop: the run has to be restarted. If the problem persists, call Service. 1130 Optical reading units data acquisition control failure. Detector interface fault, e.g. conversion did not complete, emitter light source not correct. Built-in checks detected an error. Call Service. 1131 <Arm> Arm controller failure. CRC Error detected in writing to or reading from a permanent storage device (e.g. EEPROM) Arm controller board malfunction. Call Service. 1135 Cuvettes controller failure. CRC Error detected in writing to or Cuvettes controller board malfunction. Call Service. 701 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Analyzer Alarms Analyzer Alarms – Warnings and Errors Code Message Alarm Description Cause Operator Action reading from a permanent storage device (e.g. EEPROM) 1136 Racks controller failure. CRC Error detected in writing to or reading from a permanent storage device (e.g. EEPROM) Racks controller board malfunction. Call Service. 1137 Optical Reading Units controller failure. CRC Error detected in writing to or reading from a permanent storage device (e.g. EEPROM) Optical Reading Units controller board malfunction. Call Service. 1138 Rack-Cuvette controller failure. CRC Error detected in writing to or reading from a permanent storage device (e.g. EEPROM) Rack-Cuvette controller board malfunction. Call Service. 1139 Rack-Cuvette controller failure. Error detected in updating data on a permanent storage device (e.g. EEPROM) Rack-Cuvette controller board malfunction. Call Service. 1140 Cuvettes controller failure. Error detected in updating data on a permanent storage device (e.g. EEPROM) Cuvettes controller board malfunction. Call Service. 1141 Racks controller failure. Error detected in updating data on a permanent storage device (e.g. EEPROM) Racks controller board malfunction. Call Service. 1142 Optical Reading Units controller failure. Error detected in updating data on a permanent storage Optical Reading Units controller board malfunction. Call Service. 702 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Analyzer Alarms Analyzer Alarms – Warnings and Errors Code Message Alarm Description Cause Operator Action device (e.g. EEPROM) 1143 <Arm> Arm controller failure. Error detected in updating data on a permanent storage device (e.g. EEPROM) Arm controller board malfunction. Call Service. 1151 <Arm> Arm controller voltage out of range. Voltage out-of-range fault detected on a controller. Arm controller board malfunction. Call Service. NOTE: MicroTOP shall have one arm controller only. Therefore, the term 'Instrument Arm' shall be used. 1155 Cuvettes controller voltage out of range. Voltage out-of-range fault detected on a controller. Cuvettes controller board malfunction. Call Service. 1156 Racks controller voltage out of range. Voltage out-of-range fault detected on a controller. Racks controller board malfunction. Call Service. 1157 Optical Reading Units controller voltage out of range. Voltage out-of-range fault detected on a controller. Optical Reading Units controller board malfunction. Call Service. 1158 Rack-Cuvette controller voltage out of range. Voltage out-of-range fault detected on a controller. Rack-Cuvette controller board malfunction. Call Service. 1160 Probe <Probe> coordinates error. Automatic coordinates check failure Probe coordinates mismatch. The probe cannot initialize. Perform a probe alignment. If the problem persists, call Service. 1161 Wash station coordinates error. Wash station coordinates error. Conductivity failure between probe and wash station bracket. Wipe down probe tip and clean station. 703 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Analyzer Alarms Analyzer Alarms – Warnings and Errors Code Message Alarm Description Cause Operator Action 1165 Probe <Probe> coordinate adjust required. AM coordinates have Coordinate adjustment never been adjusted procedure not executed or using the "Coordinate failed. adjustment" procedure. Service or Lab Administrator to run the Coordinate Adjust procedure. 1166 Missing coordinates of aspiration point in track. Until the user defines The coordinates of the the coordinates of the aspiration point on the LAS aspiration point on track are not defined. the LAS track, the instrument is unable to move the LAS probe there. Service or Lab Administrator to run the Coordinate Adjust procedure for LAS track position. 1170 Invalid system configuration. Invalid emitter, detection, or incubator module configuration detected, or reference channel not on installed detection module. System detected a hardware configuration that cannot support the current system configuration settings: missing or inactive optical reading unit(s), cuvettes incubator or CTS module. Check system configuration settings. Power off and restart the instrument. If the problem persists, call Service. 1175 <Probe> probe pre-heater temperature control failure. Probe Pre-Heater temperature defined to be out of range for a period exceeding the fatal error limits. Probe pre-heating system malfunction. The system performed a controlled stop. Call Service. 1180 <Probe> probe temperature control failure. Probe temperature defined to be out of range for a period exceeding the fatal error limits. Probe heating system malfunction. The system performed a controlled stop. Call Service. 1185 <Arm> arm clean fluid valve failure. Valve commanded ON(OFF) but sensor did not indicate ON (OFF) state. Clean fluid valve not responding. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. Clean pump not responding. The system performed an Emergency stop. NOTE: MiniTOP and MicroTOP have no valves. 1190 Sample Clean pump failure. Pump commanded ON(OFF) but sensor 704 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Analyzer Alarms Analyzer Alarms – Warnings and Errors Code Message Alarm Description Cause did not indicate ON (OFF) state. Operator Action Perform a Recovery. If the problem persists, call Service. NOTE: BaseTOP, CTS, LAS, MiniTOP and MicroTOP have: Sample Clean Pump Reagent Clean Pump 1191 Reagent clean pump failure. Pump commanded ON(OFF) but sensor did not indicate ON (OFF) state. Clean pump not responding. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. 1200 <Arm> arm rinse pump failure. Pump commanded ON(OFF) but sensor did not indicate ON (OFF) state. Rinse pump not responding. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. NOTE: For Micro there is only 1 pump. <Arm> will be empty. Terminology for MicroTOP shall be 'Instrument Arm' 1205 Waste pump failure. Pump commanded ON(OFF) but sensor did not indicate ON (OFF) state. Waste pump not responding. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. 1206 Coordinate File Saving Failure. Failure saving coordinates file on the FTP server Invalid FTP server configuration, AM/CM connection network not working. Call Service. 1207 ORU Stored Failure saving ORU Invalid FTP server Call Service. 705 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Analyzer Alarms Analyzer Alarms – Warnings and Errors Code Message Alarm Description Cause Reading File Saving Failure. stored reading file on the FTP server configuration, AM/CM connection network not working. 1208 CTS sample arm air pump failure. Pump commanded ON(OFF) but sensor did not indicate ON (OFF) state. Air pump not responding. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. 1209 CTS Failed to The foot hit the wash Enter Deep Wash. station edge when the CTS probe was inserted inside the wash station. This would have caused a probe mode switch failure at the end of the wash cycle. The foot hit the wash station edge when the CTS probe was inserted inside the wash station. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. 1236 Cuvette Pivot Arm failure. Failure on pivot arm movement. Pivot Arm malfunction. Either the motor, pivot arm up sensor, or pivot arm down sensor is not functioning. The system performed a controlled stop: the run has to be restarted. If the problem persists, call Service. 1237 Cuvette indexer motor failure. Failure of the indexer motor detected. Cuvette indexer motor failure. The system performed a controlled stop: the run has to be restarted. If the problem persists, call Service. 1238 Cuvette Loader Failure. Failure moving cuvette loader belts detected. Cuvette loader malfunction. Some cuvettes strips may not have been placed properly in the loader, belts motor or cuvette loader sensors malfunction. The system performed a controlled stop: the run has to be restarted. If the problem persists, call Service. 1243 Cuvettes shuttle movement failure. The motor did not complete the requested move. Cuvette was not detected in the shuttle after a cuvette pickup operation completed. OR Cuvette was not detected in the cuvette shuttle prior to a cuvette drop off. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. 706 of 992 Operator Action L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Analyzer Alarms Analyzer Alarms – Warnings and Errors Code Message 1244 Cuvettes shuttle movement failure. 1245 Alarm Description Cause Operator Action The motor did not complete the requested move. Unexpected cuvette present. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. Cuvettes shuttle movement failure. The motor did not complete the requested move. The motor moved to the left limit then to the home position at the loader and the home position was not found. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. 1246 Cuvettes shuttle movement failure. The motor did not complete the requested move. Incorrect # slots found. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. 1247 Cuvettes shuttle movement failure. The motor did not complete the requested move. Home Required. A cuvette shuttle operation was requested before the shuttle was initialized into a known state. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. 1248 Cuvettes shuttle movement failure. The motor did not complete the requested move. Cuvettes shuttle movement timeout. Move Timeout. This occurs if the software does not complete the move profile. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. 1249 Cuvettes shuttle movement failure. The motor did not complete the requested move. Cuvettes shuttle movement stalled. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. 1250 Cuvettes shuttle movement failure. The motor did not complete the requested move. Cuvettes shuttle movement hit unexpected travel limit. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. 1251 Cuvettes shuttle movement failure. The motor did not complete the requested move. Cuvettes shuttle movement timeout. Gripper back sensor failure. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. 707 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Analyzer Alarms Analyzer Alarms – Warnings and Errors Code Message 1252 Cuvettes shuttle movement failure. 1253 Cause Operator Action The motor did not complete the requested move. Cuvettes shuttle movement timeout. Gripper forward sensor failure. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. Cuvettes shuttle movement failure. The motor did not complete the requested move. Cuvettes shuttle movement timeout. Gripper move failure. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. 1254 Cuvette waste accumulator unable to empty. Accumulator is full and unable to dump Cuvette waste drawer missing. Please check that the cuvette waste drawer is present. 1255 Barcode reader movement failure. The motor did not complete the requested move prior to a motor move time out (bar code). Barcode reader movement timeout. Home Not Found. Clear obstruction and wait for barcode reader timeout to occur (homing of barcode). If problem persists call Service. 1256 Barcode reader movement failure. The motor did not complete the requested move prior to a motor move time out (bar code). Barcode reader movement timeout. Incorrect Slots Found. Clear obstruction and wait for barcode reader timeout to occur (homing of barcode). If problem persists call Service. 1257 Barcode reader movement failure. The motor did not complete the requested move prior to a motor move time out (bar code). Barcode reader movement timeout. Home Required. Clear obstruction and wait for barcode reader timeout to occur (homing of barcode). If problem persists call Service. 1258 Barcode reader movement failure. The motor did not complete the requested move prior to a motor move time out (bar code). Barcode reader movement timeout. Clear obstruction and wait for barcode reader timeout to occur (homing of barcode). If problem persists call Service. The motor did not complete the requested move prior Barcode reader movement timeout. 1259 Barcode reader movement failure. Alarm Description Move Timeout. 708 of 992 Clear obstruction and wait for barcode reader timeout to L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Analyzer Alarms Analyzer Alarms – Warnings and Errors Code 1260 1261 Message Barcode reader movement failure. All the Optical Reading Units are disabled. Analysis cannot be performed. Alarm Description Cause Operator Action to a motor move time out (bar code). Stalled. occur (homing of barcode). If problem persists call Service. The motor did not complete the requested move prior to a motor move time out (bar code). Barcode reader movement timeout. Clear obstruction and wait for barcode reader timeout to occur (homing of barcode). If problem persists call Service. All the ORU have been disabled, either manually or automatically. All the ORUs have been disabled, either automatically or manually. If the ORUs have been automatically disabled, call Service. - Automatically: ORU realtime check failed When all the ORUs are disabled the system cannot perform analysis. The instrument cannot perform any tests. Unexpected Travel Limit. - Manually: operator disabled ORU through Diagnostics If this occurs during a run, the system performs an Emergency Stop. 1263 Cuvettes accumulator failure. The accumulator does Cuvettes accumulator not return to the up movement timeout. position within 2 seconds of being emptied. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. 1264 Optical reading unit No. 1 temperature control failure. Temperature out of range in a reading unit Temperature out of range in optical reading unit. Call Service. 1265 Optical reading unit No. 2 temperature control failure. Temperature out of range in a reading unit Temperature out of range in optical reading unit. Call Service. 1266 Optical reading unit No. 3 temperature control failure. Temperature out of range in a reading unit Temperature out of range in optical reading unit. Call Service. 1267 Optical reading Temperature out of Temperature out of range in Call Service. 709 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Analyzer Alarms Analyzer Alarms – Warnings and Errors Code Message Alarm Description Cause Operator Action unit No. 4 temperature control failure. range in a reading unit optical reading unit. 1268 Cuvettes incubator No. 1 temperature control failure. Temperature out of range in an incubator Temperature out of range in cuvettes incubator. Call Service. 1269 Cuvettes incubator No. 2 temperature control failure. Temperature out of range in an incubator Temperature out of range in cuvettes incubator. Call Service. 1270 <Probe> probe temperature or dispense temperature out of range. Probe temperature or dispense temperature defined to be out of warning range but within failure range. Probe heating system malfunction. Call Service. 1273 <Probe> probe pre-heater temperature out of range. Probe Pre-Heater temperature defined to be out of warning range but within failure range Probe pre-heating system malfunction. Call Service. 1276 Reagent area temperature out of range. Reagent area temperature defined to be out of warning range but within failure range. Reagent cooling system malfunction. Call Service. 1277 Cuvette shuttle temperature out of range. Cuvette shuttle temperature defined to be out of warning range but within failure range. Cuvette shuttle heating system malfunction. Call Service. 1278 Optical reading units reference readings out of range for ORU <ORU ID>. Optical Reference readings not within expected range, possibly due to LED aging or failure. LED or electronic failure. Call Service. 1279 Optical reading unit <ORU ID> dark readings too ORU dark readings are too high, possibly indicating excessive Stray light interference or electronic failure. Call Service. 710 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Analyzer Alarms Analyzer Alarms – Warnings and Errors Code Message Alarm Description Cause Operator Action high. stray light. 1280 Optical reading units readings too noisy for ORU <ORU ID>. Optical readings too noisy, possibly due to LED aging or failure. LED or electronic failure. Call Service. 1281 Optical reading unit <ORU ID> readings out of range. ORU amplifier and/or ORU LED or electronic A/D converter failure. Amplifier and/or saturated A/D converter saturated. Call Service. 1283 Optical reading unit raw data calculation error. Math exception error (e.g. attempt to divide by zero, overflow, result not reasonable). If the problem persists, call Service. 1284 Air read drift detected for ORU# <ORU ID> Channel# <CHAN ID> Wavelength# <WAVE ID> Drift percentage <DRIFT PERCENTAGE> Current air read for this wavelength, read head and read channel is outside of the stored air read plus tolerance ORU air reading drift detected. Go to diagnostics, clean the ORU channels, enable the ORU in question and repeat the blanking procedures (AIR and Factor Diluent). 1295 Air read out of range for ORU# <ORU ID> Channel# <CHAN ID> Wavelength# <WAVE ID> Reading: <ORU READING> Current air read for this wavelength, read head and read channel is out of range ORU air reading out of range. Call Service. 1313 Failed to load When attempting to cuvette clip at the move the cuvette indexer. indexer to pick up a new cuvette clip, the indexer was not detected to be fully to the left to allow Either motor could have stalled, sensor was not reached, or sensor is not functional. