Operator’s Manual 007530-001 R8 Operator’s Manual 10901 007530-901-R6, 2013-01 © 2013 Medica Corporation (all rights reserved). No part of this manual may be reproduced in any form without prior consent in writing from Medica Corporation. The Medica EasyRA® analyzer is for In-Vitro Diagnostic use. For Service or Technical Assistance: 800 777 5983 In Continental US 781 275 4892 International 781 275 2731 (Fax) easyratech@medicacorp.com (E-mail) EasyRA and EasyQC are registered trademarks of Medica Corporation. Windows is a registered trademark of Microsoft Corporation in the United States and other countries. The information in this manual was correct at the time of printing. However, Medica Corporation continues to improve products and reserves the right to change specifications, equipment, and maintenance procedures at any time without notice. If the system is used in a manner not specified by Medica Corporation, performance of the equipment may be impaired. See all Hazards, Precautions, and Warnings. Contents Preface Intended Use..................................................................................................xiii Explanation of Symbols ...................................................................................xiv Book Conventions...........................................................................................xvi 1 Introducing EasyRA Introduction ..................................................................................................1.1 Features ..................................................................................................1.2 Options Available ....................................................................................1.3 Safety (Hazards, Precautions, and Warnings) ...................................................1.4 EasyRA Functional Areas ................................................................................1.7 Reagent/Sample Area ..............................................................................1.7 Reaction Area........................................................................................1.17 Transfer Arm..........................................................................................1.21 Fluidics Drawer......................................................................................1.24 Diluent/Waste Bottle Area ......................................................................1.30 Computer/Touch Screen .........................................................................1.32 Electronics.............................................................................................1.33 Power Cable .........................................................................................1.33 Data Cable ...........................................................................................1.33 Power Switch.........................................................................................1.33 EasyRA Workflow .......................................................................................1.34 2 Getting Started Setting Up EasyRA.........................................................................................2.1 Connecting the Tubing ..............................................................................2.2 ISE Reagent Pack .....................................................................................2.9 ISE Sensors............................................................................................2.11 Power and Computer Connection Overview ..............................................2.13 Starting EasyRA...........................................................................................2.16 Starting EasyRA for the First Time .............................................................2.16 Restarting EasyRA ..................................................................................2.17 Stopping EasyRA.........................................................................................2.18 Normal Shutdown ..................................................................................2.18 Emergency Shutdown .............................................................................2.19 Unlocking Covers ........................................................................................2.20 Loading Reagents for the First Time ................................................................2.23 Disabling (or Enabling) Tests....................................................................2.27 System Setup ..............................................................................................2.29 Setting Up Security .................................................................................2.29 Setting Up Printer Options .......................................................................2.49 Setting Up the LIS Configuration...............................................................2.61 Sending LIS Sample................................................................................2.66 v C O N T E N T S Selecting the Operator ID Option............................................................. 2.69 Selecting the Number of Stat Positions ...................................................... 2.70 Enabling or Disabling Debug Mode ......................................................... 2.72 Enabling or Disabling Auto Run After Inventory.......................................... 2.74 Enabling or Disabling Auto Recovery after Error ........................................ 2.76 Selecting the Language Displayed on the EasyRA User Interface .................. 2.77 Setting Up and Enabling Calculated Results............................................... 2.79 3 Understanding the User Interface Touch Screen ................................................................................................ 3.2 Screen Colors.......................................................................................... 3.3 EasyRA Screen Components ........................................................................... 3.4 Icon/Menu Bar ........................................................................................ 3.5 Data Area............................................................................................. 3.29 Entering Data Using the Keypads .................................................................. 3.45 Entering Alphanumeric Data.................................................................... 3.45 Entering Test Data .................................................................................. 3.46 4 Setting Up Test Configurations Configuring Tests .......................................................................................... 4.3 Setting Up the Test Panels ......................................................................... 4.4 Setting Up Test Ranges ........................................................................... 4.10 Setting Up Test Units............................................................................... 4.17 Setting Up Calculated Results........................................................................ 4.20 Setting Up and Enabling Calculated Results............................................... 4.21 Setting Up Patient Demographics .................................................................. 4.25 Searching the Patient Database ............................................................... 4.29 Configuring Chemistry Calibrators................................................................. 4.31 Setting Up Calibrators ............................................................................ 4.31 Deleting Calibrators ............................................................................... 4.50 Changing Calibration Preferences............................................................ 4.52 Viewing Calibrator Insert Sheets .............................................................. 4.55 Configuring QC Materials............................................................................ 4.59 Setting Up QC Materials......................................................................... 4.59 Setting Up QC Materials Manually .......................................................... 4.68 Deleting QC Materials............................................................................ 4.78 Changing the Condition of QC Materials.................................................. 4.80 Viewing QC Insert Sheets ....................................................................... 4.84 Setting Up Reagents .................................................................................... 4.89 Setting Up the Reagent Test Panel ............................................................ 4.89 Viewing Reagent Details ......................................................................... 4.89 Printing Reagent Setup............................................................................ 4.93 Viewing Reagent Insert Sheets ................................................................. 4.93 vi E a s y R A 5 O P E R A T O R ’ S M A N U A L Preparing EasyRA Introduction ..................................................................................................5.1 Loading and Unloading Reagent Wedges ........................................................5.2 Loading Reagent Wedges .........................................................................5.6 Unloading Reagent Wedges......................................................................5.8 Installing the Reagent Wedge Clip on a Three Reagent System ......................5.9 Replacing the ISE Reagent Pack.....................................................................5.12 Filling and Loading the Diluent Bottle .............................................................5.13 Unloading and Emptying the Waste Bottle......................................................5.15 Loading and Unloading the Sample Ring and Reagent Tray..............................5.16 Loading and Unloading the Sample Ring and Reagent Tray as a Unit...........5.18 Loading and Unloading the Sample Ring ..................................................5.21 Loading and Unloading the Reagent Tray..................................................5.24 Replacing Cuvettes ......................................................................................5.27 Replacing Cuvettes When a Run is Not in Progress ....................................5.29 Replacing Cuvettes During A Run .............................................................5.32 Loading and Unloading Samples...................................................................5.37 Loading Samples Without the LIS Connectivity Option ................................5.39 Loading Samples With the LIS Connectivity Option.....................................5.41 Unloading Samples ................................................................................5.42 Using Anti-Evaporation Caps ........................................................................5.42 Installing Anti-Evaporation Caps...............................................................5.43 Removing Anti-Evaporation Caps .............................................................5.44 6 Setting Up and Running Tests Creating and Running a Worklist - Typical Workflow .........................................6.2 Creating or Editing a Worklist Manually ..........................................................6.7 Entering Calibration Requests ..................................................................6.15 Entering Quality Control Requests ............................................................6.21 Entering Patient Test Requests ..................................................................6.24 Creating a Worklist Automatically (Tests Obtained from LIS) ........................6.28 Performing an Inventory ...............................................................................6.32 Starting a Run .............................................................................................6.35 Performing an Inventory/Starting a Run (with Auto Run Enabled) .......................6.37 Pausing and Resuming Test Runs ...................................................................6.38 Pausing a Test Run .................................................................................6.38 Resuming a Run After A Pause .................................................................6.42 Ending a Test Run...................................................................................6.44 Auto Recovery after Error During a Run ..........................................................6.47 Monitoring the Worklist................................................................................6.55 Viewing the Pending List...............................................................................6.58 Moving Tests from the Pending List to the Worklist ...........................................6.59 Calibrating the ISE Module ...........................................................................6.60 Printing ISE Calibration Results.................................................................6.63 vii C O N T E N T S Understanding the LIS Interface ..................................................................... 6.64 Introduction ........................................................................................... 6.64 Background........................................................................................... 6.64 Downloading Test Requests ..................................................................... 6.64 Uploading Test Results ............................................................................ 6.66 Supported Data Fields ............................................................................ 6.66 Viewing an LIS List....................................................................................... 6.66 7 Viewing Results Introduction .................................................................................................. 7.1 Viewing Current Results.................................................................................. 7.3 Rerunning Tests........................................................................................ 7.9 Deleting Results...................................................................................... 7.15 Viewing Calculated Results...................................................................... 7.18 Viewing Sample Details .......................................................................... 7.20 Accepting Results and Clearing the Worklist.............................................. 7.26 Entering the Operator ID......................................................................... 7.28 Viewing Last Results..................................................................................... 7.29 Viewing Patient Sample Results ..................................................................... 7.31 Displaying Results for a Particular Patient .................................................. 7.37 Viewing Sample Details for Patient Results................................................. 7.40 Printing Patient Results ............................................................................ 7.43 Viewing Calibration Results .......................................................................... 7.44 Viewing Detailed Results for Multi-Level Calibrations................................... 7.46 Printing Calibration Results ...................................................................... 7.48 Viewing QC Test Results............................................................................... 7.49 Viewing QC Results That Were Saved Automatically or Manually................ 7.49 Viewing Quantitative QC Results ............................................................. 7.53 Viewing Qualitative QC Results ............................................................... 7.61 Printing Test Results...................................................................................... 7.64 Printing from Current And Last Results Screens ........................................... 7.64 Printing from the Sample Details Screen .................................................... 7.72 Printing from the Patient Results Screen ..................................................... 7.72 Printing from the Calibration Results Screen ............................................... 7.75 Printing from the QC Results Screen ......................................................... 7.77 Results Flags ............................................................................................... 7.81 Viewing the Legend of Flag Codes ........................................................... 7.81 Details of Results Flag Codes ................................................................... 7.82 Sending Results to the LIS from the Sample Details ........................................... 7.87 8 Monitoring Status Introduction .................................................................................................. 8.1 Viewing Worklist Warnings............................................................................ 8.3 Viewing Reagent Status.................................................................................. 8.7 Performing an Inventory from the Reagent Status Screen ............................. 8.10 viii E a s y R A O P E R A T O R ’ S M A N U A L Viewing Calibration Status ...........................................................................8.11 Viewing QC Test Status................................................................................8.13 Viewing Cuvette Status.................................................................................8.15 Performing an Inventory from the Cuvette Status Screen...............................8.17 Viewing ISE Status .......................................................................................8.18 Performing an Inventory from the ISE Status Screen.....................................8.19 Viewing Cleaning Status ..............................................................................8.20 Performing an Inventory from the Cleaning Status Screen ............................8.21 Viewing the Inventory Report.........................................................................8.22 Performing an Inventory from the Inventory Report Screen ...........................8.24 Printing an Inventory Report.....................................................................8.24 Viewing Sample Inventory ............................................................................8.25 Performing an Inventory from the Sample Inventory Screen ..........................8.26 9 Quality Assurance Quality Assurance Activities in the Laboratory ...................................................9.1 The Purpose of Quality Control........................................................................9.4 Internal Laboratory Quality Control Program .....................................................9.5 QC Material............................................................................................9.5 Quality Control Charts ..............................................................................9.7 Rules of Interpretation for Levey-Jennings Charts ...........................................9.8 Quality Control Procedures......................................................................9.10 External Quality Control – Proficiency Testing .................................................9.10 Purpose.................................................................................................9.10 QC Material..........................................................................................9.11 Procedure .............................................................................................9.11 Results ..................................................................................................9.11 Method Validation .................................................................................9.12 Verification of Performance Specifications .................................................9.12 10 Performing Maintenance Hazards .....................................................................................................10.2 Accessing Daily Cleaning or Maintenance Procedures .....................................10.4 Daily Cleaning Procedures ...........................................................................10.6 Daily Inspection.........................................................................................10.10 Checking Dilutor Pump..........................................................................10.12 Checking the Probe ..............................................................................10.14 Checking the Waste and Diluent ............................................................10.16 Checking the Pump Tubes .....................................................................10.19 Daily Inspection in High Humidity and High Temperature Environments ......10.21 Weekly Testing .........................................................................................10.22 Monthly Cleaning ......................................................................................10.22 Bleaching the Diluent Bottle ...................................................................10.25 Bleaching the Waste Bottle....................................................................10.30 Cleaning the Wash Cup .......................................................................10.35 Cleaning the ISE Sample Cup ................................................................10.39 ix C O N T E N T S Cleaning Analyzer Surfaces ....................................................................... 10.43 Replacements............................................................................................ 10.44 Replacing the Probe ............................................................................. 10.48 Replacing the Wash Cup ...................................................................... 10.54 Replacing the Waste Pump Tube............................................................ 10.58 Replacing the Diluent Line ..................................................................... 10.64 Replacing the ISE Reagent Pack ............................................................. 10.67 Replacing the ISE Sensors ..................................................................... 10.73 Replacing the ISE Pump Tubes ............................................................... 10.80 Purge/Prime ............................................................................................. 10.88 Purging the Waste Line......................................................................... 10.90 Priming the Diluent ............................................................................... 10.93 Purging the ISE Waste Line ................................................................... 10.95 Priming the ISE Cal A/B ....................................................................... 10.98 Using Maintenance Logs .......................................................................... 10.100 Viewing Maintenance Logs ................................................................. 10.100 Adding an Operator ID or Notes to a Maintenance Log Entry ................. 10.107 Adding a Manual Entry to a Maintenance Log....................................... 10.110 Printing Maintenance Logs .................................................................. 10.114 Saving Results to a CD or a USB Drive....................................................... 10.115 Saving Results to a CD ....................................................................... 10.116 Saving Results to a USB ........................................................................... 10.120 11 Troubleshooting & Diagnostics Introduction ................................................................................................ 11.1 Troubleshooting .......................................................................................... 11.1 Hardware Problems ............................................................................... 11.2 Measurement Problems ......................................................................... 11.11 Range Problems................................................................................... 11.19 Running Diagnostics Tests........................................................................... 11.21 Running Tests after a System Error.......................................................... 11.22 Accessing Diagnostics Tests................................................................... 11.28 Reaction Area Diagnostics .................................................................... 11.30 Transfer Arm/Probe Diagnostics ............................................................ 11.36 Fluidics Drawer Diagnostics .................................................................. 11.45 Reagent/Sample Area Diagnostics......................................................... 11.55 Heater/Cooler Diagnostics ................................................................... 11.65 Cover/Door Latches Diagnostics ............................................................ 11.66 Precision Test Diagnostics ..................................................................... 11.67 x E a s y R A O P E R A T O R ’ S M A N U A L 12 Setting Up User-Defined Tests Reagent Wedges.........................................................................................12.2 Entering a User-Defined Reagent ...................................................................12.4 Changing a Reagent from Qualitative to Quantitative or Vice Versa ...........12.18 Programming Reagent Wedges...................................................................12.21 Modifying Reagent Parameters Before Programming RFID Reagent Wedges ...............................................................................12.25 Modifying Reagent Parameters After Programming RFID Reagent Wedges ...............................................................................12.27 Reagent Optimization - Creating a Worklist..................................................12.36 A Principles of Operation B Maintenance Logs Daily Cleaning and Inspection Log (Month: ______________ Year: ______) .......... B.2 Monthly Cleaning Log (Month: ______________ Year: ______) ........................... B.3 Replacement Log (Month: ______________ Year: ______) .................................. B.3 Recommended Replacement Schedules ...................................................... B.3 C EasyRA Specifications D Warranty Index xi C O N T E N T S xii Preface Welcome to Medica Corporation’s Easy Random Access (EasyRA) Analyzer! This guide is intended to provide you with the necessary information to operate the EasyRA general chemistry analyzer. Intended Use The Medica EasyRA analyzer is designed for clinical laboratory use and provides data on a variety of analytes, including proteins, metabolites, enzymes, and electrolytes. Sample types include serum, plasma, diluted blood, urine, and diluted urine as indicated in the insert sheets of individual analytes. Primary collection tubes or sample cups may be used. The analyzer must be used with the specified quality control (QC) materials and calibrants as described in this manual in order to obtain accurate results. The Medica chemistry analyzer is used by laboratory trained technicians in clinical laboratories to provide quantitative results on analytes indicative of hepatic, renal, metabolic, electrolyte, and other physiological disturbances. The analyzer may also be used for qualitative analysis as indicated in the corresponding reagent instructions for use. The patient results obtained must be used in conjunction with the overall patient condition and other laboratory data. xiii P R E F A C E Explanation of Symbols The following symbols appear on the EasyRA analyzer, in EasyRA’s Operator’s Manual, and on product labeling. SYMBOL xiv MEANING APPEARS: Attention In Operator’s Manual and on Product Labeling. Authorized Representative in European Union On Product Labeling. Barcode On the Analyzer and on samples and Reagents. Batch Code On Reagents, Calibrators, and QC Materials. Fuse On Product Labeling. Used on RS-232 and USB ports to show input/output to a computer. On the Analyzer. Biohazard In Operator’s Manual and on Product Labeling. CE Mark On Product Labeling. Consult the Operator’s Manual In User Interface and on Product Labeling. Consult the supplied CD. In Product Labeling. E a s y R A SYMBOL MEANING APPEARS ON: Do not freeze On Product Labeling. Fuse Phase On the Analyzer. Invitro Diagnostics (IVD) On Product Labeling. Manufacturer On Product Labeling. Note In Operator’s Manual. Catalog Number On Product Labeling. Serial Number On the Analyzer. Store at On Product Labeling. UL On Product Labeling. Expiration Date On Product Labeling. O P E R A T O R ’ S M A N U A L xv P R E F A C E Book Conventions The following conventions are used in this manual: SYMBOL MEANING Warns of exposure to a biohazard. WARNING: Warns of actions that may result in personal injury. CAUTION: Cautions of actions that may result in operational issues or physical damage to the EasyRA analyzer. Identifies important points, helpful hints, special circumstances, or alternative methods. xvi Indicates a reference to another section of this document. 1 Introducing EasyRA Introduction EasyRA is a small, random-access general chemistry analyzer as shown in Figure 1.1. Figure 1.1 EasyRA Analyzer Touch Screen/Monitor Computer Reagent/ Sample Area Electronics Panel Transfer Arm/Probe Reaction Area Fluidics Drawer Diluent/Waste This chapter describes EasyRA features and options. It also describes subsystems of EasyRA and presents a workflow for a typical shift. 1.1 I N T R O D U C I N G E a s y R A Features Key features of EasyRA include: 1.2 True random access testing, allowing many tests to be performed and monitored at the same time. The ability to run tests using the following reaction types: Enzymatic Kinetic Endpoint Turbidimetric Immunoassay (TIA) Enzymatic Immunoassay (EIA) Potentiometric (ISE Module) Up to 24 reagents on board. 24 sample positions. 72 disposable Cuvettes. Xenon Flash Lamp photometer light source. Automatic loading of Reagent parameters from a read/write radio frequency identification (RFID) chip on each Reagent’s individual package (called a Reagent Wedge). Automatic tracking of Reagent usage. Automatic loading of Calibration values and Quality Control ranges from a CD for Medica-supplied reagents. The ability to run single-level, multi-level, or multi-level/ multi-constituent calibrations. EasyRA reads the number of calibration levels required for a test from the information provided on the RFID chip on the test’s Reagent Wedge. The ability to run tests that can generate either qualitative (positive or negative) or quantitative (numerical) results. EasyRA reads the type of results that will be generated for a test from the information provided on the RFID chip on the test’s Reagent Wedge. The use of single and dual Reagent Wedges and Three Reagent Systems (comprised of a single and dual Reagent Wedge clipped together with a Reagent Wedge Clip). E a s y R A O P E R A T O R ’ S Modular design for easy maintenance and servicing. The ability to define, review, program, and use user-defined reagents on EasyRA. M A N U A L Options Available The following options are available with the EasyRA analyzer: 4-channel ISE Module for Na/K/Cl/Li. 3-channel ISE Module for Na/K/Cl with a spacer electrode. Barcode reader for use with Laboratory Information System (LIS) Connectivity function (American Society for Testing and Materials (ASTM) protocol). Touch Screen. 1.3 I N T R O D U C I N G E a s y R A Safety (Hazards, Precautions, and Warnings) The following warnings and hazards apply to EasyRA. Detailed information on when these hazards may occur are included in the procedures contained throughout this manual. Observe all Warnings, Cautions, and Notes provided in this manual. WARNING: Read the Operator’s Manual before setting up and operating the EasyRA analyzer. WARNING: There are no user serviceable parts in the Electronics area of EasyRA analyzer. When electromechanical problems are suspected, DO NOT open the back cover. Contact your EasyRA dealer. WARNING: Installation of third party software or hardware, including updates to the operating system, may render the EasyRA Analyzer inoperable. Medica does not warrant the EasyRA analyzer for damage caused by unauthorized third-party software. 1.4 E a s y R A O P E R A T O R ’ S M A N U A L BIOHAZARD: All samples should be considered a biohazard (contaminated with HIV or other pathogens). Any component which comes in contact with biological samples, including the Transfer Arm/ Probe, Reagents, Wash Cup, Cuvettes, electrodes, sensor module, pump tubing, and waste may contain contaminated material. Treat all components during use and disposal as you would any biohazard. To avoid contamination, ALWAYS observe the following safety precautions when performing EasyRA procedures marked with a Biohazard symbol: Wear protective gloves and protective clothing (such as a laboratory coat). Wear protective eyeglasses or goggles. Wash hands thoroughly with soap and water after performing any procedure involving contaminated materials. Be aware of the EasyRA components that pose a risk of contamination and handle them appropriately. Dispose of all biohazardous materials in accordance with procedures set forth in your laboratory and local regulations. WARNING: The Transfer Arm/Probe moves when EasyRA is operating. To avoid possible injury, exposure to biohazards, or damage to EasyRA, be sure that nothing comes in contact with the Transfer Arm/Probe during operation. 1.5 I N T R O D U C I N G 1.6 E a s y R A CAUTION: Use only the supplied power cord. The EasyRA analyzer contains sensitive electronics and must be properly grounded. CAUTION: Use of an uninterruptible power supply (UPS) is recommended. CAUTION: The EasyRA analyzer is not fixed to the table or bench surface. Be sure to locate the analyzer in a place where there is no risk of it being pushed or dropped from the surface. E a s y R A O P E R A T O R ’ S M A N U A L EasyRA Functional Areas EasyRA contains the following subsystems: Reagent/Sample Area. Reaction Area. Transfer Arm/Probe. Fluidics Drawer. Diluent/Waste Bottle. Touch Screen/Computer. Electronics. These subsystems are described in the following sections of this chapter. Reagent/Sample Area The components of the Reagent/Sample Area are: Reagent Tray and Reagent Wedges. Reagent Tray Covers (optional). One cover for operations and one for storage. RFID Reader. Sample Ring. Barcode Reader (if you have the LIS Connectivity option). ThermoElectric Coolers (TECs). Anti-Evaporation Caps (optional). The Reagent/Sample Area also has a cover that locks when tests are being run. The cover has a rim on the inside to help insulate the Reagent Tray. The components of the Reagent/Sample Area are described in the following sections. 1.7 I N T R O D U C I N G E a s y R A Reagent Tray The Reagent Tray is a removable tray that holds up to 24 Reagents in containers called Reagent Wedges (or Wedges). The Reagent Tray is shown in Figure 1.2. Figure 1.2 Reagent Tray Reagent Tray Wedges Loaded on the Reagent Tray Sample Ring EasyRA is delivered with one Reagent Tray. Each Reagent position on the tray is marked with a number from 1-24. The Reagent Tray is positioned in the Reagent/Sample Area. The Sample Ring rests on the outside of the Reagent Tray. You can remove the Reagent Tray as a unit with the Sample Ring. To remove the Reagent Tray separately, remove the Sample Ring first. 1.8 For information on loading and unloading the Reagent Tray, see “Loading and Unloading the Sample Ring and Reagent Tray” on page 5.16. E a s y R A O P E R A T O R ’ S M A N U A L The Reagent Tray is kept at a temperature of 12° - 15° C below ambient temperature. Reagents can be safely stored in the Reagent Tray on EasyRA for extended periods of time. Note: When storing Reagents onboard EasyRA, be sure to keep the cover of the Reagent/Sample Area closed, whenever possible, to maintain the proper temperature. Note: The cooling provided by the TECs and Cooling Plate does not cool the samples on the Sample Ring. Samples in sample cups should not be stored on the Sample Ring for more than one hour to minimize evaporation. If Anti-Evaporation Caps are being used on the samples, the samples can be stored for up to 2.5 hours because the Anti-Evaporation Caps help reduce evaporation. Reagent Wedges are loaded into the Reagent Tray. The Wedges contain Reagents used in the photometric tests. Each Wedge contains a Radio Frequency Identification (RFID) chip embedded in its label. For more information on Wedges, see “Reagent Wedges” on page 1.10. There is an RFID Reader in the base of the Reagent/Sample Area that reads the RFID chips on the Wedges and provides EasyRA with information about the Reagents that are loaded on EasyRA. This includes all Reagent parameters and the current number of tests remaining on each Wedge. Figure 1.3 shows the location of the RFID Reader in the Reagent/Sample Area. 1.9 I N T R O D U C I N G E a s y R A Figure 1.3 Location of the RFID Reader in the Reagent/Sample Area Reagent Wedges Reagent Wedges are wedge-shaped bottles that contain Reagents used in photometric testing. Three types of Reagent Wedges are available for use on EasyRA (see Figure 1.4). Figure 1.4 Single and Dual Wedges and a Three Reagent System Single Wedge Dual Wedge Three Reagent System 1.10 E a s y R A O P E R A T O R ’ S Single wedges have one compartment and hold one Reagent or solution. Dual wedges have two compartments and hold two Reagents (for R1/R2 tests) or solutions. Three Reagent Systems are comprised of a single AND a dual wedge linked together with a plastic Reagent Wedge Clip. The Three Reagent System holds three Reagents (for R1/R2/R3 tests) or solutions. CAUTION: M A N U A L The Reagent Wedge Clip is intended to keep the wedges that make up the Three Reagent System together. DO NOT remove the wedge clip. If the wedge clip is inadvertently removed, place the two wedges back into the wedge clip as described in “Installing the Reagent Wedge Clip on a Three Reagent System” on page 5.9. If you cannot use the wedge clip, keep the two wedges together. When you put the wedges on the Reagent Tray, be sure you have a single wedge and a dual wedge and that the Ref # and Lot # on the two wedges match. The wedges must be placed side by side with the dual wedge of the pair in the higher numbered position and the single wedge in the lower numbered position, unless the wedges are being placed in positions 1 and 24. In that case, the dual wedge should be place in position 1 and the single wedge should be placed in Position 24. If the wedges are not placed correctly in the Reagent Tray, the term “Unknown Pair” will display on both wedges after a reagent inventory is performed. The RFID chip on each wedge loaded on the Reagent Tray is read by an RFID Reader during inventory and provides EasyRA with the following test set up parameters for each Reagent: Name, Lot Number, and Expiration Date. Reaction Type. Qualitative or Quantitative Results. Reagent Volumes. 1.11 I N T R O D U C I N G E a s y R A Analysis Volumes for Reagents, Samples, and Diluent. Primary and Secondary Wavelengths. Reaction Read Times. Analysis (Reaction) Type. Reagent and Sample Blanking. Linear Range of Assay. Acceptable Absorbance Ranges. Sample Type Parameters. On-board Stability Settings. 0-based (saline) or 1-based calibration levels (for multi-level calibrations only). The RFID chips are used to track the location of Reagents in the Reagent Tray and to track the volume of Reagents remaining. The Medica-supplied Reagents in the Reagent Wedges generally require no preparation; they are ready to use. For user-defined reagents that are not provided by Medica, you will need to define, optimize, and program the reagents. For more information on user-defined reagents, see “Setting Up User-Defined Tests” on page 12.1 If you are using a Three Reagent System, both wedges have the same information on the RFID chip, but the information on the second wedge (dual wedge) is only used during Reagent inventory. Once the system determines the dual wedge is part of a Three Reagent System, all information about the Three Reagent System is read from the first (single) wedge only. Reagent Tray Covers There are two optional covers for the Reagent Tray that can be used to reduce condensation and evaporation in the reaction area of EasyRA. One cover, the Operations cover, has openings for each of the reagent positions (see Figure 1.5, left). It is intended for use during EasyRA operations. The holes allow the probe to enter into any of the reagents on the Reagent Tray. The second cover, the Storage cover, is solid and is intended for use when the reagents are being stored on EasyRA (see Figure 1.5, right). CAUTION: 1.12 Do not use the solid Reagent Tray Cover during EasyRA operations. Sensors in the Probe will detect the presence of the cover and will not be able to proceed. E a s y R A Figure 1.5 O P E R A T O R ’ S M A N U A L Reagent Trays with Optional Reagent Tray Covers Reagent Tray with Operations Cover with openings (to be used during EasyRA operations) Reagent Tray with Storage Cover (to be used when Reagents are stored on EasyRA) The covers prevent the reagents from being affected by the ambient environment. During normal operations, use of the operations cover (the cover with openings for the reagents), reduces condensation by approximately 30%. It also keeps the temperature more uniform. When storing reagents onboard EasyRA overnight or for more than 24 hours, use of the storage cover (the solid cover with no openings) reduces condensation by approximately 80%. 1.13 I N T R O D U C I N G E a s y R A Sample Ring The Sample Ring is a removable ring that holds up to 24 samples (see Figure 1.6). Samples include serum, urine, calibrants, and QC materials. Figure 1.6 Sample Ring Sample Ring Location of Barcode Reader (optional) Barcode on Samples EasyRA is delivered with one Sample Ring. (A second Sample Ring can be purchased as an option.) Each sample position on the Sample Ring is marked with a number from 1-24. A variety of sample tubes and cups can be loaded on the Sample Ring using different sample holders provided with EasyRA. 1.14 For more information on the types of sample tubes and cups that can be used, see “Loading and Unloading Samples” on page 5.37. E a s y R A O P E R A T O R ’ S M A N U A L The Sample Ring rests on the Reagent Tray and can be removed separately, or as a unit with the Reagent Tray. For information on loading and unloading the Sample Ring, see“Loading and Unloading the Sample Ring and Reagent Tray” on page 5.16. Barcode Reader (optional) If you have the LIS Connectivity option, the Reagent/Sample Area includes a Barcode Reader that is located at the back of the Sample Ring (see Figure 1.6). If EasyRA receives test and patient information from an LIS, each sample for which information is received is labeled with a barcode. The Barcode Reader on EasyRA reads the barcodes on the samples during inventory and links each sample with tests that have been requested by the LIS. Those tests are automatically added to the Worklist. You enter manual Worklist entries for samples without barcodes. Note: If you are using samples with barcodes, be sure the barcodes are facing out, as shown in Figure 1.6, so they can be read by the Barcode Reader. 1.15 I N T R O D U C I N G E a s y R A ThermoElectric Coolers The base of the Reagent/Sample Area includes two ThermoElectric Coolers (TECs) and a Cooling Plate (see Figure 1.7). Figure 1.7 ThermoElectric Coolers and Cooling Plate Cooling Plate 2 ThermoElectric Coolers Cooling is transmitted to the Reagent Tray from the Cooling Plate. By providing cooling to the Reagent Tray, Reagents can be stored onboard EasyRA, as long as the analyzer is powered on. (Reagent on-board stabilities cited in the Directions for Use assume refrigeration for most Reagents.) The area surrounding the Reagent Tray is insulated to maintain the proper temperature. Use the optional Storage Cover for the Reagent Tray and keep the cover of the Reagent/Sample Area closed whenever possible to ensure proper cooling. Note: The cooling provided by the TECs and Cooling Plate does not cool the samples on the Sample Ring. Samples in sample cups should not be stored in the Sample Ring for more than one hour to minimize evaporation. If Anti-Evaporation Caps are being used on the samples, the samples can be stored for up to 2.5 hours because the Anti-Evaporation Caps help reduce evaporation. 1.16 E a s y R A O P E R A T O R ’ S M A N U A L Anti-Evaporation Caps EasyRA now provides optional anti-evaporation caps that can be used to prevent evaporation of materials in Sample Cups during EasyRA operations. The anti-evaporation caps are disposable adhesive caps that can effectively prevent evaporation during EasyRA operations. The caps are pre-cut to allow the Probe to enter and exit the sample cup during operation. Anti-evaporation caps prevent evaporation from serum placed in sample cups for up to 2.5 hours. For more information on using Anti-Evaporation Caps, see “Using Anti-Evaporation Caps” on page 5.42 Reaction Area The components of the Reaction Area are: Cuvette Carousel and Cuvettes. Photometer. Heated Air Bath. This area has a cover which locks when tests are being run. When you open the cover of the Reaction Area, the Cuvette Carousel and the ISE Reagent Pack are visible. The Photometer and Heated Air Bath are located beneath the Cuvette Carousel and are hidden from view. The components of the Reaction Area are described in the following sections. 1.17 I N T R O D U C I N G E a s y R A Cuvette Carousel and Cuvettes The Cuvette Carousel, (shown in Figure 1.8), holds up to 72 individual Cuvettes (in 6 segments of 12 Cuvettes each). Each segment slot on the Cuvette Carousel is marked with a letter (A-F). Figure 1.8 1.18 Cuvette Carousel E a s y R A O P E R A T O R ’ S M A N U A L Figure 1.9 shows a Cuvette Segment with 12 individual Cuvettes. Figure 1.9 Cuvette Segment During a run, the Probe dispenses samples and Reagents into the Cuvettes in the Cuvette Carousel. At the appropriate time, the Cuvette Carousel turns, allowing each Cuvette to pass by the Photometer. At specified times, the Photometer takes absorbance readings of the material in the Cuvettes to check the concentration of the samples that react with Reagents. The Cuvette Carousel has been designed so that the beam of light from the Photometer always passes through the Cuvettes at the same height. The Cuvette Carousel holds Cuvettes securely and perpendicular to the beam of light from the Photometer. The Cuvette Segments must be replaced as they are used. EasyRA indicates when there are not enough Cuvettes to complete a run and when Cuvettes are depleted. For information on replacing Cuvettes, see “Replacing Cuvettes” on page 5.27. 1.19 I N T R O D U C I N G E a s y R A Photometer The Photometer is located beneath the Cuvette Carousel and is obstructed from view. Figure 1.10 shows the Photometer. Figure 1.10 Photometer The Photometer performs the photometric testing. The Photometer contains six interference filters and is used to make optical measurements at any of seven wavelengths (520, 340, 405, 550, 600, 660 (if 660 filter is installed), and 700 nm). Its light source is a Xenon flash lamp. The Photometer is stable and the interference filters are not susceptible to moisture and will not delaminate. EasyRA monitors the output of the flash lamp to ensure proper operation. In the event a problem is detected, an error message is displayed. Only a certified service technician can replace the Photometer. Heated Air Bath EasyRA provides a heated air bath to heat the Cuvettes to ensure that all reactions take place at a predefined temperature. The heated air bath keeps the air around the Cuvettes at 37°C ± 0.25°C. A blower circulates the air, and a filter keeps out any particulate matter. EasyRA monitors the temperature of the area. 1.20 E a s y R A O P E R A T O R ’ S M A N U A L Transfer Arm The components of the Transfer Arm are: Probe Pre-Heater Liquid Level Sensor There is a small cover below the Transfer Arm that snaps into place. Figure 1.11 shows the Transfer Arm and its components. Figure 1.11 Transfer Arm Transfer Arm Pre-Heater and Liquid Level Sensor (below Transfer Arm Cover) Probe Snap-in Cover below Transfer Arm Both the Pre-Heater and Liquid Level Sensor are located under the cover of the Transfer Arm and are not serviceable by the user. The components of the Transfer Arm are described in the following sections. 1.21 I N T R O D U C I N G E a s y R A Probe The Probe in the Transfer Arm performs the following activities: Picks up Reagents and samples and deposits them into Cuvettes. Picks up samples and deposits them into the ISE Module. Mixes Reagents and samples in Cuvettes by injecting air into the Cuvette. Receives diluent from the Dilutor Pump to clean the Probe of contaminants and delivers the waste and diluent into the Wash Cup. The Transfer Arm can move the Probe to seven different positions as shown in Figure 1.12: Figure 1.12 1.22 Probe Positions E a s y R A O P E R A T O R ’ S M A N U A L The positions are as follows: Home - The position to which the Probe automatically returns after completing any activity. The Probe must be in the Home position before the covers can be opened to prevent damage to the Probe. Test - The position of the Probe when it dispenses a sample and/or Reagent into a Cuvette for photometric testing. Electrolytes - The position of the Probe when it dispenses a sample into the ISE Module. Wash - The position of the Probe when it is being cleaned. Diluent is pumped through the Probe and is deposited into the Wash Cup. Sample - The position of the Probe when it picks up a sample from the Sample Ring. Reagent 1 - The position of the Probe when it picks up a Reagent from a single wedge or the large compartment of a dual wedge. Reagent 2 - The position of the Probe when it picks up a Reagent from the small compartment of a dual wedge. Pre-Heater The Pre-Heater is a teflon-lined heater located beneath the cover on the Transfer Arm. The Pre-Heater warms the samples and Reagents to approximately 35°C before dispensing them to Cuvettes. Liquid Level Sensor This sensor prevents the Probe from traveling to the bottom of sample tubes, sample cups, and Reagent Wedges. If the Probe touches the bottom of a sample tube, sample cup, or Reagent Wedge, the Bump Switch is triggered. Triggering the Bump Switch causes EasyRA to proceed to the Wash Cup for cleaning, and then return to the Home position. It also triggers a system error. 1.23 I N T R O D U C I N G E a s y R A Fluidics Drawer The components of the Fluidics Drawer are: Wash Cup. Dilutor Pump. Chemistry Waste Pump. ISE Module and ISE Pumps (if you have the ISE Module option). The Fluidics Drawer opens and pulls out for easy access and serviceability. Figure 1.13 shows the Fluidics Drawer in the closed and open positions. 1.24 E a s y R A Figure 1.13 O P E R A T O R ’ S M A N U A L Fluidics Drawer in the Closed and Open Positions Fluidics Drawer (Closed position) Fluidics Drawer (Open position) 1.25 I N T R O D U C I N G E a s y R A The Fluidics Drawer also has a “peek” position, in which the cover can be tilted open at a 45° angle, so you can peek into the Fluidics Drawer and monitor operation while EasyRA is running (see Figure 1.14). For example, open the Fluidics Drawer to the peek position to check for bubbles in the Dilutor Pump or monitor the Wash Cup or ISE Module during a run. Figure 1.14 Fluidics Drawer in Peek Position Fluidics Drawer peek position) EasyRA can operate in the closed or peek position. EasyRA cannot be operated when the Fluidics Drawer is in the open position. 1.26 E a s y R A O P E R A T O R ’ S M A N U A L Figure 1.15 shows the components of the Fluidics Drawer. These components are described in the following sections. Figure 1.15 Components of the Fluidics Drawer ISE Sample Cup Wash Cup ISE Module Dilutor Pump Chemistry Waste Pump ISE Cal B and Cal A Pumps ISE Waste Pump Figure 1.16 shows the label in the Fluidics Drawer that shows the flow of fluids through the pumps in EasyRA. Figure 1.16 Label Showing Flow within Fluidics Drawer Chemistry Waste Pump ISE Waste Pump ISE Cal B Pump ISE Cal A Pump 1.27 I N T R O D U C I N G E a s y R A Wash Cup After samples and/or Reagents are dispensed by the Probe, diluent is pumped through the Probe by the Dilutor Pump to clean it. Waste and diluent from the Probe are deposited into the Wash Cup (see Figure 1.15). The flow of diluent and waste is shown in Figure 1.17. Figure 1.17 Flow of Fluids Through EasyRA Flow from the Diluent Bottle to the Probe Flow from the Probe to the Waste Bottle 1.28 E a s y R A O P E R A T O R ’ S M A N U A L After samples and/or Reagents have been dispensed, the Probe moves into the Wash Cup position. Diluent flows into the Probe from the Diluent Bottle via the Dilutor Pump. EasyRA uses an overflow method to dispose of the waste. Liquid is forced through the Probe and overflows from the inner chamber of the Wash Cup into the outer chamber of the Wash Cup. The liquid from the outer chamber is drawn off to the Waste Bottle by the Waste Pump. Dilutor Pump The Dilutor Pump shown in Figure 1.15 picks up Reagents and/or samples and deposits them into Cuvettes or the ISE Module. It also moves diluent from the Diluent Bottle to the Probe, and then into the Wash Cup. The Dilutor Pump has lifetime seals, eliminating the need for pump maintenance. The Dilutor Pump has two pistons: Large Piston (on right side) - pulls Reagents, samples, and diluent into the Probe/Pre-Heater and dispenses them into Cuvettes or the ISE Module. Small Piston (on the left side) - pulls sample into the Probe and helps dispenses sample into the cuvettes. Chemistry Waste Pump The Chemistry Waste Pump is a peristaltic pump that aspirates waste from the Wash Cup to the Waste Bottle (see Figure 1.15). If you have an ISE Module, the ISE Waste Pump and the Cal A and Cal B pumps are exactly the same design as the Chemistry Waste Pump. ISE Module and Associated Pumps (with ISE Module Option) If you have an ISE Module, the Fluidics Drawer includes ion-selective electrodes and three peristaltic pumps (see Figure 1.15). The ISE Module measures the concentration of Sodium, Potassium, Chloride, or Lithium in serum. A sample entry port is located at the top of the ISE Module. The ISE Module houses snap-in, snap-out electrodes which connect directly to an electronic board within the ISE Module. Samples and calibrants are positioned in front of the electrodes by three peristaltic pumps. Two pumps move Calibrant A and Calibrant B into the ISE Module’s sample entry port and the Waste Pump positions samples and calibrants in front of the electrodes. The sample is deposited into the sample entry port by the Probe. After each sample measurement, calibrant is pumped in front of the electrodes for a single-point calibration. Waste is pumped out of the ISE Module by the ISE waste pump and deposited into the waste container. 1.29 I N T R O D U C I N G E a s y R A ISE Reagent Pack (with ISE Module Option) The ISE Reagent Pack is located to the right of the Reaction Area and is associated with the ISE Module (see Figure 1.8). It contains pouches with Calibrant A and Calibrant B. A sensor chip (Dallas Chip) on the ISE Reagent Pack tracks the amount of calibrants remaining in the ISE Reagent Pack. Diluent/Waste Bottle Area EasyRA uses diluent (Reagent grade, deionized water) stored in the Diluent Bottle to clean the Probe. A tube from the Diluent Bottle to the Dilutor Pump brings diluent to the Probe. All EasyRA waste is deposited into the Waste Bottle. The Dilutor Pump moves diluent from the Diluent Bottle to the Probe. The Diluent and Waste Bottles are located on the right side of EasyRA (see Figure 1.18). Figure 1.18 Location of Diluent and Waste Bottles Diluent Bottle Waste Bottle Figure 1.19 shows the labels that appear on the Waste and Diluent Bottles. 1.30 E a s y R A Figure 1.19 O P E R A T O R ’ S M A N U A L Labels on Waste and Diluent Bottles Waste Bottle Label Diluent Bottle Label Waste Bottle Diluent Bottle BIOHAZARD: The contents of the Waste Bottle and all associated tubing may contain contaminated material. Treat all waste, during use and disposal, as you would any biohazardous material. For information on safety procedures for handling biohazards, see page 1.5. 1.31 I N T R O D U C I N G E a s y R A Computer/Touch Screen EasyRA is controlled by an IBM-compatible PC running the Windows XP or Windows 7 operating system. All interactions with EasyRA’s user interface take place via the 15” touch screen monitor. All information is displayed on the touch screen and all EasyRA control is initiated from the touch screen. Figure 1.20 shows the touch screen. Figure 1.20 EasyRA Touch Screen A CRT monitor with a mouse and keyboard can also be used. 1.32 E a s y R A O P E R A T O R ’ S M A N U A L Electronics All EasyRA electronics are located in the rear section of the analyzer. The back of the analyzer opens up to provide access to the electronics. WARNING: There are no user serviceable parts in the Electronics area of EasyRA. When electromechanical problems beyond the scope of this manual are suspected, DO NOT open the back cover. Contact your EasyRA dealer. Power Cable Use the power cable supplied with EasyRA to connect to AC power. The cable attaches to the rear, left side of EasyRA. Data Cable You can use one of two possible data ports to connect EasyRA to the PC. Use either the RS-232 port and cable or the USB port and cable. The data ports are located on the rear, left side of EasyRA. Power Switch The Power Switch for EasyRA is located on the rear, left side of EasyRA. Use this switch to turn power on and off. EasyRA should be left on unless you are going to shut it down for an extended period of time. Continuous power is required to maintain refrigeration and to ensure reliable operation of the ISE Module (if you have this option). For more information, see “Stopping EasyRA” on page 2.18. 1.33 I N T R O D U C I N G E a s y R A EasyRA Workflow The following describes the workflow for a typical operator shift using EasyRA. This workflow assumes EasyRA has been set up and is ready for operational use. Actual workflow may vary depending on your laboratory protocols and procedures and the types of testing you perform. (See Figure 1.21 for a more detailed workflow, based on whether a test requires a single or multi-level calibration and whether it generates qualitative or quantitative results.) 1 Perform daily cleaning and daily maintenance. (Cleaning and maintenance can be performed at the end of the shift, if you prefer.) 2 Perform ISE Calibration. ISE calibration should always be performed at the start of a shift, as it is time sensitive. 3 Perform any other maintenance (Daily Inspection, Monthly Cleaning, etc.), as required. 4 View an Inventory Report. Verify that all Reagents that will be needed for this shift have been loaded on EasyRA and inventoried, so the appropriate tests can be selected. For information, see “Loading Reagents for the First Time” on page 2.23. 5 View a Calibration Status report. Look for expired calibrations. (There are two types of calibrants (photometric calibrants and ISE calibrants). EasyRA will not allow you to run tests if calibrations are expired. 6 View a QC Status report. Look for tests with expired QC. Note that running Quality Control material is highly recommended to ensure quality of EasyRA performance, although EasyRA will not prevent you from running tests if QCs have not been performed. 7 Create a Worklist and load samples into the Sample Ring. Note: If a new test is being added to the Worklist, the Reagent Wedges must be inventoried before the test will appear on the Test Select Keypad. 1.34 E a s y R A O P E R A T O R ’ S M A N U A L EasyRA gives you the flexibility to set up and perform calibration, QC, and patient tests in a single run; however, some laboratories may prefer to create Worklists that contain only calibrations, QCs, or patient tests. For more information, see “Accepting Results and Clearing the Worklist” on page 7.26. If you have the LIS Connectivity option, just load the barcoded samples into the Sample Ring. Worklist entries containing the tests to be run on the samples will be automatically entered in the Worklist during inventory. 8 An inventory is run automatically to determine if all the elements are onboard to perform the tests in the Worklist. During inventory, EasyRA indicates if any cleaning, calibration, or maintenance is required to continue. Perform cleaning, maintenance, or calibrations as needed. 9 Start the test run. If your Worklist contains calibration, QC, and patient tests, EasyRA performs the tests in the following order: Calibration. Stat patient tests. QC. All other patient tests. (Within the group of tests for each sample, EasyRA runs the longest tests first, followed by the shorter tests.) 10 Monitor the Worklist while it is running (optional). 11 View results. 12 Rerun tests as needed. You can only rerun a Worklist once, so be sure to select all tests that need to be rerun. 13 Print test results, as needed. 14 Accept test results. 15 Repeat Steps 7 - 14 throughout the shift. 16 At the end of the shift, you can either remove the entire Sample Ring or you can remove individual samples. Samples must be disposed of or stored as required. 1.35 I N T R O D U C I N G E a s y R A Note: The cooling provided by the TECs and Cooling Plate does not cool the samples on the Sample Ring. Samples in sample cups should not be stored in the Sample Ring for more than one hour to minimize evaporation. If Anti-Evaporation Caps are being used on the samples, the samples can be stored for up to 2.5 hours because the Anti-Evaporation Caps help reduce evaporation. 17 Reagents can be safely left onboard EasyRA between shifts. 18 Perform daily cleaning and daily maintenance. (Cleaning and maintenance can be performed at the beginning of the shift, if you prefer.) 19 Leave EasyRA in an idle state (do not turn off power between shifts). Figure 1.21 provides a more detailed workflow, based on whether a test requires a single or multi-level calibration and whether it generates qualitative or quantitative results. Note: When you perform an inventory of reagent wedges on the Reagent Tray on EasyRA, the system reads information from the RFID chips on each wedge. It is from this information that the system determines if the test requires a single or multi-level calibration and whether it will generate qualitative or quantitative results. To view the parameters for a particular reagent, touch the Diagnostics/Maintenance/Setup icon, then touch Setup, then touch Reagent, then touch Reagent Details and select the reagent of interest. 1.36 E a s y R A Figure 1.21 O P E R A T O R ’ S M A N U A L Detailed Workflow for Performing Tests Obtain Reagents for Test & Place in Reagent Tray** EasyRA Performs Inventory Single or Multi-Level Calibration? **There are two types of reagents: Medica-Supplied and User-Defined Reagents. For Medica-supplied Reagents, place wedge(s) in Reagent Tray. For User-Defined Reagents, follow the instructions in Chapter 12 to define, optimize, and program reagents, and then place wedge(s) in Reagent Tray. Single-Level Cal (Enzymatic, Kinetic, Endpoint) (TIA, EIA, Endpoint) Qualitative or Quantitative Results? Quantitative (Enzymatic, Kinetic, Qualitative Endpoint) (Kinetic) Quantitative (TIA or EIA) Multi-Level Cal Define Single-level Calibration Material Define Single-level Calibration Material Define Multi-level (1-6) Calibration Material Define Qual. QC Define Quant. QC Define Quant. QC Set up/Run Cal & QC in Worklist Set up/Run Cal & QC in Worklist Set up/Run Cal & QC in Worklist View Single-level Qual. Test Results View Single-Level Quant. Test Results View Multi-level Quant. Test Results Set up/Run Qual. Test in Worklist Set up/Run Quant. Test in Worklist Set up/Run Quant. Test in Worklist View Single-level Qual. Test Results View Single-level Quant. Test Results View Multi-level Quant. Test Results 1.37 I N T R O D U C I N G 1.38 E a s y R A 2 Getting Started Your distributor for the EasyRA chemistry analyzer will work with you to prepare your site and set up your new EasyRA analyzer. This chapter describes how to get started with EasyRA, including connecting all tubing, connecting to the power, connecting to the computer and printer, starting, restarting, and stopping EasyRA, and configuring system settings. Setting Up EasyRA Figure 2.1 shows the components of EasyRA after they have been installed. Figure 2.1 EasyRA - After Installation Has Been Performed Touch Screen/Monitor Computer Reagent/ Sample Area Electronics Panel Transfer Arm/Probe Reaction Area Fluidics Drawer Diluent/Waste Typically, your distributor will set up EasyRA for you. 2.1 G E T T I N G S T A R T E D Connecting the Tubing Figure 2.2 shows all EasyRA tubing. All tubing is partially installed for your convenience. Figure 2.2 ALL EasyRA Tubing The Chemistry Waste Pump Tubing, ISE Pump Tubing, and the Cal A and Cal B Tubing (if you purchased the ISE Module option) have been connected to their respective lines. To avoid overstretching or crimping during shipment, tubing is not stretched around the pump heads (see Figure 2.3). 2.2 E a s y R A Figure 2.3 O P E R A T O R ’ S M A N U A L Tubing Not Stretched Around Pump Heads It is necessary to disconnect the pump tube(s), stretch it around the pump winding(s), and then reconnect it before using EasyRA. The Chemistry Waste and Diluent lines have also been installed. It is necessary to connect the Chemistry Waste lines and the Diluent lines to the Waste and Diluent Bottles. If you have the ISE Module option, the ISE Reagent Connector is installed, but the ISE Reagent Pack and the ISE Electrodes must be installed. 2.3 G E T T I N G S T A R T E D Chemistry Waste Pump Tube This procedure describes how to stretch the Chemistry Waste Pump Tube around the pump heads before using EasyRA for the first time. This tube must be positioned around the Chemistry Waste Pump as shown in Figure 2.4. Figure 2.4 Chemistry Waste Pump Location of Pump Tubing ISE Waste Pump ISE Cal B Pump ISE Cal A Pump To stretch the Chemistry Waste Pump Tube around the pump heads: 1 2.4 Disconnect the connection on the right side of the Chemistry Waste Pump from the Waste Line at the barbed connector (the clear connector located above the opaque tubing on the Waste Pump Tube) as shown in Figure 2.5. To disconnect the Waste Line, grasp the Waste Line from the back of the Fluidics Drawer with one hand and grasp the barbed connector on the Waste Pump Tube with the other hand and pull the connector apart. E a s y R A Figure 2.5 Waste Lines Pump Inlet Pump Outlet Press down on the bottom portion of the pump and stretch the tubing around the pump head (see Figure 2.6). Figure 2.6 3 M A N U A L Disconnect One End of the Waste Pump Tube on Chemistry Waste Pump Disconnect one end of the Waste Tube Connection at the Barbed Connector 2 O P E R A T O R ’ S Stretch Tubing Around Pump Head Reconnect the Waste Pump Tube to the Waste Line at the barbed connector (see Figure 2.7). To connect the line, grasp the Waste Line from the back of the Fluidics Drawer with one hand and grasp the barbed connector on the Waste Pump Tube with the other hand and press them together to make the connection. 2.5 G E T T I N G S T A R T E D Figure 2.7 Connecting Waste Pump Tubing to Waste Line at the Barbed Connector CAUTION: Use care when connecting the inlet and outlet ends of the Waste Line to the Waste Pump Tube. The inlet is on the left side of the pump and the outlet is on the right side. Failure to connect the Waste Line properly may result in damage to EasyRA. ISE Pump Tubes (ISE Module Option) If you have the ISE Module option, follow the steps in “Chemistry Waste Pump Tube” on page 2.4 to stretch the ISE Pump Tubes around the pump heads on the ISE Waste Pump Tube and the ISE Cal A and ISE Cal B Pump Tubes. Notice that the connections on the left side of each ISE Pump Tube are slightly different than the connections on the left side of the Chemistry Waste Pump (the ISE pumps use clear tubing rather than opaque tubing on the left side). You only need to disconnect and reconnect the opaque tubing on the right side as described in the procedure referenced above to stretch the ISE Pump Tubes around the pump heads. Diluent/Waste Line(s) and Bottles The Diluent and Waste line(s) are pre-installed on EasyRA. The Diluent Bottle and Diluent Line are positioned at the rear of the Diluent/Waste Area. The Waste Bottle and Waste Line are positioned at the front of the Diluent/Waste Area. You will also need to fill the Diluent Bottle and connect the Diluent and Waste Lines. 2.6 E a s y R A O P E R A T O R ’ S M A N U A L Filling the Diluent Bottle and Connecting the Diluent Line 1 Unscrew the bottle cap of the Diluent Bottle and remove it. 2 Fill the Diluent Bottle with Reagent grade deionized water. 3 Add Medica Surfactant (5 drops per liter) to the Diluent Bottle. 4 Place the bottle cap onto the Diluent Bottle and tighten it. Verify that the tubing attached to the inside of the bottle cap extends to the bottom of the Diluent Bottle. 5 Connect the Diluent Line to the Diluent Bottle at the inlet port located on the bottle cap (see Figure 2.8). Figure 2.8 6 Connect Tubing to the Diluent Bottle Place the Diluent bottle onto EasyRA at the rear of the Waste/Diluent Area/Tray. 2.7 G E T T I N G S T A R T E D Connecting the Waste Line 1 Connect the Waste Line to the Waste Bottle at the inlet port located on the bottle cap. Please note, there is no tubing attached to the inside of the Waste Bottle (see Figure 2.9). Figure 2.9 2 Place the Waste Bottle onto EasyRA at the front of the Waste/Diluent Area/Tray. 2.8 Connect Tubing to the Waste Bottle For more information on maintenance of the Diluent/Waste Bottles during operation, please refer to “Daily Inspection” on page 10.10 and “Monthly Cleaning” on page 10.22. E a s y R A O P E R A T O R ’ S M A N U A L ISE Reagent Pack This procedure describes how to install the ISE Reagent Pack for the first time. 1 Lift the Reaction Area Cover to install the ISE Reagent Pack. When installed, the pack is located on the right side of EasyRA (see Figure 2.10) Figure 2.10 ISE Reagent Pack in EasyRA ISE Reagent Pack in EasyRA 2 Open the ISE Reagent Pack by removing the top seal to expose the nipples and the Dallas chip contacts. 3 Place the ISE Reagent Pack into EasyRA so that the rounded edge of the cutout for the ISE Reagent Connector faces the back of EasyRA and the label on the ISE Reagent Pack is visible on the right side of EasyRA. 2.9 G E T T I N G S T A R T E D 4 Connect the ISE Reagent Connector to the ISE Reagent Pack (see Figure 2.11). Figure 2.11 Connect the ISE Reagent Connector to the ISE Reagent Pack The ISE Reagent Connector will only fit one way. The rounded end of the connector should face the back of EasyRA. 5 2.10 Close the Reaction Area Cover. E a s y R A O P E R A T O R ’ S M A N U A L ISE Sensors This procedure describes how to install the ISE Sensors for the first time. 1 Open the Fluidics Drawer and slide it out. Figure 2.12 shows the ISE Module. The left view shows the labels indicating the correct positions for the ISE Electrodes. Figure 2.12 Two Views of the ISE Module ISE Electrodes (Li+, Na+, K+, Cl-) Reference Electrode Compression Plate ISE Waste Tube 2 Press and hold the Compression Plate down in the Open position (see Figure 2.13). Continue to hold the Compression Plate down during this procedure. 2.11 G E T T I N G Figure 2.13 S T A R T E D Installing the ISE Sensors for the First Time 3 Install the first Reference Electrode by inserting it above the Compression Plate until it is securely in place (see Figure 2.13). Note: The solution chamber has a small, red bead floating on top of the internal fill solution. Prior to installation, gently shake the Reference electrode to ensure that the red bead is freely floating on the surface of the internal fill solution. 4 Work upwards from the Reference Electrode beginning with the Chloride Electrode. Insert the electrode into its designated position. The handle snaps into the ISE Module. Each electrode is keyed to ensure correct placement. See Figure 2.13. Note: Prior to installation, remove the tape sealing the flow path from the K+ and Li+ electrodes. If any liquid escapes, wipe the electrode dry. CAUTION: 2.12 To avoid damaging the ISE Module, do not force electrodes into the module. 5 Repeat Step 4 for each additional electrode that requires installation. 6 Release the Compression Plate (see Figure 2.13). 7 Visually confirm that the electrodes are properly aligned. Also, press your finger against the front of each electrode to verify alignment. E a s y R A O P E R A T O R ’ S M A N U A L Power and Computer Connection Overview This section describes how to connect power to EasyRA and how to connect EasyRA to the computer. Power Cable EasyRA is factory set with the appropriate fuses and power cable for your geographic location. CAUTION: Use only the power cable supplied with EasyRA to connect to AC power. The power cable must be connected to a grounded, matching three wire outlet. Do not use an adaptor. The power cable attaches to the back, left side of EasyRA. Computer Cable(s) EasyRA is controlled by an IBM-compatible PC running Windows® XP or Windows® 7 operating system. All interaction with EasyRA’s user interface takes place via the 15” touch screen monitor. If the Touch Screen Monitor is not used, an SVGA Monitor, Keyboard and Mouse may be used. The following section describes how to physically connect the external computer, Touch Screen, and Printer to EasyRA. Initial connection to the computer and Touch Screen will be performed by your local distributor. These procedures may be required if you move EasyRA and the associated computer to another location. An external computer that meets the following minimum requirements must be used: Windows® XP or Windows® 7 CD/CD-RW (read/write) 1 Serial Communications Port – RS-232 or USB Touch Screen Monitor (Medica Supplied) or SVGA Color Monitor, Mouse and Keyboard EasyRA is connected to the external computer through one of two available connections, a 9-pin RS-232 Serial connection or a Universal Serial Bus (USB) connection. Both cables are supplied at the time of shipment. However, use of only one connection is required. 2.13 G E T T I N G S T A R T E D Figure 2.14 shows the two available cables supplied with EasyRA Figure 2.14 Cables (with Connectors) Supplied With EasyRA USB “A” Connection (to external computer) USB “B” Connection (to EasyRA) 9-pin RS-232 Serial Connector (male) 9-pin RS-232 Serial Connector (female) Connecting EasyRA to the External Computer The USB and RS-232 Serial Cables attach to the back, left side of EasyRA. Connecting EasyRA to the Computer Using the USB Connection 1 Plug the “B” connector of the USB cable into EasyRA. 2 Plug the “A” connector of the USB cable into a USB port on the external computer. Connecting EasyRA to the Computer Using the 9-pin RS-232 Connection 1 Plug the “male” RS-232 connector into EasyRA. 2 2.14 Plug the “female” RS-232 connector into the serial port on the external computer. E a s y R A O P E R A T O R ’ S M A N U A L Connecting the Touch Screen A Medica-supplied 15” Touch Screen Monitor is available for all user interface functions. The Touch Screen is connected to the external computer using a 15-pin mini D-Sub Serial connector and a USB connector. Refer to detailed instructions included with the Touch Screen Monitor. Connecting the Standard SVGA Computer Monitor, Keyboard and Mouse If a Touch Screen Monitor is not used, an SVGA Computer Monitor, Keyboard, and Mouse are also supported. Each of these components are connected to the external computer. Refer to specific instructions supplied with the external computer and each individual component, for connection to external computer. Connecting the Printer Local or Network printing connections may be used with EasyRA. The printer is connected to the external computer and not directly to the analyzer. Printers must be compatible with the minimum computer requirements. For more information on connection to the external computer, printer configurations, and installation of necessary printer drivers, refer to specific instructions supplied with the external computer and the printer. Clock Setting Several processes within the EasyRA analyzer utilize the computer’s operating system clock for status tracking. Adjustments to the date and time on the computer may compromise these functions. Please correctly set the computer’s operating system clock prior to using the EasyRA analyzer and do not adjust it once the analyzer is operational. 2.15 G E T T I N G S T A R T E D Starting EasyRA This section describes how to start EasyRA the very first time you use it and also how to restart after a normal shutdown. Starting EasyRA for the First Time Before you turn on EasyRA for the first time, you must identify the person who will be the administrator (referred to in the user interface as the Supervisor) for EasyRA. Typically this person is the Lab Manager or Lab Supervisor. The Supervisor will have privileges to add, modify, and remove up to eight users (technicians) who can access several of the System Setup features. The Supervisor will also have privileges to turn the security feature on or off and to delete test results. To turn on EasyRA for the first time: 1 Turn on the computer using the power button. 2 Close all covers on the EasyRA analyzer. 3 Turn on the analyzer using the power button on the left side of the unit. 4 Touch the EasyRA program icon on the desktop (see Figure 2.15). Figure 2.15 5 EasyRA Program Icon on the Desktop Wait for EasyRA’s startup screen to display. By default, the Security feature is disabled the first time you turn on EasyRA. All functions are available to all users when you first turn on EasyRA. Note: It is strongly recommended that you assign a Supervisor and define the Supervisor password as soon as possible after you start EasyRA for the first time. 6 2.16 For more information on the Security feature and the Supervisor password, see “Setting Up Security” on page 2.29). A popup message displays asking you to confirm that all covers are either completely up or down. Touch Ok. E a s y R A 7 O P E R A T O R ’ S M A N U A L Prime diluent, ISE Calibrants A and B (if you have the ISE Module option), and let EasyRA warm up for 30 minutes. For information on priming diluent, see “Priming the Diluent” on page 10.93. For information on priming Calibrants A and B, see “Priming the ISE Cal A/B” on page 10.98. Restarting EasyRA To restart EasyRA after a normal shutdown: 1 Turn on the computer using the power button. 2 Close all covers on the EasyRA analyzer. 3 Turn on the analyzer using the power button on the left side of the unit. 4 Touch the EasyRA program icon on the desktop. 5 Wait for EasyRA’s startup screen to display. 6 A popup message displays asking you to confirm that all covers are either completely up or down. Touch Ok. 7 Prime diluent and Calibrant A and B and let EasyRA warm up for 30 minutes. 8 Perform Daily Clean and ISE Clean. 9 Calibrate the ISE Module. 10 Calibrate all chemistry channels in need of calibration. EasyRA is now ready for use. 2.17 G E T T I N G S T A R T E D Stopping EasyRA Typically, EasyRA is not shut down between shifts, or on weekends, etc. However, if you choose to shut down the system, this section provides instructions on normal shutdown and emergency shutdown. Normal Shutdown If a test run is in progress, allow the run to complete and accept results for the tests that have been run. If you choose to end the run while it is still in progress, the results of the tests that were completed are saved, but all tests that were not started or in progress are cancelled. To shutdown EasyRA if a test run is not in progress and all results have been accepted: 1 Purge the ISE Module and remove the electrodes. For detailed instructions, see “Purging the ISE Waste Line” on page 10.95 and “Replacing the ISE Sensors” on page 10.73. 2 Touch the EasyRA icon in the top, right corner of the screen to shut down the user interface: A popup window displays asking if you want to exit the EasyRA program (see Figure 2.16). Figure 2.16 2.18 Popup Asking If You Want to Exit EasyRA 3 Touch Ok to exit the EasyRA program. 4 Remove Reagents and samples and store them appropriately. For more information, see “Loading and Unloading the Sample Ring and Reagent Tray” on page 5.16. E a s y R A 5 Turn off EasyRA using the power switch. 6 Turn off the computer. O P E R A T O R ’ S M A N U A L Emergency Shutdown In the event of an emergency, turn off EasyRA as follows: 1 Shut down the instrument using the power switch or by pulling the power plug from the outlet. 2 Shut down the computer using the power switch or by pulling the plug from the outlet. 3 Reagents requiring refrigeration should be refrigerated and ISE electrodes should be removed if EasyRA is shut down for an extended period of time. Samples (containing small sample amounts) should also be removed, as necessary. 2.19 G E T T I N G S T A R T E D Unlocking Covers This procedure describes the manual unlocking of covers during a power failure, emergency shutdown, or lock failure. To unlock the cover(s) manually: 1 Insert a thin, stiff wire (such as a straightened paper clip) into the recessed hole corresponding to the cover that is locked (see Figure 2.17 for an example). Figure 2.17 2.20 Insert Wire Into the Recessed Hole in Locked Cover 2 Push the thin, stiff wire into the recessed hole until you hear a “click” when the lock has been released. 3 When the Transfer Arm has stopped in a working position, you will need to move to the Home position manually. Lift up on the arm until the tip of the Probe is above the covers. Rotate the arm to the Home position and push down to the Park position (see Figure 2.18). E a s y R A Figure 2.18 4 O P E R A T O R ’ S M A N U A L Lift the Arm Until the Tip of the Probe is Above the Covers For more information on positions, see Figure 1.12. Open the covers as necessary. Note: For access to the Reaction Area Cover manual lock release, tilt down the Fluidics Drawer Cover as shown in Figure 2.19. If a Fluidics Drawer lock failure occurs, contact your Medica authorized dealer for assistance. 2.21 G E T T I N G S T A R T E D Figure 2.19 2.22 Access the Reaction Area Cover Manual Lock Release E a s y R A O P E R A T O R ’ S M A N U A L Loading Reagents for the First Time Before any tests can be selected or run, the Reagents for each test must be loaded on the Reagent Tray and inventoried. When Reagents are inventoried, EasyRA reads the RFID chip on each Reagent Wedge. When EasyRA inventories the Reagents, it loads all the information about that particular test into its memory. If you do not load and inventory the Reagents, the tests will never appear on the Test Select Keypad and you will not be able to select those tests. If no Reagents have been inventoried, the Test Select Keypad will only show electrolytes (Na, K, Cl, and Li) if you have the ISE Module option. Otherwise, it will be blank. Reagents only have to be loaded and inventoried once to be saved in memory and to appear on the Test Select Keypad. Even if you remove a Reagent from the Reagent Tray after it has been inventoried, EasyRA remembers it and continues to display it on the Test Select Keypad unless you disable it. For more information on disabling (or enabling) tests, see “Disabling (or Enabling) Tests” on page 2.27. Note: EasyRA tracks the on-board lifetime (use life) of Reagents. The timer for each Reagent starts the first time the Reagent is inventoried when its RFID chip is first read. If you are concerned about use life, it is recommended that you do not load and inventory new Reagents until you are ready to start using them. To load Reagents for the first time: 1 Load all Reagents on the Reagent Tray. For information on loading Reagents, see “Loading Reagent Wedges” on page 5.6. 