ADVIA Centaur® CP Immunoassay System
Operator’s Guide
086D0320-01 Rev. 04, 2019-03
© 2005–2019 Siemens Healthcare Diagnostics. All rights reserved.
No part of this manual or the products it describes may be reproduced by any means or in any form without
prior consent in writing from Siemens Healthcare Diagnostics.
ADVIA, ADVIA Centaur, CentraLink, and ReadyPack are trademarks of Siemens Healthcare Diagnostics.
CAPIJECT is a registered trademark of Terumo Medical Corporation.
EZee-Nest is a trademark of Elkay Laboratory Products.
Hitachi is a trademark of Hitachi Ltd.
Microtainer is a trademark of Becton Dickinson and Company.
Minicollect is a registered trademark of Greiner Bio-One GmbH.
Monovette and Sarstedt are trademarks of Sarstedt, Inc.
The information in this manual was correct at the time of printing. However, Siemens continues to improve
products and reserves the right to change specifications, equipment, and maintenance procedures at any
time without notice.
If the ADVIA Centaur CP system is used in a manner differently than specified by Siemens, the protection
provided by the equipment may be impaired. Observe all warning and hazard statements.
Contents
1
Overview
Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
Supplies and Waste . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
LED Color Coding. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
System Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5
Power and Signal Connections to the Workstation . . . . . . . . . . . . . . . . 1-7
Acid and Base Reagent Compartment . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8
Tip Drawers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9
Sample Compartment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-10
Reagent Compartment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-12
Solid Waste Drawer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-14
Fluidics Area. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-14
Reagent Shortage Window. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-14
Cuvette Hopper . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-15
System Interior . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-15
Workstation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-16
Software Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-18
Workspace . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-18
Display Area . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-19
Taskbar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-20
Function Buttons. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-22
Navigation Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-22
Exporting Logs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-23
Status Bar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-24
Screens and Windows . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-25
Test Sequence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-26
Technology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-28
Direct Chemiluminescence. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-28
Antibody Binding Principles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-30
Paramagnetic Particles and Magnetic Separation . . . . . . . . . . . . . . . . 1-30
Assay Reaction Formats . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-31
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-41
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ADVIA Centaur CP Operator’s Guide: Contents
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Operating the System
Daily System Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
Starting and Stopping the System . . . . . . . . . . . . . . . . . . . . . . . 2-3
Starting the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Signing In to the System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Stopping or Pausing Sample Processing . . . . . . . . . . . . . . . . . . . . . . . . 2-4
Exiting the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5
Turning the System Off. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8
Changing Your Password . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9
Managing Supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9
Replacing Acid and Base Reagents (R1 and R2) . . . . . . . . . . . . . . . . . 2-9
Viewing Available Acid and Base Volumes . . . . . . . . . . . . . . . . . . . . . 2-11
Loading Sample Tips . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-12
Adding Cuvettes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-16
Emptying the Solid Waste Drawer . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-17
Emptying and Refilling the DI Water and Wash 1 Containers . . . . . . . 2-19
Emptying the Liquid Waste Container . . . . . . . . . . . . . . . . . . . . . . . . . 2-20
Monitoring and Managing Reagent Supplies. . . . . . . . . . . . . . 2-21
Loading Primary Reagent Packs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-22
Removing Primary Packs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-26
Loading Ancillary Reagent Packs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-27
Removing Ancillary Reagent Packs . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-31
Processing Samples. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-33
Loading Samples into Sample Racks. . . . . . . . . . . . . . . . . . . . . . . . . . 2-33
Setting Tube Types . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-35
Loading Sample Racks into the System. . . . . . . . . . . . . . . . . . . . . . . . 2-35
Removing Sample Racks from the System . . . . . . . . . . . . . . . . . . . . . 2-38
Removing a Sample Rack to Retrieve a Sample . . . . . . . . . . . . . . . . . 2-39
Ensuring the Final Results are Released . . . . . . . . . . . . . . . . . . . . . . . 2-39
Scheduling Patient Samples . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-40
Scheduling Samples through the Sample Compartment Screen . . . . . 2-40
Scheduling Samples Using a Profile . . . . . . . . . . . . . . . . . . . . . . . . . . 2-41
Selecting a Dilution for a Sample Through the