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. 711 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Analyzer Alarms Analyzer Alarms – Warnings and Errors Code Message Alarm Description Cause Operator Action the clip to fall. Move is attempted for five seconds in order to search for the proper position. 1314 Failed to place cuvette clip in position for pickup. When the cuvette indexer is attempting to load the cuvette clip into the position for the cuvette shuttle to pick it up, the clip was not detected. Move is attempted for five seconds in order to search for the proper position. Either the motor could have stalled, the sensor was not reached, or the sensor is not functional. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. 1315 Pivot arm did not move to the up position. The move of the pivot arm to the up position was not detected as completed. The motor moves for 10 seconds and the expected sensor to stop the motor was not found. Either the motor was stalled or the up sensor is not functioning properly. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. 1316 Pivot arm did not move to the down position. The move of the pivot arm to the down position was not detected as completed. The motor moves for 10 seconds and the expected sensor to stop the motor was not found. Either the motor was stalled or the up sensor is not functioning properly. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. 1317 Cuvette strip not in shuttle after pick up operation. After all devices have successfully performed their individual operations to pick up a cuvette, but a cuvette was not Either the presence sensor is not functioning properly (ex. dirty) or a cable has come unplugged. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. 712 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Analyzer Alarms Analyzer Alarms – Warnings and Errors Code Message Alarm Description Cause Operator Action detected in the shuttle. 1318 No cuvette strip in shuttle to drop off. A request was made to drop off a cuvette, but no cuvette is detected in the shuttle. Either a cuvette is really not present, the presence sensor is not functioning properly (ex. dirty), or a cable has come unplugged. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. 1319 Missing cuvette strip in slot for pick up. The shuttle is ready to pick up a cuvette, but there is no cuvette in the slot. Either the operator did not place a cuvette using diagnostics, the Cuvette in slot sensor is not functioning, or the scheduler timing is not coordinated. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. 1320 Cuvette shuttle is full. The shuttle cannot perform a cuvette pick up operation because a cuvette is already detected in the shuttle. Either the presence sensor is not functioning properly (ex. dirty), a cable has come unplugged, an operator is attempting an invalid operation in diagnostics, or the scheduler timing is not correct. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. 1321 Cuvette not released into slot. After all devices have successfully performed their individual operations to drop off a cuvette, but a cuvette was still detected in the shuttle. Either the presence sensor is not functioning properly (ex. dirty), the gripper did not let go, the slot indexer did not engage the cuvette strip, a cable has come unplugged, or the gripper did not release the cuvette. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. 1323 Cuvette not present to pickup. The source position for picking up a cuvette is empty. Either a scheduler error or operator error in diagnostics. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. 1324 Cuvette destination position full. The destination position for placing a cuvette is occupied. Either a scheduler error or operator error in diagnostics. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. 713 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Analyzer Alarms Analyzer Alarms – Warnings and Errors Code Message Alarm Description Cause 1325 Cannot pickup from waste. The requested cuvette Software logic error. pick up position is the waste position which is not possible. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. 1326 Cannot drop off at loader. The requested drop Software logic error. off position is the loader position which is not possible. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. 1327 Cuvette load operation too slow. Second cuvette move operation attempted prior to the loader/indexer preparing a new cuvette strip. Clip load time is too slow. Operation did not complete prior to next request. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. 1328 Invalid number of cuvette slots. The number of cuvette slots detected is not a valid configuration (Base vs. Aurora vs. Mini). The cuvette shuttle sensors are dirty or the configuration dip switch is set incorrectly. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. 1329 Cuvette slot found too early. The number of required slots was detected too early in move distance. Either there are too many mechanical slots or the sensor has picked up noise. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. 1330 Gripper back sensor still active. During initialization Either a sensor failure, (home), the gripper cabling failure, or motor attempts to move off stall. the back sensor, but the sensor is still detected. OR Extend gripper operation performed, but the back sensor is still detected. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. 1331 Gripper back sensor not found. During initialization (home), the gripper moves off the back sensor. Once The system performed an Emergency stop. Perform a Recovery. If the problem persists, Either a sensor failure, cabling failure, or motor stall. 714 of 992 Operator Action L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Analyzer Alarms Analyzer Alarms – Warnings and Errors Code Message Alarm Description Cause detected to be off the sensor, the motor moves towards the sensor to make sure it can be detected. If the back sensor is not detected during this search then the alarm is generated. Operator Action call Service. 1332 Gripper forward sensor still active. After the gripper has completed a retract move the forward sensor is still detected. Either a sensor failure, cabling failure, or motor stall. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. 1333 Gripper forward sensor not found. Extend gripper operation did not detect the front sensor. Either a sensor failure, cabling failure, or motor stall. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. 1334 Cuvette waste tray did not dump. The accumulator is Tray mechanically stuck or energized to be in the solenoid malfunction. down position to drop the cuvettes on the tray, but the tray is still detected in the up position. Allowed 250 ms to move. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. 1335 Cuvette waste tray not ready to receive cuvettes. The accumulator is Tray mechanically stuck or deenergized to go to solenoid malfunction. the up position to get more cuvettes onto the tray, but the tray is still detected in the down position. Allowed 250 ms to move. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. 1341 X Axis - Invalid Profile Parameter X Axis - Invalid Profile Parameter The system performed an Emergency stop. Perform a Recovery. If the problem persists, The universal arm controller reporting the alarm was sent a velocity profile parameter (s) for the X axis motor that 715 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Analyzer Alarms Analyzer Alarms – Warnings and Errors Code Message Alarm Description Cause Operator Action exceeded maximum/minimum criteria or was incompatible with other profile parameters. call Service. 1342 Y Axis - Invalid Profile Parameter Y Axis - Invalid Profile Parameter The universal arm controller reporting the alarm was sent a velocity profile parameter (s) for the Y axis motor that exceeded maximum/minimum criteria or was incompatible with other profile parameters. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. 1343 Z Axis - Invalid Profile Parameter Z Axis - Invalid Profile Parameter The universal arm controller reporting the alarm was sent a velocity profile parameter (s) for the Z axis motor that exceeded maximum/minimum criteria or was incompatible with other profile parameters. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. 1344 X Axis - Speed Exceeds Profile Maximum X Axis - Speed Exceeds Profile Maximum The universal arm controller reporting the alarm was sent a command to move in the X axis at a speed that would exceed the maximum stored in the velocity profile. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. 1345 Y Axis - Speed Exceeds Profile Maximum Y Axis - Speed Exceeds Profile Maximum The universal arm controller reporting the alarm was sent a command to move in the Y axis at a speed that would exceed the maximum stored in the velocity profile. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. 1346 Z Axis - Speed Exceeds Profile Maximum Z Axis - Speed Exceeds Profile Maximum The universal arm controller reporting the alarm was sent a command to move in the Z axis at a speed that would exceed the maximum stored in the velocity profile. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. 716 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Analyzer Alarms Analyzer Alarms – Warnings and Errors Code Message 1347 X Axis - Cannot Process Steps Required 1348 Alarm Description Cause Operator Action X Axis - Cannot Process Steps Required The universal arm controller reporting the alarm was sent a command to set the velocity profile for the X axis but the parameters will generate a profile that will exceed allocated memory. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. Y Axis - Cannot Process Steps Required Y Axis - Cannot Process Steps Required The universal arm controller reporting the alarm was sent a command to set the velocity profile for the Y axis but the parameters will generate a profile that will exceed allocated memory. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. 1349 Z Axis - Cannot Process Steps Required Z Axis - Cannot Process Steps Required The universal arm controller reporting the alarm was sent a command to set the velocity profile for the Z axis but the parameters will generate a profile that will exceed allocated memory. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. 1350 X Axis - Selected Profile Is Invalid X Axis - Selected Profile Is Invalid The universal arm controller reporting the alarm was sent a command to select a particular profile for the X axis motor but the profile does not exist. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. 1351 Y Axis - Selected Profile Is Invalid Y Axis - Selected Profile Is Invalid The universal arm controller reporting the alarm was sent a command to select a particular profile for the Y axis motor but the profile does not exist. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. 1352 Z Axis - Selected Profile Is Invalid Z Axis - Selected Profile Is Invalid The universal arm controller reporting the alarm was sent The system performed an Emergency stop. 717 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Analyzer Alarms Analyzer Alarms – Warnings and Errors Code 1353 Message X Axis - Move Took Too Long To Complete Alarm Description X Axis - Move Took Too Long To Complete Cause Operator Action a command to select a particular profile for the Z axis motor but the profile does not exist. Perform a Recovery. If the problem persists, call Service. The universal arm controller reporting the alarm has detected that the an X axis move is taking longer than expected to complete. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. Possible causes: 1. The universal arm controller receives a verification pulse from the X axis motor circuitry for each step pulse. The controller assumes that an X axis move is complete when the number of verification pulses received is equal to the step pulses sent. Therefore a malfunction in the step clock/step verification circuitry will cause this alarm. 2. Software defect especially TPU loading complications. 1354 Y Axis - Move Took Too Long To Complete Y Axis - Move Took To Long To Complete The universal arm controller reporting the alarm has detected that the an Y axis move is taking longer than expected to complete. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. Possible causes: 1. The universal arm controller receives a verification pulse from the Y axis motor circuitry for each step pulse. The controller assumes that an Y axis move 718 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Analyzer Alarms Analyzer Alarms – Warnings and Errors Code Message Alarm Description Cause Operator Action is complete when the number of verification pulses received is equal to the step pulses sent. Therefore a malfunction in the step clock/step verification circuitry will cause this alarm. 2. Software defect especially TPU loading complications. 1355 Z Axis - Move Took Too Long To Complete Z Axis - Move Took Too Long To Complete The universal arm controller reporting the alarm has detected that a Z axis move is taking longer than expected to complete. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. Possible causes: 1. The universal arm controller receives a verification pulse from the Z axis motor circuitry for each step pulse. The controller assumes that a Z axis move is complete when the number of verification pulses received is equal to the step pulses sent. Therefore a malfunction in the step clock/step verification circuitry will cause this alarm. 2. Software defect especially TPU loading complications. 1356 X Axis Movement Generates Too Many Steps X Axis - Movement Generates Too Many Steps The universal arm controller reporting the alarm was sent a command to move the X axis motor to a position which would require exceeding the number of steps that can be processed. 719 of 992 The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Analyzer Alarms Analyzer Alarms – Warnings and Errors Code Message Alarm Description Cause Operator Action 1357 Y Axis Movement Generates Too Many Steps Y Axis - Movement Generates Too Many Steps The universal arm controller reporting the alarm was sent a command to move the Y axis motor to a position which would require exceeding the number of steps that can be processed. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. 1358 Z Axis Movement Generates Too Many Steps Z Axis - Movement Generates Too Many Steps The universal arm controller reporting the alarm was sent a command to move the Z axis motor to a position which would require exceeding the number of steps that can be processed. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. 1359 X Axis - Invalid Limit State While Homing X Axis - Invalid Limit State While Homing The universal arm control reporting the alarm was attempting to initialize the X axis motor but encountered a limit sensor that did not change state as expected. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. Could be caused by slippage in the X axis, software defect, or malfunctioning or misplaced limit sensor(s). 1360 Y Axis - Invalid Limit State While Homing Y Axis - Invalid Limit State While Homing The universal arm control reporting the alarm was attempting to initialize the Y axis motor but encountered a limit sensor that did not change state as expected. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. Could be caused by slippage in the Y axis, software defect, or malfunctioning or misplaced limit sensor(s). 1361 Z Axis - Invalid Limit State While Homing Z Axis - Invalid Limit State While Homing The universal arm control reporting the alarm was attempting to initialize the Z 720 of 992 The system performed an Emergency stop. Perform a Recovery. If the problem persists, L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Analyzer Alarms Analyzer Alarms – Warnings and Errors Code Message Alarm Description Cause axis motor but encountered a limit sensor that did not change state as expected. Operator Action call Service. Could be caused by slippage in the Z axis, software defect, or malfunctioning or misplaced limit sensor(s). 1362 X Axis - Limit Detected During Move X Axis - Limit Detected During Move The universal arm control reporting the alarm has detected that the X axis motor tripped a travel limit sensor during a move. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. Could be caused by: 1. slippage in the X axis. 2. software defect 3. malfunctioning or misplaced limit sensor(s) 4. X axis Encoder malfunction. 1363 Y Axis - Limit Detected During Move Y Axis - Limit Detected During Move The universal arm control reporting the alarm has detected that the Y axis motor tripped a travel limit sensor during a move. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. Could be caused by: 1. slippage in the Y axis. 2. software defect 3. malfunctioning or misplaced limit sensor(s) 4. Y axis Encoder malfunction. 721 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Analyzer Alarms Analyzer Alarms – Warnings and Errors Code Message 1364 Z Axis - Limit Detected During Move Alarm Description Z Axis - Limit Detected During Move Cause Operator Action The universal arm control reporting the alarm has detected that the Z axis motor tripped a travel limit sensor during a move. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. Could be caused by: 1. slippage in the Z axis. 2. software defect 3. malfunctioning or misplaced limit sensor(s) 4. Z axis Encoder malfunction. 1365 X Axis - Slippage X Axis - Slippage Detected Detected The universal arm control reporting the alarm has detected that the X axis motor did not reach the expected position at the completion of a move. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. Could be caused by: 1. Blockage or restricted movement in the X axis. 2. Faulty X axis position encoder. 