2 Touch the Diagnostics/Maintenance/Setup icon, and then touch Setup. 3 On the Setup menu, select Reagents. The Reagent Setup screen displays (see Figure 2.20). 2.23 G E T T I N G S T A R T E D Figure 2.20 4 Reagent Setup Screen Touch Reagent Test Menu. This screen shows all reagents that will be displayed on the Test Select Keypad in alphabetical order. It shows all the Reagents that have been loaded on the Reagent Tray and inventoried (see Figure 2.21). Test names for user-defined tests are followed by an asterisk (*), for example, PCP*. Test names for user-defined tests that have not been programmed on wedges are preceded by a plus sign (+), for example +ETOH*. User-defined tests are added to the Reagent Test Menu when they are programmed. They do not need to be inventoried to appear on this screen. If no Reagents have been loaded, the Test Select Keypad is blank, except for electrolytes, if you have the ISE Module option. Test names with the plus sign have not been programmed on wedges and will appear in the Reagent Optimization area of the Test Select Keypad. 2.24 E a s y R A Figure 2.21 O P E R A T O R ’ S Reagent Test Menu Setup 5 To load the new Reagents for the first time, touch the Read New Reagents button: 6 A message displays asking if the new Reagents are in place (see Figure 2.22). Figure 2.22 M A N U A L Read New Reagents Message If the new Reagents have been loaded into the Reagent Tray, touch OK. If they have not been loaded into the Reagent Tray, either load them now and touch OK, or touch Cancel. If you touch OK, a message displays indicating the new Reagents are being read. This message disappears when all the new Reagents have been read. 2.25 G E T T I N G S T A R T E D Reagents that have been loaded and read successfully appear on the Test Select Keypad (see Figure 2.23). Figure 2.23 Test Select Keypad 2.26 For more information on the Test Select Keypad, see “Entering Test Data” on page 3.46. E a s y R A O P E R A T O R ’ S M A N U A L Disabling (or Enabling) Tests You can disable tests that have been loaded onto EasyRA if they are not being used. Disabled tests are displayed in gray on the Reagent Test Menu and are not available on the Test Select Keypads. Tests that have been disabled can also be enabled if you choose to use them at a later time. When you enable a test, it will display in black on the Reagent Test Menu and it will be available on the Test Select Keypads. To disable (or enable) tests from the Test Select Keypad: 1 Touch the Diagnostics/Maintenance/Setup icon, and then touch Setup. 2 On the Setup menu, select Reagent. The Reagent Setup screen displays. 3 Touch Reagent Test Menu. The Reagent Test Menu displays (see Figure 2.24) Figure 2.24 Reagent Test Menu 2.27 G E T T I N G Figure 2.25 S T A R T E D 4 Touch the Modify button 5 A message displays at the top of the test grid that indicates you can press a cell to disable or enable the test in the Test Panel. Touch a test on the Reagent Test Menu that you want to disable (or enable). See Figure 2.25. Select Disabled (or Enabled) to Disable (or Enable) the Selected Test 6 Touch Disabled to disable the test or Enabled to enable the test. Disabled tests are displayed in gray on the Reagent Test Menu with the word “Disabled” below the test and will not be available on the Test Select Keypad. Enabled tests are displayed in black on the Reagent Test Menu and will be available on the Test Select Keypad. Note: Disabled tests will no longer be run as part of user-defined test panels. Historical quality control and calibration data is stored/displayed. Note: Na+ results are required for calculation of Li+ results. If Na+ is disabled, Li+ will also be disabled. 2.28 E a s y R A O P E R A T O R ’ S M A N U A L System Setup This section describes how to set up the following EasyRA system options: Security. Printing. LIS Configuration. Operator ID. Positions for Stat. Debug Mode. Auto Run After Inventory. Auto Recovery After Error Language If you enable the Security option, only the Supervisor or users with a Technician password can access these System Setup options. For more information on enabling the Security option, see “Enabling or Disabling Security” on page 2.43. Setting Up Security EasyRA’s user interface has a built-in security feature which, if enabled, restricts access to the System Setup features to a Supervisor and up to eight technicians. When setting up EasyRA, it is strongly recommended that you assign a Supervisor who has administrator privileges on the system. The Supervisor must set a Supervisor password, in order to restrict access to setup features. If you do not use the security feature (it is disabled by default), the Supervisor does not need to create any users because, without security enabled, all users have access to all features. If you do use the security feature, the Supervisor is the only user that can enable that feature. The Supervisor is also the only user that can assign passwords for up to eight other users who will be allowed to modify the system setup. The Supervisor is also the only user who can delete test results. There can be more than eight users on the system; however, users without a password are restricted from performing system setup functions. When you start EasyRA for the first time, use the Startup Supervisor password “Medica” to gain access to the Security feature on EasyRA. Once that startup password is entered, you will be prompted to change it to a unique Supervisor password. 2.29 G E T T I N G S T A R T E D Note: Passwords on EasyRA are case sensitive. There is only a single Supervisor password. If that password is forgotten or lost, contact Medica Technical Support for information on how to reset the Supervisor password. Entering the Startup Password The first time you access the Security function on EasyRA, you will be prompted to enter the Supervisor password. As soon as the Startup Supervisor password is entered, you will be prompted to enter a new password. This procedure describes how to enter the Startup Supervisor password “Medica”. For information on changing the Supervisor password at any time, see “Changing the Supervisor Password” on page 2.32. To enter the Startup Supervisor password: 1 Touch the Diagnostics/Maintenance/Setup icon, and then touch Setup. 2 Touch System to access System Setup. On the System Setup screen (see Figure 2.26), touch Security. Figure 2.26 2.30 System Setup Screen E a s y R A O P E R A T O R ’ S M A N U A L When you select Security, EasyRA prompts you to enter the Supervisor password, because only the Supervisor has access to the Security features (see Figure 2.27). Figure 2.27 3 Touch the box beside the Password field on the Supervisor Login dialog. The Alphanumeric Keypad displays at the bottom of the screen (see Figure 2.28). Figure 2.28 4 Supervisor Login Prompt Alphanumeric Keypad on Touch Screen Enter the Startup Supervisor password “Medica” by touching the letters on the keypad. For more information on entering data on the Alphanumeric Keypad, see “Entering Alphanumeric Data” on page 3.45. Note: 5 Passwords on EasyRA are case sensitive. When you are done entering the Startup password, press the Enter key on the Alphanumeric Keypad: 2.31 G E T T I N G S T A R T E D 6 If you entered the Startup password correctly, you will be prompted to change the password from the Startup password to your own password on the Change Password screen. If the Startup password is not entered correctly, access is denied and the Supervisor Login box must be closed to continue. 7 Enter the new password on the Alphanumeric Keypad and touch Enter. 8 Touch Enter on the Change Password screen to confirm the new password. Changing the Supervisor Password This procedure describes how to change the Supervisor password at any time, regardless of whether security is enabled or not. The Supervisor password can have up to 24 alphanumeric characters. It is recommended that the Supervisor chooses a password that is easy to remember. The Supervisor has administrator privileges to EasyRA and the Supervisor password should be kept in a secure location. To change the Supervisor password: 1 Touch the Diagnostics/Maintenance/Setup icon, and then touch Setup. 2 If security is not enabled (the default), touch System to access System Setup. If Security is enabled, you will be prompted to enter your password on the Security Login dialog (see Figure 2.29) before you can access the System selection from the menu. Figure 2.29 2.32 Security Login Dialog E a s y R A O P E R A T O R ’ S M A N U A L Since you will be changing your Supervisor password, enter the current Supervisor password from the Alphanumeric Keypad. When you are done, touch Enter on the keypad: 3 Touch System to access the System Setup. If you have entered the Supervisor password when you logged in, the Security submenu displays (see Figure 2.29). If you did not enter the Supervisor password, you will be prompted to enter it now. 4 Touch Supervisor Password. The Set Supervisor Password dialog displays (see Figure 2.30). Figure 2.30 Set Supervisor Password 5 Touch the box beside the New Password field. The Alphanumeric Keypad displays at the bottom of the screen. 6 Enter your new password by touching the letters or numbers on the keypad. For more information on entering data on the Alphanumeric Keypad, see “Entering Alphanumeric Data” on page 3.45. 2.33 G E T T I N G S T A R T E D Note: 7 Passwords on EasyRA are case sensitive. When you are done entering the Startup password, press the Enter key on the Alphanumeric Keypad: Your new Supervisor password becomes active and the old one is disabled. Setting Up Technician Passwords The Supervisor can add up to eight Technician passwords. Users with Technician passwords have access to all the System Setup features, except Security, which is reserved for the Supervisor. Users who do not have a Technician password can view System Setup options, but cannot modify them. When you (the Supervisor) set up Technician passwords, you assign a name and a password for each user. The name is for reference only (so you can identify the person associated with each password). The user only enters the password, when prompted for it. The password can contain up to 24 alphanumeric characters and is case sensitive. It is recommended that you allow each technician to select their own password, so they will be able to remember it easily. Note: Only the Supervisor can add, modify, or delete Technician passwords. To add or modify Technician passwords: 2.34 1 Touch the Diagnostics/Maintenance/Setup icon, and then touch Setup. If Security is enabled, the Security Login dialog displays (see Figure 2.29). 2 Enter the Supervisor password (because only the Supervisor can add Technician passwords) on the Alphanumeric Keypad and touch Enter on the keypad: E a s y R A 3 O P E R A T O R ’ S M A N U A L Touch the System submenu. The System Setup screen displays (see Figure 2.26). On the System Setup screen, touch Security. 4 Touch Technician Passwords. The Technician Passwords screen appears (see Figure 2.31). From this screen you can add or modify Technician passwords. Figure 2.31 5 Technician Passwords Screen To add a new password or change an existing password, touch the Modify button: The screen is expanded, so you can add or modify Technician passwords (see Figure 2.32). 2.35 G E T T I N G Figure 2.32 2.36 S T A R T E D Add or Modify Technician Passwords 6 To add a new password, or modify an existing one, touch the Name field for that entry. 7 The Alphanumeric Keypad displays (see Figure 2.33). E a s y R A Figure 2.33 8 O P E R A T O R ’ S M A N U A L Enter Information for the Technician Password Enter a new name or modify an existing name and then touch Enter on the keypad: 2.37 G E T T I N G S T A R T E D The name is for reference only to help you identify the person assigned to each password. The user does not enter the name when prompted for the password. The updated name appears in the Name field you selected (see Figure 2.34). Figure 2.34 2.38 Name Entered on Technician Passwords Field E a s y R A 9 O P E R A T O R ’ S M A N U A L Touch the Password field for the name you added or updated. The Alphanumeric Keypad displays. 10 Enter a new password or modify the existing password and then touch Enter on the keypad. It is recommended that you allow each technician to choose their own password so they can remember it easily. The updated password appears in the table. 11 When you are done adding or editing Technician Passwords, touch the Enter button at the top left side of the screen: This saves your entries and displays the updated Technician Passwords (see Figure 2.35). Figure 2.35 Technician Passwords 2.39 G E T T I N G S T A R T E D To delete Technician passwords: 1 Touch the Diagnostics/Maintenance/Setup icon, and then touch Setup. If Security is enabled, the Security Login dialog displays (see Figure 2.29). 2 Enter the Supervisor password (because only the Supervisor can delete Technician passwords) on the Alphanumeric Keypad and touch Enter on the keypad: 3 Touch the System submenu. The System Setup screen displays (see Figure 2.26). On the System Setup screen, touch Security. 4 Touch Technician Passwords. The Modify Technician Password screen appears (see Figure 2.31). From this screen you can deleted a Technician password. 5 To delete a password touch the Modify button: The screen is expanded, so you can delete Technician passwords (see Figure 2.32). 6 Touch the Name field for the password you want to delete. 7 On the Alphanumeric Keypad that displays, use the backspace key: to delete the name in the Name field, and then touch Enter on the keypad: The Name field for that entry is blank. 8 2.40 Touch the Password field for the same entry. E a s y R A 9 O P E R A T O R ’ S M A N U A L On the Alphanumeric Keypad that appears, use the backspace key to delete the password in the Password field, and then touch Enter on the keypad. The Password field for that entry is blank (see Figure 2.36). Figure 2.36 Delete Technician Password 10 When you are done deleting Technician passwords, touch the Enter button at the top right side of the screen: This saves your changes and displays the updated Technician Passwords screen (see Figure 2.37). The deleted password(s) have been removed from this screen. 2.41 G E T T I N G Figure 2.37 2.42 S T A R T E D Technician Passwords Screen After Deleting an Entry E a s y R A O P E R A T O R ’ S M A N U A L Enabling or Disabling Security Note: The procedure describes how to enable or disable security. It also serves as an example of how to set up the following system setup options: Enabling or Disabling Automatic Printing. Enabling or Disabling the Operator ID. Selecting the Number of Stat Positions. Enabling or Disabling Debug Mode. This manual contains brief procedures for each of these options; however, the full details of the procedure to configure these system setup options are provided here, in this example. This section describes how to enable or disable the Security feature. By enabling Security, you limit access to some system setup tasks to only those users who have a Technician password. Other users can view the settings in the system setup area, but cannot change them. If the Security feature is not enabled, any user has access to all EasyRA functions in the system except the following, which are reserved for the Supervisor: Setting the Supervisor password. Setting the Technicians password. Enabling/Disabling Security. By default, the Security feature is disabled. If you want to limit access to the system setup functions, you must enable security. Note: Only the Supervisor can enable or disable the Security feature. 2.43 G E T T I N G S T A R T E D To enable or disable security: 1 Touch the Diagnostics/Maintenance/Setup icon, and then touch Setup. If Security is enabled, the Security Login dialog displays (see Figure 2.29). 2 Enter the Supervisor/Technician password on the Alphanumeric Keypad and touch Enter on the keypad: 3 Touch the System submenu. The System Setup screen displays (see Figure 2.26. On the System Setup screen, touch Security. The Supervisor Login dialog displays (see Figure 2.27). 4 Enter the Supervisor password (because only the Supervisor can enable or disable security) on the Alphanumeric Keypad and touch Enter on the keypad: 5 Touch Security Disable/Enable. The Enable or Disable Security screen appears (see Figure 2.38). From this screen you can enable or disable security. 2.44 E a s y R A Figure 2.38 O P E R A T O R ’ S M A N U A L Enable or Disable Security 6 To change the setting for Security, touch the Modify button: 7 The next screen displays, instructing you to touch the cell to modify your setting (see Figure 2.39). 2.45 G E T T I N G Figure 2.39 S T A R T E D Touch Security Setting to Modify It 8 2.46 Touch the Disabled or Enabled cell (whichever is displayed) to change the setting. A drop-down menu displays allowing you to change the setting (see Figure 2.40). E a s y R A Figure 2.40 9 O P E R A T O R ’ S M A N U A L Drop-Down Menu to Change the Security Setting Touch the setting you want to select from the drop-down menu. Table 2.1 describes each setting: Table 2.1 Security Settings IF YOU SELECT: THEN THE SECURITY FEATURE WILL BE: Enabled Enabled, allowing only users with a Technician password to modify the System Setup functions. Disabled Disabled, allowing any user to modify the System Setup functions. The selected setting displays in the cell. 2.47 G E T T I N G S T A R T E D 10 Touch Enter at the top right side of the screen to confirm your setting: The new setting is saved and displayed (see Figure 2.41). You can change it again or move to another function. Figure 2.41 2.48 Updated Security Setting E a s y R A O P E R A T O R ’ S M A N U A L Setting Up Printer Options The printer options allow you to specify whether results will be automatically printed after a test run is complete (auto printing). All Sample Results or all Patient Reports may be configured for auto printing. You may choose to enable either of these options, or both of them. You can also specify the contents of the report header and the order in which tests are printed from the Printing menu. Enabling or Disabling Automatic Printing Before you enable automatic printing, be sure that the printer is set up correctly. By default, automatic printing is disabled (off). To enable or disable automatic printing: 1 Touch the Diagnostics/Maintenance/Setup icon, and then touch Setup. If Security is enabled, the Security Login dialog displays (see Figure 2.27). 2 Enter your password. If you are not the Supervisor or do not have a Technician password, you cannot access this function. 3 Touch the System submenu. The System Setup screen displays (see Figure 2.26). 4 Touch Printing, and then touch either Auto Print All Sample Results or Auto Print All Patient Reports. 5 When you make your selection, the setting for the selected Auto Printing function displays (see Figure 2.42 or Figure 2.43). From these screens, you can enable or disable the automatic printing of results or reports. 2.49 G E T T I N G Figure 2.42 2.50 S T A R T E D Enable or Disable Auto Printing All Sample Results E a s y R A Figure 2.43 O P E R A T O R ’ S M A N U A L Enable or Disable Auto Printing All Patient Reports Table 2.2 lists the options available for automatic printing. Table 2.2 IF YOU SELECT: THEN RESULTS OR REPORTS: Enabled Will be automatically printed when a run is completed. Disabled Will not be automatically printed when a run is completed. 6 Auto Printing Settings For a detailed description of how to change a setup option, see Steps 5 through 9 in “Enabling or Disabling Security” on page 2.43. If you want to automatically print both results and reports after each run, repeat Steps 4 and 5 for both options. If both printing options are enabled, Sample Results will be printed first, followed by individual Patient Reports for each sample in the run. 2.51 G E T T I N G S T A R T E D Specifying the Report Header This option allows you to specify the information that will be included in the header of all printed results. The following information can be specified: Lab Name. Address #1. Address #2. Telephone Number. Figure 2.44 shows a sample of a report with a report header. Figure 2.44 Report Header on Printed Report Report Header To specify the content of the report header: 2.52 1 Touch the Diagnostics/Maintenance/Setup icon, and then touch Setup. If Security is enabled, the Security Login dialog displays (see Figure 2.27). 2 Enter your password. If you are not the Supervisor or do not have a Technician password, you cannot access this function. 3 Touch the System submenu. The System Setup screen displays (see Figure 2.26). 4 Touch Printing, and then touch Report Header. The current settings for the Report Header display (see Figure 2.45). From this screen, you can specify the content of your report header. E a s y R A Figure 2.45 5 O P E R A T O R ’ S M A N U A L Report Header Screen To add information to the report header or to change an existing report header, touch the Modify button: The screen is expanded, so you can add or modify the Report Header (see Figure 2.46). 2.53 G E T T I N G Figure 2.46 S T A R T E D Add or Modify the Report Header Screen 6 To add a new entry, or modify an existing entry, touch the field you want to change (Lab Name, Address #1, Address #2, or Telephone Number). The Alphanumeric Keypad displays. 7 Enter the appropriate information for the field you selected or modify the existing information, and then touch Enter on the keypad. The updated information appears in the selected field. 8 2.54 Repeat steps 6-7 for each field, as needed, until all information has been added or updated. E a s y R A 9 O P E R A T O R ’ S M A N U A L When you are done adding or editing the Report Header fields, touch the Enter button at the top right side of the screen: This saves your entries and displays the updated information (see Figure 2.47). Figure 2.47 New Settings on Report Header Screen Any time a report is printed, the information specified in the report header will appear at the top of the report. Setting Up the Patient Report Test Order The order that tests are displayed on Sample Details screens and printed on Patient Reports may be defined by the user. Sample Results that are displayed as lists appear in alphanumeric order by test abbreviation. 2.55 G E T T I N G S T A R T E D To set up the test order: 1 Touch the Diagnostics/Maintenance/Setup icon, and then touch Setup. If Security is enabled, the Security Login dialog displays. 2 Enter your password. If you are not the Supervisor or do not have a Technician password, you cannot access this function. 3 Touch the System submenu. The System Setup screen displays. 4 Touch Printing (see Figure 2.48), and then touch Patient Report Test Order. Figure 2.48 2.56 Touch Printing and then Touch Patient Report Test Order E a s y R A O P E R A T O R ’ S M A N U A L The Test Order on Report table is displayed (see Figure 2.49). From this screen, you can set the test order for printing. Figure 2.49 5 Test Order on Report Table Touch Modify to edit the test order. The Preview Pane displays beside the Test Order on Report table (see Figure 2.50). 2.57 G E T T I N G Figure 2.50 S T A R T E D Preview Pane Beside the Test Order on Report Table 6 2.58 Touch the first row in the Test column to select the name of the first test you want printed at the top of the patient report. The Test Select Keypad displays (see Figure 2.51). E a s y R A Figure 2.51 7 O P E R A T O R ’ S M A N U A L The Test Select Keypad Showing the Test Currently in the Selected Position Touch the test that you want to appear in the selected position from the Test Select Keypad and touch Enter. For example, if you want CREA to appear first, touch CREA on the Test Select Keypad, and then touch Enter. (If a test is unavailable, it may appear in another position in the list. To move that test, locate it in the Test Order on Report table, select it to display the Test Select Keypad, and then touch the test to remove it from its current position. Once it is removed, it should be available to use in another position. 8 Touch the next cell under the Test column and choose the name of the next test you want in the patient report. 9 Continue selecting the remaining tests in the desired order. The preview pane on the right hand side of the screen displays the printing order as tests are selected (see Figure 2.52). To separate groups of tests, leave a blank Test cell between each group. 2.59 G E T T I N G Figure 2.52 S T A R T E D Preview Pane on Right Hand Side of Screen Showing Test Order on Reports Note: Tests will be printed in the order they are displayed. If any tests are not added to the Test Order on Report table, results will be printed in alphabetical order following the tests for which the order has been defined. 10 When all the tests you want to put in a particular order are added, touch the Enter button at the top right side of the screen: A message displays indicating that any remaining tests (that have not been added to the list) will appear at the end of the results. 11 Touch OK to save the Test Order. All tests on the Test Select Keypad that have not been assigned a test position are added to the bottom of the list (in alphabetical order). 2.60 E a s y R A O P E R A T O R ’ S M A N U A L Setting Up the LIS Configuration WARNING: Medica cannot guarantee the use of the EasyRA analyzer in conjunction with your LIS system. LIS connectivity is provided “AS IS.” The EasyRA analyzer transmits information to your LIS system based on the configuration information provided by you. LIS systems may vary in how information received is handled and displayed. It is your responsibility to validate (consistent with good laboratory practices) the use of the EasyRA analyzer when used in conjunction with your LIS system to ensure that results displayed by the LIS are accurate and consistent with results displayed on the EasyRA analyzer. Note: This procedure only applies if you have the LIS Connectivity option. This option allows you to specify the LIS configuration information that controls the communication between the LIS and EasyRA. The following information can be specified: Connection. Device ID. Com Port. Baud Rate. Hardware Handshake. Barcode with Checksum. Status You can also send a sample LIS message to the LIS from the LIS Setup menu. To specify the LIS configuration settings: 1 Touch the Diagnostics/Maintenance/Setup icon, and then touch Setup. If Security is enabled, the Security Login dialog displays (see Figure 2.27). 2.61 G E T T I N G S T A R T E D 2 Enter your password. If you are not the Supervisor or do not have a Technician password, you cannot access this function. 3 Touch the System submenu. The System Setup screen displays (see Figure 2.26). 4 Touch LIS. If you do not have the LIS option, LIS will be displayed in gray, rather than black. 5 Touch Settings (see Figure 2.53). Figure 2.53 LIS Setting The current settings for the LIS configuration are displayed (see Figure 2.54). If the screen is blank, no LIS Configuration information has been added. From this screen, you can specify the LIS Configuration. 2.62 E a s y R A Figure 2.54 6 O P E R A T O R ’ S M A N U A L LIS Configuration Settings To change the LIS configuration information, touch the Modify button: The screen is expanded, so you can add the LIS configuration or modify the current entries (see Figure 2.55). 2.63 G E T T I N G Figure 2.55 S T A R T E D Enter LIS Configuration Screen 7 2.64 To enter information into each field that displays, touch the field and enter the appropriate information on the keypad or make a selection from the drop-down menu that displays. E a s y R A O P E R A T O R ’ S M A N U A L Table 2.3 describes each field and its possible values: Table 2.3 8 LIS Configuration Fields FIELD DESCRIPTION POSSIBLE VALUES Connection Specifies if the analyzer has LIS connectivity or not. Enabled Disabled Device ID A unique ID specified by the LIS to identify EasyRA. Up to 30 alphanumeric characters specified by the user. Com Port The Communications Port on EasyRA used to send and receive LIS data. 1-4 Baud Rate The rate at which data travels between the LIS and EasyRA. 9600 19200 Hardware Handshake Enable or disable the Hardware Handshake function. Enabled Disabled Barcode with Checksum Specifies if barcodes used on EasyRA will or will not have a checksum. Enabled Disabled Status Specifies the status of the LIS connection. Connected Disconnected When you are done entering the LIS configuration, touch Enter: The new or updated LIS configuration displays. Note: Further information regarding interface with an LIS may be found in the separate LIS manual. 2.65 G E T T I N G S T A R T E D Sending LIS Sample From the LIS Setup, you can send a sample LIS message to verify that your analyzer is communicating properly with the LIS. When this command is selected, the text of the message sent to the LIS is displayed. When the LIS receives the message, it sends back an Acknowledgement (ACK) to confirm it has been received. To send an LIS sample message: 1 Touch the Diagnostics/Maintenance/Setup icon, and then touch Setup. If Security is enabled, the Security Login dialog displays (see Figure 2.27). 2 Enter your password. If you are not the Supervisor or do not have a Technician password, you cannot access this function. 3 Touch the System submenu. The System Setup screen displays (see Figure 2.26). 4 Touch LIS. If you do not have the LIS option, LIS will be displayed in gray, rather than black and cannot be selected. 5 Touch Send LIS Sample (see Figure 2.56). Figure 2.56 2.66 Touch Send LIS Sample E a s y R A 6 O P E R A T O R ’ S M A N U A L A standard LIS message is displayed (see Figure 2.57). Figure 2.57 Standard LIS Sample Message 2.67 G E T T I N G S T A R T E D 7 Figure 2.58 Coded Message Sent to LIS and ACK Received Back from LIS 8 2.68 Touch Send Now. The coded message that is sent to the LIS displays on the screen. When the LIS receives the message, it sends back an acknowledgement (ACK) message (see Figure 2.58). You can print the sample test message by touching the print icon: E a s y R A O P E R A T O R ’ S M A N U A L Selecting the Operator ID Option This section describes how to enable or disable the Operator ID feature. When you enable the Operator ID, EasyRA prompts users to enter their operator ID (contains a maximum of 8 alphanumeric characters that identify each operator) when they accept results or print results. By default, the Operator ID is disabled. To enable or disable the Operator ID: 1 Touch the Diagnostics/Maintenance/Setup icon, and then touch Setup. If Security is enabled, the Security Login dialog displays (see Figure 2.27). 2 Enter your security password and press Enter. If you are not the Supervisor or do not have a Technician password, you cannot access this function. 3 Touch the System submenu. The System Setup screen displays (see Figure 2.26). 4 Touch Operator ID. When you touch Operator ID, the current Operator ID setting displays (see Figure 2.59). From this screen you can enable or disable the Operator ID. Figure 2.59 Enable or Disable Operator ID Screen 2.69 G E T T I N G S T A R T E D Table 2.4 lists the choices available for the Operator ID option. Table 2.4 Operator ID Option IF YOU SELECT: THE OPERATOR ID OPTION WILL BE: Enabled Enabled. EasyRA will prompt users to enter their Operator ID before they accept or print results. Disabled Disabled. EasyRA will not prompt users to enter their Operator ID before they accept or print results. For a detailed description of how to change a setup option, see Steps 5 through 9 in “Enabling or Disabling Security” on page 2.43. Selecting the Number of Stat Positions This option allows you to select the number of positions that are reserved on the Sample Ring for stat samples (samples that must be run immediately). If you reserve some positions for stat samples, you can pause a test run that is in progress and add these stat samples to an existing run. However, if no positions are reserved, this process is much more disruptive. If you receive a stat sample into the laboratory and all the sample positions are being used, you first must pause the run, remove a sample from the Sample Ring and remove the tests for that sample from the Worklist. Then you must add the stat sample to the Sample Ring and add the new tests to the Worklist. The default number of stat positions is 1. To set the number of positions reserved for stat samples: 2.70 1 Touch the Diagnostics/Maintenance/Setup icon, and then touch Setup. If Security is enabled, the Security Login dialog displays (see Figure 2.29). 2 Enter your security password and press Enter. If you are not the Supervisor or do not have a Technician password, you cannot access this function. 3 Touch the System submenu. The System Setup screen displays (see Figure 2.26). 4 Touch Positions for Stat. When you touch Positions for Stat, the current setting is displayed (see Figure 2.60). From this screen you can modify the number of positions reserved for stat samples. E a s y R A Figure 2.60 O P E R A T O R ’ S M A N U A L Positions Reserved for Stat Screen For a detailed description of how to change a setup option, see Steps 5 through 9 in “Enabling or Disabling Security” on page 2.43. 2.71 G E T T I N G S T A R T E D Enabling or Disabling Debug Mode This section describes how to enable or disable the Debug Mode. Typically you only use Debug Mode when given instructions to do so by Medica Technical Support. Debug Mode displays additional information from the Results and Status menus for debugging purposes. When Debug Mode is enabled, a selection called Other Tables is available from the Results menu and a selection called Sample Inventory is available from the Status menu. By default, Debug Mode is disabled. To enable or disable the Debug Mode: 2.72 1 Touch the Diagnostics/Maintenance/Setup icon, and then touch Setup. If Security is enabled, the Security Login dialog displays (see Figure 2.29). 2 Enter your security password and press Enter. If you are not the Supervisor or do not have a Technician password, you cannot access this function. 3 Touch the System submenu. The System Setup screen displays (see Figure 2.26). 4 Touch Debug Mode. When you touch Debug Mode, the current setting for Debug Mode displays (see Figure 2.61). From this screen you can enable or disable Debug Mode. E a s y R A Figure 2.61 O P E R A T O R ’ S M A N U A L Enable or Disable Debug Mode Screen For a detailed description of how to change a setup option, see Steps 5 through 9 in “Enabling or Disabling Security” on page 2.43. 2.73 G E T T I N G S T A R T E D Enabling or Disabling Auto Run After Inventory The Auto Run After Inventory feature allows you to start a run immediately following the Workslist Inventory without interruption, if you have checked the status of individual components before starting a run or at the beginning of the shift. For more information, see “Performing an Inventory” on page 6.32 and “Starting a Run” on page 6.35. By default, Auto Run After Inventory is disabled. To enable or disable Auto Run After Inventory: 2.74 1 Touch the Diagnostics/Maintenance/Setup icon, and then touch Setup. If Security is enabled, the Security Login dialog displays (see Figure 2.29). 2 Enter your security password and press Enter. If you are not the Supervisor or do not have a Technician password, you cannot access this function. 3 Touch the System submenu. The System Setup screen displays (see Figure 2.26). 4 Touch Auto Run After Inventory. The current setting for Auto Run After Inventory displays (see Figure 2.62). From this screen you can enable or disable Auto Run After Recovery Mode. E a s y R A Figure 2.62 O P E R A T O R ’ S M A N U A L Enable or Disable Auto Run After Inventory Screen For a detailed description of how to change a setup option, see Steps 5 through 9 in “Enabling or Disabling Security” on page 2.43. 2.75 G E T T I N G S T A R T E D Enabling or Disabling Auto Recovery after Error The Auto Recovery after Error feature allows EasyRA to attempt to recover from certain errors instead of stopping the run when an error is encountered. If auto recovery is enabled, EasyRA will stop the run when it encounters the fourth error. For more information, see “Auto Recovery after Error During a Run” on page 6.47. By default, Auto Recovery after Error is enabled. To enable or disable Auto Recovery after Error: 2.76 1 Touch the Diagnostics/Maintenance/Setup icon, and then touch Setup. If Security is enabled, the Security Login dialog displays (see Figure 2.29). 2 Enter your security password and press Enter. If you are not the Supervisor or do not have a Technician password, you cannot access this function. 3 Touch the System submenu. The System Setup screen displays (see Figure 2.26). 4 Touch the down arrow to go to the second page of the list and touch Auto Recovery after Error. When you touch Auto Recovery after Error, the current setting for Auto Recovery after Error displays (see Figure 2.63). From this screen you can enable or disable Auto Recovery after Error Mode. E a s y R A Figure 2.63 O P E R A T O R ’ S M A N U A L Enable or Disable Auto Recovery After Error Screen For a detailed description of how to change a setup option, see Steps 5 through 9 in “Enabling or Disabling Security” on page 2.43. For an example of how EasyRA behaves when Auto Recovery after Error is enabled, see “Auto Recovery after Error During a Run” on page 6.47. Selecting the Language Displayed on the EasyRA User Interface This section describes how to select the language displayed on the EasyRA user interface. By default, English is the language displayed on EasyRA. To select a different language: 1 Touch the Diagnostics/Maintenance/Setup icon, and then touch Setup. If Security is enabled, the Security Login dialog displays (see Figure 2.29). 2 Enter your security password and press Enter. If you are not the Supervisor or do not have a Technician password, you cannot access this function. 3 Touch the System submenu. The System Setup screen displays (see Figure 2.26). 2.77 G E T T I N G S T A R T E D 4 Figure 2.64 Touch the down arrow to go to the second page of the list and touch Language. When you touch Language, the current setting for the Language displays (see Figure 2.64). From this screen you can select any of the languages that are available. Select the Language Displayed on the EasyRA User Interface For a detailed description of how to change the language option, see Steps 6 through 10 in “Enabling or Disabling Security” on page 2.43. Instead of choosing from Enabled or Disabled in Step 9, select the desired language. Your choices are: 2.78 English Chinese French Italian Polish Portugese Russian Spanish E a s y R A Turkish German O P E R A T O R ’ S M A N U A L Once the language selection has been made, touch Enter and the EasyRA user interface will switch to the new language. Setting Up and Enabling Calculated Results Calculated Results are derived when the results of tests that are run on samples are used as input in formulas. EasyRA provides four Calculated Results: cAnGap (calculated with results from Cl-, CO2, and Na+) cBU/Cr (calculated with results from BUN and CREA) cLDL (calculated with results from CHOL, HDL, and TRIG) eGFR (calculated with results from CREA) To receive a calculated result, you must first set up and enable calculated results. For more information on calculated results, see “Viewing Calculated Results” on page 7.18. To set up and enable Calculated Results: 1 Touch the Diagnostics/Maintenance/Setup Icon, and then touch Setup. 2 If Security is enabled, the Security Login dialog displays. Enter the Supervisor password or a Technician password on the Alphanumeric Keypad and then touch Enter. 3 On the Setup menu, touch Tests. The Setup Tests screen displays. Touch Calculated Results (see Figure 2.65). Figure 2.65 Setup Tests 2.79 G E T T I N G S T A R T E D The list of available Calculated Results displays (see Figure 2.66). Notice that the list includes an indication as to whether the Calculated Result is enabled or disabled. Figure 2.66 4 2.80 Calculated Results Available in EasyRA Touch the Calculated Result of interest. A table displays to the right of the list showing the formula(s) and other information for the selected Calculated Result. Figure 2.67 shows an example of the Calculated Result called eGFR. E a s y R A Figure 2.67 O P E R A T O R ’ S M A N U A L Example of Calculated Result Screen for eGFR The table contains the following information: The name of the Calculated Result and the units for the Calculated Result. The formula (or formulas) used to generate the Calculated Result. Some Calculated Results use a single formula and others, like eGFR, require different formulas for male and female patients. Tabular information indicating the Tests Needed for this Calculated Result, whether the tests are in the Reagent Test Menu, and the units specified for each component test. If any of tests are not in the Reagent Test Menu (meaning that the Reagent has never been loaded on EasyRA and therefore will not appear in the Test Select Keypad when you set up your worklist), the test name will appear in red and you will need to load it before you can enable this Calculated Result. For more information on loading reagents, see “Loading Reagents for the First Time” on page 2.23 2.81 G E T T I N G S T A R T E D If the units specified for the component tests are not all the same, the units appear in red and you will need to modify the units of one or more tests until they all match. For more information on changing the test units for particular test, see “Setting Up Test Units” on page 4.17 Note: The units setting for a test is systemwide. Use care when changing units for tests used in a Calculated Result. If that same test is used in more than one Calculated Result, changing the units for one Calculated Result may cause a mismatch of units in another Calculated Result. If a mismatch of units occurs, the Calculated Result will be disabled until the mismatch is corrected. 2.82 The Enable/Disable button that allows you to enable or disable the Calculated Result. 5 Before attempting to enable a Calculated Result, verify that no tests or units are displayed in red. 6 To enable a Calculated Result, touch the Disabled button and select Enabled from the drop-down box. (If the Calculated Result is enabled, you can disable it by selecting the Enabled button and selecting Disabled from the drop-down box.) Once the Calculated Result is enabled, it will be computed and displayed for any sample for which the appropriate component tests are included in the Worklist. 3 Understanding the User Interface This chapter provides a referenced-based description of EasyRA’s user interface, including descriptions of all user-interface features, such as the touch screen, all screen components, and using the keypads. Note: The EasyRA manual has been written based on the use of a Touch Screen monitor for control of the user interface. EasyRA may also be operated with a standard monitor, keyboard, and mouse. All functions in this text that relate to touching buttons, icons, or fields may be accomplished with a mouse. All functions in this text that relate to data entry of information may be accomplished with the keyboard. 3.1 U N D E R S T A N D I N G T H E U S E R I N T E R F A C E Touch Screen EasyRA’s user interface is a touch screen. All information related to EasyRA is displayed on the touch screen and all commands are issued by touching buttons or icons on the touch screen. Figure 3.1 shows an example of a screen display. Figure 3.1 Example EasyRA Screen To make selections, gently touch the desired icon, button, or field on the touch screen. In some cases, you must also touch an Enter button or a confirmation button to indicate that your action is complete. All user interface functions can be performed via the touch screen. 3.2 E a s y R A O P E R A T O R ’ S M A N U A L Screen Colors The user interface uses a number of visual cues, including colors, to help you quickly determine what type of action is being performed. Each of the four main areas in the user interface has a unique color associated with it. Table 3.1 provides a list of the main user interface areas and the color associated with each one. Table 3.1 Summary of EasyRA Areas and Colors AREA ICON COLOR Worklist Blue Results Yellow/Gold Status Green Diagnostics/ Maintenance/ Setup Pink For example, if you touch Edit Worklist or Monitor Worklist from the Worklist menu, blue is the primary color on the screens. Similarly, if you select Current Results or Patient Results from the Results menu, yellow/gold is the primary color on the screens. 3.3 U N D E R S T A N D I N G T H E U S E R I N T E R F A C E EasyRA Screen Components Figure 3.2 shows an example of an EasyRA screen and its main components. Figure 3.2 EasyRA Screen Icon/Menu Bar Data area EasyRA’s user interface is designed with every screen having a common Icon/Menu bar at the top followed by a Data area. You are alerted to various conditions from the Icon/Menu bar and you issue commands from this bar. Various screens and controls display in the Data area, based on the selections you make from the Icon/Menu bar. You can view data and perform various actions from the Data area. 3.4 E a s y R A O P E R A T O R ’ S M A N U A L Icon/Menu Bar The Icon/Menu bar, located at the top of every EasyRA window, consists of a series of buttons and icons as shown in Figure 3.3. Figure 3.3 Icon/Menu Bar Run button Worklist icon/menu System icon Status icon/menu Results icon/menu Date/Time Diagnostic/ Maintenance/ Setup icon/menu Pause button System icon This figure shows two views of the icon/menu bar. The Run button is shown on the upper view and the Pause/End Run, Run Timer, and Cuvette Timer are shown in the lower view. Also, two variations of the System icon are shown. Icons can blink to indicate that various conditions (that may require further attention) have occurred. When you touch the Worklist, Results, Status, or Diagnostic/Maintenance/Setup icons, a drop-down menu appears, giving you access to the functions of EasyRA. Icons Table 3.2 describes the function of each icon. For information on the drop-down menus that display when you select an icon, see “Drop-Down Menus” on page 3.8. 3.5 U N D E R S T A N D I N G T H E U S E R I N T E R F A C E Table 3.2 Summary of Icon Functions ICON NAME DESCRIPTION Run button The Run button appears only when EasyRA is prepared to run tests. If EasyRA is not ready to run, this area is blank. When you touch Run, the run begins and the button toggles to the Pause/End Run button. A timer displays below the Pause/End Run button, indicating the time left in the run. When you touch Pause/End Run, EasyRA asks if you want to pause or end the run. If you select Pause, the run is paused and the user interface returns to the Edit Worklist screen. The Run button will reappear when the Worklist is complete. If you select End Run, the run is cancelled immediately. Pause/End Run button and Run Timer The Pause/End Run timer displays in red when: You have programmed a calibration that is necessary for other tests to be completed with the run. A blank is being performed. Runs cannot be performed when this timer is displayed in red. System icon (All Unlocked) 3.6 (All Locked) This icon flashes to indicate a change in status. The icon also changes to show additional information, such as the number of the Sample Ring being run. Status shown by this icon is related to EasyRA hardware and software, rather than a particular test run. When you touch the System icon, the System Status screen displays. For more information on the System Status screen, see “Viewing System Status Information” on page 3.9. The grayed representation of the system icon above indicates the system is unlocked. All areas of EasyRA are accessible to the user. The representation of the system icon to the left indicates the system is locked and all areas of EasyRA are locked during a run. Cuvette Replacement icon This icon and timer only appear when EasyRA determines that it will run out of cuvettes before the run is completed. The icon and timer display to the right of the System icon. The number above the icon indicates the amount of cuvettes needed to finish the run. The timer below the icon indicates the time left in the run until the EasyRA runs out of cuvettes. Worklist icon When you touch the Worklist icon, the Worklist menu displays. When you make a selection from the menu, the Worklist icon is highlighted with a blue border to indicate you are viewing or updating the Worklist. For more information on these activities, see Chapter 5, “Preparing EasyRA.”. E a s y R A O P E R A T O R ’ S M A N U A L Table 3.2 Summary of Icon Functions ICON NAME DESCRIPTION Results icon When you touch the Results icon, the Results menu displays. When you make a selection from the menu, the Results icon is highlighted with a yellow border to indicate you are viewing results. For more information on these activities, see Chapter 7, “Viewing Results.” Status icon This icon flashes to indicate that an event has occurred that may require attention. When you touch the Status icon, the Status menu displays. When you make a selection from the menu, the Status icon is highlighted with a green border to indicate you are viewing status. For more information on these activities, see Chapter 8, “Monitoring Status.” Diagnostic/ Maintenance/ Setup icon The icon flashes to indicate that cleaning is needed. When you touch the Diagnostic/Maintenance/Setup icon, the Diagnostic/ Maintenance/Setup menu displays. When you make a selection from the menu, the Diagnostic/Maintenance/Setup icon is highlighted with a pink border to indicate you are performing Diagnostic, Maintenance, or Setup functions. For more information on these activities, see Chapter 2, “Getting Started,” Chapter 4, “Setting Up Test Configurations,” Chapter 10, “Performing Maintenance,” or Chapter 11, “Troubleshooting & Diagnostics.” Logo/Date/ Time Shows the version of EasyRA you are running and the current date and time. Touch the logo to exit EasyRA’s user interface during shutdown procedures. For more information, see “Stopping EasyRA” on page 2.18. The Worklist, Status, and Diagnostic/Maintenance/Setup icons may blink to indicate that various conditions require further attention. If you select a blinking icon to open the menu, the submenu item requiring attention will also blink. If you acknowledge the issue, but do not resolve it, or if there are additional items requiring attention in the menu, the Worklist, Status, or Diagnostic/Maintenance/Setup icons will stop blinking, but a small triangle appears in the corner of the affected icon to indicate that further attention is required in that area of the system. Figure 3.4 shows the triangle that replaces the blinking icon. Figure 3.4 Triangle in Corner of Icon to Indicate Attention is Needed 3.7 U N D E R S T A N D I N G T H E U S E R I N T E R F A C E Drop-Down Menus The Icon/Menu bar, located at the top of every EasyRA window, consists of a series of icons as shown in Figure 3.3. Touch the System icon to display System Status or Test Counts. Touch the Worklist, Results, Status, or Setup icons to display the drop-down menus. Figure 3.5 shows an overview of the EasyRA menus. Each of these menus are described in detail in this manual. Figure 3.5 Test Count 3.8 Overview of EasyRA Menus E a s y R A O P E R A T O R ’ S M A N U A L Viewing System Status Information From the System Status icon, you can view the EasyRA system status. To view system status: Touch the System icon to display the System Status screen. Touch Status (see Figure 3.6). Figure 3.6 Touch Status The System Status displays (see Figure 3.7). Figure 3.7 System Status Screen 3.9 U N D E R S T A N D I N G T H E U S E R I N T E R F A C E The System Status screen shows the status of key system components in the first six lines of data. In the event that errors occur, EasyRA displays an error table below the system status information. For each error generated, EasyRA displays an error code and the location in the system where the error occurred. For more information on error codes and how to recover from errors, see “Hardware Problems” on page 11.2. Most errors are best cleared by performing diagnostic tests of the system indicated by the error code. However, if this procedure fails to clear the error, EasyRA hardware may be reset by touching the Hardware Reset button located above the System Status table. Note: You can toggle back and forth between the System Status and the Test Count by selecting either Status or Test Count. 3.10 E a s y R A O P E R A T O R ’ S M A N U A L Viewing Test Counts From the System Status icon, you can select to view the Test Count Log. This table shows the number of tests for Patient, Calibration, and QC that have been run in the past day, week, month, or year. In addition, you can define a date range and view the number of tests run in that time period. Note: The test counts are stored in encrypted files on EasyRA, so that they cannot be manually modified. Figure 3.8 shows the Test Count Logging screen. Figure 3.8 Test Count Logging Screen 3.11 U N D E R S T A N D I N G T H E U S E R I N T E R F A C E To view the Test Count Log: 1 Touch the System icon to display the System Status screen. 2 Touch Test Count (see Figure 3.9). Figure 3.9 Select Test Count Note: You can toggle back and forth between the System Status and the Test Count by selecting either Status or Test Count. The Test Counts Logging screen displays (see Figure 3.10). 3.12 E a s y R A Figure 3.10 O P E R A T O R ’ S M A N U A L Test Count Logging Screen From this screen, select the time interval for which you want to display the test count. The definition of each preset data range is shown on the bottom of the screen. 3 To select one of the preset time intervals, select: All (the default) Day (the current day) Week (the last 7 days) Month (the last 31 days) Year (the last 365 days) 3.13 U N D E R S T A N D I N G T H E U S E R I N T E R F A C E When you make your selection, the data for the selected preset time interval displays on the screen. Figure 3.11 shows an example of test counts for a Week. Figure 3.11 3.14 Example of Test Counts When Week is Selected E a s y R A 4 O P E R A T O R ’ S M A N U A L To define a date range, touch the Enter Date Range field. The Enter Date Range dialog displays (see Figure 3.12). Figure 3.12 Enter Date Range Dialog Touch the Month, Day, and/or Year fields to select the Start and End Date of the desired date range for the Test Count and touch Enter. The selected date range displays in the Enter Date Range field and the test counts for the selected date range are displayed (see Figure 3.13). 3.15 U N D E R S T A N D I N G Figure 3.13 3.16 T H E U S E R I N T E R F A C E Example of Test Counts for Selected Date Range E a s y R A 5 O P E R A T O R ’ S M A N U A L To display the details for any one test listed on the Test Count screen, click on the test name of interest in the Test column. For the selected test, the test counts for Patient, Calibration and QC tests are displayed for the selected time interval. Figure 3.14 shows an example of the Test Count for the Chol test for the selected date range of 9/19/2012 to 10/19/2012. Figure 3.14 Example of Detailed Test Count for a Selected Test (CHOL) 3.17 U N D E R S T A N D I N G T H E U S E R I N T E R F A C E Using the Menu Bar To use the menu bar: 1 Touch one of the four main icons on the touch screen to display a drop-down menu. 2 Touch a selection from the drop-down menu to choose a function to be performed. Note: Some menu selections may be password protected. These selections may appear grayed out (disabled). You cannot select grayed menu items. After you make your selection, the selected icon is highlighted with a colored border to indicate the area in which you are working. The icon remains highlighted until you select another icon. 3.18 E a s y R A O P E R A T O R ’ S M A N U A L The Worklist Menu In order to run tests on EasyRA, the tests must be entered into a Worklist. The Worklist contains the list of all tests to be performed in a particular EasyRA run. An EasyRA Worklist can contain tests for up to 24 sample positions. The Worklist menu enables you to view, create, edit, and monitor the Worklist. It also allows you to view a Laboratory Information System (LIS) list that has been downloaded from an external LIS system, view a list of pending tests, or perform ISE calibration. Note: If you do not have the ISE Module option, and ISE Calibration is selected from the menu, a message displays indicating that the function is not available. Figure 3.15 shows the Worklist menu. Figure 3.15 Worklist Menu 3.19 U N D E R S T A N D I N G T H E U S E R I N T E R F A C E The following selections are available from the Worklist menu: 3.20 View LIS List - displays a Worklist downloaded from an external LIS system. Edit Worklist - displays the Edit Worklist screen from which you can create a new Worklist or edit an existing Worklist. Monitor Worklist - monitors the progress of the Worklist that is currently running. View Pending List - shows the Pending List. The Pending List contains all tests that were added to the Worklist, but that could not be run because EasyRA detected a problem during inventory (for example, the Reagent required to run the test was not available). ISE Calibration - performs a calibration for the ISE Module. ISE activities are included in the Worklist menu because ISE calibration must be performed after every 8 hours of use. E a s y R A O P E R A T O R ’ S M A N U A L The Results Menu The Results menu enables you to view the results of tests that have been run on EasyRA. Results from the current test run are stored in Current Results until they are accepted. When you accept results, they are moved from Current Results and saved in Last Results, and in Patient, Calibration, or QC results, as appropriate. Figure 3.16 shows the Results menu. Figure 3.16 Results Menu 3.21 U N D E R S T A N D I N G T H E U S E R I N T E R F A C E The following selections are available from the Results menu: 3.22 Current Results - shows the results from the tests run on the current Worklist. These results have not yet been accepted by the operator. From Current Results, you can print results, rerun tests, or accept results. Test results outside the linear or normal range are automatically highlighted and can be rerun. Last Results - current results are moved to Last Results when they are accepted. This selection allows you to easily view the results of the last test run. The Last Results are overwritten each time a new set of Current Results is accepted; however, these results remain available in the Patient, Calibration, and QC results areas. Patient Results - results of all patient tests are moved from Current Results to Patient Results when the results are accepted. Patient results show a list of test runs (by date) on the left side of the screen. Detailed results for a particular run can be displayed by selecting the run from the list. EasyRA stores patient results for 2000 samples. Calibration Results - results for all calibration tests are moved from Current Results to the Calibration Results when the results are accepted. The list of calibration results are ordered alphabetically by test. Only the last two calibrations for any test are shown. QC Results - results for all QC tests are moved from Current Results to QC Results when the results are accepted. QC results show a list of the QC materials on the left side of the screen. Detailed results for any material can be displayed by selecting the material from the list. You can also display Levey-Jennings plots for the last 31 days of the QC results. E a s y R A O P E R A T O R ’ S M A N U A L The Status Menu The Status menu enables you to display events that may require your attention, as well as view the status of various components. A summary of the warnings is displayed from the Worklist Warnings selection and detailed information on selected components is shown from the other selections. Figure 3.17 shows the Status menu. Figure 3.17 Status Menu 3.23 U N D E R S T A N D I N G T H E U S E R I N T E R F A C E The following selections are available from the Status menu: 3.24 Worklist Warnings. Shows a summary of all events related to the current run that may require your attention. The Status icon blinks when an event occurs to indicate you should check the status. Reagents. Shows the detailed status of the Reagents, including number of tests remaining and time when the Reagent will expire. Calibration. Shows the detailed status of the calibration for each test, including when the next calibration is required. QC. Shows the detailed status of the QC, including Lot #, Last QC, and date and time. Cuvettes. Shows the detailed status of the cuvettes, including which Cuvettes are used, which are onboard, but not usable, and which are usable. ISE. Shows the detailed status of the ISE Module, including Reagent Pack details, expiration date, slopes, calibration expiration, ISE Reagent Pack, ISE Calibration, and cleaning status and calibration. If you do not have the ISE Module option, ISE displays in gray rather than black. Cleaning. Shows a detailed status of EasyRA cleaning. Inventory Report. Shows a detailed status from the most recent Reagent, Sample (if you have the Barcode Reader option), and Cuvette inventory that has been performed. It is good practice to view the Inventory Report at the start of each shift and before you create a Worklist to ensure that sufficient Reagents and Cuvettes are available for the run. The report can be printed to help prepare the analyzer for a work day. Sample Inventory (only appears when Debug Mode has been selected) - Shows which positions are occupied with barcoded samples. E a s y R A O P E R A T O R ’ S M A N U A L The Diagnostic/Maintenance/Setup Menu The Diagnostic/Maintenance/Setup menu allows you to perform various diagnostic, maintenance, and setup functions. When you open this menu, touch Cleaning, Diagnostics, Maintenance, or Setup as shown in Figure 3.18 to select the function you want to perform. Figure 3.18 Diagnostic/Maintenance/Setup Menu The Cleaning selection displays the Cleaning screen. The other three selections (Diagnostics, Maintenance, and Setup) display a list of additional functions from which you select the function to be performed. Cleaning Selection. Perform the following special cleaning activities from this selection: Probe cleaning. ISE cleaning or ISE cleaning and calibration. 3.25 U N D E R S T A N D I N G T H E U S E R I N T E R F A C E Diagnostics Submenu. Perform diagnostic tests from this submenu: Reaction Area. Transfer Arm/Probe. Fluidics Drawer. Reagent/Sample Area. Heater/Cooler. Covers/Door Latches. Precision Test For more information, see Chapter 11, “Troubleshooting & Diagnostics.” Maintenance Submenu. Perform the following maintenance activities from this submenu: 3.26 Daily Inspection. Monthly Cleaning. Replacements (performed on an as-needed basis). Purge/Prime Fluidics (performed on an as-needed basis). Save Results to CD Save Results to USB E a s y R A O P E R A T O R ’ S M A N U A L Setup Submenu Note: If security has been enabled on EasyRA, only operators with Setup access privileges can make changes from the Setup menu. Other users can view data from the Setup menu, but cannot modify settings. For information on accessing the Setup menu if security has been enabled, see “Accessing the Setup Menu if Security is Enabled” on page 3.28. You can perform the following setup activities from the Setup menu: System. Tests. Patients. Calibration. QC. Reagent. For more information on System Setup, see Chapter 2, “Getting Started.” For more information on Test, Patient, Calibration, QC, or Reagent Setup, see Chapter 4, “Setting Up Test Configurations.” 3.27 U N D E R S T A N D I N G T H E U S E R I N T E R F A C E Accessing the Setup Menu if Security is Enabled If security is enabled, the Security Login dialog displays when you touch the Setup submenu from the Diagnostic/Maintenance/Setup icon as shown in Figure 3.19. Figure 3.19 Security Login Dialog To access the Setup submenu and modify a setting (if you have the appropriate privileges): 1 Touch the Password field. The Alphanumeric Keypad displays. 2 Enter your password using the keypad, and then press Enter to close the keypad. Note: 3 3.28 Passwords on EasyRA are case sensitive. If your password is accepted, the Setup submenu is displayed and you can view and modify selections on that menu. E a s y R A O P E R A T O R ’ S M A N U A L Viewing Setup Information If your password is not accepted, you can view the setup selections, but you cannot change them. To view settings from the Setup submenu (if you do not have appropriate privileges to make changes): 1 Touch the Just View button. The Setup submenu displays in View only mode. Data Area The Data area of the screens contains different information depending on the function selected. The Data Area includes control buttons and icons and a Data Area specific to the type of screen that is being displayed (Worklist, Results, Status, or Diagnostic/Maintenance/Setup). Figure 3.20 shows an example of the Data Area: Figure 3.20 EasyRA Data Area Control Buttons/ Icons Data Area 3.29 U N D E R S T A N D I N G T H E U S E R I N T E R F A C E Control Buttons/Icons Many of the screens have one or more control buttons and icons. Table 3.3 lists the various icons and control buttons that may appear in the Data Area: Table 3.3 Summary of Control Buttons in Data Area CONTROL BUTTON FUNCTION The Enter button is used to complete functions and continue. For example, you touch Enter to indicate the Worklist is complete and the inventory can begin. You also touch Enter to accept results, when you are finished entering data on a keypad, or when a maintenance or diagnostic procedure is complete. The Delete button clears all entries from the Worklist or table you are working with. EasyRA asks you to confirm any deletion before the selection is removed. The Add button adds an entry to a table. Touch the Add button to display an editable screen on which you can add new information. The Modify button allows you to modify an existing entry in a table. Touch the Modify button to display an editable screen on which you can modify existing information. The Print button allows you to print results or reports from EasyRA. There are several choices available for printing. For more information, see Chapter 7, “Viewing Results.” The Rerun button allows you to rerun selected tests. Test results that are above the linear range are automatically highlighted and checked for rerun. Test results that are outside the normal range are automatically highlighted to indicate their results were abnormal and they may need to be rerun. You can also select tests to be rerun. You are only allowed to rerun each Worklist once. For more information, see Chapter 7, “Viewing Results.” The Sample Details button allows you to display detailed results for a particular sample on the Sample Ring. The Flag button allows you to display a legend of all the flag codes. The flag icon also displays the number of flagged results. For more information, see “Viewing Current Results” on page 7.3. 3.30 E a s y R A Table 3.3 O P E R A T O R ’ S M A N U A L Summary of Control Buttons in Data Area CONTROL BUTTON FUNCTION The arrow keys allow you to scroll through a list of items displayed on the screen (for example, entries in the Worklist, results, etc.). You can scroll to the first item, the previous item, the next item, or the last item using these arrow keys. You may advance through the selected lists quickly by holding down any of the scroll buttons. If the arrows are not filled in, you are at the end of the list and cannot scroll in that direction. If the arrows are filled, you are not at the end of the list and can scroll in that direction. In some cases, only one half of the Sample Ring/Reagent Tray is displayed on the screen. To see a visual representation of the remaining positions on the ring, touch the left or right arrow in the center of the ring to shift the display left or right. You can choose to edit the Worklist for either Sample Ring A or Sample Ring B. The letters A and B indicate the Sample Rings for which you can edit the Worklist. The circle around the letter indicates the Worklist that is currently being edited. When a Worklist is running, it cannot be edited unless the run is paused. Touch this icon to begin the process of downloading Calibration or QC data from a CD, or to view Reagent, QC, or Calibrator insert sheets. There are a number of additional buttons needed to perform various tasks from the Data Area. Examples of the buttons are shown here. Touch these buttons to perform the designated function. Examples of such buttons that appear in the Data Area include: Test Panels Test Ranges Preferences Start Reagent Inventory Start Diagnostic Test or Maintenance procedure Read New Reagents (during Setup) Indicates that the measurement system being used for all tests and for selecting the test units displayed for each individual test is the International System of Units (referred to as “SI” units.). Indicates that the measurement system being used for all tests and for selecting the test units displayed for each individual test is English units (referred to as “non-SI” units). 3.31 U N D E R S T A N D I N G T H E U S E R I N T E R F A C E Data Area Each of the different types of screens (Worklist, Results, Status, and Diagnostic/Maintenance/Setup) have different information displayed in the Data Area. The following sections describe the Data Area for each type of screen. Worklist Data Area Figure 3.21 shows an example of a window that displays when you are creating or editing a Worklist: Figure 3.21 Example of Worklist Data Area This screen shows a series of icons and controls across the top. The main area of the screen shows the Worklist in a table. There is one row for each sample position on the Sample Ring. You can use the arrow keys on the right side of the table to scroll through the list. 3.32 E a s y R A O P E R A T O R ’ S M A N U A L A representation of one half of the Sample Ring/Reagent Tray displays on the left side of the Worklist. The outer ring shows the sample positions. A dotted white circle is displayed around the position on the ring which is currently being edited. A solid white circle displays around each position on the ring for which tests have been assigned. If you select a multi-level calibrator on the Worklist that requires between 2 and 6 calibrator materials in separate sample cups, the representation of the samples will be linked together by a line to indicate that all the samples are related to a multi-level calibration. The representation of the Sample Ring in Figure 3.22 shows that positions 1 through 5 are linked together for a multi-level calibration. Figure 3.22 Samples are Linked for Multi-Level Calibrations As tests are added to a sample on the Worklist, the volume of the selected sample required to perform the selected tests is displayed on the graphic representation of the Sample Ring (see position 4 in Figure 3.23). As more tests are added, this sample volume is increased as needed. The Sample Volume for the selected sample position displays until you select another sample position. 3.33 U N D E R S T A N D I N G Figure 3.23 T H E U S E R I N T E R F A C E Sample Volume Required for Tests Selected for Sample Position 4 This information is most helpful when you are using sample cups on EasyRA for QC, Calibrators, or Validation materials. The volume displayed does not include standard “dead volumes” associated with different sample cups. For complete information on samples and sample cups, see “Loading and Unloading Samples” on page 5.37. The inner part of the Sample Ring/Reagent Tray shows the Reagents loaded on the Reagent Tray (see Figure 3.21). The representation of the Reagent Wedges are filled with color to indicate the actual level of the Reagent. Reagent Wedges that are shaded in gray indicate an unknown level of Reagent. The text color indicates the status of the Reagent Wedge: Black: Standard/Default Red: Reagent or Calibration Expired Yellow: 2 days or 10 tests remaining Reagent Wedges that are part of a Three Reagent System (two reagent wedges linked together with a Reagent Wedge Clip) are represented with a Lock icon to indicate they are locked together (see Figure 3.24). 3.34 E a s y R A Figure 3.24 O P E R A T O R ’ S M A N U A L Three Reagent System on Worklist and the Sample Ring/Reagent Tray Display Shifted Left Touch the small right arrow button in the center of the ring (see Figure 3.21) to shift the display of the Sample Ring/Reagent Tray to the left to show the remaining samples and Reagents. Figure 3.24 shows the ring when it is shifted left. Touch the left arrow in the center of the ring to shift the display of the ring back to the original position. A similar screen displays when you are monitoring the Worklist. It contains a table of results and a representation of the Sample Ring/ Reagent Tray on the left side of the table. When tests are in progress, the sample locations on the outer ring are displayed in blue. When all tests on a sample are complete, the sample locations on the outer ring display in gold. 3.35 U N D E R S T A N D I N G T H E U S E R I N T E R F A C E Results Data Area Figure 3.25 and Figure 3.26 show examples of screens that display when viewing results. Figure 3.25 3.36 Example of Current Results Screen E a s y R A Figure 3.26 O P E R A T O R ’ S M A N U A L Example of Patient Results Figure 3.25 shows a Current Results screen. The screen for Last Results is similar. Both of these screens show results in relation to the position of the samples on the Sample Ring. This screen shows icons and controls across the top which allow you to perform various functions. The main area of the screen shows the results in a table. The table contains one row of results for each test. There may be multiple rows of results for a sample position, if several different tests were run on a sample. If a test was rerun, that test will have two rows of results (one result for the original run and one result for the rerun). You can use the arrow keys on the right side of the table to scroll through the list. 3.37 U N D E R S T A N D I N G T H E U S E R I N T E R F A C E A representation of one half of the Sample Ring/Reagent Tray displays on the left side of the Results. The outer ring shows the sample positions. Sample positions whose tests are complete are displayed in gold. If the test was a Stat, the sample position is displayed as a triangle, rather than a circle. The inner part of the Sample Ring/Reagent Tray shows the Reagents loaded on the Reagent Tray. The representation of the Reagent Wedges are filled with color to indicate the actual level of the Reagent. Reagent Wedges that are shaded in gray indicate an unknown level of Reagent. The text color indicates the status of the Reagent Wedge: Black: Standard/Default Red: Reagent or Calibration Expired Yellow: 2 days or 10 tests remaining Touch the small right arrow button in the center of the ring to shift the display of the Sample Ring/Reagent Tray to the left to show the remaining samples and Reagents. Figure 3.26 shows the Patient Results screen. The screens for Calibration and QC results are similar. Results for Patients, Calibration, and QC are stored and are not associated with a position on the Sample Ring. This screen shows icons and controls across the top which allow you to perform various functions. The main area of the screen shows results in various formats. The Patient and QC results screens show a summary table on the left. Touch any position in the summary table to view more detailed results in a table on the right. The Calibration Results shows a single table of Calibration results listed alphabetically by test. You can use the arrow keys on the right side of any of the tables to scroll through the data. 3.38 E a s y R A O P E R A T O R ’ S M A N U A L Status Data Area Figure 3.27 shows an example of a Status screen (Cuvette Status). Similar screens are provided for Reagent, Calibration, and QC status. Figure 3.27 Example of Status Screen The screen shows a button from which you can perform a Cuvette inventory located at the top of the Cuvette Status area. The main area of the screen shows the status of the selected item (cuvettes in this case) in a table. There is one row for each cuvette. A representation of the Cuvette Carousel displays on the left side of the table. Most status screens include a graphic representation of the selected component, such as Cuvettes. 3.39 U N D E R S T A N D I N G T H E U S E R I N T E R F A C E Diagnostic Data Area Figure 3.28 shows an example of the Diagnostics Data Area. Figure 3.28 3.40 Example of Diagnostics Data Area E a s y R A O P E R A T O R ’ S M A N U A L The diagnostics selections available are shown on the left side of the screen. When you choose a diagnostic test to be performed, information, such as that shown on the right side of Figure 3.28 displays. It may include one or more graphics, a table of results, and a button to start the selected test. In the Diagnostics Data Area, the Start button: is used to start a test on EasyRA (such as checking the Photometer). After the test has been run, the results may be displayed in the table and the words “Passed,” “Failed,” or “Complete” appear at the bottom of the screen, The Enter button: is used to confirm that the diagnostic test is complete. 3.41 U N D E R S T A N D I N G T H E U S E R I N T E R F A C E Maintenance Data Area Figure 3.29 shows an example of the Maintenance Data Area. Figure 3.29 Example of Maintenance Data Area The maintenance selections available are shown on the left side of the screen. When you choose a maintenance activity to be performed, information, such as that shown on the right side of Figure 3.29 displays. It may include one or more graphics with instructions and one or more buttons to start or confirm the selected activity. Follow the onscreen instructions to perform the various maintenance activities. In the Maintenance Data Area, the Start button: is used to start a process on EasyRA (such as purging or priming a pump). The Enter button: is used to confirm that a step in a process or the entire maintenance action is complete. 3.42 E a s y R A O P E R A T O R ’ S M A N U A L Setup Data Area Figure 3.30 and Figure 3.31 show examples of the Setup Data Area. Figure 3.30 Example of Setup Data Area 3.43 U N D E R S T A N D I N G Figure 3.31 T H E U S E R I N T E R F A C E Example of the Setup Data Area The setup selections available are shown on the left side of the screen. When you choose a setup action to be performed, information such as that shown on the right side of Figure 3.30 and Figure 3.31 display. The screen may contain a single item to be configured (see Figure 3.30), or it may include a table of information that can be set up (see Figure 3.31). Use the Modify button on the Setup screens: to expand the information displayed, so that it can be modified. 3.44 E a s y R A O P E R A T O R ’ S M A N U A L Entering Data Using the Keypads In some cases you need to enter alphanumeric data or select tests on EasyRA. Because the system uses a touch screen rather than a keyboard and mouse, EasyRA provides two keypads on the touch screen to allow you to enter data: The Alphanumeric Keypad. The Test Select Keypad. To access either keypad, touch a field that requires data to be entered. If alphanumeric data is required the Alphanumeric Keypad displays. If test data is required, the Test Select Keypad displays. The following sections describe how to enter data using these keypads. Entering Alphanumeric Data 1 Touch a field requiring alphanumeric data. The Alphanumeric Keypad displays as shown in Figure 3.32. Figure 3.32 Alphanumeric Keypad Note: If only numeric data is allowed in the selected field, only the numeric keypad on the right of the Alphanumeric Keypad displays. 2 Touch the keys on the keypad to enter the required data. Data entry on the keypad is similar to a keyboard, except you touch each key on the screen, as required. As you touch each letter or number, it appears in the selected field. Touch the forward arrow to insert a space, touch the backward arrow to backspace over a character that has been typed. The down arrow is a Shift key, allowing you to toggle between upper and lower case letters. 3.45 U N D E R S T A N D I N G T H E 3 U S E R I N T E R F A C E When you are done typing, touch Enter to close the keypad. This saves your entry in the selected field. You cannot enter data in another field or perform any other functions until you close the keypad. Entering Test Data Figure 3.33 1 Touch a field requiring test data. The Test Select Keypad displays as shown in Figure 3.33. 2 Touch the test keys to select tests. Selected tests are highlighted. To deselect a test, touch it again. The test will no longer be highlighted. Test Select Keypad Note: If a test is missing from the Test Select Keypad, the Reagent has not been loaded on EasyRA and inventoried yet. This set up step is required for tests to appear on the Test Select Keypad. For information on loading Reagents for the first time, see “Loading Reagents for the First Time” on page 2.23. In some cases, when you select the first test in the Test Select Keypad, some of the available tests are disabled (grayed), indicating that those tests are incompatible with the first test selected. For example, if you are selecting tests for a multi-level calibration, only tests with the same number of calibration levels and the same numbering scheme (0- or 1-based) as the first test selected are active. This prevents you from selecting incorrect tests. 3.46 E a s y R A 3 O P E R A T O R ’ S M A N U A L On the right side of the screen, there are five (or six, when the ISE Module is detected and configured) preset Test Panels, a Custom panel, and a Previous button. If you touch any of the preset test panels, a set of tests is automatically highlighted on the Test Select Keypad. This allows you to quickly enter a standard list of tests for a sample. You can add or remove tests from the Test Select Keypad after you select a Test Panel. You can change the definitions of the Test Panels or define tests for up to four Custom test panels at any time. For more information, see “Setting Up the Test Panels” on page 4.4. 4 You can select to run tests in the Reagent Optimization mode by selecting the Reagent Optimization button below the table of tests. A message displays indicating that you are changing worklist modes and all current worklist entries will be deleted. Touch OK to use Optimization mode or touch Cancel to remain in normal test mode. When in Optimization mode, you can only select tests from the Reagent Optimization line in the Test Select Keypad. Only one optimization test can be run per worklist. Figure 3.34 shows the Test Select Keypad when you are using Optimization mode. Figure 3.34 5 Test Select Keypad in Optimization Mode For more information on Reagent Optimization mode, see see “Reagent Optimization - Creating a Worklist” on page 12.36. You can also specify whether or not you want to run multiple test sets (replicates) on the sample from the Test Select Keypad by touching the Replicates button. When you select Replicates, a drop-down displays allowing you to select the number of replicates (see Figure 3.35). (Replicates do not apply to calibrations or QC.) 3.47 U N D E R S T A N D I N G T H E U S E R I N T E R F A C E Note: Typically, if you use replicates, you would only run two replicates per test. If you choose to run more than two replicates per test, the Status field on the Results screen for each test result will display the message, “Not for Clinical Use.” The results are tagged with this message because running more than two replicates is not a typical use of EasyRA. Figure 3.35 Select the Number of Replicates from the Test Select Keypad When you make your selection, both the Replicates button and the Tests column for the selected sample indicate the number of replicates to be performed (see Figure 3.36). 