Sample Compartment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-41
Setting Replicates Through the Sample Compartment . . . . . . . . . . . . 2-43
Setting up Batch Orders Through the Sample Compartment. . . . . . . . 2-44
Checking Sample Status Through the Sample Compartment . . . . . . . 2-44
Scheduling a Worklist Using the Results Screen . . . . . . . . . . . . . . . . . 2-45
Scheduling Replicates Using a Worklist . . . . . . . . . . . . . . . . . . . . . . . . 2-45
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Scheduling Dilutions Using a Worklist . . . . . . . . . . . . . . . . . . . . . . . . . 2-46
Downloading Orders Automatically from the LIS . . . . . . . . . . . . . . . . . 2-47
Scheduling a Worklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-48
Scheduling a Worklist for Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-48
Scheduling a Control Bracketed Patient Sample . . . . . . . . . . . . . . . . . 2-49
Scheduling a Control Bracketed Control as a QC Sample . . . . . . . . . . 2-50
Entering STAT Samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-51
Deleting Results and Scheduled Tests . . . . . . . . . . . . . . . . . . . . . . . . . 2-52
Editing Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-52
Using Multicomponent Testing . . . . . . . . . . . . . . . . . . . . . . . . . 2-53
Printing on Your Local Printer. . . . . . . . . . . . . . . . . . . . . . . . . . 2-61
Printing a Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-61
Printing Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-61
Automating the Printing of Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-61
Recalling Sample IDs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-62
Entering Sample IDs not Captured by the Barcode Reader. . . . . . . . . 2-62
Entering Patient Demographic Information . . . . . . . . . . . . . . . 2-63
Entering Patient Demographic Information Through the Worklist . . . . 2-63
Entering Patient Demographic Information Through the Sample
Compartment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-64
Start Sampling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-64
Processing Samples in Batch Mode. . . . . . . . . . . . . . . . . . . . . . . . . . . 2-65
Managing Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-65
Results Tabs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-65
Viewing Workorders from the LIS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-66
Viewing Result Summaries. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-66
Viewing Result Details . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-66
Viewing (Filtering) Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-67
Viewing Pending Control Bracketed Results . . . . . . . . . . . . . . . . . . . . 2-67
Moving Results to the Historical Tab . . . . . . . . . . . . . . . . . . . . . . . . . . 2-68
Printing Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-68
Deleting Results and Scheduled Tests . . . . . . . . . . . . . . . . . . . . . . . . . 2-69
Exporting Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-70
Exporting Results to a CD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-71
Entering Comments for Patient Results . . . . . . . . . . . . . . . . . . . . . . . . 2-71
Rerunning Patient Samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-72
Automatically Scheduling a Rerun Test . . . . . . . . . . . . . . . . . . . . . . . . 2-72
Automatically Scheduling a Rerun Test in the Event of an Error . . . . . 2-72
Manually Scheduling a Rerun Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-72
Releasing the Hold Status for a Result. . . . . . . . . . . . . . . . . . . . . . . . . 2-73
Releasing the Hold Status for a Ratio Result . . . . . . . . . . . . . . . . . . . . 2-73
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ADVIA Centaur CP Operator’s Guide: Contents
Editing Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-73
Entering an Offsystem Result. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-74
Downloading Orders. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-75
Processing Failed Samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-75
Responding to Depleted Reagent Volume . . . . . . . . . . . . . . . . . . . . . . 2-75
Moving Results to the Historical Tab . . . . . . . . . . . . . . . . . . . . . . . . . . 2-76
3
Calibration and Quality Control
Calibration Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
Master Curve Development . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
Two-point Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
Calibration Evaluation Criteria . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4
Retaining Calibrations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7
Autoexcluding Calibrator Replicates. . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9
Workflow to Process Calibrators . . . . . . . . . . . . . . . . . . . . . . . . 3-9
Scheduling Calibrators for a Control Bracketed Test . . . . . . . . . . . . . . . 3-9
Scheduling Calibrators for a Multicomponent Test . . . . . . . . . . . . . . . . 3-11
Entering Calibrator Information Manually . . . . . . . . . . . . . . . . . . . . . . . 3-11
Adding Calibrator Values. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-12
Adding a New Calibrator Definition. . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-12
Defining a Master Curve. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-13
Managing Calibration Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-15
Viewing Calibrations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-15
Viewing Calibration Result Summaries . . . . . . . . . . . . . . . . . . . . . . . . 3-16
Viewing Quality Controls by Status. . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-16
Viewing Calibration Result Details . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-17
Viewing (Filtering) Calibration Results . . . . . . . . . . . . . . . . . . . . . . . . . 3-17
Printing Calibration Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-18
Excluding a Calibrator RLU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-18