3. X axis velocity profile parameters are incompatible with current system. 1366 Y Axis - Slippage Y Axis - Slippage Detected Detected The universal arm control reporting the alarm has detected that the Y axis motor did not reach the expected position at the completion of a move. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. Could be caused by: 722 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Analyzer Alarms Analyzer Alarms – Warnings and Errors Code Message Alarm Description Cause Operator Action 1. Blockage or restricted movement in the Y axis. 2. Faulty Y axis position encoder. 3. Y axis velocity profile parameters are incompatible with current system. 1367 Z Axis - Slippage Detected Z Axis - Slippage Detected The universal arm control reporting the alarm has detected that the Z axis motor did not reach the expected position at the completion of a move. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. Could be caused by: 1. Blockage or restricted movement in the Z axis. 2. Faulty Z axis position encoder. 3. Z axis velocity profile parameters are incompatible with current system. 1368 X Axis - Cannot Store More Ramps X Axis - Cannot Store More Ramps The universal arm controller reporting the alarm ran out of memory allocated for storage of ramps for the X axis motor. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. 1369 Y Axis - Cannot Store More Ramps Y Axis - Cannot Store More Ramps The universal arm controller reporting the alarm ran out of memory allocated for storage of ramps for the Y axis motor. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. 1370 Z Axis - Cannot Store More Ramps Z Axis - Cannot Store More Ramps The universal arm controller reporting the alarm ran out of memory allocated for storage of ramps for the Z axis The system performed an Emergency stop. Perform a Recovery. If the problem persists, 723 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Analyzer Alarms Analyzer Alarms – Warnings and Errors Code 1371 Message X Axis - Motor Stalled Alarm Description X Axis - Motor Stalled Cause Operator Action motor. call Service. The universal arm controller reporting the alarm is reporting that periodic readings of the X axis motor position encoder indicate that the current move is being restricted or blocked. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. Could be caused by: 1. Blockage or restricted movement in the X axis. 2. Faulty X axis position encoder. 3. X axis velocity profile parameters are incompatible with current system. 1372 Y Axis - Motor Stalled Y Axis - Motor Stalled The universal arm controller reporting the alarm is reporting that periodic readings of the Y axis motor position encoder indicate that the current move is being restricted or blocked. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. Could be caused by: 1. Blockage or restricted movement in the Y axis. 2. Faulty Y axis position encoder. 3. Y axis velocity profile parameters are incompatible with current system. 1373 Z Axis - Motor Stalled Z Axis - Motor Stalled The universal arm controller reporting the alarm is reporting that periodic 724 of 992 The system performed an Emergency stop. Perform a Recovery. L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Analyzer Alarms Analyzer Alarms – Warnings and Errors Code Message Alarm Description Cause Operator Action readings of the Z axis motor position encoder indicate that the current move is being restricted or blocked. If the problem persists, call Service. Could be caused by: 1. Blockage or restricted movement in the Z axis. 2. Faulty Z axis position encoder. 3. Z axis velocity profile parameters are incompatible with current system. 1374 X Axis Operation Timeout X Axis - Operation Timeout The universal arm controller reporting the alarm has detected that the X axis motor is taking too long to complete a move. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. Possible causes: 1. The universal arm controller receives a verification pulse from the X axis motor circuitry for each step pulse. The controller assumes that an X axis move is complete when the number of verification pulses received is equal to the step pulses sent. Therefore a malfunction in the step clock/step verification circuitry will cause this alarm. 2. Software defect especially TPU loading complications. 1375 Y Axis Operation Y Axis - Operation Timeout The universal arm controller 725 of 992 The system performed an Emergency stop. L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Analyzer Alarms Analyzer Alarms – Warnings and Errors Code Message Alarm Description Timeout Cause Operator Action reporting the alarm has detected that the Y axis motor is taking too long to complete a move. Perform a Recovery. If the problem persists, call Service. Possible causes: 1. The universal arm controller receives a verification pulse from the Y axis motor circuitry for each step pulse. The controller assumes that an Y axis move is complete when the number of verification pulses received is equal to the step pulses sent. Therefore a malfunction in the step clock/step verification circuitry will cause this alarm. 2. Software defect especially TPU loading complications. 1376 Z Axis Operation Timeout Z Axis - Operation Timeout The universal arm controller reporting the alarm has detected that the Z axis motor is taking too long to complete a move. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. Possible causes: 1. The universal arm controller receives a verification pulse from the Z axis motor circuitry for each step pulse. The controller assumes that a Z axis move is complete when the number of verification pulses received is equal to the step pulses sent. Therefore a malfunction in the step clock/step verification 726 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Analyzer Alarms Analyzer Alarms – Warnings and Errors Code Message Alarm Description Cause Operator Action circuitry will cause this alarm. 2. Software defect especially TPU loading complications. 1377 X Axis Operation Failed X Axis - Operation Failed This is an internal software error. Cause is always software defect. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. Incorrect message was placed on a queue. 1378 Y Axis Operation Failed Y Axis - Operation Failed This is an internal software error. Cause is always software defect. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. Incorrect message was placed on a queue. 1379 Z Axis Operation Failed Z Axis - Operation Failed This is an internal software error. Cause is always software defect. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. Incorrect message was placed on a queue. 1380 Tube Release Procedure Failed Tube Release Procedure Failed The universal arm controller reporting the alarm has detected during initialization the tube release operation failed. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. The tube release operation is fairly complicated, but in general it attempts to extract the piercer from a capped tube during initialization by 727 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Analyzer Alarms Analyzer Alarms – Warnings and Errors Code Message Alarm Description Cause Operator Action locking the foot and moving the piercer up until the cap detect is no longer active. This is only applicable to CTS instruments. The failure can have many causes: 1. Faulty cap, limit, piercer position, or piercer latch sensors. 2. restricted or blocked movement in the Z axis. 3. Piercer latch solenoid. 4. Excessive friction between piercer latch and probe. 5. Excessive force required to extract the piercer from the cap. 6. Software defect. 1381 Sensor Or Motor Failure Caused Latch Offset Measurement To Fail Sensor Or Motor Failure Caused Latch Offset Measurement To Fail The universal arm controller reporting the alarm has detected that the latch offset measurement operation failed. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. This is only applicable to CTS instruments. The failure can have many causes: 1. Faulty cap, limit, piercer position, or piercer latch sensors. 728 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Analyzer Alarms Analyzer Alarms – Warnings and Errors Code Message Alarm Description Cause Operator Action 2. Restricted or blocked movement in the Z axis. 3. Piercer latch solenoid. 4. Excessive friction between piercer latch and probe. 5. Software defect. 1382 LLD Hardware Failure LLD Hardware Failure The universal arm controller reporting the arm has detected that the LLD circuitry is not interrupting the processor at the required rate. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. 1383 Piercer Was Not In The Expected State Piercer Was Not In The Expected State The universal arm controller reporting the alarm was sent a command to verify that the piercer was in a particular state (CTS or Sample). The verification failed. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. i.e. There is a mismatch between the state that the Master SW expects the Piercer to be in and the state that the universal arm controller thinks the piercer is in. 1384 Z Axis - Power DAC failed Z Axis - Power DAC failed The universal arm controller reporting the alarm has detected that DAC controlling the amount of power to the Z axis motor is not performing within tolerances. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. 1385 Syringe Is Always Busy Syringe Is Always Busy The universal arm controller reporting the alarm is waiting for the syringe to complete an operation but it The system performed an Emergency stop. Perform a Recovery. If the problem persists, 729 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Analyzer Alarms Analyzer Alarms – Warnings and Errors Code Message Alarm Description Cause Operator Action is taking too long. call Service. 1387 Syringe Took Too Long To Respond Syringe Took Too Long To Respond The universal arm controller reporting the alarm is waiting for the syringe to respond to a previous command but it took too long. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. 1388 Syringe Could Not Be Initialized Syringe Could Not Be Initialized The universal arm controller reporting the alarm could not initialize the arms syringe pump. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. 1389 Syringe Does Not Understand The Command Syringe Does Not Understand The Command The universal arm controller reporting the alarm received an error message from the arms syringe indicating that the syringe did not understand the last command sent to it. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. 1390 Syringe Command Parameter Is Invalid Syringe Command Parameter Is Invalid The universal arm controller reporting the alarm received an error message from the arms syringe indicating that the last command sent to it contained an invalid parameter. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. 1391 Syringe Must Be Initialized Syringe Must Be Initialized The universal arm controller reporting the alarm received an error message from the arms syringe indicating that it must be initialized before any further commands can be performed. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. 1392 Syringe Plunger Is Overloaded Syringe Plunger Is Overloaded The universal arm controller reporting the alarm received an error message from the arms syringe indicating that the plunger is overloaded. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. 1393 Syringe Valve Is Overloaded Syringe Valve Is Overloaded The universal arm controller reporting the alarm received The system performed an Emergency stop. 730 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Analyzer Alarms Analyzer Alarms – Warnings and Errors Code Message Alarm Description Cause Operator Action an error message from the arms syringe indicating that the valve is overloaded. Perform a Recovery. If the problem persists, call Service. 1394 Syringe Move Is Not Permitted Syringe Move Is Not Permitted The universal arm controller reporting the alarm received an error message from the arms syringe indicating that a plunger move is not permitted. When the valve is in bypass or throughput position plunger movement commands are not allowed. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. 1395 Syringe Error With Unknown Source Syringe Error With Unknown Source The universal arm controller reporting the alarm received an error message from the syringe but it is not a recognized published error. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. 1396 Error Communicating With The Syringe Error Communicating With The Syringe The universal arm controller reporting the alarm is indicating that either The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. 1. The buffer used for receiving serial data from the syringe has overflowed. 2. The control signals used for coordinating serial data transmission to the syringe are not in the correct state. 1397 Syringe Hardware Malfunction Syringe Hardware Malfunction Not used. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. 1414 CTS piercer lock not locked CTS piercer lock not locked The AM has detected that the piercer latch is not in one of it's detent positions. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. 731 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Analyzer Alarms Analyzer Alarms – Warnings and Errors Code Message 1415 CTS probe mode switch failure Alarm Description CTS probe mode switch failure Cause Operator Action The AM attempted to set the CTS mode (sample or CTS) but after verifying determined that the piercer was not in the expected mode. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. Possible causes: 1. CTS spring tension too light. 2. Faulty CTS position, or latch sensor 3. Faulty latch solenoid or circuitry. 1416 Cannot switch CTS between piercing and sample mode. The CTS hardware used to change the probe between piercing mode and sample mode failed to switch. The sensor was not seen after performing the CTS mode switch operation. Failure could be sensor, spring, solenoid, or software. Perform a recovery. If the problem persists, call service. 1417 Location unreachable by Probe <Probe>: track # <Rack>,position <Position>. Vial Location Unreachable Invalid arm homing position or coordinate adjustment failure. Perform Coordinates Adjustment. If the problem persists, call service. 1418 Location unreachable by Probe <Probe>: cuvette <Cuvette Slot ID>, well <well position>. Cuvette Location Unreachable Invalid arm homing position or coordinate adjustment failure. Perform Coordinates Adjustment. If the problem persists, call service. 1439 <Probe> probe communications failure. Cannot communicate with the probe. Cannot communicate with the probe. Either communications cable is not in place or probe computer board has malfunctioned. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. 732 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Analyzer Alarms Analyzer Alarms – Warnings and Errors Code Message Alarm Description Cause Operator Action 2010 <Cover ID> open. Safety cover detected open not in diagnostics. The cover was left open. Close the cover. The system performed an Emergency stop: once the cover is closed, perform a Recovery. 2080 Unrecoverable scheduling time violation. The actual execution did not meet a critical scheduling time. The job failed and it is not possible to recover Internal scheduling conflict. The system performed an Emergency stop. Perform a Recovery. If the problem persists, call Service. 2081 Rack in <Track ID> slot unplugged. A rack already inserted becomes unplugged with the reader not in front of the rack. Rack accidentally dislodged. Perform Recovery operation. 2082 ORU Air Calibration data not available for ORU <ORU ID>. Air Calibration data for the specified ORU are not available. The Optical Reading Unit air calibration procedure has never been executed for this ORU. Go to Diagnostics and run the Air Calibration procedure. The instrument is not able to perform air reading drift checks. 2084 An invalid blanking value has been accepted for ORU <ORU ID> (Value = <VALUE>). The ORU will be automatically disabled. An invalid ORU blanking value has been accepted by the user. The ORU will be automatically disabled. The user has accepted an out of range blanking value. Go to Diagnostics and run ORU Blanking procedure again. 2085 ORU Factor Diluent Calibration data not available for ORU <ORU ID>. Factor Diluent Calibration data for the specified ORU are not available. The Optical Reading Unit Factor Diluent Calibration procedure has never been executed for this ORU. Go to Diagnostics and run the Stored Factor Diluent Calibration procedure. The instrument is not able to calculate 733 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Analyzer Alarms Analyzer Alarms – Warnings and Errors Code Message Alarm Description Cause Operator Action absolute absorbance. 2087 Maximum number of tests allowed per run exceeded. There is not more memory in the AM for processing more tests. There is not enough memory for processing more tests. The tests exceeding the maximum number per run are not performed. Run canceled tests within another analytical session. 2091 CTS Filter missing. CTS Filter missing Foot could not reach the expected position of the CTS Filter. Please install a clean CTS filter. 2092 Air pressure sensor not operating correctly. Air pressure sensor not operating correctly. The air pressure sensor is not responding. Air is not being discharged to CTS piercer correctly due to obstructed, damaged or disconnected air pressure Valves. Call Service. 2093 Not enough free disk space. System detected not enough free disk space to run the application The system detected less than 100 megabytes of free space in the disk where the ACL TOP application is installed. Shutdown the CM application and free some disk space. If this problem persists, contact your System Administrator. 