3.48 E a s y R A Figure 3.36 6 O P E R A T O R ’ S M A N U A L Number of Replicates Selected When you are done selecting tests, touch Enter to close the keypad. This saves the selected tests in the Tests field. You cannot enter data in another field or perform any other functions until you close the keypad. 3.49 U N D E R S T A N D I N G 3.50 T H E U S E R I N T E R F A C E 4 Setting Up Test Configurations This chapter describes how to set up test configurations. These actions are performed from the Setup menu (see Figure 4.1). Figure 4.1 Setup Menu 4.1 S E T T I N G U P T E S T C O N F I G U R A T I O N S Most of these actions must be completed before you attempt to create a Worklist and run tests. These actions allow you to set up and view the following: 4.2 Tests - The submenu allows you to set up preset Test Panels on the Test Select Keypad, set normal, critical, and rerun test ranges, and set up test units. It also allows you to configure Calculated Results. Patient - This submenu allows you to set up patient demographic information that can be associated with samples. Patient information includes demographics (such as patient ID, name, date of birth, age, physician, etc.). If you are using the LIS Connectivity option, you may not need to set up patient information. Calibration - The submenu allows you to set up calibrators and calibrator preferences. You cannot run calibrations until you set up calibrators. EasyRA supports both single-level calibrations and multi-level calibrations. All calibrators purchased from Medica include a CD from which you can quickly load calibration setup information. QC - This submenu allows you to set up QC materials. You cannot run QC until you set up the QC materials. All QC materials purchased from Medica include a CD from which you can quickly load QC setup information. Reagent - From this submenu you can view a complete list of all Reagents and data that have been loaded onto EasyRA and inventoried. Complete insert sheets for each Reagent can also be viewed from this submenu. E a s y R A O P E R A T O R ’ S M A N U A L Configuring Tests This section describes how to set up preset Test Panels, test ranges, and test units from the Setup submenu. Figure 4.2 shows the Tests Setup screen from which you configure these options. Figure 4.2 Tests Setup Screen 4.3 S E T T I N G U P T E S T C O N F I G U R A T I O N S Setting Up the Test Panels You select the tests to be run on the Worklist from the Test Select Keypad (see Figure 4.3). Figure 4.3 Test Select Keypad (Without ISE Unit Configured) The tests that appear on the upper left side of the Test Select Keypad are determined by the Reagents that have been loaded and inventoried on EasyRA. (For more information on loading Reagents, see “Loading Reagents for the First Time” on page 2.23. The tests that appear on the lower left side of the Test Select Keypad (adjacent to the Reagent Optimization button) are tests that have been defined by the user (not supplied by Medica), but which have not been optimized (performance of these tests have not been verified) or programmed. You can choose to run a Worklist in Reagent Optimization mode to verify the performance of these tests. For more information on reagent optimization, see Chapter 12, “Reagent Optimization - Creating a Worklist.” On the right side of the Test Select Keypad, there is a panel with five (or six, if the ISE Unit is configured) pre-named test buttons and one Custom test button. When you select any of the Test Panels, a set of tests is automatically selected. The Test Panels allow you to quickly choose a standard set of tests for a particular sample. Before using the test panel, you must specify the tests associated with each panel. Also, you can define up to four Custom panels that are available when you select the Custom button. The next sections describe how to set up the five pre-named Test Panels and rename them, if desired. These sections also describe how to name up to four Custom test panels and assign tests to them. 4.4 E a s y R A O P E R A T O R ’ S M A N U A L Configuring the Tests in Each Test Panel You must configure the tests that will be associated with each Test Panel. To modify or define the Test Panels: 1 Touch the Diagnostic/Maintenance/Setup icon, and then touch Setup. 2 If Security is enabled, the Security Login dialog displays. Enter the Supervisor password or a Technician password on the Alphanumeric Keypad and touch Enter on the keypad. 3 Touch Tests from the Setup menu. The Tests Setup screen displays. 4 Touch Test Panels. The Setup Test Panels screen displays showing the tests associated with each Test Panel (see Figure 4.4). Figure 4.4 5 Setup Test Panel Screen (With ISE Unit Configured) To change the Test Panels, touch Modify: 4.5 S E T T I N G Figure 4.5 U P T E S T C O N F I G U R A T I O N S 6 Touch the Tests field for one of the Test Panels (one of the rows in the table). 7 The Test Select Keypad displays for the selected Test Panel (see Figure 4.5). Notice that the Test Panels on the right side are disabled while you are defining the tests for each Test Panel. Test Select Keypad to Modify or Define Test Panels 8 To add a test to the selected Test Panel, touch a test on the Test Select Keypad. Selected tests are highlighted. All tests that are already associated with the Test Panel are highlighted. To remove a test from the Test Panel, touch the highlighted test on the keypad to deselect it. 9 When you are done, touch Enter to close the keypad: The tests that were selected display in the Tests column for the selected Test Panel (see Figure 4.6). 4.6 E a s y R A O P E R A T O R ’ S M A N U A L Note: If you assign tests to the Custom 1 through Custom 4 panels, those panels will not display on the Test Select Keypad. To access those panels, select the CUSTOM test panel and select one of the four custom test panels from the drop-down list. Figure 4.6 Tests Selected for a Test Panel 10 Repeat Steps 5-8 until all Test Panels have been modified or defined as needed. 11 When you are done setting up the preset Test Panels, touch Enter at the top of the screen: The next time you use the preset Test Panels from the Test Select Keypad, the tests associated with the panels will reflect the settings made during this procedure. 4.7 S E T T I N G U P T E S T C O N F I G U R A T I O N S Changing the Name of a Test Panel To change the name of the panel: Figure 4.7 1 Touch Modify from the Setup Test Panel screen. 2 Touch the name of the panel you want to change. 3 The Alphanumeric Keypad displays (see Figure 4.7). To remove the default name, touch backspace until the entry is removed. Alphanumeric Keypad 4 Enter the new name for the panel. When you are done, press Enter to close the keypad. 5 The new Panel Name will be displayed on the Test Select Keypad in the Worklist (see Figure 4.8). Note: If you rename the Custom 1 through Custom 4 panels, the new names will not display on the Test Select Keypad. To access those panels, select the CUSTOM test panel and select one of the four custom test panels from the drop-down list. 4.8 E a s y R A Figure 4.8 O P E R A T O R ’ S M A N U A L New Panel Name in Test Select Keypad on Worklist Setting Up Custom Test Panels The Test Select Keypad also has four Custom Test Panels that are similar to the other Test Panels, except that they are only accessible by selecting the CUSTOM test panel button and then selecting one of the four custom panels from the drop-down list. You can assign tests to custom test panels or rename the custom test panels in the same way you define any other test panel. See “Configuring the Tests in Each Test Panel” on page 4.5 and “Changing the Name of a Test Panel” on page 4.8. 4.9 S E T T I N G U P T E S T C O N F I G U R A T I O N S Setting Up Test Ranges Each laboratory typically sets up their own test ranges. Normal ranges are set based upon a laboratory’s instrument, method, patient population, etc. Critical ranges are used to flag results which are beyond critical clinical decision values for a particular test. This screen also provides a field where you can adjust the reportable range (linear range) that is published by Medica and programmed on the individual reagent wedge RFID chip. Note: The first time a test is loaded on the EasyRA analyzer, the default ranges for male and female patients found on the Reagent Insert Sheet will be assigned as the Normal Range for the test. It is recommended that each laboratory establish its own range of expected values, since differences exist among instruments, laboratories and patient populations. Please refer to the Reagent Insert Sheets, where test-specific information regarding ranges can be found, for more information. Note: If normal ranges and critical ranges are not set, the NR (outside normal range) and CR (outside critical range) flags will not be displayed in the results. Note: If reportable ranges are being adjusted after normal, critical, and rerun ranges have been entered, make sure to check that these entries are now within the new reportable range. You can view a summary of the Normal Ranges that have been assigned for each test from the Test Ranges submenu. All test ranges must be set up manually. Viewing a Summary of the Normal Ranges Assigned for Each Test To view a summary of the Normal Ranges assigned for each test: 4.10 1 Touch the Diagnostics/Maintenance/Setup icon, and then touch Setup. 2 Touch the Tests submenu. The Tests Setup screen displays. 3 Touch Test Ranges. The Setup Test Ranges screen displays (see Figure 4.9). User-defined tests appear at the top of the list, followed by all other tests. E a s y R A Figure 4.9 O P E R A T O R ’ S M A N U A L Setup Test Ranges Screen 4 Touch the View Details button: 5 A list of the Normal Ranges assigned for Adult males and females for each test displays (see Figure 4.10). 4.11 S E T T I N G Figure 4.10 U P T E S T C O N F I G U R A T I O N S Summary of Normal Ranges Assigned for Adults Males and Females You can print the Text Ranges by touching the Print button: or close the window by touching the Close box: 4.12 E a s y R A O P E R A T O R ’ S M A N U A L Setting Up All Test Ranges Manually To set up test ranges for serum or urine: 1 Touch the Diagnostics/Maintenance/Setup icon, and then touch Setup. 2 Touch the Tests submenu. The Tests Setup screen displays. 3 Touch Test Ranges. The Setup Test Ranges screen displays (see Figure 4.11). User-defined tests appear at the top of the list, followed by all other tests. Figure 4.11 Setup Test Ranges Screen The screen shows a list of all tests (including electrolytes) for which you have loaded Reagents. 4.13 S E T T I N G U P T E S T C O N F I G U R A T I O N S 4 Select the test for which you want to modify test ranges (Normal, Critical, and Rerun). When you touch a test, a screen displays on which you can modify test ranges (see Figure 4.12). Figure 4.12 Edit Test Ranges Screen 5 The Sample Type is displayed in the upper left corner of the data area. This information is read from the RFID on the Reagent Wedge, or it is specified during the definition of a user-defined test. For ISE tests, an additional drop-down box displays allowing you to select the Range Type (Serum/Plasma or Urine). Choose the appropriate range type for the selected ISE test. If you change this value, the sample type displayed in the upper left corner of the data area is updated immediately. 6 4.14 Touch the Modify button to modify the test range for the selected test: E a s y R A O P E R A T O R ’ S M A N U A L When you touch the Modify button, the rows are expanded to allow change to the limits of each range. 7 Touch the fields which you want to change and modify them as needed using the Alphanumeric Keypad. Values must be entered in each field for each of these ranges. This will permit correct flagging of results and prompt reruns when necessary. Table 4.1 describes each field and its possible values: Table 4.1 Normal Range Fields FIELD DESCRIPTION POSSIBLE VALUES The low and high value for the normal range for an adult. An adult is greater than 18 years old. Enter this information for male and female patients. Numeric value The low and high value for the normal range for an child. A child is between 2 and 18 years old. Enter this information for male and female patients. Numeric value The low and high value for the normal range for an infant. An infant is less than 2 years old. Enter this information for male and female patients. Numeric value The low and high value for the critical range. Numeric value The low and high value for the rerun range. Numeric value The low and high value for the user-defined reportable range. Numeric value NORMAL RANGE FIELDS Adult Low Adult High (female and male) Child Low Child High (female and male) Infant Low Infant High (female and male) CRITICAL RANGE FIELDS Low High RERUN RANGE FIELDS Low High REPORTABLE RANGE Low High For more information, see “Rerunning Tests” on page 7.9. 4.15 S E T T I N G U P T E S T C O N F I G U R A T I O N S 8 When you are done editing the test ranges for the selected test, touch Enter at the top of the screen: This saves the test ranges for the selected test. If you need to add or modify test ranges for other tests, repeat steps 3-8 for each test. 4.16 E a s y R A O P E R A T O R ’ S M A N U A L Setting Up Test Units Setting up Test units involves selecting the measurement system used for all tests and selecting the test units displayed for each individual test. This section provides procedures to make each of these selections. You can select to have all test units display in the International System of Units (referred to as SI) or English units (referred to as non-SI). To select the Measurement System and/or test units for individual tests: 1 Touch the Diagnostics/Maintenance/Setup icon, and then touch Setup. 2 Touch the Tests submenu. The Tests Setup screen displays. 3 Touch Test Units. The Setup Test Units screen displays (see Figure 4.13). Figure 4.13 Set up Test Units Screen The screen is populated with all tests for which you have loaded Reagents on EasyRA. One of the icons shown in Table 4.2 displays at the top of the screen indicating the measurement system selected. 4.17 S E T T I N G U P T E S T C O N F I G U R A T I O N S Table 4.2 ICON Icons for Measurement Systems DESCRIPTION Indicates the International System of Units. Indicates English units (referred to as non-SI). 4 Touch the Modify button to change the measurement system being used or to modify the test units for any test: When you touch the Modify button, the measurement system icon moves to the right so it can be changed and the rows in the table are expanded so you may change the units for individual tests. 5 To change the measurement system being used, touch the measurement system icon. The icon toggles between the International System of Units and English Units (see Table 4.2) and the units displayed for each test toggle between the two measurements systems, if they are different for each system. Note: You can override the units specified by the measurement system for a particular test by changing the units after you select the measurement system. 4.18 6 To change the units for a test, touch the test for which you want to change the units. A drop-down menu displays for the selected test indicating the units available for that test. 7 Select the units you want to use from the drop-down menu. E a s y R A 8 O P E R A T O R ’ S M A N U A L When you are done modifying the measurement system and units for all tests, touch Enter at the top of the screen: This saves the measurement system and the test units you have selected. 4.19 S E T T I N G U P T E S T C O N F I G U R A T I O N S Setting Up Calculated Results Calculated Results allow you to use the results of tests that are run on samples as input into formulas to calculate additional results. EasyRA provides four Calculated Results: cAnGap (calculated with results from Cl-, CO2, and Na+) cBU/Cr (calculated with results from BUN and CREA) cLDL (calculated with results from CHOL, HDL, and TRIG) eGFR (calculated with results from CREA) Three conditions must be met for Calculated Results to be displayed for a particular sample: The Calculated Result must be enabled. Calculated results are enabled systemwide. If you enable a particular Calculated Result, the result will be displayed for any sample for which it can be calculated. All tests required for a Calculated Result must be run on the sample in order for the Calculated Result to be computed and displayed for the sample. For example, if you expect to see a cLDL Calculated Result for Sample 3, then you must perform CHOL, HDL, and TRIG tests on Sample 3. The results of these tests will be used to compute the Calculated Result. All of the tests used as input for a Calculated Result must use the same units. If the units for the component tests are not the same, you will not be able to enable the Calculated Result. Note: The Calculated Result generated for cBu/Cr is a ratio. If the units for the component tests BUN and CREA both use SI measurement units, then you can enable cBu/Cr even if the units do not match. Specifically, you can enable cBu/Cu if BUN uses mmol/L units and CREA uses mol/L units. 4.20 E a s y R A O P E R A T O R ’ S M A N U A L Table 4.3 shows the formulas used for each of the Calculated Results that are available. Table 4.3 Formulas for Calculated Results CALCULATED RESULT FORMULA cAnGap cBU/Cr cLDL eGFR Setting Up and Enabling Calculated Results To set up and enable Calculated Results: 1 Touch the Diagnostics/Maintenance/Setup Icon, and then touch Setup. 2 If Security is enabled, the Security Login dialog displays. Enter the Supervisor password or a Technician password on the Alphanumeric Keypad, and then touch Enter on the keypad. 3 On the Setup menu, touch Tests. The Setup Tests screen displays. Touch Calculated Results (see Figure 4.14). 4.21 S E T T I N G U P T E S T C O N F I G U R A T I O N S Figure 4.14 Setup Tests The list of Calculated Results available displays (see Figure 4.15). Notice that the list includes an indication as to whether the Calculated Result is enabled or disabled. Figure 4.15 4 4.22 Calculated Results Available in EasyRA Touch the Calculated Result of interest. A table displays to the right of the list showing the formula(s) and other information for the selected Calculated Result. Figure 4.16 shows an example of the Calculated Result called eGFR. E a s y R A Figure 4.16 O P E R A T O R ’ S M A N U A L Example of Calculated Result Screen for eGFR The table contains the following information: The name of the Calculated Result and the units for the Calculated Result. The formula (or formulas) used to generate the Calculated Result. Some Calculated Results use a single formula and others, like eGFR, require different formulas for male and female patients. Tabular information indicating the Tests Needed for this Calculated Result, whether the tests are in the Reagent Test Menu, and the units specified for each component test. If any of tests are not in the Reagent Test Menu (meaning that the Reagent has never been loaded on EasyRA and therefore will not appear in the Test Select Keypad when you set up your worklist), the test name will appear in red and you will need to load it before you can enable this Calculated Result. For more information, see “Loading Reagents for the First Time” on page 2.23. 4.23 S E T T I N G U P T E S T C O N F I G U R A T I O N S If the units specified for the component tests are not all the same, the units appear in red and you will need to modify the units of one or more tests until they all match. For more information on changing the test units for particular test, see “Setting Up Test Units” on page 4.17. Note: The units setting for a test is systemwide, so use care when changing units for tests used in a Calculated Result. If that same test is used in more than one Calculated Result, changing the units for one Calculated Result may cause a mismatch of units in another Calculated Result. If a mismatch of units occurs, the Calculated Result will be disabled until the mismatch is corrected. The Enable/Disable button that allows you to enable or disable the Calculated Result. 5 Before attempting to enable a Calculated Result, verify that no tests or units are displayed in red. 6 To enable a Calculated Result, touch the Disabled button and select Enabled. Once the Calculated Result is enabled, it will be computed and displayed for any sample for which the appropriate component tests are included in the Worklist. For information on viewing Calculated Results, see “Viewing Calculated Results” on page 7.18. 4.24 E a s y R A O P E R A T O R ’ S M A N U A L Setting Up Patient Demographics EasyRA provides a feature that allows you to add demographic information (patient name, age, sex, etc.) and associate that information with a sample on which tests are being run. If patient information is added, it is included on the printed report for the patient. If you are not using the LIS Connectivity option, this information is very useful when reporting results. To use this feature, you can either add patient information during setup or you can add patient information from the Worklist. This procedure describes how to add patient information from the Setup menu. For more information on adding patient information from the Worklist, see Chapter 5, “Preparing EasyRA.” To set up patient information: 1 Touch the Diagnostics/Maintenance/Setup icon, and then touch Setup. 2 If Security is enabled, the Security Login dialog displays. Enter the Supervisor password or a Technician password on the Alphanumeric Keypad and touch Enter on the keypad. 3 On the Setup menu, touch Patients. 4 Touch Patient Info. The Patient Setup screen displays (see Figure 4.17). Figure 4.17 Patient Setup Screen If no patients have been added, no entries appear in the list. If patients have already been added, a list of all patients currently defined displays in the center of the screen. The list of patients is sorted alphabetically by the patient’s last name. Use the Find Patient area to locate a particular patient by last name or patient ID. 4.25 S E T T I N G Figure 4.18 U P T E S T C O N F I G U R A T I O N S 5 To add a new patient, touch the Add button: 6 The Enter Patient Data screen displays (see Figure 4.18). Notice that New Entry displays at the top of the Patient Info list. This is the new entry for the patient being added. Enter Patient Data Screen 7 4.26 To enter information into each field that displays, touch the field and enter the appropriate information on the Alphanumeric Keypad or select it from the drop-down menu that displays. E a s y R A O P E R A T O R ’ S M A N U A L Table 4.4 describes each field and its possible values. Fields marked with an asterisk (*) are required. Table 4.4 Patient Data Fields FIELD DESCRIPTION POSSIBLE VALUES Patient ID A unique number that identifies this patient. EasyRA displays a warning if you attempt to enter a Patient ID that has already been used. Up to 14 alphanumeric characters. Last Name The family name of the patient. The list of patients is sorted by Last Name. Up to 14 alphabetic characters. First Name The first name of the patient. Up to 14 alphabetic characters. MI The middle initial of the patient. One alphabetic character. Sex The sex of the patient. Male Female If sex is not entered in the Patient Information, results are not flagged if the results are out of normal range. Date of Birth The patient’s date of birth. Values for the Month, Day, and Year are selected from three separate drop-down menus. Month = 1-12 Day = 1-31 Year = 1800-2025 If age is not entered in the Patient information, results outside the normal range are not flagged. Physician The name of the patient’s physician. Up to 20 alphabetic characters. 4.27 S E T T I N G U P T E S T C O N F I G U R A T I O N S 8 When you are done entering information on the Enter Patient Data screen, touch Enter: The new patient appears at the top of the list and is highlighted. All the information for the patient is displayed on the right side of the screen (see Figure 4.19). Figure 4.19 4.28 New Patient Has Been Added E a s y R A O P E R A T O R ’ S M A N U A L From this screen you can add more new patients, by touching the Add button: or modify existing patients, by touching a patient and then touching the Modify button: Searching the Patient Database You may search the patient database to locate particular patients. This procedure describes how to access the list of patients that have been added and then search for a particular patient. To search for a patient: 1 Touch the Diagnostics/Maintenance/Setup icon, and then touch Setup. 2 If Security is enabled, the Security Login dialog displays. Enter the Supervisor password or a Technician password on the Alphanumeric Keypad and touch Enter on the keypad: 3 On the Setup menu, touch Patients. 4 The Patient Setup screen displays (see Figure 4.17). 5 Touch Patient Info. 6 If no patients have been added, no entries appear in the list. If patients have already been added, a list of all patients currently defined displays in the center of the screen. The list of patients is sorted alphabetically by the patient’s last name. 7 To search for a patient, enter either the patient’s last name or the patient’s ID number in the Find Patient area located over the patient information list (see Figure 4.19). 4.29 S E T T I N G U P T E S T C O N F I G U R A T I O N S Touch either the By ID or By Last Name box. When you make that selection, the Alphanumeric Keypad appears. Type either name patient’s ID or the patient’s last on the keypad and touch Enter: EasyRA searches for the selected patient. Results appear in the Patient information area of the screen. 4.30 E a s y R A O P E R A T O R ’ S M A N U A L Configuring Chemistry Calibrators All non-enzymatic tests require periodic calibrations. These calibrations may be required every 8 hours to every 28 days or more. If calibrations are not performed or if the current calibrator expires, EasyRA will not allow you to run tests that require calibration. Calibrators may or may not be purchased from Medica. Before you perform calibrations from the Worklist, set up the calibrator name, tests, and values from the CD provided with each calibrator or by manually entering the information from the Setup menu. You cannot calibrate tests on EasyRA unless the calibrators are first configured under the Setup menu. EasyRA supports single level calibrations and multi-level calibrations (with up to six levels). It also supports multi-level/multi-constituent calibrations (with up to six levels and more than one test to be calibrated for each level). The numbering for multi-level calibrations can be either 0-based (first level is 0, for example, saline) or 1-based (first level is 1) for Medica-supplied reagents. For user-defined reagents, the numbering for multi-level calibrations can only be 1-based. Multi-level calibrations require between two and six points to calculate the calibration curve. The system determines if a test requires 0-based or1-based numbering by reading that information from the Reagent Wedge for the selected test. For information on entering a calibration for a test on the Worklist, see “Entering Calibration Requests” on page 6.15. Note: ISE calibrators are different than chemistry calibrators. You do not need to set up calibrators for ISE tests. For information on performing ISE calibrations, see “Calibrating the ISE Module” on page 6.60. Setting Up Calibrators Set up calibrators by first entering the name, lot number, and expiration date of the calibrator. Lastly, enter information about the tests to be calibrated. The information includes the test names, concentration, and units. The calibrators can be set up using the CD provided with the calibrator (recommended), or they can be set up manually. 4.31 S E T T I N G U P T E S T C O N F I G U R A T I O N S Setting Up Calibrators Using the CD If you choose to set up calibrators using the CD provided with the calibrator from Medica (recommended), all setup information is downloaded. CDs provided by Medica are unique to each calibrator. This information can be manually modified after it has been downloaded, if necessary. To set up calibrators using the CD: 1 Touch the Diagnostics/Maintenance/Setup icon, and then touch Setup. 2 If Security is enabled, the Security Login dialog displays. Enter the Supervisor password or a Technician password on the Alphanumeric Keypad and touch Enter on the keypad. 3 On the Setup menu, touch Calibration. The Calibration Setup screen displays (see Figure 4.20). Figure 4.20 4 Calibration Setup Screen Touch Calibrators. If calibrators have not been added, no entries appear in the list. If calibrators have already been added, a list of all current defined calibrators displays in the center of the screen. 5 To add a new calibrator from the CD, touch the Add button: The Modify Calibrator Data screen displays (see Figure 4.21). Notice that a calibrator called New Entry displays at the top of the list. This is a placeholder for the new entry being added. 4.32 E a s y R A Figure 4.21 6 O P E R A T O R ’ S M A N U A L Modify Calibrator Data Screen To set up the calibrator, touch the CD Download icon: 4.33 S E T T I N G U P T E S T C O N F I G U R A T I O N S 7 Place the Calibrator CD into drive D: (or primary CD drive). The Read Data from CD popup displays (see Figure 4.22). Figure 4.22 Read Data From CD Popup Touch Ok. 4.34 E a s y R A 8 M A N U A L A popup window automatically displays, listing the folder containing the Calibrator Data and the Calibrator Instructions for Use (see Figure 4.23). Figure 4.23 9 O P E R A T O R ’ S Folder Containing the Calibrator Data and the Calibrator Instructions for Use For more information on calibration instructions for use, see “Viewing Calibrator Insert Sheets” on page 4.55. Touch the folder named for the Calibrator you are setting up. For example, EasyCal Calibrator Touch Open. 4.35 S E T T I N G U P T E S T C O N F I G U R A T I O N S 10 Touch the folder containing the Calibration Setup data to be downloaded. For example, EasyCal Calibration Setup See Figure 4.24. Figure 4.24 Folder Containing Calibration Setup Data to be Downloaded Touch Open. 4.36 E a s y R A O P E R A T O R ’ S M A N U A L 11 Touch the file containing the data to be downloaded. For example, EasyCal Data.xml See Figure 4.25. Figure 4.25 File Containing Data to be Downloaded Touch Open. The name, lot number, expiration date, number of calibration levels (if applicable), tests, concentrations, and units for the calibrator are downloaded from the CD. The New Entry is replaced with a new calibrator that was downloaded from the CD (see Figure 4.26). 4.37 S E T T I N G Figure 4.26 U P T E S T C O N F I G U R A T I O N S New Entry is Replaced with New Calibration Downloaded from the CD Note: Before proceeding, ensure that the name and lot number of the information displayed on the Modify Calibrator Data screen matches the vial(s) of Calibrator you are working with. 4.38 E a s y R A O P E R A T O R ’ S M A N U A L 12 When you are done with the Modify Calibrator Data screen, touch Enter: The tests, concentrations, and units associated with the Calibrator are automatically displayed (see Figure 4.27). Figure 4.27 Tests, Concentrations, and Units Associated with the Calibrator T 4.39 S E T T I N G U P T E S T C O N F I G U R A T I O N S Setting Up Calibrators Manually To set up calibrators manually, you have to set up the following: The name, lot number, and expiration date for the calibrator. The tests to be calibrated and the concentrations for the tests. (The tests selected determine the number of calibrator levels for each calibrator being set up. Each calibrator can only be used for tests with the same number of levels and the same calibration level numbering (0-based or 1-based).) Information about calibration can be found on each test’s insert sheet and information about the calibration materials can be found on the calibrator insert sheets. To set up the name, lot number and expiration date: 1 Touch the Diagnostics/Maintenance/Setup icon, and then touch Setup. 2 If Security is enabled, the Security Login dialog displays. Enter the Supervisor password or a Technician password on the Alphanumeric Keypad and touch Enter on the keypad. 3 On the Setup menu, touch Calibration. The Calibration Setup screen displays (see Figure 4.28). Figure 4.28 4 Calibration Setup Screen Touch Calibrators. If no calibrators have been added, no entries appear in the list. If calibrators have already been added, a list of all calibrators currently defined displays in the center of the screen. 4.40 E a s y R A O P E R A T O R ’ S 5 To add a New Entry, touch the Add button: 6 The Modify Calibrator Data screen displays (see Figure 4.29). Notice that a calibrator called New Entry displays at the top of the list. This is a placeholder for the new entry being added. Also notice that there is a line indicating the number of calibrator levels. Depending on the first test you select (and the number of calibrator levels it has), this value will be filled in by the system. Figure 4.29 7 M A N U A L Modify Calibrator Data Screen To enter information into each field that displays, touch the field and enter the appropriate information on the keypad or from the drop-down menu that displays. 4.41 S E T T I N G U P T E S T C O N F I G U R A T I O N S Table 4.5 describes each field and its possible values: Table 4.5 Calibrator Fields FIELD DESCRIPTION POSSIBLE VALUES Name The name of the calibrator. Be sure to name calibrators carefully so that you can distinguish one from another easily. Up to 16 alphanumeric characters. Lot The lot number of the calibrator. This information can be obtained from the insert sheet for the calibrator. Up to 12 alphanumeric characters. Exp. Date The expiration date of the calibrator. This information can be obtained from the insert sheet for the calibrator. Month = 1-12 Day = 1-31 Year = 2006-2025 Entries for the Month, Day, and Year are selected from three separate drop-down menus. # of Calibrator Levels This field is blank and will be filled in by the system based on the tests selected from the Test Select Keypad. All tests selected for a calibration material must have the same number of levels. 1-6 levels The system obtains the number of levels required for each test from the RFID chip on the Reagent wedges. 8 When you are done with the Modify Calibrator Data screen, touch Enter: The new calibrator appears in the list (in alphabetical order) and is highlighted. 4.42 Continue to “Adding Tests for Calibrators” on page 4.43. E a s y R A O P E R A T O R ’ S M A N U A L Adding Tests for Calibrators When you have entered the name, lot number, and expiration date, a table appears on which you can enter tests for this calibrator (see Figure 4.30). Figure 4.30 Enter Tests for the New Calibrator To enter the tests to be calibrated, the concentrations, and the units for the calibrator, do the following: 1 Touch anywhere below the headings and data (if any) in the table. 2 The Test Select Keypad displays at the bottom of the screen, from which you can select one or more tests to be added (see Figure 4.31). Tests that are not available are inactive (grayed). 4.43 S E T T I N G Figure 4.31 U P T E S T C O N F I G U R A T I O N S Entering Tests for the Calibrator from the Test Select Keypad 3 Choose the first test to be calibrated from the Test Select Keypad. Notice that when the first test is selected, there is an indication of the Calibration Levels displayed in the upper right corner of the Test Select Keypad (see Figure 4.32). Figure 4.32 4.44 Test Select Keypad Showing Calibrator Levels in Upper Right Corner E a s y R A O P E R A T O R ’ S M A N U A L When you select that first test, all tests that have the same number of levels (and the same numbering scheme) as the selected test remain active. Tests with a different number of calibration levels or a different level numbering scheme become inactive (grayed). You can select one or more tests from the active tests on the Test Select Keypad. If you want to select a test with a different number of calibrator levels, you must first deselect all tests with the current level and then select a test with a different number of levels. Figure 4.33 shows an example of the Test Select Keypad with a test selected that has five calibrator levels. Figure 4.33 Test Select Keypad Showing Tests with Calibrator Level = 5 4 Verify that you have selected tests with the correct number of levels for the calibrator you are defining (refer to the insert sheet for each test to be calibrated for this information). Once you touch Enter on the Test Select Keypad, the number of levels for this calibrator cannot be changed. 5 When you are sure the number of levels is correct on the Test Select Keypad, touch Enter: For information on using the Test Select Keypad, see “Entering Test Data” on page 3.46. The selected test(s) appear in the table (see Figure 4.34). If you selected more than one test, each test is listed in a separate row. 4.45 S E T T I N G Figure 4.34 U P T E S T C O N F I G U R A T I O N S Tests to be Calibrated (Calibrator Level = 1) If the test has multiple levels, the table also displays the levels for each test selected. Figure 4.35 shows one five-level test selected for this calibrator. 4.46 E a s y R A Figure 4.35 6 O P E R A T O R ’ S M A N U A L Tests to be Calibrated (Calibrator Level = 5) Touch the Concentration field beside each test (or level) to select the concentration for the test. You can obtain the concentration for the calibrator being configured from the corresponding insert sheet. Enter the concentration on the Numeric Keypad. Be sure to select the concentration value corresponding to the units displayed on the screen. 7 For more information setting up test units, see “Setting Up Test Units” on page 4.17. For more information on entering data from the Numeric Keypad, see “Entering Alphanumeric Data” on page 3.45. When you are done entering concentrations for each test (or level), touch Enter at the top of the screen (see Figure 4.36). 4.47 S E T T I N G Figure 4.36 U P T E S T C O N F I G U R A T I O N S Touch Enter to Save the Calibrator Setup Information (Single Level Calibrator Level) The new calibrator remains highlighted in the list of calibrators and all the information for the calibrator displays in the table on the right side of the screen (see Figure 4.37 for a single-level calibrator and Figure 4.38 for a multi-level calibrator). Figure 4.37 4.48 Saved Calibrators (Single Level Calibrator) E a s y R A Figure 4.38 O P E R A T O R ’ S M A N U A L Saved Calibrators (Multi-Level Calibrator) From this screen you can add new calibrators, by touching the Add button: or modify existing calibrators, by touching a calibrator and then touching the Modify button: 4.49 S E T T I N G U P T E S T C O N F I G U R A T I O N S Deleting Calibrators If a calibrator has expired or you are no longer using it, it can be deleted. To delete a calibrator: 1 Touch the Diagnostics/Maintenance/Setup icon, and then touch Setup. 2 If Security is enabled, the Security Login dialog displays. Enter the Supervisor password or a Technician password on the Alphanumeric Keypad and touch Enter on the keypad. 3 On the Setup menu, touch Calibration. The Calibration Setup screen displays. 4 Touch Calibrators. If no calibrators have been added, no entries appear in the list. If calibrators have been added, a list of all calibrators currently defined displays in the center of the screen (see Figure 4.39). Figure 4.39 4.50 Set up Calibrators Screen E a s y R A 5 O P E R A T O R ’ S M A N U A L Touch the calibrator to be deleted. The table showing the details for the selected calibrator displays. 6 Touch the Modify button: The Modify Calibrator Data for the selected calibrator displays (see Figure 4.40). Figure 4.40 7 Modify Calibrator Data Screen Touch the Delete buttons: A message box displays stating that the selected calibrator will be deleted. 4.51 S E T T I N G U P T E S T C O N F I G U R A T I O N S 8 Touch OK to confirm the deletion. The selected calibrator is removed from the list of calibrators. Changing Calibration Preferences Calibration preferences are preset for each test. The calibration preference values are filled in automatically from the RFID chip the first time the test is loaded into EasyRA. After the first time an RFID chip is read for a particular test, you may change these preferences (calibration interval, calibration replicates, and calibration deviation). Calibration preferences are not updated each time an RFID chip is read for a test. Your user-adjusted preferences will be retained by the system. Note: Periodically, Medica may suggest changes to the calibration preferences. Changes will need to be updated manually. Suggested changes will be included in the Reagent Wedge packaging. To change calibration preferences manually: 1 Touch the Diagnostics/Maintenance/Setup icon, and then touch Setup. 2 On the Setup menu, select Calibration. The Calibration Setup screen displays (see Figure 4.41). Figure 4.41 3 Calibration Setup Screen Touch Preferences. The Calibration Preference screen displays (see Figure 4.42), showing all tests that require calibration, including user-defined tests. 4.52 E a s y R A Figure 4.42 O P E R A T O R ’ S M A N U A L Calibration Preferences To change calibration preferences: 1 Touch the Modify button: The rows of the table expand, allowing you to modify an existing entry (see Figure 4.43). 4.53 S E T T I N G U P T E S T C O N F I G U R A T I O N S Figure 4.43 2 Add or Modify Calibration Preferences Touch the Cal Interval (Days) field beside each test to enter the frequency for the calibration. Enter the calibration frequency on the numeric keypad that appears. (The RFID Chip on each Reagent Wedge contains a default value for the Cal Interval.) 3 Touch the Cal Replicates field beside each test to enter the number of calibration repetitions (replicates). Enter the calibration repetitions on the numeric keypad that appears. (The RFID Chip on each Reagent Wedge contains a default value for the Cal Replicates.) 4 Touch the Cal Deviation (%) field beside each test to enter the calibration deviation. Enter the permissible calibration deviation on the numeric keypad that appears. The Cal Deviation defines the deviation from the Mean Value (as a percentage) that is allowed for calibration results. (The RFID Chip on each Reagent Wedge contains a default value for the Cal Deviation.) 4.54 E a s y R A 5 O P E R A T O R ’ S M A N U A L When you are done entering information for each test, touch Enter at the top of the screen. This saves the information and displays a screen from which you can add or modify additional calibration preferences (see Figure 4.44). Figure 4.44 Calibration Preferences Screen Viewing Calibrator Insert Sheets EasyRA allows you to view insert sheets directly through the user interface. Insert Sheet CDs are included with each package of Reagents, QC, and Calibrator Materials. There is no need for a separate computer to view and print the insert sheets. Note: If for any reason you cannot view the insert sheet, contact Medica or your dealer for a paper copy. To view Calibrator Insert Sheet from a CD: 1 Touch the Diagnostics/Maintenance/Setup icon, and then touch Calibration. The Calibration Setup menu displays (see Figure 4.45). 4.55 S E T T I N G U P T E S T C O N F I G U R A T I O N S Figure 4.45 2 Calibration Setup Menu Touch View Insert Sheet. The blank Insert Sheet screen displays (see Figure 4.46). Figure 4.46 4.56 Blank Insert Sheet Screen E a s y R A O P E R A T O R ’ S 3 Touch the CD Download button: 4 Place the Calibrator Insert Sheet CD into drive D: (or primary CD drive) and Touch Ok. M A N U A L The Read Insert Sheet from CD popup displays (see Figure 4.47). Figure 4.47 5 Read Insert Sheet from CD Popup Touch Ok. A popup window automatically displays, listing the folders and/or files containing the Calibrator Insert Sheet (see Figure 4.48). 4.57 S E T T I N G U P T E S T C O N F I G U R A T I O N S Figure 4.48 6 Figure 4.49 4.58 Popup Showing Folders and Files Containing the Calibrator Insert Sheet Touch the desired file and language (see Figure 4.49). Select File and Language 7 Touch Open. 8 The Insert Sheet automatically opens with the EasyRA user interface. 9 To print a copy of the Calibrator Insert Sheet, touch the Print button: E a s y R A O P E R A T O R ’ S M A N U A L Configuring QC Materials EasyRA does not require you to run quality control (QC) tests; however it is strongly recommended that QC tests are run on a regular basis to ensure the quality of EasyRA results. QC materials may or may not be purchased from Medica. Before you can enter QC tests on the Worklist, set up the QC materials and tests from the CD provided with each QC materials or by manually entering the information from the Setup menu. You cannot run QC tests on EasyRA unless the QC materials are first configured under the Setup menu. For information on entering a QC test on the Worklist, see “Entering Quality Control Requests” on page 6.21. For more information on the quality control process, see “Quality Assurance” on page 9.1. When configuring QC materials for EasyRA, there can be up to 50 active QC materials and up to 50 transitional QC materials defined on EasyRA. There is no limit to the number of inactive QC materials that can be added to EasyRA. Setting Up QC Materials You set up QC materials by first entering the name, lot number, expiration date, and condition, and then entering information about the tests to be run on each QC material. This information includes test name, low limit, high limit, and units. The QC materials can be set up, using the CD provided with each QC material, or they can be set up manually. Setting Up QC Materials Using the CD If you choose to set up QC materials using the CD provided with the QC material from Medica, all setup information is downloaded. CDs provided by Medica are unique to each QC material. This information can be manually modified after it has been downloaded, if necessary. To set up QC materials using the CD: 1 Touch the Diagnostics/Maintenance/Setup icon, and then touch Setup. 2 If Security is enabled, the Security Login dialog displays. Enter the Supervisor password or a Technician password on the Alphanumeric Keypad and touch Enter on the keypad. 3 On the Setup menu, touch QC. The QC Setup screen displays (see Figure 4.50). 4.59 S E T T I N G U P T E S T C O N F I G U R A T I O N S Figure 4.50 4 QC Setup Screen Touch QC Materials. If no QC materials have been added, no entries appear in the list. If QC materials have already been added, a list of all QC materials currently defined displays in the center of the screen. 5 To add a new QC material from a CD, touch the Add button: The Modify QC Material Data screen displays (see Figure 4.51). Notice that a QC material called New Entry displays at the top of the list. This is a placeholder for the new entry being added. When a new material is entered, the Condition is automatically set to Transitional. 4.60 E a s y R A Figure 4.51 6 O P E R A T O R ’ S M A N U A L Modify QC Materials Data Screen To set up the QC material, touch the CD Download icon: 4.61 S E T T I N G U P T E S T C O N F I G U R A T I O N S 7 Figure 4.52 Place the QC material CD into drive D: (or the primary CD drive). The Read Data from CD popup displays (see Figure 4.52). Read Data from CD Popup Touch Ok. 8 4.62 A popup window automatically displays, listing the folder containing the QC Material Data and the QC Material Instructions for Use (see Figure 4.53). E a s y R A Figure 4.53 9 O P E R A T O R ’ S M A N U A L Folder Containing QC Material Data and QC Material Instructions for Use For information on QC instructions for use, see “Viewing QC Insert Sheets” on page 4.84. Touch the folder named for the QC Material you are setting up. For example, EasyQC Chem & Elec Level B - Lot 10273 Touch Open. 10 Open the folder containing the QC Material Setup data to be downloaded. For example, EAsyQC Chem & Elect Level B Setup See Figure 4.54. 4.63 S E T T I N G Figure 4.54 U P T E S T C O N F I G U R A T I O N S Folder Containing QC Material Setup Data to be Downloaded Touch Open. 11 Touch the file containing the data to be downloaded. For example, EasyQC Level B_1273.xml See Figure 4.55. 4.64 E a s y R A Figure 4.55 O P E R A T O R ’ S M A N U A L File Containing Data to be Downloaded Touch Open. The name, lot number, expiration date, tests, conditions, tests, low and high limit, and units for the QC material are downloaded from the CD. The New Entry is replaced with a new QC material that was downloaded from the CD (see Figure 4.56). 4.65 S E T T I N G Figure 4.56 U P T E S T C O N F I G U R A T I O N S New Entry is Replaced with New QC Material Downloaded from the CD Note: Before proceeding, ensure that the name and lot number of the information displayed on the Modify QC Material Data screen matches the vial of QC material you are working with. 12 When you are done with the Modify QC Material Data screen, touch Enter: The tests, low limit, high limit, and units associated with the QC material are automatically displayed (see Figure 4.57). 4.66 E a s y R A Figure 4.57 O P E R A T O R ’ S M A N U A L Tests, Limits, and Units Associated with the QC Material 4.67 S E T T I N G U P T E S T C O N F I G U R A T I O N S Setting Up QC Materials Manually To set up QC materials manually, you have to set up the following: The name, lot number, expiration date, condition for the QC material, and whether or not the results will be qualitative. The tests to be run and the test results (low and high limits for quantitative tests or whether the results will be positive or negative for qualitative tests). Information for each QC material can be found on the individual QC Material Insert Sheets. To set up the name, lot number, expiration date, and status: 1 Touch the Diagnostics/Maintenance/Setup icon, and then touch Setup. 2 If Security is enabled, the Security Login dialog displays. Enter the Supervisor password or a Technician password on the Alphanumeric Keypad and touch Enter on the keypad. 3 On the Setup menu, touch QC. The QC Setup screen displays. Touch QC Materials (see Figure 4.58). Figure 4.58 4.68 QC Setup E a s y R A O P E R A T O R ’ S 4 If no QC materials have been added, no entries appear in the list. If QC materials have already been added, a list of all QC materials currently defined displays in the center of the screen. 5 To add a new QC material, touch the Add button: M A N U A L The Modify QC Material Data screen displays (see Figure 4.59). Notice that a QC material called New Entry displays at the top of the list. This is a placeholder for the new entry being added. When a new material is entered, the Condition is automatically set up as Transitional. Figure 4.59 6 Modify QC Material Data Screen To enter information in each field that displays, touch the field and enter the appropriate information on the Alphanumeric Keypad or select it from the drop-down menu that displays. 4.69 S E T T I N G U P T E S T C O N F I G U R A T I O N S Table 4.6 describes each field and its possible values: Table 4.6 QC Material Fields FIELD DESCRIPTION POSSIBLE VALUES Name The name of the QC material. Up to 16 alphanumeric characters. Lot The lot number of the QC material. This information can be obtained from the insert sheet for the QC material. Up to 12 alphanumeric characters. Exp. Date The expiration date of the QC material. This information can be obtained from the insert sheet for the QC material. Month = 1-12 Day = 1-31 Year = 2006-2025 Values for the Month, Day, and Year are selected from three separate drop-down menus. Condition Specifies whether the QC material is active, transitional, or inactive. Value is selected from a drop-down menu. If the Condition is Active or Transitional, the QC material can be selected from the Worklist under Sample Type/QC. If the condition is Inactive, the QC material will not be available during inventory. When the expiration date occurs, the Condition automatically changes from Active to Inactive. Qualitative 4.70 Specify whether or not the results will be qualitative. If they are not qualitative, they will be quantitative. If you select Yes, only qualitative tests will be selectable from the Test Select Keypad. If you select No, only quantitative tests will be selectable. Active - The QC material which is currently being used to assure quality results. Up to 10 lots of QC material may be in the Active condition at one time. If there are 10 active lots in the database, one must be deleted or changed to the Inactive condition before a new active lot may be added. Transitional - A QC material for which data is being collected in preparation for its use as an active material, when the currently active QC material expires. Up to 10 lots of QC material may be in the Transitional condition at one time. Inactive - The QC material is not being used now, but has served as the active QC material in the past. Up to 5 lots of QC material may be in the Inactive condition at one time. Yes or No. E a s y R A 7 O P E R A T O R ’ S M A N U A L When you are done with the Modify QC Material Data screen, touch Enter: The new QC material appears in alphabetical order in the list and is highlighted. A table appears to the right of the list on which you can enter tests for this QC material If this is a QC material that will generate quantitative results, continue to “Adding Tests for Quantitative QC Tests” on page 4.71. If this is a multi-level calibrator, skip to “Adding Tests for Qualitative QC Tests” on page 4.75. Adding Tests for Quantitative QC Tests When you have entered the name, lot number, expiration date, condition, and Qualitative = No, a table appears in which you can enter tests for this QC material (see Figure 4.60). Figure 4.60 Enter Tests for the New Quantitative QC Materials 4.71 S E T T I N G U P T E S T C O N F I G U R A T I O N S To enter the tests to be run, the low and high limits, and the units for the results from the QC material: Figure 4.61 1 Touch anywhere in the table on the right side of the screen. The first row of the table expands, allowing you to make a new entry in the table. 2 The Test Panel displays on the bottom of the screen, from which you can select one or more tests to be added (see Figure 4.61). Entering Tests for the QC Material from the Test Select Keypad 3 Select the test(s) to be added by touching one or more tests on the Test Select Keypad and touching Enter: For information on using the Test Select Keypad, see “Entering Test Data” on page 3.46. The selected tests appear in the table. If you selected more than one test, each test is listed in a separate row. 4.72 E a s y R A 4 O P E R A T O R ’ S M A N U A L Touch the Low Limit field beside each test to select the low limit for the test. Touch the High Limit field beside each test to select the high limit for the test. You can obtain the low and high limit information from the insert sheet for the QC material. After the laboratory has gained sufficient experience with the QC material, the laboratory may transition the QC to an active material and enter the User Mean and Standard Deviation. For more information on changing the condition from Transitional to Active, see “Changing the Condition of QC Materials” on page 4.80. Enter the low and high limits on the numeric keypad that appears. Touch Enter on the keypad when you have entered the correct limits for each test. 5 The Units field cannot be changed. It displays the Units for the selected tests that were selected during test unit setup. 6 For information on using the numeric keypad, see “Entering Alphanumeric Data” on page 3.45. For more information setting up test units, see “Setting Up Test Units” on page 4.17. When you are done entering information for each test, touch Enter at the top of the screen (see Figure 4.62). 4.73 S E T T I N G Figure 4.62 U P T E S T C O N F I G U R A T I O N S Touch Enter to Save QC Materials Setup Information The new QC material appears in alphabetical order in the list and is highlighted. All the information for the QC material displays in a table on the right side of the screen (see Figure 4.63). Figure 4.63 Saved QC Materials From this screen you can add additional QC materials, by touching the Add button: 4.74 E a s y R A O P E R A T O R ’ S M A N U A L or modify existing QC materials, by touching a QC material and then touching the Modify button: Adding Tests for Qualitative QC Tests When you have entered the name, lot number, and expiration date, condition and Qualitative = Yes, a table appears on which you can enter tests for this QC material (see Figure 4.64). Figure 4.64 Enter Tests for the New Qualitative QC Material To complete this table for QC material generating qualitative results: 1 Touch anywhere in the table on the right side of the screen. The Test Select Keypad displays at the bottom of the screen, from which you can select one or more tests to be added (see Figure 4.65). The Test Select Keypad indicates that the tests generate Qualitative results. 4.75 S E T T I N G Figure 4.65 U P T E S T C O N F I G U R A T I O N S Adding Qualitative Tests for the QC Material from the Test Select Keypad 2 Select the test(s) to be added by touching one or more tests on the Test Select Keypad, and then touching Enter: Note: If you specified Qualitative in Figure 4.59, you can only select qualitative tests from the Test Select Keypad. All other tests are disabled. For information on using the Test Select Keypad, see ““Entering Test Data” on page 3.46. Note: If user-defined tests have not been optimized or the wedges have not been programmed, select tests from the Reagent Optimization area of the Test Select Keypad. The selected tests appear in the table. If you selected more than one test, each test is listed in a separate row. 4.76 E a s y R A O P E R A T O R ’ S 3 Touch the Positive/Negative field to specify if the results should be positive or negative. If the QC Value obtained from the insert sheet that accompanied the user-defined reagent is greater than the calibration concentration (cutoff), set this value to Positive. If the QC Value is less than the calibration concentration (cutoff), set this value to Negative. 4 The Units field cannot be changed. It displays the Units for the selected tests. 5 M A N U A L For more information on setting up test units, see “Setting Up Test Units” on page 4.17. When you are done entering information for each test, touch Enter at the top of the screen. The new QC material appears in the list (in alphabetical order) and is highlighted. All the information for the QC material displays in a table on the right side of the screen (see Figure 4.66). Figure 4.66 Saved QC Materials (for Qualitative Tests) From this screen, you can add additional QC materials, by touching the Add button: or modify existing QC materials, by touching a QC material and then touching the Modify button: 4.77 S E T T I N G U P T E S T C O N F I G U R A T I O N S Deleting QC Materials If a QC material has expired or you are no longer using it, it can be deleted. To delete a QC material: 1 Touch the Diagnostics/Maintenance/Setup icon, and then touch Setup. 2 If Security is enabled, the Security Login dialog displays. Enter the Supervisor password or a Technician password on the Alphanumeric Keypad and touch Enter on the keypad. 3 On the Setup menu, touch QC Setup. The QC Setup screen displays. 4 Touch QC Materials. If no QC materials have been added, no entries appear in the list. If QC materials have been added, a list of all QC materials currently defined displays in the center of the screen (see Figure 4.67). Figure 4.67 5 Set up QC Materials Screen Touch the QC material to be deleted. The Modify QC Material Data screen displays (see Figure 4.68). 6 4.78 Touch the Modify button: E a s y R A Figure 4.68 7 O P E R A T O R ’ S M A N U A L Modify QC Material Data Screen Touch the Delete button: A message box displays indicating the selected QC material will be deleted. 8 Touch OK to confirm the deletion. The selected QC material is removed from the list of QC materials in the center of the QC Materials Setup screen. 4.79 S E T T I N G U P T E S T C O N F I G U R A T I O N S Changing the Condition of QC Materials When a lot of QC material is set up for the first time, the condition is automatically set at Transitional. This condition allows you to test the performance of the QC material and make adjustments prior to transitioning to an Active condition. For more information on QC Condition, see Table 4.6. To change the condition of a QC material to Active: 1 Touch the Diagnostics/Maintenance/Setup icon, and then touch Setup. 2 If Security is enabled, the Security Login dialog displays. Enter the Supervisor password or a Technician password on the Alphanumeric Keypad and touch Enter on the keypad. 3 On the Setup menu, touch QC. The QC Setup screen displays. 4 Touch QC Materials. A list of all QC materials currently defined displays in the center of the screen (see Figure 4.69). Figure 4.69 5 4.80 Setup QC Materials Screen Touch the QC material which must have its condition modified. E a s y R A 6 O P E R A T O R ’ S M A N U A L The Modify QC Material Data screen displays (see Figure 4.70 for an example of a Qualitative QC). Figure 4.70 Modify QC Material Data Screen 7 Touch the Condition field and select Active as the new condition for this material. 8 When you are done with the Modify QC Material Data screen, touch Enter: 4.81 S E T T I N G U P T E S T C O N F I G U R A T I O N S When you make this selection, the following message displays indicating that EasyRA will automatically fill in the User Mean and User Standard Deviation for the QC material with the current Mean and current Standard Deviation from the QC results (see Figure 4.71). Notice that the message also indicates that none of the User Mean and Standard Deviation fields can be set to 0. Figure 4.71 Message About Auto-Filling the User Mean and User Standard Deviation A table of the tests and parameters for this material is displayed (see Figure 4.72 for an example of a Quantitative QC). If you selected a Qualitative QC, the table is slightly different. Figure 4.72 4.82 Table of Test and Limits for the QC Material E a s y R A O P E R A T O R ’ S M A N U A L If any of the values of User Mean and User Standard Deviation are 0, a second message displays indicating that for Active QC setup, the User Mean and Standard Deviation cannot be 0 (see Figure 4.73). Figure 4.73 Message Indicating the User Mean and User Standard Deviation for Active QC Setup Cannot Be 0 The User Mean, User SD, and QC Flag Limit are now active for entry by the user. 4.83 S E T T I N G U P T E S T C O N F I G U R A T I O N S 9 To enter information for each field that is displayed, touch the field and enter the appropriate information from the numeric keypad or select from the drop-down menu that displays. The User Mean and User SD may be obtained from the Running Statistics section of the QC Levey-Jennings Chart for each test. For more information on QC Levey-Jennings Charts, see “Viewing A Levey-Jennings Chart for Quantitative QC” on page 7.56. The SD Flag limit is also set by the user at 2, 2.5, or 3 SD. The SD Flag limit is used in flagging QC results and for graphing limits on the QC Levey-Jennings Chart. For more information on flagging results, see “Printing Test Results” on page 7.64. 10 When all entries for the test are complete, touch the Enter button. Note: If you change the condition of the selected QC Material from Active back to Transitional or Inactive, the User Mean, SD, and SD limits shown in Figure 4.72 are greyed out and the Upper and Lower Limit fields are highlighted. Viewing QC Insert Sheets EasyRA allows you to view insert sheets directly through the user interface. Insert Sheet CDs are included with each package of Reagents, QC, and Calibrator Materials. There is no need for a separate computer to view and print the insert sheets. Note: If for any reason you cannot view the insert sheet, contact Medica or your Dealer for a paper copy. 4.84 E a s y R A O P E R A T O R ’ S M A N U A L To view QC Insert Sheet from a CD: 1 Touch the Diagnostics/Maintenance/Setup icon, and then touch QC. The QC Setup menu displays (see Figure 4.74). Figure 4.74 2 QC Setup Menu Touch View Insert Sheet. The blank Insert Sheet screen displays (see Figure 4.75). Figure 4.75 Blank Insert Sheet Screen 4.85 S E T T I N G U P T E S T C O N F I G U R A T I O N S 3 Touch the CD Download button: 4 Place the QC Insert Sheet CD into drive D: (or primary CD drive) and Touch Ok. The Read Insert Sheet from CD popup displays (see Figure 4.76). Figure 4.76 4.86 Read Insert Sheet from CD Popup E a s y R A 5 O P E R A T O R ’ S M A N U A L Touch Ok. A popup window automatically displays, listing the folders and/or files containing the QC Insert Sheet (see Figure 4.77). Figure 4.77 6 Popup Showing Folders and/or Files Containing the QC Insert Sheet Touch the desired file and language (see Figure 4.78). Figure 4.78 Select File and Language from Popup 4.87 S E T T I N G 4.88 U P T E S T C O N F I G U R A T I O N S 7 Touch Open. 8 The Insert Sheet automatically opens with the EasyRA user interface. 9 To print a copy of the QC Insert Sheet, touch the Print button: E a s y R A O P E R A T O R ’ S M A N U A L Setting Up Reagents Set up the Reagent Test Panel, view Reagent Details, or view an insert sheet from the Reagent Setup menu. Setting Up the Reagent Test Panel You must load Reagents and inventory them before they appear on the Test Select Keypad. The tests corresponding to the Reagents cannot be selected until they appear on the Test Select Keypad. There is no limit to the number of tests that can be loaded in the Test Select Keypad; however, if you are creating user-defined tests, only 20 user-defined tests can appear in the Reagent Optimization list on the Test Select Keypad. There can be up to 48 user-defined reagents on EasyRA For complete details on setting up the Reagent Test Panel, see “Loading Reagents for the First Time” on page 2.23. Viewing Reagent Details You can view the setup information for the Reagents that have been loaded onto EasyRA and inventoried by the system. These Reagents do not have to be onboard the analyzer at the current time to appear on this list, as long as they were loaded and inventoried at least once. To view Reagent setup information: 1 Touch the Diagnostics/Maintenance/Setup icon, and then touch Setup. 2 On the Setup menu, select Reagents. The Reagents Setup screen displays (see Figure 4.79). Figure 4.79 Reagent Setup Screen 4.89 S E T T I N G U P T E S T C O N F I G U R A T I O N S 3 Touch Reagent Details. This Reagent Info screen (see Figure 4.80) shows all Reagents that have been loaded onto EasyRA and inventoried. This is the complete list of Reagents that have been inventoried, not just the Reagents that are currently loaded on the Reagent Tray. Figure 4.80 4 Reagent Info Screen Touch the Reagent which you want to view. A table displays on the right side of the Reagent Setup screen (see Figure 4.81 and Figure 4.82). 4.90 E a s y R A Figure 4.81 O P E R A T O R ’ S M A N U A L Reagent Setup Screen 1 4.91 S E T T I N G Figure 4.82 U P T E S T C O N F I G U R A T I O N S Reagent Setup Screen 2 The table displays all of the information that has been read from the RFID chip on the selected Reagent Wedge. This screen is for information only. You cannot modify the information that has been read from the RFID chips on the Reagent Wedges; however you can print the Reagent Setup information. Note: If there are user-defined tests (test names are preceded by a plus sign (+)), there will be a Modify button at the top of the table from which you can change the Reagent Setup Details. 4.92 E a s y R A O P E R A T O R ’ S M A N U A L Printing Reagent Setup You can print the setup information for any Reagent from the Reagent Setup screen. To print the Reagent Setup: Touch the Print button: The Reagent report that prints looks similar to the information in the table on the right side of the screen. Viewing Reagent Insert Sheets EasyRA allows you to view insert sheets directly through the user interface. Insert Sheet CDs are included with each package of Reagents, QC, and Calibrator Materials. There is no need for a separate computer to view and print the insert sheets. Note: Before viewing or printing Reagent instructions for use, confirm that the version number printed on the Reagent Wedge label matches the version number printed on the CD label. The version is represented with “VER” followed by three numbers and/or letters. The version number is also contained on each instructions for use. Note: If for any reason you cannot view the insert sheets, contact Medica or your dealer for a paper copy. To view Reagent Insert Sheet from a CD: 1 Touch the Diagnostics/Maintenance/Setup icon, and then touch Reagents. The Reagent Setup menu displays (see Figure 4.83). 4.93 S E T T I N G U P T E S T C O N F I G U R A T I O N S Figure 4.83 2 Reagent Setup Menu Touch View Insert Sheet. The blank Insert Sheet screen displays (see Figure 4.84). Figure 4.84 4.94 Blank Insert Sheet Screen E a s y R A O P E R A T O R ’ S 3 Touch the CD Download button: 4 Place the Reagent Insert Sheet CD into drive D: (or primary CD drive) and Touch Ok. M A N U A L The Read Insert Sheet from CD popup displays (see Figure 4.85). Figure 4.85 5 Read Insert Sheet from CD Popup Touch Ok. A popup window automatically displays, listing the folders and/or files containing the Reagent Insert Sheet (see Figure 4.86). 4.95 S E T T I N G Figure 4.86 U P T E S T C O N F I G U R A T I O N S Popup Showing Folders and/or Files Containing the Reagent Insert Sheet 6 Figure 4.87 4.96 Touch the desired file and language (see Figure 4.87). Select File and Language from Popup E a s y R A O P E R A T O R ’ S 7 Touch Open. 8 The Insert Sheet automatically opens with the EasyRA user interface. 9 To print a copy of the Reagent Insert Sheet, touch the Print button: M A N U A L 4.97 S E T T I N G 4.98 U P T E S T C O N F I G U R A T I O N S 5 Preparing EasyRA Introduction This chapter describes how to prepare EasyRA for use. It covers the physical setup of the system, including loading and replacing consumables. These tasks include: Loading and Unloading Reagent Wedges. Replacing the ISE Reagent Pack. Filling and Loading the Diluent Bottle. Unloading and Emptying the Waste Bottle. Loading and Unloading the Sample Ring and Reagent Tray. Replacing Cuvettes. Loading and Unloading Samples. 5.1 P R E P A R I N G E a s y R A Loading and Unloading Reagent Wedges Before any tests can be run on EasyRA, the required Reagents must be loaded and inventoried by EasyRA. The action of loading and performing an inventory on a Reagent causes the test name to appear on the Test Select Keypad. If you do not take this action, the test will not appear on the keypad and you will be unable to select it. For more information on loading Reagents for the first time, see “Loading Reagents for the First Time” on page 2.23. Reagents are supplied in small bottles in the shape of a wedge. These bottles are commonly referred to as “Reagent Wedges” or “Wedges.” EasyRA uses single wedges, that hold a single Reagent, dual wedges, that have two compartments and hold two Reagents (both of which are used to perform a test), and Three Reagent Systems that are comprised of a single and a dual wedge linked with a Reagent Wedge Clip and that hold three Reagents (all of which are used to perform a test). Figure 5.1 shows Single and Dual Wedges and the Three Reagent System. Figure 5.1 Single and Dual Wedges and the Three Reagent System Tab to grasp when installing Label with RFID chip Label with RFID chip Reagent Wedge Clip Caps Cap Single Wedge 5.2 Tab to grasp when installing Dual Wedge Dual Wedge Single Wedge Three Reagent System E a s y R A CAUTION: O P E R A T O R ’ S M A N U A L The Reagent Wedge Clip is intended to keep the two wedges that make up the Three Reagent System together. DO NOT remove the Reagent Wedge Clip. If the wedge clip is inadvertently removed, place the two wedges back into the wedge clip as described in “Installing the Reagent Wedge Clip on a Three Reagent System” on page 5.9. If you have lost or broken the wedge clip, keep the two wedges together. When you put the wedges on the Reagent Tray, be sure they are side by side with the dual wedge of the pair in the higher numbered position and the single wedge in the lower numbered position, unless the wedges are being placed in positions 1 and 24. In that case, the dual wedge should be placed in position 1 and the single wedge should be placed in Position 24. A radio frequency identification (RFID) chip is embedded in the label of each Reagent Wedge (see Figure 5.1). This RFID chip contains information to identify the parameters associated with the Reagent Wedge. EasyRA reads this information from the RFID chip during inventory. In Three Reagent Systems, both wedges contain information on the RFID chip, but once the wedges are inventoried and the system determines they are a pair, all information for the pair is taken from the RFID chip on the first wedge. Note: The cleaners used for EasyRA are packaged in both Single and Dual Reagent Wedges and are loaded in the Reagent Tray when needed. In the single Reagent Wedge, the wedge contains only bleach and is used for analyzers not equipped with the ISE Module. In the dual Reagent Wedge, the larger compartment contains bleach (for Probe cleaning) and the small compartment contains Pepsin (for cleaning the ISE Module). The Cleaner Wedge has an RFID chip like all the wedges, and is loaded and inventoried like all other wedges. All procedures related to loading and unloading wedges and performing Reagent inventory also apply to the Cleaner Wedge. 5.3 P R E P A R I N G E a s y R A The wedges are loaded into a Reagent Tray on EasyRA as shown in Figure 5.2. Figure 5.2 Wedges Loaded on the Reagent Tray Reagent Tray Sample Ring Wedges loaded on Reagent Tray Three Reagent System loaded on Reagent Tray If you have loaded one or more Three Reagent Wedges in the Reagent Tray, you will notice that the wedges are connected with Reagent Wedge Clips (see Figure 5.3). Figure 5.3 Three Reagent System Linked Together with a Reagent Wedge Clip Reagent Wedge Clip 5.4 E a s y R A O P E R A T O R ’ S M A N U A L The Lock icon displayed on the Reagent Wedge Clip also appears on the graphic representation of the Reagent Tray that appears when you perform an inventory of reagents or when you monitor the worklist (see Figure 5.4). Figure 5.4 The Three Reagent System Represented on the Worklist Monitor Screen The Lock icon indicates the wedges in Positions 23 and 24 make up a Three Reagent System. In most cases, the wedge in the lower numbered position indicates the name of the material in the Three Reagent System and the wedge in the higher numbered position is blank. The exception to this is if the wedges are located in positions 1 and 24. In that case, the wedge in Position 24 indicates the name of the material in the Three Reagent System and the wedge in Position 1 is blank. Up to 24 individual wedges can be loaded into the Reagent Tray on EasyRA at any time. The Reagent Tray is cooled, allowing Reagents that require refrigeration to be stored onboard EasyRA between runs. Many Reagents will be stable on-board EasyRA for 30 days. The following procedures describe how to load and unload wedges from the Reagent Tray. For information on loading and unloading the Reagent Tray, see “Loading and Unloading the Sample Ring and Reagent Tray” on page 5.16. 5.5 P R E P A R I N G E a s y R A Loading Reagent Wedges Wedges can be loaded in the Reagent Tray while it is on EasyRA or before the Reagent Tray has been placed on EasyRA. To load single or dual wedges or the Three Reagent System on the Reagent Tray: 1 If the optional Reagent Tray Cover is in place, remove it by lifting it off the Reagent Tray. 2 Grasp the wedge (or one of the wedges in a Three Reagent System) by the small tab on the top of the bottle (see Figure 5.5). Figure 5.5 Loading Single or Dual Wedges or Three Reagent Systems 3 Locate one empty position in the Reagent Tray for a single or dual wedge or two contiguous empty positions for a Three Reagent System. 4 Align the wedge(s) over one (or two) empty position(s) and gently press the wedge(s) into place. Be sure the wedge(s) are pushed all the way down onto the Reagent Tray. 5 Remove the cap(s) from the wedge or the Three Reagent System. 6 Repeat until all wedges and Three Reagents Systems are loaded. Note: When Reagents are stored on EasyRA, you may want to place wedge caps on the Reagent Wedges when EasyRA is not in use to prevent evaporation. Be sure to remove the wedge caps from the Reagent Wedges before attempting to use EasyRA. 5.6 E a s y R A 7 O P E R A T O R ’ S M A N U A L Install the optional Reagent Tray Cover on the Reagent Tray if desired. To install the Reagent Tray Cover, align the wide and narrow keys on the cover with the wide and narrow keys on the Reagent Tray and lower the cover into place. When the cover is properly installed, it will fit securely and will not move back and forth if you attempt to turn it. If the cover does move back and forth, remove it, realign the wide and narrow keys, and re-install it. Depending on whether you will use the Reagent Tray for EasyRA operations or storage, use the cover with holes or the solid cover, respectively. Note: If you are adding a wedge to ensure that there is sufficient Reagent for a run, be certain to place the additional full wedge in a Reagent Tray position greater than the position of the first wedge. For example, if an additional Glucose wedge is being added to a Reagent Tray where there is already a GLU wedge in position number 4, the additional GLU wedge should be placed in position 5 or greater. If this procedure is not followed, the new full wedge will be depleted first and the older wedge may not be used before its expiration. Although this new wedge may have the same lot number as the wedge that is already loaded, it may require a calibration. Review the Reagent insert sheet for details. 5.7 P R E P A R I N G E a s y R A Unloading Reagent Wedges Wedges or Three Reagent Systems can be unloaded with the Reagent Tray in place on EasyRA or before the Reagent Tray has been loaded. To remove a wedge or a Three Reagent System from the Reagent Tray: 1 If the optional Reagent Tray Cover is in place, remove it by lifting it off the Reagent Tray. 2 Locate the wedge or Three Reagent System to be removed. 3 Grasp the tab on the top of the wedge (or on the top of one of the wedges) and gently pull it out of the Reagent Tray (see Figure 5.6). Figure 5.6 5.8 Unloading Single or Dual Wedges or Three Reagent Systems 4 Check the label on the wedge or Three Reagent System to ensure the correct wedge(s) have been removed. 5 Store or discard the wedge or Three Reagent System, as required. If the wedge or Three Reagent System is to be stored, be sure to cap the wedge(s) with the original cap(s) or unused cap(s). 6 Install the optional Reagent Tray Cover on the Reagent Tray if desired. To install the Reagent Tray Cover, align the wide and narrow keys on the cover with the wide and narrow keys on the Reagent Tray and lower the cover into place. When the cover is properly installed, it will fit securely and will not move back and forth if you attempt to turn it. If the cover does move back and forth, remove it, realign the wide and narrow keys, and re-install it. Depending on whether you will use the Reagent Tray for EasyRA operations or storage, use the cover with holes or the solid cover, respectively. E a s y R A O P E R A T O R ’ S M A N U A L BIOHAZARD: All wedges and Three Reagent Systems that have been used should be considered biohazardous. The contents may contain contaminated material. Treat used wedges, during use and disposal, as you would any biohazardous material. Installing the Reagent Wedge Clip on a Three Reagent System The Three Reagent System is delivered with the Reagent Wedge Clip installed. This clip insures that the pair of wedges that make up the Three Reagent System stay together so that they can be installed and used correctly on the Reagent Tray. The Reagent Wedge Clip should never be removed from a Three Reagent System; however, if the clip has been inadvertently removed, you can re-install it. CAUTION: If the Reagent Wedge Clip is missing or broken, you must keep the pair of wedges that make up the Three Reagent System together and install them properly on the Reagent Wheel in order for the system to operate properly. Before you reconnect a pair of wedges with a Reagent Wedge Clip: Verify that the two wedges to be clipped together are a pair. Both wedges should have the same name (HbA1c for example). The single wedge will be labeled "R1" and the dual wedge will be labeled "R2/R3". Also the lot number and expiration dates on both wedges should match. Optional: Place the caps on the openings of both wedges. Although the caps are not required, it is easier to manipulate the wedges when the caps are in place (to avoid spilling the contents). Locate the Reagent Wedge Clip that came with the Three Reagent System (see Figure 5.7). 5.9 P R E P A R I N G E a s y R A Figure 5.7 Reagent Wedge Clip The process of installing the wedges into the Reagent Wedge Clip involves putting the clip onto the neck of each opening on the single and dual wedges and then locking the clip into place. This process is simple if you install the openings of the wedges into the clip in the order specified in Figure 5.7. The openings of the dual wedge are placed into positions 1 and 2 in the Reagent Wedge Clip, and the opening of the single wedge is placed into position 3 in the clip. The process of installing the wedge openings into the clip is described below. You repeat this same process three times to lock the dual wedge and the single wedge into the clip. With the Lock icon on the Reagent Wedge Clip facing up, align the large opening at position 1 on the clip over an opening on the wedge. Push the Reagent Wedge Clip down onto the neck of the opening on the wedge (see Figure 5.8, top). Figure 5.8 5.10 Installing Wedges Into the Reagent Wedge Clip Gently grasp the Reagent Wedge Clip between your thumb and forefinger and pull the clip to lock the wedge into the smaller opening for the position (see Figure 5.8). Repeat for positions 2 and 3 on the Reagent Wedge Clip. E a s y R A O P E R A T O R ’ S M A N U A L To reconnect a pair of wedges with a Reagent Wedge Clip to make a Three Reagent System: 1 Align the dual wedge opening that is located furthest from the label on the wedge with position 1 of the Reagent Wedge Clip. Push the neck into position 1 of the clip and then pull the clip in the direction of the arrow shown in Figure 5.9 to lock the clip into place. Figure 5.9 2 Rotate the Reagent Wedge Clip to the left so that you can install the second opening of the dual wedge into position 2 of the clip. Pull the clip in the direction of the arrow shown in Figure 5.10 to lock the clip into place. Figure 5.10 3 Place the Dual Wedge into Position 1 on the Reagent Wedge Clip Place the Second Opening of the Dual Wedge into Position 2 on the Reagent Wedge Clip Align the opening of the single wedge below position 3 of the Reagent Wedge Clip and push the opening into position 3 on the wedge. Pull the clip in the direction of the arrow shown in Figure 5.11 to lock the clip into place. 