Waiving a Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-19
Accepting a Calibration that is in Verify State . . . . . . . . . . . . . . . . . . . . 3-20
Assigning a Calibration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-21
Quality Control Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-21
Workflow to Process Quality Control Samples . . . . . . . . . . . . . . . . . . . 3-22
Adding and Editing Quality Control Values . . . . . . . . . . . . . . . 3-23
Adding a New Quality Control Definition . . . . . . . . . . . . . . . . . . . . . . . 3-23
Editing a Quality Control Definition. . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-26
Deleting a Quality Control Definition. . . . . . . . . . . . . . . . . . . . . . . . . . . 3-26
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Scheduling a Control from the Primary Reagent Window . . . 3-27
Defining a Control Definition for a Multicomponent Test. . . . . . . . . . . . 3-28
Scheduling Controls for Multicomponent Tests . . . . . . . . . . . . . . . . . . 3-28
Managing Quality Control Data . . . . . . . . . . . . . . . . . . . . . . . . . 3-28
Viewing Quality Control Summaries . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-28
Viewing Quality Control Details . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-29
Viewing (Filtering) Quality Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-29
Printing Quality Control. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-30
Deleting Quality Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-30
Exporting Quality Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-30
ADVIA QC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-31
4
Maintenance
Managing Maintenance Tasks . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
Maintenance Frequency Checklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
Reviewing Maintenance Tasks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
Recording Maintenance Tasks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
Printing Maintenance Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
Defining Maintenance Tasks. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
Deleting Maintenance Tasks. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5
Importing and Exporting Maintenance Tasks . . . . . . . . . . . . . . . . . . . . . 4-5
Canceling a Maintenance Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6
Automated Maintenance Procedures . . . . . . . . . . . . . . . . . . . . . 4-6
Performing an Automated Daily Cleaning . . . . . . . . . . . . . . . . . . . . . . . 4-6
Performing an Automated Weekly Cleaning. . . . . . . . . . . . . . . . . . . . . . 4-8
Performing an Automated Monthly Cleaning . . . . . . . . . . . . . . . . . . . . 4-10
Maintaining Compartments and Drawers. . . . . . . . . . . . . . . . . 4-13
Cleaning the Acid and Base Reagent Compartment . . . . . . . . . . . . . . 4-13
Cleaning the Solid Waste Drawer and Liner. . . . . . . . . . . . . . . . . . . . . 4-14
Cleaning the Sample Compartment . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-17
Cleaning the Sample Compartment Shutters . . . . . . . . . . . . . . . . . . . . 4-19
Cleaning the Sample Racks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-21
Cleaning the Reagent Compartment . . . . . . . . . . . . . . . . . . . . . . . . . . 4-22
Cleaning the Reagent Compartment Shutter . . . . . . . . . . . . . . . . . . . . 4-24
Maintaining System Containers . . . . . . . . . . . . . . . . . . . . . . . . 4-26
Cleaning the Wash 1 Container . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-26
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Maintaining the System Interior . . . . . . . . . . . . . . . . . . . . . . . . 4-30
Cleaning the Incubation Ring Cover. . . . . . . . . . . . . . . . . . . . . . . . . . . 4-30
Cleaning the Exterior of the Reagent Probe. . . . . . . . . . . . . . . . . . . . . 4-31
Cleaning the Exterior of the Waste Probe . . . . . . . . . . . . . . . . . . . . . . 4-32
Cleaning the Probe Rails . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-33
Maintaining the System Exterior . . . . . . . . . . . . . . . . . . . . . . . . 4-34
Cleaning the System Exterior . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-34
Cleaning the Workstation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-34
Performing Database Maintenance. . . . . . . . . . . . . . . . . . . . . . 4-35
Maintaining the System Database . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-35
Backing Up System Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-36
Restoring System Data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-37
General Maintenance Tasks . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-37
Preparing the Cleaning Solution used on the System . . . . . . . . . . . . . 4-37
Performing an Automated System Prime . . . . . . . . . . . . . . . . . . . . . . . 4-37
Opening the Top Cover. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-38
Installation, Relocation and Extended System Downtime . . . . . . . . . . 4-38
Disabling Assays . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-38
Checking the Acid and Base Pumps . . . . . . . . . . . . . . . . . . . . . . . . . . 4-39
Replacing the Blue Peripump Tubing . . . . . . . . . . . . . . . . . . . . . . . . . . 4-41
Replacing the Gray Peripump Tubing. . . . . . . . . . . . . . . . . . . . . . . . . . 4-47
Clearing a Jam from the Cuvette Loader . . . . . . . . . . . . . . . . . . . . . . . 4-51
Performing Dark Counts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-58
Repositioning the Aspirate Probe Tubing . . . . . . . . . . . . . . . . . . . . . . . 4-59
5
Troubleshooting Principles and Diagnostics
Troubleshooting Principles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
Monitoring the Event Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
Troubleshooting an Event. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2
Responding to a Database Almost Full Message. . . . . . . . . . . . . . . . . . 5-3
Performing an Emergency Stop . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3
Recovering from a System Power Failure or System Lockup . . . . . . . . 5-3