2094 The default file path for the log files does not exist and cannot be created. If the default file path does not exist, the system tries to automatically create it. The operation could fail for different causes: Wrong file path specification or insufficient rights to write to the drive or HW/SW failure of the drive. Verify the file path specification: if it is wrong, correct it and retry. If this is not the case, verify he has the appropriate write permissions or call service to repair the drive. Two racks with the same ID Remove one of the - wrong file path specification - insufficient rights to write to the drive - HW/SW failure of the drive 3023 Duplicated Rack Two different Racks 734 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Analyzer Alarms Analyzer Alarms – Warnings and Errors Code Message Alarm Description Cause ID, Rack ID <Rack ID>. have been identified with the same Rack ID. have been loaded on-board. two racks with the duplicated ID. 3046 Analyzer Status changed from <AM Status> to <AM Status>. AM status changed 3211 Auto Run failed. Auto Run could not be started and the instrument is Ready. Possible causes are: The system looks for an opportunity to auto start every 1 minute. Certain conditions might change without operator's intervention. - CTS Filter was not detected (for CTS configuration only). - Enhanced clean required. - Temperatures are out of range. Operator Action Identify the cause among the following and resolve if necessary: - CTS Filter missing: install a new filter (Maintenance activity). - Enhanced Clean required: perform Enhanced Clean for all probes (Maintenance activity). - Temperatures are out of range: wait until the temperatures stabilize (depending from the system and ambient conditions, this might take more than 30 minutes); if they do not stabilize, call Service. 735 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Analyzer Alarms Analyzer Alarms – Warnings and Errors Code Message Alarm Description 3212 <Controller Name> controller has been upgraded to version <Version Name>. Controller upgraded successfully. 3213 The system detected a software version designed for experimental use. Software version is for experimental use only. A controller, master, IM or CM is compiled in debug or the version name is experimental. CM is a Demo installation. 3214 Interface Module has been upgraded to version <Version Name>. IM has been upgraded. 4004 Invalid barcode size. 4005 Cause Operator Action CM, AM Master software or controller software is not a system release version. Call Service. Barcode size bigger than the maximum size of sample Id (16 characters) Barcode label bigger that 16 characters. Use valid barcode labels. Rack rejected. The bar code label read is invalid. Rack barcode reading error, missing barcode labels or rack entered too quickly. Reinsert the rack. If the problem persists, use another rack. 4006 CTS rack rejected. CTS rack rejected. CTS Rack inserted when cap piercing is not enabled or CTS arm not installed. Enable cap piercing and reinsert the rack or use a non-CTS rack. 4007 Cap not detected for sample in rack <Rack ID>, position <position #>, track <Track ID>. Cap not detected by the piercer The CTS probe descended down to the maximum cap search depth but could not detect the presence of a cap for the sample in the specified position. Possible cause is the presence of a sample cup or a similar lowheight sample container. If a sample cup is loaded in that position, remove it from the CTS rack and load it on a open-tube sample rack. Only capped sample tubes should be loaded on CTS racks. Sample cups and uncapped 736 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Analyzer Alarms Analyzer Alarms – Warnings and Errors Code Message Alarm Description Cause Operator Action sample containers should be loaded on open-tube sample racks. 4015 Rack button identification failure. The rack button pressed is not a valid code. Rack position keypad malfunction. Call Service. 4020 Barcode reader communication failure. Cannot communicate with the bar code reader. Cable disconnected. Barcode reader malfunction. Call Service. Rack controller or Reader Traveling board malfunction. 4051 A new set of ORU air blanking values has been saved. A new set of ORU air blanking values has been saved. The ORU air blanking procedure has been successfully performed and a new set of ORU air blanking values has been saved. 4052 A new set of ORU factor diluent blanking values has been saved. A new set of ORU factor diluent blanking values has been saved. The ORU factor diluent blanking procedure has been successfully performed and a new set of ORU factor diluent blanking values has been saved. 4053 Probe <Probe>: Coordinates adjustment procedure completed. Probe Coordinates adjustment procedure completed. The coordinates adjustment for the specified probe has been successfully completed and the coordinates file has been successfully updated. 4054 The analyzer is unable to process the request to change CTS piercing probe mode. The analyzer is unable to process the request to change CTS mode or change Lower z-depth piercing probe mode. The analyzer is able to process the request only if the instrument status is POWER UP, READY or DIAGNOSTICS and the sample probe is not performing any diagnostics activity and there is no CTS rack inserted. Remove the CTS rack. Define the piercing mode when the instrument is in the proper status. 4055 The analyzer is The analyzer is The analyzer is able to Disable again the piercing mode when 737 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Analyzer Alarms Analyzer Alarms – Warnings and Errors Code Message Alarm Description Cause Operator Action unable to process the request to disable CTS piercing probe mode. unable to process the request to disable CTS or disable Lower z-depth piercing probe mode. process the request only if the instrument status is POWER UP, READY or DIAGNOSTICS and the sample probe is not performing any diagnostics activity. the instrument is the proper status. 4057 CM in use is from The system detected a different ACL the instrument model TOP model. is different than during last connection. This will happened between MicroTOP, MiniTop and TOP models (base TOP, CTS, LAS). A database has been restored from a different model or the application is connected to a different instrument model. The use of this CM will require service intervention. Please call service. 4058 Unable to create Unable to create a raw data report raw data report file. <path&filename>. Unable to create raw data report file. Please verify that there is enough disk space on the system. Please verify that the raw data report path is legitimate and you have write privileges in the log folder. Back to Alarm Messages. 738 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting External Communications Alarms External Communications Alarms Back to Alarm Messages. The alarms in this section are sorted by code number. External Communications Alarms – Warnings and Errors Code Message Alarm Description Operator Action Category 0059 Interface Module upgrade failed. IM Upgrade Failed The application must be re-started in order to execute the IM upgrade process again. If the problem persist, call Service. LAS 0060 Incompatible IM software version. Incompatible IM software version. Call Service LAS 3022 The LIS host has requested a test with invalid demographic data. The LIS host has requested a test with invalid demographic data like a birthdate greater than current date. 3031 Incorrect Instrument ID (<Instrument ID>) message received from LIS host. The ACL-TOP instrument has received a message from the LIS host with an Instrument ID and/or Host ID, which do not match the configured ones. Check the Instrument ID in Host communications configuration, and modify its value if required. Otherwise, check LIS host operation. LIS 3032 Message received with incorrect Host ID (<Host ID>). The ACL-TOP instrument has received a message from the LIS host with an Instrument ID and/or Host ID, which do not match the configured ones. Check the Host ID in Host communications configuration, and modify its value if required. Otherwise, check LIS host operation. LIS 3033 Invalid Test Code received from host The LIS host has requested an unknown test. Check tests currently available or contact the host administrator. LIS The user requests a manual job orders download that the ACL-TOP instrument cannot accomplish. In the same way, the ACL-TOP Report the error to the host administrator. LIS LIS (LIS # <LIS #>). 3034 Test orders downloading from host not performed. 739 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting External Communications Alarms External Communications Alarms – Warnings and Errors Code Message Alarm Description Operator Action Category instrument tries to perform an automatic job orders downloading, and the result is the same. 3035 Test results uploading to LIS host not performed. The user requests a manual test results upload that the ACL-TOP instrument cannot accomplish. In the same way, the ACL-TOP instrument tries to perform an automatic test results uploading, and the result is the same. Report the error to the host administrator. LIS 3036 Invalid Test Request received from host (LIS # <LIS #>). The LIS host has requested a test that is either disabled, inconsistent or a locked manually ordered test. Update test definition and/or enable it. Check whether the test can be manually programmed. LIS 3037 Duplicated Test Order for <SampleId> received from host (LIS # <LIS #>). The LIS host has requested a test that is already present in the instrument. 3038 Invalid Instrument Sample ID <Instrument Sample ID> received from host. The LIS host has requested a test for sample whose Instrument Sample ID is unknown. Report the error to the host administrator. LIS 3039 LIS request not allowed. LIS host sent a request that is not implemented for TOP. Report the error to the host administrator. LIS 3040 Invalid message format received from LIS host. The format of the message or fields contained in it are not compliant with the TOP specifications. Report the error to the host administrator. LIS 3041 Host Query not performed. The ACL-TOP instrument tries to perform an automatic host query without succeeding. Report the error to the host administrator. LIS 3042 Communications Communications between the between the instrument and the LIS have been instrument and the lost. LIS have been lost. Report the error to the host administrator. LIS 740 of 992 LIS L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting External Communications Alarms External Communications Alarms – Warnings and Errors Code Message Alarm Description Operator Action 3043 Test Order cancellation not performed (LIS # <LIS #>). The ACL-TOP could not process a test order cancellation coming from the LIS host. Report the error to the host administrator. LIS 3044 Creation of the LIS The ACL-TOP could not create a communication channel for communicating with the channel failed. LIS Host. Report the error to the host administrator. LIS 3045 Current LIS channel configuration is not supported. The current channel configuration defined through the control panel is not supported. Report the error to the host administrator. LIS 3200 Storage of messages sent to LIS <%> full. The UDC storage is almost full of messages waiting to be sent to LIS. Check communication status in both ends. If communication cannot be restored, disable them and call service. LIS 3201 Storage of messages sent to LIS overloaded. New uploaded messages will be rejected. The UDC storage is almost full of messages waiting to be sent to LIS. No more messages are accepted. Check communication status in both ends. If communication cannot be restored, disable them and call service. LIS 3202 Upload message was rejected and therefore not sent to LIS. UDC Rejected Uploaded Message Check communication status in both ends. If communication cannot be restored, disable them and call service. LIS 4059 LAS Interface Manager (IM) communications error. LAS Interface Manager (IM) communications error. Check LAS Interface Manager (IM) connection, if the problem persists call Service. During IM Upgrade process, ignore this alarm. LAS 10000 LAS Track communications error. LAS Track communications error. Check LAS Track/IM connection. If the problem persists, call Service. LAS 10002 LAS Track LAS Track Unavailable. Check LAS Track. If the LAS 741 of 992 Category L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting External Communications Alarms External Communications Alarms – Warnings and Errors Code Message Alarm Description Unavailable. Operator Action Category problem persists call Service of Track Vendor. 10003 LAS Sample <Sample ID> rejected. LAS Track has provided sample data with inconsistencies. LAS 10004 LAS Sample <Sample ID> rejected. Capped Tube provided by the LAS Track. LAS 10005 Reset Queue Request denied. Allow to clear the physical queue is unsafe. LAS Track has requested to reset the Check Analyzer. queue but the instrument does not let it do that. Check LAS probe to ensure the LAS probe is not inside the sample tube. If problem persists, call Service. LAS 10007 LAS Sample <Sample ID> rejected. LAS Sample was intended to be provided while a Reset Queue was in progress. LAS 10006 LAS Sample <Sample ID> cannot be processed at this time. The instrument rejects the LAS Sample because it is not ready for sampling. 10008 LAS Sample <Sample ID> not expected at Aspiration Point. This sample shall not be processed. Sample not expected at Aspiration Point. LAS 10009 LAS Sample Sample not expected at Aspiration <Sample ID> order Point. different than the expected at Aspiration Point. This sample shall be processed. LAS 10010 LAS Sample <Sample ID> not processed. LAS Sample Not processed due to the jobs are not available. 742 of 992 If problem persists, call Service. LAS L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting External Communications Alarms External Communications Alarms – Warnings and Errors Code Message Alarm Description Operator Action Category 10011 LAS Sample <Sample ID> not processed. Sample Not processed due to the Sample Tube Queue is empty LAS 10012 LAS Sample <Sample ID> not processed. Sample Not processed due to a not fluid detected. LAS 10013 LAS Sample <Sample ID> not processed. Sample Not processed due to an Insufficient Volume. LAS 10014 LAS Sample <Sample ID> not processed. Sample Not Processed due to a LAS Arm Failure. LAS 10015 LAS Sample <Sample ID> not processed. ID before aspiration: <Sample ID>. ID after aspiration: <Sample ID>. Sample ID mismatching when releasing the Sample Tube. LAS 10016 LAS Track request not supported. LAS Track sent a request that is not implemented/supported for TOP. Report the error to the administrator. If problem persists, call Service. LAS 10017 Invalid Format Message. The format of the message or fields contained in it are not compliant with the TOP specifications. Report the error to the administrator. LAS The Operating System Event Log can be reviewed for further information about the field that was not properly formatted. 10018 Creation of the LAS Track communication channel failed. The ACL-TOP could not create a channel for communicating with the LAS Track. Report the error to the administrator. LAS 10019 Creation of the LAS Track communication channel failed. The current channel configuration defined through the control panel is not supported. Report the error to the administrator LAS 743 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting External Communications Alarms External Communications Alarms – Warnings and Errors Code Message Alarm Description Operator Action 10020 Storage of messages sent to the LAS Track <%> full. The Synapse storage is almost full of messages waiting to be sent to the LAS Track. Check communication status in both ends. If communication cannot be restored, disable them and call service. LAS 10021 Storage of messages sent to the LAS Track overloaded. New uploaded messages will be rejected. The Synapse storage is almost full of messages waiting to be sent to the LAS Track. No more messages are accepted. Check communication status in both ends. If communication cannot be restored, disable them and call service. LAS 10022 LAS Track communications error. Message not delivered to the LAS Track. Check communication status in both ends. If communication cannot be restored, disable them and call service. LAS 10023 LAS Sample <Sample ID> rejected. Tube Type provided by the LAS Track not supported. LAS 10024 LAS Sample <Sample ID> not processed. Sample Not Processed due to an Instrument Hardware Error. LAS 10026 IM software error. IM Software internal exception. Report the error to the administrator. LAS 10027 LAS Track communications error. Message not responded by the LAS Track. Check communication status in both ends. If communication cannot be restored, disable them and call service. LAS 10028 LAS Sample <Sample ID> not supported. This tube shall be released. Sample ID not supported. 10029 LAS Sample <Sample ID> not processed. Sample Not Processed due to LAS Sample Aspiration timeout. 10030 LAS Manager LAS Manager communications error. Check LAS Manager/IM 744 of 992 Category LAS Resend the tube to the track in case the tube needs to be processed. LAS LAS L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting External Communications Alarms External Communications Alarms – Warnings and Errors Code Message Alarm Description communications error. Operator Action Category connection. If the problem persists call Service. 10031 LAS Manager communications error. LAS Manager communications error. Check LAS Manager/IM connection. If the problem persists call Service. LAS 10032 LAS Manager communications error. LAS Manager communications error. Check LAS Manager/IM connection. If the problem persists call Service. LAS 10033 LAS Manager communications error. Capped Tube provided by the LAS Track. Report the error to the administrator. If problem persists, call Service. LAS 10034 Reset Queue Request denied. Allow to clear the physical queue is unsafe. Invalid Message value. Report the error to the administrator. The Operating System Event Log can be reviewed for further information about the field that was not properly formatted. LAS 10035 Creation of the LAS Manager communication channel failed. The ACL-TOP could not create a channel for communicating with the LAS Manager. 