5.11 P R E P A R I N G E a s y R A Figure 5.11 Place the Single Wedge into Position 3 on the Reagent Wedge Clip The Reagent Wedge Clip is now properly installed. Replacing the ISE Reagent Pack The ISE Reagent Pack is located to the right of the Reaction Area. ISE calibrants are supplied in the ISE Reagent Pack. The ISE Reagent Pack has the capacity to perform approximately 400-1000 Na, K, CL, and Li tests (depending on how it is used). It contains two foil pouches - one with Cal A and one with Cal B. An electronics chip is embedded in the ISE Reagent Pack. The electronics chip contains all the information associated with the ISE Reagent Pack. EasyRA reads this information from the electronics chip during inventory. After a run is completed, EasyRA updates (writes to) the chip with the amount of fluid remaining in the ISE Reagent Pack. Before starting a run, EasyRA checks the ISE Reagent Pack to make sure there is sufficient ISE calibrant to perform the tests in the Worklist. 5.12 For information on installing the ISE Reagent Pack, see “ISE Reagent Pack” on page 2.9. E a s y R A O P E R A T O R ’ S M A N U A L Filling and Loading the Diluent Bottle The Diluent Bottle is located on the right side of EasyRA, behind the Waste Bottle (see Figure 5.12). Figure 5.12 Waste and Diluent Bottles Diluent Bottle Waste Bottle The Diluent Bottle must be filled with Reagent grade deionized water. Diluent is used to wash the Probe after each dispense to ensure that the Probe is clean and free of contamination. EasyRA should be idle while the Diluent Bottle is being refilled. It is good practice to check the level of the diluent before starting your shift to ensure you have enough diluent to perform the required activities.The Diluent Bottle should be filled if it is less than 50% full at the start of a shift. 5.13 P R E P A R I N G E a s y R A To fill the Diluent Bottle: 1 Lift the Diluent Bottle up and off of EasyRA. 2 Unscrew the bottle cap of the Diluent Bottle and remove it. Be sure to place the bottle cap and the attached tubing on absorbent plastic-backed paper to absorb any excess diluent. 3 Fill the Diluent Bottle with Reagent grade, deionized water (DI). 4 Add Medica Surfactant (5 drops per liter as shown on the label) to the Diluent Bottle to reduce carry over. 5 Place the bottle cap back onto the Diluent Bottle and tighten it. Verify that the tubing attached to the bottle cap extends to the bottom of the Diluent Bottle. 6 Place the Diluent Bottle back onto EasyRA. 7 The Diluent Bottle is now filled. Note: The Diluent Bottle should be cleaned with bleach once a month. For more information on cleaning the Diluent Bottle, see “Bleaching the Diluent Bottle” on page 10.25. 5.14 E a s y R A O P E R A T O R ’ S M A N U A L Unloading and Emptying the Waste Bottle The Waste Bottle is located on the right side of EasyRA, in front of the Diluent Bottle (see Figure 5.12). The Waste Bottle is filled with waste as tests are run and maintenance is performed. The Waste Bottle must be emptied when it is 95% full and it should be emptied on a daily basis. BIOHAZARD: All EasyRA waste should be considered biohazardous. The contents of the Waste Bottle may contain contaminated material. Treat all waste, during use and disposal, as you would any biohazardous material. It is good practice to check the level of the waste before starting your shift to ensure that you will not have to stop and empty waste during your shift. You should empty the Waste Bottle if it is more than 50% full at the start of a shift. EasyRA should be idle while the Waste Bottle is being emptied. To empty the Waste Bottle: 1 Remove the tubing from the Dilutor Pump. 2 Lift the Waste Bottle up and off of EasyRA. 3 Unscrew the bottle cap of the Waste Bottle and remove it. 4 Dispose of the biohazardous waste from the Waste Bottle according to your laboratory’s procedures and local regulations. 5 Place the bottle cap back onto the Waste Bottle and tighten it. 6 Place the Waste Bottle back onto EasyRA. 7 Re-insert tubing into the Waste Bottle. 8 The Waste Bottle is now empty. Note: The Waste Bottle should be cleaned with bleach once a month. For more information on cleaning the Waste Bottle, see “Bleaching the Waste Bottle” on page 10.30. 5.15 P R E P A R I N G E a s y R A Loading and Unloading the Sample Ring and Reagent Tray The Sample Ring and the Reagent Tray can be loaded and unloaded from EasyRA as a unit. Each component can also be loaded or unloaded separately; however, the Sample Ring rests on the Reagent Tray, so if they are loaded separately, the Reagent Tray must be loaded first followed by the Sample Ring. If they are unloaded separately, the Sample Ring must be unloaded first, followed by the Reagent Tray. If you are using the optional Reagent Tray Cover, it must be removed before you can load or unload the Sample Ring or the Reagent Tray (see Figure 5.13). Figure 5.13 Sample Ring and Reagent Tray with Optional Cover in Place Reagent Tray with Cover Sample Ring 5.16 E a s y R A O P E R A T O R ’ S M A N U A L Figure 5.14 shows the Sample Ring and Reagent Tray. Figure 5.14 Sample Ring and Reagent Tray Sample Ring Reagent Tray The following procedures describe how to load and unload the Sample Ring and Reagent Tray as a unit, or separately. 5.17 P R E P A R I N G E a s y R A Loading and Unloading the Sample Ring and Reagent Tray as a Unit To load the Sample Ring and Reagent Tray as a unit: 1 If the optional Reagent Tray Cover is in place, remove it by lifting it off the Reagent Tray. 2 Grasp the Sample Ring and Reagent Tray by placing one hand on the yellow center ring of the Reagent Tray and one hand on the outer edge of the Sample Ring (see Figure 5.15) Figure 5.15 3 5.18 Lifting the Sample Ring and Reagent Tray to Load Align the slot in the center of the Reagent Tray with the post on the base of the Sample/Reagent Area (see Figure 5.16). E a s y R A Figure 5.16 4 O P E R A T O R ’ S M A N U A L Aligning the Sample Ring and Reagent Tray to the Sample/Reagent Area Carefully lower the Sample Ring and Reagent Tray into the Sample/ Reagent Area, making sure the slot and post are aligned. When the Sample Ring and Reagent Tray are properly positioned, they will be securely seated and will not rock from side to side. 5 Install the optional Reagent Tray Cover on the Reagent Tray if desired. To install the Reagent Tray Cover, align the wide and narrow keys on the cover with the wide and narrow keys on the Reagent Tray and lower the cover into place. When the cover is properly installed, it will fit securely and will not move back and forth if you attempt to turn it. If the cover does move back and forth, remove it, realign the wide and narrow keys, and re-install it. Depending on whether you will use the Reagent Tray for EasyRA operations or storage, use the cover with holes or the solid cover, respectively. 5.19 P R E P A R I N G E a s y R A To unload the Sample Ring and Reagent Tray as a unit: 1 If the optional Reagent Tray Cover is in place, remove it by lifting it off the Reagent Tray. 2 Grasp the Sample Ring and Reagent Tray by placing one hand on the yellow center ring of the Reagent Tray and one hand on the outer edge of the Sample Ring (see Figure 5.17). Figure 5.17 3 Lifting the Sample Ring and Reagent Tray to Unload Press down on the center of the ring while carefully lifting the Sample Ring and Reagent Tray off of EasyRA. Note: When you remove the Sample Ring and Reagent Tray from EasyRA, be sure to store samples and Reagents at the correct temperature. Samples and Reagents should be covered to prevent evaporation. Be certain to use the original wedge cap(s) for each Reagent Wedge. Do not mix Reagent Wedge caps among the Reagents. 5.20 E a s y R A 4 O P E R A T O R ’ S M A N U A L Install the optional Reagent Tray Cover on the Reagent Tray if desired. To install the Reagent Tray Cover, align the wide and narrow keys on the cover with the wide and narrow keys on the Reagent Tray and lower the cover into place. When the cover is properly installed, it will fit securely and will not move back and forth if you attempt to turn it. If the cover does move back and forth, remove it, realign the wide and narrow keys, and re-install it. Depending on whether you will use the Reagent Tray for EasyRA operations or storage, use the cover with holes or the solid cover, respectively. Loading and Unloading the Sample Ring The Sample Ring is installed on the outside of the Reagent Tray. You can load and unload the Sample Ring from the Reagent Tray at any time, whether or not the Reagent Tray is loaded on EasyRA, and whether or not the Reagent Tray Cover is in place. To load the Sample Ring onto the Reagent Tray: 1 Using both hands, grasp the Sample Ring on opposite sides (see Figure 5.18). Figure 5.18 2 Loading the Sample Ring Align the two tabs on the Reagent Tray with the notches on the Sample Ring (see Figure 5.19). 5.21 P R E P A R I N G Figure 5.19 E a s y R A Align Tabs on the Reagent Tray with Notches on Sample Ring Notch Notch Tab Tab 3 Carefully lower the Sample Ring onto the Reagent Tray, making sure the tabs and notches are aligned. When the Sample Ring is positioned properly, it will be securely seated and will not rock from side to side. 5.22 E a s y R A O P E R A T O R ’ S M A N U A L To unload the Sample Ring from the Reagent Tray 1 Using both hands, grasp the Sample Ring on opposite sides (see Figure 5.20). Figure 5.20 Unloading the Sample Ring . 2 Carefully lift the Sample Ring off of the Reagent Tray. Note: When you remove the Sample Ring, be sure to store samples at the correct temperature. 5.23 P R E P A R I N G E a s y R A Loading and Unloading the Reagent Tray The Reagent Tray is located inside the Sample Ring. You can only unload the Reagent Tray from EasyRA after the Sample Ring and the optional Reagent Tray Cover have been removed. Note: The Reagent Area is refrigerated to 15°C below ambient. If you remove the Reagent Tray from EasyRA, the Reagents are no longer refrigerated. Be sure to store Reagents at the correct temperature when you remove the Reagent Tray. To load the Reagent Tray: 1 If the optional Reagent Tray Cover is in place, remove it by lifting it off the Reagent Tray. 2 Pick up the Reagent Tray by placing one hand on the yellow center ring of the Reagent Tray and one hand on the outer edge of the Reagent Tray (see Figure 5.21). Figure 5.21 5.24 Loading the Reagent Tray E a s y R A 3 M A N U A L Align the slot in the center of the Reagent Tray with the post on the base of the Sample/Reagent Area (see Figure 5.22). Figure 5.22 4 O P E R A T O R ’ S Aligning the Reagent Tray on EasyRA Carefully lower the Reagent Tray into the Sample/Reagent Area, making sure the post and slot are aligned. When the Reagent Tray is properly positioned, it will be securely seated and will not rock from side to side. 5 Install the optional Reagent Tray Cover on the Reagent Tray if desired. To install the Reagent Tray Cover, align the wide and narrow keys on the cover with the wide and narrow keys on the Reagent Tray and lower the cover into place. When the cover is properly installed, it will fit securely and will not move back and forth if you attempt to turn it. If the cover does move back and forth, remove it, realign the wide and narrow keys, and re-install it. Depending on whether you will use the Reagent Tray for EasyRA operations or storage, use the cover with holes or the solid cover, respectively. 5.25 P R E P A R I N G E a s y R A To unload the Reagent Tray: 1 If the optional Reagent Tray Cover is in place, remove it by lifting it off the Reagent Tray. 2 Grasp the center ring on the Reagent Tray with both hands and place both thumbs on the yellow center ring (see Figure 5.23). Figure 5.23 Unloading the Reagent Tray 3 Press down on the center ring with your thumbs while carefully lifting the Reagent Tray off of EasyRA. 4 Install the optional Reagent Tray Cover on the Reagent Tray if desired. To install the Reagent Tray Cover, align the wide and narrow keys on the cover with the wide and narrow keys on the Reagent Tray and lower the cover into place. When the cover is properly installed, it will fit securely and will not move back and forth if you attempt to turn it. If the cover does move back and forth, remove it, realign the wide and narrow keys, and re-install it. Depending on whether you will use the Reagent Tray for EasyRA operations or storage, use the cover with holes or the solid cover, respectively. Note: When you remove the Reagent Tray from EasyRA, be sure to store Reagents at the correct temperature. Reagents should be recapped when stored for long periods of time. 5.26 E a s y R A O P E R A T O R ’ S M A N U A L Replacing Cuvettes EasyRA can hold up to six Cuvette Segments, each of which contains 12 Cuvettes (for a total of 72 Cuvettes). Figure 5.24 shows a Cuvette Segment. Figure 5.24 Cuvette Segment Cuvette Segments must be replaced after one-time use. It is good practice to check the number of Cuvettes available before starting a run. This minimizes the interruptions that may occur during the run. You can determine whether there are sufficient cuvettes for a run in advance by performing either a Worklist Inventory or a Cuvette Inventory. For information on Worklist Inventory, see “Performing an Inventory” on page 6.32. For information on checking Cuvette Status, see “Viewing Cuvette Status” on page 8.15. BIOHAZARD: All used Cuvettes should be considered biohazardous. The contents of the Cuvettes may contain contaminated material. Treat used Cuvettes, during use and disposal, as you would any biohazardous material. 5.27 P R E P A R I N G E a s y R A Note: If used Cuvettes have been left standing in EasyRA for a long period of time (more than 24 hours), the material in the Cuvettes may evaporate or dry up. When you perform a Cuvette inventory, it is possible that the residue on the used Cuvettes will not be detected and EasyRA will indicate the Cuvettes are clean and ready for use when they are actually used. If used Cuvettes are left on EasyRA for more than 24 hours, it is recommended that you manually inspect the Cuvettes before running an inventory. It is important to discard Cuvettes which are used, but which EasyRA recognizes as OK. The following procedures describe how to replace Cuvettes. The first procedure describes replacing Cuvettes when a run is not in progress and the second procedure describes additional steps that must be taken if you replace Cuvettes during a run. Before you begin, it is recommended that you have a supply of Cuvette Segments available and ready for use. These Cuvettes should be stored in a dust-free area. 5.28 E a s y R A O P E R A T O R ’ S M A N U A L Replacing Cuvettes When a Run is Not in Progress To replace Cuvettes: 1 Open the Reaction Area cover. Notice that each segment of the Cuvette Carousel is identified with a letter, A-F (see Figure 5.25.) Figure 5.25 2 Cuvette Carousel Inside Reaction Area Remove the used Cuvette Segments one at a time. If you are not sure which segments have been used, view Cuvette Status from the Status menu. For more information, see “Viewing Cuvette Status” on page 8.15. To remove a Cuvette Segment, use your thumb and first finger to grasp each end of the Cuvette Segment, and then gently lift up one end of the segment, then lift up the other side (see Figure 5.26). 5.29 P R E P A R I N G E a s y R A Figure 5.26 3 Removing Cuvette Segment Discard the used Cuvette Segments. BIOHAZARD: All used Cuvettes should be considered biohazardous. The contents of the Cuvettes may contain contaminated material. Treat used Cuvettes, during use and disposal, as you would any biohazardous material. 4 Replace the Cuvette Segments with new, unused segments. To replace the Cuvette Segments, grasp each end of the new Cuvette Segment with your thumb and first finger, align the new segment over a slot in the Cuvette Carousel, and gently snap the segment into a slot (see Figure 5.27). 5.30 E a s y R A Figure 5.27 5 M A N U A L Replacing Cuvette Segment If desired, perform a Cuvette inventory from the Status menu before closing the Reaction Area cover. 6 O P E R A T O R ’ S For more information, see “Viewing Cuvette Status” on page 8.15. Close the Reaction Area cover when all Cuvette Segments have been replaced. 5.31 P R E P A R I N G E a s y R A Replacing Cuvettes During A Run During the Worklist Inventory, EasyRA checks the number of tests that are scheduled and determines if there are enough Cuvettes available to perform those tests. If there are not enough Cuvettes to complete the run, EasyRA generates a Status message under Worklist Warnings. You can either replace Cuvettes before starting the run, or start the run and allow it to proceed until the Cuvettes run out. If you chose to start the run without replacing Cuvettes, or your run requires more than the 72 Cuvettes available, the run begins and proceeds until EasyRA runs out of Cuvettes. When the run begins, EasyRA displays a Cuvette Replacement icon with a Cuvette Replacement Countdown Timer on the icon/menu bar (see Figure 5.28). Figure 5.28 Cuvette Replacement Icon Cuvette Replacement Icon The icon indicates the number of Cuvettes needed to complete the run and the timer counts down the time until the Cuvettes run out. The time is in minutes:seconds (MMM:SS) format and the timer stops to counting when EasyRA is paused. You can manually pause the run at any time and replace Cuvettes, or EasyRA will automatically pause the run when all the Cuvettes have been used. 5.32 For information on pausing the run manually, see “Pausing and Resuming Test Runs” on page 6.38. If you manually pause the run to replace Cuvettes, you should perform a Cuvette inventory so you know exactly which Cuvettes have been used. E a s y R A O P E R A T O R ’ S M A N U A L If you allow EasyRA to run until the Cuvettes run out, it pauses automatically when no more Cuvettes are available. When it pauses, the Pause and Run buttons are unavailable. The Cuvette Status screen displays indicating Cuvettes need to be replaced (see Figure 5.29). Figure 5.29 Replace Cuvettes Message The Reaction Area cover is unlocked when this message is displayed. All used Cuvettes are displayed in green. 5.33 P R E P A R I N G E a s y R A To replace Cuvettes when EasyRA has been paused: 1 Follow steps 1-6 in “Replacing Cuvettes When a Run is Not in Progress” on page 5.29. When you are done, touch OK on the Replacement Complete? message. The Cuvette inventory begins (see Figure 5.30). Note: If any covers besides the Reaction Area cover were opened while EasyRA was paused, the system runs a full inventory, not just a Cuvette inventory. Figure 5.30 5.34 Inventory in Progress After Cuvettes Have Been Replaced E a s y R A O P E R A T O R ’ S M A N U A L The status of the Cuvettes displayed on the Cuvette Carousel is updated as the inventory progresses. When the inventory is complete, all new Cuvettes that are ready to use are displayed in white. The Run button displays at the top of the screen (see Figure 5.31). Figure 5.31 Cuvette Status After Cuvette Replacement and Inventory Are Complete 5.35 P R E P A R I N G E a s y R A 2 Touch Run to resume the run. The Worklist Monitoring screen displays, showing the status of the run as it progresses (see Figure 5.32). Note: When Auto Run After Inventory is enabled, the run will begin immediately following the Worklist Inventory. For more information, see “Performing an Inventory/Starting a Run (with Auto Run Enabled)” on page 6.37. Figure 5.32 5.36 Worklist Monitoring Screen After the Run Resumes E a s y R A O P E R A T O R ’ S M A N U A L Loading and Unloading Samples Up to 24 samples can be loaded on the Sample Ring. The samples are placed in the 24 numbered holes located around the outer edge of the Sample Ring (see Figure 5.33). Figure 5.33 Samples Loaded on the Sample Ring To load samples, a sample cup holder or sample tube holder is placed into the openings on the Sample Ring, and then sample tubes or sample cups are placed into the sample holder. Table 5.1 and Table 5.2 list the types of sample tubes and sample cups that can be used with EasyRA. The tables also list the inserts or sample cup holders that can be used with each tube or cup. 5.37 E a s y R A P R E P A R I N G Table 5.1 DRAW Types of Sample Tubes Used by EasyRA LENGTH DIAMETER VOLUME MAXIMUM DISTANCE INSERT FROM TOP OF TUBE TO SAMPLE 10 mL 100 mm 16 mm 2 in 5.1 cm 100x16 mm plastic insert 5 mL 100 mm 13 mm 2 in (5.1 cm) 100x13 mm plastic insert 3.5 mL 75 mm 13 mm 1.5 in (3.8 cm) 75x13 mm plastic insert Table 5.2 Types of Sample Cups Used by EasyRA CUP/SIZE LENGTH DIAMETER MINIMUM SAMPLE SAMPLE CUP HOLDER SIZE REQUIRED IN CUP 2 mL 20 mm 13 mm 100 L EasyRA Sample Cup Holder small nesting cup/1mL 29.7 mm 9 mm 150 L EasyRA Sample Cup Holder or 75x13 mm tube in a plastic insert or 100x13 mm tube in a plastic insert large nesting cup/2mL 29.7 mm 12 mm 150 L 100 x 16 mm tube in a plastic insert To ensure the correct operation of the Level Detector, the top of the spun-down samples should be within two inches of the top of the sample tube. Visually inspect the sample to ensure there are no bubbles. If bubbles are viewed, aspirate the bubbles from the sample using a pipette. If 2 mL sample cups are used, a minimum sample size of 100 L is required. 5.38 E a s y R A O P E R A T O R ’ S M A N U A L Nesting sample cups within the sample tube allows the barcode on the sample tube to be used for sample identification. The sample size in the nesting sample cup should be at least 150 L. For more information on nesting sample cups, see Table 5.2. Note: Samples placed in 2 mL sample cups are subject to evaporative errors. A typical 0.5 mL sample in this cup may be subject to 1.2% positive bias after approximately 45 minutes of exposure on the Sample Ring. Smaller samples sizes will be more susceptible to evaporation. It is possible to extend that time to up to 2.5 hours by using anti-evaporation caps. Samples placed in sample cups should be analyzed as soon as possible. Loading Samples Without the LIS Connectivity Option Note: It is critical that the samples are loaded into the sample positions that correspond to their location entries in the Worklist, as well as into the correct Sample Ring. Based on your laboratory protocols and procedures, you may load the Sample Ring before you create the Worklist, while you are creating the Worklist, or after you create the Worklist. Regardless of when the Sample Ring is loaded, use care to ensure the samples are loaded in the correct positions before starting the run. BIOHAZARD: All samples should be considered biohazardous. The contents of the samples may contain contaminated material. Treat samples, during use and disposal, as you would any biohazardous material. To load a sample on the Sample Ring if you are not using the LIS Connectivity option and the Barcode Reader: 1 Locate the appropriate sample tube or sample cup and sample holder to be used. 2 Place the sample holder into the correct position on the Sample Ring (see Figure 5.34). 5.39 P R E P A R I N G E a s y R A Figure 5.34 3 Place the sample tube or sample cup into the sample holder (see Figure 5.35). Figure 5.35 4 5.40 Inserting a Sample Holder into the Sample Ring Inserting Sample Tubes or Cups into Sample Holders If desired, place an Anti-evaporation cap on a Sample Cup. For more information, see “Installing Anti-Evaporation Caps” on page 5.43. E a s y R A O P E R A T O R ’ S M A N U A L Loading Samples With the LIS Connectivity Option BIOHAZARD: All samples should be considered biohazardous. The contents of the samples may contain contaminated material. Treat samples, during use and disposal, as you would any biohazardous material. To load a sample on the Sample Ring if you are using the LIS Connectivity option and the Barcode Reader: 1 Locate the appropriate sample tube or sample cup and sample holder to be used. 2 Place the sample holder into a position on the Sample Ring (see Figure 5.34). 3 Place the sample tube or sample cup into the sample holder (see Figure 5.35). Be sure that the barcodes on the sample tubes are facing outward so they can be read by the Barcode Reader. If sample cups are used, be sure that they are placed in positions corresponding to their position on the Worklist. 5.41 P R E P A R I N G E a s y R A Unloading Samples To unload a sample from the Sample Ring: 1 Locate the appropriate sample to be removed. 2 Carefully lift the sample tube or sample cup from the Sample Ring. 3 Cap the sample and store it for future use, or properly dispose of it. BIOHAZARD: All samples should be considered biohazardous. The contents of the samples may contain contaminated material. Treat samples, during use and disposal, as you would any biohazardous material. Using Anti-Evaporation Caps EasyRA now provides an optional anti-evaporation cap that can be used to prevent evaporation of materials in Sample Cups during EasyRA operations. The anti-evaporation caps are disposable adhesive caps that can effectively prevent evaporation during EasyRA operations. The caps are pre-cut to allow the Probe to enter and exit the Sample Cup during operation. Anti-evaporation caps prevent evaporation from serum placed in Sample Cups for up to 2.5 hours. Figure 5.36 shows an anti-evaporation cap on a Sample Cup. Figure 5.36 Anti-Evaporation Cap on a Sample Cup Anti-Evaporation Cap Sample Cup in Sample Cup Holder 5.42 E a s y R A O P E R A T O R ’ S M A N U A L The disposable anti-evaporation caps are provided in a roll of 500 adhesive caps that can be easily peeled away from their backing and adhered to Sample Cups. The anti-evaporation caps can also be easily removed and disposed of when they are no longer needed. Installing Anti-Evaporation Caps To install anti-evaporation caps: 1 Pull the tape backing from the box of anti-evaporation caps (see Figure 5.37) and gently separate the narrow edge of the backing at the perforation. Figure 5.37 Remove One Anti-Evaporation Cap from Box 2 Using your thumb and forefinger, grasp the tab of the anti-evaporation cap (the part that is no longer adhered to the backing) and lift the cap off the backing. Avoid touching the adhesive on the circular portion of the anti-evaporation cap. 3 Align the anti-evaporation cap over the opening on the Sample Cup so that the circle printed on the cap is centered over the opening (see Figure 5.38). 5.43 P R E P A R I N G E a s y R A Figure 5.38 Installing an Anti-Evaporation Cap onto a Sample Cup 4 Press the cap down onto the sample cup and the sample cup holder and verify that the adhesive holds the cap in place (see Figure 5.38). 5 The Anti-evaporation cap will prevent evaporation during normal operations. BIOHAZARD: Anti-Evaporation Caps that have been used should be considered biohazardous. The caps may be contaminated material. Treat the anti-evaporation caps, during use and disposal, as you would any biohazardous material. Removing Anti-Evaporation Caps To remove anti-evaporation caps: 1 Grasp the Sample Cup in one hand and grasp the tab on the anti-evaporation cap with the other hand. 2 Peel back the anti-evaporation cap (see Figure 5.39) and dispose of it properly. BIOHAZARD: Sample Cups may contain biohazardous material. Use caution not to spill any biohazardous material when removing the Anti-Evaporation Caps. 5.44 E a s y R A Figure 5.39 O P E R A T O R ’ S M A N U A L Remove Anti-Evaporation Cap from a Sample Cup BIOHAZARD: Anti-Evaporation Caps that have been used should be considered biohazardous. The caps may be contaminated material. Treat the anti-evaporation caps, during use and disposal, as you would any biohazardous material. 5.45 P R E P A R I N G 5.46 E a s y R A 6 Setting Up and Running Tests A Worklist defines all the tests that will be run on samples in a particular EasyRA test run. EasyRA allows you to run tests on up to 24 samples in a single run. From the Worklist, you can specify that several tests will be run on each sample. Tests to be included in the Worklist are manually entered. If you have the LIS Connectivity option, tests can be automatically added to the Worklist from the LIS. This chapter presents a typical workflow for creating and running a Worklist. It then provides detailed procedures for the following tasks: Creating a Worklist. Performing an inventory. Starting a run. Pausing and resuming a run. Ending a run. Monitoring a run. Viewing the Pending List. Moving tests from the Pending List to the Worklist. Calibrating the ISE Module. It also describes the LIS interface and how to view an LIS list. Note: Samples placed in 2 mL sample cups are subject to evaporative errors. A typical 0.5 mL sample in this cup may be subject to 1.2% positive bias after approximately 45 minutes of exposure on the Sample Ring. Smaller sample sizes will be more susceptible to evaporation. It is possible to extend that time to up to 2.5 hours by using anti-evaporation caps. Samples placed in sample cups should be analyzed as soon as possible. 6.1 S E T T I N G U P A N D R U N N I N G T E S T S Creating and Running a Worklist - Typical Workflow Figure 6.1 shows a summary of the workflow for creating and running a Worklist. Figure 6.1 1 Obtain Samples 2 Determine tests to be run 3 Select the Sample Ring 4 Open Edit Worklist & Select Sample Ring 5 Create Worklist Entries 6 Check the Pending List 7 Load the Sample Ring 8 Perform a Worklist Inventory 9 Check Status/ Worklist Warnings 10 Start the Run 11 12 6.2 Summary of the Workflow Monitor the Run View and Accept Test Results Auto Run. See “Performing an Inventory/Starting a Run (with Auto Run Enabled)” on page 6.37. E a s y R A O P E R A T O R ’ S M A N U A L Note: The workflow varies slightly, depending on whether or not you are using the LIS Connectivity option. The workflow includes information about creating the Worklist manually or creating the Worklist from data provided by an LIS. Some of the detailed procedures describe these tasks separately depending on whether or not you are using an LIS. The following provides details for each of the steps in the workflow. Note: Before setting up a run, it is recommended that you view the Inventory Report and the Cuvette Status to assess the status of EasyRA. By checking status before you begin, you can ensure EasyRA is ready to run the tests that have been entered. For information on viewing the Inventory report, see “Viewing the Inventory Report” on page 8.22. For information on viewing Cuvette Status, see “Viewing Cuvette Status” on page 8.15. 1 Obtain the samples on which you want to run tests. 2 Determine which tests should be run on each sample. For tests that will be manually entered into the Worklist, use the list of tests provided with the samples when they arrive in your laboratory. For tests that are sent to EasyRA via an LIS, a list of tests is not required. EasyRA will read the barcode from each sample during the sample inventory and will match the samples to the tests that have been downloaded from the LIS. You do not need to manually enter tests in the Worklist for samples received from an LIS. 3 Select the Sample Ring (A or B) to be loaded with samples. 4 Open the Edit Worklist screen and select the Sample Ring. (It is possible to create (or edit) a Worklist for one Sample Ring, while running a Worklist on the other Sample Ring.) 6.3 S E T T I N G U P A N D R U N N I N G 5 T E S T S Create entries in the Worklist for the tests to be run. Before running patient tests, it is often necessary to set up and run calibration and QC. The way in which Worklists are set up to perform calibration and QC depends on your laboratory protocol and procedures. EasyRA gives you the flexibility to set up and perform calibration, QC, and patient tests in a single run; however, some laboratories may prefer to create Worklists that contain only calibrations, QC, or patient tests. Calibration for a test is specific to the lot number of the Reagent being used for each test. Only one lot number of Reagent may be calibrated in any run. Multiple lots of Reagent can be used in a run, provided not more than one lot number of Reagents requires calibration. Note: Calibration requests cannot be obtained from the LIS. These tests must be set up manually on EasyRA. 6 Check the Pending List. Check the Pending List for samples that could not be run at an earlier time, but which may run now. If there are tests in the Pending List that can be run, enter their Sample ID/Lot number into a blank entry in the Worklist. EasyRA will search the Pending List for a match. If a match is found, EasyRA adds the pending test to the Worklist and removes it from the Pending List. 6.4 E a s y R A 7 O P E R A T O R ’ S M A N U A L Load the Sample Ring. Place the samples into the selected Sample Ring. The order in which you place the samples into the Sample Ring depends on your laboratory protocol and procedures. You may load the Sample Ring as you enter tests in the Worklist, or you may load the Sample Ring either before or after you enter tests into the Worklist. Regardless of when you load the Sample Ring, it is critical that you place the samples into the positions on the Sample Ring that correspond with the entries in the Worklist. If you are using an LIS, place the samples into the Sample Ring in positions that correspond to empty positions in the Worklist. When EasyRA runs an inventory, it will read the barcodes from the samples and match the samples to test requests that were downloaded from the LIS. If it finds a match, the test information is automatically filled in on the Worklist. If you are performing a combination of manual tests and tests from an LIS, it is recommended that you place the samples into the Sample Ring in the following order for ease of operation: 8 Samples for which you will manually enter tests on the Worklist. Samples whose tests were moved from the Pending List. Samples whose tests will be obtained from the LIS. These samples should be placed in sample positions that correspond to empty positions in the Worklist. Perform an inventory. When you are done entering tests on the Worklist, press Enter to perform an inventory. Note: If you have selected Auto Run mode, see “Performing an Inventory/Starting a Run (with Auto Run Enabled)” on page 6.37. During the inventory EasyRA determines if adequate Reagent and Cuvette resources are available to perform the tests that have been set up in the Worklist. If you are using an LIS, it is during the inventory that the barcodes are read from the samples and the information from the LIS is associated with the barcoded samples. 6.5 S E T T I N G U P A N D R U N N I N G 9 T E S T S Check status, if required. If, after the inventory, EasyRA determines that some tests cannot be run, the Status icon blinks. Touch the Status icon and view Worklist Warnings for a list of any problems that may have been identified during the inventory. Depending on the problems, you can either decide to resolve them and repeat Step 8 (inventory), or you can continue with the run. 10 Start the Run. After performing the inventory and checking Worklist Warnings, you can start the run. If entries have been added from the LIS during the inventory, you may want to review the Worklist before starting the run. 11 Monitor the run. As the tests are performed, the status of the tests is displayed. The status is updated as the tests occur. You can monitor the tests as they are performed, or you can wait until all tests are complete and view the results. 12 View and accept results. When all tests are finished, view the results of the tests. At this point, you can choose to rerun tests as needed (rerun is only available once per run), print test results, or delete test results (requires the Supervisor password). When you are ready to store the results, you accept them. This stores the results and clears the Worklist, so you can begin running a new Worklist. 6.6 E a s y R A O P E R A T O R ’ S M A N U A L Creating or Editing a Worklist Manually The Worklist can have up to 24 sample entries, one for each of the 24 sample positions on the Sample Ring. Each sample entry can have up to 24 photometric and four ISE tests associated with it. Use the Worklist to specify the tests to be run on each sample. You can run several different tests on each sample. Note: If you are using a Laboratory Information System (LIS), you can create a Worklist automatically. See “Creating a Worklist Automatically (Tests Obtained from LIS)” on page 6.28 for information on creating a Worklist automatically. The following information is entered for each Worklist entry: Priority of the test (stat or normal). This selection is not applicable for calibration or QC. The position of the sample on the Sample Ring. The sample type: Patient sample type (Serum, Plasma, Diluted Blood, Urine, or Diluted Urine). Calibrator. QC. Sample ID or Lot number for the sample. The specific test(s) to be run on the sample (up to 24 photometric tests and four ISE tests). The Patient ID which is a unique identifier for every patient and patient details, if desired, such as name, age, sex, etc. The Patient ID field is not applicable for calibration or QC. The Date and Time when the patient sample was collected. This field is not applicable for calibration or QC. You manually enter this information for each sample, or, if you have the LIS Connectivity option, this information will be read from an LIS list that was downloaded to EasyRA. 6.7 S E T T I N G U P A N D R U N N I N G T E S T S Note: When you create a Worklist, it is critical that the samples are loaded into the sample positions that correspond to their entries in the Worklist. Based on your laboratory protocols and procedures, you may load the Sample Ring before you create the Worklist, while you are creating the Worklist, or after you create the Worklist. Regardless of when the Sample Ring is loaded, use care to ensure the samples are loaded in the correct positions before starting the run. To create a new Worklist or edit an existing Worklist: 1 Touch the Worklist icon. On the drop-down menu that appears, touch Edit Worklist (see Figure 6.2). Figure 6.2 Worklist Icon and Menu A blank Edit Worklist screen appears as shown in Figure 6.3 if you are creating a new Worklist. If you are editing a Worklist, the Edit Worklist screen displays a Worklist that is in progress. 6.8 E a s y R A Figure 6.3 2 O P E R A T O R ’ S M A N U A L Worklist Edit Screen You can edit the Worklist for either Sample Ring A or Sample Ring B. Select the Worklist to edit by touching the A or B at the top of the screen. The Worklist currently being created or edited is indicated by a circle around the Sample Ring letter. Note: If you need to edit a Worklist that is running, you must pause the test run first. For information on pausing a run, see “Pausing and Resuming Test Runs” on page 6.38. 3 Enter the information for each sample position (1-24) in the Worklist, as described in Table 6.1. The information for each sample position specifies the tests that will be run on the sample located in the corresponding position on the Sample Ring. 6.9 S E T T I N G U P A N D R U N N I N G T E S T S Note: If you are using an LIS, it is not necessary to enter this information for those samples in the Worklist. Simply insert the sample(s) into the Sample Ring and leave the Worklist entry for that position blank. EasyRA will read the barcode from the sample and match the sample to tests received from the LIS. Table 6.1 Edit Worklist Fields FIELD NAME POSSIBLE VALUES DESCRIPTION STAT On or Off (Black Triangle displays in field when it is On) Specifies the priority of the sample. If the Stat column is selected (turned on) for a sample, the test(s) for that sample have a higher priority than other tests in the Worklist. Tests designated as Stats will run before other patient tests. If calibration is required to run the Stat test(s), then calibration is run before a Stat; however, Stat samples always take precedence over QC and other patient samples. This field is not applicable to calibration and QC. POS 1-24 Indicates the position of the sample on the Sample Ring and the Worklist. This field cannot be edited. IMPORTANT: It is CRITICAL that samples are placed in the positions in the Sample Ring that correspond to their entries in the Worklist. TYPE Serum Plasma Diluted Blood Urine Diluted Urine Calibrator QC Select the sample type to be run from the drop-down menu. Patient sample types are: Serum, Plasma, Diluted Blood (only for HbA1c tests only), Urine, and Diluted Urine (for ISE tests only). You can also run Calibration and QC. Sample type varies according to the analyte used. Consult the analyte’s Reagent insert sheet for specific information. IMPORTANT: If you enter a multi-level calibrator in the worklist, be aware that it will require one sample position for each calibration level. Make sure that there are enough empty sample positions available for each level. If there are not enough empty sample positions for the multi-level calibration, a message displays indicating you are entering a multi-level calibrator and this selection will overwrite tests already entered in the next few positions. For more information on running calibration, see “Entering Calibration Requests” on page 6.15. For more information on running quality control, see “Entering Quality Control Requests” on page 6.21. 6.10 E a s y R A O P E R A T O R ’ S M A N U A L Table 6.1 Edit Worklist Fields FIELD NAME POSSIBLE VALUES DESCRIPTION SAMPLE Up to 14 alphanumeric characters. Specifies a unique sample ID or a lot number of the QC or calibrator material for this sample (also referred to as the Accession Number). This number uniquely identifies the sample and is used to identify results after tests are run. ID/LOT For information on using the Alphanumeric Keypad to enter the Sample ID/Lot, see “Entering Alphanumeric Data” on page 3.45. TESTS Select one or more tests. Enter the tests or select a Test Panel to be run on the sample from the Test Select Keypad. EasyRA disables tests that are not valid based on the fields selected on the worklist. As you select tests, the volume of the sample required to perform the tests is displayed on the graphic representation of the Sample Ring. You can also choose to replicate tests by selecting the Replicates button on the Test Select Keypad and choosing the number of times you want to replicate the test (from 1-10). The number of replicates selected displays on the Worklist. You cannot run replicates on calibration or QC tests. Each sample can have up to 24 photometric tests and 4 ISE tests selected. No more than 20 user-defined tests can be used in a single worklist. Any of the 20 user-defined tests can be qualitative, however, only up to six of them can be non-qualitative. If a user-defined test is used once in a worklist, that same test can be used again in a different sample position, and it will not count against the limit of 20 user-defined tests. For information on using the Test Select Keypad, see “Entering Test Data” on page 3.46. For more information on running patient tests (Serum, Plasma, Diluted Blood, Urine, or Diluted Urine), see “Entering Patient Test Requests” on page 6.24. 6.11 S E T T I N G U P A N D R U N N I N G T E S T S Table 6.1 Edit Worklist Fields FIELD NAME POSSIBLE VALUES DESCRIPTION PATIENT ID Up to 14 alpha numeric characters. Specify a unique ID for each patient. The patient ID allows you to associate patient demographic information (Patient Details) with a sample.The demographic information (patient name, date of birth, physician, and sex) will appear in your test results reports. (INCLUDES PATIENT DETAILS) (bullet) appears if Patient Details have been added. Specify the Patient ID in this field as needed. After you specify the Patient ID, it appears in the Patient ID field. Touch the Patient ID field again to enter Patient Details. The Enter Patient Data screen displays (see Figure 6.4). Fill in the patient’s name, date of birth, physician, and sex on this screen, and then touch Enter. The patient details do not appear on the Worklist, however, if patient details have been entered, a bullet ( ) appears below the Patient ID in the Worklist to indicate that information has been entered (see the Patient ID column in Figure 6.5). Touch the bullet ( ) to view or modify the existing patient details for the Patient ID. If the field is does not have a bullet below the Patient ID, you can touch this field to add new patient details for the selected Patient ID. If Patient Details have been added, they will appear in the test results reports. The Patient Details are not applicable to calibration and QC. COLLECTION TIME 6.12 Date is in MM/DD/YYYY format and time is in HH:MM format. Specifies the time and date at which the sample was collected. This information is not required and may be input independently from the Patient ID. If this information is provided, it will be displayed on the Sample Details screen and printed on Patient Reports. E a s y R A O P E R A T O R ’ S Figure 6.4 Enter Patient Data Screen Figure 6.5 Indicator that Patient Details Have Been Entered for the Selected Patient M A N U A L 6.13 S E T T I N G U P A N D R U N N I N G T E S T S Figure 6.6 shows an example of the Worklist Edit screen with several tests. Figure 6.6 Completed Worklist Edit Screen 4 6.14 When you have entered information for all samples into the Worklist: Verify that samples are located in the correct position on the Sample Ring. If you have the LIS Connectivity option, verify that samples whose test details will be obtained from the LIS list, are in sample positions that correspond to blank entries in the Worklist. If you place a barcoded sample in a sample position that corresponds with a manual entry in the Worklist, that manual Worklist entry will be overwritten by the entry from the LIS (if the barcode on the sample matches an entry in the LIS list). Verify that the barcode is in the window of the sample tube holder, facing the Barcode Reader. Verify that the Sample Ring is loaded on EasyRA. Verify that all EasyRA covers are closed. E a s y R A 5 O P E R A T O R ’ S M A N U A L When the Worklist is complete, touch Enter to perform Cuvette and Reagent inventories: Touching Enter starts an inventory. For detailed information on performing an inventory, see “Performing an Inventory” on page 6.32. Entering Calibration Requests This section provides more detail on requesting calibration for chemistry tests. Note: Calibration for the ISE Module is performed separately from photometric tests. For more information on ISE Calibration, see “Calibrating the ISE Module” on page 6.60. Many tests require that you run calibration at regular intervals (anywhere between every 8 hours and every 28 days depending on the test). If calibrations have not been run or have expired on any test, EasyRA will not allow you to run that test. Therefore, it is critical that you set up and run the calibrations before you run the patient tests. EasyRA allows you to configure single-level calibrations, multi-level calibrations (calibrations with between 2 and 6 levels), and multi-level, multi-constituent calibrations (multi-level calibrations that require more than one test at each level). Multi-level calibrations are required when the system requires 2 or more points to calculate the calibration curve. Each level corresponds to one of the point used to calculate the curve. Calibration for a test is specific to the lot number of the Reagent being used for each test. Only one lot number of Reagent may be calibrated in any run. Multiple lots of Reagent can be used in a run, provided not more than one lot number of Reagents requires calibration. You will need to place the calibration sample (or samples for multi-level calibrators) into the Sample Ring either before, during, or after you enter the calibration on the Worklist. Be sure that the sample(s) are placed in the position(s) on the Sample Ring that corresponds to the entry(s) in the Worklist. 6.15 S E T T I N G U P A N D R U N N I N G T E S T S Entering Single-Level Calibration Tests To enter single-level calibration requests in the Worklist, fill in the fields are follows: Figure 6.7 1 The Stat column does not apply to calibration tests. If a calibration is expired and a patient test requiring a calibration has been entered on the Worklist, the calibration is automatically run first (before Stat patient tests). 2 The position field (Pos) indicates the location where the calibration sample is placed in the Sample Ring. 3 Select Calibrator in the Type field to select a calibration. 4 When you touch the Sample ID/Lot field, a drop-down menu appears listing the calibrators that have been set up for EasyRA (see Figure 6.7). Select Calibrator from Drop-Down Menu Select the calibrator to use from the drop-down menu. If no calibrators have been set up, a message displays indicating calibrators must be configured. Calibrators are set up from the Diagnostics/Maintenance/Setup icon. 6.16 For information on setting up calibrators, see “Configuring Chemistry Calibrators” on page 4.31. E a s y R A O P E R A T O R ’ S 5 When you select a calibrator from the drop-down menu, the Test Select Keypad displays and the tests that can be selected for the selected calibrator are active. Touch the tests to be calibrated (tests that have been selected are highlighted with a gray background on the Test Select Keypad). To remove a selected test, touch the Tests field and use the Test Select Keypad to deselect any tests you do not want to run. Touch Enter on the Test Select Keypad to select the tests. 6 The Patient ID and Details fields do not apply to calibration, as calibration results are not associated with a particular patient. Leave these fields blank. M A N U A L Entering Multi-Level and/or Multi-Constituent Calibration Tests You can enter multi-level or multi-level/multi-constituent calibrations to the worklist. Multi-level calibrations have multiple calibrators and require one sample position for each level. The data collected for each sample position (level) is used to calculate the calibration curve. For example HbA1c is a 5-level calibrator and requires five sample positions for calibration material. Multi-level/multi-constituent calibrations require more than one test be run for each calibration level. The insert sheet provided with the calibration material provides the necessary information about the calibration material. Medica-supplied reagents that require multi-level calibrations can use one of two different numbering systems: The base-0 numbering system for which the first level is level 0 (for example, saline), or The base-1 numbering system for which the first level is level 1. The numbering system used for a multi-level calibration is obtained from the data programmed on the RFID chip for the selected reagent. User-defined reagents can only use a base-1 numbering system. To enter multi-level and/or multi-constituent calibration requests in the Worklist, fill in the fields as follows: 1 The Stat column does not apply to calibration tests. If a calibration is expired and a patient test requiring a calibration has been entered on the Worklist, the calibration is automatically run first (before Stat patient tests). 2 The position field (Pos) indicates the location where the calibration samples are placed in the Sample Ring. For multi-level calibrations, verify that there are enough open sample positions for all calibration levels. 6.17 S E T T I N G Figure 6.8 U P A N D R U N N I N G T E S T S 3 Select Calibrator in the Type field to select a calibration. 4 When you touch the Sample ID/Lot field, a drop-down menu appears listing the calibrators that have been set up for EasyRA (see Figure 6.8). Select Calibrator from Drop-Down Menu Select the multi-level calibrator from the drop-down menu. If no calibrators have been set up, a message displays indicating calibrators must be configured. Calibrators are set up from the Diagnostics/Maintenance/Setup icon. 5 6.18 For information on setting up calibrators, see “Configuring Chemistry Calibrators” on page 4.31. When you select a calibrator from the drop-down menu, the Test Select Keypad displays and the tests that can be selected for this calibrator are active (see Figure 6.9). E a s y R A Figure 6.9 6 O P E R A T O R ’ S M A N U A L Tests That Can Be Selected for this Calibrator Are Active For multi-level calibrators, only the tests with the same number of levels AND the same calibration level numbering (base-0 or base-1) are active. Touch the tests to be calibrated. If this is a multi-level/multi-constituent test, you can select multiple tests. To remove a selected test, touch the Tests field and use the Test Select Keypad to deselect any tests you do not want to run. Touch Enter on the Test Select Keypad. If there are not enough open sample positions for the number of samples required for a multi-level calibration material being added, a message displays indicating that this multi-level calibration will overwrite the next few sample positions. If this message displays, touch OK. Be aware that you may need to go back and add the tests that were overwritten into open sample positions. 6.19 S E T T I N G U P A N D R U N N I N G T E S T S Figure 6.10 shows an example of a multi-level calibration for HbA1c in positions 1-5. Figure 6.10 Example of Worklist with a Multi-Level Calibration for HbA1c The Patient ID and Details fields do not apply to calibration, as calibration results are not associated with a particular patient. Leave these fields blank. 6.20 E a s y R A O P E R A T O R ’ S M A N U A L Entering Quality Control Requests This section provides more detail on entering QC requests. It is strongly recommended that you perform QC to ensure the quality of your test results. You will need to place the QC sample into the Sample Ring either before, during, or after you enter QC on the Worklist. Be sure that the sample is placed in the position on the Sample Ring that corresponds to the entry in the Worklist. Note: Always pre-treat the QC material in the same way that you pre-treated the sample. For example, if a sample was diluted with Urine Diluent, then the QC material to be used with that sample must diluted in the same way. To enter QC requests in the Worklist, fill in the fields as follows: 1 The Stat column does not apply to QC tests. 2 The position field (Pos) indicates the location where the QC sample is placed in the Sample Ring. 3 Select QC in the Type field to select QC. 4 When you touch the Sample ID/Lot field, a drop-down menu appears listing the QC materials that have been set up for EasyRA. Only QC materials that have been configured as Active or Transitional appear in the list (see Figure 6.11). 6.21 S E T T I N G Figure 6.11 U P A N D R U N N I N G T E S T S Select QC Material from the Drop-Down Menu Select the QC material to use from the drop-down menu. There are different QC materials for quantitative and qualitative tests. Be sure to select a QC material for the types of results you want to obtain. If no QC materials have been set up, a message displays indicating QC materials must be configured. QC materials are set up from the Diagnostics/Maintenance/Setup icon. 5 6.22 For information on setting up the QC materials, see “Configuring QC Materials” on page 4.59. When you select a QC material from the drop-down menu, the tests for the selected QC material automatically populate the Tests field. If you select a Qualitative QC material, the word “Qualitative” appears in the upper right corner of the Test Select Keypad to indicate you can only select Qualitative tests (see Figure 6.12). E a s y R A Figure 6.12 O P E R A T O R ’ S M A N U A L Select Qualitative Results from the Test Select Keypad To remove tests, touch the Tests field and use the Test Select Keypad to deselect any tests you do not want to run. 6 The Patient ID and Details fields do not apply to QC, as QC results are not associated with a particular patient. Leave these fields blank. Figure 6.13 shows an example of the worklist with QC requests on sample positions 2 and 3 that will generate qualitative results. 6.23 S E T T I N G Figure 6.13 U P A N D R U N N I N G T E S T S Worklist with QC Requests That Will Generate Qualitative Results Entering Patient Test Requests This section provides more detail on entering patient requests. Depending on the test you select, you may need to perform a calibration before the patient test. If calibration has not been set up or has expired, a calibration must be run and successfully completed before the patient tests can be run. If the calibration and the patient test(s) are in the same Worklist, the calibration will be run first. For more information, see “Entering Calibration Requests” on page 6.15. Place the sample into the Sample Ring either before, during, or after you enter the patient test on the Worklist. Be sure that the sample is placed in the position on the Sample Ring that corresponds to the entry in the Worklist. 6.24 E a s y R A O P E R A T O R ’ S M A N U A L To enter patient tests in the Worklist, fill in the following fields: 1 Specify whether or not this test is high priority (stat). If you touch the Stat field, a black triangle appears in that field. This causes the tests on this sample to be run before all other patient tests. If all calibrations are up to date, the “Stat” patient test runs first. If calibrations need to be run for the Stat patient test, the calibrations run first, followed by Stat patient tests, then QC, then all remaining patient tests. 2 The position field (Pos) indicates the location where the sample should be placed in the Sample Ring. 3 There are several patient sample types available on EasyRA depending on the analyte (refer to the corresponding insert sheet for more information): Serum. Plasma. Diluted Blood (for HbA1c tests only). Urine. Diluted Urine (only for ISE tests, Cl-, K+, and Na+). By selecting any of these types, you are specifying that you want to perform patient tests. You must be aware of which tests require calibration. 4 Enter the Sample ID/Lot number using the Alphanumeric Keypad. The Sample ID is a string (up to 14 alphanumeric digits) that uniquely identifies this sample. 5 Enter the tests to be run on this sample from the Test Select Keypad. Also specify if you want to run multiple test sets (replicates). 6 For information on selecting tests from the Test Select Keypad, see “Entering Test Data” on page 3.46. If you want to associate the results of the tests for this sample with a particular patient whose information is stored on EasyRA, enter the patient ID in the Patient ID field. When that ID has been entered, EasyRA checks to see if that patient ID has previously been entered into EasyRA. If the patient ID is found and patient details have been added for that ID, a bullet ( ) displays in the Patient ID field. Touch the bullet ( ) in the Patient ID field to view and/or modify the patient information for the selected patient ID (see Figure 6.14). 6.25 S E T T I N G Figure 6.14 U P A N D R U N N I N G T E S T S View Patient Information from Worklist Edit Screen 1 2 6.26 Touch the bullet ( ) to view or modify Patient Details View or modify patient information If the patient ID is found, but no patient details have been added, no bullet ( ) displays in the Patient ID field. Touch the Patient ID field for that sample to add new patient information for the Patient ID that was entered (see Figure 6.15). E a s y R A Figure 6.15 O P E R A T O R ’ S M A N U A L Add Patient Information from Worklist Edit Screen Touch the Patient ID field to add new Patient Information Enter new patient information 1 2 For more information on adding patient information into the Enter Patient Data screen see “Setting Up Patient Demographics” on page 4.25. 6.27 S E T T I N G U P A N D R U N N I N G T E S T S Creating a Worklist Automatically (Tests Obtained from LIS) This procedure describes how to create a Worklist automatically, when all samples are barcoded and the test information for the samples is provided by an LIS connected to EasyRA. If you are using an LIS, it is not necessary to enter any test information on the Edit Worklist screen. Simply insert the barcoded samples into the Sample Ring and leave the Worklist entries for the sample positions blank. During inventory EasyRA will read the barcode from the sample and match the samples to the tests received from the LIS (or already stored on the Pending List). The Worklist is automatically populated with the test information for the barcoded samples. Note: Calibrations cannot be obtained from the LIS. If they are required, they must be entered manually into the Worklist. To create a new Worklist automatically using information obtained from an LIS and barcoded samples: 1 Touch the Worklist icon. On the drop-down menu that appears, touch Edit Worklist (see Figure 6.2). A blank Edit Worklist screen appears as shown in Figure 6.16. 6.28 E a s y R A Figure 6.16 2 O P E R A T O R ’ S M A N U A L Worklist Edit Screen You can edit the Worklist for either Sample Ring A or Sample Ring B. Select the Worklist to edit by touching the A or B at the top of the screen. The Worklist currently being created or edited is indicated by a circle around the Sample Ring letter. 3 Place the barcoded samples in the Sample Ring. Be sure that the barcodes on the samples are facing out (see Figure 5.33), so they can be read by the Barcode Reader. (This procedure assumes all tests are being obtained from the LIS. If there is a mixture of samples for which tests are being entered manually and samples for which tests are being set up from the LIS, be sure to place samples only in positions on the Sample Ring that correspond to blank entries on the Edit Worklist screen.) 6.29 S E T T I N G U P A N D R U N N I N G 4 T E S T S When all samples are loaded, touch Enter to start an inventory: For detailed information on performing an inventory, see “Performing an Inventory” on page 6.32. A Sample inventory, Reagent inventory, and Cuvette inventory are performed. During the Sample inventory, the barcodes on all samples are read and EasyRA associates the barcoded samples with the requested tests for each sample that have been downloaded from the LIS. The tests to be run on each sample are added to the Worklist automatically. Only 24 photometric tests and four ISE tests per sample may be programmed on the Worklist. When the inventory is complete, the populated Edit Worklist screen displays (see Figure 6.17). 6.30 E a s y R A Figure 6.17 5 O P E R A T O R ’ S M A N U A L Edit Worklist Screen After Inventory (with tests from LIS) Review the Worklist to verify that all barcoded samples have been read and appear in the Worklist. You may also want to review the Worklist to view the tests that will be performed during the run. You are now ready to start a test run. 6.31 S E T T I N G U P A N D R U N N I N G T E S T S Performing an Inventory When you are done editing or creating a Worklist, EasyRA performs an inventory. During the inventory, EasyRA checks the status of Reagents and Cuvettes and determines if adequate resources are available to run the tests you entered in the Worklist. If you have the LIS Connectivity option, samples with barcodes are scanned by EasyRA during inventory and are matched to tests in the LIS list. If a match is found, the details of the tests to be run for that sample are filled in on the Edit Worklist screen. You can also perform inventories on EasyRA disposables (for example, Reagents, Cuvettes, cleaners, etc.) from the Status screens. For more information on performing inventories from the Status screens, see Chapter 8, “Monitoring Status.” To run an inventory from the Edit Worklist screen: 1 Add all entries to the Worklist and verify that it is complete. 2 Verify that all EasyRA covers are closed. 3 Touch Enter on the Edit Worklist screen to complete the Worklist and start the inventory: The Worklist Inventory screen displays, along with a popup window with a progress bar indicating that the inventory is in progress. As Reagents are read, they appear on the graphic representation of the Sample Ring/Reagent Tray on the Worklist Inventory screen. If you have placed barcoded samples on the Sample Ring, samples appear on the Sample Ring as they are read. (Samples without barcodes are not read or displayed during inventory). Three Reagent Systems appear as two Reagent Wedges with a Lock icon between them. If there are any Unknown Reagents, or Unknown Pairs, those also appear during the inventory. For more information, see “Viewing Reagent Status” on page 8.7. When the inventory is complete, the popup disappears and the status of the inventory is displayed (see Figure 6.18). 6.32 E a s y R A Figure 6.18 O P E R A T O R ’ S M A N U A L Worklist Inventory Complete Reagents read during Inventory Samples read during inventory Three Reagent System 4 If any problems were detected during inventory, the Status icon blinks. The Status icon may blink to indicate that a Reagent or sample is missing, Cuvettes need to be replaced, or a calibration is expired. To view the status messages, touch the Status icon and select Worklist Warnings. 5 For information on viewing Worklist Warnings, see “Viewing Worklist Warnings” on page 8.3. After the inventory has been performed, the Run button displays in the upper left corner of the screen, provided at least one test on the Worklist can be run (see Figure 6.19). Note: When Auto Run After Inventory is enabled, the run will begin immediately following the Worklist Inventory. For more information, see “Performing an Inventory/Starting a Run (with Auto Run Enabled)” on page 6.37. 6.33 S E T T I N G Figure 6.19 U P A N D R U N N I N G T E S T S Run Button on Worklist Edit Screen Run button For detailed instructions on starting the run, see “Starting a Run” on page 6.35. If Worklist Warnings indicate that some tests cannot be run, you can either resolve the problems and perform another inventory or proceed with the run. If you proceed with the run, any tests that could not be run are moved to the Pending List where they are saved to be run at a later time. For information on the Pending List, see “Viewing the Pending List” on page 6.58. 6.34 E a s y R A O P E R A T O R ’ S M A N U A L Starting a Run A test run can be started when a Worklist is complete and the inventory indicates that at least one test in the Worklist can be completed. EasyRA indicates the Worklist is ready by displaying the Run button in the upper left corner. To start a run: 1 Touch the Run button. The Worklist monitoring screen displays as shown in Figure 6.20. Figure 6.20 Worklist Monitoring Screen Pause/ End Run button Run timer 6.35 S E T T I N G U P A N D R U N N I N G T E S T S The Run button toggles to the Pause/End Run button (two vertical lines) when the run is started and a Run Timer displays below the Pause/End Run button (see Figure 6.20). This timer counts down the time until the run is complete. During the run, all covers are locked (see Figure 6.21). Figure 6.21 System Icon (All Covers Locked) All tests that can be run are listed on the Worklist Monitoring screen. Note: If a test you entered on the Worklist is not displayed on the Worklist Monitoring screen, EasyRA was not able to run that test (possibly because the Reagent or sample is missing, or a calibration is expired). Tests that cannot be run are sent to the Pending List, where they are saved to be run at a later time. For more information on the Pending List, see “Viewing the Pending List” on page 6.58. 6.36 For detailed information on monitoring the Worklist during a run, see “Monitoring the Worklist” on page 6.55. E a s y R A O P E R A T O R ’ S M A N U A L Performing an Inventory/Starting a Run (with Auto Run Enabled) The Auto Run After Inventory feature allows users who have checked the status of individual components prior to their run or at the beginning of the shift, to start running tests immediately following the Worklist Inventory without interruption. For more information on enabling the Auto Run feature, see “Enabling or Disabling Auto Run After Inventory” on page 2.74 For more information on viewing the status of individual components, see Chapter 8, “Monitoring Status.” During the Worklist Inventory, EasyRA checks the status of Reagents and Cuvettes and determines if adequate resources are available to run tests entered in the Worklist. When Auto Run After Inventory is enabled, the Worklist Inventory is still performed. However, the need to press the Run button is eliminated. The run will begin automatically as long as at least one test in the Worklist can be completed. For more information on performing a Worklist Inventory, see “Performing an Inventory” on page 6.32. If any problems are detected during inventory, the Status icon blinks. The Status icon may blink to indicate that a Reagent or sample is missing, Cuvettes need to be replaced, or a calibration is expired. To view the status messages, touch the Start icon and select Worklist Warnings. For more information on viewing Worklist warnings, see “Viewing Worklist Warnings” on page 8.3. If Worklist Warnings indicate that some tests cannot be run, you can pause the run to resolve the problems and perform another inventory or proceed with the run. If you proceed with the run, any tests that could not be run are moved to the Pending List where they are saved to be run at a later time. For information on the Pending List, see “Viewing the Pending List” on page 6.58. Following the Worklist Inventory and the automatic start of the run, all other functions associated with setting up and running tests remain the same as when Auto Run After Inventory is disabled. 6.37 S E T T I N G U P A N D R U N N I N G T E S T S Pausing and Resuming Test Runs You can pause and resume EasyRA runs as needed. You may need to pause a run to add a new sample (a Stat sample, for example) or to add one or more tests to an existing sample. You may also need to add a Reagent or replenish a Reagent that is running low. Note: Edits cannot be made to samples that already have tests started or completed. This section describes how to pause runs and resume runs after a pause. Pausing a Test Run A test run can be paused if you need to open EasyRA’s covers or edit the Worklist that is running. After a run has been started, pause it by touching the Pause/End Run button. A popup displays asking if you want to end the run or pause the run. When you select Pause, EasyRA may not stop immediately. All tests that are in progress (about to be dispensed and already dispensed to the Reaction area) must first be completed. Some chemistry tests require multiple Reagent additions. If one of these tests has begun and you select the Pause/End Run button, you will be given the option to wait for the current dispense to finish (select OK) or to pause right away (by selecting Stop Dispense). The time required to finish the current dispense is displayed. An immediate pause will cause any Reagent material that has been dispensed for the test in question to be wasted. New material will have to be dispensed when the run is resumed. However, this option gives you the choice of waiting until the dispense is complete, or stopping the dispense to run something else more urgent first. When EasyRA finishes dispensing tests, the Reagent/Sample Area cover is unlocked and you can edit the Worklist. If stat tests are added to the Worklist during a pause, the stat tests will be run immediately when the run is resumed. If additional tests are added to the Worklist during a pause, they will be scheduled after the last dispense on an on-going Worklist. Runs cannot be paused immediately when the Pause/End run time is displayed in red. The Pause/End Run time will display in red when: You have programmed a critical calibration that is necessary for other tests to be completed in the run. A blank is being performed. The Pause/End Run time will return to gray following completion of the above tasks. As described above, the selections you make to pause a run vary depending on the type of test currently being dispensed. The next 6.38 E a s y R A O P E R A T O R ’ S M A N U A L two sections describe how to pause a run for a test with only a single reagent and how to pause a run for a test with more than one reagent. Pausing a Run When a Test Requiring a Single Reagent is in Process To pause a run when only a single reagent is used in the test: 1 Touch the Pause/End Run button while a run is in progress. (The Pause/End Run button only appears when a run is in progress.) A popup window displays asking if you want to pause or end the run (see Figure 6.22). Figure 6.22 2 Pause or End Run Popup WIndow Touch Pause to pause the run. If you want to end the run, see “Ending a Test Run” on page 6.44. If a calibration or blank is in progress, a popup window displays indicating that the pause will be delayed until critical calibrations or blanks are complete. Touch Ok to accept a delayed pause. Touch Cancel to return to normal operation. If a calibration or blank is in process or if you accepted the delayed pause, a popup window displays indicating EasyRA is entering Pause mode (see Figure 6.23). The popup has a progress bar to indicate the status of the pause. EasyRA cannot pause until the test that was in the process of being dispensed is completed and the Probe returns to the Home position. At this time, the Reagent/Sample Area cover is unlocked, but the Reaction Area cover remains locked until the analysis of the dispensed tests is complete. 6.39 S E T T I N G U P A N D R U N N I N G Figure 6.23 3 T E S T S Entering Pause Mode When EasyRA is ready to pause, the popup window disappears and the following actions occur: The run is paused. The Pause/End Run disappears. The Edit Worklist screen displays. The Reagent/Sample Area cover is unlocked and the Probe returns to the Home position. Note: If all covers are left in the closed position and no changes are made to the Worklist when EasyRA is paused, the Run button remains on the screen. However, if you open any covers or edit the Worklist, an inventory must be performed before the test run can resume. The Run button does not display until the inventory is run. 4 Perform the activities required during the pause. 5 To resume the run after a pause, see “Resuming a Run After A Pause” on page 6.42. Pausing a Run When a Test Requiring More than One Reagent is in Process To pause a run when the test being run requires more than one reagent. 1 Touch the Pause/End Run button while a run is in progress. (The Pause/End Run button only appears when a run is in progress.) A popup window displays and asks if you want to wait for the current dispense to finish or stop the dispense immediately (see Figure 6.24). If you choose to stop the dispense immediately, the reagent material for the test in progress is wasted and the reagent will have to be 6.40 E a s y R A O P E R A T O R ’ S M A N U A L re-dispensed when the run is resumed. The time required to complete the dispense of all reagents is displayed in the popup window to help you decide if you want to stop the dispense and pause immediately or wait until the dispense finishes before you pause. Figure 6.24 2 Pause a Run When a Dispense for a Test Requiring Multiple Reagents is in Progress Touch Stop Dispense to stop the dispense of the reagents and pause the run immediately. If you want to end the run, see “Ending a Test Run” on page 6.44. OR Touch Ok to wait for the current dispense to finish. The popup window includes the time required to finish the dispense. 3 When EasyRA is ready to pause, the popup window disappears and the following actions occur: The run is paused. The Pause/End Run disappears. The Edit Worklist screen displays. The Reagent/Sample Area cover is unlocked and the Probe returns to the Home position. Note: If all covers are left in the closed position and no changes are made to the Worklist when EasyRA is paused, the Run button remains on the screen. However, if you open any covers or edit the Worklist, an inventory must be performed before the test run can resume. The Run button does not display until the inventory is run. 6.41 S E T T I N G U P A N D R U N N I N G T E S T S 4 Perform the activities required during the pause. 5 To resume the run after a pause, see “Resuming a Run After A Pause” on page 6.42. Resuming a Run After A Pause The process for resuming a run after a pause depends on the actions that were taken during the pause: If no covers were opened during the pause and the Worklist was not modified, you can resume the run at any time by pressing the Run button. If any covers were opened or the Worklist was modified, the Run button is no longer available. An inventory must be performed by touching the Enter button on the Edit Worklist screen before the run can be resumed. Resuming a Run (Inventory Required) To resume a run when an inventory is required: 1 Touch Enter on the Edit Worklist screen to start an inventory. The Worklist Inventory screen displays, along with a popup window with a progress bar indicating that the inventory is in progress. As Reagents and barcoded samples are detected, they appear on the Sample Ring/Reagent Tray displayed on the Worklist Inventory screen (see Figure 6.18). When the inventory is complete, the popup disappears. 2 If any problems were detected during inventory, the Status icon blinks. The Status icon may blink to indicate such things as a Reagent or sample is missing, Cuvettes need to be replaced, or a calibration is expired. To view the status messages displayed, touch the Status icon and select Worklist Warnings. 3 6.42 For information on viewing Worklist Warnings, see “Viewing Worklist Warnings” on page 8.3. After the inventory has been performed, the Run button displays in the upper left corner of the screen, as long as at least one test on the Worklist can be run (see Figure 6.19). E a s y R A O P E R A T O R ’ S M A N U A L Note: When Auto Run After Inventory is enabled, the run will begin immediately following the Worklist Inventory. For more information, see “Performing an Inventory/Starting a Run (with Auto Run Enabled)” on page 6.37. 4 Touch the Run button to start the run. For detailed instructions on starting the run, see “Starting a Run” on page 6.35. During the run, all covers are locked. If Worklist Warnings indicates that some tests cannot be run, you can either resolve the problems and perform another inventory or proceed with the run. If you proceed with the run, any tests that could not be run are moved to the Pending List where they are saved to be run at a later time. For information on the Pending List, see “Viewing the Pending List” on page 6.58.) 6.43 S E T T I N G U P A N D R U N N I N G T E S T S Ending a Test Run A test run can be ended if for some reason you determine that the current run should not run through to completion. Some likely reasons why a test run would be ended include: You incorrectly loaded a sample and/or Reagent and incorrect results are being reported. Incorrect results are being reported and you need to check EasyRA functionality or the samples/Reagents loaded. For example, if you loaded the wrong sample ring, you could get incorrect results. After a run has been started, end it by touching the Pause/End Run button. A popup displays asking if you want to end the run or pause the run. When you select End Run, EasyRA asks you to confirm this action. When you confirm that the run should be ended, the Results screen displays showing that all tests in the run that were dispensed or scheduled are “Cancelled.” If any tests were completed, their results are reported, but any tests that were in progress or not started are cancelled. Like any other run, you must accept the Results to clear the Worklist and begin a new run. All tests are cleared from the Worklist. To rerun tests that were cancelled, you must enter them into a new Worklist. To end a run: 1 Touch the Pause/End Run button while a run is in progress. (The Pause/End Run button only appears when a run is in progress.) A popup window displays asking if you want to pause or end the run (see Figure 6.25). Figure 6.25 6.44 Pause or End Run Popup Window E a s y R A 2 O P E R A T O R ’ S M A N U A L Touch End Run to end the run. If you want to pause the run, see “Pausing a Test Run” on page 6.38. Another popup window displays asking you to confirm that you want to end the run (see Figure 6.26). Figure 6.26 3 Confirm End Run Touch OK to confirm that the run should be ended. The run is stopped immediately. The Results screen displays. Test results for tests that were completed are stored, when you accept the results. All other tests (those whose status is scheduled, started, or measuring) are cancelled immediately (see Figure 6.27) and all covers are unlocked. 6.45 S E T T I N G Figure 6.27 U P A N D R U N N I N G T E S T S Results of Run That Has been Ended Notice that the word “Cancelled” appears after any test that was scheduled or in progress. 4 To continue, touch Accept. This saves the results and clears the Worklist, so that you can begin another run. 6.46 For more information see “Accepting Results and Clearing the Worklist” on page 7.26. E a s y R A O P E R A T O R ’ S M A N U A L Auto Recovery after Error During a Run This section describes how EasyRA will attempt to recover from certain types of errors if the Auto Recovery after Error option has been enabled. When Auto Recovery after Error is enabled (see “Enabling or Disabling Auto Recovery after Error” on page 2.76), a test run will continue if it is able after Probe and/or Transfer Arm errors occur. The Status icon at the top of the screen blinks to indicate an error has occurred. Within the system, a counter keeps track of the number of errors that have occurred during the run. If it is able, EasyRA will skip tests that cannot be run and will continue running the Worklist until the fourth error occurs. When EasyRA detects the fourth error, the test run is stopped. EasyRA beeps to notify the operator of a problem with the run. A message displays indicating that error messages are located on the Worklist Warning screen and in the System Error Log. It is recommended that you view these areas to determine which errors occurred during the run. If any tests were completed during the run, the results are displayed and can be accepted. When you accept the Results, another message displays asking if you want to recover the canceled tests to a new Worklist. If you touch Yes, the tests that were skipped as a result of the errors are put on a new Worklist. The errors recorded in the Worklist Warnings screen are saved until you run the new Worklist. If you choose not to recover the canceled tests to a Worklist, those tests will be deleted. The following describes a sample scenario of the EasyRA’s behavior when Auto Recovery after Error is enabled and errors occur. This scenario includes the following four errors: Probe Error (Probe hit cap on ALP bottle) Probe Error (Sample cup missing) Transfer Arm Error (Arm is not able to move to required position) Transfer Arm Error (Arm is not able to move to required position) The following describes EasyRA’s behavior during this test run: 1 Error Handling is enabled by selecting the Diagnostics/ Maintenance/Setup icon, and then selecting System > Auto Recovery after Error, and then selecting Enable. 2 A worklist is created, an inventory is performed, and the test run is started. 3 During the run, EasyRA attempts to access the ALP reagent bottle. Since the cap was not removed from that bottle, an error occurs generating the message “Check Reagent.” EasyRA counts this as Error #1. 6.47 S E T T I N G U P A N D R U N N I N G 4 The Status icon blinks to indicate an error occurred (see Figure 6.28). Figure 6.28 5 Figure 6.29 6.48 T E S T S Status Icon Blinks to Indicate an Error Has Occurred If you are monitoring the run, open the Worklist Warnings screen to view the error that occurred. Figure 6.29 shows an example of a Worklist Warning message when the reagent bottle cover has not been removed. The Worklist Warning Screen After Error #1 Has Occurred 6 All tests using the ALP reagent are skipped and the run continues. The Worklist will show these tests crossed out. 7 When the Probe accesses the Sample is position 2, it detects that the sample cup is missing. Another error occurs, generating the message “Check Sample.” EasyRA counts this as Error #2. 8 If you are monitoring the run, open the Worklist Warnings screen to view the error. Figure 6.30 shows an example of the message when E a s y R A O P E R A T O R ’ S M A N U A L the sample cup is missing. Notice that the message is at the top of the list. Figure 6.30 9 Error Message for Second Error All tests scheduled on the sample in Sample Position 2 are skipped and the run continues. 10 Later in the run, a Transfer Arm error occurs. This means that the Arm was not able to move to the required position. EasyRA counts this as Error #3. 