Recovering from a Software Failure . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4
Recovering from a Facility Power Failure. . . . . . . . . . . . . . . . . . . . . . . . 5-5
Enabling Remote Access . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6
Viewing the Status of Remote Access . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6
Diagnostics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-7
Recovering from a System Halt while in Diagnostics . . . . . . . . . . . . . . . 5-7
Initializing the Incubation Ring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-7
Emptying the Incubation Ring. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-8
Filling the Incubation Ring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-8
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Contents-7
Emptying and Refilling the Incubation Ring . . . . . . . . . . . . . . . . . . . . . . 5-9
Initializing the System Probes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-10
Homing the Probes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-10
Homing the Entire System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-11
Performing Dark Counts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-11
Priming Individual System Fluids . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-11
Testing the Sample Probe for Clogs . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-12
Testing the Reagent Probe to Verify the Bubble Detector . . . . . . . . . . 5-12
Testing the Sample Barcode Scanner . . . . . . . . . . . . . . . . . . . . . . . . . 5-13
Testing the Primary Reagent Barcode Scanner . . . . . . . . . . . . . . . . . . 5-14
Scanning the Ancillary Pack . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-14
Calibrating the Solid Waste Bin Sensor . . . . . . . . . . . . . . . . . . . . . . . . 5-15
6
System Setup
Assay Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
Defining Ratio and Off-system Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
Multicomponent Assays . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-6
Modifying General Options for an Assay . . . . . . . . . . . . . . . . . . . . . . . . 6-8
Using Control Bracketing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-11
Modifying the Reagent Stability Options for an Assay . . . . . . . . . . . . . 6-13
Modifying Evaluation, Repeat, and Reflex Ranges . . . . . . . . . . . . . . . 6-14
Modifying Calculation Options for an Assay . . . . . . . . . . . . . . . . . . . . . 6-18
Modifying Dilution Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-23
Unlocking a Disabled Assay . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-25
Profile Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-26
Assay and Dilution Profiles. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-26
Physicians . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-28
Defining Physician Profiles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-28
Deleting a Physician Profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-28
Users . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-29
Defining User Profiles. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-29
Deleting a User Profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-29
Setting Your Password . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-29
LIS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-30
System Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-30
Setting the Sample Scheduling Mode . . . . . . . . . . . . . . . . . . . . . . . . . 6-30
Setting the Priority of Sample Scheduling of a Test . . . . . . . . . . . . . . . 6-31
Setting the Total STAT Sample Scheduling Mode . . . . . . . . . . . . . . . . 6-31
Changing the Designated STAT Lane . . . . . . . . . . . . . . . . . . . . . . . . . 6-32
Setting the System Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-32
Specifying the Date Format . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-33
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ADVIA Centaur CP Operator’s Guide: Contents
Specifying the Time Format . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-33
Specifying the Decimal Point . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-33
Setting the Language for the System . . . . . . . . . . . . . . . . . . . . . . . . . . 6-33
Setting the Language for the Online Help . . . . . . . . . . . . . . . . . . . . . . 6-33
Specifying Sample Tube Types . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-34
Adding Headers to Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-35
Allowing Automatic Repeat and Reflex of Samples . . . . . . . . . . . . . . . 6-35
Quality Control Using ADVIA QC . . . . . . . . . . . . . . . . . . . . . . . 6-36
Changing User Units in ADVIA QC . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-36
Viewing Out of Range QC Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-36
Transmitting QC Results to ADVIA QC. . . . . . . . . . . . . . . . . . . . . . . . . 6-37
Transmitting QC Results to an LIS . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-37
Transmit Flashcurve . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-37
Audible Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-38
Setting Audible Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-38
Turning Off the Audible Alarms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-38
Miscellaneous System Settings . . . . . . . . . . . . . . . . . . . . . . . . 6-39
Setting Minimum and Maximum Sample ID Lengths . . . . . . . . . . . . . . 6-39
Automatically Printing Sample Results. . . . . . . . . . . . . . . . . . . . . . . . . 6-39
Setting System Backup Information . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-39
Setting System Handling of Expired Calibrations . . . . . . . . . . . . . . . . . 6-40
Appendix A: Safety Information
Protecting Yourself from Biohazards . . . . . . . . . . . . . . . . . . . . . A-1
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-2
Protecting Yourself from Barcode Scanner Lasers . . . . . . . . . A-3
Appendix B: Warranty