10036 Creation of the LAS Manager communication channel failed. The current channel configuration defined through the control panel is not supported. Report the error to the administrator. LAS 10037 Storage of messages sent to the LAS Manager %1 full. The Synapse storage is almost full of messages waiting to be sent to the LAS Manager. Check communication status in both ends. If communications cannot be restored disable them and call service. LAS 10038 Storage of messages sent to the LAS Manager overloaded. New uploaded messages The Synapse storage is almost full of messages waiting to be sent to the LAS Manager. No more messages are accepted. 745 of 992 LAS LAS L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting External Communications Alarms External Communications Alarms – Warnings and Errors Code Message Alarm Description Operator Action Category will be rejected. 10039 LAS Manager requested to stop LAS Tubes from the LAS Track. LAS 10040 LAS Manager requested to start LAS Tubes from the LAS Track. LAS Back to Alarm Messages. 746 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Setup Alarms Setup Alarms Back to Alarm Messages. The alarms in this section are sorted by code number. Setup Alarms – Warnings and Errors Code Message Alarm Description The test cannot be saved. Some of the Test Units that have been removed are referenced in one or more of the QC Definitions. Test Definitions: Result Unit referenced in a QC Definition cannot be removed. The test cannot be saved. Some of the Test Units that have been removed are referenced in one or more of the Reflex Rules. Test Definitions: Result Unit referenced in a Reflex Rule cannot be removed. The test cannot be saved. Some of the Test Units that have been removed are referenced in Sample List. Test Definitions: Result Unit referenced in Sample List cannot be removed. 3060 Test Definition <test name> has been added. A new Test Definition has been added. 3061 Test Definition <test name> has been modified. An existing Test Definition has been modified. 3062 Test Definition <test name> has been deleted. A Test Definition has been deleted. 3063 Material Definition <material name> has been added. A new Material Definition has been added. 3064 Material Definition <material name> has been deleted. A Material Definition has been deleted. 3065 Material Definition <material name> modified: ISI value (active Lot). The Active Lot - ISI value of a Material Definition has been changed. 3066 Material Definition <material name> modified: onboard stability. The stability configuration of a Material Definition has been changed. 3067 Material Definition <material name> modified: assigned value for Test <test name> (active Lot). The active Lot - assigned value of a Material Definition & Test Definition has been changed. 3068 Material Definition <material name> modified: expiration date (active Lot). The active Lot - expiration date cfg. of a Material Definition has been changed. 3069 Material Definition <material name> modified: Lot management. The Lot management cfg. of a Material Definition has been changed. 3070 Material Definition <material name> modified: Lot The active Lot - Lot Number of a Material 747 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Setup Alarms Setup Alarms – Warnings and Errors Code Message Alarm Description Number (active Lot). Definition has been changed. 3071 Material Definition <material name> modified: Alternative Lot cfg. The alternative Lot cfg. of a Material Definition has been changed. 3072 Material Definition <material name> generic change. An existing Material Definition has been modified. 3073 System Definitions: generic change. Global change in System Definitions. 3074 System Definitions: Barcode parameters modified. System Definitions, Barcode parameters changed. 3075 System Definitions: LIS parameters modified. System Definitions, LIS parameters changed. 3076 QC Definition <Test name> - <Material name> has been added. A new QC Definition has been added. 3077 QC Definition <Test name> - <Material name> has been deleted. A QC Definition has been deleted. 3078 QC Definition <Test name> - <Material name> modified: Target Mean. The Target Mean of a QC Definition has been changed. 3079 QC Definition <Test name> - <Material name> modified: Target SD. The Target SD of a QC Definition has been changed. 3080 QC Definition <Test name> - <Material name> modified: Patient Flags. The Patient Flags of a QC Definition have been changed. 3081 QC Definition <Test name> - <Material name> modified: Rules cfg. The Rules cfg. of a QC Definition have been changed. 3082 QC Definition <Test name> - <Material name> modified: Frequency cfg. The Frequency cfg. of a QC Definition has been changed. 3083 QC Definition <Test name> - <Material name> modified: QC Unit. The Unit of a QC Definition has been changed. 3100 Software access permissions have been modified. The user changed some access levels in the Software access screen. 3101 User Definition <User Name> has been added. A new User Definition has been added 3102 User Definition <User Name> has been deleted. An existing User Definition has been deleted. 3103 User Definition <User Name> has been modified. An existing User Definition has been modified. 748 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Setup Alarms Setup Alarms – Warnings and Errors Code Message Alarm Description 3104 User Definition <User Name> modified: Security Level. The security Level of an existing User Definition has been changed. 3105 User Definition <User Name> locked by the system. The user intended to log in with erroneous password 3 consecutive times, so the system has locked this user. 3110 Reflex Rule <Reflex Rule Name> has been added. A new Reflex Rule has been added. 3111 Reflex Rule <Reflex Rule Name> has been deleted. An existing Reflex Rule has been deleted. 3112 Reflex Rule <Reflex Rule Name> has been modified. Reflex Rule has been modified. 3120 Auto-Validation Rules have been modified. Auto-Validation Rules have been modified. 3130 Sender Definition <Sender Code> has been added. A new Sender Definition has been added. 3131 Sender Definition <Sender Code> has been deleted. An existing Sender Definition has been deleted. 3132 Sender Definition <Sender Code> has been modified. An existing Sender Definition has been modified. 3140 Test Profile <Test Profile Name> has been added. A new Test Profile Definition has been added. 3141 Test Profile <Test Profile Name> has been deleted. A Test Profile Definition has been deleted. 3142 Test Profile <Test Profile Name> has been modified. A Test Profile Definition has been modified. 3145 QC Profile <QC Profile Name> has been added. A new QC Profile Definition has been added. 3146 QC Profile <QC Profile Name> has been deleted. A QC Profile Definition has been deleted. 3147 QC Profile <QC Profile Name> has been modified. A QC Definition has been modified. 3161 Test Definition <source test Name> has been promoted to <target test Name>. A Test Definition has been promoted. 3164 Vial Properties <Vial Type Name> <Vial Properties Revision> has been added. AVial Properties has been added by the user. 3165 Vial Properties <Vial Type Name> <Vial Properties Revision> has been updated. AVial Properties has been deleted by the user. 3166 Vial Properties <Vial Type Name> <Vial AVial Properties has been deleted by the 749 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Setup Alarms Setup Alarms – Warnings and Errors Code Message Alarm Description Properties Revision> has been deleted. user. 3167 Vial Set <Vial Set Name> has been added. AVial Set has been added by the user. 3168 Vial Set <Vial Set Name> has been updated. AVial Set has been deleted by the user. 3169 Vial Set <Vial Set Name> has been deleted. AVial Set has been deleted by the user. 3180 LAS parameters modified. LAS Definitions parameters changed. 3181 IM parameters modified. IM parameters changed. 3186 Imported Params Report files deleted. Analytical Version in files is different than current one. Files to generate Imported Params report have been deleted. 4060 Test counter statistics have been reset. User reset the test counter statistics 4061 A new software version has been created with following label: <Data Dictionary-SW Version>. A new system software version has been detected. 4062 A new hardware event has been created with following label: <Data Dictionary-HW Event>. A new Hardware event has been added by the user. Back to Alarm Messages. 750 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Other Alarms Other Alarms Back to Alarm Messages. The alarms in this section are sorted by code number. Other Alarms Code Message Alarm Description Incorrect username or password. Username or password mismatch. SW New password must be different from the current password. The given new password is equal to the old password. SW The user <User Name> is currently locked. Please contact your administrator. User has exceeded the maximum consecutive number of allowed attempts to log in with an incorrect password. SW Temperatures out of Range. Do you want to initiate the Run? Temperatures are out of range. SW The following Optical Reading Units have been disabled: One or more ORUs have been disabled, either manually, through Diagnostics, or automatically. The instrument can continue, but with decrease throughput. SW l l l l ORU No <Head #> ORU No <Head #> l ORU No <Head #> l ORU No <Head #> l Operator Action Category TOP 700, 700 CTS and 700 LAS instruments have four ORUs available. TOP 500 instrument has three ORUs available. TOP 300 has two ORUs available. Do you want to initiate the Run? Enhanced Clean must be performed. Enter maintenance to perform the appropriate clean operation for: Enhanced Clean was not performed due an LLD or an Emergency Stop and it is required before a new run begins. SW <Probe> <Probe> 751 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Other Alarms Other Alarms Code Message Alarm Description Operator Action Category <Probe> Replace CTS Filter. CTS Filter was not detected during Enter maintenance to mechanical initialization. perform the appropriate activity. SW Processing Run Command... The System is accessing to the database for retrieving the test definition data required for processing the jobs. Wait. SW Startup of database failed, DB could not connect to MS data engine. The startup of the database failed. DB could not connect to MS Data Engine. Not applicable. SW Startup of database The startup of the database failed. failed. the DB The DB subsystem version does subsystem version does not match TOP database version. not match TOP database version. SW An unrecoverable data base exception has occurred. The database service is down and it is not accessible. Start SQL service. Start CM app. SW 3106 Successful log in by user: <User>. User was recognized and could log into the system. Other 3107 Unsuccessful log in by user: <User>. User could not be recognized and could not log into the system. Other 3108 Logout by user: <User>. User logged out from the system. Other 3109 The user modified patient demographics for sample <Sample Id>. The user modified patient demographic information. Other 4063 Description: User entered a manual alarm. Other <Description> Functional Area: <Functional Area> 752 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Other Alarms Other Alarms Code Message Alarm Description Operator Action Category 5090 (Prep) Material dispense error AM reported a material dispense error. An unexpected material dispense error was detected by the AM software. Not expected behavior. SW 5100 Measured result failed The result unit is the measured result and DR has been unable to compute it SW 5568 Calibration and parallelism transformations do not match Calibration transformations do not match parallelism transformations. XXXXX <Restricted> This message displays instead of patient information when a nonauthorized user is logged on. Other 753 of 992 L0027503450 R00 Calibration X or Y transformations do not match. Calibration may require recalculation. SW Back to Alarm Messages. ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Popup Alarms Popup Alarms Back to Alarm Messages. Some warnings and errors are displayed in windows to warn the operator or to prompt for action. For the LIS, warnings and errors may also be displayed on the LIS host. Popup Alarms – Warnings and Errors Message Alarm Description %s directory does not exist. Do you want to create it? Before saving Global Definition, the system checks if the selected folder for Logs exists, if it does not, then it asks the user if s/he wants to create it. A software upgrade is in process. Please do not shut down the CM or AM. An AM software components being upgraded. AC Load Cycle: AC Load Cycle: Before aspiration clean volume must be less than or equal to <Data Dictionary - Clean Cup Capacity> uL. Test Definitions - Analytical Cycle: Inconsistent Before Aspiration Clean Volume. AC Load Cycle: After dispensation clean total volume exceeds the maximum allowed by the syringe. Test Definition: After dispensation clean total volume exceeds the maximum allowed by the syringe. AC Load Cycle: After dispensation sample clean volume must be less than or equal to <Data Dictionary - Clean Cup Capacity> uL. Test Definitions - Analytical Cycle: Inconsistent After Dispensation Sample Clean Volume.. AC Load Cycle: At least one of the after dispensation clean volumes is less than the minimum syringe volume. Test Definition: At least one of the after dispensation clean volumes is less than the minimum syringe volume. AC Load Cycle: At least one of the before aspiration clean volumes is less than the minimum syringe volume. Test Definition: At least one of the before aspiration clean volumes is less than the minimum syringe volume. AC Load Cycle: At least one of the material transport volumes is less than the minimum syringe Test Definition: for a single dispensing, any of the material 754 of 992 Operator Action L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Popup Alarms Popup Alarms – Warnings and Errors Message Alarm Description volume. volumes defined (including head volume and air gaps) cannot be less than the minimum syringe volume. AC Load Cycle: Before aspiration clean total volume exceeds the maximum allowed by the syringe. Test Definition: Before aspiration clean total volume exceeds the maximum allowed by the syringe. AC Load Cycle: The material after dispensation clean pipetting volumes are out of the Syringe volume limits. See associated Material Definition. Test Definition: the after dispensation total clean volume exceeds syringe max. or any individual clean volume is less than the syringe min. Alternative Predilution: At least one of the before aspiration diluent clean volumes is less than the minimum syringe volume. Test Definition: At least one of the before aspiration clean volumes for alternative predilution diluent is less than the minimum syringe volume. Alternative Predilution: At least one of the before aspiration sample/mixture clean volumes is less than the minimum syringe volume. Test Definition: At least one of the before aspiration clean volumes for alternative predilution sample/ mixture is less than the minimum syringe volume. Alternative Predilution: Before aspiration diluent clean volume must be less than or equal to <Data Dictionary - Clean Cup Capacity> uL. Test Definitions - Alternative Sample Predilution: Inconsistent Alternative Pre-dilution diluent before aspiration Clean Volume. Alternative Predilution: Before aspiration sample/mixture clean volume must be less than or equal to <Data Dictionary - Clean Cup Capacity> uL. Test Definitions - Sample Alternative Predilution: Inconsistent Pre-dilution sample/mixture before aspiration Clean Volume. Alternative Predilution: Diluent after dispensation clean volume exceeds the limits allowed by the Syringe. See associated Material Definition. Test Definition: for a single dispensing the material volume (including air gaps) must be within the syringe volume. Alternative Predilution: Diluent Test Definition: Alternative pre- 755 of 992 Operator Action L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Popup Alarms Popup Alarms – Warnings and Errors Message Alarm Description before aspiration clean total volume exceeds the maximum allowed by the syringe. dilution diluent before aspiration clean total volume exceeds the maximum allowed by the syringe. Alternative Predilution: Sample/mixture before aspiration clean total volume exceeds the maximum allowed by the syringe. Test Definition: Alternative predilution sample/mixture before aspiration clean total volume exceeds the maximum allowed by the syringe. Automatic Dilutions Calibration: At least one of the before aspiration calibrator clean volumes is less than the minimum syringe volume. Test Definition: At least one of the before aspiration clean volumes for calibrator material is less than the minimum syringe volume. Automatic Dilutions Calibration: At least one of the before aspiration diluent clean volumes is less than the minimum syringe volume. Test Definition: At least one of the before aspiration clean volumes for calibration diluent is less than the minimum syringe volume. Automatic Dilutions Calibration: Before aspiration calibrator clean volume must be less than or equal to <Data Dictionary - Clean Cup Capacity> uL. Test Definitions - Automatic Dilutions Calibration: Inconsistent calibrator material before aspiration Clean Volume. Automatic Dilutions Calibration: Before aspiration diluent clean volume must be less than or equal to <Data Dictionary - Clean Cup Capacity> uL. Test Definitions - Automatic Dilutions