11 EasyRA logs Transfer Arm errors in the System Log File, not the Worklist Warnings screen. Figure 6.31 shows the System Log File with a Transfer Arm Error. 6.49 S E T T I N G Figure 6.31 U P A N D R U N N I N G T E S T S System Log File with Transfer Arm Error 12 EasyRA is able to continue the run after the Transfer Arm Error. 13 Later in the run, another Transfer Arm error occurs. Again, the Arm was not able to move to the required position. EasyRA counts this as Error #4. 14 EasyRA logs the Transfer Arm error in the System Log File. 15 The Auto Recovery after Error feature stops the test run when the fourth error occurs in a run. EasyRA beeps to notify the operator that there is a problem with the run. 16 If any tests were completed during the run, the results screen displays. A message appears indicating that more than 3 Probe or Arm errors have occurred (see Figure 6.32). The message tells you to look at the Worklist Warning screen and the System Log File to see the errors. 6.50 E a s y R A Figure 6.32 O P E R A T O R ’ S M A N U A L Message Stating More Than Three Probe or Arm Errors Occurred 17 Touch OK to clear the message. View the Worklist Warnings or the System Log File to see all the errors. 18 Another message displays asking you to accept the results (see Figure 6.33). All tests that were cancelled or not run have a Cancelled status. 6.51 S E T T I N G U P A N D R U N N I N G Figure 6.33 T E S T S Accept Results if Any are Available 19 Touch OK and then touch Enter on the results screen. When you accept the results, a message displays asking if you want to recover the cancelled tests in a new Worklist (see Figure 6.34). Figure 6.34 6.52 Message to Recover Cancelled Tests to New Worklist E a s y R A O P E R A T O R ’ S M A N U A L 20 Touch OK save any results that were completed in Last Results and to put all the tests that could not be run into a new Worklist. Touch No to delete all the tests that could not be run. Note: The Worklist Warnings that displayed during the run will remain available for viewing until the next Worklist is run. Once the new Worklist is started, the Worklist Warnings screen is cleared. The following describes what happens when Auto Recovery after Error is enabled and less than four errors occur during a run. Error messages are logged on the Worklist Warnings screen and/or the System Log File as they occur, but if less than four errors are detected, the test run will skip any tests that cannot be completed and continue to the end. 1 When the run is complete, the results screen displays. A message appears indicating that errors occurred during the run (see Figure 6.35). The message tells you to look at the Worklist Warning screen and the System Log File to see the errors. Figure 6.35 Message Stating Errors Occurred During the Run 2 Touch OK to clear the message. View the Worklist Warnings or the System Log File to see the errors that occurred. 3 Touch Enter on the Results screen to accept the results. 6.53 S E T T I N G U P A N D R U N N I N G 4 When you accept the results, a message displays asking if you want to recover the cancelled tests in a new Worklist (see Figure 6.34). Figure 6.36 5 6.54 T E S T S Message to Recover Cancelled Tests to New Worklist Touch OK to put all the tests that could not be run in a new Worklist. Touch No to delete all the tests that could not be run. E a s y R A O P E R A T O R ’ S M A N U A L Monitoring the Worklist When you start a run, the Worklist Monitoring screen appears automatically showing the status of the run as it proceeds. (see Figure 6.37). Figure 6.37 Worklist Monitoring Screen List of tests to be run You can also view the Worklist Monitoring screen by touching the Worklist icon and then touching Monitor Worklist at any time. The Run button toggles to the Pause/End Run (two vertical lines) when the run is started and a Run Timer displays below the Pause/End Run. This timer counts down the time until the run is complete. The Pause/End Run time will display in red when critical calibrations or blanks are being performed. All tests that can be run are listed on the Worklist Monitoring screen. 6.55 S E T T I N G U P A N D R U N N I N G T E S T S Note: If a test entered on the Worklist is not displayed on the Worklist Monitoring screen, EasyRA was not able to run that test (possibly because the Reagent or sample is missing, or a calibration is expired). Tests that cannot be run are sent to the Pending List, where they are saved to be run at a later time. For more information on the Pending List, see “Viewing the Pending List” on page 6.58. A list of tests to be run appears in a table on the right side of the screen. The table includes one line per test. If multiple tests have been ordered on a sample, the table will have multiple lines for that sample. If the test is being rerun, the Rerun check box for that test will be checked. The left side of the screen shows a graphic representation of the Sample Ring/Reagent Tray. As the tests run, the status of the tests are updated on this screen (see Figure 6.38). Test states are: Scheduled. Started. Measuring. Completed. Status of sample positions are also updated as follows on the graphic representation of the Sample Ring (see Figure 6.38): 6.56 White - Tests on this sample have not been started. Blue - Tests on this sample are in progress. Gold - All tests on this sample are complete. E a s y R A Figure 6.38 O P E R A T O R ’ S M A N U A L Test Status Displayed on Sample Ring Gold indicates tests for this sample are complete. Light blue indicates tests for this sample are in progress. White indicates tests for this sample have not been started. When all the tests have been completed, the Worklist Monitoring screen indicates all tests are complete. (Status in the table is Complete for all tests and all the samples on the Sample Ring display in gold.) The Worklist Monitoring screen is replaced with the Results screen. For more information, see “Viewing Current Results” on page 7.3. 6.57 S E T T I N G U P A N D R U N N I N G T E S T S Viewing the Pending List The Pending List contains all tests that were added to a Worklist, but that EasyRA determined could not be run. Possible reasons a test cannot be run include a Reagent or sample is missing, a calibration or cleaning is required, or some other maintenance procedure is required. To view tests on the Pending List: 1 Touch the Worklist icon, and then touch View Pending List. The Pending List displays (see Figure 6.39). Figure 6.39 Pending List The Pending List contains one row for each sample that has been moved to the Pending List. The following information is displayed for each entry: Sample Type (Serum, Urine, Calibrator, QC). Sample ID/Lot Number for the sample. Tests to be run on the sample. Time when the test was entered into the Pending List. Tests may be deleted from the Pending List by checking the box for that test in the Delete column and touching the Delete icon (see Figure 6.39). 6.58 E a s y R A O P E R A T O R ’ S M A N U A L Moving Tests from the Pending List to the Worklist Tests are placed in the Pending List if EasyRA determines they cannot be run. It is a good practice to view the Pending List when you are entering tests on the Worklist to determine if some of the tests on the Pending List can now be run (for example, if a missing Reagent has been added). Note: EasyRA automatically removes tests from the Pending List after 30 days. Tests may also be deleted from the Pending List at any time as described in “Viewing the Pending List” on page 6.58. To add a sample from the Pending List into the Worklist: 1 View the Pending List by touching the Worklist icon, and then touching View Pending List. 2 Make a note of the Sample ID/Lot number for the sample(s) you want to add to the Worklist. 3 Touch the Worklist icon and then touch Edit Worklist. When you are entering tests on the Worklist, place the sample for the tests in the Pending List into an empty sample position on the Sample Ring. 4 On the Edit Worklist screen, go to the sample position selected in Step 3. 5 Enter the Sample ID/Lot number of the sample from the Pending List into the Sample ID/Lot field on the Worklist (see Step 2). When you enter the Sample ID/Lot number from the sample on the Pending List, EasyRA automatically detects the sample in the Pending List and moves the entry from the Pending List to the Worklist being edited. 6 When you are done editing the Worklist, touch Enter to complete the Worklist. An inventory is run. If the inventory determines that the test that was previously on the Pending List can be run, it will be run with the other tests on the Worklist. If EasyRA determines the test cannot be run, the sample will be put back in the Pending List. 6.59 S E T T I N G U P A N D R U N N I N G T E S T S Calibrating the ISE Module Note: This procedure is only required if you have the optional ISE Module. The ISE Module must be calibrated after every 8 hours of use. You must also calibrate the ISE Module after every ISE Module cleaning (every 24 hours). ISE tests cannot be performed if the ISE Module is not properly cleaned and calibrated. Because the ISE calibration is run frequently, you can select it directly from the Worklist menu. If EasyRA detects that an ISE Calibration is due to be performed, the Worklist icon blinks to warn you that the ISE Calibration has expired. If you attempt to run ISE tests, EasyRA displays a message indicating that ISE Calibration is required. You may choose not to run the ISE tests or you may perform the ISE Calibration to proceed with patient testing or QC. To calibrate the ISE Module: 1 Touch the Worklist icon, and then touch ISE Calibration. If you do not have the ISE Module option, ISE displays in gray rather than black. The ISE Calibration screen displays as shown in Figure 6.40: 6.60 E a s y R A Figure 6.40 O P E R A T O R ’ S M A N U A L ISE Calibration Screen This screen displays the results of the previous ISE Calibration that was performed. From this screen, you can start a new calibration cycle. Note: If the calibration for any of these tests has expired, you must perform a calibration before you can run ISE tests. 2 To start the ISE calibration, touch the Start Now button: The ISE calibration starts. The calibration takes approximately 2 minutes. During the ISE calibration, the ISE Cal in Progress message displays. When the ISE calibration is complete, the ISE Calibration screen is cleared and the new results are displayed (see Figure 6.41). 6.61 S E T T I N G U P A N D R U N N I N G Figure 6.41 T E S T S ISE Calibration Results (You can also review the ISE Calibration results by choosing ISE from the Status menu.) The results of the ISE calibration show the following information for each ISE Calibration in two tables. Fields in Table 1: Test - The ISE tests being calibrated. Na = Sodium K = Potassium Cl = Chloride Li = Lithium Slope - A calculated value (using the Nernst equation) determined by the voltage difference resulting from measurements of Cal A and Cal B. Cal A and Cal B contain different concentrations of sodium, potassium, chloride, and lithium. Flags - Represents range and measurement errors associated with each sensor during the calibration process. 6.62 For information on ISE range and measurement errors, see “Measurement Problems” on page 11.11 and “Range Problems” on page 11.19. E a s y R A O P E R A T O R ’ S Units (mV/Decade) - The units associated with the slope of an electrode. For example, the change in a Sodium sensor’s mVs (millivolts) associated with a tenfold change in concentration of the Sodium ion. Time Due - Date and time when the ISE Calibration expires. This is when the next ISE Calibration will be due. Comments - Indicates Calibration OK, Calibration Failed, or Calibration Expired for each sensor. M A N U A L Fields in Table 2: Position - Always 0 because the ISE Calibration process does not use a position on the Sample Ring. Material - The name of the calibration material. AMV or BMV (AMV = Cal A millivolts and BMV = Cal B millivolts). Na, K, Cl, Li - The millivolts (AMV or BMV) are shown for each sensor in the order they are analyzed. Printing ISE Calibration Results The ISE Calibration results can be printed from this screen by touching the Print button at the top of the screen. 6.63 S E T T I N G U P A N D R U N N I N G T E S T S Understanding the LIS Interface Introduction The EasyRA chemistry analyzer has the capability to communicate with a Laboratory Information System or LIS, based on the ASTM standard ASTM-1394. The communication protocol is not a complete implementation of the standard, but will cover those areas that will allow the EasyRA to receive and send test requests and orders consistent with the requirements of the standard. A summary of the communication format is described below, but a more complete discussion may be found in the separate LIS Interface Document. Background The ASTM-1394 standard specifies the formatting of patient, test, and result information in a text message. Each message consists of a series of records. There are several types of records. The records EasyRA supports are: Header – Provides information about the sender and the receiver, the ASTM version, and the date and time. Patient – Demographic information about a particular patient. Order – Information about which tests are to be run. Each order record identifies the specimen to be tested. One or more order records will follow a patient record. Result – The results of the test(s) described in the order. When results are reported, the patient and order records are echoed back to the LIS. One or more result records follow each order record. Terminator – Specifies the end of the message. Downloading Test Requests When connected to an LIS system, EasyRA is always listening for test requests. EasyRA does not operate in a host query mode. A maximum number of 200 pending samples and associated tests are stored in the program's buffer. Additional test requests overwrite earlier ones (the oldest request is overwritten first). The user interface provides a menu selection to allow you to view the LIS pending list. 6.64 For more information on viewing the LIS list, see “Viewing an LIS List” on page 6.66. E a s y R A O P E R A T O R ’ S M A N U A L The following data elements appear with each sample/order request: Patient Name. Specimen ID (Accession Number). Selected Tests. Date of Birth. Gender. Attending Physician. Time of Collection. EasyRA recognizes only one patient record at a time. Within an order record, EasyRA supports its own test identification scheme detailed in its LIS Interface Document. If a test is ordered which is not supported, EasyRA ignores it. EasyRA recognizes sample tubes labeled with barcodes using one of the following formats: Codabar Code 39 128 Interleaved 2 of 5 Barcodes must be no longer than 5.72 cm and have a line width of no less than 0.5mm. When EasyRA is in the LIS mode of operation, a Worklist inventory function attempts to read a barcode at every sample position. At the end of the inventory, the program compares pending LIS requests with the barcodes that were read. If any of the selected tests are not available to run, you are informed in the same manner as when the EasyRA is operating in the non-LIS mode. If a barcode is read that cannot be matched to a pending request, a warning of this condition is displayed. 6.65 S E T T I N G U P A N D R U N N I N G T E S T S Uploading Test Results In order to avoid the overhead of handling orphaned test requests which cannot be run (for example, blood gas or missing sample), EasyRA will not batch test results with samples. As a test result becomes available, a result record is composed, attached to its patient and order record, and echoed back to the LIS. Requested tests not performed are purged from the LIS pending list after 30 days. Data elements in a result record include: Specimen ID. Selected Test. Result Value. Units. Normal Ranges. Abnormality Flags. Operator ID. Result Status. Time of Result. A detailed description of the abnormality flags is included in the LIS Interface Document. Comment records are not supported. The Header record in a result message contains sufficient information to determine which EasyRA instrument is sending results information, should there be more than one EasyRA connected to the LIS. Supported Data Fields The data fields supported by EasyRA are described in the LIS Interface Document. Viewing an LIS List You can view the data elements that are downloaded from the LIS using EasyRA’s Worklist menu. 6.66 7 Viewing Results Introduction When you run tests on EasyRA, the results display automatically when the tests are complete. You must accept the results to save them. When you accept results, the Worklist is cleared to allow for the creation of a Worklist with new tests. There are several types of results: Current Results - The results of the most recent run. Currents Results are available to view until the results are accepted (saved) on EasyRA. You can rerun tests, delete results, view sample details, accept results, and print results from Current Results. Last Results - When Current Results are accepted, they are saved to Last Results (and to Patient, Calibration, and QC Results, as appropriate). The Last Results allow you to view the results of the last run that was completed. When Current Results are accepted, the Last Results are overwritten. You can view sample details and print results from Last Results. Patient Sample, Calibration, and QC Results - When results of a run are accepted they are saved into their respective categories (Patient, Calibration, and QC Results). From Patient, Calibration, and QC Results, you can view the results for each type of test. You can print results from these categories. Calculated Results - Results that are derived when results of tests that are run on samples are used as input in formulas. EasyRA provides four Calculated Results: cAnGap (calculated with results from Cl-, CO2, and Na+) cBU/Cr (calculated with results from BUN and CREA) cLDL (calculated with results from CHOL, HDL, and TRIG) eGFR (calculated with results from CREA) You must set up and enable calculated results for them to be calculated. You identify results as Calculated Results based on their test names (see bullets above). Calculated results appear in the Current Results in alphabetical order of the test names. Calculated Results also appear on the Sample Details screens and the Patient Reports. You can specify the order in which the Calculated Results appear in the same way you can specify the order of any other test. 7.1 V I E W I N G R E S U L T S This chapter describes the following functions: 7.2 Viewing Current Results. Rerunning Tests. Deleting Test Results. Viewing Calculated Results. Viewing Sample Details. Accepting Results and Clearing the Worklist. Viewing Last Results. Viewing Patient Sample Results. Viewing Results for a Selected Patient. Viewing Calibration Results. Viewing QC Results. Printing Test Results. Resending Results to the LIS from the Sample Details E a s y R A O P E R A T O R ’ S M A N U A L Viewing Current Results When EasyRA completes a run, the results are automatically displayed on the Current Results screen. You can also display Current Results at any time by touching the Results icon and then touching Current Results. Figure 7.1 shows an example of the Current Results for tests generating either quantitative and qualitative results. It also shows results for single level calibrations and QC. Figure 7.1 Example 1 - Current Results Screen Figure 7.2 shows an example of results for a multi-level calibration. If the results include a multi-level calibration, there will be one result for each level (the level is listed in the Sample ID/Lot field). For example in Figure 7.2 the results show a 5-level HbA1c calibration with levels 0-4. To view detailed results of a multi-level calibration, you must view the Sample Details. 7.3 V I E W I N G Figure 7.2 R E S U L T S Example 2 - Current Results Screen Current Results show one line of results for each test that was run. (If more than one test is run on a sample, one line of results is displayed for each test. Also, if you have elected to run replicates on a test, one line of results is displayed for each replicate. This means there may be multiple lines of results for a single sample position.) The results are sorted by position. All results for tests run on Sample Position 1 are shown first, followed by all results for tests run on Sample Position 2, etc. The results of multi-level/multi-constituent calibrations are displayed by level on the Current or Last Results screens. Results for all tests run on the first level are grouped together (in a single sample position), followed by the results for all tests run on the second level, etc. For example, if you were running a 5 level calibration on three tests (BAR, AMP, and COC), the results of each of the three tests (BAR, AMP, and COC) run on Level 1 would be displayed first, followed by the results of each of the three tests (BAR, AMP, and COC) run on Level 2, etc. If you prefer to view the results by test (all BAR test results grouped together, followed by all AMP test results, followed by all COC tests), you can do so by viewing the Sample Details from the Current or Last Results screen. 7.4 E a s y R A O P E R A T O R ’ S M A N U A L The results for each test contain the information described in Table 7.1: Table 7.1 Current Results Fields FIELD DESCRIPTION STAT Indicates if the test is a Stat. (If the Stat check box is checked, the sample is a Stat and was run before other patient samples. If the box is not checked, the sample is not a Stat.) This information does not apply to QC or Calibration results. POS Indicates the position of the sample on the Sample Ring. (If more than one test is run on a sample, then there will be one line of results for each test run on the sample in that position.) TYPE Specifies the type of sample that was run: Serum, Plasma, Diluted Blood, Urine, Diluted Urine, Calibrator, QC, or Blank (for calibrations only). SAMPLE ID/LOT Specifies the unique Sample ID (Accession Number) for patient samples or Lot Number for Calibration or QC samples. TEST Specifies the name of the test for which results are reported. RESULTS Displays the results of the test that was run. UNITS If the test generated quantitative results, a numerical value is displayed. If the test generated qualitative results, this column indicates if the results were positive or negative. If results are out of the linear range or an error occurred, results will not be reported. Displays the units used to report the results. 7.5 V I E W I N G Table 7.1 R E S U L T S Current Results Fields FIELD DESCRIPTION FLAG Result Flag codes display if the results are out of range or if there is a measurement error for Calibration, QC, and Sample tests. The Flag field may be blank, it may contain up to 2 two-letter codes, or it may contain an error message (-E-). The number of flagged results is located next to the flag icon. There are two categories of flags: range errors and measurement errors. If only one category of flag is reported, the code appears in the center of the column. If both categories of flags are reported, the range errors are in the left and the measurement errors are in the right with a space between them. If results are outside of the normal or critical ranges, the results for the test are also highlighted to draw your attention to them. Red indicates the results are outside of the Critical Range and gold/ yellow indicates the results are outside of the Normal Range. Figure 7.3 shows an example of the Results screen with flags. If the Flags field is blank, the test was completed and no errors were detected during analysis. Results displayed in the Result field are in the normal range (if normal range and patient information were specified during Setup). If the field contains an error message (-E-), an error occurred and no results were reported. At any time, you can view a legend of the Flags by clicking on the Flag icon on the Results screen (see Figure 7.3). For detailed information on Flag codes, see Table 7.3 and Table 7.4. 7.6 E a s y R A Table 7.1 O P E R A T O R ’ S M A N U A L Current Results Fields FIELD DESCRIPTION RERUN Check this box to indicate that you want to rerun a test. This check box may also be automatically checked if results are outside the high end of the linear range, rerun range, or there is substrate depletion. After the rerun has been performed, the Rerun box is checked on the rerun results line. The previous line shows the results of the original test run and the line with the checked Rerun box shows the result of the rerun. You are not allowed to re-run multi-level calibration tests. COMPLETION The time when the test was completed. TIME STATUS Figure 7.3 Test status, indicating if the test was complete, etc. Possible status messages are: Not Started, Test Started, Measuring, Calibration Error, or Complete. Results Screen with Flag Codes Red indicates results are outside Critical Range. Yellow/Gold indicates results are outside Normal Range. 7.7 V I E W I N G R E S U L T S You can scroll through the Current Results to view any results that are not visible. From Current Results, you can: View a legend of Results Flag codes. Also displays the number of flagged results. For more information, see Table 7.3 and Table 7.4. Rerun tests, except for multi-level calibrations which cannot be rerun. Each Worklist can only be rerun once. For more information, see “Rerunning Tests” on page 7.9. Delete test results. Users with Supervisor privileges are allowed to delete test results that may be invalid. Calibration results cannot be deleted. For more information on deleting test results, see “Deleting Results” on page 7.15. View Sample Details. From Current Results or Last Results you can view a detailed report for a selected sample and also raw data for the selected sample. For more information, see “Viewing Sample Details” on page 7.20. Print all sample results, or patient, calibration, or QC reports. For more information, see “Printing from Current And Last Results Screens” on page 7.64. Accept results and clear the Worklist. 7.8 For more information, see “Accepting Results and Clearing the Worklist” on page 7.26. E a s y R A O P E R A T O R ’ S M A N U A L Rerunning Tests After all tests in a Worklist have been run and Current Results are displayed, you can choose to rerun tests on the Worklist if the results are abnormal or need to be verified. Tests to be rerun are selected (either automatically or manually) in Current Results. Note: Multi-level calibrations cannot be rerun using the Rerun function. To rerun a multi-level calibration, you must re-enter it in the Worklist. Multi-level calibrations can only be run in their entirety (you cannot run individual parts of a multi-level calibration). Note: You can only rerun a Worklist once. Be sure all tests to be rerun are selected before starting the rerun. The Rerun option is not available after a Worklist has been rerun once. There are two types of reruns: Test results out of the Rerun Range, Linear Range, or where Substrate Depletion occurs (semi-automatic rerun) - If EasyRA detects that the results are outside the Rerun Range or Linear Range, or that Substrate Depletion has occurred, the results are automatically selected to be rerun. (The Linear Range and Substrate Depletion Range are read from the RFID Chip on the Reagent Wedge. The default Rerun Range is the Linear Range read from the RFID Chip on the Reagent Wedge. The Rerun Range can be modified during Setup.) You can deselect any tests that are automatically selected to prevent them from being rerun. If tests that are out of the Linear Range or Substrate Depletion Range are rerun, one half to one third of the normal sample volume is aspirated during sampling to effectively extend the Linear Range. Manual Rerun - You can select to rerun any test(s) reported in Current Results by touching the Rerun check box in the line of interest. You may choose to rerun tests to verify the results that were reported. To rerun tests from Current Results: 1 From the Current Results screen, scroll through the results and determine if any tests have been automatically selected for rerun (the Rerun check box is selected on each test selected for rerun). (Figure 7.4 shows tests that have been automatically selected for rerun). 7.9 V I E W I N G Figure 7.4 R E S U L T S Tests in Current Results That Have Been Automatically Selected for Rerun To deselect test(s) that have been automatically selected for rerun, touch the Rerun check box for each test. 2 To manually select test(s) to be rerun, touch the Rerun check box in the line for the test of interest. To deselect a test, touch the checked Rerun box for the test. 3 When all tests that you want to rerun have been selected, touch the Rerun button to start the rerun: A confirmation message displays asking you to confirm that the selected tests will be rerun (see Figure 7.5). 7.10 E a s y R A Figure 7.5 4 O P E R A T O R ’ S M A N U A L Rerun Confirmation Message Touch OK to confirm the Rerun. The Edit Worklist screen displays (see Figure 7.6). Notice that the tests that have been selected for rerun are underlined in the Worklist and the numbers on the samples being used on the representation of the Sample Ring on the left side of the screen are also underlined. The Rerun icon now appears around the Sample Ring in progress. Figure 7.6 Edit Worklist for Reruns Indicates rerun(s) in progress on Sample Ring A Tests to be rerun are underlined. Samples to be rerun are underlined. 7.11 V I E W I N G R E S U L T S On the Edit Worklist screen, you cannot change or delete any tests that have already been run, however, you can add tests to existing Worklist entries, or you can add new samples to empty positions in the Sample Ring and add tests for those samples. Verify that the tests to be rerun are underlined. 5 When the Worklist is complete, touch Enter: Touching Enter starts an inventory. 6 For detailed information on performing an inventory, see “Performing an Inventory” on page 6.32. After the inventory has been performed, the Run button displays in the upper left corner of the screen, as long as at least one test on the Worklist can be run. Note: When Auto Run After Inventory in enabled, the run will begin immediately following the Worklist Inventory. For more information, see “Performing an Inventory/Starting a Run (with Auto Run Enabled)” on page 6.37. If any problems are detected during inventory, the Status icon blinks. The Status icon may blink to indicate that a Reagent or sample is missing, Cuvettes need to be replaced, or a calibration has expired. To view the status messages, touch the Status icon and select Worklist Warnings. For information on viewing Worklist Warnings, see “Viewing Worklist Warnings” on page 8.3. To rerun the selected tests, touch the Run button: The Worklist Monitoring screen displays. During the run, the tests that are being rerun are underlined (see Figure 7.7). If new tests are added before the rerun, the new tests are not displayed with an underline. 7.12 E a s y R A Figure 7.7 O P E R A T O R ’ S M A N U A L Worklist Monitoring Screen During Reruns Indicates rerun(s) in progress on Sample Ring A This screen shows all previous status results (as completed) in gold letters. The tests that are being rerun are underlined. Tests being run for the first time display in black. When the reruns are complete, the Worklist Monitoring screen is replaced with the Current Results screen. The results of tests that have been rerun are interleaved into the previous test results so that the original result is listed first, followed by the rerun result. The Rerun check box is selected for the results of all reruns to help you quickly identify results of tests that have been rerun. See Figure 7.8. 7.13 V I E W I N G Figure 7.8 R E S U L T S Current Results Displayed After a Rerun Indicates rerun(s) in progress on Sample Ring A Result of original test Result of rerun (Rerun check box is checked) After one rerun has been performed, the Rerun button is no longer next to the Delete button: You are only allowed to rerun tests once from the Current Results screen. To save the Current Results, you must accept them. 7.14 For more information see “Accepting Results and Clearing the Worklist” on page 7.26. E a s y R A O P E R A T O R ’ S M A N U A L Deleting Results If security is activated, EasyRA allows a user with Supervisor privileges to delete results that may be incorrect or invalid. To help prevent valid results from being accidentally deleted, only the Supervisor has privileges to delete results. If security is not activated, EasyRA allows any user to delete results. The following are reasons why you might want to delete results: Tests were run on the wrong sample because an incorrect sample was loaded into a position on the Sample Ring. Incorrect tests were selected for the sample. QC failed for this run. An incorrect run. Note: Use caution when deleting results to avoid deleting valid results. Calibration results cannot be deleted. To delete results: 1 From the Current Results screen, scroll through the results and determine if there are any results that should be deleted. 2 Manually select the test result(s) to be deleted. To select the test, touch anywhere (except in the Rerun column) in the line for the test of interest to highlight the test (see Figure 7.9). Notice in this example, the GLU-T test result in Position 2 (top line of the screen) is highlighted for deletion. 7.15 V I E W I N G Figure 7.9 R E S U L T S Select Results to be Deleted To deselect results that have been selected, touch the highlighted line for the test. 3 When all results that you want to delete have been highlighted, touch the Delete button to delete the selected results: A confirmation message displays asking you to confirm that the selected results will be deleted (see Figure 7.10). 7.16 E a s y R A Figure 7.10 4 O P E R A T O R ’ S M A N U A L Delete Confirmation Message Touch OK. The Supervisor Login dialog displays (see Figure 7.11). Figure 7.11 Supervisor Login Dialog Only a user with Supervisor privileges (usually the Lab Manager or Supervisor) can delete results. 5 Enter the Supervisor password from the Alphanumeric Keypad and press Enter. If you do not have Supervisor privileges, you are not allowed to delete results. 6 EasyRA displays the Current Results screen again. The test results that were selected are deleted from the Results screens (see Figure 7.12). In this example, the GLU-T test result in Position 2 that had been highlighted was deleted. 7.17 V I E W I N G Figure 7.12 R E S U L T S Current Results After Results Have Been Deleted To save the Current Results, you must accept them. For more information see “Accepting Results and Clearing the Worklist” on page 7.26. Viewing Calculated Results You can only view Calculated Results if you have set them up and enabled them before the Worklist is run. For a overview of Calculated Parameters and details on how to set them up and enable then, see “Setting Up Calculated Results” on page 4.20. This section describes how to view Calculated Results after a run has been completed. Figure 7.13 shows an example of a Worklist for which a CREA test will be run on Samples 1 and 2. 7.18 E a s y R A Figure 7.13 O P E R A T O R ’ S M A N U A L Worklist with CREA Test on Samples 1 and 2 If the Calculated Result eGRF was enabled before this Worklist was run, the Current Results for the Worklist will include the results of the chemistry tests (CREA) and the calculated result (eGFR) for Samples 1 and 2. The test results for each sample (including chemistry tests and calculated results) are listed in alphabetical order (see Figure 7.14). Figure 7.14 Current Results Including eGFR Calculated Result Calculated Results also appear on Sample Details screens and Patient Reports. You can specify the order in which each Calculated Result will appear, in the same way you can specify the order of any other test. For information on specifying test order in Sample Details and Patient Reports, see “Setting Up the Patient Report Test Order” on page 2.55. 7.19 V I E W I N G R E S U L T S Viewing Sample Details From the Current and Last Results screens, you can view detailed results for any sample. For patient tests, the Sample Details include the Patient ID, Patient Name, Sex, Date of Birth, and Physician, if that information was entered during setup. It also includes the results of each test (chemistry test, calibration, or QC) that was performed on the selected sample. To display Sample Details: 1 From the Current Results or Last Results screen, do one of the following: Touch the Sample Details icon: The Sample Details for sample position 1 displays. Touch one of the numbered samples on the graphic representation of the Sample Ring If you take either of these actions, the Sample Details screen displays (see Figure 7.15), showing the sample details for the sample. 7.20 E a s y R A Figure 7.15 O P E R A T O R ’ S M A N U A L Sample Details Note: If LIS is enabled, the Send to LIS icon appears next to the Print icon. You can use the Send to LIS icon to send the displayed test results to the LIS. Use the scroll arrows on the bottom of the screen or touch another sample position on the representation of the Sample Ring to view details for another sample. If a Patient ID has been used and Normal ranges have been entered for tests, the range will be displayed. If the results are outside of the Normal range, Outside Normal Limits will be displayed in the Comments column. The information provided for QC results is similar. If the results are outside of the QC range, Outside QC Limits will be displayed in the Comments column 2 To print the Sample Details for a sample, see “Printing from the Sample Details Screen” on page 7.72. 7.21 V I E W I N G R E S U L T S 3 To close the Sample Details screen, touch the Close button on the Sample Details window: You are returned to the Current or Last Results screen from which you selected the Sample Details icon. Viewing Raw Data Results from the Sample Details Raw Data results may also be viewed from the Sample Details screen. Raw Data results may by useful in troubleshooting test performance or during Reagent Optimization when setting up user-defined tests. For more information on troubleshooting, see “Troubleshooting & Diagnostics” on page 11.1. For more information on user-defined tests, see “Setting Up User-Defined Tests” on page 12.1. Note: Raw data results are not displayed for ISE tests. The following information is available for each sample: 7.22 Slope of the reaction. A graph depicting absorbance readings over time (in seconds). Absorbance measurements for each read at a particular wavelength. Completion time in seconds. E a s y R A O P E R A T O R ’ S M A N U A L To display Raw Data details: 1 From the Sample Details Screen, touch the Raw Data button. Data for this sample are displayed (see Figure 7.16). Figure 7.16 Raw Data for the Selected Sample 2 Touch Select Test and Filter # to display results for each test and wavelength available for the sample. Choose the test and/or filter number from the drop down list. 3 For tests with multiple readings, use the scroll arrows to the right of the table to scroll through the list of results. 4 To view other sample positions that are not displayed, use the scroll arrows at the bottom of the page. Adding User Comments to the Sample Details Comments may be added to the Sample Details for a selected sample before results are accepted (from the Current Results screen only). Comments will be displayed on the Current and Last Results screens and will appears on the printed Patient Report. 7.23 V I E W I N G R E S U L T S To enter comments: Figure 7.17 7.24 1 On the Current Results screen, touch the Sample Details icon. The Sample Details for the selected sample displays. 2 Touch the Comments section on the Sample Details screen. The Enter Comment box displays (see Figure 7.17). Enter Comments Box on the Results of the Selected Sample 3 Touch the blank field in the Enter Comments box. The Alphanumeric Keypad displays. 4 Enter a comment about the results containing up to 250 characters (see Figure 7.18). E a s y R A Figure 7.18 O P E R A T O R ’ S M A N U A L Enter a Comment in the Enter Comments Box Using the Keypad 5 Touch Enter to close the keypad and save the comments. 6 Comments are displayed on the results screen (see Figure 7.19) and in the printed Patient Report. 7.25 V I E W I N G Figure 7.19 R E S U L T S Comments Are Displayed on the Sample Results Details Screen Accepting Results and Clearing the Worklist After tests are complete, you must accept the results to save them. When you accept results, Current Results are moved to Last Results. The Current Results are also divided into their respective categories and saved as Patient Results, Calibration Results, and QC Results. When you accept results, the tests for that run are no longer available on the Worklist screen and the Worklist is cleared, so that you can begin to enter another Worklist with new tests. To accept test results: 7.26 1 From the Current Test Results screen, touch Enter to accept results and clear the Worklist. 2 A confirmation box displays asking you to confirm your action (see Figure 7.20). This box also reminds you to perform all reruns or deletions before accepting results. After results have been accepted, tests in this run cannot be rerun and test results from this run cannot be deleted. E a s y R A Figure 7.20 3 O P E R A T O R ’ S M A N U A L Accept Confirmation Message If the Operator ID option has been turned on, EasyRA prompts you to enter an Operator ID before you can accept results. Enter your Operator ID and touch Enter on the Alphanumeric Keypad, or touch Skip. For more information on the Operator ID option, see “Entering the Operator ID” on page 7.28. Accepting results stores the test results in Last Results and in Patient, Calibration, and QC Results. It also clears the Worklist and displays a blank Edit Worklist screen on which a new Worklist can be created. For more information, see “Creating or Editing a Worklist Manually” on page 6.7. To view Last Results, or Patient, Calibration, or QC Results at this time, touch the Results icon and then touch the appropriate menu section. This chapter provides information on viewing each type of results. 7.27 V I E W I N G R E S U L T S Entering the Operator ID EasyRA provides an option that prompts you to enter an Operator ID before you accept or print results. The purpose of this ID is to identify the operator responsible for the run for logging and tracking purposes. For more information on setting up the Operator ID option, see “Selecting the Operator ID Option” on page 2.69. To use the Operator ID option (if it has been enabled): 1 If the Operator ID option has been enabled, anytime you attempt to accept results or print results, you will be prompted to enter your Operator ID (see Figure 7.21). Figure 7.21 2 Operator ID Dialog Enter your Operator ID by touching the Operator ID field or touch Skip to continue without entering an Operator ID. If you touch the Operator ID field, the Alphanumeric Keypad displays allowing you to enter your ID. If you choose Skip, no Operator ID will appear in the Operator ID field on the screens or printed reports, but you can still proceed with accepting or printing results. Note: If your laboratory uses the Operator ID option, it is recommended that you enter your Operator ID wherever you are prompted for it. EasyRA prompts for an Operator ID when you accept or print results. This information helps identify the operator of the run for tracking purposes. 7.28 E a s y R A O P E R A T O R ’ S M A N U A L Viewing Last Results In addition to viewing the results of the current run, you can also view the results of the last run. However, once you accept results, the Current Results overwrite the previous set of Last Results. You can only access one set of Last Results at a time. To view older results, use the Patient, Calibration, and QC Results features. To view Last Results: 1 Touch the Results icon and select Last Results. The results of the last Worklist, for which results were accepted, are displayed (see Figure 7.22) Figure 7.22 Last Results Screen The information displayed on the Last Results screen is the same as the information which had been in Current Results, except that Last Results have been stored on EasyRA. For a description of the fields in Last Results, see Table 7.1. 7.29 V I E W I N G R E S U L T S From Last Results, you can: View Sample Details. From Current Results or Last Results you can view a detailed report for a selected sample. Print all sample results, or patient, calibration, or QC reports. 7.30 For more information, see “Viewing Sample Details” on page 7.20. For more information, see “Printing from Current And Last Results Screens” on page 7.64. E a s y R A O P E R A T O R ’ S M A N U A L Viewing Patient Sample Results You can view all Patient Sample Results that have been saved automatically or manually. The results of patient tests are stored automatically when you accept Current Results. Up to 2000 patient results or up to 56,000 test results may be stored. When this amount is exceeded, oldest results are automatically deleted to create memory space for the newest results. Your lab should establish a plan to periodically save results on external media to preserve all past patient results. You can also choose to manually save selected results to your hard drive or to an external USB drive. The methods to view patient results are the same regardless of whether the results were saved automatically or manually. Patient Sample Results are grouped by test run. To view Patient Sample Results, select the test run of interest. The results for each patient sample test in the run are displayed. Table 7.2 shows the information provided in the Patient Sample Results display: Table 7.2 Patient Sample Results Fields FIELD DESCRIPTION TYPE Specifies the type of sample that was run (Serum, Plasma, Diluted Blood, Urine, Diluted Urine). SAMPLE ID/LOT Specifies the unique Sample ID (Accession Number) for patient samples or Lot Number for Calibration or QC samples. TEST Specifies the name of the test for which results are reported. RESULTS Displays the results of the test that was run. UNITS If the test generated quantitative results, a numerical value is displayed. If the test generated qualitative results, this column indicates if the results were positive or negative. If results are out of the linear range or an error occurred, results will not be reported. Displays the units used to report the results. 7.31 V I E W I N G Table 7.2 R E S U L T S Patient Sample Results Fields FIELD DESCRIPTION FLAG Result Flag codes display if the results are out of range or if there is a measurement error for Sample tests. The Flag field may be blank, it may contain up to 2 two-letter codes, or it may contain an error message (-E-). The number of flagged results is located next to the flag icon. There are two categories of flags: range errors and measurement errors. If only one category of flag is reported, the code appears in the center of the column. If both categories of flags are reported, the range errors are in the left and the measurement errors are in the right with a space between them. If results are outside of the normal or critical ranges, the results for the test are also highlighted to draw your attention to them. Red indicates the results are outside of the Critical Range and gold/ yellow indicates the results are outside of the Normal Range. Figure 7.3 shows an example of the Results screen with flags. If the Flags field is blank, the test was completed and no errors were detected during analysis. Results displayed in the Result field are in the normal range (if normal range and patient information were specified during Setup). If the field contains an error message (-E-), an error occurred and no results were reported. At any time, you can view a legend of the Flags by clicking on the Flag icon on the Results screen (see Figure 7.3). For detailed information on Flag codes, see Table 7.3 and Table 7.4. COMPLETION The time when the test was completed. TIME PATIENT ID 7.32 The ID for the selected patient. E a s y R A O P E R A T O R ’ S M A N U A L To view Patient Sample Results: 1 Touch the Results icon and select Patient Results. The Patient Sample Results screen displays showing a Worklist Summary on the left side of the screen (see Figure 7.23). Figure 7.23 Patient Sample Results (Worklist Summary) The Worklist Summary includes the following information for each test run: Date/Time of the run. Run number. Number of samples in the run. Operator ID for the run (if the Operator ID option is enabled). The runs are ordered by date and time, with the most recent run listed first. Notice that the Folder icon displays above the Worklist Summary (see upper left of Figure 7.23): The Folder icon is used to allow you to retrieve results that you have saved manually onto the computer’s hard drive or an external USB drive. If you choose to retrieve data that has been saved manually, you can select the run containing the retrieved data and review the results of that run just as you can view the results of a Current run that has been saved automatically. 7.33 V I E W I N G R E S U L T S 2 To retrieve results that have been saved manually, touch the Folder icon. (If you do not want to view results that have been saved manually, skip to Step 3). A dialog box displays from which you can select the location of the saved data (see Figure 7.24). Figure 7.24 Dialog for Selecting Results File to be Retrieved Navigate to the .xml file containing the results you want to view, (“YYYY-MM-DD ResultsData.xml” for example) touch the file name, and then touch Open. The Worklist Summary area of the screen is modified to show a Current Results button (Current) and a second button containing the path of the results that were retrieved (see Figure 7.25). 7.34 E a s y R A Figure 7.25 O P E R A T O R ’ S M A N U A L Buttons Allowing You to Display Current Results or Saved Results To display the list of runs from the Current Results, touch the Current button. To display the list of runs from the retrieved results that were saved manually, touch the button with the path name of the retrieved results. 3 To view the results of the samples for tests for a particular run, touch a line in the Worklist Summary. A listing of all Patient Sample Results from the selected run display in the Patient Sample Results screen (see Figure 7.26 for an example of a run saved automatically when Current Results are accepted). Figure 7.26 Patient Sample Results 7.35 V I E W I N G R E S U L T S The Patient Sample Results lists all tests in the selected run, sorted by date and time. The table shows one line of results for each test that was run. There may be multiple lines per sample, if several different tests were run on the sample. Scroll through the list of tests to locate a particular patient or to view results that are not visible. 4 From Patient Sample Results, you can: Search for a particular patient by Patient ID and view all results for that patient. For more information, see “Displaying Results for a Particular Patient” on page 7.37. View sample details for a particular patient result. For more information on viewing sample details, see see “Viewing Sample Details for Patient Results” on page 7.40. Print patient reports. A table similar to the Patient Sample Results screen is printed. For more information, see “Printing Patient Results” on page 7.43. 5 7.36 When you are done viewing the Patient Results, touch any menu icon to make another selection. To view patient results from another run, go back to Step 2 and touch the Folder icon to select another file. E a s y R A O P E R A T O R ’ S M A N U A L Displaying Results for a Particular Patient This section describes how to search for a particular patient (by Patient ID) from the Patient Sample Results and display all results for that patient. When you use the search function from the Patient Sample Results, you are searching for the Patient ID in all test runs on EasyRA. To search for a patient and display all tests results for the selected patient: 1 From the Patient Sample Results screen, touch the Find Patient ID in All field (see Figure 7.26). The Alphanumeric Keypad displays (see Figure 7.27). Figure 7.27 Alphanumeric Keypad Displays on Patient Sample Results Screen 7.37 V I E W I N G R E S U L T S 2 Figure 7.28 7.38 Enter the Patient ID in the Find Patient ID in All field and touch Enter on the keypad (see Figure 7.28). Enter Patient ID in the Find Patient ID in All Field E a s y R A O P E R A T O R ’ S M A N U A L EasyRA searches all results in all test runs for the selected Patient ID and displays all results with a matching Patient ID (see Figure 7.29). Figure 7.29 Results of Search for a Patient ID (852) You can also choose to enter a specific date range by selecting Date Range from the Enter Date Range drop-down and then entering a start and end date. By making that selection you only display results for the selected patient for tests run during the selected date range. 7.39 V I E W I N G R E S U L T S Sorting Patient Results By default the results of all tests for the selected Patient ID are sorted by date and time (in reverse order), but they can be sorted by any of the displayed column headings. Patient results may be sorted specifically, in the following common ways: By Date/Time. By Sample ID or Patient ID. By Test. (All tests of the same type are grouped together. Tests display in alphabetical order.) To sort results displayed for a particular patient: Touch the heading of the column you want to sort by. The results are re-ordered based on the sorting option selected. To reverse the order of the sorting, touch the column heading again. Viewing Sample Details for Patient Results From the Patient Results, you can view detailed results for any run. For patient tests, the Sample Details include the Patient Name, Patient ID, Age, Date of Birth, Age, Sex, Sample ID, Sample Type, Physician, Completion Time, Collection Time, and Operator ID if that information was entered during setup. It also includes the results of each test that was performed (by sample position). To display Sample Details: 1 From the Patient Sample Results screen, touch the Sample Details icon: The Sample Details for the first sample position displays. The Sample Results Details screen displays (see Figure 7.30), showing the sample results for the first sample position. 7.40 E a s y R A Figure 7.30 O P E R A T O R ’ S M A N U A L Sample Details For qualitative reagents, the Calibrator Cutoff is now displayed. The Calibrator Cutoff value displayed is entered when you set up the calibration material for the test. Figure 7.31 shows the Patient Sample Results for a qualitative reagent showing the Calibrator Cutoff. 7.41 V I E W I N G Figure 7.31 R E S U L T S Patient Sample Results with Calibrator Cutoff Use the scroll arrows on the bottom of the screen to view details for the next sample position. If a Patient ID has been used and Normal ranges have been entered for tests, the range will be displayed. If the results are outside of the Normal range, Outside Normal Limits will be displayed in the Comments column. 2 To print the Sample Details for a sample, see “Printing Patient Results” on page 7.43. 3 To close the Sample Details screen, touch the Close button on the Sample Details window: You are returned to the Patient Sample Results screen from which you selected the Sample Details icon. 7.42 E a s y R A O P E R A T O R ’ S M A N U A L Printing Patient Results Displaying and Reprinting an Individual Patient Report To display a Patient Report for a particular patient and sample: 1 Touch the Sample Details icon. The Sample Details for the selected sample displays. 2 Touch the Print icon to print a single Patient Report. Printing Reports (All Results) for a Patient To print a list of all results for a particular patient: 1 On the Results/Patient Samples screen, touch the Print icon. The Print Dialog Box displays. 2 Touch All Sample Results and touch OK. The All Sample Results Report prints. Sample results will be printed in the displayed sorting order for: The particular patient. The date range selected. To print all patient reports with results displayed for a particular patient: 1 On the Results/Patient Samples screen, touch the Print icon. The Print Dialog Box displays. 2 Touch All Patient Reports and touch OK. Individual Patient Reports will be printed for all displayed results in the displayed sorting order for: The particular patient. The date range selected. For complete information on patient reports, see see “Printing All Patient Reports from Current or Last Results” on page 7.67. 7.43 V I E W I N G R E S U L T S Viewing Calibration Results You can view all Calibration Results that have been saved. When a lot of calibrator expires, all calibration results are automatically added. Calibration Results are stored when you accept Current Results. Calibration results for both quantitative and qualitative tests provide the same types of information. Calibration Results are sorted by test and are listed in alphabetical order. Calibration Results include the following information: Test Name. Reagent Lot #. Last Calibration Factor. (A numerical value is displayed for tests with a single calibration level. A Curve icon is displayed for tests with multiple calibrations levels (see Figure 7.32. Click on the Curve icon to display detailed calibration results for each level.) Figure 7.32 Example of Single- and Multi-Level Calibration Results Last Cal Factor/Cal Factor for Single Level Calibration (Numerical Result) Last Cal Factor/Cal Factor for Multi-Level Calibration (Curve icon) Calibration Factor. (Results are displayed in the same way as Last Calibration Factor). See Figure 7.32. Date/Time of Next Calibration. Status. 7.44 For information on the Calibration Status messages, see “Viewing Calibration Status” on page 8.11. E a s y R A O P E R A T O R ’ S M A N U A L To view Calibration Results: Touch the Results icon and select Calibration Results. The Calibration Results are displayed (see Figure 7.33). Figure 7.33 Calibration Results Results are displayed by test. You can scroll through the results to view a particular test or a result that is not visible. For multi-level calibrations, a Curve icon is displayed under Last Cal Factor and Cal Factor to indicate that additional results are available for each level. 7.45 V I E W I N G R E S U L T S Viewing Detailed Results for Multi-Level Calibrations To view detailed results for multi-level calibrations from the Calibration Results: 1 Figure 7.34 Touch the Curve icon for a particular test to view details for the multi-level calibration. Figure 7.34 shows an example of the calibration details if you touched the Curve icon for a calibration results. This shows the calibration curve and a table of individual results for each calibration level. It shows the date/time stamp for the Current results (displayed in block) and the Last Results (displayed in gold). Example of Calibration Details for Multi-Level Calibrations Note: If you have selected to run replicates for this multi-level calibration, the data displayed in the Absorbance column is the average of the results from all replicates. Results for individual tests can only be viewed from the Current Results before you accept them. 7.46 E a s y R A 2 O P E R A T O R ’ S M A N U A L For user-defined tests only (open system), a drop-down appears in the upper right corner of the screen (see Figure 7.35). Figure 7.35 Drop-Down for User Defined Tests From this box, you can select to display the following: The Current Results and the Last results on a single plot for comparison. The Current Results using the selected curve fitting routine (either Cubic Spline or Logit - Log 4) and the Current Results using the other curve fitting routine. By comparing the data using the two curve fitting routines, you can see which one best fits the data. For example, the Cubic Spline curve may give you a result where the curve goes through all the data points, but it has a hump at 500 ng/mL, indicating there may be a potential problem, while the Logit - Log 4 curve is a smooth curve and the point at 500 ng/mL is slightly above the calibration curve. Generally, you will choose the smoother curve. This function can only be used during reagent optimization. Note: The selection of the curve fitting routine is only available for user-defined tests. The curve fitting routine for Medica-supplied reagents cannot be changed from what is programmed on the RFID chip. Note: To change the curve fitting routine for a user-defined test, go to Setup > Reagent, select Reagent Details, select the user-defined reagent of interest, select the Modify button and change the Cal Curve fitting setting on page 2 of the Reagent Parameters. For more information on modifying the Cal Curve fitting setting, see “Modifying All Reagent Parameters” on page 12.30. 7.47 V I E W I N G R E S U L T S From Calibration Results, you can: Print Calibration Results. A table similar to the Calibration Results screen is printed. For more information, see “Printing from the Calibration Results Screen” on page 7.75. Printing Calibration Results Printing All Calibration Results To print all calibration results: 1 On the Results/Calibration screen, touch the Print icon. The Print Dialog Box displays. All current calibration results display in a list. For multi-level calibrations, a tilde (~) character indicates that additional results are available for that test. The results include: Test Reagent Lot # Last Cal Factor Cal Factor Next Calibration Status Printing Results for Multi-Level Calibrations To print the results for a multi-level calibration: 7.48 1 On the Results/Calibration screen, touch the Curve icon for the multi-level calibration of interest. 2 The Result Calibration Details screen displays for the selected calibration. 3 Touch the Print icon to print a the results that are displayed (the plot and the tabular results). E a s y R A O P E R A T O R ’ S M A N U A L Viewing QC Test Results You can view all Quality Control (QC) Results that have been saved automatically or manually. QC Results are stored automatically when you accept Current Results. You can also choose to manually save selected results to your hard drive or to an external USB drive. The methods to view QC results are the same regardless of whether the results were saved automatically or manually. The results recorded are different depending on whether or not you have set up the tests to return quantitative or qualitative results. This section first describes how to access QC results that were saved automatically or manually and the following sections describe how to view the different types of results (quantitative or qualitative). Viewing QC Results That Were Saved Automatically or Manually To view QC results that have been saved automatically or manually, do the following: 1 Touch the Results icon and select QC Results. The QC Samples Results screen displays showing a list of all QC materials on the left side of the screen (see Figure 7.36). Figure 7.36 QC Sample Results (QC Materials List) 7.49 V I E W I N G R E S U L T S The list of QC Materials includes the following information for each material: Material name. Lot number. Expiration Date. Condition (Transitional or Active). The QC materials are ordered alphabetically. Notice that the Folder icon displays above the list of QC Materials (see upper left of Figure 7.36). The Folder icon is used to allow you to retrieve results that you have saved manually onto the computer’s hard drive or an external USB drive. If you choose to retrieve QC results that have been saved manually, you can select the QC material that has been saved and review the QC results just as you can view the results of QC material that was saved automatically when you accepted Current Results. 2 7.50 To retrieve results that have been saved manually, touch the Folder icon. (if you do not want to view results that have been saved manually, skip to Step 3). A dialog box displays from which you can select the location of the saved data (see Figure 7.37). E a s y R A Figure 7.37 O P E R A T O R ’ S M A N U A L Dialog for Selecting Results File to be Retrieved Navigate to the .xml file containing the results you want to view, (QCData.xml for example) touch the file name, and then touch Open. The QC Material area of the screen is modified to show a Current Results button (Current) and a second button containing the path of the QC results that were retrieved (see Figure 7.38). Figure 7.38 Buttons Allowing You to Display Current Results or Saved Results 7.51 V I E W I N G R E S U L T S To display the list of QC Materials from the Current Results, touch the Current button. To display the list of QC Materials from the retrieved results that were saved manually, touch the button with the path name of the retrieved results. 3 Figure 7.39 7.52 Quantitative QC Results To view the results of the tests run on a particular QC material, touch a line in the list of QC Materials. A list of all QC Results for the selected QC Material displays in the QC Sample Results screen (see Figure 7.39 for an example of a Quantitative QC result that was saved automatically when Current Results were accepted). E a s y R A O P E R A T O R ’ S M A N U A L Viewing Quantitative QC Results To view quantitative QC Results, first select the QC material of interest that has been saved automatically or manually (see “Viewing QC Results That Were Saved Automatically or Manually” on page 7.49), then you can view the results of each test on that QC material. The QC materials are listed in alphabetical order. For each QC material, QC Results are sorted by test type. Quantitative QC Results display the following information: Test Name. Mean. Standard Deviation (SD). Units. Coefficient of Variation (CV). Number of Tests Performed (N). Low Limit. High Limit. User Mean. User SD. QC Flag Limit. You can also view a Levey-Jennings Chart for any QC material and test. This chart shows the results for that test over a period of 31 days. To view quantitative QC Results: 1 Touch the Results icon, and then select QC Results. The QC Results screen displays, showing a list of all QC materials (see Figure 7.40). You can view QC Materials that were saved automatically or manually (see “Viewing QC Results That Were Saved Automatically or Manually” on page 7.49). 7.53 V I E W I N G R E S U L T S Figure 7.40 2 Figure 7.41 7.54 QC Sample Results QC Materials Touch one of the QC materials to display the QC Results for that material (see Figure 7.41 for an example of a QC Material from the automatically saved results). E a s y R A O P E R A T O R ’ S M A N U A L You can scroll through the results to view QC Results that are not visible. From the QC Samples Results, you can: View and print the Levey-Jennings Chart. For more information on viewing the Levey-Jennings Chart, see “Viewing A Levey-Jennings Chart for Quantitative QC” on page 7.56. For more information on printing a Levey-Jennings Chart, see “Printing a Levey-Jennings Chart from the QC Results Screen” on page 7.78. Print QC Results. A table similar to the QC Sample Results screen is printed. For more information, see “Printing All QC Results for a Selected QC Material” on page 7.77. 7.55 V I E W I N G R E S U L T S Viewing A Levey-Jennings Chart for Quantitative QC The Levey-Jennings Chart shows a graph of the results of a test for the selected QC material over the last 31 days. To view a Levey-Jennings Chart: 1 Touch the Results icon, and then select QC Results. The QC Results screen displays, showing a list of all QC materials (see Figure 7.40). You can display QC Materials that were saved automatically or manually (see “Viewing QC Results That Were Saved Automatically or Manually” on page 7.49). Figure 7.42 7.56 2 Touch any of the QC materials listed on the left side of the screen to display the test results for that QC material (see Figure 7.41 for an example of a QC Material from the automatically saved results). 3 Touch any line on the QC Sample Results screen to display a Levey-Jennings Chart for that selected test (see Figure 7.42). Levey-Jennings Chart for QC E a s y R A O P E R A T O R ’ S M A N U A L The Levey-Jennings Chart shows lines for +/- 2 Standard Deviations and the Mean. The full range of the Levey-Jennings Chart is +/- 4 Standard Deviations. Up to five points may be illustrated for each day on the Levey-Jennings Chart. The Levey-Jennings Chart also shows a Delete column for each result. If you check the Delete box for a result, then touch the Delete button, the Levey-Jennings data will be recalculated (without the selected result). An updated Levey-Jennings chart displays. This re-calculation can only be performed by a Supervisor using a password. If you check the Delete box, then touch the Delete button, the Levey-Jennings data will be deleted. Records should be kept indicating the reason for deleting any QC data. 4 To close the Levey-Jennings Chart, touch the Close button in the upper right corner of the chart: 7.57 V I E W I N G R E S U L T S Viewing a Levey-Jennings Chart for Transitional QC When a QC material is programmed with a Transitional Condition, the following chart displays (see Figure 7.43). Figure 7.43 Levey-Jennings Chart for a Transitional Condition If programming a QC material for the first time, Transitional is the default condition. The high limit and low limit are displayed for each test. Results are plotted on the graph. The Running Statistics show the actual, current QC performance of the test including the actual Mean, SD, CV% and the N (number of results used in the calculation). By default, the Data Range shows the last 31 days of data. You can also choose to view any month’s data by selecting Monthly from the Date Range drop-down and entering a Month and Year. Figure 7.44 shows an example of one month’s data. Notice that in addition to the Totals for the Running Statistics, the totals for the month are also displayed in the lower left side of the screen. 7.58 E a s y R A Figure 7.44 O P E R A T O R ’ S M A N U A L Levey-Jennings Chart for a Transitional Condition for a Selected Month Running Statistics may also be used when changing a QC Material from Transition to Active. For more information on modifying a QC Material, see “Changing the Condition of QC Materials” on page 4.80. 7.59 V I E W I N G R E S U L T S Viewing a Levey-Jennings Chart for Active QC When QC material is programmed with an Active Condition, a Levey-Jennings Chart displays (see Figure 7.45). Figure 7.45 Levey-Jennings Chart for an Active Condition The chart shows lines for the Mean and SD limits (+/- 2, 2.5, or 3) programmed by the user. 7.60 For more information on Active QC Material, see “Changing the Condition of QC Materials” on page 4.80. E a s y R A O P E R A T O R ’ S M A N U A L Viewing Qualitative QC Results To view qualitative QC Results, you first select the QC material of interest that has been saved automatically or manually (see “Viewing QC Results That Were Saved Automatically or Manually” on page 7.49), then you can view the results of each test on that QC material. The QC materials are listed in alphabetical order. For each QC material, QC Results are sorted by test type. Qualitative QC Results display the following information: Test Name. Number of Tests Performed (N). Number of Positive Results (N of Positive). Number of Negative Results (N of Negative). There is no Levey-Jennings Chart for qualitative testing on QC materials; however you can view additional detail for each test. The details shows Positive and Negative results for each test. To view qualitative QC Results: 1 Touch the Results icon, and then select QC Results. The QC Results screen displays, showing a list of all QC materials (see Figure 7.46). You can display QC Materials that were saved automatically or manually (see “Viewing QC Results That Were Saved Automatically or Manually” on page 7.49). Figure 7.46 QC Materials 7.61 V I E W I N G R E S U L T S 2 Touch one of the QC materials to display the QC Results for that material (see Figure 7.47). Figure 7.47 QC Sample Results You can scroll through the results to view QC Results that are not visible. From the QC Samples Results, you can: View and print detailed results. For more information on viewing detailed results, see “Viewing Detailed Qualitative QC Results” on page 7.62. Print QC Results. A table similar to the QC Sample Results screen is printed. For more information, see “Printing All QC Results for a Selected QC Material” on page 7.77. Viewing Detailed Qualitative QC Results The detailed results for any qualitative QC test can be viewed by touching any line of data in the QC results (for example, if you selected the line of data displayed in Figure 7.47, the detailed results shown in Figure 7.48 for the AMP test would be displayed). This detailed results screen also indicates if the results were expected to be +Pos or -Neg (below the test name). 7.62 E a s y R A Figure 7.48 O P E R A T O R ’ S M A N U A L Detailed Results for Qualitative QC Tests To view detailed QC Results for Qualitative tests: 1 Touch the Results icon, and then select QC Results. The QC Results screen displays, showing a list of all QC materials (see Figure 7.46). You can display QC Materials that were saved automatically or manually (see “Viewing QC Results That Were Saved Automatically or Manually” on page 7.49). 2 Touch any of the QC materials listed on the left side of the screen to display the test results for that QC material (see Figure 7.47). 3 Touch any line on the QC Sample Results screen to display detailed results for that selected test (see Figure 7.48). 7.63 V I E W I N G R E S U L T S Printing Test Results You can print results from the Current Results, Last Results, Patient Sample Results, Calibration Results, and QC Results screens. Before you can print, verify that the printer has been set up. EasyRA has an option that allows you to specify the name of the operator who prints (or accepts) results. If an Operator ID is entered, it will appear on the printed results. For more information on setting up the Operator ID option, see “Selecting the Operator ID Option” on page 2.69. For more information on using the Operator ID option, see “Entering the Operator ID” on page 7.28. All printed reports will have a header including the name and address of the laboratory performing the tests, if that information was entered during System Setup. Printing from Current And Last Results Screens You can print the following from Current or Last Results: All Sample Results. All Patient Reports. Calibrator Reports. All QC Reports. The printed results (data) contain the same information regardless of whether you select them from Current or Last Results. 7.64 E a s y R A O P E R A T O R ’ S M A N U A L Printing All Sample Results from Current or Last Results When you print all sample results from the Current or Last Results screens, a table similar to the Current or Last Results screens is printed. For each test, the following information is printed: Stat. Position in Sample Ring. Test Type. Sample ID. Test Name. Results. Units. Flag. Rerun. Completion Time. Status. To print All Sample Results from the Current or Last Results screen: 1 From either the Current or Last Results screen, touch the Print button: The Print dialog displays (see Figure 7.49). Figure 7.49 Print Dialog Box 7.65 V I E W I N G R E S U L T S 2 Touch All Sample Results and touch OK. 3 If the Operator ID option has been turned on, EasyRA prompts you to enter an Operator ID before you can print results. Enter your Operator ID and touch Enter on the Alphanumeric Keypad, or touch Skip. For more information on the Operator ID option, see “Entering the Operator ID” on page 7.28. The All Sample Results Report prints. (See Figure 7.50 for an example of the All Sample Results that are printed.) Figure 7.50 7.66 All Sample Results E a s y R A O P E R A T O R ’ S M A N U A L Printing All Patient Reports from Current or Last Results When you print all patient reports from the Current or Last Results screen, EasyRA prints one Patient Report for each sample. Each page includes the following information for each sample: Patient demographics (if they were entered during Setup or when the Worklist was created): Patient Name. Patient ID. Date of Birth. Sex. Physician. Information about the sample: Sample ID. Sample Type. Completion Time. Operator ID (if it was entered). A table of results for all tests run on the sample. The table includes: Test Name. Result. Units. Ranges. Comments. To print All Patient Reports from the Current or Last Results screen: 1 From either the Current or Last Results screen, touch the Print button: The Print dialog box displays (see Figure 7.49). 2 Touch All Patient Reports and touch OK. 3 If the Operator ID option has been turned on, EasyRA prompts you to enter an Operator ID before you can print results. Enter your Operator ID and touch Enter on the Alphanumeric Keypad, or touch Skip. For more information on the Operator ID option, see “Entering the Operator ID” on page 7.28. 7.67 V I E W I N G R E S U L T S One Patient Report prints for each sample in the run. See Figure 7.51 for an example of one page from the All Patients Report that is printed. Figure 7.51 7.68 One Page of the All Patients Report E a s y R A O P E R A T O R ’ S M A N U A L Printing All Calibrator Reports from Current or Last Results When you print all calibrator reports from the Current or Last Results screens, EasyRA prints a report that contains one page of results for each calibrator. Each page includes the following information for each calibrator. Information about the sample: Sample ID (Lot # of the calibrator). Sample Type (Calibrator). Completion Time. Operator ID (if it was entered). A table of results for all tests run on the sample. The table includes: Test Name. Result. Units. Ranges (Not used). Comments. To print Calibrator Reports from the Current or Last Results screen: 1 From either the Current or Last Results screen, touch the Print button: The Print dialog box displays (see Figure 7.49). 2 Touch Calibrator Reports and touch OK. 3 If the Operator ID option has been turned on, EasyRA prompts you to enter an Operator ID before you can print results. Enter your Operator ID and touch Enter on the Alphanumeric Keypad, or touch Skip. For more information on the Operator ID option, see “Entering the Operator ID” on page 7.28. 7.69 V I E W I N G R E S U L T S One page of results prints for each calibrator in the run. See Figure 7.52 for an example of one page from the Calibrator Report that is printed. Figure 7.52 One Page of the Calibrator Report Printing All QC Reports from Current or Last Results When you print all QC reports from the Current or Last Results screens, EasyRA prints one QC Report for each sample. Each page includes the following information for each QC sample: 7.70 Information about the sample: Sample ID (Lot # of QC). Sample Type (QC). Completion Time. Operator ID (if it was entered). A table of results for all tests run on the sample. The table includes: Test Name. Result. Units. Ranges (QC Ranges). Comments. E a s y R A O P E R A T O R ’ S M A N U A L To print all QC Reports from the Current or Last Results screen: 1 From either the Current or Last Results screen, touch the Print button: The Print dialog box displays (see Figure 7.49). 2 Touch All QC Reports and touch OK. 3 If the Operator ID option has been turned on, EasyRA prompts you to enter an Operator ID before you can print results. Enter your Operator ID and touch Enter on the Alphanumeric Keypad, or touch Skip. For more information on the Operator ID option, see “Entering the Operator ID” on page 7.28. One page of results prints for each QC material in the run. See Figure 7.53 for an example of one page from the All QC Report that is printed. Figure 7.53 One Page of the All QC Report 7.71 V I E W I N G R E S U L T S Printing from the Sample Details Screen You can print a one page report from the Sample Details screen that shows the results for the selected sample. To print Sample Details from the Sample Details screen: 1 Access the Sample Details screen by touching the Sample Details icon from the Current or Last Results and navigate to the sample for which you want to print results. For more information, see “Viewing Sample Details” on page 7.20. Touch the Print button on the Sample Details window: A one page report prints, showing the Sample Details for the selected sample. See Figure 7.51 for an example of the Sample Details that is printed. Printing from the Patient Results Screen From the Patient Results screen, you can print the following: All Sample Results from a selected run. All Sample Results for a selected patient from all EasyRA runs that have been performed. Printing All Sample Results for a Selected Run When you print All Sample Results for a selected run, a table similar to the Patient Sample Results screen is printed. The table includes the following: 7.72 Name of Run (title) The format of the run name is “Date of Run_ Run Number.” An example of the name of Run #2 that was performed on May 5, 2006 is: 5/15/2006_2.) Sample ID/Lot. Test Name. Result. Units. Flag. Completion Time. Patient ID. E a s y R A O P E R A T O R ’ S M A N U A L To print All Sample Results for a selected run: 1 From the Patient Sample Results screen, touch the test run of interest in the Worklist Run Summary list on the left side of the screen. The results for the selected run are displayed on the Patient Sample Results screen. 2 Touch the Print button to print all sample results from a selected run: The All Patients Results of the Run report prints. See Figure 7.54 for an example of the All Patient Results that are printed. Figure 7.54 Results for A Selected Run 7.73 V I E W I N G R E S U L T S Printing All Sample Results for a Selected Patient (from all EasyRA Runs) When you view patient results, EasyRA allows you to search for a selected patient and view and print results of all tests that have been run on that patient over ALL EasyRA runs. For the selected patient, this report includes the following information: “Stored Runs” (title). This designator indicates that the results are for one patient over ALL EasyRA runs, rather than for a particular run. Sample ID/Lot. Test Name. Result. Units. Flag. Completion time. Patient ID. To print All Sample Results for a selected patient over all EasyRA runs: 1 From the Patient Sample Results screen, touch the Find Patient ID box. Search for a selected Patient ID and sort the results as desired (by Date/Time, Sample ID, or Test) as described in “Displaying Results for a Particular Patient” on page 7.37. The results for the selected patient are displayed. 2 Touch the Print button to print all sample results for a selected patient (from all EasyRA runs). The All Patients Results of the Run report prints. The designator at the top of the report indicates the results are from “Stored Runs,” rather than a particular run. See Figure 7.55 for an example of the All Patient Results that is printed. 7.74 E a s y R A Figure 7.55 O P E R A T O R ’ S M A N U A L Results for A Selected Patient Over All EasyRA Runs Printing from the Calibration Results Screen When you print All Current Calibration from the Calibration Results screen, a table similar to the Calibration Results screen is printed. For each test, the results include the following information: Test Name. Reagent Lot Number. Last Calibration Factor. Calibration Factor. Time and Date of Next Calibration. Status. To print from the Calibration Results screen: 1 From the Calibration Results screen, touch the Print button: 7.75 V I E W I N G R E S U L T S A Calibration Results Report prints. See Figure 7.56 for an example of the Calibration Results Report that is printed. Figure 7.56 7.76 Calibration Results Report E a s y R A O P E R A T O R ’ S M A N U A L Printing from the QC Results Screen From the QC Results screen, you can print the following: A QC Material Results Summary for a selected QC material. Levey-Jennings Chart for a selected test using that QC material. Printing All QC Results for a Selected QC Material When you print all QC Results for a selected QC material from the QC Results screen, a table similar to the QC Samples Results screen is printed. For the selected QC material, quantitative results include the following information: Name of Material (title). Test Name. Mean. Standard Deviation. Units. CV. N. Low Limit. High Limit. For the selected QC material, qualitative results include the following information: Name of Material (title). Test Name. Number of Tests Performed (N). Number of Positive Results (N of Positive). Number of Negative Results (N of Negative). To print the QC Results for the selected QC material: 1 From the QC Samples Results screen, touch the QC material of interest from the QC materials listed on the left side of the screen. A list of all QC Results for the selected QC material displays. 