Limited System Warranty and Service Delivery Policy. . . . . . . B-1
Appendix C: Reagents Information
Reagent Handling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-1
Primary Reagent Packs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .C-1
Ancillary Reagent Packs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .C-1
Primary Reagent Packs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .C-1
Ancillary Reagent Packs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .C-4
Ancillary Pack Usage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .C-5
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Contents-9
Reagent Water Quality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-6
Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .C-6
What is Reagent Water? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .C-6
Purifying Water . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .C-7
Maintaining Water Quality. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .C-9
Problems Caused by Water . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .C-10
SI Unit Conversion Factors . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-11
System Fluids . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-13
Appendix D: Specifications
System Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-1
Safety Certifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .D-1
Electromagnetic Compatibility (EMC). . . . . . . . . . . . . . . . . . . . . . . . . . .D-1
System Dimensions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .D-2
Workstation Dimensions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .D-2
Environmental Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .D-2
Electrical Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .D-3
Tube Types . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-4
Sample Volume Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .D-5
Pre-Set Tube Types . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .D-6
Appendix E: Supplies
Appendix F: Symbols
Appendix G: Contacts
Appendix H: Glossary
Appendix I: Index
086D0320-01, Rev. 04
Contents-10
086D0320-01, Rev. 04
ADVIA Centaur CP Operator’s Guide: Contents
1
Overview
Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
Supplies and Waste . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
LED Color Coding. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
System Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5
Power and Signal Connections to the Workstation . . . . . . . . . . . . . . . . 1-7
Acid and Base Reagent Compartment . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8
Tip Drawers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9
Sample Compartment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-10
Reagent Compartment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-12
Solid Waste Drawer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-14
Fluidics Area. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-14
Reagent Shortage Window. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-14
Cuvette Hopper . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-15
System Interior . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-15
Workstation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-16
Computer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-16
Touch Screen Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-16
Keyboard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-17
Mouse . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-17
Barcode Scanner . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-17
Software Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-18
Workspace . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-18
Display Area . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-19
System and User Data Area . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-20
Taskbar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-20
Task Buttons. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-20
Function Buttons. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-21
Sign-in Button . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-21
Exit Button . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-21
Online Help Button . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-21
Function Buttons. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-22
Navigation Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-22
Exporting Logs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-23
Removing a Memory Stick . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-24
Status Bar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-24
Screens and Windows . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-25
Opening and Closing Windows. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-25
Window Elements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-26
Test Sequence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-26
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ADVIA Centaur CP Operator’s Guide: Contents
Technology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-28
Direct Chemiluminescence. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-28
Antibody Binding Principles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-30
Paramagnetic Particles and Magnetic Separation . . . . . . . . . . . . . . . . 1-30
Assay Reaction Formats . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-31
Sandwich Format . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-31
Competitive Format . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-34
Antibody-capture Format . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-38
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-41
086D0320-01, Rev. 04
1 Overview
Introduction
The ADVIA Centaur® CP system is an automated, immunoassay analyzer that offers
optimal productivity and efficiency. No-pause reloading of primary and ancillary reagents,
samples, and supplies means that the system is always ready to process samples. The
ADVIA Centaur CP system is intended for professional use in a laboratory environment
only.