Calibration: Inconsistent calibration diluent before aspiration Clean Volume. Automatic Dilutions Calibration: Calibrator before aspiration clean total volume exceeds the maximum allowed by the syringe. Test Definition: Calibrator material before aspiration clean total volume exceeds the maximum allowed by the syringe. Automatic Dilutions Calibration: Diluent after dispensation clean volume exceeds the limits allowed by the Syringe Volume. See associated Material Definition. Test Definitions - Calibration Diluent after dispensation Clean transport volumes exceed syringe volume limits. Automatic Dilutions Calibration: Test Definition: Calibration 756 of 992 Operator Action L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Popup Alarms Popup Alarms – Warnings and Errors Message Alarm Description Diluent before aspiration clean total volume exceeds the maximum allowed by the syringe. diluent before aspiration clean total volume exceeds the maximum allowed by the syringe. Autorun not available due to: Missing CTS filter. This message shall be displayed as a tooltip when autorun status is in error if the instrument has a CTS probe and a CTS filter was not detected. Autorun not available due to: Need to run enhanced clean on Reagent 1 Probe. This message shall be displayed as a tooltip when autorun status is in error if an enhanced clean is required on Reagent 1 probe. Autorun not available due to: Need to run enhanced clean on Reagent 2 Probe. This message shall be displayed as a tooltip when autorun status is in error if an enhanced clean is required on Reagent 2 probe. Autorun not available due to: Need to run enhanced clean on Sample Probe. This message shall be displayed as a tooltip when autorun status is in error if an enhanced clean is required on Sample probe. Autorun not available due to: No ORU is enabled. This message shall be displayed as a tooltip when autorun status is in error if there is no enabled ORU. Autorun not available due to: Temperatures out of range. This message shall be displayed as a tooltip when autorun status is in error if temperatures are out of range. Backup or restore could not be performed. The backup or restore failed due to an unknown error. Calibration DR: If selected math model is Polynomial and is not measured on X results, then extrapolation range is required. Calibration DR: If selected math model is Polynomial and is not measured on X results, then extrapolation range is required. Calibration is failed. Failed calibrations cannot be validated. Calibration unit changed. The calibration unit in the calibration job does not match the 757 of 992 Operator Action L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Popup Alarms Popup Alarms – Warnings and Errors Message Alarm Description Operator Action current calibration unit in the test definition. Clean volume settings cannot be less than the minimum syringe volume. Clean volume for <Data Dictionary - Clean Airgap>, <Data Dictionary - Clean Volume> and <Data Dictionary Clean Transport Airgap> is less than the minimum syringe volume. Concentration value changed. A concentration value has changed in the test definition since the execution of the calibration or dilution mode is different. Coordinates are: Measured X = <measured X> mm Measured Y = <measured Y> mm Measured Z start LLD = <measured z-start> mm Measured Z end LLD = <measured z-max> mm Press OK to save or Cancel to Abort Diagnostics "Defining the LAS aspiration point - Manual procedure" activity: message to display the measured coordinates. Data base fragmentation. It's suggested to shutdown the application. DB Indexes are fragmented. Defragmentation is recommended. Database backup or restore failed The backup or restore failed because the database engine is because the database engine was down. The operation cannot be down. performed. Exit application. Restart PC to automatically restart database engine. Database installation failed The installation of a new database failed due to an unknown error. Database installation failed due to disk full. Increase free space and start again. The installation of a new database failed because there is not enough free space on the disk selected for installation. Database installation failed due The installation of a new database 758 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Popup Alarms Popup Alarms – Warnings and Errors Message Alarm Description to installation scripts are not available in installation scripts directory. Please exit the application and reinstall the ACL TOP application. failed due to were not found the installation scripts in scripts directory. Database installation failed. Database engine is not functioning. Please exit the application and restart the CM to automatically restart database engine. The installation of a new database failed due to the database engine was down. Database installation failed. There is another application using the TOP database. Please close all open applications. The installation of a new database failed due to existed open connections to TOP databases. Database upgrade failed The upgrade of the database failed due to an unknown error. Operator Action Database upgrade failed because The upgrade of the database failed the database engine is down. The because the database engine was operation cannot be performed. down. Exit application. Restart PC to automatically restart database engine. Database upgrade failed because there are no upgrades available. Exit application. The upgrade of the database failed because there are no available upgrades. Database upgrade failed because upgrade script is invalid. Exit application. Reinstall ACL TOP. The upgrade of the database failed because the upgrade script was invalid. Database upgrade failed due to disk full. Increase free space and start again. The upgrade to a new database failed because there is not enough free space on the disk selected for upgrade. Database upgrade failed due to The upgrade of the database failed existing open connections to TOP due to existing open connections database. Please close all open to TOP databases. data base connections first. Deleting sample %1 of %2. Deleting sample %1 of %2. 759 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Popup Alarms Popup Alarms – Warnings and Errors Message Alarm Description During adjusting thermal, temperatures may appear within range, but the system is still stabilizing. Warning message (static label) to let the user know that during adjusting thermal, temperatures may appear within range, but the system is still stabilizing. Error writing disk due to disk capacity exceeded or invalid network access. Increase free space and start again. Check network connections if a network unit was used. The backup or restore failed because there is not enough free space on installation location or a network error was detected. First you must select a clean material in this activity's detail dialog. Enhanced Clean: error message to notify the user that the clean material is not configured. Fluid may flow out of the probe when the valve position is changed. Diagnostics "Set Valve" Test: Message to let the user know that changing the syringe valve position some liquid could flow out of the probe Global Definition incorrect syringe settings: cuvette blind volume must be less than the LAS minimum dispense volume. The field Cuvette Blind Volume has a value greater than LAS Min. Dispense Volume in LAS Configuration. High data base fragmentation. It's highly recommended to shutdown the application. DB Indexes are fragmented. Defragmentation is highly recommended. High data base fragmentation. The application will automatically shutdown. DB Indexes are fragmented. Defragmentation is mandatory. Impossible to create the selected Default path for Logs. Do you want to continue saving? The user agreed to create the Logs folder, but the system cannot create neither current, not controlled users. LAS Definition incorrect syringe settings. Min. Dispense volume greater than Max. probe volume. The field Min. Dispense Volume has a value greater than Max. probe volume when saving LAS configuration. LAS Definition incorrect syringe The field Airgap greater than 760 of 992 Operator Action Save LAS configuration (Setup - L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Popup Alarms Popup Alarms – Warnings and Errors Message Alarm Description settings: Airgap greater than Max. Max. probe volume probe volume. Operator Action LAS Configuration) LAS Definition incorrect syringe settings: Aliquoting area expiration time greater than LAS sample expiration time. The field Aliquoting area expiration time has a value greater than LAS sample expiration time. LAS Definition incorrect syringe settings: Head volume greater than Max. probe volume. The field Head volume greater than Max. probe volume LAS Definition incorrect syringe settings: LAS minimum dispense volume must be greater than the cuvette blind volume. The field Cuvette Blind Volume has a value greater than LAS Min. Dispense Volume in LAS Configuration. LAS Definition incorrect syringe settings: Max. sample volume too small. The field Max. sample volume is too small when saving LAS configuration. LAS Definition incorrect syringe settings: Min. syringe volume greater than Airgap. The field Min. syringe volume greater than Airgap. LAS Definition incorrect syringe settings: Min. syringe volume greater than Clean airgap. The field Min. syringe volume has Save LAS configuration (Setup a value greater than Clean airgap. LAS Configuration) LAS Definition incorrect syringe settings: Min. syringe volume greater than Clean volume. The field Min. syringe volume has Save LAS configuration (Setup a value greater than Clean LAS Configuration) volume. LAS Definition incorrect syringe settings: Min. syringe volume greater than Head volume airgap. The field Min. syringe volume greater than Head volume airgap. Save LAS configuration (Setup LAS Configuration) LAS Definition incorrect syringe settings: Min. syringe volume greater than Head volume. The field Min. syringe volume greater than Head volume. Save LAS configuration (Setup LAS Configuration) LAS Definition incorrect syringe settings: Min. syringe volume greater than Max. probe volume. The field Min syringe Volume has a value greater than Max Probe Volume when saving LAS configuration. LAS Definition incorrect syringe settings: Min. syringe volume The field Min. syringe volume has a value greater than Min. dispense 761 of 992 Save LAS configuration (Setup LAS Configuration) Save LAS configuration (Setup LAS Configuration) L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Popup Alarms Popup Alarms – Warnings and Errors Message Alarm Description Operator Action greater than Min. dispense volume. volume. LAS Definition incorrect syringe settings: Min. syringe volume greater than Transport airgap after dispense. The field Min. syringe volume greater than Transport airgap after dispense. Save LAS configuration (Setup LAS Configuration) LAS Definition incorrect syringe settings: Min. syringe volume greater than Transport airgap. The field Min. syringe volume greater than Transport airgap. Save LAS configuration (Setup LAS Configuration) LAS Definition incorrect syringe settings: Transport airgap greater than Max. probe volume. The field Transport airgap greater than Max. probe volume Save LAS configuration (Setup LAS Configuration) Lower the LAS probe to the maximum reachable position in the sample tube. Diagnostics "Defining the LAS aspiration point - Manual procedure" activity: message to ask the user to move the probe to zMax position. Manually raise the LAS probe to the liquid level detection start position. Diagnostics "Defining the LAS aspiration point - Manual procedure" activity: message to ask the user to move the probe to the LLD start position. Material lot changed – different lots. Material <Data Dictionary Material Name> used with lot <Data Dictionary - Lot Number> and current lot is <Data Dictionary - Lot Number>. Material lot changed – lot disabled. Material <Data Dictionary Material Name>' used with lot <Data Dictionary - Lot Number> and current lot is disabled. Material lot changed – lot enabled. Material <Data Dictionary Material Name> used with lot disabled and current lot is enabled. Material position warning Material position warning Materials changed. Materials used to run the job differ from current materials 762 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Popup Alarms Popup Alarms – Warnings and Errors Message Alarm Description Operator Action defined for the test. One or more of the QCs could not be processed probably because not all materials are onboard or the test definition is not consistent. One or more QCs could not be processed due to a lack of materials or a test definition inconsistency. Place a 20 mL vial containing Clean B in the LAS Cover aspiration point. Maintenance "Enhanced Clean " activity: message to ask the user to place the vial containing the clean material in the LAS cover aspiration point. Place cylinder under the probe and press the button to start the Rinse Pump For Sample Probe - Rack S4 Position 5 For Reagent Probe - Rack R3 Position 3 Diagnostics Flow Rate Test: Directions to the user about where to place the graduate cylinder and how to proceed. Only for TOP, CTS & MiniTOP instruments. Place cylinder under the probe and press the button to start the Rinse Pump For Sample Probe (use graduated cylinder) - Rack S4 Position 5 For Reagent Probe (use graduated cylinder)- Rack R3 Position 3 Diagnostics Flow Rate Test: Directions to the user about where to place the graduate cylinder and how to proceed. Only for MicroTOP instruments. Place empty container under the probe and press the button to start the Rinse Pump For LAS Probe (use empty 20 ml vial) - LAS Arm Cover Aspiration Point For Sample Probe (use graduated cylinder) - Rack S4 Position 5 For Reagent Probes (use graduated cylinder)- Rack R3 Position 3 Diagnostics Flow Rate Test: Directions to the user about where to place the graduate cylinder or empty 20 ml vial and how to proceed. Only for LAS instrument. Place the Aspiration Point Alignment Tool at the LAS Aspiration Point to proceed Diagnostics "Defining the LAS aspiration point - Semi-Automatic procedure" activity: message to ask the user to place the alignment tool on the LAS track 763 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Popup Alarms Popup Alarms – Warnings and Errors Message Alarm Description Operator Action aspiration point. Please place a 20mL vial containing Clean B in the LAS cover aspiration point. Press OK to proceed or Cancel to abort. Enhanced Clean for LAS probe: message to ask the user to place the clean material Please remove the alignment tool from the LAS track aspiration point. Diagnostics Defining the LAS aspiration point - Semi-Automatic procedure: Message to remind the user to remove the alignment tool from the LAS track Please remove the Clean B vial from the LAS cover aspiration point and press OK to proceed. Enhanced Clean for LAS probe: message to ask the user to remove the clean material Please remove the following racks Diagnostics Travel To Target and press Okay to proceed: Test: Request to remove racks if Z Racks D2, R1-R4 limit position is selected Please remove the following racks Diagnostics Travel To Target and press Okay to proceed: Test: Request to remove racks if Z Racks D3, R1-R6 limit position is selected Please remove the following racks Diagnostics Travel To Target and press Okay to proceed: Test: Request to remove racks if Z Racks S1-S4, D1, R1-R3 limit position is selected Please remove the following racks Diagnostics Travel To Target and press Okay to proceed: Test: Request to remove racks if Z Racks S1-S8, D1 limit position is selected Please remove the following racks Diagnostics Travel To Target and press Okay to proceed: Test: Request to remove racks if Z Racks S1-S12, D1-D2 limit position is selected Probe warning The probe is going to move. QC Profile Error: Duplicated Name. QC Profile name is already used by another QC profile. Required Clean Material not placed or there is not enough volume to perform this activity. Enhanced Clean: error message to notify the user that the clean is not placed or there is not enough volume 764 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Popup Alarms Popup Alarms – Warnings and Errors Message Alarm Description Sample Predilution: At least one of the before aspiration diluent clean volumes is less than the minimum syringe volume. Test Definition: At least one of the before aspiration clean volumes for pre-dilution diluent is less than the minimum syringe volume. Sample Predilution: At least one of the before aspiration sample/mixture clean volumes is less than the minimum syringe volume. Test Definition: At least one of the before aspiration clean volumes for pre-dilution sample/ mixture is less than the minimum syringe volume. Sample Predilution: Before aspiration diluent clean volume must be less than or equal to <Data Dictionary - Clean Cup Capacity> uL. Test Definitions - Sample Predilution: Inconsistent Predilution diluent before aspiration Clean Volume. Sample Predilution: Before aspiration sample/mixture clean volume must be less than or equal to <Data Dictionary - Clean Cup Capacity> uL. Test Definitions - Sample Predilution: Inconsistent Predilution sample/mixture before aspiration Clean Volume. Sample Predilution: Diluent after dispensation clean volumes exceed the limits allowed by the Syringe. See associated Material Definition. Test Definition: for a single dispensing the material volume (including air gaps) must be within the syringe volume limits. Sample Predilution: Diluent before aspiration clean total volume exceeds the maximum allowed by the syringe. Test Definition: Pre-dilution diluent before aspiration clean total volume exceeds the maximum allowed by the syringe. Sample Predilution: Sample/mixture before aspiration clean total volume exceeds the maximum allowed by the