2 Touch the Print button: 7.77 V I E W I N G R E S U L T S The QC Materials Results Summary report prints showing results for all tests on the selected QC material. See Figure 7.57 for an example of the QC Material Results Summary for quantitative tests that is printed. You can print a Levey-Jennings Chart for quantitative QC results and a detailed results chart for qualitative QC results. Figure 7.57 QC Material Results Summary Printing a Levey-Jennings Chart from the QC Results Screen You can print a Levey-Jennings Chart from the QC Results screen for quantitative results. This chart shows the results of a particular test on a selected QC material over the last 31 days. To print a Levey-Jennings Chart from the QC Results screen. 1 View the Levey-Jennings Chart from the QC Results screen. 2 7.78 For more information, see “Viewing A Levey-Jennings Chart for Quantitative QC” on page 7.56. Touch Print on the Levey-Jennings Chart: E a s y R A O P E R A T O R ’ S M A N U A L The Levey-Jennings Chart for the selected test is printed (see Figure 7.58). The Levey-Jennings Chart shows a plot of data for the last 30 days. The table below the chart shows QC history, including data prior to the last 30 days. You may view all data, but you can only print the data for the last 30 days. Figure 7.58 Levey-Jennings Chart 7.79 V I E W I N G R E S U L T S Printing a Detailed QC Results Screen for Qualitative Tests You can print a detailed QC Results screen for qualitative tests. This chart shows the results of a particular test (number of positive results and number of negative results for the test. To print a Detailed QC Results screen for Qualitative Tests: 1 View the detailed results for any qualitative test. 2 For more information, see “Viewing Detailed Qualitative QC Results” on page 7.62. Touch Print on the screen: The QC Results Detail chart for the selected test is printed (see Figure 7.59). Figure 7.59 7.80 Detailed Results for Qualitative QC Testing E a s y R A O P E R A T O R ’ S M A N U A L Results Flags This section provides additional details on the Results Flag codes that may appear on the Results screens. For more information on where these codes display, see Table 7.1 on page 7.5. Viewing the Legend of Flag Codes Figure 7.60 shows a legend of the Results Flag codes that you can view at any time. To view the legend, touch the Flag icon on the Results screen: Figure 7.60 Legend of Results Flag Codes 7.81 V I E W I N G R E S U L T S Details of Results Flag Codes Table 7.3 and Table 7.4 list the codes that may be displayed in the Results Flag field. Codes appear in the Flags field on the Results screens if any of the conditions described in the tables occur. If results are not displayed, an error message (-E-) will be displayed in the Results column. (ISE Calibration flags are shown on the ISE Calibration screen that can be accessed from the Worklist menu.) Table 7.3 CODE Range Error Flag Descriptions NAME DESCRIPTION CALIBRATION RANGE ERRORS CD Calibration Deviation One or more of the calibration results deviate more than a preset percentage from the Mean Value, as defined on the RFID chip. Calibration results are shown, but sample testing is not allowed. Calibration fails. CF Calibration Factor Range Calibration Factor result is outside the allowable range, as defined on the RFID chip. Calibration results are shown, but sample testing is not allowed. Calibration fails. BA Blank Absorbance Results exceed absorbance limits, as defined on the RFID chip. Calibration results are shown, but sample testing is not allowed. Calibration fails. SR Calibration Slope Range Slopes are outside the listed ranges of each of the electrodes: Analyte Li+ + Lower Slope Limit Upper Slope Limit 47 mV/Dec 64 mV/Dec 52 mV/Dec 64 mV/Dec K+ 52 mV/Dec 64 mV/Dec Cl- 40 mV/Dec 55 mV/Dec Na Calibration results are shown, but sample testing is not allowed. 7.82 E a s y R A Table 7.3 CODE O P E R A T O R ’ S M A N U A L Range Error Flag Descriptions NAME DESCRIPTION QC RANGE ERRORS QC QC Confidence Range QC material is outside the confidence interval for a particular test. User defines the range from the Setup menu. SAMPLE RANGE ERRORS NR Outside Normal Range Test result is outside the normal range for a particular test. User defines the ranges from the Setup menu. Results are highlighted in gold/yellow. CR Outside Critical Range Test result is outside the critical range for a particular test. User defines the ranges in the Setup menu. Results are highlighted in Red. RR Outside Re-run Range Test result is outside the re-run range for a particular test. User defines re-run ranges in the Setup menu. Rerun check box is checked automatically. Table 7.4 CODE Measurement Error Flag Descriptions NAME DESCRIPTION CALIBRATION, QC, AND SAMPLE ERRORS SD Substrate Depletion (System) The software looks at the absorbance of the very first point (from the First Absorbance Limit RFID parameter), as well as the difference between the first two absorbance points. If this point is below the first point limit (for down reactions) or above the first point limit (for up reactions), this flag is issued. If the limit is not exceeded, the software then looks at the difference between the first two absorbance points. If this is greater than a pre-set value, this flag is issued and no enzyme activity results are calculated for the sample. The Rerun check box is automatically checked and results are not shown. 7.83 V I E W I N G Table 7.4 CODE R E S U L T S Measurement Error Flag Descriptions NAME DESCRIPTION QC AND SAMPLE ERRORS LL Outside Low Linear Test Range Limit (System) Results are below the low linearity claim with “Normal Dilution,” as defined on the RFID chip. Results are not shown. LH Outside High Linear Test Range Limit (System) Results exceed the high linearity claim with “Normal Dilution,” as defined on the RFID chip. Tests are automatically checked for Rerun. One half to one third of the normal sample volume is aspirated during sampling to effectively extend the Linear Range. Results are not shown. CALIBRATION, QC, AND SAMPLE RD Reaction Direction Incorrect reaction direction on the RFID chip. Results are shown. HN High Reactions Rate Noise (System) Two or more points are 0.003 Abs. away from the line of best fit. Results are not shown. RN Reaction Rate Noise (System) One point is more than 0.003 Abs. units away from the line of best fit. Point is eliminated from calculations. Results are shown. EN End Point Noise (System) Two primary wavelength end point absorbance measurements differ by more than 1% or 0.002 Abs. units, whichever is larger. Results are shown. HA High Absorbance (System) Absorbance greater than 2.5 Abs. units. Results are shown. CALIBRATION DS Slope Drift (ISE) The calibration slope for each sensor changed by more than a proscribed amount for back to back calibrations. Calibration fails. CC 7.84 Calibration Curve Direction The curve for multi-level calibrations is going in the opposite direction than was expected. For example, if the curve was supposed to be ascending and it is descending and vice versa. E a s y R A Table 7.4 O P E R A T O R ’ S M A N U A L Measurement Error Flag Descriptions CODE NAME DESCRIPTION CALIBRATION, QC, AND SAMPLES MV Cal A/Cal B Out of mV Range Cal A or Cal B mV are out of the preset range of 0-250 mV. The liquid level sensor failed to detect a sample. Analyte Cal A Range Cal B Range + Na 80-170 mV 60-150 mV K+ 80-170 mV 60-150 mV Cl- 40-110 mV 60-130 mV Li+ 85-155 mV 45-140 mV Test results are shown. AA Air in Cal A Air bubble detected in Cal A. Test results are shown. AB AD Air in Cal B (Urine, QC, and Samples only) Air bubble detected in Cal B. Cal A mV Drift Two subsequent Cal A measurements differ by more than a specified value. Test results are shown. Test results are shown. AN Cal A mV Noise Multiple readings for a single Cal A measurement differ from the mean by a larger than acceptable value > 0.7 mV away from a mean detected during a test. Test results are shown. BN Cal B mV Noise (Urine, QC, and Samples only) Multiple readings for a single Cal B measurement differ from the mean by a larger than acceptable value > 0.7 mV away from a mean detected during a test. Test results are shown. QC AND SAMPLES AS Air in Sample Air bubble detected in Sample slug. System Error or Ended by User These errors involve hardware/software errors not associated with measurements. This code is also shown when the run has been ended by the user. (ISE) System Error Hardware or system error in the ISE Module during sample analysis. SYSTEM ERROR SE ISE IE 7.85 V I E W I N G Table 7.4 R E S U L T S Measurement Error Flag Descriptions CODE NAME DESCRIPTION NF (ISE) No Fluid Flow Indicates that the ISE Module was not able to detect fluid of any kind. SN Sample Noise Indicates that the measurement of ISE sample was outside the specified noise limits. 7.86 E a s y R A O P E R A T O R ’ S M A N U A L Sending Results to the LIS from the Sample Details In earlier versions of EasyRA, you could manually resend the results of tests that were requested by the LIS back to the LIS. This was useful in the event that the test results were not received by the LIS when the results were originally generated. In the current version of EasyRA, you can manually send (or resend) the results of any test (whether it was requested via the LIS or on EasyRA) to the LIS. Results can be sent to the LIS if the LIS option is enabled AND the results are stored in Current Results, Last Results, or Patient Results. Results can only be sent for one sample at a time. To send (or resend) results to the LIS: 1 From Current Results, Last Results, or Patient Results, touch the Sample Details icon. The Sample Details for the selected sample displays (see Figure 7.61). Figure 7.61 2 Sample Details for the Selected Sample Touch the Send to LIS icon at the top of the screen. All test results for the selected sample are transmitted to the LIS. 7.87 V I E W I N G 7.88 R E S U L T S 8 Monitoring Status Introduction This chapter describes how to use the Status menu to view the status of the current run and how to view the status of various EasyRA components. If any events that may require your attention occur after you perform an inventory for a particular Worklist, the Status icon blinks to notify you. You should review Worklist Warnings from the Status menu for more information. You can perform the following tasks from the Status menu (see Figure 8.1): Figure 8.1 Status Menu 8.1 M O N I T O R I N G S T A T U S View Worklist Warnings. View all events associated with the current EasyRA run. View Reagent Status. View detailed status of Reagents. View QC Status. View detailed status of QC. View Cuvette Status. View detailed status of Cuvettes. View ISE Status. View detailed status of the ISE Module and ISE calibrations. View Inventory Report. View a detailed report on Reagents, calibration, and QC. View Sample Inventory. View a detailed report on samples. (This view is only available if you have the LIS Connectivity option with a Barcode Reader.) View Cleaning Status. View detailed status of daily and ISE cleaners and cleaning cycles. If you do not have the ISE Module option, ISE displays in gray rather than black. 8.2 E a s y R A O P E R A T O R ’ S M A N U A L Viewing Worklist Warnings EasyRA provides a summary of warnings associated with a particular run under the Status menu. When an event occurs that may require your attention (and prevents one or more tests from running), the Status icon blinks. It is recommended that you view Worklist Warnings if the Status icon is blinking. To view warnings: Touch the Status icon, and then touch Worklist Warnings. You can view Worklist Warnings at any time; however, if the Status icon is blinking, it is recommended that you view Worklist Warnings to assess any problems that may have occurred. The Worklist Warnings screen shows the status for this run. If the Status icon is blinking, you can correct the problems indicated on this screen and perform another inventory (which may resolve the issues that caused the icon to blink), or you can start the run. If you choose to start the run, the Status icon will continue to blink until the run is completed and the results have been accepted. Figure 8.2 shows an example of the Worklist Warnings screen. Figure 8.2 Worklist Warnings Screen 8.3 M O N I T O R I N G S T A T U S This screen shows a table of warnings with one warning or event per line (listed by test). It also shows a graphic representation of the Sample Ring/Reagent Tray and the status of the samples and Reagents on EasyRA. When events are displayed on the Worklist Warnings screen, they indicate that there is a problem with one or more tests in the current Worklist. These problems may prevent some or all of the tests on the Worklist from being run. It is recommended that you view Worklist Warnings to determine the nature of the problems before continuing. If EasyRA determines that no tests in the Worklist can be run, the Run button does not appear after the inventory is performed. However, if EasyRA is able to run at least one test, the Run button appears and you can choose to ignore some or all of the warnings and continue with the run. If Auto Run After Inventory is enabled, the run will start automatically. Any tests that could not be run, as indicated in the Worklist Warnings screen, are moved from the Worklist to the Pending List, where they are saved. When problems are corrected, the tests can be moved from the Pending List back to a Worklist and run. 8.4 For more information on the Pending List, see “Viewing the Pending List” on page 6.58 and “Moving Tests from the Pending List to the Worklist” on page 6.59. E a s y R A O P E R A T O R ’ S M A N U A L Table 8.1 shows a list of the warnings that may be displayed in the Worklist Warnings screen and possible actions you can take to correct the problems. Warnings are displayed by test and position. Table 8.1 AREA Summary of EasyRA Worklist Warnings PROBLEM EXPLANATION AND POSSIBLE ACTION DESCRIPTION Reagents Reagent Not On Board The Reagent required for this test is not loaded on EasyRA. Reagent Expired The Reagent has expired and is no longer usable. Insufficient Reagent There is not enough Reagent available to complete the current run. To run the test, load the new Reagent and perform an inventory before continuing. To run the test, load the new Reagent and perform an inventory before continuing. Continue with the current Reagent Wedge and perform only those tests that can be performed. OR Load the new Reagent and perform an inventory before continuing. No Reagents On Board There are no Reagents loaded on EasyRA. Reagent Pack Expired The ISE Reagent Pack has expired and is no longer usable. Reagent Pack Empty The ISE Reagent Pack is empty and will need to be changed prior to performing tests. To run tests, load the necessary Reagents and perform an inventory before continuing. To run the test, load the new ISE Reagent Pack and perform an inventory before continuing. Load a new ISE Reagent Pack and perform an inventory before continuing. Reagent Pack Not Installed During inventory, Easy RA did not detect that an ISE Reagent Pack was installed. If an ISE Reagent Pack is currently installed, remove the ISE Reagent Connector and reconnect it. Perform and inventory before continuing. OR If no ISE Reagent Pack has been installed, load a new ISE Reagent Pack and perform an inventory before continuing. Reagent Pack Invalid ISE Reagent Pack Distributor Code does not match the EasyRA Distributor Code. Contact your Medica dealer. 8.5 M O N I T O R I N G Table 8.1 S T A T U S Summary of EasyRA Worklist Warnings AREA PROBLEM EXPLANATION AND POSSIBLE ACTION DESCRIPTION Reagents (continued) Check Reagent Reagent error occurred during the run. Sample Check Sample Sample error occurred during the run. Cleaner Cleaning Required A cleaning cycle (Probe, ISE, or both) must be performed prior to running tests. Perform necessary cleaning cycles and when complete, perform an inventory before continuing. Calibration Not Calibrated A calibration is required prior to performing this test. Cal Expired The calibration for this test has expired. Set up the required calibration in the Worklist and perform an inventory before continuing. Set up the required calibration and perform an inventory before continuing. Cal Factor The Calibration Factor result for the last calibration performed on this test was outside of the allowable range, as defined on the RFID chip. A calibration will be needed prior to running tests. Setup the required calibration in the Worklist and perform an inventory before continuing. Blank Absorbance The result of the last calibration performed on this test exceeded the absorbance limits as defined on the RFID chip. A calibration will be needed prior to running tests. Set up the required calibration in the Worklist and perform an inventory before continuing. 8.6 E a s y R A O P E R A T O R ’ S M A N U A L Viewing Reagent Status You can view a detailed status of the Reagents currently loaded on EasyRA. To view Reagent status: Touch the Status icon, and then touch Reagents. The Reagent Status screen displays as shown in Figure 8.3. Figure 8.3 Reagent Status 8.7 M O N I T O R I N G S T A T U S This screen shows a table of Reagents that were loaded when the last inventory was run. The table contains one line for each Reagent that was loaded, with the following information: Position (1-24). Test Name (This field will be blank if there is no wedge in the position. Also, this field may be blank if the Reagent is the second wedge in a Three Reagent System, or it might be blank if the system is unable to read the RFID chip on the wedge or if there is a problem with the wedge. If there is a wedge in the position and it is blank, refer to the last column of the table, Status, for more information. Reagent Lot Number. Number of Tests Left. Expiration Date. Status Possible values for Reagent Status are: Reagent OK Reagent Expired - Reagent use life was exceeded. Empty - Reagent test count limit was reached. Unknown - Reagent was not recognized. Unknown Pair - Linked reagent was not recognized. Unknown Level - Unable to record usage back to reagent. Distributor Code - Distributor code does not match instrument. Mismatched Parameters - Critical parameters do not match details stored for an open system reagent. No 660 Filter - Reagent calls for wavelength measurement that was not available in the instrument. RFID Read Error - Unable to complete the read of reagent data. RFID Lock Error - Unable to lock reagent data. Figure 8.3 also shows a graphic representation of the Reagent Tray indicating the position, name, and level of each Reagent. If the Reagent bottle is filled with green, it is full. If it is only partially filled with green, the filled portion indicates the percentage of Reagent left in the bottle. If the Reagent bottle is shaded in gray, the Reagent has an unknown level of Reagent. This can be caused by an RFID Write Error. The analyzer will allow you to continue using the wedge, however, the level of Reagent must be manually tracked. 8.8 E a s y R A O P E R A T O R ’ S M A N U A L The Three Reagent System is represented on the Reagent Tray as two wedges with a Lock icon between them to indicate they are part of a pair. The bottle to the right displays the name of the reagent and the bottle to the left shows only the volume of the reagent, not the name. The name is not shown because that bottle is “locked” to the Reagent to its right as part of a Three Reagent System (see positions 4 and 5 in Figure 8.3). If a Reagent bottle is outlined in gray and contains the word, “Unknown” it is an unknown reagent (a reagent wedge is located in the position, but the system cannot determine what it is). If a Reagent bottle is outlined in gray and contains the words “Unknown Pair”, it is one of the two wedges used to make up a Three Reagent System, but there is a problem associated with the pair of wedges (see positions 5 and 22 in Figure 8.4). Figure 8.4 Unknown Pair on Reagent Status Screen 8.9 M O N I T O R I N G S T A T U S The problem may include: Both wedges for the Three Reagent System are on the Reagent Tray, but they are not in the correct positions. The two wedges in the Three Reagent System must be located in consecutive positions with the single wedge in the lower numbered position and the dual wedge in the higher numbered position, unless they are located in positions 1 and 24. In that case, the dual wedge is located in position 1 (lower numbered position) and the single wedge is located in position 24 (higher numbered position). One of the two wedges in the Three Reagent System is missing. If you observe the status as the inventory is being performed, it is possible that a wedge will first display a Test Name and then change to “Unknown Pair” if the system does not find the other wedge for the Three Reagent System in the correct position on the tray. The text color indicates the status of the Reagent Wedge: Black: Standard/Default Red: Reagent or Calibration Expired Yellow: 2 days or 10 tests remaining Performing an Inventory from the Reagent Status Screen You can perform a Reagent inventory from the Reagents Status screen to get an up-to-date status of Reagents. Note: A Sample Ring must be installed on EasyRA before you start the inventory. Note: The Sample/Reagent Area Cover should be closed before you perform the inventory. To perform a Reagent inventory from the Reagent Status screen: Touch the perform Reagent Inventory button: The status screen is cleared and filled in as the Reagent inventory is performed. 8.10 E a s y R A O P E R A T O R ’ S M A N U A L Viewing Calibration Status You can view a detailed status of the calibrations that have been performed on EasyRA. If calibrations for a test have not been run or have expired, those tests cannot be run. To view calibration test status: Touch the Status icon, and then touch Calibration. The Calibration Status screen displays as shown in Figure 8.5. Figure 8.5 Calibration Status 8.11 M O N I T O R I N G S T A T U S This screen shows a table of Reagents that are loaded and the calibration status for each Reagent. The table contains one line for each Reagent position, with the following information: Position (1-24). Test Name. Reagent Lot Number. Date of Last Calibration. Date when Next Calibration is Required. Calibration Status - Limits are set for slope, Reagent response, and maximum time between calibrations. If these limits are exceeded, this is indicated under Calibration Status. Possible values for Calibration Status include: Calibration OK Calibration Expired Not Calibrated Calibration Error Not Required The screen also shows a graphic representation of the Reagent Tray indicating the position, name, and level of each Reagent. If the Reagent bottle is filled with green, it is full. If it is only partially filled with green, the green portion indicates the percentage of Reagent left in the bottle. 8.12 E a s y R A O P E R A T O R ’ S M A N U A L Viewing QC Test Status You can view a detailed status of the quality control (QC) that has been performed on EasyRA. EasyRA does not require you to run QC; however it is strongly recommended that QC is run on a regular basis to ensure the quality of EasyRA results. To view QC test status: Touch the Status icon, and then touch QC. The QC Status screen displays as shown in Figure 8.6. Figure 8.6 QC Status 8.13 M O N I T O R I N G S T A T U S This screen shows a table of Reagents that are onboard and the QC status for each Reagent. The table contains one line for each Reagent position, with the following information: Position (1-24). Test Name. Reagent Lot Number. Date of Last QC. The screen also shows a graphic representation of the Reagent Tray indicating the position, name, and level of each Reagent. If the Reagent bottle is filled with green, it is full. If it is only partially filled with green, the filled portion indicates the percentage of Reagent left in the bottle. 8.14 E a s y R A O P E R A T O R ’ S M A N U A L Viewing Cuvette Status You can view detailed status of the Cuvettes available in the Reaction Area. The Reaction Area contains 6 segments of 12 Cuvettes each for a total of 72 Cuvettes. The status of a Cuvette may be OK or Used. It is good practice to check the Cuvette status before creating a new Worklist or starting a run. By verifying the Cuvette status, you can minimize the time a run is interrupted to replace Cuvettes. Note: If you have left used Cuvettes standing in EasyRA for a long period of time (more than 24 hours), the material in the Cuvettes may evaporate or dry up. When you perform a Cuvette inventory, it is possible that the residue on the used Cuvettes will not be detected and EasyRA will indicate the Cuvettes are clean and ready for use when they are actually used. If used Cuvettes are left on EasyRA for more than 24 hours, it is recommended that you manually inspect the Cuvettes before running an inventory. It is important to discard Cuvettes which are used, but which EasyRA recognizes as unused. To view Cuvette status: Touch the Status icon, and then touch Cuvettes. The Cuvette Status screen displays as shown in Figure 8.7. 8.15 M O N I T O R I N G Figure 8.7 S T A T U S Cuvette Status Segment A, Position 1 8.16 Segment A, Position 12 E a s y R A O P E R A T O R ’ S M A N U A L This screen shows the status of the Cuvettes in a table. Each Cuvette Segment (A-F) is listed across the horizontal axis of the table and the 12 Cuvettes in each segment are listed along the vertical axis. Cuvette status is reported as follows: OK - a Cuvette is in that position and is ready to use. Used - a Cuvette is in that position, but has been used or no Cuvette is present. The screen also shows a graphic representation of the Cuvette Carousel, indicating the status of Cuvettes using colors as follows: OK - White. Used/Empty - Green. Not inventoried - Gray. The numbering of the Cuvettes (1-12) within each segments should be read from left to right (counterclockwise), starting with the Cuvette in segment A located closest to the 6 o’clock position (see Figure 8.7). Performing an Inventory from the Cuvette Status Screen You can perform a Cuvette inventory from the Cuvette Status screen to get an up-to-date status of Cuvettes. Note: The Reaction Area Cover must be closed before you perform the inventory. To perform a Cuvette inventory from the Cuvette Status screen: Touch the Perform Cuvette Inventory button: The status screen is cleared and filled in as the Cuvette inventory is performed. 8.17 M O N I T O R I N G S T A T U S Viewing ISE Status You can view detailed ISE status from the Status menu. ISE status displays the status of the ISE Reagent Pack and the ISE electrodes. If you do not have the ISE Module option, ISE displays in gray rather than black. To view ISE status: Touch the Status icon, and then touch ISE. The ISE Status screen displays as shown in Figure 8.8. Figure 8.8 8.18 ISE Status E a s y R A O P E R A T O R ’ S M A N U A L This screen shows the overall status of the ISE Reagent Pack and the status of the ISE electrodes. The status is displayed in two tables and contains the following information: ISE Reagent Pack: Lot number of Reagent Pack. Size (number of mLs left in pack). Percentage of Cal A and Cal B Remaining. Status (Installed, Not Installed) Expiration Date. Installation Date. Status by Test (Na, K, Cl, Li): Slope (last calibration for each channel) Units (mVs/Decode) Time at which next ISE calibration is due. Comment - Reason why a channel is not in calibration (Drift, Noise, Limits). Performing an Inventory from the ISE Status Screen You can perform an ISE inventory from the ISE Status screen to get an up-to-date status of the ISE Reagent Pack and electrodes. Note: The Fluidics Drawer should be closed before you perform the inventory. To perform an ISE inventory: Touch the Perform ISE Inventory button: The status screen is cleared and filled in as the ISE inventory is performed. 8.19 M O N I T O R I N G S T A T U S Viewing Cleaning Status You can view the status of the Probe (daily) cleaner and the ISE cleaner from the Status menu. This status indicates both the status of the cleaner (how much is available) and the status of the cleaning (if cleaning is required). To view cleaning status Touch the Status icon, and then touch Cleaning. The Cleaning Status screen displays as shown in Figure 8.9. Figure 8.9 Cleaning Status This screen show the status of the Probe cleaner and the ISE cleaner. The status is displayed in two tables and contains the following information: 8.20 Date of Next Cleaning. Status (Cleaner Required...). Position of Cleaner Wedge on Sample Ring. Expiration Date of Cleaner Wedge. Installation Date of Cleaner Wedge. Use Life. Days Remaining. E a s y R A O P E R A T O R ’ S M A N U A L Performing an Inventory from the Cleaning Status Screen You can perform a cleaner inventory from the Cleaning Status screen to get an up-to-date status of cleaning and cleaners. Note: The Sample/Reagent Area Cover should be closed before you perform the inventory. To perform a cleaner inventory: Touch the Perform Cleaner Inventory button: The status screen is cleared and filled in as the Cleaner inventory is performed. 8.21 M O N I T O R I N G S T A T U S Viewing the Inventory Report You can view a detailed inventory report which shows the current status of the Reagents, calibrations, QC, cuvettes, and cleaning. It is recommended that you view the Inventory report before creating a new Worklist or starting a run to assess the status of EasyRA. To view an inventory report: Touch the Status icon, and then touch Inventory Report. The Inventory Report screen displays as shown in Figure 8.10. Figure 8.10 8.22 Inventory Report E a s y R A O P E R A T O R ’ S M A N U A L This screen shows a table of Reagents, calibrations, and QC by Reagent position. The table contains one line for each Reagent position, with the following information: Position (1-24). Test Name. Reagent Lot Number. Number of Tests Left. Number of Days Left. Status (Reagent OK, Reagent Expired, Empty, Not Calibrated, Unknown Level, RFID Read Error, RFID Write Error, RFID Lock Error) Date of Last Calibration. Date of Next Calibration. Calibration Status Possible values for Calibration Status include: Calibration OK Calibration Expired Not Calibrated Calibration Error Not Required Date of Last QC. This screen also shows additional tables for the following: Cleaning Status. Cuvette Status. ISE Reagent Pack Status. You can perform an inventory from the Inventory Report screen. This performs a full inventory of Reagents, Cuvettes, and samples (if you have the LIS Connectivity option with a Barcode Reader). 8.23 M O N I T O R I N G S T A T U S Performing an Inventory from the Inventory Report Screen Note: All EasyRA covers must be closed before you perform the inventory. To perform an inventory from the Inventory Report screen: Touch the Inventory All button: For more information on performing an inventory, see “Performing an Inventory” on page 6.32. This screen also lists ISE Reagent Pack information including: Lot Number. Percentage of Cal A/Cal B Left. Expiration Date: Installation Date. Size of Cal A/Cal B Reagent Volumes. Information on ISE Calibration status, cuvette status, and cleaning status is also shown. Printing an Inventory Report You can print the Inventory Report from the Inventory Report screen. Before printing the Inventory Report, verify that the printer has been connected to EasyRA and configured. For more information on setting up the printer, see “Connecting the Printer” on page 2.15. To print an inventory report: Touch the Print button A preview of the report to be printed displays and the report is printed. 8.24 E a s y R A O P E R A T O R ’ S M A N U A L Viewing Sample Inventory If you have the LIS Connectivity option with a Barcode Reader, you can view an inventory of the samples on the Sample Ring. If you do not have this option, this selection is not available. To view sample position status: Touch the Status icon, and then touch Sample Inventory. The Sample Inventory Report screen displays (see Figure 8.11). Figure 8.11 Sample Inventory Report This screen shows a table of samples that are loaded on EasyRA. The table contains one line for each sample position, with the following information: Position (1-24). Sample ID (the barcode read from the sample). The screen also shows a graphic representation of the Sample Ring and Reagent Tray indicating the position of each sample and the name and level of each Reagent. If a sample is located in the Sample Ring, it is indicated on the outer ring. If the Reagent bottle is filled with green, it is full. If it is only partially filled with green, the filled portion indicates the percentage of Reagent left in the bottle. 8.25 M O N I T O R I N G S T A T U S Performing an Inventory from the Sample Inventory Screen You can perform a sample inventory from the Sample Inventory screen to get an up-to-date status of samples. Note: The Sample/Reagent Area Cover should be closed before you perform the inventory. To perform a sample inventory: Touch the Inventory Samples button: The status screen is cleared and filled in as the sample inventory is performed. 8.26 9 Quality Assurance The goal of the clinical laboratory is to provide timely, accurate, diagnostic test information to facilitate patient care. This goal is realized when the laboratory addresses every activity in the lab and assures that quality is being managed in each. Quality Assurance Activities in the Laboratory A number of elements are required in the laboratory to assure the quality of test results. These include the following:1 Procedure Manual. A written procedure manual for all tests, assays, and examinations performed by the laboratory should be available to, and followed by, laboratory personnel. Test Systems (Equipment, Instruments, Reagents, Materials, and Supplies). Testing, using the EasyRA analyzer, Reagents and other consumables should be performed following Medica's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system. Establishment and verification of method performance specifications. For more information, see “External Quality Control – Proficiency Testing” on page 9.10. Equipment Maintenance and Function Checks. The laboratory should perform and document the following: Maintenance as defined by Medica and with at least the frequency specified by Medica. Function checks as defined by Medica and with at least the frequency specified by Medica. Function checks should be within Medica's established limits before patient testing is conducted. 1.Section §493.1200 of Subpart K, Quality Systems for Non-waived Testing (CLIA). 9.1 Q U A L I T Y A S S U R A N C E Calibration and Calibration Verification Procedures. For more information, see Chapter 4, “Setting Up Test Configurations,” Chapter 6, “Setting Up and Running Tests,” and Chapter 7, “Viewing Results.” Quality Control Procedures. The laboratory is responsible for having control procedures, for each test system. These procedures monitor the accuracy and precision of the complete analytical process. Comparison of Test Results. If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory should have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. The laboratory should have a system to identify and assess patient test results that appear inconsistent with the following relevant criteria, when available: For more information, see Chapter 4, “Setting Up Test Configurations,” Chapter 6, “Setting Up and Running Tests,” and Chapter 7, “Viewing Results.” 1 Patient age. 2 Sex. 3 Diagnosis or pertinent clinical data. 4 Distribution of patient test results. 5 Relationship with other test parameters. The laboratory should document all test result comparison activities. Corrective Actions. Corrective action policies and procedures should be available and followed as necessary to maintain the laboratory's operation for testing patient specimens in a manner that ensures accurate and reliable patient test results and reports. 9.2 E a s y R A O P E R A T O R ’ S M A N U A L Test Records. The laboratory should maintain an information or record system that includes the following: The positive identification of the specimen. The date and time of specimen receipt into the laboratory. The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). Analytical Systems Assessment. The laboratory should establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified while operating the EasyRA. Additionally, particular attention should be given to the following other activities. Correct Sample Handling Procedures. Use of Reagents, Calibrators, Quality Control material and consumables that have been qualified and recommended by Medica Corporation. Rigorous adherence to preventive maintenance procedures as described in Chapter 10, “Performing Maintenance.” Initial training and continued education of all laboratory personnel who operate the EasyRA. 9.3 Q U A L I T Y A S S U R A N C E The Purpose of Quality Control Control procedures are an important part of the laboratory’s Quality Assurance program. The purposes of a Quality Control Program are to: Assure Accuracy. Establishing laboratory system accuracy is done by comparing daily quality control values to assayed values for the QC material being used or by comparing daily quality control values to values obtained by other methods. Assure Precision. Physicians want to know what variation in day to day results are due to inherent variation of the analyzer and what variation is due to the patient. Performing daily QC quantifies the inherent variation of the analyzer and assures that there are no significant changes in the inherent analyzer variation. Quality Control is performed in the laboratory through the use of both Internal and External Quality Control Programs. 9.4 E a s y R A O P E R A T O R ’ S M A N U A L Internal Laboratory Quality Control Program Internal laboratory QC programs use three major tools to assure the accuracy and precision of patient test results. These include: QC Material. Quality Control Charts/Statistics. Rules for deciding whether the diagnostic analyzer, the EasyRA, is “in control” and thereby reporting valid, reliable patient test results. QC Material Quality Control material should emulate patient samples as much as possible. For this reason QC materials are usually human-based serum containing most, if not all, of the analytes which are measured by the analyzer. The material may be assayed, with assigned values for each chemistry, or unassayed, with no value assignments. Medica provides EasyQC for chemistry which is an assayed QC material. A range for each chemistry is given on the CD which accompanies this QC material. While the laboratory will initially use the ranges on the CD for each chemistry, the laboratory should eventually establish its own mean values and variation (SD or CV) for each chemistry by observing the calculated mean and standard deviation for each chemistry which is calculated for the Levey -Jennings charts. Laboratory assigned mean values must always be within the range provided in the insert sheet. You can adjust the ranges for QC that will result in flags from the Setup menu. If a QC result falls outside the preset range a “QC” will appear in the Flag column of the QC result. For more information on setting up the QC ranges, see “Setting Up QC Materials Manually” on page 4.68. Medica’s EasyQC-Chemistry serum is supplied in freeze-dried (lyophilized) form and must be reconstituted and mixed thoroughly before use. Follow the directions for use included with the QC material. After use, vials of the reconstituted serum should be re-capped to assure that there is no evaporation. The reconstituted material may also be divided into smaller, single-use containers to preserve sample integrity. Evaporation can cause drift in the chemistry values and add imprecision to the QC measurement unrelated to the analyzer’s inherent variability. Reconstitution of the serum should be done carefully, so that no variation is introduced in chemistry values due to variations in the volume of the diluent (water, usually) added to the serum during reconstitution. 9.5 Q U A L I T Y A S S U R A N C E It is best to purchase sufficient material to last at least one year. This will allow the EasyRA analyzer to accumulate a large amount of data with which to compute the mean and standard deviation for each chemistry. This will result in the most accurate statistical quantification against which daily QC values can be compared QC material is also available for performing quality control on urine chemistries. The same precautions should be used for urine material as are used for serum QC material. 9.6 E a s y R A O P E R A T O R ’ S M A N U A L Quality Control Charts Termed Levey-Jennings Charts, these graphs plot the value(s) obtained each day when running a particular control. An example is shown in Figure 9.1. Figure 9.1 Example of Levey-Jennings Chart on EasyRA The vertical axis shows possible values for the particular chemistry, with a range of plus or minus 3 or 4 standard deviations. The horizontal axis shows the day of the month. EasyRA plots the chart over a range of 31 days. A Levey-Jennings chart is plotted for each chemistry. After at least five QC specimens have been run, the EasyRA calculates the mean. This value is plotted at the center of the Levey-Jennings chart. The EasyRA also calculates the standard deviation of the measurements according to the relationship: 9.7 Q U A L I T Y A S S U R A N C E Upper and lower limits are also plotted on the EasyRA Levey-Jennings chart. These values are equal to the mean plus two standard deviations and the mean minus two standard deviations. These values are termed the “control limits”. These limits are different from the limits supplied with EasyQC, because they are calculated by running Easy QC on the EasyRA. After running 20 samples, daily QC values should generally fall between these calculated limits. Statistically, one in every 20 values should fall outside these limits. EasyRA continually adjusts these limits slightly as more and more data is collected. You may review both the computed standard deviation and the original limits entered under setup by selecting the view results icon and selecting QC. Levey-Jennings charts may also be selected for viewing. For more information, see “Viewing A Levey-Jennings Chart for Quantitative QC” on page 7.56 Rules of Interpretation for Levey-Jennings Charts Conceived by Westgard1, these rules may be used to determine if the EasyRA is “in control” or behaving in a controlled manner. If the EasyRA is in control, the all sample results may be reported. If the EasyRA is not in control, then all sample results run after the out of control QC value is reports should be rejected. Application of these rules should at the discretion of the laboratory. Use of the rules assume use of two levels of quality control material, although a single level can be used.2 Quality control materials should be run for at least 20 days to establish the true mean and standard deviation for each level of control for each analyte. If the EasyRA is judged not to be “in control” because the QC results fail to meet the following criteria, then the laboratory must repeat all samples back to a run when a good set of QC results were obtained. EasyRA will notify you if QC has expired. It will also flag results outside of the plus and minus two standard deviation limits. But, unlike calibration, EasyRA will not prevent you from running patient tests. This decision is left to the user. The rules for rejecting a run are as follows: 1.Westgard QC, 7614 Gray Fox Trail, Madison WI 53717 2.Fundamentals of Clinical Chemistry, Tietz, 4th Edition 9.8 E a s y R A Table 9.1 O P E R A T O R ’ S M A N U A L Rules for Rejecting a run NAME DESCRIPTION 13s Rule Reject a run when a single control measurement exceeds the mean plus 3s or the mean minus 3s control limit. 12s Rule Perform careful inspection of the control data, using the other rules, when one control value falls beyond the plus or minus 2s control limit. 22s Rule Reject a run when 2 consecutive control measurements exceed the same mean plus 2s or the same mean minus 2s control limit. R4s Rule Reject a run when 1 control measurement in a group exceeds the mean plus 2s and another exceeds the mean minus 2s. 41s Rule Reject a run when 4 consecutive control measurements exceed the same mean plus 1s or the same mean minus 1s control limit. 10x Rule Reject a run when 10 consecutive control measurements fall on one side of the mean. ILLUSTRATION 9.9 Q U A L I T Y A S S U R A N C E Quality Control Procedures This section describes the quality control procedures. Assay Values on the Quality Control Assay Disk The mean value obtained by the analyzer for the quality control material should be within the assay values shown on the Quality Control Assay CD for each chemistry. If not, the QC value for that chemistry will be shown with a flag, (symbol QC). After 20 days of QC results, QC limits should be entered which are equal to the actual 2 standard deviation limits so that flags reflect QC results against true statistics as calculated by the EasyRA. Daily Use of QC Material Two levels of quality control material should be run for each chemistry which is being reported by the laboratory, each day. Some laboratories, run two levels of QC material for each work shift, but this should be at the discretion of the laboratory. For more information on running QC material, see “Entering Quality Control Requests” on page 6.21. Weekly Use of the EasyRA Precision Test In addition to running daily quality control samples, the laboratory should run the EasyRA Precision Test weekly. This test checks the precision of the photometer and pipetting systems. For more information on running Precision tests, see “Precision Test Diagnostics” on page 11.67. External Quality Control – Proficiency Testing The quality control procedures reviewed in the previous section relate to a laboratory’s internal QC activities. It is also wise to participate in an external QC program as well, known a Proficiency Testing Program. Purpose Participation in an external proficiency program allows the laboratory to compare its results with other laboratories using the same method as well as laboratories using different methods. Comparing results with other laboratories using the same method allows the lab to assess it accuracy. Usually the mean of all laboratory values for that method is considered to be the “true” value. 9.10 E a s y R A O P E R A T O R ’ S M A N U A L QC Material In order to participate, laboratories send data to programs run by national or regional sponsoring organizations. One example for hospital laboratories would be the CAP (College of American Pathologists). An example for group practices in the US would be the API (American Proficiency Institute). Procedure All participating laboratories receive a sample of QC material from the same production lot. Each lab handles and measures the material in the same way as would be done for patient samples and submits the test result to the sponsoring organization. Results The sponsoring organization gathers data from all participants and computes statistics on the data. A mean of all laboratories submitted values is computed as well as the standard deviation of all values. This is done for each subset of analyzer/methods and takes several weeks. Data is segmented by major analyzers/methods. It is normal to see differences between the means for each method. Your Laboratory’s Method It is important to note how your laboratory’s mean compares to the group mean for the analyzer/method used in your laboratory. One way of determining to what degree your laboratory agrees with the group is to calculate and SDI or Standard Deviation Interval. This is calculated using the relationship: SDI = (Laboratory Mean – Group Mean)/(Analyzer/Method Standard Deviation) If the calculation of SDI results in a value greater 2.0, this indicates that your laboratory is not in good agreement with the group. Other Methods Comparing the means of different methods for a given chemistry allows the lab to observe bias between methods. This can be useful when a lab in considering changing its analyzer because it permits the lab to predict in what way patient values may change after the method is implemented. 9.11 Q U A L I T Y A S S U R A N C E Method Validation In some regions, laboratories should validate the performance of all methods run in their laboratory before reporting results. Many of the tests performed on the EasyRA fall into the Non-Waived (US) Test category, for which method validation studies should be performed following these recommendations:1 Verification of Performance Specifications2 Each laboratory should demonstrate that it can obtain performance specifications comparable to EasyRA specifications for the following performance characteristics: Accuracy. Precision. Reportable range of test results for the test system. Verify that Medica's reference intervals (normal values) are appropriate for the laboratory's patient population. This would generally mean performing four experiments: A comparison of methods experiment to estimate inaccuracy or bias, A replication experiment to estimate imprecision, A linearity type experiment to determine the reportable range, and Collecting reference values to verify the reference range (alternatively, the laboratory medical director can document that Medica's ranges or textbook ranges are appropriate for the clientele being served). A suggested format for the above experiments may be found at http://www.westgard.com/cliafinalrule5.htm.3 1.CFR Section §493.1200 Subpart K, Quality Systems for Non-waived Testing 2.From: Final CLIA Rule. Part IV: The New Method Validation Regulations, Sharon S. Ehrmeyer, Ph.D. Copyright © 2003. All rights reserved. Westgard QC, 7614 Gray Fox Trail, Madison, WI 53717 3.Westgard QC, 7614 Gray Fox Trail, Madison WI 53717 9.12 10 Performing Maintenance This chapter describes the maintenance procedures required for EasyRA. EasyRA has been designed so that it is easy to maintain with minimal assistance from professional technical service personnel. EasyRA requires the following types of maintenance: Daily Cleaning. Daily Inspection. Weekly Testing. Monthly Cleaning. Surface Cleaning (performed on an as-needed basis) Replacements (performed on an as-needed basis). Purge/Prime Fluidics (performed on an as-needed basis). Each type of maintenance and the associated procedures are described in this chapter. This chapter also describes the Maintenance Log and how to Save Results to a CD or USB EasyRA’s user interface provides a Cleaning menu and a Maintenance menu. From the Cleaning menu, you can perform the required daily cleaning functions. From the Maintenance menu, you can select the various types of maintenance to be performed. Additional screens are displayed to guide you through the maintenance procedures. EasyRA provides a Daily Inspection Log, a Daily Cleaning Log, a Monthly Cleaning Log, a Replacement Log, and a Precision Test Log that will be generated when maintenance activities are performed. You can enter the Operator’s ID and notes in each log entry, add manual entries to all logs except the Daily Cleaning Log and the Precision Test Log, and print all logs. Details on using the maintenance logs are provided in “Using Maintenance Logs” on page 10.100. Appendix B, “Maintenance Logs.” contains a maintenance log that you can use to manually record all maintenance activities. 10.1 P E R F O R M I N G M A I N T E N A N C E Hazards The following hazards and precautions apply to EasyRA maintenance procedures. WARNING: There are no user serviceable parts in the electronics area of EasyRA. When electromechanical problems beyond the scope of this manual are suspected, DO NOT open the back cover. Contact your EasyRA dealer. WARNING: The safety protection provided by EasyRA may be impaired if EasyRA is used in any way other than as is described in this manual. Many components of EasyRA may be contaminated with biohazardous materials. Use care to avoid exposure to these biohazards. 10.2 E a s y R A O P E R A T O R ’ S M A N U A L BIOHAZARD: All samples should be considered biohazardous (contaminated with HIV or other pathogens). Any component which comes in contact with biological samples, including the Probe, Reagents, Wash Cup, Cuvettes, electrodes, sensor module, pump tubing, waste, and the ISE Reagent Pack may contain contaminated materials. Treat all components during use and disposal, as you would any biohazardous material. To avoid contamination, ALWAYS observe the following safety precautions when performing EasyRA maintenance tasks marked with a Biohazard symbol: Wear protective gloves and protective clothing (such as a laboratory coat). Wear protective eyeglasses or goggles. Wash hands thoroughly with soap and water after performing any procedure involving contaminated materials. Be aware of the EasyRA components that pose a risk of contamination and handle them appropriately. Dispose of all biohazardous materials in accordance with procedures set forth in your laboratory and local regulations. 10.3 P E R F O R M I N G M A I N T E N A N C E Accessing Daily Cleaning or Maintenance Procedures To access EasyRA’s cleaning or maintenance procedures: 1 Touch the Diagnostics/Maintenance/Setup icon, and then touch either Cleaning or Maintenance on the menu (see Figure 10.1). Figure 10.1 Diagnostics/Maintenance/Setup Icon and Menu If you select Cleaning, the Cleaning screen displays, from which you can select the various cleaning tasks: Clean Probe. Clean ISE Module. Clean and calibrate the ISE Module. You can also view the Daily Cleaning Log from the Cleaning screen. If you select Maintenance, the main Maintenance screen displays from which you can select the various maintenance tasks (see Figure 10.2). 10.4 E a s y R A Figure 10.2 O P E R A T O R ’ S M A N U A L Main Maintenance Screen 10.5 P E R F O R M I N G M A I N T E N A N C E Daily Cleaning Procedures Select the Cleaning menu to access the daily cleaning procedures that are required. The Probe must be cleaned daily (once every 24 hours) and the ISE Module must be cleaned daily (once every 24 hours). Note: This ISE cleaning and calibration is only required if you have the ISE Module option. If EasyRA detects that either of these cleaning cycles are due to be performed, the Diagnostics/Maintenance/Setup icon blinks to warn you that one or more cleaning cycles are required. Note: If the Diagnostics/Maintenance/Setup icon is blinking, EasyRA will not allow you to perform chemistry tests until the Probe is cleaned or ISE tests until the ISE Module is cleaned (and calibrated, if required). It is strongly recommended that you clean the Probe and the ISE Module daily to ensure the quality of EasyRA results. Do not clean the ISE Module more than instructed in the user interface or this manual, unless advised by service personnel. If you attempt to run tests while the Diagnostics/Maintenance/Setup icon is blinking, EasyRA displays a message indicating that cleaning is required. EasyRA allows you to override the cleaning and calibration cycle once. If after 24 hours of operation, you choose not to clean either the Probe or the ISE Module, you can override the cleaning (and calibration) cycles and continue to run for an additional 24 hours. Use of the cleaning override feature requires a password. However, after the second 24 hour period, EasyRA will not allow you to run chemistry tests until the Probe is cleaned or ISE tests until the ISE Module is cleaned and calibrated. You are not allowed to override the cleaning cycle a second time. 10.6 E a s y R A O P E R A T O R ’ S M A N U A L Probe cleaning can be performed using either a single or dual Cleaner Wedge. ISE cleaning requires a dual Cleaner Wedge, which includes pepsin. Note: Before you begin the cleaning cycles, be sure the Cleaner Wedge is loaded into the Reagent Tray (in any position). Note: A Sample Ring must be installed on EasyRA before you run this test. To perform daily cleaning: 1 Touch the Diagnostics/Maintenance/Setup icon, and then touch Cleaning. The Cleaning screen displays (see Figure 10.3). Figure 10.3 Cleaning Screen 10.7 P E R F O R M I N G M A I N T E N A N C E From this screen, you can choose to: Clean the Probe, and Clean the ISE Module, or Clean and Calibrate the ISE Module. (The ISE Module must be calibrated after every cleaning cycle.) You can also perform ISE Calibration by selecting ISE Calibration from the Worklist menu. This screen displays the status of each type of cleaning, including the number of samples left before cleaning is required, when the next cleaning cycle is required, and the status of cleaning (for example, Cleaning OK or Cleaning Required). 2 Touch the cleaning function(s) you want to perform, and then touch Start Now: EasyRA displays the following messages during the Cleaning cycle, as appropriate: 10.8 Cleaning Inventory In Progress. Performing Probe Clean. Performing ISE Clean. Performing ISE Cleaning and Calibration. E a s y R A 3 O P E R A T O R ’ S M A N U A L When the cleaning cycles are complete, the information on the Cleaning screen is updated (see Figure 10.4). The All Cycles are Successful message is displayed at the bottom of the screen.Touch the Enter button beside the message to confirm that daily cleaning is complete. If cleaning fails, one or more system error codes will be displayed. Look up the error code(s) in Table 11.1 and follow the instructions to recover from the error(s). After successfully recovering from the problem, re-run the cleaning procedures. Figure 10.4 4 All Cleaning Cycles are Successful You can view the Daily Cleaning Log by touching the Log button. For more information, see “Using Maintenance Logs” on page 10.100. 10.9 P E R F O R M I N G M A I N T E N A N C E Daily Inspection The following are the daily inspection tasks for EasyRA: Check the Dilutor Pump. Check the Probe. Check the Waste/Diluent. Check the Pump Tubes. Daily Inspection in High Humidity and High Temperature Environments. You can also view the Daily Inspection Log. For more information, see “Using Maintenance Logs” on page 10.100. To perform daily inspections: 1 Touch the Diagnostics/Maintenance/Setup icon and then touch Maintenance. The main Maintenance screen displays (see Figure 10.2). 2 Touch Daily Inspection. A list of the daily inspection tasks displays (see Figure 10.5). The due date for each maintenance task is displayed. If the maintenance task is overdue, the due date displays in red. Figure 10.5 10.10 Daily Inspection Tasks E a s y R A O P E R A T O R ’ S M A N U A L From this screen you can choose one or more of the daily inspection tasks to perform by touching the check boxes beside the tasks. If you choose more than one task, these tasks will be performed one after the other. Note: Some tasks are incompatible and must be performed independently from others. When you make your first selection, any tasks that are not compatible with the selected task are disabled (grayed out). If those tasks are required, they can be performed after the first task(s) are completed. When selecting Daily Inspection Tasks, Check Dilutor Pump, Check Waste/Diluent, and/or Check Pump Tubes can be selected (run) at the same time; however Check Probe must be selected (run) independently from the other tasks. When you select each task, an illustration showing the area to be inspected displays. If more than one task is selected, multiple illustrations are displayed (see Figure 10.6). Figure 10.6 Multiple Daily Inspection Tasks Selected Each of the tasks are described separately. If multiple tasks are selected, all inspections are performed before selecting Inspection Done?. 10.11 P E R F O R M I N G M A I N T E N A N C E Checking Dilutor Pump This is a visual inspection for bubbles in the Dilutor Pump. To check the Dilutor Pump for bubbles: 1 From the Maintenance screen, touch Daily Inspection, and then touch the Check Dilutor Pump check box. The Check Dilutor Pump screen displays ((see Figure 10.7). Figure 10.7 Check Dilutor Pump 2 10.12 Open the Fluidics Drawer. E a s y R A 3 O P E R A T O R ’ S M A N U A L Look for bubbles in the Dilutor Pump, in the area of the two pistons (see Figure 10.8): Figure 10.8 Check Dilutor Pump for Bubbles Look for bubbles above the large and small piston. 4 If you see bubbles in that area, prime the diluent as described in “Priming the Diluent” on page 10.93. 5 When all inspections are complete, touch Enter beside the Inspection Done? message (see Figure 10.7). 10.13 P E R F O R M I N G M A I N T E N A N C E Checking the Probe This is a visual inspection to verify that the Probe is free of debris and buildup and is not damaged in any way. Note: All EasyRA covers must be closed before you can perform this procedure because the Probe has to be able to move into a position where it can be inspected. To check the Probe: 1 From the Maintenance screen, touch Daily Inspection, and then touch Check Probe. The Check Probe screen displays (see Figure 10.9). Figure 10.9 Check Probe Screen 2 10.14 Before you can inspect the Probe, it must be moved from the Home position to a position just over the Wash position so you can see it. To move the Probe, touch the Start Now button (see Figure 10.9). E a s y R A O P E R A T O R ’ S 3 After the Probe moves into a position where you can see it, visually inspect the Probe. The Probe should be free of all rust or any other debris or buildup. It should also be aligned with the Wash Cup. 4 If there is noticeable debris or buildup on the Probe, clean it with a lint-free wipe dipped in 70% isopropyl alcohol. 5 After the inspection is complete: If the Probe is damaged, bent, or has visible rust, see “Replacing the Probe” on page 10.48. If the Probe is undamaged, touch Enter beside the Inspection Done? message to send the Probe back to the Home position. M A N U A L 10.15 P E R F O R M I N G M A I N T E N A N C E Checking the Waste and Diluent This is a visual inspection to check the levels of the Waste and Diluent Bottles. Figure 10.10 shows the locations of the Waste and Diluent Bottles. Figure 10.10 Location of Waste and Diluent Bottles Diluent Bottle Waste Bottle To check the levels of these bottles: 10.16 1 From the Maintenance screen, touch Daily Inspection, and then touch Check Waste/Diluent. 2 The Check Waste/Diluent screen displays (see Figure 10.11). E a s y R A O P E R A T O R ’ S M A N U A L Figure 10.11 Check Waste and Diluent Screen BIOHAZARD: The contents of the Waste Bottle and all associated tubing may contain contaminated material. Treat all waste, during use and disposal, as you would any biohazardous material. For information on safety procedures for handling biohazards, see page 10.3. 10.17 P E R F O R M I N G M A I N T E N A N C E 3 Observe the level of the waste in the Waste Bottle (at the front of EasyRA). The bottle must be emptied when it is 95% full. If you are just starting a shift and expect heavy use of the analyzer, it is good practice to empty the Waste Bottle when it is more than 50% full. 4 Observe the level of the diluent in the Diluent Bottle (at the rear of EasyRA). The bottle must be refilled with diluent when it is 95% empty. If you are starting a shift and expect heavy use of the analyzer, it is good practice to fill the Diluent Bottle if it is less than 50% full. 5 10.18 For information on emptying the Waste Bottle, see “Unloading and Emptying the Waste Bottle” on page 5.15. For information on filling the Diluent Bottle, see “Filling and Loading the Diluent Bottle” on page 5.13. When all inspections are complete, touch Enter beside the Inspection Done? message (see Figure 10.11). E a s y R A O P E R A T O R ’ S M A N U A L Checking the Pump Tubes This is a visual inspection for pinching or wear on the tubes around the peristaltic pump heads on EasyRA. During this check, observe the tubing on following pumps (see Figure 10.12): Chemistry Waste Pump. ISE Pumps (ISE Waste Pump and Cal A and Cal B Pumps). This check only applies if you have the ISE Module option. Figure 10.12 Locations of Pump Tubing To check the pump tubing: 1 From the Maintenance screen, touch Daily Inspection, and then touch Check Pump Tubes. 2 The Check Pump Tubes screen displays (see Figure 10.13). 10.19 P E R F O R M I N G M A I N T E N A N C E Figure 10.13 Check Pump Tubes Screen 3 Open the Fluidics Drawer and slide it out. 4 Inspect all pump tubing for the following conditions: Pinching in the tubing. Wear on the tubing. Leaks in the tubing. If the tubes are worn or leaking, see “Replacing the Waste Pump Tube” on page 10.58 or “Replacing the ISE Pump Tubes” on page 10.80. 10.20 5 When the inspection is complete, push the Fluidics Drawer back into place and close it. 6 When all inspections are complete, touch the Enter button beside the Inspection Done? message (see Figure 10.13). E a s y R A O P E R A T O R ’ S M A N U A L Daily Inspection in High Humidity and High Temperature Environments EasyRA should be operated in conditions not exceeding 15°-30°C (59°-86°F) and 85% humidity, non-condensing atmospheric air environment. When operating EasyRA at the upper level of both temperature and humidity conditions, condensation in the Reagent Tray may occur. When operating under these conditions, the Reagent Tray should be inspected for condensation on a daily basis. To inspect for condensation: 1 Remove the Reagents from the tray to visually inspect for condensation. 2 If you observe condensation, remove it by wiping it with absorbent plastic-backed paper or other absorbent material. 10.21 P E R F O R M I N G M A I N T E N A N C E Weekly Testing You must perform the Precision Test weekly to ensure performance. For detailed information on the Precision Test, see “Precision Test Diagnostics” on page 11.67. Monthly Cleaning The following are the monthly cleaning tasks for EasyRA: Bleach the Diluent Bottle. Bleach the Waste Bottle. Clean the Wash Cup. Clean the ISE Sample Cup (if you have the ISE Module option). You can also view the Monthly Cleaning Log. For more information, see “Using Maintenance Logs” on page 10.100. This section describes how to perform monthly cleaning tasks. EasyRA provides a Monthly Cleaning submenu. From this submenu, you can choose the item or items you wish to clean. EasyRA guides you through the key steps needed to complete the monthly cleaning. To perform the monthly cleaning procedures: 1 Touch the Diagnostics/Maintenance/Setup icon, and then touch Maintenance. The Maintenance screen displays (see Figure 10.2). 2 Touch Monthly Cleaning. A list of the monthly cleaning tasks that are available displays (see Figure 10.14). The due date for each cleaning task is displayed. If the cleaning task is overdue, the due date displays in red. 10.22 E a s y R A O P E R A T O R ’ S M A N U A L Figure 10.14 Monthly Cleaning Tasks From this screen, select one or more monthly cleaning tasks to perform by touching the check boxes beside the tasks. If you choose more than one task, these tasks will be performed one after the other. Note: Some tasks are incompatible and must be performed independently. When you make your first selection, any tasks that are not compatible with the selected task are disabled (grayed out). If those tasks are required, they can be performed after the first task(s) are completed. When selecting Monthly Cleaning Tasks, Bleach Diluent Bottle, Bleach Waste Bottle, and/or Clean Wash Cup can be selected (run) at the same time; however Clean ISE Sample Cup must be selected (run) independently. It is efficient to run the first three tasks together, as they each require a Waste Line purge before each task and a Diluent prime after each task is complete. Grouping these tasks results in only having to purge the Waste Line and prime the Diluent once. When you select each task, an illustration showing the component to be cleaned displays. If more than one task is selected, multiple illustrations are displayed (see Figure 10.15). 10.23 P E R F O R M I N G M A I N T E N A N C E Figure 10.15 Multiple Monthly Cleaning Tasks Selected Select multiple tasks and touch the Start button. The Waste Line is purged once, then you can perform each of the monthly cleaning tasks selected one after the other. When all selected tasks are complete, touch the Enter button beside the Done? message. At that time, the Diluent is primed. 10.24 E a s y R A O P E R A T O R ’ S M A N U A L Bleaching the Diluent Bottle Once a month, clean the Diluent Bottle with bleach. WARNING: Bleach is used to clean the Diluent Bottle. For safety, wear protective gloves, clothing, and eyeglasses while performing this procedure. To bleach the Diluent Bottle: 1 From the Maintenance screen, touch Monthly Cleaning, and then touch the Bleach Diluent Bottle check box. You can also select additional monthly cleaning tasks by touching the corresponding check boxes. Figure 10.16 displays. Note that Step 1: Purge Waste Line is highlighted in pink. Figure 10.16 Bleach Diluent Bottle Screen 10.25 P E R F O R M I N G M A I N T E N A N C E 2 Before you can remove the Diluent Bottle the Waste Line must be purged of all fluids. To purge the Waste Line, touch the Start button in Step 1: When the purge is complete, Step 2 is highlighted (see Figure 10.17). If more than one cleaning task is selected, the corresponding illustrations are displayed beside Step 2. Figure 10.17 Waste Line is Purged - Ready to Bleach Diluent Bottle You can now bleach the Diluent Bottle as described in the following steps. 10.26 3 Pinch the tubing connector to remove the tubing from the Diluent Bottle. 4 Lift the Diluent Bottle up and off of EasyRA. 5 Unscrew the bottle cap of the Diluent Bottle and remove it. Be sure to place the bottle cap and the attached tubing on absorbent plastic-backed paper to absorb any excess diluent. E a s y R A 6 O P E R A T O R ’ S M A N U A L Dispose of the deionized (DI) water in the Diluent Bottle (see Figure 10.18). Figure 10.18 Bleaching the Diluent Bottle 7 Add approximately 160 ml of DI water to the bottle (see Figure 10.18). 8 Add approximately 40 ml of full strength bleach to the bottle (see Figure 10.18). 9 Place the bottle cap back onto the Diluent Bottle and tighten it. 10 Swirl the bleach in the bottle, so all internal parts are cleaned. Let it sit for 10 minutes (see Figure 10.18). 11 Unscrew the bottle cap of the Diluent Bottle and remove it. 12 Dispose of the bleach (see Figure 10.18). 13 Thoroughly rinse the Diluent Bottle with tap water until you no longer smell bleach (at least six times). See Figure 10.18. 14 Then thoroughly rinse the Diluent Bottle three times with plenty of DI water (see Figure 10.18). 15 Fill the Diluent Bottle to the fill line (3 liters) with DI water (see Figure 10.18). 16 Medica Surfactant (5 drops per liter) must be added to the Diluent Bottle to reduce carry over (see Figure 10.18). 10.27 P E R F O R M I N G M A I N T E N A N C E 17 Place the bottle cap back onto the Diluent Bottle and tighten it. Verify that the tubing attached to the inside of the bottle cap extends to the bottom of the Diluent Bottle 18 Place the Diluent Bottle back onto EasyRA. 19 The Diluent Bottle is now clean. If more than one monthly cleaning task has been selected, complete the steps to perform those tasks (see “Bleaching the Waste Bottle” on page 10.30 and/or “Cleaning the Wash Cup” on page 10.35. When all cleaning tasks are complete, touch the Enter button in Step 2 (see Figure 10.17) to indicate that the cleaning is complete: After you touch Enter, Step 3 is highlighted and the prime begins. 10.28 E a s y R A O P E R A T O R ’ S M A N U A L 20 When the prime is complete, a Cleaning Complete status message displays at the bottom of the screen indicating that the cleaning procedure was completed successfully (see Figure 10.19). Touch Enter beside the message to confirm the cleaning is complete: Figure 10.19 Bleach Diluent Bottle - Confirm Completion 10.29 P E R F O R M I N G M A I N T E N A N C E Bleaching the Waste Bottle Once a month, clean the Waste Bottle with bleach. WARNING: Bleach is used to clean the Waste Bottle. For safety, wear protective gloves, clothing, and eyeglasses while performing this procedure. BIOHAZARD: The contents of the Waste Bottle and all associated tubing may contain contaminated material. Treat all waste, during use and disposal, as you would any biohazardous material. For information on safety procedures for handling biohazards, see page 10.3. EasyRA should be idle while the Waste Bottle is being emptied. To bleach the Waste Bottle: 1 From the Maintenance screen, touch Monthly Cleaning, and then touch the Bleach Waste Bottle check box. You can also select additional monthly cleaning tasks by touching corresponding check boxes. Figure 10.20 displays. Note that Step 1: Purge Waste Line is highlighted in pink. 10.30 E a s y R A O P E R A T O R ’ S M A N U A L Figure 10.20 Bleach Waste Bottle Screen 2 Before you can remove the Waste Bottle to bleach it, you must purge the Waste Line of all fluids. To purge the Waste Line, touch the Start button in Step 1: Purge Waste Line: When the purge is complete, Step 2 is highlighted (see Figure 10.21). If more than one cleaning task is selected, the corresponding illustrations are displayed beside Step 2. 10.31 P E R F O R M I N G M A I N T E N A N C E Figure 10.21 Waste Line is Purged - Ready to Bleach Waste Bottle You can now bleach the Waste Bottle as described in the following steps. 10.32 3 Pinch the tubing connector to remove the tubing from the Waste Bottle. 4 Lift the Waste Bottle up and off of EasyRA. 5 Unscrew the bottle cap of the Waste Bottle and remove it. 6 Dispose of the biohazardous waste from the Waste Bottle according to your laboratory’s procedures and local regulations (see Figure 10.22). E a s y R A O P E R A T O R ’ S M A N U A L Figure 10.22 Bleaching the Waste Bottle 7 Add approximately 160 ml of deionized (DI) water to the bottle (see Figure 10.22). 8 Add approximately 40 ml of full strength bleach to the bottle (see Figure 10.22). 9 Place the bottle cap back onto the Waste Bottle and tighten it. 10 Swirl the bleach in the bottle, so all internal parts are cleaned (see Figure 10.22). Let it sit for 10 minutes. 11 Unscrew the bottle cap of the Waste Bottle and remove it. 12 Dispose of the bleach according to your laboratory’s procedures and local regulations (see Figure 10.22). 13 Thoroughly rinse the Waste Bottle with tap water until you no longer smell bleach (see Figure 10.22). 14 Then thoroughly rinse the Waste Bottle three times with 200 mL of deionized water (see Figure 10.22). 15 Place the bottle cap back onto the Waste Bottle and tighten it. 16 Place the Waste Bottle back onto EasyRA. 17 Reconnect the tubing to the Waste Bottle. 10.33 P E R F O R M I N G M A I N T E N A N C E 18 The Waste Bottle is now clean. If more than one monthly cleaning task has been selected, complete the steps to perform those tasks (see “Bleaching the Diluent Bottle” on page 10.25 and/or “Cleaning the Wash Cup” on page 10.35. When all cleaning tasks are complete, touch the Enter button in Step 2 (see Figure 10.21) to indicate that the cleaning is complete: After you touch Enter, Step 3 is highlighted and the prime begins. 19 When the prime is complete, a Cleaning Complete status message displays at the bottom of the screen indicating that the cleaning procedure was completed successfully (see Figure 10.23). Touch Enter beside the message to confirm the cleaning is complete: Figure 10.23 Bleach Waste Bottle - Confirm Completion 10.34 E a s y R A O P E R A T O R ’ S M A N U A L Cleaning the Wash Cup The Wash Cup must be cleaned once a month. Figure 10.24 shows the Wash Cup. Figure 10.24 Wash Cup BIOHAZARD: The Wash Cup and all associated tubing may contain contaminated material. Treat the Wash Cup and the associated tubing as you would any biohazardous material. For information on safety procedures for handling biohazards, see page 10.3. To clean the Wash Cup: 1 From the Maintenance screen, touch Monthly Cleaning, and then touch the Clean Wash Cup check box. You can also select additional monthly cleaning tasks by touching the corresponding check boxes. Figure 10.25 displays. Note that Step 1 is highlighted in pink. 10.35 P E R F O R M I N G M A I N T E N A N C E Figure 10.25 Clean Wash Cup Screen 2 Before you can clean the Wash Cup, you must purge the Waste Line of all fluids. To purge the Waste Line, touch the Start button in Step 1: When the purge is complete, Step 2 is highlighted (see Figure 10.26). If more than one cleaning task is selected, the corresponding illustrations are displayed before Step 2. 10.36 E a s y R A O P E R A T O R ’ S M A N U A L Figure 10.26 Waste Line is Purged - Ready to Clean Wash Cup You can now clean the Wash Cup as described in the following steps. 3 Open the Fluidics Drawer and slide it out. 4 The Wash Cup is a double-walled cup with the main Wash Cup and an Overflow Chamber. Because of this design, some fluid will remain in the Wash Cup after the waste has been purged. To remove any remaining fluid from the Wash Cup or the Overflow Chamber, aspirate the fluid out of the Wash Cup using a plastic disposable pipette. 5 Clean the cup and the overflow chamber with a lint-free wipe that has been dipped in 70% isopropyl alcohol. 6 Allow the cup and the overflow chamber to air dry. 7 Push the Fluidics Drawer back into place and close it. 10.37 P E R F O R M I N G M A I N T E N A N C E 8 The Wash Cup is now clean. If more than one monthly cleaning task has been selected, complete the steps to perform those tasks (see “Bleaching the Diluent Bottle” on page 10.25 and/or “Bleaching the Waste Bottle” on page 10.30. When all cleaning tasks are complete, touch the Enter button in Step 2 (see Figure 10.26) to indicate that the cleaning is complete: After you touch Enter, Step 3 is highlighted and the prime begins. 9 When the prime is complete, a Cleaning Complete status message displays at the bottom of the screen indicating that the cleaning procedure was completed successfully (see Figure 10.27). Touch Enter beside the message to confirm the cleaning is complete: Figure 10.27 Clean Wash Cup - Confirm Completion 10.38 E a s y R A O P E R A T O R ’ S M A N U A L Cleaning the ISE Sample Cup Note: This procedure is only required if you have the ISE Module option. The ISE Sample Cup (see Figure 10.28) must be cleaned of dried salts or protein once a month. Figure 10.28 Location of ISE Sample Cup on the ISE Module ISE Sample Cup BIOHAZARD: The ISE Sample Cup, all associated tubing, and the ISE Module may contain contaminated material. Treat the ISE Sample Cup, the associated tubing, and the ISE Module as you would any biohazardous material. For information on safety procedures for handling biohazards, see page 10.3. 10.39 P E R F O R M I N G M A I N T E N A N C E To clean the ISE Sample Cup: 1 From the Maintenance screen, touch Monthly Cleaning, and then touch the Clean ISE Sample Cup check box. If you do not have the ISE Module option, Clean ISE Sample Cup displays in gray. Figure 10.29 displays. Note that Step 1 is highlighted in pink. Figure 10.29 Clean ISE Sample Cup Screen 2 Before you can clean the ISE Sample Cup, you must purge the ISE Waste Line of all fluids. To purge the ISE Waste Line, touch the Start button in Step 1: When the purge is complete, Step 2 is highlighted (see Figure 10.30). 10.40 E a s y R A O P E R A T O R ’ S M A N U A L Figure 10.30 ISE Waste Line is Purged - Ready to Clean ISE Sample Cup You can now clean the ISE Sample Cup as described in the following steps. 3 Open the Fluidics Drawer and slide it out. 4 Manually turn the Cal A Pump head in the direction of the arrow until the ISE Sample Cup is about half full of Cal A. CAUTION: To prevent damage to the Cal A Pump, only turn the pump head in the direction of the arrow on the pump itself. 5 Carefully wipe the ISE Sample Cup with a cotton swab to remove any dried salts or proteins. 6 Push the Fluidics Drawer back into place and close it. 10.41 P E R F O R M I N G M A I N T E N A N C E 7 The ISE Sample Cup is now clean. Touch Enter in Step 2 (see Figure 10.30) to indicate that the cleaning is complete: After you touch Enter, Step 3 is highlighted and the prime begins. 8 When the prime is complete, a Cleaning Complete status message displays at the bottom of the screen indicating that the cleaning procedure was completed successfully (see Figure 10.31). Touch Enter beside the message to confirm the cleaning is complete: Figure 10.31 Clean ISE Sample Cup - Confirm Completion 10.42 E a s y R A O P E R A T O R ’ S M A N U A L Cleaning Analyzer Surfaces Clean the surfaces of the analyzer as needed. Use a cleaning agent consisting of a 10% bleach (0.4-6% NaClO) solution. To clean the outside surfaces of the EasyRA analyzer: Dampen a cloth with the solution and wipe down all outside surfaces. CAUTION: When cleaning the analyzer surfaces wear protective gloves and protective clothing (such as a laboratory coat) and protective eyeglasses or goggles. To clean any component of EasyRA: Use only water or bleach (NaClO) solutions. DO NOT use solvents, such as methyl alcohol, ethyl alcohol, or isopropyl alcohol). 10.43 P E R F O R M I N G M A I N T E N A N C E Replacements The following are the replacement procedures for EasyRA: Replace the Probe. Replace the Wash Cup. Replace the Waste Pump Tube. Replace the Diluent Line. Replace the ISE Reagent Pack. Replace the ISE Sensors. Replace the ISE Pump Tubes. Note: This procedure is only required if you have the ISE Module option. You can also view the Replacement Log, the ISE Sensor Replacement Log, and the Replacement Schedule. For more information, see “Using Maintenance Logs” on page 10.100. Appendix B, “Maintenance Logs.” contains a maintenance log which includes a recommended replacement schedule. This section describes how to perform the replacement procedures. EasyRA provides a Replacement submenu. From this submenu, you can choose the item or items you wish to replace. EasyRA guides you through the key steps needed to replace components. Some of the steps must be performed manually. Complete instructions for all replacement procedures are provided in this section. Note: Once you start a replacement procedure, EasyRA does not allow other functions to be performed until the replacement is complete. You can also replace components manually, without using the Replacement screens as a guide. This is especially useful if you want to replace multiple components at the same time. If you choose to replace components without accessing the Replacement menu, refer to the procedures in this section to ensure you perform all the steps required before and after each replacement. For example, before you replace the Probe, you must purge the Waste Line, and after you replace the Probe, you must prime the diluent. 10.44 E a s y R A O P E R A T O R ’ S M A N U A L To perform replacement procedures: 1 Touch the Diagnostics/Maintenance/Setup icon and then touch Maintenance. The Maintenance screen displays (see Figure 10.2). 