syringe. Test Definition: Pre-dilution sample/mixture before aspiration clean total volume exceeds the maximum allowed by the syringe. Select import parameters file. The user shall select an import parameters file if the ACL-TOP executing in a unattended parameters mode without an specified file. The <material description> vial Diagnostics Fluid Precision Test: 765 of 992 Operator Action Choose a file or cancel the import parameters operation. L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Popup Alarms Popup Alarms – Warnings and Errors Message Alarm Description for fluid precision test is empty. Place a new vial and then press OK to continue. Press Cancel to abort the procedure. Note: <material description> is "optical control" or "factor diluent" One of the vials used to perform the fluid precision test didn't have enough liquid to complete the execution of the test. The arm is going to move back into the instrument. Diagnostics "Defining the LAS aspiration point - Manual procedure" activity: Warning message to notify the user that the arm is going to be moved back inside the instrument. The database restore failed because the ACL TOP application installation is invalid. Exit the DB Backup/Restore application. Reinstall the ACL TOP application. Restart the database restore operation. The restore failed because the upgrade after the restore failed. The descriptor file is not a valid xml-file. Perform another backup. The restore failed due to an invalid backup descriptor. The modification of these parameters might alter the consistency of the Test Definitions in the system. Please, confirm changes. Changing any Sample/Reagent Probe Dilution or Cuvette Dilution Parameter will trigger a full Consistency checking for all defined Tests (a lengthy operation), because these parameters affect directly to the feasibility of the Analytical Cycle, automatic and prediluted Dilution algorithms and may result in some Test being nonFeasible. The operation cannot be performed. Please close all open data base connections first. The backup or restore failed due to existing open connections to TOP databases. The restore operation from a CD The backup or restore from a CD failed because the CD was 766 of 992 Operator Action L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Popup Alarms Popup Alarms – Warnings and Errors Message Alarm Description failed. Check that provided CD has valid format and content. Use another backup. corrupted. The value of # Slots for dilution preparation has changed. Saving this configuration will perform a Cuvette Evacuation Cycle maintenance activity. This operation could take some time. Do you want to save the LAS configuration anyway? When the user tries to save the LAS configuration and s/he has changed the # of slots for dilution preparation, the system will show this message to warn the user this may be a lengthy operation (because it may trigger a Cuvette Evacuation Cycle) and let him/her abort the saving operation. There is no available information to print. The "Monthly Report" will display this message if no data is available after applying the filter Unable to modify CTS mode. CTS rack in use or invalid instrument status. Enable CTS Mode cannot be changed when a CTS rack is onboard or Instrument Status is different than Not Connected, Power up or , Ready. You don't have enough write rights in the Default path for Logs. Do you want to continue saving? If the user has not write rights for the log path the alarms is risen Operator Action Back to Alarm Messages. 767 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Alarm Buttons Alarm Buttons Alarm buttons appear in the status bar at the bottom of all ACL TOP instrument screens. The system notifies you of new alarm messages in the following ways: l A blinking red or yellow exclamation point appears on the alarm button in the status bar. l The system provides an audible beep. The ACL TOP instrument produces two types of alarm messages: Errors and Warnings. Warning Alarms A warning message indicates that some user action may be required. Warnings do not affect the operation of the instrument. However, an error condition may eventually occur if the operator does not perform the required action. Warnings are indicated by a yellow exclamation point on the alarm button in the status bar. Error Alarms An error message indicates that a condition has been detected that requires immediate action. Failure to act may result in the instrument performing an emergency stop. Errors display a red exclamation point on the alarm button in the status bar. No New Alarms When an alarm button in the status bar is enabled but without an exclamation point, there are no new alarms. 768 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Alarm Buttons Alarm Buttons in the Status Bar The following alarm buttons appear in the status bar. Alarm Button Alarm Name Description Material Alarms related to the availability of materials on board the AM1. Job Frequency Alarms related to the ability of the analyzer to complete a test. Quality Control Alarms related to the Quality Control functionality. Maintenance Alarms that indicate a maintenance operation must be performed. Analyzer Alarms related to the AM functionality. External Communications Alarms Alarms related to the host connection or to LAS. See Also l Status Bar l Alarm Messages l Data Flags 1The part of the instrument where sample processing and testing are performed. Also called the Analyzer or the Analytical Module. 769 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Troubleshooting Other Problems Troubleshooting Other Problems Instrument problems that do not display alarm warnings, errors, or messages are listed below along with suggested operator actions. Item Problem Suggested Actions 1 Make sure the bar code label is not damaged or dirty. Instrument doesn’t recognize rack See Restriction Map. Verify that you are using a bar code format supported by the system. See Bar Code Definitions Setup. Check that the rack flag (the part of the rack that is inserted and detected) is not broken or defective. Call Service. 2 Rack labels not Do not continue to use rack as loose labels will cause racks to jam. secured to rack Clean rack label area carefully so labels are not damaged. or fall off 3 Rack jams upon Verify that tubes are pushed all the way down into the rack position. insertion Be sure you are using the correct sample containers and sample racks. See Samples and Restriction Map. Check that bottles and containers are held on center within rack. 4 Sample tube or Check that there is no buildup on the rack. IL recommends that all exposed reagent surfaces be cleaned as needed with a cloth moistened with 10% bleach bottles/auxiliary solution and rinsed with deionized water. Alternatively, Cavicide® can be containers not used for surface decontamination. held in center Use only sample containers specified for the ACL TOP instrument. within rack See Sample Containers and Adapters. Be sure to use correct bottles and correct adapters for the 4 mL and 10 mL reagent bottles. See Reagents and Material Definition. 5 Cuvette supply warning LED doesn’t light Call Service. 6 Cuvette supply warning LED constantly on even when cuvette supply is full Call Service. 7 Material not stirred Be sure to place material that needs stirring in position 1 or 2 of a reagent rack. Check that the correct magnetic stir bar (IL Part Number 00009746606) is placed into the bottle with the solution to be stirred. See Material Definition and Parts and Consumables List. 8 Reagent and/or Be sure there is no obstacle preventing the magnetic lock from engaging. See sample cover Instrument Description/AM Safety Covers. won’t close Call Service. 770 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Troubleshooting Other Problems Item Problem Suggested Actions 9 Frequent reagent temperature warnings Remove and clean air filters periodically. Replace air filters as needed. See Parts and Consumables List. Rinse or clean fluid leak external to instrument Check that the Rinse or Clean bottle has no cracks. If so, replace rinse or clean bottle with an undamaged bottle. 10 If problem persists, call Service. Be sure rinse or clean bottle caps are tightened. Be sure all tubing is intact and connected, without bending or kinking. If the tubing has holes or is internally clogged, replace tubing assembly. See Parts and Consumables List and Rinse Fluid or Clean Fluid. 11 Waste fluid Check that the waste bottle has no cracks. If so, replace the waste bottle with leak external to an undamaged bottle. instrument Be sure the waste bottle cap is tightened. Be sure all tubing is intact and connected, without bending or kinking. If the tubing has holes or internally clogged, replace tubing assembly. The TOP 300 CTS liquid waste line cannot rest in a horizontal position across the table or bench that holds the instrument. It must maintain a negative slope across the entire length of the tubing to minimize the backup of waste fluids. There must be no crimping in the tubing. See Parts and Consumables List and Fluid Waste. If none of the above cases are true and the waste fluid leak is due to bottle overflow, the waste sensors may be defective. Call Service. See Also l Alarm Messages l Data Flags l Reference Section Overview 771 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Data Flags Data Flags Data Flags are associated with test results and can be either warning-level or error-level. Also, data flags are categorized into groups. See Accessing Data Flags. Data flag codes are always transmitted with the results to the LIS. Warning Data Flags A warning data flag indicates that a test result has been generated, but a condition has been detected, or a limit exceeded, that may affect the quality of the result. Error Data Flags An error data flag indicates a condition has been detected, or an error limit exceeded, that will result in no test results generated. In normal conditions, samples are displayed on the screen with no flags. If a flag exists, it is displayed in capital letters, for example, CE (coagulation error), CW (coagulation warning). If a test and/or sample has multiple flags, the flag with the highest priority is displayed/printed with both capital letters underlined to indicate that there are more flags beyond what is displayed/printed. All flags and codes are listed in Test Details screen. 772 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Data Flags Data Flag Groups Data flags are categorized into the following groups (listed from highest to lowest priority): Data Flag Group Description Blank No error IU Investigational use only SE Sampling error HE Hardware error CE Coagulation error RE Individual result error HC Out of calibration range high LC Out of calibration range low HW Hardware warning CW Coagulation warning RW Individual result warnings QC Quality control flag NP NPP flag HT Out of test range high LT Out of test range low HL Out of linear range high LL Out of linear range low HH Out of therapeutic range high (mean value) LH Out of therapeutic range low (mean value) HN Out of normal range high (mean value) LN Out of normal range low (mean value) CR Out of calibration range (high or low) TR Out of test range (high or low) LR Out of linear range (high or low) HR Out of therapeutic range (high or low) NR Out of normal range (high or low) CA Calibration flag MT Maintenance Flags ME Material Errors/Warnings NOTE: An underlined data flag group on the screen (for example, HR), indicates there are multiple data flags associated with the result, even only one is type displayed. And among data flags associated with the sample, the underlined type is the highest priority. 773 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Data Flags Data Flags List Data Flags Code Flag Message Error/ Warning Description 5000 HE LLD Error E The AM has detected liquid where liquid should not be (a false positive). 5002 HE Error detected in ORU E General ORU error. If the signal check for a particular test is disabled, all ORU flags are treated as an error. 5003 HE Air read failure E The reading of the air just prior to acquisition is outside of the stored air read value plus/minus some tolerance amount. 5004 HE Aspiration Baseline Error E The probe did not stay immersed in the liquid properly during an aspiration or the liquid was not properly detected prior to the aspiration. 5005 HE Unexpected LLD Error E Liquid has been detected, but it is not in the proper location (it is found too early) so we suspect a false positive reading. 5050 CE (Data) First point out of range E Out of starting point range 5051 CE (Data) Baseline average low E baseline average too low 5052 CE (Data) Baseline SD exceeds error limit E Baseline SD is out of range 5053 CE (Data) Baseline average high E baseline average too high 5054 CE (Data) Endpoint SD exceeds error limit E Endpoint SD is out of range 5055 CE (Data) Endpoint average high E endpoint average too high 5056 CE (Data) Too many invalid raw data points E too many invalid raw - points do not fall within specified signal range or have an ORU error associated with them 774 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Data Flags Data Flags Code Flag Message Error/ Warning Description 5057 CE (Data) Curve min. and max. not in correct sequence E invalid curve max after min -- curve behaves in an unexpected manner - raw data should go from maxima to minima value (on ACL-Advance). User specifies correct sequence on Top. 5058 CE (Data) Last point out of range E curve drifting -- the last point in the raw data is outside specified % of curve 5059 CE (Data) Incorrect number of raw data points E too few or too many data points in curve -- indicates an error in scheduler, should never occur. 5060 CE (Data) Normalized curve delta too low E delta of curve invalid -- indicates that raw data does not have enough signal across curve 5061 CE (Data) Calculation error E calculation error -- i.e. divide by zero 5062 CE (Coag) First threshold limit not found E didn't reach first threshold -- not enough signal in curve to find threshold limit value 5063 CE (Coag) Second threshold limit not found E second threshold not found -- not enough signal in curve to find threshold check value and user has configured the algorithm to fail if check value not located (otherwise a warning) 5064 CE (Coag) Max (min) time span violation E time exceeded -- too much time (or too little time) between threshold limit-check or derivative min-max peaks. 5065 CE (Data) Curve sequence unknown E Unable to determine curve sequence 5066 CE (Reaction) Linear Regression SD exceeds error limit E SD out of range in Linear Regression 775 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Data Flags Data Flags Code Flag Message Error/ Warning Description 5067 CE (Range) Below measured result test range E measured result fails -- does not meet test range (low) 5068 CE (Range) Above measured result test range E measured result fails -- does not meet test range (high) 5069 CE (Data) Missing ORU blank value E ORU Blank correction is enabled, but the Blank value for that channel is unavailable 5070 CE (Data) Endpoint average low E endpoint average too low 5071 CE (Coag) First derivative peak not found E Not identified any maximum peak meeting the criteria 5072 CE (Coag) Second derivative peak not found E No maximum or minimum peak meeting the criteria 5073 CE (Data) Interference error E The Interference Check of the Statistics Algorithm has failed 5074 CE (Data) Number of spikes exceeds error limit E Too many spikes were detected in the data. 5075 CE (Params) No algorithm selected E The user has disabled the primary algorithm so there will be no measured result 5076 CE (Reaction) Initial slope exceeds error limit E The slope of the initial part of the reaction curve was greater than the maximum slope allowed. 5077 CE (Prep) Insufficient liquid detected (Sample) E The AM has detected that there was not enough sample material to run the test 776 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Data Flags Data Flags Code Flag Message Error/ Warning Description 5078 CE (Prep) Insufficient liquid detected (Reagent) E The AM has detected that there was insufficient reagent material with which to run the test. 5079 CE (Prep) Liquid level detection error E A hardware error has occurred with the probe. 5080 CE (Data) Insufficient points remaining for calculation E Due to points being removed from the original data curve due to either the signal check, the spike removal check, or the moving SD check, the number of points in the remaking data curve is too few to perform an operation that requires a specific number of data points. 5081 CE (ORU) Hardware error E A hardware error has occurred that will prevent the measured result from being computed 5082 CE (Prep) Missing post dispense rinse/clean detected E A missing dispense rinse and/or clean step has been detected by the SW. 5083 CE (Data) Normalized curve delta less than lowest calibrator delta E The delta of the sample is less than the delta of the lowest calibrator (minus some tolerance amount). 5084 CE (Coag) Too many first derivative peaks E Too many peaks were found within the first derivative and the specified window, indicating that the data curve is noisy. 5085 CE (Coag) Too many second derivative peaks E Too many peaks were found within the second derivative curves specified window, indicating that the data curve is noisy. 5086 CE (Data) Result exceeds Negative Value Limit E The measured result is more negative than the maximum negative value allowed (zero if no negative values are allowed) 5087 CE (Data) Result Check failed E The Result Check measured result failed. 777 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Data Flags Data Flags Code Flag Message Error/ Warning Description 5088 CE (Prep) Aspiration Baseline Error E Error when performing the aspiration baseline check 5089 CE (Prep) Unexpected LLD Error E AM reported an unexpected LLD error 5090 CE (Prep) Material dispense error E AM reported a material dispense error. An unexpected material dispense error was detected by the AM software. Not expected behavior. 