2 Touch Replacement. A list of the replacement procedures that are available displays (see Figure 10.32). The due date for each replacement task is displayed, If the replacement is overdue, the due date displays in red. Figure 10.32 Replacement Procedures From this screen you can select one or more replacement procedures to perform by touching the check boxes beside the procedures. If you choose more than one procedure, these procedures will be performed one after the other. Note: Some procedures are incompatible and must be performed independently. When you make your first selection, any procedures that are not compatible with the selected procedure are disabled (grayed out). If those procedures are required, they can be performed after the first procedure(s) are completed. 10.45 P E R F O R M I N G M A I N T E N A N C E When selecting Replacement procedures, replacing the Probe must be selected independently. Replacing the Wash Cup and Waste Pump Tube can be selected at the same time, and replacing the ISE Reagent Pack, ISE Sensors, and ISE Pump Tubes can be selected together. It is efficient to replace the Wash Cup and Waste Pump Tube together as they each require a Waste Line purge before starting each task and a Diluent prime after each task is complete. Grouping these tasks results in only having to purge the Waste Line and prime the Diluent once. It is also efficient to replace the ISE Reagent Pack, ISE Sensors, and ISE Pump Tubes together as they each require that an ISE Waste Link purge before staring each task and an ISE Calibration A and B prime after each task is complete. Grouping these tasks results in only having to purge the ISE Waste Line and prime the ISE Calibration A and B once. When you select each replacement procedure, an illustration showing the components to be replaced displays. If more than one task is selected, multiple illustrations are displayed (see Figure 10.33). Figure 10.33 Multiple Replacement Tasks Selected 10.46 E a s y R A O P E R A T O R ’ S M A N U A L Each of the replacement tasks are described separately. If you select multiple replacements, you only need to perform the initial purge task and the final prime task once for all the replacements selected. When all replacements are complete, touch the Enter button next to the Done? message to indicate the replacements are complete and you begin the prime. 10.47 P E R F O R M I N G M A I N T E N A N C E Replacing the Probe This procedure describes how to replace the Probe. Before you begin, make sure you have a replacement Probe available to install. Note: All EasyRA covers must be closed before you replace the Probe. BIOHAZARD: The Probe and all EasyRA components that come in contact with the Probe (samples, Reagents, wash cups, Cuvettes, ISE Module, etc.) may contain contaminated material. Treat the Probe and all associated components as you would any biohazardous material. For information on safety procedures for handling biohazards, see page 10.3. To replace the Probe: 1 From the main Maintenance screen, touch Replacement, and then touch the Probe check box. Figure 10.34 displays. Note that Step 1 is highlighted in pink. 10.48 E a s y R A O P E R A T O R ’ S M A N U A L Figure 10.34 Probe Replacement Screen 2 Before you can replace the Probe, it must be moved from the Home position to the Wash position so you can access it. The Probe must also be purged of all fluids. To move the Probe and purge it of fluids, touch the Start button in Step 1: Note: As soon as you touch the Start button in Step 1 on any replacement procedure, EasyRA prevents you from accessing any other EasyRA function until the replacement is complete. The Probe moves from the Home position to the Wash position and air is pushed through the Probe to purge all fluids into the Wash Cup. 10.49 P E R F O R M I N G M A I N T E N A N C E When the process is complete, Step 2 is highlighted (see Figure 10.35). Figure 10.35 Probe is Prepared - Ready to Replace Probe You can now replace the Probe manually as described in the following steps. 3 10.50 Remove the Transfer Arm/Probe cover by gently lifting it up until it is free from the Transfer Arm. E a s y R A 4 O P E R A T O R ’ S M A N U A L Gently disconnect the clear plastic tubing from the top of the Probe (see Figure 10.36). Figure 10.36 Remove Tubing from Probe Disconnect tubing Grasp ring and unscrew the Probe 5 Grasp the plastic ring at the top of the Probe and unscrew it (see Figure 10.36). 6 Gently lift the Probe up and out of the Transfer Arm/Probe as shown in Figure 10.37). Figure 10.37 Lift Probe Out of Transfer Arm 10.51 P E R F O R M I N G M A I N T E N A N C E 7 Grasp the white ring on the top of the new Probe and install it by inserting it into the hole in the Transfer Arm/Probe and then screwing it securely into place. Hand tighten the Probe until the threads can no longer turn. Note: Verify that Probe is straight before continuing. 8 Reconnect the clear, plastic tubing to the top of the Probe until it touches the plastic ring. 9 The Probe replacement is complete. Touch Enter in Step 2 (see Figure 10.35) to indicate that the manual replacement is complete: After you touch Enter, Step 3: Prime Diluent is highlighted and the prime begins. 10 While the system is being primed, observe the alignment of the Probe over the Wash Cup. The Probe should be approximately centered over the Wash Cup. Figure 10.38 shows proper and improper alignment of the Probe. Figure 10.38 Probe Alignment 10.52 E a s y R A O P E R A T O R ’ S M A N U A L If the Probe is not properly aligned over the Wash Cup, perform the alignment procedure described in Chapter 11, “Troubleshooting & Diagnostics.” When the Probe is properly aligned and the prime is complete, a Cleaning Complete status message displays at the bottom of the screen indicating that the Probe replacement was completed successfully (see Figure 10.39). Touch Enter beside the message to confirm the replacement is complete: Figure 10.39 Probe Replacement - Confirm Completion 11 Following the Probe replacement, perform a Precision Test to ensure proper performance of the pipetting systems. For information, see “Precision Test Diagnostics” on page 11.67. At this time, EasyRA allows you to access any other EasyRA function. 10.53 P E R F O R M I N G M A I N T E N A N C E Replacing the Wash Cup This procedure describes how to replace the Wash Cup. Before you begin, make sure you have a replacement Wash Cup available to install. BIOHAZARD: The Wash Cup and all associated tubing may contain contaminated material. Treat the Wash Cup and the associated tubing as you would any biohazardous material. For information on safety procedures for handling biohazards, see page 10.3. To replace the Wash Cup: 1 From the main Maintenance screen, touch Replacement, and then touch the Wash Cup check box. You can also select the Waste Pump Tube check box. Figure 10.40 displays. Note that Step 1: Purge Waste Line is highlighted in pink. Figure 10.40 Wash Cup Replacement Screen 10.54 E a s y R A 2 O P E R A T O R ’ S M A N U A L Before you can replace the Wash Cup, the Wash Cup and Waste Line must be purged of all fluids. To purge the Wash Cup and Waste Line, touch the Start button in Step 1: Note: As soon as you touch the Start button in Step 1 on any replacement procedure, EasyRA prevents you from accessing any other EasyRA function until the replacement is complete. When the process is complete, Step 2 is highlighted (see Figure 10.41). If the Waste Pump Tube is also selected, there will be two illustrations displayed beside Step 2. Figure 10.41 Waste Line Purge Complete - Ready to Replace Wash Cup 10.55 P E R F O R M I N G M A I N T E N A N C E You can now replace the Wash Cup manually as described in the following steps. 3 The Wash Cup is a double-walled cup with the main Wash Cup and an Overflow Chamber. Because of this design, some fluid will remain in the Wash Cup after it has been purged. To remove any remaining fluid from the Wash Cup or the Overflow Chamber, aspirate the fluid using a plastic disposable pipette. 4 Disconnect the Waste Line located under the Wash Cup (see Figure 10.42). 5 Grasp the neck of the Wash Cup and lift it up and out of the Wash Cup Arm (see Figure 10.42). Figure 10.42 Disconnect Waste Line Under Wash Cup and Lift and Remove Wash Cup 10.56 6 Install a new or clean Wash Cup by positioning it in the Wash Cup Arm and pressing down gently until it snaps into place. 7 Reconnect the Waste Line to the bottom of the Wash Cup. E a s y R A 8 O P E R A T O R ’ S M A N U A L The Wash Cup replacement is complete. If you also selected Waste Pump Tube, complete the steps to perform that replacement (see “Replacing the Waste Pump Tube” on page 10.58). When all replacement tasks are complete, touch Enter in Step 2 (see Figure 10.41) to indicate that the manual replacement is complete: After you touch Enter, Step 3 is highlighted and the prime begins. 9 When the prime is complete, a Replacement Complete status message displays at the bottom of the screen indicating the Wash Cup replacement was completed successfully (see Figure 10.43). Touch Enter beside the message to confirm the replacement is complete: Figure 10.43 Wash Cup Replacement - Confirm Completion At this time, EasyRA allows you to access any other EasyRA function. 10.57 P E R F O R M I N G M A I N T E N A N C E Replacing the Waste Pump Tube This procedure describes how to replace the Chemistry Waste Pump Tube (see Figure 10.12 and Figure 10.44). Before you begin, make sure you have a replacement tube available for the peristaltic pump. Figure 10.44 Chemistry Waste Pump Tubing This tube is positioned around the Chemistry Waste Pump (see Figure 10.45). Figure 10.45 Pump Tube Installed On Pump Pump Tubing on Pump 10.58 E a s y R A O P E R A T O R ’ S M A N U A L BIOHAZARD: All waste and the Waste Pump Tubing may contain contaminated material. Treat all waste and Waste Pump Tubing, during use and disposal, as you would any biohazardous material. For information on safety procedures for handling biohazards, see page 10.3. To replace the Waste Pump Tube: 1 From the main Maintenance screen, touch Replacement, and then touch the Waste Pump Tube check box. You can also select the Wash Cup check box. Figure 10.46 displays. Note that Step 1 is highlighted in pink. Figure 10.46 Waste Pump Tube Screen 10.59 P E R F O R M I N G M A I N T E N A N C E 2 Before you can replace the Waste Pump Tube, the Overflow Cup and Waste Line must be purged of all fluids. To purge the Overflow Cup and Waste Line, touch the Start button in Step 1: Note: As soon as you touch the Start button in Step 1 on any replacement procedure, EasyRA prevents you from accessing any other EasyRA function until the replacement is complete. When the process is complete, Step 2 is highlighted (see Figure 10.47). Figure 10.47 Waste Line Purge Complete - Ready to Manually Replace Pump Tubing You can now replace the Waste Pump Tube manually as described in the following steps. 10.60 E a s y R A 3 O P E R A T O R ’ S M A N U A L Disconnect both ends of the Waste Pump Tube from the Waste Line at the barbed connectors (the clear connectors) as shown in Figure 10.48. To disconnect the connectors, grasp the Waste Line from the back of the Fluidics Drawer with one hand and grasp the barbed connector on the Waste Pump Tube with the other hand and pull the connector apart. Repeat for the second barbed connector. Figure 10.48 Disconnect the Waste Pump Tube on Chemistry Waste Pump Disconnect Waste Tube Connections Waste Lines Pump Inlet 4 Pump Outlet Push down on the bottom portion of the pump and remove the Waste Pump Tube as shown in Figure 10.49. 10.61 P E R F O R M I N G M A I N T E N A N C E Figure 10.49 Remove the Waste Pump Tube 5 Install a new Waste Pump Tube by connecting one end of the Waste Pump Tube to the Waste Line at the barbed connector. The Waste Pump Tube is symmetrical, so you can connect either end of the Waste Pump Tube first. 6 Press down on the bottom portion of the pump and stretch the tubing around the pump head. 7 Connect the other end of the Waste Pump Tube to the Waste Line at the barbed connector. CAUTION: 10.62 Use care when connecting the inlet and outlet ends of the Waste Line to the Waste Pump Tube. The inlet is on the left side of the pump and the outlet is on the right side. Failure to connect the Waste Line properly may result in damage to EasyRA. E a s y R A 8 O P E R A T O R ’ S M A N U A L The Waste Pump Tube replacement is complete. If you also selected Wash Cup, complete the steps to perform that replacement (see “Replacing the Wash Cup” on page 10.54. When all replacement tasks are complete, touch Enter in Step 2 (see Figure 10.47) to indicate that the manual replacement is complete: After you touch Enter, Step 3 is highlighted and the prime begins. 9 When the prime is complete, a Replacement Complete status message displays at the bottom of the screen indicating the Waste Pump Tube replacement was completed successfully (see Figure 10.50). Touch Enter beside the message to confirm the replacement is complete: Figure 10.50 Waste Pump Tube Replacement - Confirm Completion At this time, EasyRA allows you to access all other EasyRA function. 10.63 P E R F O R M I N G M A I N T E N A N C E Replacing the Diluent Line This procedure describes how to replace the Diluent Line (see Figure 10.51 and Figure 10.52). Before you begin, make sure you have a replace Diluent Line available. Figure 10.51 Replacement of Diluent Line The tube is positions in the groove connecting the Diluent Bottle and the Dilutor Pump. Figure 10.52 Diluent Line in the Groove 10.64 E a s y R A O P E R A T O R ’ S M A N U A L To replace the Diluent Line: 1 Remove the tubing connector from the Diluent Bottle Cover. Be sure to place the diluent line connector on absorbent plastic-backed paper to absorb any excess diluent. 2 Prime the diluent as described in “Priming the Diluent” on page 10.93. The prime cycle removes excess diluent and pulls air into the Diluent Line. After the diluent prime, you can now replace the Diluent Line as described in the following steps: 3 Open the Fluidics Drawer and slide it out. 4 Open the Reaction Area Cover. 5 Disconnect the Diluent Line from the barbed fitting attached to the right side of the Dilutor Pump Housing (see Figure 10.53). Figure 10.53 Disconnect Diluent Line from Barbed Fitting 10.65 P E R F O R M I N G M A I N T E N A N C E 6 Pull the Diluent Line out of the groove in the Reaction Area. 7 Match the marks on the replacement Diluent Line with each end of the groove in the Reaction Area. Press the tubing into the grooved section of the Reaction Area (see Figure 10.54). Figure 10.54 Press Diluent Tubing into Grooved Section of the Reaction Area 8 Reconnect the tubing connector to the Diluent Bottle Cover. 9 Connect the other end of the Diluent Line to the barbed fitting attached to the right side of the Dilutor Pump Housing (see Figure 10.53. 10 Close the Reaction Area Cover. 11 Prime the diluent as described in “Priming the Diluent” on page 10.93. The prime cycle will bring diluent back into the Diluent Line. 12 Check the Dilutor Pump for air bubbles as described in “Checking Dilutor Pump” on page 10.12. 13 Following a successful Dilutor Pump check, push the Fluidics Drawer back into place and close it. 10.66 E a s y R A O P E R A T O R ’ S M A N U A L Replacing the ISE Reagent Pack Note: This procedure is only required if you have the ISE Module option. This procedure describes how to replace the ISE Reagent Pack. Before you begin, make sure you have a replacement ISE Reagent Pack available to install. To replace the ISE Reagent Pack: 1 From the main Maintenance screen, touch Replacement, and then touch the ISE Reagent Pack check box. You can also select additional replacement tasks by touching the corresponding check boxes. If you do not have the ISE Module option, ISE Reagent Pack displays in gray, rather than black. Figure 10.55 displays. Note that Step 1 is highlighted in pink. Figure 10.55 ISE Reagent Pack Replacement Screen 10.67 P E R F O R M I N G M A I N T E N A N C E 2 Before you can replace the ISE Reagent Pack, the ISE Waste Line must be purged. To purge the ISE Waste Line, touch the Start button in Step 1: Note: As soon as you touch the Start button in Step 1 on any replacement procedure, EasyRA prevents you from accessing any other EasyRA function until the replacement is complete. When the process is complete, Step 2 is highlighted (see Figure 10.56). If more than one replacement task is selected, the corresponding illustrations are displayed beside Step 2. Figure 10.56 ISE Waste Line Purge Complete - Ready to Replace ISE Reagent Pack You can now replace the ISE Reagent Pack manually as described in the following steps. 10.68 E a s y R A 3 O P E R A T O R ’ S M A N U A L Lift the Reaction Area Cover to access the ISE Reagent Pack. It is located on the right side of EasyRA (see Figure 10.57). Figure 10.57 Location of ISE Reagent Pack ISE Reagent Pack 10.69 P E R F O R M I N G M A I N T E N A N C E 4 Disconnect the yellow ISE Reagent Connector from the top of the ISE Reagent Pack (see Figure 10.58). Figure 10.58 Remove the ISE Reagent Connector from the ISE Reagent Pack 5 Set the ISE Reagent Connector down on the bench. 6 Carefully lift the used ISE Reagent Pack out of EasyRA and dispose of it properly. 7 Place the replacement ISE Reagent Pack into EasyRA so that the rounded edge of the cutout for the ISE Reagent Connector faces the back of EasyRA and the label on the ISE Reagent Pack is visible on the right side of EasyRA (see Figure 10.59). Figure 10.59 Insert Replacement ISE Reagent Pack into EasyRA 8 10.70 Remove the red caps from the ISE Reagent Pack. E a s y R A 9 O P E R A T O R ’ S M A N U A L Connect the ISE Reagent Connector to the replacement ISE Reagent Pack (see Figure 10.60). The ISE Reagent Connector will only fit one way. Figure 10.60 Connect the ISE Reagent Connector to the ISE Reagent Pack 10 Close the Reaction Area cover. 11 The ISE Reagent Pack replacement is complete. If more than one replacement task has been selected, complete the steps to perform those tasks (see “Replacing the ISE Sensors” on page 10.73 and/or “Replacing the ISE Pump Tubes” on page 10.80. When all replacement tasks are complete, touch Enter in Step 2 (see Figure 10.56) to indicate that the manual replacement is complete: 10.71 P E R F O R M I N G M A I N T E N A N C E After you touch Enter Step 3: Prime ISE Cal A/B is highlighted and the prime begins. 12 When the prime is complete, a Replacement Complete status message displays at the bottom of the screen indicating the ISE Reagent Pack replacement was completed successfully (see Figure 10.61). Touch Enter beside the message to confirm the replacement is complete: Figure 10.61 ISE Reagent Pack Replacement - Confirm Completion At this time, EasyRA allows you to access all other EasyRA function. 10.72 E a s y R A O P E R A T O R ’ S M A N U A L Replacing the ISE Sensors Note: This procedure is only required if you have the ISE Module option. This procedure describes how to replace the ISE Sensors. Before you begin, make sure you have replacement ISE Sensors available to install. BIOHAZARD: The ISE Module and all associated tubing may contain contaminated material. Treat the ISE Module and the associated tubing as you would any biohazardous material. For information on safety procedures for handling biohazards, see page 10.3. All ISE Sensors have a minimum life of 6 months or 10,000 samples, whichever comes first. For best results, change the Reference Electrode every six months and the other electrodes as required. You can record the installation date in the maintenance log in Appendix B of this manual. Note: Check all new electrodes for o-rings prior to installation. If an o-ring is missing, replace it with a new o-ring. Extra o-rings are supplied in the electrode boxes. To replace the ISE Sensors: 1 From the main Maintenance screen, touch Replacement, and then touch the ISE Sensors check box. You can also select additional replacement tasks by touching the corresponding check boxes. If you do not have the ISE Module option, ISE Sensors displays in gray, rather than black. Figure 10.62 displays. Note that Step 1 is highlighted in pink. 10.73 P E R F O R M I N G M A I N T E N A N C E Figure 10.62 ISE Sensors Replacement Screen 2 Before you can replace the ISE Sensors, the ISE Module must be purged of all fluids. To purge the module of fluids, touch the Start button in Step 1: Note: As soon as you touch the Start button in Step 1 on any replacement procedure, EasyRA prevents you from accessing any other EasyRA function until the replacement is complete. When the process is complete, Step 2 is highlighted (see Figure 10.63). If more than one replacement task is selected, the corresponding illustrations are displayed beside Step 2. 10.74 E a s y R A O P E R A T O R ’ S M A N U A L Figure 10.63 ISE Waste Line Purge Complete - Ready to Replace ISE Sensor(s) You can now replace the ISE Sensor(s) as described in the following steps. 3 Open the Fluidics Drawer and slide it out. Figure 10.64 shows the ISE Module and the location of each electrode. 10.75 P E R F O R M I N G M A I N T E N A N C E Figure 10.64 ISE Module ISE Electrodes (Li+, Na+, K+, Cl-) Reference Electrode Compression Plate ISE Waste Tube 4 Press and hold the Compression Plate down into the Open position. Hold the Compression Plate down during this procedure (see Figure 10.65). Figure 10.65 Replacing ISE Sensors 5 10.76 Remove the Reference electrode by gripping the electrode handle, squeezing it to release it, and then pulling it out. E a s y R A O P E R A T O R ’ S M A N U A L Note: The solution chamber has a small, red bead floating on top of the internal fill solution. Prior to installation, gently shake the Reference electrode to ensure that the red bead is freely floating on the surface of the internal fill solution. Before installing a new Reference electrode, the tube must be removed from the fluid path. Wet the area surrounding the tube, then gently pull to remove it. 6 Install a new Reference electrode by pushing it in above the Compression Plate until it is securely in place. 7 Remove the first electrode that needs to be replaced by gripping the electrode handle, squeezing it to release it, and gently pulling it out straight from the ISE Module (see Figure 10.65). Note: Prior to installation, remove the tape sealing the flow path from the K+ and Li+ electrodes. If any liquid escapes, wipe the electrode dry. Make sure the O-ring is in place. 8 To install a new electrode, push the electrode into its designated position. The handle snaps into the ISE Module. Each electrode is keyed to assure correct placement (see Figure 10.65). CAUTION: 9 To avoid damaging the ISE Module, do not force electrodes into the module. Repeat Steps 7 and 8 for each electrode that needs to be replaced. 10 Release the Compression Plate (see Figure 10.65). 11 Visually confirm the electrodes are properly aligned. Also press your finger against each electrode to verify the alignment. 10.77 P E R F O R M I N G M A I N T E N A N C E 12 Replacement of the ISE Sensor(s) is complete. If more than one replacement task has been selected, complete the steps to perform these tasks (see “Replacing the ISE Reagent Pack” on page 10.67 and/or “Replacing the ISE Pump Tubes” on page 10.80). When all replacement tasks are complete, touch Enter in Step 2 (see Figure 10.63) to indicate that the manual replacement is complete: After you touch Enter, Step 3: Prime ISE Cal A/B is highlighted and the prime begins. 13 When the process is complete, a Replacement Complete status message displays at the bottom of the screen indicating the ISE Sensor(s) replacement was completed successfully (see Figure 10.66). Touch Enter beside the message to confirm the replacement is complete: 10.78 E a s y R A O P E R A T O R ’ S M A N U A L Figure 10.66 ISE Sensor Replacement - Confirm Completion At this time, EasyRA allows you to access all other EasyRA function. 10.79 P E R F O R M I N G M A I N T E N A N C E Replacing the ISE Pump Tubes Note: This procedure is only required if you have the ISE Module option. This procedure describes how to replace the tubes for the three ISE Pumps (see Figure 10.12 and Figure 10.67). Before you begin, make sure you have replacement tubes available for each peristaltic pump. Figure 10.67 ISE Pump Tubing Follow the same procedure to replace the tubes on all three pumps (the ISE Waste Pump and the Cal A and Cal B pumps. Only replace the tubes that are worn or damaged. The tubes are positioned around the ISE Pumps (see Figure 10.68). 10.80 E a s y R A O P E R A T O R ’ S M A N U A L Figure 10.68 Pump Tube Installed On Pump Pump Tubing on Pump BIOHAZARD: The ISE Module and all associated tubing may contain contaminated material. Treat the ISE Module and the associated tubing as you would any biohazardous material. For information on safety procedures for handling biohazards, see page 10.3. To replace the ISE Pump Tubes: 1 From the main Maintenance screen, touch Replacement, and then touch the ISE Pump Tubes check box. You can also select additional replacement tasks by touching the corresponding check boxes. If you do not have the ISE Module option, ISE Pump Tubes displays in gray, rather than black. The ISE Pump Tubes screen displays (see Figure 10.69). Note that Step 1 is highlighted in pink. 10.81 P E R F O R M I N G M A I N T E N A N C E Figure 10.69 ISE Pump Tube Screen 2 Before you can replace the ISE Pump Tube, the ISE Waste Line must be purged of all fluids. To purge the ISE Waste Line, touch the Start button in Step 1: Note: As soon as you touch the Start button in Step 1 on any replacement procedure, EasyRA prevents you from accessing any other EasyRA function until the replacement is complete. When all fluid has been purged, Step 2 is highlighted (see Figure 10.70). If more than one replacement task is selected, the corresponding illustration are displayed beside Step 2. 10.82 E a s y R A O P E R A T O R ’ S M A N U A L Figure 10.70 ISE Waste Line Purge Complete - Ready to Start Replacement You can now replace the ISE Waste Pump Tubes manually as described in the following steps. 3 For each ISE pump that requires new tubing, disconnect both ends of the ISE Pump Tube from the ISE Line. On the left side of each pump, disconnect the clear tubing from double fitted connector (the silver tipped connector). On the right side of each ISE pump, disconnect the barbed connector from the ISE Waste Line (see Figure 10.71). To disconnect the barbed connector, grasp the Waste Line from the back of the Fluidics Drawer with one hand and grasp the barbed connector with the other hand and pull the connector apart. Note: Because the Cal A and Cal B Pump Tubes cannot be purged, there may be fluid in the Cal A and Cal B pump tubing when you disconnect the pump tube connections. Have absorbent plastic-backed paper ready to catch any fluid that may drip from the tubes when you disconnect them. 10.83 P E R F O R M I N G M A I N T E N A N C E Figure 10.71 Pump Tube on ISE Waste Pump Disconnect Waste Tube Connections Pump Inlet 4 10.84 Pump Outlet Push down on the bottom portion of the pump and remove the ISE Pump Tube as shown in Figure 10.72. E a s y R A O P E R A T O R ’ S M A N U A L Figure 10.72 Remove the ISE Pump Tube 5 Install a new ISE Pump Tube by connecting the double fitted connector to the clear tubing on the left side of the pump. 6 Press down on the bottom portion of the pump and stretch the tubing around the pump head. 7 Connect the ISE Pump Tube to the Waste Line at the barbed connector. To connect the line, grasp the Waste Line from the back of the Fluidics Drawer with one hand and grasp the barbed connector on the ISE Pump Tube with the other hand and press them together to make the connection. CAUTION: Use care when connecting the inlet and outlet ends of the Waste Line to the ISE Waste Pump Tube. Failure to connect the ISE Waste Line properly may result in damage to EasyRA. 10.85 P E R F O R M I N G M A I N T E N A N C E CAUTION: Use care when connecting the inlet and outlet ends of the Cal A and Cal B Tubes to the Cal A and Cal B Pump Tubes. Failure to connect the Cal A and Cal B Tubes properly may result in damage to EasyRA. 8 Repeat Steps 3-7 as needed until all the pump tubing for all three ISE Pumps requiring maintenance have been replaced. 9 The ISE Pump Tube Replacement is complete. If more than one replacement task has been selected, complete the steps to perform those tasks (see “Replacing the ISE Reagent Pack” on page 10.67 and/or “Replacing the ISE Sensors” on page 10.73). When all replacement tasks are complete, touch Enter in Step 2 (see Figure 10.70) to indicate that the manual replacement is complete: After you touch Enter, Step 3: Prime ISE Cal A/B is highlighted and the prime begins. 10 When the prime is complete, a Replacement Complete status message displays at the bottom of the screen indicating the ISE Pump Tube(s) replacement was completed successfully (see Figure 10.73). Touch the Enter button beside the message to confirm the replacement is complete: 10.86 E a s y R A O P E R A T O R ’ S M A N U A L Figure 10.73 ISE Waste Pump Tube(s) Replacement - Confirm Completion At this time, EasyRA allows you to access all other EasyRA function. 10.87 P E R F O R M I N G M A I N T E N A N C E Purge/Prime The following are the purge/prime tasks for EasyRA: Purge Waste Line. Prime Diluent. Purge ISE Waste Line. Prime ISE CAl A/B. Note: The ISE procedures are only available if you have the ISE Module option. This section describes the purge/prime procedures. You may use these procedures if you detect bubbles in the system or if you replace components without using the Replacement menu. To perform the purge/prime procedures: 1 Touch the Diagnostics/Maintenance/Setup icon and then touch Maintenance. The Maintenance screen displays (see Figure 10.2). 2 Touch Purge/Prime. A list of the purge/prime tasks that are available displays (see Figure 10.74. 10.88 E a s y R A O P E R A T O R ’ S M A N U A L Figure 10.74 Purge/Prime Procedures From this screen you can choose to perform any of the purge/prime procedures. 10.89 P E R F O R M I N G M A I N T E N A N C E Purging the Waste Line This procedure describes how to purge the Chemistry Waste Line. By purging the Waste Line, you remove all fluids from the Probe, the Wash Cup, and the associated Waste Lines. Use this procedure to clear fluids before replacing any components of the chemistry module (Probe, Wash Cup, Chemistry Waste Pump Tube). BIOHAZARD: All waste and the Waste Pump Tubing may contain contaminated material. Treat all waste and Waste Pump Tubing, during use and disposal, as you would any biohazardous material. For information on safety procedures for handling biohazards, see page 10.3. To purge the Waste Line: 1 From the main Maintenance screen, touch Purge/Prime, and then touch Purge Waste Line. The Purge Waste Line screen displays (see Figure 10.75). 10.90 E a s y R A O P E R A T O R ’ S M A N U A L Figure 10.75 Purge Waste Line Screen 2 To purge the Waste Line, touch the Start Now button: During the purge, the In Progress message displays. When all fluid has been purged, the Complete message displays at the bottom of the screen (see Figure 10.76). Touch the Enter button beside the message to confirm that the purge is complete: 10.91 P E R F O R M I N G M A I N T E N A N C E Figure 10.76 Fluids Have Been Purged from the Waste Line 10.92 E a s y R A O P E R A T O R ’ S M A N U A L Priming the Diluent This procedure describes how to prime the Probe with diluent. You perform this prime if there are bubbles in the Dilutor Pump or if any components of the chemistry module (Probe, Wash Cup, Chemistry Waste Pump Tube) have been replaced. This procedures brings fluid back into EasyRA to prepare it for use. To prime diluent: 1 From the main Maintenance screen, touch Purge/Prime, and then touch Prime Diluent. The Prime Diluent screen displays (see Figure 10.77). Figure 10.77 Prime Diluent 10.93 P E R F O R M I N G M A I N T E N A N C E 2 To prime the diluent, touch the Start Now button: During the prime, the In Progress message displays. When the diluent has been primed, the Complete message displays at the bottom of the screen (see Figure 10.78). Touch the Enter button beside the message to confirm the prime is complete: Figure 10.78 Diluent Has Been Primed 10.94 E a s y R A O P E R A T O R ’ S M A N U A L Purging the ISE Waste Line Note: This procedure is only available if you have the ISE Module option. This procedure describes how to purge the ISE Waste Line. By purging the ISE Waste Line, you remove all fluids from the ISE Module and the associated Waste Lines. Use this procedure to clear fluids from the ISE Module before replacing ISE components. BIOHAZARD: The ISE Module Waste Line may contain contaminated material. Treat the ISE Module Waste Line as you would any biohazardous material. For information on safety procedures for handling biohazards, see page 10.3. To purge the ISE Waste Line: 1 From the main Maintenance screen, touch Purge/Prime, and then touch Purge ISE Waste Line. If you do not have the ISE Module option, Purge ISE Waste Line displays in gray, rather than black. The Purge ISE Waste Line screen displays (see Figure 10.79). 10.95 P E R F O R M I N G M A I N T E N A N C E Figure 10.79 Purge ISE Waste Line Screen 2 To purge the ISE Waste line, touch the Start Now button: During the purge, the In Progress message displays. When the ISE Waste line has been purged, the Complete message displays at the bottom of the screen (see Figure 10.80). Touch the Enter button beside the message to confirm the purge is complete: 10.96 E a s y R A O P E R A T O R ’ S M A N U A L Figure 10.80 ISE Waste Line Has Been Purged 10.97 P E R F O R M I N G M A I N T E N A N C E Priming the ISE Cal A/B Note: This procedure is only available if you have the ISE Module option. This procedure describes how to prime ISE Cal A and Cal B. You perform this prime if bubbles are detected in the ISE Cal A/Cal B Lines or if any components of the ISE Module have been replaced. This procedure brings fluid back into the ISE Module to prepare it for use. To prime the ISE Cal A/Cal B: 1 From the main Maintenance screen, touch Purge/Prime, and then touch Prime ISE Cal A/ B. If you do not have the ISE Module option, ISE Cal A/B displays in gray, rather than black. The Prime ISE Cal A/B screen displays (see Figure 10.81). Figure 10.81 Prime ISE Cal A/B 10.98 E a s y R A 2 O P E R A T O R ’ S M A N U A L To prime Cal A and Cal B, touch the Start Now button: During the prime, the In Progress message displays. When the ISE Cal A and Cal B has been primed, the Complete message displays at the bottom of the screen (see Figure 10.82). Touch the Enter button beside the message to confirm the prime is complete: Figure 10.82 ISE Cal A/Cal B Have Been Primed 10.99 P E R F O R M I N G M A I N T E N A N C E Using Maintenance Logs As maintenance activities are performed, entries are made into the automatically generated maintenance logs: Daily Inspection Log Daily Cleaning Log Monthly Cleaning Log Replacement Log Precision Log (diagnostic test) As each entry is logged, EasyRA automatically enters a check mark to show it has been completed. You can add an Operator ID for the person performing the maintenance and notes about the activity. You can also add additional manual entries to the maintenance logs and print the logs. Lastly, EasyRA will display due dates for each maintenance task and will highlight tasks that are past due. This section describes how to use the maintenance logs. Viewing Maintenance Logs The maintenance logs can be viewed by touching the Log button that displays on some maintenance, cleaning, or diagnostic screens. To view maintenance logs: 1 2 10.100 Touch the Diagnostics/Maintenance/Setup icon, and then touch any of the following: Diagnostics > Precision Test Cleaning Maintenance > Daily Inspection Maintenance > Monthly Cleaning Maintenance > Replacement When you touch any of the above selections, a Log button displays in the upper right corner of the screen. (See Figure 10.83 for an example of the Log button for the Daily Inspection screen). E a s y R A O P E R A T O R ’ S M A N U A L Figure 10.83 Log Button on Daily Inspection Screen 10.101 P E R F O R M I N G M A I N T E N A N C E 3 To display the log for the selected maintenance activities, touch the Log button. The appropriate maintenance log displays. When you select the Log button for the Precision Test, the Precision Log displays (see Figure 10.84). Figure 10.84 Precision Log 10.102 E a s y R A O P E R A T O R ’ S M A N U A L When you select the Log button for Cleaning, the Daily Cleaning Log displays (see Figure 10.85). Figure 10.85 Daily Cleaning Log 10.103 P E R F O R M I N G M A I N T E N A N C E When you select Daily Inspection, the Daily Inspection Log displays (see Figure 10.86). Figure 10.86 Daily Inspection Log 10.104 E a s y R A O P E R A T O R ’ S M A N U A L When you select Monthly Cleaning, the Monthly Cleaning Log displays (see Figure 10.87). Figure 10.87 Monthly Cleaning Log When you select Replacements, the Replacement Log displays. The Replacement Log has three tabs: Replacements (see Figure 10.88) ISE Sensor Replacement Log (see Figure 10.89) Replacement Schedule (see Figure 10.90) 10.105 P E R F O R M I N G M A I N T E N A N C E Figure 10.88 Replacement Log Figure 10.89 ISE Sensor Replacement Log 10.106 E a s y R A O P E R A T O R ’ S M A N U A L Figure 10.90 Replacement Schedule Adding an Operator ID or Notes to a Maintenance Log Entry When maintenance activities are completed, a popup displays allowing entry of an Operator ID or Notes for all logs, except the Precision Log and the Cleaning Log. This information will be added into the maintenance log entry. To add an operator ID or notes to a maintenance log entry: 1 From the main Maintenance screen, select either Daily Inspection, Monthly Cleaning, or Replacement or from the main Diagnostics screen, select Precision Test (for Operator ID only). 2 Touch one or more check boxes to select the maintenance task(s) to be completed or select Precision Test from the Diagnostics menus. 3 Complete the selected test(s). 10.107 P E R F O R M I N G M A I N T E N A N C E 4 When the test or tests are complete, a dialog displays. Depending the test that was run, you will be asked to enter the Operator Initials, and/or Notes (see Figure 10.91 for an example of the dialog) These are optional entry fields. Figure 10.91 Enter Operator Initials and Notes 10.108 5 Touch each field and enter alphanumeric characters on the alphanumeric keypad to complete it, then touch Enter. The Operator initial field can have up to 4 characters and the Notes field can have up to 30 characters. 6 Touch Enter on the dialog when you are done. 7 Touch the Log button. The new entry is added to the log. This entry includes the information that was manually entered (see Figure 10.92). The check marks indicating that maintenance has been completed are replaced with the operator’s initials if an Operator ID was entered in Step 5. E a s y R A O P E R A T O R ’ S M A N U A L Figure 10.92 Maintenance Log with Operator ID and Notes Added 10.109 P E R F O R M I N G M A I N T E N A N C E Adding a Manual Entry to a Maintenance Log You can add entries to any of the following maintenance logs: Daily Inspection Log Monthly Cleaning Log Replacement Log ISE Replacement Log To add an entry to the log 1 Touch the Add icon (+) on the logs listed above (see Figure 10.93). Figure 10.93 Touch the Add Icon (+) to Add a Manual Entry 2 10.110 A new dated entry appears on the maintenance log (see Figure 10.94, top). Touch the field of interest that you want to fill in. The alphanumeric keypad appears from which you can enter data in the selected field. Touch Enter on the keypad when you are done entering data in that field. E a s y R A O P E R A T O R ’ S M A N U A L Figure 10.94 Use the Alphanumeric Keypad to Enter Data in Manual Entry 3 Repeat Step 2 as required to fill in all fields in the manual entry. 10.111 P E R F O R M I N G M A I N T E N A N C E 4 Touch Enter at the top of the Maintenance Log (see Figure 10.95). Figure 10.95 Touch Enter at the Top of the Maintenance Log 10.112 E a s y R A O P E R A T O R ’ S M A N U A L The manual entry is added to the maintenance log (see Figure 10.96). Figure 10.96 The Manual Entry is Added to the Maintenance Log 10.113 P E R F O R M I N G M A I N T E N A N C E Printing Maintenance Logs There are two printing options for all logs except the Precision Log. You can print either the current maintenance log being displayed or you can print a set of all maintenance logs (Daily Inspection Log, Monthly Cleaning Log, Replacement Log, and ISE Sensor Replacement Log) for a selected month. (You can only print the current Log for the Precision Log.) To print maintenance logs: 1 Touch the Print button on any of the maintenance logs (see Figure 10.97 for an example of the Print button on the Monthly Cleaning Log). Figure 10.97 Print Button on the Monthly Cleaning Log 2 A drop down menu appears allowing you to choose either the Current Table or a Monthly Report (see Figure 10.98). Figure 10.98 Print Log Drop Down 10.114 E a s y R A O P E R A T O R ’ S If Current Table is selected, all the log entries in the log that is currently displayed are printed. For example, all data logged in the Monthly Cleaning Log since you started using EasyRA will be printed If Monthly Report is selected, a dialog opens asking you to select the month and year of interest. When you touch Enter, all data logged in all maintenance logs for the selected month and year will be printed. This Monthly Maintenance Report includes a Daily Cleaning and Inspection Log, Monthly Cleaning Log, Replacement Log, and ISE Sensor Replacement Log. The Daily Cleaning and Inspection Log contains entries from both the Daily Inspection Log and Daily Cleaning Log. M A N U A L Saving Results to a CD or a USB Drive The following sections describe how to save EasyRA results to a CD or an external USB drive. Results that may be saved to a CD or USB Drive include the following: Patient/Test Results. Calibration Results. QC Results. All Results (Patient, Calibration and QC). Data is saved in an .xml format, which may be imported into common Windows programs such as Word® or Excel® (2003 or later versions). All Patient/Test, Calibration and QC results are recorded onto the CD or USB Drive each time these processes are performed. To view patient sample results or QC test results that have been saved manually, the results must first be saved to a CD or a USB Drive as described below in order to view them at a later date. For more information on viewing patient sample results, see “Viewing Patient Sample Results” on page 7.31 and for more information on viewing QC test results, see “Viewing QC Test Results” on page 7.49. The EasyRA analyzer stores up to: 2000 patient results (56,000 test results). 31 days, 9 results/day of QC results for each QC material. Current and last Calibration Results. When the above onboard storage limits are reached, the oldest results will be deleted from the system first. If the Save Data to a CD or USB feature is used, it is recommended that you save results on a preset interval to ensure that all results are saved before they are automatically purged from EasyRA. 10.115 P E R F O R M I N G M A I N T E N A N C E An example of saving data is listed below: Your lab averages 50 patients per day, with 10 tests per patient (15,000 tests per 30 day period). Quality control material is run daily with six data points for each level. Calibrations are performed on an as needed basis based on the calibration intervals for individual analytes. Patient Results may be saved every 90 days (45,000 test results) unless an increase in patient testing is observed. QC Results may be saved every 31 days. Calibration results may be saved as necessary depending on the intervals set by individual analytes. Saving Results to a CD Note: The following information is for Saving All Results to a CD. However, the same procedure may be followed for individual result sets: Patient, Calibration or QC Results. Before you begin, make sure you have a blank CD available and CD burner in place. To save all results to a CD: 1 Touch the Diagnostics/Maintenance/Setup icon and then touch Maintenance. The Maintenance screen displays (see Figure 10.2). 2 10.116 Touch Save Results to CD. E a s y R A O P E R A T O R ’ S M A N U A L A list of the different types of results that can be saved displays (see Figure 10.99). Figure 10.99 Save Results to CD Screen From this screen you can choose to save various results to the CD. 10.117 P E R F O R M I N G M A I N T E N A N C E 3 To save all results to the CD, touch All Results. The Save Results screen displays (see Figure 10.100). Figure 10.100 Save Results to CD Screen 10.118 E a s y R A 4 O P E R A T O R ’ S M A N U A L Place a blank CD in the CD burner and touch the Run button: The Save Results to CD popup displays (see Figure 10.101). Figure 10.101 Save Results to CD Popup 10.119 P E R F O R M I N G M A I N T E N A N C E 5 Touch Ok. Saving Results uses the Windows-based CD writing program. The CD writing wizard displays (see Figure 10.102). Figure 10.102 Windows CD Writing Wizard 6 The CD Writing Wizard will ask you to name your CD. The default name is the current date. After naming your CD, touch Next. 7 Follow the on-screen instructions for writing to a CD. 8 The CD writing Wizard will confirm that the information was successfully written to the CD. Saving Results to a USB For complete information on types of results that can be saved, see “Saving Results to a CD or a USB Drive” on page 10.115 This procedure describes how to save EasyRA results to a USB Drive. Before you begin, make sure you have a USB (Universal Serial Bus) or storage device available. To save all results to a USB Drive: 1 10.120 Touch the Diagnostics/Maintenance/Setup icon and then touch Maintenance. The Maintenance screen displays (see Figure 10.2). E a s y R A 2 O P E R A T O R ’ S M A N U A L Touch Save Results to USB. A list of the different types of results that can be saved displays (see Figure 10.103). Figure 10.103 Save Results to USB Screen From this screen you can choose to save various results to the USB Drive. 10.121 P E R F O R M I N G M A I N T E N A N C E 3 To save all results to the USB Drive, touch All Results. The Save Results screen displays (see Figure 10.104). Figure 10.104 Save Results to USB Drive Screen 4 Insert the USB Drive into the USB port and touch the Run button: A Browser dialog opens. Select the USB Drive and the location on that drive where the data should be saved and select Save. 5 10.122 The selected data is saved to the USB Drive. The Browser dialog disappears to reveal the Save Results screen shown in Figure 10.104 when the data has been saved. 11 Troubleshooting & Diagnostics Introduction This chapter describes troubleshooting and diagnostics for EasyRA. Troubleshooting The Troubleshooting section is divided into three different areas: Hardware Problems Measurement Problems Range Problems Hardware problems, when they occur, are associated with the flashing System icon found in the upper left hand corner of the screen. By touching the System icon, you can access information about the hardware problems in an error table. Hardware problems also display a popup message informing you of the nature of the problem. If a Worklist is ended by a hardware problem or is ended by a user, an SE (System Error) error code appears in the Flags column on the Results screen. Measurement problems are shown on the Results screen in the center or left side of the Flags column. Range problems are shown on the Results screen in the center or right side of the Flags column. 11.1 T R O U B L E S H O O T I N G & D I A G N O S T I C S Hardware Problems Whenever a hardware (or scheduler) error occurs, a code is presented that defines the area of the system that triggered the error and a description of what caused the error. The code is a five digit alphanumeric string having the form: axxyy a - represents either a subsystem area or scheduler software where EasyRA detected the problem. Possible values are for hardware errors: a = Transfer Arm r = Reaction Area/Cuvette Wheel d = Dilutor Pump p = Probe s = Sample/Reagent Area Wheel f = Photometer i = ISE Module t = Radio Frequency Tag Possible values are for schedule errors: c = Communications Error xx - represents either the hardware position on the Sample Ring/ Reagent Tray (01=Position 1, 24 = Position 24, etc.), or the position on the Cuvette Carousel (01 = Position 1, 72 = Position 72). yy - furthers pinpoint the location and type of problem. Hardware error codes help you troubleshoot and correct problems. Scheduler errors also indicate the location and type of software problems that have occurred. The scheduler error codes assist you in providing service personnel with information in the event that a problem occurs. 11.2 E a s y R A O P E R A T O R ’ S M A N U A L Table 11.1 shows the errors that may be displayed and describes how to recover from each error. More information on the diagnostics procedures referred to in the table are available in “Running Diagnostics Tests” on page 11.21. Most errors are best cleared by performing diagnostic tests indicated by the error code. However, if this procedure fails to clear the error, EasyRA hardware may be reset by touching the Reset button located above the System Status table. Table 11.1 Hardware Problems -- Error Codes with Recovery Steps ERROR LOCATION CODE MEANING Transfer Arm a0001 Failure to find Home. TROUBLESHOOTING AND RECOVERY Check for: An object in the path of the Transfer Arm, or a hand or arm inadvertently placed in the path of the Transfer Arm. Other Causes: Optical Sensor Failure, or Electro/Mechanical Failure. To recover: Go to Diagnostic menu and select Transfer Arm/ Probe, Arm Positioning, Press Start. If unsuccessful: Touch the Reset button located above the System Status Table to reset the hardware. Call Service. Transfer Arm a0002 Failure to stop at a position selected. See Transfer Arm, Error a0001. 11.3 T R O U B L E S H O O T I N G Table 11.1 & D I A G N O S T I C S Hardware Problems -- Error Codes with Recovery Steps ERROR LOCATION CODE MEANING Cuvette Wheel r0001 Failure to find Home. TROUBLESHOOTING AND RECOVERY Check for: Foreign object preventing rotation of Cuvette Wheel. Other Causes: Optical Sensor Failure, or Electro/Mechanical Failure. To recover: Go to the Diagnostics menu and touch Reaction Area. Touch Cuvette Wheel, and then touch Start. If unsuccessful: Touch the Reset button located above the System Status Table to reset the hardware. Call Service. Cuvette Wheel r0002 r0005 r0006 Failure to stop at position selected. See Cuvette Wheel, Error r0001. Dilutor Pump d0001 Failure to find Home. Caused by: Optical Sensor Failure, or Electro/Mechanical Failure. To recover: Go to the Diagnostics menu and touch Fluidics Drawer. Touch Dilutor Pump, and then touch Start. If unsuccessful: Touch the Reset button located above the System Status Table to reset the hardware. Call Service. Dilutor Pump 11.4 d0002 Failure to move to position selected. See Dilutor Pump, Error d0001. E a s y R A Table 11.1 O P E R A T O R ’ S M A N U A L Hardware Problems -- Error Codes with Recovery Steps ERROR LOCATION CODE MEANING Probe pxxx1 Failure to find Home. TROUBLESHOOTING AND RECOVERY Check for: Foreign object preventing the Transfer Arm from reaching its proper height. Other Causes: Optical Sensor Failure, or Electro/Mechanical Failure. To recover: Go to the Diagnostics menu and touch Transfer Arm/Probe. Touch Probe Positioning and then touch Start. If unsuccessful: Touch the Reset button located above the System Status Table to reset the hardware. Call Service. Probe pxxx2 Failure to move to down. Caused by: Optical Sensor Failure, or Electro/Mechanical Failure. To recover: Go to the Diagnostics menu and touch Transfer Arm/Probe. Touch Probe Positioning and then touch Start. If unsuccessful: Touch the Reset button located above the System Status Table to reset the hardware. Call Service. Probe pxxx3 pxxx6 pxxx7 Liquid Level Sensor failure. Caused by: Electro/Mechanical Failure. To recover: Go to the Diagnostics menu and touch Transfer Arm/Probe. Touch Liquid Level Sensing. Place a Sample Cup filled with 1 mL of water in Position 1 and then press Start. If unsuccessful, call Service. 11.5 T R O U B L E S H O O T I N G Table 11.1 & D I A G N O S T I C S Hardware Problems -- Error Codes with Recovery Steps ERROR LOCATION CODE MEANING Probe pxx34 Probe collisions at Wash Cup. TROUBLESHOOTING AND RECOVERY Check for: Foreign Objects Blocking the Access of the Probe. Other Causes: Electro/Mechanical Failure. To recover: Go to the Diagnostics menu and touch Transfer Arm/Probe. Touch Probe Positioning and then touch Start. If test runs successfully, error is resolved. If unsuccessful, call Service. Probe pxx44 Probe collisions at ISE Cup. Check for: Foreign objects blocking the access of the Probe to the ISE Cup. Other Causes: Electro/Mechanical Failure. To recover: Probe pxx54 Probe collisions at Cuvette. See Probe, Error p0034. Check for: Foreign objects blocking the access of the Probe to the Cuvette. Other Causes: Electro/Mechanical Failure. To recover: Probe pxx64 Probe collisions at Park position (Home). See Probe, Error p0034. Check for: Foreign objects blocking the access of the Probe to the Park Position. Other Causes: Electro/Mechanical Failure. To recover: 11.6 See Probe, Error p0034. E a s y R A Table 11.1 O P E R A T O R ’ S M A N U A L Hardware Problems -- Error Codes with Recovery Steps ERROR LOCATION CODE MEANING Probe p0104 Probe collisions at Reagent Wedge (R2) Reagent Position 1. TROUBLESHOOTING AND RECOVERY Check for: Caps on the Reagent Wedge in Position 1. If caps are present, they must be removed. Foreign objects preventing the Probe from accessing Reagent 2 position. Other Causes: Electro/Mechanical Failure. To recover: Probe p0105 Exceeded Maximum Step Number at Reagent Wedge (R2) Reagent Position 1. See Probe, Error p0034. Check for: The presence of a Sample in Position 1. If a Sample is not present, add the correct Sample to Position 1. The Volume in the Sample Tube in Position 1 is above the indicator notch on the holder. If the volume in the tube is below the notch, transfer some serum to a Nesting Cup and place the Cup in the Collection Tube and restart the run. Other Causes: Electro/Mechanical Failure. To recover: Probe p0114 Probe collisions at Reagent Wedge (R1) in Reagent Position 1. See Probe, Error p0034. Check for: Caps are removed from the Reagent Wedge in Position 1. No foreign objects are preventing the Probe from accessing Reagent Position 1. Other Causes: Electro/Mechanical Failure. To recover: See Probe, Error p0034. 11.7 T R O U B L E S H O O T I N G Table 11.1 & D I A G N O S T I C S Hardware Problems -- Error Codes with Recovery Steps ERROR LOCATION CODE MEANING Probe p0124 Probe collisions at Sample. TROUBLESHOOTING AND RECOVERY Check for: Stopper Is removed from Collection Tube in Position 1. If a Cup is present in Position 1, check that is it filled with Sample, Cal, or QC fluid. No foreign objects prevent the Probe from accessing Reagent Position 1. Other Causes: Electro/Mechanical Failure. To recover: Sample/ Reagent Wheel s0001 Failure to find Home. See Probe, Error 0034. Check for: Sample Ring is present and installed correctly. The Reflector (under Position 13) on Inside Wall of Sample Ring is not blocked. Encoder Slots are Clean. Other Causes: Electro/Mechanical Failure. To recover: Go to the Diagnostics menu and touch Reagent/ Sample Area. Touch Sample Wheel, and then touch Start. If test runs successfully, error is resolved. If unsuccessful, call Service. Sample/ Reagent Wheel s0002 Failure to stop at position selected. Check for: Sample Ring is present and installed correctly. Encoder Slots are Clean. Other Causes: Electro/Mechanical Failure. To recover: 11.8 See Sample/Reagent Wheel, Error s0001. E a s y R A Table 11.1 O P E R A T O R ’ S M A N U A L Hardware Problems -- Error Codes with Recovery Steps ERROR LOCATION CODE MEANING Photometer f0020 Filter Wheel failed to find Home. TROUBLESHOOTING AND RECOVERY May be Caused by Electro/Mechanical Failure. To recover: Go to the Diagnostics menu and touch Reaction Area. Touch Photometer, and then touch Start. If test runs successfully, the error is resolved. If unsuccessful, call Service. Photometer f0021 Filter Wheel failed to position correctly. See Photometer, Error f0020. Photometer f0022 Filter Wheel position is unknown. See Photometer, Error f0020. Photometer f0023 Photometer Timeout failure. See Photometer, Error f0020. Photometer f0024 Signal Conversion Error. See Photometer, Error f0020. ERROR TROUBLESHOOTING AND RECOVERY LOCATION CODE MEANING Photometer f0025 Flash Lamp timing sequence failed. See Photometer, Error f0020. Photometer f0026 Optical Sensor failed. See Photometer, Error f0020. Photometer f0027 Conversion out of acceptable range. See Photometer, Error f0020. Photometer f0029 Communication Timeout. See Photometer, Error f0020. Photometer f0030 Initialization ADC Error. See Photometer, Error f0020. Photometer f0031 Calibration ADC Error. See Photometer, Error f0020. Photometer f0032 EE Prom Error. See Photometer, Error f0020. Photometer f0033 Photometer Diagnostic Failure Periodic Photometer Diagnostic Failure To recover: Rerun Photometer Diagnostic. If unsuccessful, call Service. Photometer f0099 Communication Error. See Photometer, Error f0020. ISE Module i0060 Communication failure. Call Service. ISE Module i0061 Response Time Out. Call Service. 11.9 T R O U B L E S H O O T I N G Table 11.1 & D I A G N O S T I C S Hardware Problems -- Error Codes with Recovery Steps ERROR LOCATION CODE MEANING System Communications cxxxx Communication Errors. Writing to Radio Frequency Tags t0145 TROUBLESHOOTING AND RECOVERY To recover: Press the Reset Hardware button on the System Status screen. Check Serial cable. Restart EasyRA User Interface. If that fails to establish communications, call Service. Position 1 RFID Tag ID Write Error. This error may be caused by a defective RFID Tag on a Reagent Wedge in Position 1. This error occurs after all Reagents and Samples from a run have been dispensed. It will not result in a System Error flag being shown in the Current Results table. The System Status icon will blink because the instrument was unable to write data to the RFID chip. To recover: Writing to Radio Frequency Tags 11.10 t0146 Position 1 RFID Write Verification Error. To determine whether the RFID Tag is defective, place the Reagent Wedge that failed in Position 1 of the Reagent Tray. Go to the Diagnostics menu and touch Reagent/ Sample Area. Touch RFID, and then press Start. If the RFID Tag passes, the System icon stops blinking. If it fails, the Tag may be defective. Place a new Reagent Wedge in Position 1 and repeat the test. If it still fails, call Service. If it passes, the first Reagent Wedge RFID is defective. See Writing to Radio Frequency Tags, Error t0145. E a s y R A O P E R A T O R ’ S M A N U A L Measurement Problems Measurement problems appear in the Results screen on the left side of the Flags column when combined with a Range error) or in the center of the Flags column. Measurement problems can also appear on the ISE Calibration Results screen in the Flags column. These errors occur during the Measurement phase of the test, and may affect the result presented. In some cases, test results are suppressed because they will not represent an accurate assessment of the activity or concentration present. Table 11.2 shows the errors that may be displayed and describes how to recover from each error. Table 11.2 CHEMISTRIES Measurement Problems ABBREVIATION MEANING TROUBLESHOOTING AND RECOVERY Substrate depletion. Reagent ran out of substrate for enzymes. AFFECTED Optical Measurement Flags ALT ALP AMY AST CK GGT LDH SD ALB BUN Ca CHOL CO2 CREA CREA-U DBIL Fe GLU HDL, Mg PHOS TBIL TP TRIG URIC LH To recover: Rerun the test. The Rerun program will automatically reduce the Sample volume to either 0.5 or 0.33 of the original Sample volume and add to this same Reagent volume. If the SD flag persists after auto dilution, dilute the Sample with normal saline, and then rerun the Sample. Linear Range - High Results exceeded the high end of the Linear Range of a Reagent for a particular test. To recover: The Analyzer will automatically rerun the test with a smaller Sample, but with the same Reagent volume. If the LR flag persists after auto dilution, dilute the Sample with normal saline, and then rerun the Sample. 11.11 T R O U B L E S H O O T I N G Table 11.2 CHEMISTRIES & D I A G N O S T I C S Measurement Problems ABBREVIATION MEANING TROUBLESHOOTING AND RECOVERY ALT ALP AMY AST CK GGT LDH BUN CREA CREA-U RN Reaction Rate Noise. A single point is more than 0.003 mAbs from the Line of Best Fit. The point is removed and the rate is recalculated. ALT ALP AMY AST CK GGT LDH BUN CREA CREA-U HN ALB Ca CHOL CO2 DBIL Fe GLU HDL Mg PHOS TBIL TP EN AFFECTED 11.12 To recover: If this occurs infrequently, no troubleshooting is required. If this occurs frequently, check for air and fluid leaks in the Fluidics connections to the Probe and Dilutor. High Reaction Rate Noise. Two or more points are 0.003 mAbs from the Line of Best Fit. The results are not shown. Check for: Leaks in the Fluidics connections. To recover: Go to Maintenance menu and touch Prime Diluent to remove bubbles. Replace the Probe, if necessary. End Point Noise. Primary Wavelength Absorbance measurements differ by more than 1% or 0.002 Abs., whichever is larger. Check for: Photometer errors. Presence of bubbles in the Cuvette. To recover: Go to Diagnostics menu and touch Check Photometer. Perform a Prime Diluent to remove bubbles from the Cuvette. Replace the Probe, if necessary. E a s y R A Table 11.2 CHEMISTRIES O P E R A T O R ’ S M A N U A L Measurement Problems ABBREVIATION MEANING TROUBLESHOOTING AND RECOVERY ALB ALT ALP AMY AST Ca BUN CHOL CK CO2 CREA CREA-U DBIL Fe GGT GLU HDL LDH Mg PHOS TBIL TP TRIG URIC HA High Absorbance. The Absorbance for the test is greater than 2.5 Abs. units. ALT ALP AMY AST CK GGT LDH BUN CREA CREA-U RD AFFECTED To recover: Reaction Direction. Dilute the Sample 1:1 with saline and rerun the test. The Reaction Rate is trending in the wrong direction. Check for: An extremely Lipemic Sample. Sample may be clearing as Reaction proceeds. Cuvettes with bubbles in the Optical Path. To recover: Perform a Prime Diluent to remove bubbles from the Optical Path. Replace the Probe, if necessary. 11.13 T R O U B L E S H O O T I N G Table 11.2 CHEMISTRIES & D I A G N O S T I C S Measurement Problems ABBREVIATION MEANING TROUBLESHOOTING AND RECOVERY CF Calibration Factor Range. The Calibration Factor is Outside a Pre-set Range. AFFECTED ALB Ca BUN CHOL CO2 CREA CREA-U DBIL Fe GLU HDL Mg, PHOS TBIL TP TRIG URIC To recover: Verify that the concentration of the Calibrant is entered correctly. If concentration of the Calibrant is correct, install a new Reagent Wedge and recalibrate. If the error persists, call Service. ISE Measurement Flags and Errors Na+ + K Li+ Cl– BN, AN, SN Noise in measurement of Cal B, Cal A, or Sample. A persistent noise error occurring on a single sensor indicates a deteriorating sensor or transient Electrical Noise. Persistent noise errors occurring on multiple Sensors indicate a faulty Reference Electrode. To recover: 11.14 Replace the noisy sensor, if indicated. Replace the Reference Electrode, if indicated. E a s y R A Table 11.2 CHEMISTRIES O P E R A T O R ’ S M A N U A L Measurement Problems ABBREVIATION MEANING TROUBLESHOOTING AND RECOVERY AD, BD Two subsequent Cal A or Cal B results differ by more than a preset voltage. Occasional errors may be caused by changes in temperature of the ISE Module or a new sensor that needs hydration. Some sensors may require 10 minutes to rehydrate. A persistent error on a single sensor indicates a deteriorating sensor. Errors occurring on multiple sensors indicate a faulty Reference Electrode. AFFECTED Na+ + K Li+ Cl– To recover: Na+ K+ Li+ Cl– AS Air in Sample. Allow adequate time for sensors to rehydrate. Replace the deteriorating sensor, if indicated. Replace the Reference Electrode, if indicated. This error may be caused by a short sample or a clot in the sample Probe or the ISE Module. Check for: Adequate sample volume. The presence of clots in the sample. To recover: Increase sample volume if indicated. If a clot is present, perform a System and ISE Cleaning. If the error persists, call Service. 11.15 T R O U B L E S H O O T I N G Table 11.2 CHEMISTRIES & D I A G N O S T I C S Measurement Problems ABBREVIATION MEANING TROUBLESHOOTING AND RECOVERY AA, AB Air in Cal A or Cal B. This problem can be caused by a bubble trapped in the Cal A or Cal B. If you repeat the analysis without an error, then it was an isolated problem that resolved itself. AFFECTED Na+ + K Li+ Cl– If the problem persists the system may be obstructed from a clot or the sensor stack may have a leak. To recover: Repeat the analysis. If the error persists, run the ISE Cleaner to remove the clot and/or disassemble the ISE stack and carefully clean each component. Ensure that the sensor o-rings are in place and each sensor is properly compressed. Na+ K+ Li+ Cl– SR Slope of one or more sensors is out of Acceptable Range. The following problems may cause sensor slopes to be out of range: A sensor is misaligned. A sensor is deteriorated. The Reference Sensor is deteriorated. There is an air bubble on the Reference Sensor membrane. The operating temperature is too high. To recover: Remove the misaligned sensor, reseat it, and recalibrate. Replace the deteriorated sensor and recalibrate. If an air bubble is present on the Reference Sensor membrane, remove the sensor, tap it to dislodge the bubble, and then reseat it and recalibrate. If the ambient temperature is higher than 31°C, move the instrument to a cooler location. 11.16 E a s y R A Table 11.2 CHEMISTRIES O P E R A T O R ’ S M A N U A L Measurement Problems ABBREVIATION MEANING TROUBLESHOOTING AND RECOVERY BD ISE Bubble Detector Error. The Bubble Detector can fail because of a faulty Waste Pump or a faulty Bubble Detector. AFFECTED Na+ + K Li+ To recover: Cl– Perform a Prime Cycle. Replace the ISE Waste Pump tubing and then perform the ISE Diagnostic Test. If the error persists, call Service. Na+ PC ISE Pump Cal Error. K+ Li+ Generally Pump Calibration failure is caused by a faulty peristaltic pump or an obstruction of the flow path. To recover: Cl– Na+ MV + K Cal A or Cal B Voltage outside a Preset Range. Inspect the sensors and flow path for the blockage, and then perform an ISE Cleaning Cycle. Perform a Prime Cycle. Perform the ISE Diagnostic Test. If the Pump Calibration is still out of range, replace the three ISE pump tubes. Repeat the ISE Diagnostic test. If the Pump Calibration is still out of range, replace the ISE Reagent Pack. If the error persists, call Service. May be caused by a misaligned or faulty sensor. Li+ To recover: Cl– Reseat the sensor and retest. If the error persists, replace the sensor. If the error persists, call Service. Na+ + K RW Dallas Chip Read/Write Error. The instrument is unable to communicate with the Dallas Chip on the ISE Reagent Pack. Li+ To recover: Cl– Reseat the ISE Reagent Connector. If the error persists, replace the ISE Reagent Pack. If the error persists, call Service. 11.17 T R O U B L E S H O O T I N G Table 11.2 CHEMISTRIES & D I A G N O S T I C S Measurement Problems ABBREVIATION MEANING TROUBLESHOOTING AND RECOVERY IE Communication Failure with ISE Module The instrument is unable to communicate with the ISE module. AFFECTED Na+ + K Li+ To recover: Cl– Turn EasyRA off, and then on. Enter the EasyRA User Interface. If the error persists, call Service. Na+ + K Li+ Cl– NF ISE Module Fails to Position Sample or Standard May be caused by a disconnected Reagent connector or an obstruction in the flow path of the ISE Electrodes. To recover: Reseat the ISE Reagent Connector and perform an ISE Prime. If the error persists, slide out the Fluidics Drawer and remove all electrodes. Using a stylus or blunt needed, ensure there is no obstruction in the ISE flow path by pushing the stylus through (from top to bottom) the hole located in the bottom of the ISE Cup. Reinstall the ISE Electrodes and perform an ISE Prime. If the error persists, call Service. 11.18 E a s y R A O P E R A T O R ’ S M A N U A L Range Problems EasyRA allows you to set four different ranges: QC Ranges, Normal Ranges, Critical Ranges, and ReRun Ranges. These range errors appear in the Results screen in the Flags column. They occur because the calculated results fall outside the preset ranges you set (or the default values). Table 11.3 shows the errors that may be displayed and describes how to recover from each error. Table 11.3 Range Problems CHEMISTRIES ABBREVIATION MEANING TROUBLESHOOTING AND RECOVERY QC Values for QC Results outside of Preset Range. Values for QC samples can fall outside of the Normal Ranges based upon simple statistical rules. Persistent values outside the acceptable QC Range may indicate that the QC or Cal Ranges were entered incorrectly. AFFECTED All chemistries To recover: Verify the QC and Cal Ranges are correct. If the values were entered correctly, EasyRA may require recalibration. If recalibration does not correct the QC Flag, replace the old Reagent Wedge with a new Reagent Wedge and recalibrate. If problem persists, call Service. All chemistries NR Values outside of Preset Normal Range. A significant number of patient samples are falling outside the Normal Range. To recover: Verify the Normal Range Limits are correct. Verify calibration and QC ranges and values are correct. If all values are correct and the error persists, call Service. 11.19 T R O U B L E S H O O T I N G & D I A G N O S T I C S Table 11.3 Range Problems CHEMISTRIES ABBREVIATION MEANING TROUBLESHOOTING AND RECOVERY CR Values outside of Preset Critical Range. A significant number of patient samples are falling outside the Critical Range. AFFECTED All chemistries To recover: Verify the Critical Range Limits are correct. Verify calibration and QC ranges and values are correct. If all values are correct and the error persists, call Service. All chemistries RR Values outside of Preset Rerun Range. A significant number of patient samples are falling outside the Rerun Range values. To recover: Verify the Rerun Range Limits are correct. Verify the calibration and QC ranges and values are correct. If all values are correct and the error persists, call Service. 11.20 E a s y R A O P E R A T O R ’ S M A N U A L Running Diagnostics Tests This section provides a detailed description of the diagnostics tests available from EasyRA. It includes a description of each test, how to run each test, and what to do after the test is run. Table 11.4 describes the symptoms that may occur that indicate that a diagnostic test should be run. Table 11.4 Symptoms Indicating Diagnostics Should Be Run SYMPTOM DIAGNOSTIC TEST TO BE RUN OR ACTION TO BE TAKEN Test or QC measurements appear to be noisy (more variable than expected). Reaction Area - Photometer Error message reports that some aspect of the Cuvette Wheel function has failed. Reaction Area - Cuvette Wheel Probe positioning error has been reported. Transfer Arm/Probe - Arm Positioning Probe positioning error has been reported. Transfer Arm/Probe - Probe Positioning Bump Switch error has been reported in the sample cup or Reagent Wedge. Transfer Arm/Probe - Liquid Level Sensing Dilutor Pump error occurs, OR Precision Dye Test fails, OR Patient (QC) results are noisy. Fluidics Drawer - Diluter Pump Wash Cup does not empty properly or is overflowing. Fluidics Drawer - Waste Pump Accuracy and precision of ISE measurements are questionable. Fluidics Drawer - ISE Sensor System Some aspect of the Reagent/Sample Area function (positioning, stopping, starting) has failed. Reagent/Sample Area - Sample Wheel The Barcode Reader is not functioning properly. Reagent/Sample Area - Barcode Reader The RFID Reader is not functioning properly. Reagent/Sample Area - RFID Reader Temperature errors have been reported. Heater/Cooler Improper locking of covers. Covers and Latches Precision and accuracy of Dilutor Pump, and, to a lesser degree, the Photometer, are questionable. Precision Test Increase in Analyzer temperature. Check the filter for dirt and clean if necessary. Large numbers of cuvettes are being rejected. Check the cuvettes for dirt/dust. If dirt and dust have built up, check the air filter and clean it if necessary. 11.21 T R O U B L E S H O O T I N G & D I A G N O S T I C S Running Tests after a System Error When a System Error occurs during a run, EasyRA beeps to alert you of the error. The System icon flashes and a popup error message appears. If possible, EasyRA automatically washes the Probe and returns the Probe/ Transfer Arm to the Home position. The popup error message displays information about the error that has occurred and gives you choices as to how to proceed (see Figure 11.1). Figure 11.1 Popup Error Message During most system errors, you may choose to end the run or continue measuring. The following describes each choice and the steps required to receive results. Ending the Run If you choose End Run, all tests that are in process (status is Scheduled, Started, or Measuring on the Current Results Screen or the Worklist Monitoring Screen) are cancelled. Results are reported for tests that were finished prior to the error (status is Complete on the Current Results Screen or the Worklist Monitoring Screen). To end the run after an error has occurred: 1 From the popup window, touch End Run (see Table 11.2). Figure 11.2 11.22 Select End Run from the Popup Window E a s y R A O P E R A T O R ’ S M A N U A L The run stops immediately and the Results screen displays (see Figure 11.3). Test results for tests that were completed prior to the system error are stored when you accept the results. All other tests (those whose status is Scheduled, Started, or Measuring) are cancelled immediately. The tests which were cancelled appear on the Current Results screen with a System Error (SE) flag. Figure 11.3 Results Screen After Selecting End Run Notice that the word “Cancelled” appears after any test that was scheduled or in progress. 2 To continue, touch Accept: This saves the results. 11.23 T R O U B L E S H O O T I N G & D I A G N O S T I C S Accepting results stores the test results in Last Results and in Patient, Calibration, and QC Results. After accepting results, a popup displays asking if you want to recover cancelled tests to a new Worklist. 3 For information on recovering cancelled tests to a new Worklist, see “Recovering Cancelled Tests” on page 11.27. After Results are accepted and the recover cancelled test message is cleared, EasyRA allows you to access any other EasyRA function to correct the System Error. At this time, you can access the System icon, view the System Error, and/or perform diagnostics, if necessary. Continuing to Measure If you choose Continue Measuring, all tests that are in process (status is Started or Measuring on the Current Results Screen or the Worklist Monitoring Screen) are completed and results display. Results also display for tests that were finished prior to the error (status is Complete on the Current Results Screen or the Worklist Monitoring Screen). Tests that were not scheduled at the time of the system error are cancelled. To continue measuring after an error has occurred: 1 From the popup window, touch Continue Measuring (see Figure 11.4). Figure 11.4 11.24 Select Continue Measuring from the Popup Window E a s y R A O P E R A T O R ’ S M A N U A L EasyRA finishes all tests that have a status of Scheduled, Started or Measuring. Following completion, the Results screen displays (see Figure 11.5). Test results for tests that were completed are stored when you accept the results. All other tests that were not started prior to the system error are cancelled. The tests which were cancelled appear on the Current Results screen with a System Error (SE) flag Figure 11.5 Results Screen After Selecting Continue Measuring Notice that the word “Cancelled” appears after any test that not started. 11.25 T R O U B L E S H O O T I N G 2 & D I A G N O S T I C S To continue, touch Accept: This saves the results Accepting results stores the test results in Last Results and in Patient, Calibration, and QC Results. After accepting results, EasyRA allows you to recover cancelled, unfinished tests to a new Worklist to be run after the error has been cleared. 3 11.26 For more information on recovering cancelled tests during a system error, see “Recovering Cancelled Tests” on page 11.27. After results are accepted and the recover cancelled test message is cleared, EasyRA allows you to access any other EasyRA function to correct the System Error. At this time, you can access the System icon, view the System Error, and/or perform diagnostics, if necessary. E a s y R A O P E R A T O R ’ S M A N U A L Recovering Cancelled Tests After accepting results, EasyRA allows you to recover cancelled, unfinished tests to a new Worklist to be run after the error has been cleared. A popup window displays asking if you would like to recover the cancelled tests to a new Worklist (see Figure 11.6). This message displays regardless of whether you chose End Run or Continue Measuring. Figure 11.6 Popup Message Asking if you Want to Recover Cancelled Tests Select Ok to recover all tests that show Cancelled in the Status column, to a new Worklist. Select Cancel to delete the test requests for all cancelled, unfinished tests. If you choose Cancel, the deleted test requests will need to be re-entered on the Edit Worklist screen, when necessary. To recover cancelled, unfinished tests to a new Worklist: 1 From the popup window that displays see Figure 11.6), touch OK. Touching OK sends all cancelled, unfinished tests to a new Worklist. The Edit Worklist screen displays automatically, listing any samples with unfinished tests. Additional samples can be added to this new Worklist if desired. 2 For more information, see “Creating or Editing a Worklist Manually” on page 6.7. After results are accepted and the recover cancelled test message is cleared, EasyRA allows you to access any other EasyRA function to correct the System Error. At this time, you can access the System icon, view the System Error, and/or perform diagnostics, if necessary. 11.27 T R O U B L E S H O O T I N G & D I A G N O S T I C S Accessing Diagnostics Tests To access EasyRA’s Diagnostics tests: 1 Touch the Diagnostics/Maintenance/Setup icon, and then touch Diagnostics on the menu (see Figure 11.7). Figure 11.7 11.28 Diagnostics/Maintenance/Setup Icon and Menu E a s y R A O P E R A T O R ’ S M A N U A L If you select Diagnostics, the main Diagnostics screen displays, from which you can select the various diagnostics tests (see Figure 11.8). Figure 11.8 Main Diagnostics Screen 11.29 T R O U B L E S H O O T I N G & D I A G N O S T I C S Reaction Area Diagnostics The following are the diagnostics tests that can be run on the Reaction Area: Photometer Test. Cuvette Wheel Test. To perform Reaction Area diagnostics: 1 Touch the Diagnostics/Maintenance/Setup icon and then touch Diagnostics. The main Diagnostics screen displays (see Figure 11.8). 2 Touch Reaction Area. A list of the Reaction Area diagnostics tests displays (see Figure 11.9). Figure 11.9 Reaction Area Diagnostics From this screen you can choose either of the Reaction Area diagnostics tests. 11.30 E a s y R A O P E R A T O R ’ S M A N U A L Photometer Test The Photometer test gauges the performance of the Photometer. The test measures: The voltage output of the Read and Reference photodiodes. The ratio of the Read and Reference photodiodes at each wavelength. The flash-to-flash precision (N=50) at each wavelength. The Photometer test should be used when test or QC measurements appear to be noisy. To run the Photometer test: 1 From the Diagnostics screen, touch Reaction Area, and then touch Photometer. The Photometer test screen displays ((see Figure 11.10). Notice that the results of that last Photometer test appear on the screen and that the Start Now button is highlighted in pink. Figure 11.10 Photometer Test Screen 11.31 T R O U B L E S H O O T I N G 2 & D I A G N O S T I C S Touch the Start Now button: While the Photometer diagnostic test is running, a message displays indicating the test is in progress: When the test is complete, the older results on the screen are cleared and are replaced with the new results. The Complete message displays at the bottom of the screen (see Figure 11.11). Figure 11.11 Photometer Test Complete 11.32 E a s y R A 3 O P E R A T O R ’ S M A N U A L You can print the results of the Photometer diagnostics by touching the Print button: The results will be printed. If you print from Current Results results, the printed report will indicate if the test passed or failed. 4 Touch Enter beside the Complete message to confirm that the test is complete. If the test results are within the specified ranges, continue running tests on EasyRA. If the results are outside the specified ranges, the Photometer performance may be substandard. Repeat this test several times. If results are still outside the specified ranges, contact Service. 11.33 T R O U B L E S H O O T I N G & D I A G N O S T I C S Cuvette Wheel Test The Cuvette Wheel test verifies operation of the Cuvette Wheel by checking that it is starting, stopping, and turning properly. Run this test if you have received an error message indicating some aspect of the Cuvette Wheel function has failed. To run the Cuvette Wheel test: 1 From the Diagnostics screen, touch Reaction Area, and then touch Cuvette Wheel. The Cuvette Wheel test screen displays (see Figure 11.12). Notice that the Start Now button is highlighted in pink. Figure 11.12 Cuvette Wheel Test Screen 2 11.34 Touch the Start Now button: E a s y R A O P E R A T O R ’ S M A N U A L While the Cuvette Wheel test is running, a message displays indicating the test is in progress: When the test is complete, the test results are displayed at the bottom of the screen. The possible results are Passed or Failed (see Figure 11.13). Figure 11.13 3 Cuvette Wheel Test Complete Touch Enter beside the message to confirm that the test is complete. If the test passes, continue using EasyRA to run tests. If the next run proceeds normally, no further action is required. If the test fails, there is a problem with the Cuvette Wheel. Contact Service. 11.35 T R O U B L E S H O O T I N G & D I A G N O S T I C S Transfer Arm/Probe Diagnostics The following are the diagnostics tests that can be run on the Transfer Arm/Probe Area: Arm Positioning. Probe Positioning. Liquid Level Sensing. To perform Transfer Arm/Probe diagnostics: 1 Touch the Diagnostics/Maintenance/Setup icon and then touch Diagnostics. The main Diagnostics screen displays (see Figure 11.8). 2 Touch Transfer Arm/Probe. A list of the Transfer Arm/Probe diagnostic tests displays (see Figure 11.14). Figure 11.14 Transfer Arm/Probe Diagnostics From this screen you can choose any of the Transfer Arm/Probe diagnostics tests. 11.36 E a s y R A O P E R A T O R ’ S M A N U A L Arm Positioning Test The Arm Positioning test allows you to check the alignment of the Probe over each opening. Run this test if you have received a Probe Positioning Error. To run the Arm Positioning test: 1 From the Diagnostics screen, touch Transfer Arm/Probe, and then touch Arm Positioning. The Arm Positioning test screen displays (see Figure 11.15). Notice that the Start Now button is highlighted in pink. Figure 11.15 Arm Positioning Test Screen 2 Touch the Start Now button: 11.37 T R O U B L E S H O O T I N G & D I A G N O S T I C S While the Arm Positioning test is running, a message displays indicating the test is in progress: When the test is complete, the test results are displayed at the bottom of the screen (see Figure 11.16). Figure 11.16 Arm Positioning Test Complete. 3 Touch Enter beside the message to confirm that the test is complete. If you observe that the Probe is out of alignment at any of the positions, contact Service. 11.38 E a s y R A O P E R A T O R ’ S M A N U A L Probe Positioning Test The Probe Positioning test positions the Probe over the Wash Cup and the Test Position. The Probe descends into the Wash Cup and into the Cuvette. Run this test if you have received a Probe Positioning Error. To run the Probe Positioning test: 1 From the Diagnostics screen, touch Transfer Arm/Probe, and then touch Probe Positioning. The Probe Positioning test screen displays (see Figure 11.17). Notice that the Start Now button is highlighted in pink. Figure 11.17 Probe Positioning Test Screen 11.39 T R O U B L E S H O O T I N G 2 & D I A G N O S T I C S Touch the Start Now button: While the Probe Positioning diagnostic test is running, a message displays indicating the test is in progress: When the test is complete, the test results are displayed at the bottom of the screen (see Figure 11.18). Figure 11.18 Probe Positioning Test Complete. 11.40 E a s y R A 3 O P E R A T O R ’ S M A N U A L Touch Enter beside the message to confirm that the test is complete. If you observe that the Probe is out of alignment (does not descend into the center of the Wash Cup or Cuvette), contact Service. 11.41 T R O U B L E S H O O T I N G & D I A G N O S T I C S Liquid Level Sensing Test Run this test if a Bump Switch error has occurred in a sample cup or a Reagent Wedge. To run the Liquid Level Sensing test, you must place at least 150 l of water into a sample cup and place it in position 1 on the Sample Ring. When the test is run, the Probe descends into the sample cup until it senses the liquid. To run the Liquid Level Sensing test: 1 From the Diagnostics screen, touch Transfer Arm/Probe, and then touch Liquid Level Sensing. The Liquid Level Sensing test screen displays (see Figure 11.19). Notice that the Start Now button is highlighted in pink. Figure 11.19 Liquid Level Sensing Test Screen 11.42 E a s y R A 2 O P E R A T O R ’ S M A N U A L Touch the Start Now button: While the Liquid Level Sensing diagnostic test is running, a message displays indicating the test is in progress: When the test is complete, the test results are displayed at the bottom of the screen. The possible results are Passed or Failed (see Figure 11.20). Figure 11.20 Liquid Level Sensing Test Complete. 11.43 T R O U B L E S H O O T I N G 3 & D I A G N O S T I C S Touch Enter beside the message to confirm that the test is complete. If the test passes, the Probe senses the liquid correctly. Continue using EasyRA to run tests. If the test fails (the Probe has hit the bottom or sides of the sample cup), contact Service. 11.44 E a s y R A O P E R A T O R ’ S M A N U A L Fluidics Drawer Diagnostics The following are the diagnostics tests that can be run on the Fluidics Drawer: Dilutor Pump. Waste Pump. ISE Sensor System. To perform Fluidics Drawer diagnostics: 1 Touch the Diagnostics/Maintenance/Setup icon and then touch Diagnostics. The main Diagnostics screen displays (see Figure 11.8). 2 Touch Fluidics Drawer. A list of the Fluidics Drawer diagnostics tests displays (see Figure 11.21). Figure 11.21 Fluidics Drawer Diagnostics From this screen you can choose any of the Fluidics Drawer diagnostic tests. 11.45 T R O U B L E S H O O T I N G & D I A G N O S T I C S Dilutor Pump Test The Dilutor Pump test checks the operation of the Dilutor Pump. During this test, you observe the operation of the Dilutor Pump. You will first observe three drops of diluent coming out of the Probe (when the small piston of the Dilutor Pump is supplying diluent to the Probe), followed by a continuous stream of diluent coming out of the Probe (when the large piston of the Dilutor Pump is supplying diluent to the Probe). Run this test when any of the following occur: A Dilutor Pump error. Precision Test fails. Patient (QC) Results are noisy. Note: To observe the operation of the Dilutor Pump, you must open the Fluidics Drawer to the Peek position. To run the Dilutor Pump test: 1 From the Diagnostics screen, touch Transfer Arm/Probe, and then touch Dilutor Pump. The Dilutor Pump test screen displays (see Figure 11.22). Notice that the Start Now button is highlighted in pink. 11.46 E a s y R A O P E R A T O R ’ S M A N U A L Figure 11.22 Dilutor Pump Test Screen 2 Touch the Start Now button: While the Dilutor Pump diagnostic test is running, a message displays indicating the test is in progress: During the test, the Probe positions itself above the Wash Cup. The Dilutor Pump aspirates diluent. The valves connect the small piston to the Probe. The piston moves up and you will see small droplets of diluent coming out of the Probe. The Dilutor Pump then aspirates more diluent. The valves connect the large piston to the Probe. The piston moves up and you observe a continuous stream of liquid coming out of the Dilutor Pump. 11.47 T R O U B L E S H O O T I N G & D I A G N O S T I C S When the test is complete, the test results are displayed at the bottom of the screen (see Figure 11.23). Figure 11.23 Dilutor Pump Test Complete 3 Touch Enter beside the message to confirm that the test is complete. If the test passes, the Dilutor Pump is operating normally. Continue using EasyRA to run tests. If you do not observe diluent as described, verify that the Diluent Bottle is full. Also check that the connections between the Diluent Bottle and the Dilutor Pump, and between the Dilutor Pump and the Probe. If these connections are good and the problem persists, contact Service. 11.48 E a s y R A O P E R A T O R ’ S M A N U A L Waste Pump Test The Waste Pump test checks the operation of the Waste Pump. During this test, you observe the Waste Pump turning clockwise and waste fluid flowing in the chemistry waste line. Run this test when the Wash Cup does not empty properly or is overflowing. Note: To observe the operation of the Dilutor Pump, you must open the Fluidics Drawer to the Peek position. To run the Waste Pump test: 1 From the Diagnostics screen, touch Transfer Arm/Probe, and then touch Waste Pump. The Waste Pump test screen displays (see Figure 11.24). Notice that the Start Now button is highlighted in pink. Figure 11.24 Waste Pump Test Screen 11.49 T R O U B L E S H O O T I N G 2 & D I A G N O S T I C S Touch the Start Now button: While the Waste Pump diagnostic test is running, a message displays indicating the test is in progress: When the test is complete, the test results are displayed at the bottom of the screen (see Figure 11.25). Figure 11.25 Waste Pump Test Complete. 11.50 E a s y R A 3 O P E R A T O R ’ S M A N U A L Touch Enter beside the message to confirm that the test is complete. If the test passes, the Waste Pump is operating normally. Continue using EasyRA to perform tests. If the Waste Pump turns, but not all liquid was evacuated from the Wash Cup, replace the Waste Pump tube and repeat the Waste Pump test. For information on replacing the Waste Pump windings, see “Replacing the Waste Pump Tube” on page 10.58. If the Waste Pump fails to turn, contact Service. 11.51 T R O U B L E S H O O T I N G & D I A G N O S T I C S ISE Sensor System Test The ISE Sensor test measures the functionality of the entire ISE module. It tests: The output of the Bubble Detector with liquid and air. The number of pump counts for the three ISE peristaltic pumps to move a given volume. The output of sensors with Cal A and Cal B in front of them. Run this test when the accuracy or precision of the ISE measurements are questionable. To run the ISE Sensor System test: 1 From the Diagnostics screen, touch Fluidics Drawer, and then touch ISE Sensor System. If you do not have the ISE Module option, ISE Sensor System displays in gray, rather than black. The ISE Sensor System test screen displays (see Figure 11.26). Notice that the results of the last ISE Sensor System test appear on the screen and that the Start Now button is highlighted in pink. Figure 11.26 ISE Sensor System Test Screen 11.52 E a s y R A 2 O P E R A T O R ’ S M A N U A L Touch the Start Now button: While the ISE Sensor System diagnostic test is running, a message displays indicating the test is in progress: When the test is complete, the older results on the screen are cleared and are replaced with the new results. The Complete message displays at the bottom of the screen (see Figure 11.27). Figure 11.27 ISE Sensor System Test Complete. 11.53 T R O U B L E S H O O T I N G & D I A G N O S T I C S The result show: 3 Air and liquid bubble detector values and compares them to preset values. Pump counts for Cal A, Cal B, and Waste and compares them to preset values. mV output for all four sensors for Cal A and Cal B and compares them to preset values. You can print the results of the ISE Sensor System diagnostics by touching the Print button: The results will be printed. If you print from Current Results results, the printed report will indicate if the test passed or failed 4 Touch Enter beside the Complete message to confirm that the test is complete. If all values are within the preset values, the test passes. Continue running tests on EasyRA. If any of the values are outside the preset ranges, repeat the test again. If the air/liquid bubble detector tests are out of range, contact Service. If the pump calibrations are out of range, change the pump windings and repeat the test. If it continues to fail, contact Service. For information on replacing the pump windings, see “Replacing the Waste Pump Tube” on page 10.58. If the mV for a particular sensor is out of range, change that sensor and repeat the test. If the mV is out of range for all sensors, change the reference electrode and repeat the test. If the mV continues to be out of range, contact Service. 11.54 For more information on replacing ISE Sensors or the reference electrode, see “Replacing the ISE Sensors” on page 10.73. E a s y R A O P E R A T O R ’ S M A N U A L Reagent/Sample Area Diagnostics The following are the diagnostic tests that can be run on the Reagent/ Sample Area: Sample Wheel. Barcode Reader. RFID Reader. To perform Reagent/Sample Area diagnostics: 1 Touch the Diagnostics/Maintenance/Setup icon and then touch Diagnostics. The main Diagnostics screen displays (see Figure 11.8). 2 Touch Reagent/Sample Area. A list of the Reagent/Sample Area diagnostics tests displays (see Figure 11.28). Figure 11.28 Reagent/Sample Area Diagnostics From this screen you can choose any of the Reagent/Sample Area diagnostic tests. 11.55 T R O U B L E S H O O T I N G & D I A G N O S T I C S Sample Wheel Test The Sample Wheel test runs a preset cycle that checks the positioning of sensors and motor drives for starting and stopping. Run this test if you have received an indication that the Sample Wheel is not functioning properly. Note: A Sample Ring must be installed on EasyRA before you run this test. To run the Sample Wheel test: 1 From the Diagnostics screen, touch Reagent/Sample Area, and then touch Sample Wheel. The Sample Wheel test screen displays (see Figure 11.29). Notice that the Start Now button is highlighted in pink. Figure 11.29 Sample Wheel Test Screen 11.56 E a s y R A 2 O P E R A T O R ’ S M A N U A L Touch the Start Now button: While the Sample Wheel diagnostic test is running, a message displays indicating the test is in progress: When the test is complete, the test results are displayed at the bottom of the screen. The possible results are Passed or Failed (see Figure 11.30). Figure 11.30 Sample Wheel Test Complete. 11.57 T R O U B L E S H O O T I N G 3 & D I A G N O S T I C S Touch Enter beside the message to confirm that the test is complete. If the test passes, continue running tests on EasyRA. If the test fails, repeat the test. If it fails again, contact Service. 11.58 E a s y R A O P E R A T O R ’ S M A N U A L Barcode Reader Test The Barcode test checks EasyRA’s ability to read a barcode from a sample tube on an analyzer equipped with the LIS option. This test runs a preset cycle that positions a barcoded sample tube in front of the Barcode Reader and attempts to scan the barcode. Run this test if you receive an indication that the Barcode Reader is not functioning properly. Note: This tests can only be performed on analyzers that are equipped with the LIS option. To run the Barcode Reader test: 1 From the Diagnostics screen, touch Reagent/Sample Area, and then touch Barcode Reader. The Barcode Reader test screen displays ((see Figure 11.31). Notice that the results of that last Barcode Reader test appear on the screen and that the Start Now button is highlighted in pink. Figure 11.31 Barcode Reader Test Screen 11.59 T R O U B L E S H O O T I N G & D I A G N O S T I C S 2 Place a sample tube with a barcode and a corresponding alphanumeric code in Sample Position 1. Leave Sample Position 2 empty. The barcode must be visible through the slot on the sample holder. Close the cover to the Reaction/Sample Area. 3 Touch the Start Now button: While the Barcode Reader diagnostic test is running, a message displays indicating the test is in progress: When the test is complete, the older results on the screen are cleared and are replaced with the new results. The Complete message displays at the bottom of the screen (see Figure 11.32). Figure 11.32 Barcode Reader Test Complete 11.60 E a s y R A 4 O P E R A T O R ’ S M A N U A L Touch Enter beside the Complete message to confirm that the test is complete. If the test passes, the Barcode Reader is functioning properly. Continue to run tests using EasyRA. If the test fails, verify that the barcode is positioned correctly in the sample tube holder and the sample tube holder is in the correct position. Repeat the test. If the test fails again, contact Service. 11.61 T R O U B L E S H O O T I N G & D I A G N O S T I C S RFID Reader Test The RFID Reader test checks EasyRA’s ability to communicate with an RFID labeled Reagent Wedge. The RFID Reader test runs a preset cycle that brings the RFID labeled wedge placed in position 1 in front of the RFID Reader. The reader attempts to communicate with the RFID label. Run this test if you receive an indication that the RFID Reader is not functioning properly. To run the RFID Reader test: Note: A Sample Ring must be installed on EasyRA before you run this test. 1 From the Diagnostics screen, touch Reagent/Sample Area, and then touch RFID Reader. The RFID Reader test screen displays (see Figure 11.33). Notice that the results of that last RFID Reader test appear on the screen and that the Start Now button is highlighted in pink. Figure 11.33 RFID Reader Test Screen 11.62 E a s y R A O P E R A T O R ’ S 2 Install a Reagent Wedge in Reagent position 1. Close the Reagent/ Sample Area cover. 3 Touch the Start Now button: M A N U A L While the RFID Reader diagnostic test is running, a message displays indicating the test is in progress: When the test is complete, the older results on the screen are cleared and are replaced with the new results. The results should match the name and lot number of the Reagent Wedge placed in Position 1. The Complete message displays at the bottom of the screen (see Figure 11.34). Figure 11.34 RFID Reader Test Complete 11.63 T R O U B L E S H O O T I N G 4 & D I A G N O S T I C S Touch Enter beside the Complete message to confirm that the test is complete. If the test passes, continue running tests on EasyRA. If the test fails, verify that you placed the tests wedge in position 1 and reseat the wedge. Repeat the test. If it fails again, call Service. 11.64 E a s y R A O P E R A T O R ’ S M A N U A L Heater/Cooler Diagnostics The Heater/Cooler diagnostic test reports the temperature for the Reagent/Sample Area, the Probe Preheater, and the Reaction Area. These results display immediately upon selecting the Heater/Cooler diagnostic test. The screen indicates whether the results are within the specified ranges. To perform Heater/Cooler diagnostics: 1 Touch the Diagnostics/Maintenance/Setup icon and then touch Diagnostics. The main Diagnostics screen displays (see Figure 11.8). 2 Touch Heater/Cooler. The Heater/Cooler reports results immediately (see Figure 11.35). Figure 11.35 Heater/Cooler Test Screen If the temperatures are outside the specified ranges, call Service. 11.65 T R O U B L E S H O O T I N G & D I A G N O S T I C S Cover/Door Latches Diagnostics The Cover/Latches diagnostic test reports the status (open or closed) of the Reagent/Sample Area Cover, the Reaction Area Cover, and the Fluidics Drawer. These results are displayed immediately upon selecting the Cover/Door Latches diagnostic test. The screen provides visual indicators as well as text messages showing the status of the covers. To perform Cover/Door Latches diagnostics: 1 Touch the Diagnostics/Maintenance/Setup icon and then touch Diagnostics. The main Diagnostics screen displays (see Figure 11.8). 2 Touch Cover/Door Latches. EasyRA reports results immediately (see Figure 11.36). Opening and closing each cover/door will result in a change in the condition on the screen. Figure 11.36 Cover/Door Latches Test Screen If the display does not show the covers opening and closing, contact Service. 11.66 E a s y R A O P E R A T O R ’ S M A N U A L Precision Test Diagnostics The Precision Test gauges the performance of the Dilutor Pump, Fluidics Drawer, and the Photometer. This test should also be performed following a Probe replacement. Note: The Precision Test takes approximately 12 minutes to run. It requires 20 unused cuvettes in the Reaction Area, and a Precision Dye wedge in the Reagent/Sample Area. The Precision Dye wedge contains two dye solutions, one more concentrated than the other. Note: A Sample Ring must be installed on EasyRA before you run this test. To perform Precision Test: 1 Verify that there are at least 20 unused cuvettes in the Reaction Area. 2 Verify that the Precision Dye wedge is in the Reagent Area. 3 Touch the Diagnostics/Maintenance/Setup icon and then touch Diagnostics. The main Diagnostics screen displays (see Figure 11.8). 4 Touch Precision Test. The Precision Test screen displays (see Figure 11.37). Notice that the results of that last Precision test appear on the screen and that the Start Now button is highlighted in pink. 11.67 T R O U B L E S H O O T I N G & D I A G N O S T I C S Figure 11.37 Precision Test Screen 5 Touch the Start Now button: While the Precision Test is running, a message displays at the bottom of the screen indicating the test is in progress: During the Precision Test, EasyRA picks up 16 l of Level 1 Dye and dilutes it with 180 l of diluent in a cuvette. This is repeated ten times, and the absorbance at 340 nm is read in each cuvette. The Mean, Standard Deviation (SD), and Coefficient of Variation (%CV) is calculated for the ten values. 11.68 E a s y R A O P E R A T O R ’ S M A N U A L EasyRA then picks up 2 l of Level 2 Dye and dilutes it with 255 l of diluent in a cuvette. This is repeated ten times, and the absorbance at 340 nm is read in each cuvette. The Mean, SD, and %CV is calculated for the ten values. The acceptable %CV for the 16 l pickup is < 1%, and the acceptable %CV for the 2 l pickup is < 2%. This test checks the precision and accuracy of the Dilutor Pump and, to a lesser degree, the Photometer. The results of the test are reported as the test progresses (see Figure 11.38 and Figure 11.39). Figure 11.38 Precision Test is In Progress - No Results Reported Yet 11.69 T R O U B L E S H O O T I N G & D I A G N O S T I C S Figure 11.39 Precision Test in Progress - Partial Results are Displayed When the test is complete, all the results are filled in and there is an indication as to whether the test passed or failed (see Figure 11.40). 11.70 E a s y R A O P E R A T O R ’ S M A N U A L Figure 11.40 Precision Test Complete 11.71 T R O U B L E S H O O T I N G 6 & D I A G N O S T I C S You can print the results of the Precision Test diagnostics by touching the Print button: The results will be printed. If you print from Current Results results, the printed report will indicate if the test passed or failed 7 The results of all Precision Test diagnostics are recorded in a Maintenance Log. See “Using Maintenance Logs” on page 10.100 for information on the Maintenance Logs. 8 Touch Enter beside the message to confirm that the test is complete. If the Precision Test passes, continue running tests using EasyRA. If the Precision Test fails, check the Dilutor fitments (the threaded fitting on the right side of the Dilutor pump) and the Probe Tip. The fitments should be tightened. The Probe should also be replaced. You should also check for bubbles inside the Dilutor Pump. After those adjustments have been made, repeat the test. If the test fails again. contact Service. 11.72 12 Setting Up User-Defined Tests This chapter describes how to define, review, program, and use user-defined tests on EasyRA. It covers the steps required for the following: Entering test-specific information into the EasyRA User Interface. Optimizing the Reagent for use on EasyRA. Programming Reagent Wedges. Modifying the Reagent program. Tests may be performed on EasyRA that follow the specifications found on page C.1 of this manual. Up to six tests may be programmed on EasyRA at any one time. WARNING: The information contained in this section is to be used for guideline purposes only. Preparing Reagent parameters for use on EasyRA should be completed by individuals trained in the application of Reagents on clinical chemistry analyzers. Medica Corporation takes no responsibility for the performance of user-defined tests on EasyRA or the performance of Medica supplied Reagents used in conjunction with user-defined tests. It is up to you to validate the performance of these Reagents and/or the interference with Medica supplied Reagents per local, state, or federal regulations. Note: RFID (Radio Frequency Identification) Reagent Wedges that have been programmed cannot be changed. If modifications to the Reagent parameters are required, new Reagent Wedges will require programming. For more information on modifying Reagent parameters, see “Modifying Reagent Parameters Before Programming RFID Reagent Wedges” on page 12.25 12.1 S E T T I N G U P U S E R - D E F I N E D T E S T S Reagent Wedges User-defined Reagents require the use of Medica Reagent Wedges, with RFID (Radio Frequency Identification) labeling. There are two types of Reagent Wedges for user-defined Reagents (see Figure 12.1). Single Wedges - tests requiring only one Reagent. Dual Wedges - tests requiring two Reagents or a single Reagent and a special wash solution. User-defined reagents can only be loaded into single or dual wedges. The Three Reagent System is not available for user-defined reagents. Figure 12.1 Single and Dual Reagent Wedges Single Wedge Dual Wedge Each Reagent Wedge labeled with an RFID tag allows for Reagent parameters to be programmed onto the Reagent Wedge. The RFID tag must be programmed by you prior to use. For more information on programming Reagent Wedges, see “Programming Reagent Wedges” on page 12.21 Reagent Wedges may be programmed only once. Once programmed, the Reagent will behave like Medica provided Reagents. EasyRA will use information contained on the RFID chip to perform the specific test. 12.2 For more information on RFID Reagent Wedges, see “Reagent Wedges” on page 1.10. E a s y R A O P E R A T O R ’ S M A N U A L Note: If a test program is changed, new Reagent Wedges must be programmed. Information contained within the Modify Parameters screens are used only for the programming of Reagent Wedges and not during the performance of the actual test. For more information on modifying Reagent parameters, see “Modifying Reagent Parameters Before Programming RFID Reagent Wedges” on page 12.25 Space has been allowed on each tag to write the name/abbreviation of the Reagent and the lot number. It is recommended that a pen with permanent ink be used. Do not write on the section labeled with the EasyRA symbol. Note: Check the inside of the neck of the wedge for foam while filling, replacing the cap, or placing the wedge on the analyzer. If there is foam, remove it with a swab or a disposable pipette before performing the test. 12.3 S E T T I N G U P U S E R - D E F I N E D T E S T S Entering a User-Defined Reagent To set up user-defined Reagents: 1 Touch the Diagnostics/Maintenance/Setup icon, and then touch Setup. 2 If Security is enabled, the Security Login dialog displays. Enter the Supervisor password or a Technician password on the Alphanumeric Keypad and touch Enter on the keypad. 3 On the Setup menu, touch Reagent. The Reagent Setup screen displays (see Figure 12.2). Figure 12.2 4 Reagent Setup Screen Touch Reagent Details (see Figure 12.3). This Reagent Info screen shows all Reagents that have been loaded onto EasyRA and inventoried. This is the complete list of Reagents that have been inventoried, not just the Reagents that are currently loaded on the Reagent Tray. 12.4 For more information on viewing Reagent Details, see “Setting Up Reagents” on page 4.89. E a s y R A Figure 12.3 5 O P E R A T O R ’ S M A N U A L Touch Reagent Details on the Reagent Setup Screen To add a new test, touch the Add button: The Modify Reagent Parameters screen displays (see Figure 12.4). 12.5 S E T T I N G U P U S E R - D E F I N E D Figure 12.4 6 T E S T S Modify Reagent Parameters Screen To enter information into each field that displays, touch the field and enter the appropriate information on the Alphanumeric Keypad or select it from the drop-down menu that display. For more information on each field, see Table 12.1. There are six distinct pages for entry. Use the up and down arrows to navigate between pages. Shaded fields are required. You will not be able to advance pages until all required entries are complete. 12.6 E a s y R A O P E R A T O R ’ S M A N U A L Table 12.1 Summary of User-Defined Fields NAME DESCRIPTION POSSIBLE VALUES Select the test to be programmed from the drop-down list. Names of tests that are user-defined are followed by an asterisk (*). ALB* - Albumin ALB-U* - Albumin (Urine) ALP* - Alkaline Phosphatase ALT* - Alanine Aminotransferase AMMON* - Ammonia AMP* - Amphetamine AMY* - Amylase AP* - Acid Phosphatase APOA* - Apoloprotein A APOB* - Apoloprotein B ASO* - Anti-Streptolysin AST* - Aspartase Aminotransferase BAR* - Barbituate BileA* - Bile Acids BUN* - Urea Nitrogen BUP* - Buprenorphine BZO* = Benzodiazepine C4c* - C4c Complement Ca* - Total Calcium, CARI* - Carisoprodol, CHOL* - Cholesterol CK* - Creatine Kinase CKMB* - Creatine Kinase (Muscle/Brain) CO2* - Total Carbon Dioxide COC* - Cocaine COT* - Continine CREA* - Creatinine CREA-U* - Creatinine (Urine) CRP* - C-reactive Protein DBIL* - Direct Bilirubin ETG* - Ethyl Glucuronide ETOH* - Ethanol FA* - Fatty Acid Fe* - Iron FENT* - Fentanyl FERR* - Ferritin FruAm* - Fructosamine GGT* - Gamma-glutamyl Transferase GLU-H* - Glucose (Hexokinase) GLU-T* - Glucose (Trinder) continued on next page... PAGE 1 OF 6 Test Example: User-defined Albumin test = ALB* 12.7 S E T T I N G U P U S E R - D E F I N E D Table 12.1 Summary of User-Defined Fields NAME DESCRIPTION T E S T S POSSIBLE VALUES from previous page... HbA1c* - Glycated Hemoglobin HDL* - High Density Lipoprotein IgA* - Immunoglobulin A IgG* - Immunoglobulin G IgM* - Immunoglobulin M INS* - Insulin LDH* - Lactate Dehydrogenase LDL* - Low Density Lipoprotein LIP* - Lipase LSD* - Lysergic Acid diethylamide mAMP* - Methamphetamine Mg* - Magnesium MTD* - Methadone MTQ* - Methaqualone OPI* - Opiate OXY* - Oxycodone PCP* - Phencyclidine PHOS* - Inorganic Phosphorus PPX* - Propoxyphene PreALB* - PreAlbumin PROT-U* - Urine Protein RF* -Rheumatoid Factor T4* - Thyroxine TBIL* - Total Bilirubin TCA* - Tricyclic Antidepressant Tf* - Transferrin THC* - Marijuana TIBC* - Total Iron Binding Capacity TP* - Total Protein TP-U* - Total Protein (Urine) TRAM* - Tramadol TRIG* - Triglycerides uALB* - MicroAlbumin UIBC* - Urine Iron Binding Capacity UREA-U* - Urea (Urine) URIC* - Uric Acid XTC* - Ecstacy Reagent Lot Lot number of the Reagent. Up to 10 digits Exp. Date Expiration date of the Reagent. Month = 1 - 12 Day = 1 - 31 Year = 2010 - 2034 Use Life Number of days available on-board. 1-255 12.8 E a s y R A O P E R A T O R ’ S M A N U A L Table 12.1 Summary of User-Defined Fields NAME DESCRIPTION POSSIBLE VALUES Wavelengths (nm) 1st (Primary) and 2nd (Secondary) wavelength to be used in the reaction. A 1st (Primary) wavelength must be selected. Depending on the test, a 2nd (Secondary) wavelength may be set to "None". 340, 405, 520, 550, 600, 700, 660 None (available for Secondary Wavelength only) Default Units Test units to be displayed for test results. %, %NGSP, delta A, delta A/min, g/dL, g/L, IU/L, mEq/L, mg/dL, mg/L, mIU/L, mmol/L, mmol/mol, mol/L, ng/dL, ng/L, ng/mL, nmol/L, pg/mL, pmol/L, U/L, mg/dL, mg/L, mg/mL, mmol/L Default Decimal Decimal places to be displayed for test results. 0-4 Select whether or not this reagent generates qualitative results (Yes) or quantitative results (No). If you select Yes, the Reaction Type can only be Kinetic. If you select No, the Reaction Type can be Enzymatic, Kinetic, Endpoint, TIA, or EIA. Yes or No. If the 660 wavelength is selected and the 660 filter has not been installed on EasyRA, a message displays in the Reagent Status indicating “No 660 filter.” If the 660 Filter is not installed, the 660 choice is not displayed and the tests using that filter will be disabled on the Test Panel (TIBC for example). PAGE 2 OF 6 Qualitative Result For user-defined reagents, it is possible to change the type of results generated from Qualitative to Quantitative or vice versa at any time. For more information on changing the type of results being generated, see “Changing a Reagent from Qualitative to Quantitative or Vice Versa” on page 12.18 12.9 S E T T I N G U P U S E R - D E F I N E D T E S T S Table 12.1 Summary of User-Defined Fields NAME DESCRIPTION POSSIBLE VALUES Reaction Type Analysis method to be used in the reaction. Use Kinetic for enzymatic tests that require calibration. Use Kinetic for Qualitative tests. Enzymatic Kinetic Endpoint TIA (Turbidimetric Immunoassay) EIA (Enzymatic Immunoassay) If Qualitative Result = No, select Enzymatic, Kinetic, Endpoint, TIA, or EIA. If Qualitative Result = Yes, select Kinetic. Enzyme Factor The enzyme factor is used for tests that use a calculation factor. Calibration is not necessary when Enzymatic is selected for the Reaction Type. 0 - 25,000 Displayed for Reaction Type = Enzymatic Enzyme Max 1st Interval Abs. Change Maximum change in absorbance allowed during the test’s first cycle. 0.001 - 0.200 Displayed for Reaction Type = Enzymatic First Abs Limit Limit of first absorbance level. 0.1 - 25.5 Displayed for Reaction Type = Enzymatic This is a new value added in EasyRA Version 7.0 to determine if the Substrate Depletion (SD) flag should be issued. Reaction Direction The direction of the absorbance during the reaction. If the absorbance decreases during the reaction, choose Down. If the absorbance increases during the reaction, choose Up. Down or Up Cal Curve Fitting The curve fitting routine that best fits the calibration results. Cubic Spline Logit - Log 4 Displayed for Reaction Type = TIA or EIA Cal Curve Direction 12.10 The direction of calibration curve. Displayed for Reaction Type = TIA or EIA Down or Up E a s y R A O P E R A T O R ’ S Table 12.1 Summary of User-Defined Fields NAME DESCRIPTION POSSIBLE VALUES Sample Type Specify the sample type to determine the parameters to be used for the reaction. The sample type selected here will be appear in the test setup and in the Worklist. This information will also be displayed with patient results. Serum/Plasma Urine Diluted Blood Linear Range (Serum or Urine) Linear range of the test. The Linear Range entered will allow for proper flagging of results outside of the user set limits. If the Sample Type is Diluted Blood, the linear range is displayed in the Serum field. 0 - 999999 M A N U A L This parameter is not used when the Reagent is set up to generate Qualitative Results. Linear High (LH) and Linear Low (LL) flags will not be displayed in results for Qualitative tests. PAGE 3 OF 6 Sample Volume per Test (L) Sample used in performing the test. 2.0 - 25.0 (0.1 L increments) # of Reagents Needed Number of Reagents to be used in performing the test. 1 or 2 12.11 S E T T I N G U P U S E R - D E F I N E D T E S T S Table 12.1 Summary of User-Defined Fields NAME DESCRIPTION POSSIBLE VALUES Reagent Wedge Volume (mL) Volume of Reagent in the Reagent Wedge. Tests using two Reagents require two volumes to be entered. Single Reagent Reagent 1: 5 - 40 A small amount of Reagent is required in addition to the Reagent that is used for tests. The additional Reagent ensures that no air is aspirated when a Reagent Wedge is near empty. This additional Reagent is automatically subtracted from the Reagent Wedge Volume. Dual Reagent Reagent 1: 4 - 30 Reagent 2: 2 - 10 Extra (Dead) Volume - Single Reagent: 4 mL Extra (Dead) Volume - Dual Reagent (R1/R2): 3 mL/1 mL Reagent Volume per Test - Serum or Urine (L) Reagent volume used in performing the test with serum or urine samples. Tests using two Reagents require two volumes to be entered. R1: 1 - 350 R2: 1 - 150 (1 L increments) Diluent Volume per Test (L) Diluent volume used in performing the test. Tests using two Reagents require two diluent volumes to be entered. D1: 0 - 20 D2: 0 - 20 Total Volume per Test - Serum or Urine (L) The total volume of serum or urine sample, Reagent(s), and diluents must equal between 150 L and 400 L. The value is calculated by EasyRA from the data entered on this screen and displayed. 150 - 400 Total Volume = Sample + R1 + (R2) + D1 + (D2) Test Count The test count is calculated based on the Reagent Wedge Volume (usable for tests; total volume less extra (dead) volume) and the Reagent Volume used per test. Reagent Wedge Volume (mL) x 1000/Reagent Volume per Test (L) 12.12 Test Count is calculated by the system and displayed. E a s y R A Table 12.1 Summary of User-Defined Fields NAME DESCRIPTION POSSIBLE VALUES Determines if the 2nd Reagent is to be pipetted immediately following the 1st Reagent. If Yes is selected, the 2nd Reagent will be added at the cycle number specified in Reagent 2nd Addition at Cycle #. Yes or No O P E R A T O R ’ S M A N U A L PAGE 4 OF 6 Delay Reagent 2 Addition Displayed when # Reagents Needed = 2 Sample Blank Choose Yes if a sample blank is to be performed prior to each analysis. If Yes is chosen, the Sample absorbance will be measured in the cuvette and subtracted from the final test result. Yes or No Displayed for Reaction Type = Endpoint Sample Blank Read at Cycle # The cycle number at which the sample blank is to be read. 0 - 24 Displayed for Reaction Type = Endpoint Reagent 2 Addition at Cycle # The cycle number at which the 2nd Reagent will be pipetted and deposited in the cuvette. 0 - 45 Displayed when Delay Reagent 2 Addition = No First Read at Cycle # The cycle number that the first absorbance will be read. 0 - 45 # of Reads The total number of absorbance measurements to be taken throughout the reaction. 2 - 10 # Cycles Between Reads If multiple reads are selected, the number of cycles between each read. 1 - 24 Last Cycle # EasyRA displays the number of the last cycle. Must be < 50 12.13 S E T T I N G U P U S E R - D E F I N E D T E S T S Table 12.1 Summary of User-Defined Fields NAME DESCRIPTION POSSIBLE VALUES Determines if a Reagent blank is necessary for the test. If Yes is chosen, the Reagent absorbance will be measured in the cuvette and subtracted from both the calibration and sample absorbance. Yes or No PAGE 5 OF 6 Reagent Blank Displayed when Reaction Type = Endpoint or Kinetic. Reagent Blank Abs. Limits The high and low limits in absorbance allowed for the Reagent Blank. 0.10 - 1.50 Displayed when Reagent Blank = Yes Reagent Blank Frequency (days) Frequency of the Reagent Blank. 1 - 31 (days); Every Test Dilution Factor Dilution factor to be used by EasyRA during a rerun when results fall above the high end of the Linear Range. 1:1, 1:2, 1:9, None Dilution Correlation Used when a delayed 2nd Reagent is selected. Since the volume of the reaction is changed with the delayed addition of the R2 Reagent, there is a dilution correction factor (dF) included in the calculation. 0.90 - 1.10 Displayed when Reagent Blank = Yes df = Reag1 Vol + Dil. Vol. + Samp. Vol. Total Final Volume Interfering Chemistries Up to 4 interfering tests may be selected. Up to 4 Special Rinse in R2 (Require duo reagent wedge A special rinse may be programmed for tests that have a high instance of carryover. A dual Reagent Wedge is necessary. Yes or No 12.14 E a s y R A Table 12.1 Summary of User-Defined Fields NAME DESCRIPTION POSSIBLE VALUES Number of replicates used in determining the calibration factor. An average of the results for the total number of replicates is used in determining the Calibration Factor. 1-4 O P E R A T O R ’ S M A N U A L PAGE 6 OF 6 # of Calibration Replicates Displayed when Reaction Type = Endpoint, Kinetic, TIA, or EIA Cal Dev Calibration Deviation (%) allowed between replicate Calibration results. 3, 5, 10, or 15 Displayed when Reaction Type = Endpoint, Kinetic, TIA, or EIA Calibration Frequency (days) The number of days between calibrations. 1 - 31 Displayed when Reaction Type = Endpoint or Kinetic, TIA, or EIA Cal Levels Specifies the number of points required to plot calibration results. 1-6 Automatically set to 1 when Reaction Type = Endpoint or Kinetic. Can be set to 2-6 when Reaction Type = TIA or EIA. Calibration Factor Range Expected factor range used in assessing the calibration results. -80,000 - 80,000 Displayed when Reaction Type = Endpoint or Kinetic Cal level 1 Range to Cal level 6 Range Calibration range for each Cal level. Set the range for each level specified in the # of Levels screen. -0.8 - 2.500 Displayed when Reaction Type = TIA, or EIA (1-6 levels) 7 When all entries for the test are complete, touch the Enter button. 12.15 S E T T I N G U P U S E R - D E F I N E D 8 Figure 12.5 T E S T S The newly defined test is added to the Reagent list (see Figure 12.5). User-defined tests appear at the top of the list in alphabetical order. The selected settings for the reagent are displayed in the two page display (see Figure 12.5 and see Figure 12.6). Example of a User-Defined Test Added to the Reagent List (page 1) + = Not programmed "*" = User Defined Test 12.16 E a s y R A Figure 12.6 9 O P E R A T O R ’ S M A N U A L Example of a User-Defined Test Added to the Reagent List (page 2) RFID labeled Reagent Wedges may be programmed immediately or you may test the performance of the Reagent parameters prior to use. For more information on programming RFID Reagent Wedges, see “Programming Reagent Wedges” on page 12.21. For more information on testing Reagent parameters prior to use, see “Reagent Optimization - Creating a Worklist” on page 12.36. Note: Before user-defined reagents are programmed, they can only be selected from the Test Select keypad when you are in Reagent Optimization mode. For more information on Reagent Optimization Mode, see “Entering Test Data” on page 3.46 or “Reagent Optimization - Creating a Worklist” on page 12.36. 12.17 S E T T I N G U P U S E R - D E F I N E D T E S T S Changing a Reagent from Qualitative to Quantitative or Vice Versa Some reagents can generate both qualitative or quantitative results. If you define a reagent (Oxycodone for example) to generate qualitative results, you can choose to change it, so that quantitative results will be generated. The same process applies for changing between quantitative and qualitative results. To change the type of results generated for a reagent: 1 Touch the Diagnostics/Maintenance/Setup icon, and then touch Setup. 2 If Security is enabled, the Security Login dialog displays. Enter the Supervisor password or a Technician password on the Alphanumeric Keypad and touch Enter on the keypad. 3 On the Setup menu, touch Reagent. The Reagent Setup screen displays. 4 Touch Reagent, then Reagent Details. 5 Touch the test to be modified (see Figure 12.5). Note: Only tests with an "*" or an "*" and a "+" may be modified. Modification of Reagent programs will cancel any stored calibrations. 6 Touch the Modify icon. The Modify Reagent Parameters screen displays. 7 12.18 Touch the down arrow to advance to the second page of the Reagent Details (see Figure 12.7). E a s y R A Figure 12.7 O P E R A T O R ’ S M A N U A L Modify Reagent Parameters Screen 8 Select the Qualitative field and choose the option that is not currently selected (if it is set to Yes, select No, or if it is set to No, select Yes). 9 Touch the down arrow to advance through the remaining pages of the Reagent Details screens. Using the insert sheet for the selected reagent, update any values in the Reagent Setup as required. When you get to the final screen (6/6) touch the Enter button: A message displays indicating that the Qualitative Result setting for this Reagent has changed and that all QC materials for this Reagent Name will be affected (see Figure 12.8). 12.19 S E T T I N G U P U S E R - D E F I N E D Figure 12.8 T E S T S Message Indicating Qualitative Results Setting Has Been Changed If you select OK, another message displays indicating that critical parameters for this reagent have changed and recalibration is required (see Figure 12.9). Figure 12.9 Message Indicating Recalibration is Required for this Reagent 10 Touch Ok. The Reagent Parameters are updated with the change to the Qualitative Result setting. 11 To complete the setup, up must go to the Calibration setup and QC setup and modify the calibrator and QC materials that have been defined for the modified reagent. If you intend to use this reagent to generate both qualitative and quantitative results, it is recommended that you set up separate calibration and QC materials (rather than modifying the existing calibration and QC materials) for each type of results being generated (qualitative and quantitative). 12.20 E a s y R A O P E R A T O R ’ S M A N U A L For more information on setting up calibration materials, see “Setting Up Calibrators” on page 4.31. For more information on setting up QC materials, see “Setting Up QC Materials” on page 4.59. When you run tests, only those QCs of the currently selected type (qualitative or quantitative) will be displayed, however, earlier results collected from this reagent will be available from the Results > QC Results menu selection. Programming Reagent Wedges To program RFID Reagent Wedges: 1 On the Reagent Details menu, touch the Reagent you wish to program (see Figure 12.10). User-Defined tests ("+") will be displayed at the top of the list. Figure 12.10 Touch the Reagent to be Programmed 12.21 S E T T I N G U P U S E R - D E F I N E D T E S T S The details for the selected Reagent display (see Figure 12.11). Figure 12.11 Details for the Selected Reagent 2 Touch the RFID Programming icon. 3 Place an unused, new RFID Reagent Wedge in the Reagent Area in position #1 (see Figure 12.12). For tests that require one Reagent, use a Single RFID Reagent Wedge. For tests that require two Reagents or a single Reagent and a special wash, use a Dual RFID Reagent Wedge. 12.22 E a s y R A O P E R A T O R ’ S M A N U A L Figure 12.12 Reagent Program Popup Touch OK. 4 After the RFID Reagent Wedge is programmed, the test is added to the test list and may be selected from the Test Select Keypad on the Worklist (see Figure 12.13 and Figure 12.14). Figure 12.13 Test is Added After the RFID Reagent Wedge Has Been Programmed 12.23 S E T T I N G U P U S E R - D E F I N E D T E S T S Figure 12.14 Test Can Be Selected from Test Select Keypad on the Worklist Note: Make sure the Reagent volume(s) added to the wedge match the volumes on the RFID program. The EasyRA uses these volumes to track the number of tests remaining in the wedge. 12.24 E a s y R A O P E R A T O R ’ S M A N U A L Modifying Reagent Parameters Before Programming RFID Reagent Wedges To modify Reagent parameters before programming RFID Reagent Wedges: 1 Touch the Diagnostics/Maintenance/Setup icon, and then touch Setup. 2 If Security is enabled, the Security Login dialog displays. Enter the Supervisor password or a Technician password on the Alphanumeric Keypad and touch Enter on the keypad. 3 On the Setup menu, touch Reagent. The Reagent Setup screen displays. 4 Touch Reagent, then Reagent Details. 12.25 S E T T I N G U P U S E R - D E F I N E D 5 T E S T S Touch the test to be modified (see Figure 12.15). Figure 12.15 Touch the Test to be Modified on the Reagent Setup Screen Note: Only tests with an "*" or an "*" and a "+" may be modified. Modification of Reagent programs will cancel any stored calibrations. 6 Touch the Modify icon. The Modify Reagent Parameters screen displays (see Figure 12.16). 12.26 E a s y R A O P E R A T O R ’ S M A N U A L Figure 12.16 Modify Reagent Parameters Screen 7 Change Reagent parameters as necessary. 8 When all entries for the test are complete, touch the Enter button. Modified Reagents will be displayed with a "+" and returned to the top of the Reagent list. Example: ALB* becomes +ALB* following a modification. Modifying Reagent Parameters After Programming RFID Reagent Wedges After programming the RFID Reagent Wedges, you can modify the following: Reagent Lot number and Expiration Date only All Reagent parameters 12.27 S E T T I N G U P U S E R - D E F I N E D T E S T S Modifying Only the Reagent Lot Number and Expiration Date To modify Reagent Lot number or Expiration Date after programming RFID Reagent Wedges: 1 Touch the Diagnostics/Maintenance/Setup icon, and then touch Setup. 2 If Security is enabled, the Security Login dialog displays. Enter the Supervisor password or a Technician password on the Alphanumeric Keypad and touch Enter on the keypad. 3 On the Setup menu, touch Reagent. The Reagent Setup screen displays. 4 Touch Reagent, then Reagent Details. 5 Touch the test to be modified (see Figure 12.17). Figure 12.17 Touch the Test to be Modified on the Reagent Setup Screen Note: modified. 12.28 Only tests with an "*" or an "*" and a "+" may be E a s y R A 6 Touch the Modify icon. 7 The Reagent Program popup displays (see Figure 12.18). O P E R A T O R ’ S M A N U A L Figure 12.18 Reagent Program Popup Touch OK to modify only the lot number and expiration date. 8 Change the lot number and expiration date as necessary (see Figure 12.19). Figure 12.19 Modify Reagent Parameters Screen 12.29 S E T T I N G U P U S E R - D E F I N E D 9 T E S T S When all entries for the test are complete, touch the Enter button. 10 The Reagent is now available to program new RFID Reagent Wedges. For more information programming Reagent Wedges, “Programming Reagent Wedges” on page 12.21. Modifying All Reagent Parameters To modify all Reagent parameters after programming RFID Reagent Wedges: 12.30 1 Touch the Diagnostics/Maintenance/Setup icon, and then touch Setup. 2 If Security is enabled, the Security Login dialog displays. Enter the Supervisor password or a Technician password on the Alphanumeric Keypad and touch Enter on the keypad. 3 On the Setup menu, touch Reagent. The Reagent Setup screen displays. 4 Touch Reagent, then Reagent Details. E a s y R A 5 O P E R A T O R ’ S M A N U A L Touch the test to be modified (see Figure 12.20). Figure 12.20 Touch the Test to be Modified on the Reagent Setup Screen Note: Only tests with an "*" or an "*" and a "+" may be modified. 6 Touch the Modify icon. 12.31 S E T T I N G U P U S E R - D E F I N E D 7 T E S T S The Reagent Program popup displays (see Figure 12.21). Figure 12.21 Reagent Program Popup Touch No to modify any parameters, not just the lot number and expiration date. 8 Change the Reagent parameters as necessary (see Figure 12.22). Figure 12.22 Modify Reagent Parameters Screen 12.32 E a s y R A 9 O P E R A T O R ’ S M A N U A L When all entries for the test are complete, touch the Enter button. 10 The Reagent is now available to program new RFID Reagent Wedges. For more information programming Reagent Wedges, see “Programming Reagent Wedges” on page 12.21. Deleting Reagent Parameters To delete Reagent parameters: 1 Touch the Diagnostics/Maintenance/Setup icon, and then touch Setup. 2 If Security is enabled, the Security Login dialog displays. Enter the Supervisor password or a Technician password on the Alphanumeric Keypad and touch Enter on the keypad. 3 On the Setup menu, touch Reagent. The Reagent Setup screen displays. 4 Touch Reagent, then Reagent Details. 5 Touch the test to be modified (see Figure 12.23). 12.33 S E T T I N G U P U S E R - D E F I N E D T E S T S Figure 12.23 Touch the Test to be Modified on the Reagent Setup Screen Note: Only tests with an "*" or an "*" and a "+" may be modified. 12.34 6 Touch the Modify icon. 7 The Reagent Program popup displays (see Figure 12.24). E a s y R A O P E R A T O R ’ S M A N U A L Figure 12.24 Reagent Program Popup Touch No. 8 Touch the Delete button: A message box displays indicating the selected Reagent will be deleted. 9 Touch OK to confirm the deletion. The selected Reagent is removed from the list of Reagents on the Reagent Details screen. 12.35 S E T T I N G U P U S E R - D E F I N E D T E S T S Reagent Optimization - Creating a Worklist EasyRA allows for testing of Reagent programs prior to programming Reagent Wedges. Reagent optimization allows for the user to verify the performance of the test prior to programming Reagent Wedges and reporting patient results. Reagent optimization may be performed multiple times prior to programming of Reagent Wedges. Only one test may be optimized at a time. Reagent usage and expiration is not tracked. To perform testing on new user-defined Reagents: 1 Touch the Worklist icon. On the drop-down menu that appears, touch Edit Worklist (see Figure 12.25). Figure 12.25 Worklist Drop-Down Menu 2 Enter the information for the first sample position (1) on the Worklist. For more information on entering information on the Worklist, see “Creating or Editing a Worklist Manually” on page 6.7. The information for each sample position specifies the tests that will be run on the sample located in the corresponding position on the Sample Ring. 12.36 E a s y R A O P E R A T O R ’ S M A N U A L Note: If choosing QC or Calibrator, QC Materials and/or Calibrator Materials must be configured. For more information on programming quality control materials, see “Configuring QC Materials” on page 4.59. For more information on configuring calibrator materials, see “Configuring Chemistry Calibrators” on page 4.31. Calibration for Endpoint and Kinetic tests must be performed prior to running QC or serum samples. 3 Touch the field requiring test data. The Test Select Keypad displays as shown in Figure 12.26. Figure 12.26 Test Select Keypad 4 Touch Reagent Optimization. Tests that have been stored, but not programmed will be highlighted for selection (see Figure 12.27). Figure 12.27 Tests That Are Stored, But Not Programmed are Highlighted 5 Touch the test name to select a test for optimization. Touch the Enter button. 12.37 S E T T I N G U P U S E R - D E F I N E D 6 T E S T S All Test fields are automatically filled in with the test to be optimized (see Figure 12.28). Figure 12.28 All Test Fields on the Worklist are Filled In With the Test to be Optimized 7 Enter the information for all remaining sample positions as necessary. 8 When the Worklist is complete, touch Enter to perform Cuvette and Reagent inventories: Touching enter starts an inventory. The Worklist Warning popup displays (see Figure 12.29). Because the RFID label on the Reagent Wedge has not been programmed, the Reagent must be placed position #1 in the Reagent Tray to perform the test. 12.38 E a s y R A O P E R A T O R ’ S M A N U A L Figure 12.29 Worklist Warning Popup Touch OK. 9 After placing the Reagent in position #1, close the Reagent Area Cover and touch OK. 10 If any problems are detected during inventory, the Status icon blinks. The Status icon may blink to indicate that a Reagent or sample is missing, Cuvettes need to be replaced, or a calibration is expired. To view the status messages, touch the Status icon and select Worklist Warnings. 11 After the inventory has been performed, the Run button displays in the upper left corner of the screen provided there is at least one test on the Worklist. 12.39 S E T T I N G U P U S E R - D E F I N E D T E S T S 12 Touch the Run button. After completion of the run, results will be displayed in the Current Results menu. Any result flags will be displayed on the Current Results screen. Results obtained during Reagent Optimization are marked "For Reagent Optimization use only. Not for clinical use." For more information on viewing results, see “Viewing Results” on page 7.1. If the performance of the test is acceptable, RFID Reagent Wedges may be programmed. 12.40 For more information on programming Reagent Wedges, see “Programming Reagent Wedges” on page 12.21. If modifications are required to the Reagent parameters, see “Modifying Reagent Parameters Before Programming RFID Reagent Wedges” on page 12.25 or “Modifying Reagent Parameters After Programming RFID Reagent Wedges” on page 12.27. A Principles of Operation The Medica EasyRA clinical chemistry analyzer is a random access, software-controlled system for in-vitro diagnostic testing used for the quantitative determination of a wide variety of analytes in body fluids. Chemistry measurements are initiated when precise amounts of sample and Reagents are aspirated, then dispensed and mixed inside a cuvette. A chemical reaction proceeds, resulting in a change in “color” intensity which is measured by the optical system (see Figure A.1). Figure A.1 EasyRA Optical System The components of the Optical System are listed below: 1. Flash lamp 2. Filter wheel 3. Beamsplitter 4a. Sample mirror 4b. Reference mirror 5. Reference photodiode detector 6. Cuvette segment 7. Sample photodiode detector A.1 P R I N C I P L E S O F O P E R A T I O N The contents of the cuvette are incubated at 37º C. Then, using the principles of absorbance transmittance photometry, the contents of the cuvette are analyzed at specific times and wavelengths using parameters set forth in protocols explicit for each analyte. The methods (Rate and Endpoint) that are used to convert the optical measurements to reportable concentration units are contained within the protocols. The test protocols reside on the RFID chip which provides instructions for the execution of each test. A test-specific RFID chip is mounted on each wedge. Single (monochromatic) wavelength or dual (bichromatic) wavelength measurements, along with the use of Reagent blanks and sample blanks, may be used to provide optimized assay performance for each analyte. The optional ISE module measures Sodium (Na), Potassium (K), Chloride (Cl), or Lithium (Li) in biological fluids, using ion selective electrolyte technology. The flow-through Sodium electrode uses selective membrane tubing, specifically formulated to be sensitive to sodium ions. The Potassium, Chloride, and Lithium electrodes employ similar designs with appropriate selective membrane materials. The potential of each electrode is measured relative to a fixed, stable voltage established by the double-junction silver/silver chloride reference electrode. When a sample is introduced, the specific ion is transported into the membrane and the ion selective electrode develops a voltage that varies with the concentration of the ion to which it responds. A.2 B Maintenance Logs This appendix contains the following maintenance logs: Daily Cleaning and Inspection Log. Monthly Cleaning Log. Replacement Log. It also contains a recommended replacement schedule to assist you in performing replacements when needed. Note: It is strongly recommended that you copy these maintenance logs and use them to track all maintenance performed on your EasyRA analyzer. For more information on the various maintenance procedures, see Chapter 10, “Performing Maintenance.” B.1 M A I N T E N A N C E L O G S Daily Cleaning and Inspection Log (Month: ______________ Year: ______) DAILY CLEANING DAILY INSPECTION CHECK DAY 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 B.2 INITIALS CHECK CHECK PROBE ISE DILUTOR CHECK WASTE/ PUMP CLEAN CLEAN PUMP PROBE DILUENT TUBES NOTES E a s y R A O P E R A T O R ’ S M A N U A L Monthly Cleaning Log (Month: ______________ Year: ______) DATE BLEACH BLEACH CLEAN CLEAN CLEAN ISE DILUENT WASTE WASH CUP AIR SAMPLE CUP BOTTLE BOTTLE INITIALS NOTES FILTER Replacement Log (Month: ______________ Year: ______) COMPONENT DATE INITIALS REPLACED NOTES Recommended Replacement Schedules CHEMISTRY COMPONENTS 4 MONTHS 6 MONTHS 9 MONTHS 1 YEAR PROBE WASH CUP WASTE PUMP TUBE DILUENT LINE ISE MODULE COMPONENTS* 4 MONTHS 6 MONTHS 9 MONTHS AS NEEDED ISE REAGENT PACK ISE PUMP TUBES ** + ISE Na SENSOR + ISE K SENSOR ISE Cl SENSOR ISE Li+ SENSOR ISE REFERENCE SENSOR *If you have this option. **High Volume User (greater than 100 ISE samples per day). B.3 M A I N T E N A N C E B.4 L O G S C EasyRA Specifications This appendix contains the technical specifications for EasyRA. Table C.1 EasyRA Specifications System Specifications True Random Access, Clinical Chemistry Analyzer. Throughput 150 tests/hour (300+ including ISE); Patient per hour, photometric: Up to 120 tests/hour; Patient results per hour, photometric with ISE: Up to 340 tests/hour; Stat Time: 8 minutes (Na+, K+, Cl-, CO2, GLU, BUN, CREA) Types of Analysis Enzymatic. Kinetic. Endpoint. Turbidimetric Immunoassay (TIA) Enzymatic Immunoassay (EIA) Samples 24 sample positions per Sample Ring for Patient Calibrator or QC samples; Optional second Sample Ring uniquely identified by analyzer. Samples/ Reagents Automatic dilution - 1:1 and 1:2. STAT up to 5 user-defined positions. Sample Type Serum, Plasma, Diluted Blood, Urine and Diluted Urine (as stated in the Intended Use). Sample Volume Photometric Chemistries: 20 - 25 L; programmed in 0.1 L steps. Sample Containers Sample Cups or Primary Tubes. ISE Chemistries: Serum 80-90 L; Urine 140 L. The Sample Holder accommodates a wide range of primary tube and sample cup sizes. For detailed specifications on sample tubes and cups, see Table C.2 and Table C.3 on page C.5. Sample Identification Position ID, Barcode ID (optional). Barcode Types: Codabar, Code 39, 128, Interleaved 2 of 5. C.1 E a s y R A Table C.1 S P E C I F I C A T I O N S EasyRA Specifications Reagents 24 Positions for Reagents. Reagent Cooling Temperature 12°-15° less than ambient. Reagent Identification - RFID (Radio Frequency Identification) Technology – automatic tracking and entry of Reagent information. Some of the information included on Medica’s Reagent Wedges is listed below: Name, Lot Number, and Expiration Date. Reagent Volumes. Analysis Volumes for Reagents, Samples, and Diluent. Primary and Secondary Wavelengths. Reaction Read Times. Analysis Type. Reagent and Sample Blanking. Linear Range of Assay. Acceptable Absorbance Ranges. Urine Parameters Internal Reagent checks on board stability and use tracked by chip). Quantitative or Qualitative Results For multi-level calibrations, whether the calibration levels are 0-based or 1-based. The RFID chips are used to track the location of Reagents in the Reagent Tray and to track the volume of Reagents remaining. The Reagents in the Reagent Wedges require no preparation; they are ready to use. Typical Reagent Volumes Reagent Volume (R1)/test 120-350 L; programmed in 1 L steps. Reagent Volume (R2)/test 10-50 L; programmed in 1 L steps. Water Supply Reagent Grade Deionized Water, Diluent Bottle. Sampling System Single Probe with RF Liquid Level Sensing. Pre-Heater. Inner and Outer Probe Washing. C.2 E a s y R A Table C.1 O P E R A T O R ’ S M A N U A L EasyRA Specifications Reaction System Cuvette Material Optical Acrylic; Disposable Segments; 12 Cuvettes per segment; 6 total segments in Reaction Area. Reaction Time 1-15 minutes. Reaction Temperature 37° ± 0.25° C (photometric chemistries) Wavelength 340, 405, 520, 550, 600, 660, 700. Half Bandwidth 10 ± 2 nm. Light Source Xenon Flash Lamp. 5 Year Typical Life. Photometric Linearity 0.0-2.0 Abs units for 6 mm pathlength (1% deviation). Photometric Resolution 0.0001 Abs units at 1.0 Abs. Quality Control 2 levels of controls (Levey-Jennings plots for two levels). Calibration Single and Multi-level calibration (based on Analyte). User Interface Edit/Monitor Worklists. Review Results. Review Calibration and Quality Control Results. Levey-Jennings Charts for 31-days of QC Results. On-board Diagnostics and Individual Component Monitoring. Graphic Instructions for Daily, Weekly and Monthly Maintenance Procedures. Data Storage 2000 patient results; 56,000 test results. Power Requirements 100 VAC-240 VAC ± 10%, 50-60 Hz, 4.0/2.0A. Dimensions 40” W x 15” H x 26” D (102 cm x 38 cm x 66 cm). 94 lbs (43 kgs) without Reagents. Ambient Conditions 15° - 30° C (59° - 86° F). <85% relative humidity, non-condensing atmospheric air environment. C.3 E a s y R A Table C.1 Computer S P E C I F I C A T I O N S EasyRA Specifications Minimum Requirements: Windows XP or Windows 7. CD/CD-RW (read-write). 1 Serial Communications Port (RS-232 or USB). Touch Screen Monitor (Medica Supplied) OR SVGA Color Monitor, Mouse, and Keyboard. Printing Local or Network Printer Optional Features C.4 4-channel ISE Module for Na/K/Cl/Li. Laboratory Information System (LIS) Connectivity (ASTM protocol) with onboard sample Barcode Reader. E a s y R A Table C.2 DRAW O P E R A T O R ’ S M A N U A L Types of Sample Tubes Used by EasyRA LENGTH DIAMETER VOLUME MAXIMUM DISTANCE INSERT FROM TOP OF TUBE TO SAMPLE 10 mL 100 mm 16 mm 2 in 5.1 cm 100x16 mm plastic insert 5 mL 100 mm 13 mm 2 in (5.1 cm) 100x13 mm plastic insert 3.5 mL 75 mm 13 mm 1.5 in (3.8 cm) 75x13 mm plastic insert Table C.3 Types of Sample Cups Used by EasyRA CUP/SIZE LENGTH DIAMETER MINIMUM SAMPLE SAMPLE CUP HOLDER SIZE REQUIRED IN CUP 2 mL 20 mm 13 mm 100 L EasyRA Sample Cup Holder small nesting cup/1mL 29.7 mm 9 mm 150 L EasyRA Sample Cup Holder or 75x13 mm tube in a plastic insert or 100x13 mm tube in a plastic insert large nesting cup/2mL 29.7 mm 12 mm 150 L 100 x 16 mm tube in a plastic insert C.5 E a s y R A C.6 S P E C I F I C A T I O N S D Warranty Medica warrants the EasyRA analyzer will be free of defects in material and workmanship for a period of twelve months from the date of purchase, excepting only software provided for use in conjunction with the EasyRA analyzer and those parts which are consumed or expended in normal use. In the case of consumables or expendables, the warranty time period shall be the usage time, providing such consumable or expendable is used prior to any "install by" or expiration date. The warranty is only applicable when the EasyRA analyzer is used under normal operating conditions and maintained in accordance with the instructions in the operator's manual and if the EasyRA analyzer has not been subjected to accident, alteration (including the installation of third-party software), or misuse. In the event of failure within the warranty period, Medica will repair or replace any Analyzer returned and not conforming to the above warranty or, at its option, refund the purchase price. With respect to the software provided by Medica for use on a computer system in conjunction with the EasyRA analyzer, all warranties are voided by any (1) misuse of the software, (2) modification of software, (3) failure to operate the EasyRA software within the hardware and software environment provided by the distributor. If a computer is included with the EasyRA, refer to the original manufacturer's warranty for service. THE WARRANTY DESCRIBED ABOVE IS EXCLUSIVE AND IN LIEU OF ALL OTHER WARRANTIES WHETHER STATUTORY, EXPRESS, OR IMPLIED (INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE AND ALL WARRANTIES ARISING FROM THE COURSE OF DEALING OR USAGE OF TRADE). THE BUYER'S SOLE AND EXCLUSIVE REMEDY IS FOR REPAIR OR REPLACEMENT OF THE DEFECTIVE ANALYZER OR PART THEREOF, OR REFUND OF THE PURCHASE PRICE OF SUCH PRODUCT; BUT IN NO EVENT SHALL MEDICA BE LIABLE TO THE BUYER OR ANY PERSON FOR ANY SPECIAL, INDIRECT, INCIDENTAL, OR CONSEQUENTIAL DAMAGES OR OTHERWISE WITH RESPECT TO, OR ARISING OUT OF, THE PRODUCT FURNISHED THEREUNDER. D.1 W A R R A N T Y Representations and warranties made by any person, including Dealers, Representatives and employees, which are inconsistent or in conflict with, or in addition to, the terms of this warranty shall not be binding upon Medica unless in writing and signed by one of its officers. For warranty service in the USA or Canada, please call our er Service Department, 1-800-777-5983. Outside the United States and Canada, please contact your local distributor. D.2 E a s y R A Index A accepting results 7.26 operator ID 7.28 add button 3.30 adding patient demographics 4.25 patient information 4.25 aligning probe 10.52 alphanumeric keypad entering data on 3.45 area computer/touch screen 1.32 diluent/waste bottle 1.30 electronics 1.33 fluidics drawer 1.24 reaction 1.17 reagent/sample 1.7 transfer arm 1.21 arm positioning test diagnostics 11.37 automatic printing enabling/disabling 2.49 B barcode reader 1.15 barcode reader test diagnostics 11.59 barcodes position in sample ring 5.41 biohazard 1.5 bleaching diluent bottle 10.25 waste bottle 10.30 book conventions xvi bottle diluent filling and loading 5.13 waste unloading and emptying 5.15 bump switch 1.23 buttons add 3.30 delete 3.30, 7.16 download CD 3.31 O P E R A T O R ’ S M A N U A L buttons (continued) flag legend 3.30 modify 3.30 pause 3.6 print 3.30 rerun 3.30, 7.10 run 3.6, 3.30 sample details 3.30 scroll 3.31 C cables data 1.33 power 1.33 Cal A/B priming 10.98 calibrating the ISE module 6.60 calibration configuring 4.31 entering requests 6.15 multi-level 3.46, 4.2, 4.31, 6.17, 7.3 printing all reports 7.69 single level 4.2 status 8.11 calibration results 7.1 printing from 7.75 viewing 7.44 calibrators configuring 4.31 deleting 4.50 setting up 4.31 setting up manually 4.40 setting up using a CD 4.32 CD for setting up calibration 4.32 for setting up QC materials 4.59 changing supervisor password 2.32 checking probe 10.14 pump tubes 10.19 waste and diluent 10.16 chemistry pump tubes 10.19 waste line purging 10.90 waste pump tube replacing 10.58 cleaner wedges 10.7 Index.1 I N D E X cleaning daily 10.6 daily log B.2 inventory 8.21 monthly 10.22 monthly log B.3 status 8.20 inventory from 8.21 the diluent bottle 10.25 the wash cup 10.35 the waste bottle 10.30 wash cup 10.35 weekly 10.22 clearing the worklist 7.26 closed position fluidics drawer 1.25 colors of icons 3.3 on screen 3.3 components of EasyRA 1.1 computer 1.32 cable connecting 2.13 monitor connecting 2.15 configuring calibrators 4.31 LIS setup 2.61 tests 4.3 connecting computer cable 2.13 computer monitor 2.15 diluent bottle/line 2.7 ISE pump tube 2.6 ISE reagent pack 2.9 ISE sensors 2.11 keyboard 2.15 mouse 2.15 power cable 2.13 printer 2.15 touch screen 2.15 tubing 2.2 waste line 2.8 waste pump tube 2.4 control buttons 3.30 conventions xvi cover diagnostics 11.66 Index.2 creating worklist automatically (from LIS) 6.28 manually 6.7 workflow 6.2 critical ranges setting up 4.14 current results 7.1 accepting 7.26 deleting 7.15 printing all calibration reports 7.69 all patient reports 7.67 all QC reports 7.70 all samples 7.65 from 7.64 viewing 7.3 sample details 7.20 curve icon 7.44, 7.45, 7.46 cuvette carousel 1.18 diagnostics 11.34 cuvettes 1.18 inventory 8.17 replacing 5.27 status 8.15 inventory from 8.17 D daily cleaning 10.6 ISE module 10.8 probe 10.8 inspection diluent 10.16 dilutor pump 10.12 maintenance 10.10 probe 10.14 pump tubes 10.19 waste 10.16 logs maintenance B.2 data cables 1.33 entering on the alphanumeric keypad 3.45 data area diagnostic 3.40 maintenance 3.42 on user interface 3.29 results 3.36 setup 3.43 status 3.39 Worklist 3.32 E a s y R A debug mode enabling/disabling 2.72, 2.74, 2.76 delete button 3.30, 7.16 deleting calibrators 4.50 QC materials 4.78, 4.80 results 7.15 reasons for 7.15 demographics adding patient 4.25 diagnostic data area 3.40 icon 3.7 Diagnostic/Maintenance/Setup menu using 3.25 diagnostics 11.1 arm positioning test 11.37 barcode reader test 11.59 cooler 11.65 cover/door latches 11.66 cuvette carousel test 11.34 dilutor pump test 11.46 fluidics drawer 11.45 heater 11.65 ISE sensor system test 11.52 liquid level sensing test 11.42 photometer test 11.31 precision test 11.67 probe 11.36 probe positioning test 11.39 reaction area 11.30 reagent area 11.55 RFID reader test 11.62 running 11.21 sample area 11.55 sample wheel test 11.56 table of symptoms 11.21 transfer arm 11.36 waste pump test 11.49 diluent bottle filling and loading 5.13 monthly cleaning 10.25 daily inspection 10.16 maintenance 10.16 priming 10.93 diluent bottle/line connecting 2.7 diluent/waste bottle area 1.30 O P E R A T O R ’ S M A N U A L dilutor pump 1.29 daily inspection 10.12 maintenance 10.12 test diagnostics 11.46 disabling automatic printing 2.49 debug mode 2.72, 2.74, 2.76 operator ID 2.69 security 2.43 door latches diagnostics 11.66 download CD button 3.31 drop-down menus 3.8 E EasyRA biohazard 1.5 components 1.1 diagnostics 11.1 features 1.2 flow of fluids through 1.28 hazards 1.4 intended use xiii precautions 1.4 principles of operation A.1 safety 1.4 setting up 2.1 specifications C.1 starting 2.16 stopping 2.18 symbols xiv troubleshooting 11.1 warnings 1.4 warranty D.1 workflow 1.34 electronics 1.33 emptying the waste bottle 5.15 enabling automatic printing 2.49 debug mode 2.72, 2.74, 2.76 operator ID 2.69 security 2.43 ending a test run 6.44 entering data on the alphanumeric keypad 3.45 operator ID 7.28 Index.3 I N D E X entering (continued) tests on the test select keypad 3.46 the startup password 2.30 entries worklist 6.7 error codes on system status 3.9, 3.11 errors measurement 7.83 range 7.82 F features 1.2 fields for worklist entries 6.10 filling diluent bottle 5.13 flags in results 7.6, 7.32 legend 7.6, 7.8, 7.32 button 3.30 measurement errors 7.83 range errors 7.82 flow of fluids through EasyRA 1.28 fluidics drawer 1.24 closed position 1.25 components 1.27 diagnostics 11.45 dilutor pump test 11.46 ISE sensor system test 11.52 open position 1.25 peek position 1.26 waste pump test 11.49 fluids flowing through EasyRA 1.28 H hardware problems 11.1, 11.2 hazards 1.4 during maintenance 10.2 heated air bath 1.20 heater/cooler diagnostics 11.65 I icons 3.30 colors of 3.3 curve 7.44, 7.45, 7.46 diagnostic/maintenance/setup 3.7 on user interface 3.5 results 3.7 Index.4 icons (continued) status 3.7 system 3.6 worklist 3.6 ID patient 4.27 sample 6.11 inspection daily 10.10 daily log B.2 intended use xiii interface LIS 6.64 inventory cleaning 8.21 cuvette 8.17 ISE 8.19 performing 6.32 problems detected during 6.33 reagent 8.10 sample 8.26 starting 6.32 inventory report printing 8.24 status 8.22 updating 8.24 ISE Calibrant A and B pumps 1.29 calibrating the ISE module 6.60 calibration results 6.62 inventory 8.19 module 1.29 calibrating 6.60, 10.8 cleaning 10.8 pump tube connecting 2.6 pump tubes 10.19 pumps 1.29 reagent pack 1.30 connecting 2.9 replacing 10.64, 10.67 sensor system test diagnostics 11.52 sensors connecting 2.11 replacing 10.73 status 8.18 inventory from 8.19 waste line purging 10.95 E a s y R A ISE (continued) waste pump 1.29 waste pump tube replacing 10.80 K keyboard connecting 2.15 keypads alphanumeric 3.45 on the user interface 3.45 test select 3.46 L last results 7.1 printing all calibration reports 7.69 all patient reports 7.67 all QC reports 7.70 all sample 7.65 from 7.64 viewing 7.29 viewing sample details 7.20 legend results flags 7.6, 7.8, 7.32 Levey-Jennings chart printing 7.78, 7.80 viewing 7.56, 7.62 liquid level sensing test diagnostics 11.42 liquid level sensor 1.23 LIS configuration setting up 2.61 configuring 2.61 creating worklist from 6.28 list viewing 6.66 understanding 6.64 LIS Connectivity option loading samples with 5.41 loading samples without 5.39 loading diluent bottle 5.13 reagent tray 5.24 reagent wedges 5.2 reagents for the first time 2.23 sample ring 5.21 sample ring and reagent tray 5.16 as unit 5.18 samples 5.37 with LIS Connectivity option 5.41 without LIS Connectivity option 5.39 O P E R A T O R ’ S M A N U A L logs daily cleaning B.2 daily inspection B.2 maintenance B.1 monthly cleaning B.3 replacement B.3 lot number 6.11 M maintenance bleaching diluent bottle 10.25 bleaching waste bottle 10.30 checking diluent 10.16 checking dilutor pump 10.12 checking probe 10.14 checking pump tubes 10.19 checking waste 10.16 cleaning ISE module 10.8 probe 10.8 wash cup 10.35 daily cleaning 10.6 daily inspection 10.10 daily logs B.2 data area 3.42 hazards 10.2 icon 3.7 logs B.1 monthly cleaning 10.22 monthly logs B.3 priming diluent 10.93 ISE Cal A/B 10.98 purging the chemistry waste line 10.90 the ISE waste line 10.95 purging and priming 10.88 replacement log B.3 replacement schedule B.3 replacements 10.43, 10.44 replacing ISE reagent pack 10.64, 10.67 ISE sensors 10.73 ISE waste pump tube 10.80 probe 10.48 the chemistry waste pump tube 10.58 wash cup 10.54 weekly cleaning 10.22 measurement problems 11.1, 11.11, 11.19 measurement errors flags 7.83 Index.5 I N D E X menus Diagnostic/Maintenance/Setup 3.25 drop-down 3.8 on user interface 3.8 overview 3.8 results 3.21 Status 3.23 status 8.1 Worklist 3.19 modify button 3.30 modules ISE 1.29 monitoring the worklist 6.55 monthly cleaning 10.22 bleaching diluent bottle 10.25 bleaching waste bottle 10.30 wash cup 10.35 logs maintenance B.3 mouse connecting 2.15 multi-level calibration 3.46, 4.31, 6.17, 7.3 results 7.46 N normal ranges setting up 4.14 number of stat positions selecting 2.70 O open position fluidics drawer 1.25 operation principles of A.1 operator ID enabling/disabling 2.69 entering 7.28 P pack ISE reagent 1.30 passwords startup 2.30 supervisor 2.32 technicians 2.34 patient demographics adding 4.25 Index.6 patient (continued) entering tests 6.24 ID 4.27 viewing results for 7.37 information adding 4.25 viewing from Worklist Edit screen 6.26 printing all reports 7.67 printing all report for a 7.74 reports printing all 7.67 results printing from 7.72 sample results 7.1 viewing 7.31 viewing by patient ID 7.37 searching for results 7.37 setting up 4.25 sorting results 7.40 viewing sample results 7.31 viewing results for a 7.37 pause button 3.6 pausing a test run 6.38 peek position fluidics drawer 1.26 pending list moving tests to the worklist 6.59 photometer 1.20 diagnostics 11.31 power cable 1.33 connecting 2.13 power switch 1.33 precautions 1.4 precision test diagnostics 11.67 pre-heater 1.23 priming diluent 10.93 ISE Cal A/B 10.98 maintenance 10.88 principles of operation A.1 print button 3.30 printer connecting 2.15 printer options setting up 2.49 E a s y R A printing all calibrations from current results 7.69 all calibrations from last results 7.69 all patients from current results 7.67 all patients from last results 7.67 all QC from current results 7.70 all QC from last results 7.70 all QC results 7.77 all results from a run 7.72 all sample results for a patient 7.74 all samples from current results 7.65 all samples from last results 7.65 enabling/disabling automatic printing 2.49 from calibration 7.75 from current results 7.64 from last results 7.64 from patient results 7.72 from QC results 7.77 from sample details 7.72 inventory report 8.24 Levey-Jennings chart 7.78, 7.80 operator ID 7.28 reagents 4.93 results operator ID 7.28 test results 7.64 probe 1.22 check alignment after replacement 10.52 cleaning 10.8 daily inspection 10.14 maintenance 10.14 positions 1.22 replacing 10.48 probe positioning test diagnostics 11.39 problems hardware 11.1, 11.2 measurement 11.1, 11.11, 11.19 range 11.1 symptoms of 11.21 pump tubes chemistry 10.19 daily inspection 10.19 ISE 10.19 maintenance 10.19 pumps checking dilutor pump 10.12 dilutor 1.29 ISE Calibrant A and B 1.29 waste 1.29 waste (chemistry) 1.29 O P E R A T O R ’ S M A N U A L purging chemistry waste line 10.90 ISE waste line 10.95 maintenance 10.88 Q QC entering requests 6.21 printing all reports 7.70 printing all results 7.77 status 8.13 QC materials deleting 4.78, 4.80 setting up 4.59 setting up manually 4.55, 4.68, 4.84, 4.93 setting up using a CD 4.59 QC report printing all 7.70 QC results 4.70, 7.1 printing from 7.77 quantitative 4.70 viewing 7.49 viewing Levey-Jennings chart 7.56, 7.62 qualitative 4.70 results 1.2, 12.9 qualitative QC results 7.61 quantitative results 1.2, 12.9 quantitative QC results 7.53 R range errors flags 7.82 ranges critical 4.14 normal 4.14 problems 11.1 rerun 4.14 reaction area 1.17 cuvette carousel test 11.34 diagnostics 11.30 photometer test 11.31 reagent area diagnostics 11.55 reagent pack ISE 1.30 replacing 10.64, 10.67 reagent tray 1.8 loading and unloading 5.16, 5.24 loading and unloading with sample ring 5.18 Index.7 I N D E X reagent wedges 1.10 loading and unloading 5.2 reagent/sample area 1.7 barcode reader test 11.59 RFID reader test 11.62 sample wheel test 11.56 reagents inventory 8.10 loading for the first time 2.23 printing 4.93 setting up 4.89 status 8.7 inventory from 8.10 viewing all 4.89 wedges 1.10 replacements check probe alignment 10.52 ISE reagent pack 10.64, 10.67 ISE sensors 10.73 log B.3 probe 10.48 procedures 10.43, 10.44 recommended schedule B.3 wash cup 10.54 waste pump tube chemistry 10.58 ISE 10.80 replacing chemistry waste pump tube 10.58 cuvettes 5.27 probe 10.48 the ISE reagent pack 10.64, 10.67 the ISE sensors 10.73 the ISE waste pump tube 10.80 the wash cup 10.54 report header specifying 2.52 reports printing all sample results for a patient 7.74 printing inventory 8.24 specifying header 2.52 requests entering calibration 6.15 entering QC 6.21 rerun button 3.30, 7.10 ranges setting up 4.14 results of 7.14 tests 7.9 rerunning tests 7.9 Index.8 results accepting 7.26 calibration 7.1 current 7.1 data area 3.36 deleting 7.15 flag field 7.6, 7.32 flag legend 3.30 flags legend 7.6, 7.8, 7.32 icon 3.7 ISE calibration 6.62 last 7.1 menu using 3.21 multi-level calibration 7.46 of rerun 7.14 operator ID 7.28 patient sample 7.1, 7.31 print from patient results 7.72 printing 7.64 all from a run 7.72 all QC 7.77 printing from calibration 7.75 printing from current 7.64 printing from last 7.64 printing from patient 7.72 printing from QC 7.77 printing from sample details 7.72 QC 7.1 qualitative 1.2, 12.9 qualitative and quantitative 7.3 qualitative QC 7.61 qualitative to quantitative 12.18 quantitative 1.2, 12.9 quantitative QC 7.53 quantitative to qualitative 12.18 sample details 7.20 searching for a patient 7.37 sorting 7.40 viewing calibration 7.44 current 7.3 for a particular patient 7.37 last 7.29 Levey-Jennings chart 7.56, 7.62 QC 7.49 resuming a test run 6.42 a test run (inventory required) 6.42 RFID reader test diagnostics 11.62 E a s y R A run button 3.6, 3.30 ending 6.44 pausing 6.38 printing all results from 7.72 resuming 6.42 resuming (inventory required) 6.42 starting a 6.35, 6.37 timer 3.6 running worklist workflow 6.2 S safety 1.4 sample cups used on EasyRA 5.38, C.5 details button 3.30 printing from 7.72 viewing 7.20 ID 6.11 patient viewing 7.31 results printing all 7.65 ring 1.14 loading and unloading 5.16, 5.21 position of barcodes 5.41 tubes used on EasyRA 5.38, C.5 sample area diagnostics 11.55 sample ring loading and unloading with reagent tray 5.18 sample wheel test diagnostics 11.56 sample/reagent area 1.7 samples inventory 8.25, 8.26 status 8.25 loading and unloading 5.37 loading with LIS Connectivity option 5.41 loading without LIS Connectivity option 5.39 printing all results 7.65 status inventory from 8.26 unloading 5.42 schedule for replacements B.3 screen colors 3.3 O P E R A T O R ’ S M A N U A L screen components on user interface 3.4 scroll buttons 3.31 searching for patient results 7.37 security enabling/disabling 2.43 setting up 2.29 selecting number of stat positions 2.70 sensors ISE replacing 10.73 setting up calibrators 4.31 calibrators manually 4.40 calibrators using a CD 4.32 computer cable 2.13 connecting tubing 2.2 critical ranges 4.14 diluent bottle/line 2.7 EasyRA 2.1 ISE pump tube 2.6 ISE reagent pack 2.9 ISE sensors 2.11 LIS configuration 2.61 normal ranges 4.14 patients 4.25 power cable 2.13 printer options 2.49 QC materials 4.59 QC materials manually 4.55, 4.68, 4.84, 4.93 QC materials using a CD 4.59 reagents 4.89 rerun ranges 4.14 technician passwords 2.34 test panels 4.4 test ranges 4.10 test units 4.17 user-defined tests 12.1 waste line 2.8 waste pump tube 2.4 setup data area 3.43 icon 3.7 sorting patient results 7.40 specifications for EasyRA C.1 technical C.1 specifying report header 2.52 Index.9 I N D E X starting a test run 6.35, 6.37 EasyRA 2.16 startup password entering 2.30 stat selecting number of positions on ring 2.70 status calibration 8.11 cleaning 8.20 cuvette 8.15 data area 3.39 icon 3.7 inventory report 8.22 ISE 8.18 menu 8.1 QC 8.13 reagent 8.7 sample inventory 8.25 system 3.9, 3.11 worklist warnings 8.3 Status menu using 3.23 stopping EasyRA 2.18 subsystem computer/touch screen 1.32 diluent/waste bottle 1.30 electronics 1.33 fluidics drawer 1.24 reaction 1.17 reagent/sample 1.7 transfer arm 1.21 supervisor password changing 2.32 switch power 1.33 symbols xiv symptoms for diagnostics 11.21 system icon 3.6 status 3.6 system setup 2.29 automatic printing enabling/disabling 2.49 debug mode enabling/disabling 2.72, 2.74, 2.76 LIS configuration 2.61 number of stat positions selecting 2.70 operator ID enabling/disabling 2.69 Index.10 system setup (continued) report header specifying 2.52 security 2.29 changing the supervisor password 2.32 enabling/disabling 2.43 entering startup password 2.30 setting the technician passwords 2.34 setting up printer options 2.49 system status error codes 3.9, 3.11 viewing 3.9, 3.11 T technical specifications C.1 technician passwords setting up 2.34 TECs 1.16 test panels setting up 4.4 test ranges setting up 4.10 test run ending 6.44 pausing 6.38 resuming 6.42 resuming (inventory required) 6.42 starting a 6.35, 6.37 test select keypad entering tests on 3.46 test states worklist monitoring 6.56 test units setting up 4.17 tests configuring 4.3 deleting results 7.15 diagnostics 11.21 entering on the test select keypad 3.46 entering patient tests 6.24 moving from the pending list to the worklist 6.59 printing results 7.64 qualitative QC 4.75 quantitative QC 4.71 rerunning 7.9 user-defined 6.11, 12.1 thermoelectric coolers 1.16 timer run 3.6 touch screen 1.32, 3.2 connecting 2.15 transfer arm 1.21 E a s y R A transfer arm/probe arm positioning test 11.37 diagnostics 11.36 liquid level sensing test 11.42 probe positioning test 11.39 troubleshooting 11.1 hardware problems 11.1, 11.2 measurement problems 11.1, 11.11, 11.19 range problems 11.1 tubing connecting EasyRA 2.2 U understanding LIS interface 6.64 the user interface 3.1 unloading reagent tray 5.24 reagent wedges 5.2 sample ring 5.21 sample ring and reagent tray 5.16 as unit 5.18 samples 5.37, 5.42 the waste bottle 5.15 updating inventory report 8.24 user interface data area 3.29 icons 3.5 keypads 3.45 menus 3.8 screen colors 3.3 screen components 3.4 touch screen 3.2 understanding 3.1 user-defined tests setting up 12.1 V viewing calibration results 7.44 calibration status 8.11 cleaning status 8.20 current results 7.3 cuvette status 8.15 inventory report 8.22 ISE status 8.18 last results 7.29 LIS list 6.66 patient information from Worklist Edit screen 6.26 patient sample results 7.31 QC results 7.49 Levey-Jennings chart 7.56, 7.62 O P E R A T O R ’ S M A N U A L viewing (continued) QC status 8.13 reagent status 8.7 reagents 4.89 results for a particular patient 7.37 sample details 7.20 sample inventory 8.25 system status 3.9, 3.11 worklist warnings 8.3 W warnings 1.4 worklist 8.3, 8.5 warranty D.1 wash cup 1.28 monthly cleaning 10.35 replacing 10.54 waste bottle monthly cleaning 10.30 unloading and emptying 5.15 daily inspection 10.16 maintenance 10.16 waste line connecting 2.8 purging 10.90 waste pump 1.29 waste pump test diagnostics 11.49 waste pump tube chemistry replacing 10.58 connecting 2.4 ISE replacing 10.80 waste/diluent bottle area 1.30 wedges 1.10 cleaner 10.7 reagent loading and unloading 5.2 weekly cleaning 10.22 workflow 1.34 creating and running worklist 6.2 Worklist data area 3.32 worklist clearing 7.26 contents of entries 6.7 creating automatically (from LIS) 6.28 manually 6.7 Index.11 I N D E X worklist (continued) defined 6.7 fields 6.10 icon 3.6 monitoring 6.55 test states 6.56 moving tests from the pending list 6.59 typical workflow for creating and running 6.2 warnings 8.3 defined 8.5 Worklist Edit screen viewing patient information 6.26 Worklist menu using 3.19 Index.12 007530-901-R6, 2013-01 For Service or Technical Assistance: 800 777 5983 In Continental US 781 275 4892 International 781 275 2731 (Fax) medica@medicacorp.com (E-mail) Medica Corporation 5 Oak Park Drive Bedford, Massachusetts 07130-1413 USA