5091 CE (Data) Normalized curve delta too high E delta of curve invalid -- indicates that raw data exceeds allowed signal change across curve 5092 CE (Data) Normalized data contains multiple thresholds E The threshold error value is found more than one time in the data and the time between each of the consecutive occurrences of the threshold is greater than the defined time span. 5093 CE (Coag) First derivative negative check failed E The Error Threshold value has been found in the first derivative curve. 5100 RE Measured result failed E The result unit is the measured result and DR has been unable to compute it 5101 RE NPP undefined E ratio denominator undefined. This could occur if not properly set up by the user or, in the case of an NPP material, if it was not executed prior to computing results that require it. 5102 RE NPP failed E NPP result used in result calculation is failed. 5103 RE ISI undefined E ISI value undefined 5104 RE Estimation failed E result cannot be calculated 5105 RE Paired partner test not available E The result is based on paired tests and one of them is not available due to being not configured properly. 778 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Data Flags Data Flags Code Flag Message Error/ Warning Description 5106 RE Paired partner test failed E The result is based on paired tests and one or both of them are failed 5107 RE Inconsistent test units between paired tests E The paired results do not have consistent result units with which to perform the paired result calculation. If using the measured result, the measured result units must be the same (i.e. both seconds). If using the calibrated result unit, the calibrated result units must be the same (i.e. both % activity). 5108 RE Unable to compute parallelism CR E Unable to compute the Corrected Result for this determination and/or concentration 5109 RE Unable to compute parallelism mean of CR E Unable to compute the mean of the corrected result (CR) excluding the 100% parallelism concentration. 5110 RE Unable to compute parallelism mean of CR and 100% E Unable to compute the mean of the corrected result (CR) including the 100% parallelism concentration 5111 RE Unable to compute parallelism mean 100% E Unable to compute the mean result of the 100% parallelism concentration 5112 RE Unable to compute parallelism %CV of CR E Unable to compute the %CV of the corrected result (CR) from each concentration excluding the 100% concentration 5113 RE Unable to compute parallelism %CV of CR and 100% E Unable to compute the %CV of the Corrected Result (CR) from each concentration including the 100% concentration 5114 RE Unable to compute parallelism slope E 779 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Data Flags Data Flags Code Flag Message Error/ Warning 5115 RE Unable to compute parallelism yintercept E 5116 RE Unable to compute parallelism r2 E 5117 RE Below Secondary Algorithm Range E The result value was computed using the secondary algorithm and was less than the minimum value allowed. 5118 RE ISI value undefined. Lot not defined. E Unable to obtain ISI value because the lot of material is no longer defined. 5119 RE Active calibration unit and calibration unit in the test definition do not match E The calibrated unit in the active calibration does not match the calibrated unit in the calibration definition. 5120 RE Maximum negative value exceeded E The result value was negative and was more negative than allowed for this unit. 5121 RE Above Secondary Algorithm Range E The result value was computed using the secondary algorithm and was greater than the maximum value allowed. 5122 RE Calibrated result is out of Calibration Range High 5190 HW Temperature out of range W Generic flag indicating that at least one temperature reading was out of range. All temperature out of range alarms are mapped to a single flag within each determination 5191 HW Warning detected in W Generic ORU warning. If signal checks are enabled in the test definitions for the particular test, all ORU flags are E Description For polynomial regression. The measured result is larger than the measured value for the highest calibration point, but the calibrated value is below the highest target value. 780 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Data Flags Data Flags Code Flag Message Error/ Warning ORU Description treated as warning. 5192 HW Material stirring warning W The AM has detected that the material stirring mechanism is not stirring the material and this is a coagulation test (stirring prolongs material stability) 5200 CW (Data) First point out of range W Out of starting point range 5201 CW (Data) Baseline SD exceeds warning limit W Baseline SD is out of range 5202 CW (Data) Baseline average low W Baseline average too low 5203 CW (Data) Baseline average high W Baseline average too high 5204 CW (Data) Invalid point(s) W At least one data point has been found out of the acceptable range or with an ORU flag associated with it. 5205 CW (Data) Endpoint SD exceeds warning limit W Endpoint SD is out of range 5206 CW (Data) Endpoint average low W endpoint average too low 5207 CW (Data) Endpoint average high W endpoint average too high 5208 CW (Data) Delta of Curve Lower Limit below warning limit W curve delta below valid delta 5209 CW (Coag) Maxima of 1st derivative below warning limit W first derivative peak below limit 781 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Data Flags Data Flags Code Flag Message Error/ Warning Description 5210 CW (Coag) Maxima of 2nd derivative below warning limit W 2nd derivative maxima peak below limit 5211 CW (Coag) Minima of 2nd derivative is below warning limit W 2nd derivative minima peak below limit 5212 CW (Reaction) Linear regression SD exceeds warning limit W maximum SD exceeded for linear regression 5213 CW (Coag) Second threshold limit not found W second threshold not found 5214 CW (Coag) Max (min) time violation W time exceeded on threshold/derivative check 5216 CW (Data) Last point out of range W curve drifting -- the last point in the raw data is outside specified % of curve 5217 CW (Coag) 1st derivative peak delta below warning limit W max peak to baseline delta below minima 5218 CW (Coag) 1st derivative max peak delta % below warning limit W max peak to baseline delta percent lower than warning limit 5219 CW (Coag) 2nd derivative peak delta below warning limit W peak delta below minima 782 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Data Flags Data Flags Code Flag Message Error/ Warning Description 5220 CW (Coag) 2nd derivative peak delta % below warning limit W peak delta percent lower than warning limit 5221 CW (Data) Interference warning W The Interference Check of the Statistics Algorithm failed. 5222 CW (Data) Number of spike(s) exceeds warning limit W At least one spike has been detected in the data 5223 CW (Reaction) Initial slope exceeds warning limit W The initial slope of the reaction curve is greater than the specified warning limit 5224 CW (Coag) Derivative first point W The clotting time selected for the derivative curve corresponds to the first data point in the derivative curve 5225 CW (Coag) Threshold Check W The result found using the backwards threshold check is not within the valid range of the result found using the first or second derivative algorithm. 5227 CW (Data) Normalized curve delta less than lowest calibrator delta W The delta of the normalized data curve is less than the warning tolerance amount based upon the delta of the lowest calibration point. 5228 CW (Coag) 2nd derivative max peak delta below minima W max peak to baseline delta below minima 5229 CW (Coag) 2nd derivative max peak delta % below warning limit W max peak to baseline delta percent lower than warning limit 5230 CW (Data) Result Check failed W The algorithm used with the result check produced a failed measured result. 783 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Data Flags Data Flags Code Flag Message Error/ Warning Description 5231 CW (Data) Delta of Curve Upper Limit above warning limit W curve delta above valid delta 5232 CW (Data) Normalized data contains multiple thresholds W The threshold warning value is found more than one time in the data and the time between each of the consecutive occurrences of the threshold is greater than the defined time span. 5250 RW Missing determinations W Less determinations than currently configured 5251 RW Too many concentrations W More concentrations than currently configured 5252 RW %Max difference of replicates exceeded W Max Difference between replicates greater than allowed 5253 RW Max. variance of parallelism dilution out of range W The difference between each dilution and the 100% dilution of the parallelism result is exceeded 5254 RW Slope out of range W 5255 RW Parallelism r2 out of range W 5256 RW Too many determinations W More determinations than currently configured 5257 RW Missing concentrations W Less concentrations than currently configured 5259 RW %CV of the CR is greater than the maximum %CV allowed W Calculated CV exceeds the limits 5260 RW %CV of the W Calculated CV exceeds the limits 784 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Data Flags Data Flags Code Flag Message Error/ Warning Description CR and the 100% dilution is greater than the maximum %CV allowed. 5261 RW Parallelism has one or more dilutions that exceeds the max.variance W Calculated variance exceeds the limits 5262 RW Results recalculated W This test has had its results recalculated. 5266 RW DR warning on measured result W The measured result that was used to compute this result had a warning associated with it. 5267 RW One or more failed replicates W One or more replicate result(s) is failed. 5268 RW One or more component results used to calculate the paired result contains a flag W One of the component results used to calculate a paired result contains a flag (error or warning). 5301 QC QC overdue E The expiration date for a QC has been reached. 5302 QC QC failed E QC rules have failed. It is a hint to detect problems in the measurement. 5400 NP NPP has warning W NPP used to compute result from the same test definition had a warning (only true if NPP is configured to run as a material). This flag may be set for paired results (that use NPP in their calculation) as well as R and INR results. The flags within the NPP sample that will result in this flag are the following: 1. There is a warning on the NPP measured result. 2. There is an error on the NPP measured result. 3. There is a warning on the NPP calibrated result (if 785 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Data Flags Data Flags Code Flag Message Error/ Warning Description computed). 4. The measured result is outside of one of the enabled ranges. 5. One of the materials used to generate the NPP sample has expired. 6. One of the materials used to generate the NPP sample has expired stability. 7. The NPP frequency has expired. 8. A maintenance procedure was expired or failed when the NPP material was run. 9. One of the materials used to generate the NPP sample had a stirring warning. NOTE: NPP from master test is not checked for this flag 5401 NP NPP overdue E Job executed when NPP frequency was expired. Job is using NPP during the calculation and the NPP is from the same test definition (Master Test NPP in a Master/Paired relation is not checked for this flag). 5500 HT Above Test Range W One or more results is out of test range high 5501 LT Below Test Range W One or more results is out of test range low 5502 HL Above Linear Range W One or more results is out of linear range high 5503 LL Below Linear Range W One or more results is out of linear range low 5504 HH Above Therapeutic Range W One or more results is out of Therapeutic range high 5505 LH Below Therapeutic Range W One or more results is out of Therapeutic range low 5506 HN Above Normal Range W One or more results is out of Normal range high 786 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Data Flags Data Flags Code Flag Message Error/ Warning Description 5507 LN Below Normal Range W One or more results is out of Normal range low 5508 HC Above Extrapolation Range E The computed calibrated result value is greater than the maximum calibrated result value allowed. 5509 LC Below Extrapolation Range E The calibrated result value is less than the minimum value allowed for a calibrated result. 5510 CR One or more results are out of Calibration Range (High or Low) W One or more results is out of Calibration Range 5511 TR One or more results are out of Test Range (High or Low) W One or more results is out of Test range. 5512 LR One or more results are out of Linear Range (High or Low) W One or more results is out of Linear range 5550 CA Valid calibration is not available W Calibration has been disabled or there is no validated calibration with the same reagent lots or the validated calibration is failed and the job requires a calibration to complete its result computations. Calibration is imported by results data from a nonvalidated or non existing master calibration. 5551 CA Calibration overdue E Job has been executed with the calibration in overdue status. 5552 CA Calibration estimation failed E calibration does not have result 5553 CA Calibration slope out of range E calibration slope out of range 787 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Data Flags Data Flags Code Flag Message Error/ Warning Description 5554 CA Calibration r2 out of range E Coefficient of determination out of range 5555 CA Calibration failed due to lack of data E not enough "good" points 5556 CA Calibration yintercept out of range E y-intercept out of range 5557 CA Calibration %CV of dilution exceeded E The %CV of a particular dilution is greater than the maximum CV allowed 5558 CA Calibration has one or more dilutions that exceeds %CV E Calculated CV exceeds the limits 5560 CA First and last calibration points cannot be the same E The measured results of the calibration are not valid. The data generated is not consistent with what is expected for calibration data. 5563 CA Calibration minimum number of replicates for dilution is not found. E The minimum number of replicates for the particular dilution do not have good result values. 5564 CA Calibration has one or more dilutions that do not have the minimum number of replicates E At least one dilution does not have the minimum number of replicates as specified. 5565 CA Calibration failed. Lot not defined. E The lot of material that was used to generate the original calibration results is no longer defined and therefore the calibration cannot be recalculated. 5566 CA Calibration E The results of the calibration do not follow a consistent 788 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Data Flags Data Flags Code Flag Message Error/ Warning results trend not consistent Description trend, either all values must increase or all values must decrease, but they cannot increase and decrease as the concentration levels change 5567 CA Calibration curve not monotonic E The calibration curve will be flagged as not monotonic, if the monotonic check is enabled and detects multiple results for the one or more measured value in one or more segment within the tested range. For Spline calibrations, the range is the limit of the spline calibration points. For Polynomial calibrations, the range is the limit of the extrapolation range. 5568 CA Calibration and parallelism transformations do not match W Calibration transformations do not match parallelism transformations. User modified the parallelism transformation values and has not recalculated the calibration results. 5569 CA Dilution mean exceeded tolerance range 5600 MT Maintenance overdue or failed W Job executed with some maintenance activity in overdue status. 5650 ME Material stability W One or more materials stability has expired for this determination 5651 ME Material expired W One or more of the materials used to run this determination has expired. 5653 ME Alternate lot in use W An alternative lot was in use when the job was run 5654 ME Alternate lot in use W An alternative lot was used for jobs that this job uses to compute results.(Calibration, NPP or master job) 5657 ME One or more determinations has a material stability warning E Remaining stability for last vial expired. 5658 ME One or more determinations E The present date is greater than the expiration date of the last available vial/lot. Dilution mean exceeded tolerance range. 789 of 992 L0027503450 R00 ACL TOP Family Operator's Manual Chapter 12 – Alarms and Troubleshooting Data Flags Data Flags Code Flag Message Error/ Warning Description has a material expiration warning 5659 ME One or more determinations has a material stirring warning W The stirring mechanism for a material requiring stirring is no longer functional. 5660 ME LAS Sample expired during processing W LAS Sample Expired during processing 5700 SE Volume Tracking Insufficient Liquid (Sample) E Error indicating that there was insufficient sample to pipette. If this happens during a dilution preparation, all replicates for that dilution are flagged. 5701 SE Volume Tracking Insufficient Liquid (Reagent) E The AM determined that there was insufficient reagent to pipette. If this happens during a dilution preparation, all replicates for that dilution are flagged. 5702 SE Missing post dispense rinse/clean detected E Error indicating missing dispense of rinse or clean was detected in the software. 5703 SE Material dispense error E Because of a scheduling error, a material that should have been dispensed into the reaction cuvette was not dispensed. This check is done for safety purposes and it is intended that this error will never be seen. 5800 IU For Investigational Use Only W The test parameters have been developed for investigational use only. 5801

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