Comprehensive assay groups provide for cost-effective workstation consolidation. The
assay groups include fertility, thyroid function, oncology, cardiovascular, anemia, and
therapeutic drug monitoring. All the assays use direct chemiluminescent technology. Tests
performed using the ADVIA Centaur CP system are intended for in vitro diagnostic use.
As with all diagnostic tests, a definitive clinical diagnosis should not be based on the
results of a single test, but should only be made by the physician after all clinical and
laboratory findings have been evaluated.
The ADVIA Centaur CP system allows a throughput of up to 180 tests per hour and a time
to first result of 15-20 minutes, depending on the assay. The ADVIA Centaur CP system
provides true continuous operation, allowing you to attend to most of the functions,
including loading samples, primary and ancillary reagents, and supplies, or emptying
waste without pausing or interrupting test processing.
BIOHAZARD
Wear personal protective equipment. Use universal precautions. Refer to Appendix A,
Safety Information, for recommended precautions when working with biohazardous
materials.
086D0320-01, Rev. 04
1-2
ADVIA Centaur CP Operator’s Guide: 1 Overview
Features
Feature
Description
No-pause Reloading
You can load samples, primary and ancillary reagents, and
supplies at any time, even while the system processes
samples.
Optimal Productivity
The throughput is up to 180 tests per hour and the
walkaway time is up to 400 tests.
Automatic Reflex Testing
The system automatically schedules reflex tests based on
parameters that you define.
Onboard Refrigeration
Reagents remain in the cooled reagent areas, so you can
process samples without time-consuming system
preparation.
True STAT Capabilities
The system efficiently schedules STAT requests without
disrupting sample processing.
Sample Clot Detection and
Management
The system ensures sample integrity by detecting
complete obstructions in the sample probe, notifying you
of the condition, and then performing management and
recovery tasks.
Reagent Volume Integrity
Detection
The system ensures the integrity of the reagent aspiration
and dispense in the reagent probe.
Automated Maintenance
The system performs automated daily and monthly
cleaning procedures, with minimal hands on time.
Workspace
The workspace provides maximum information retrieval
with minimum operator intervention. Context-sensitive
help is available for all screens and windows at the touch
of a button. Online procedures are available for all
standard customer operations.
LIS Interface
Bidirectional laboratory information system (LIS)
interface allows you to send to and receive information
from your LIS. The system supports the ASTM interface
protocol.
Concordant Technology
The ADVIA Centaur CP system uses the same primary
and ancillary reagent packs, sample tips, and cuvettes, as
the ADVIA Centaur system.
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Supplies and Waste
You can load supplies and empty waste anytime the system is processing samples. See
Section 2, Operating the System, for procedures that describe how to replenish supplies
and empty wastes.
The system tracks the status of supplies, samples, QC exceptions, reagents, maintenance,
and events and alerts you if a system area needs attention. Using the status buttons on the
workspace, you can monitor the status of the different system areas.
At the workspace, select the Supplies status button to review the status of supplies. Refer
to the Screen Help section of the online help system for a description of the status
messages for each supply.
The system has the following capacity for supplies:
Supply
Capacity
Cuvettes
400 cuvettes
Tips
480 tips
Solid Waste
400 tests
Liquid Waste
7.5 L
DI Water
7.5 L
Wash 1 solution
7.5 L
Acid Reagent (R1)
300 mL
Base Reagent (R2)
300 mL
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LED Color Coding
Light-emitting diodes (LEDs) on the front cover above the tip drawers, sample
compartment, and reagent compartment illuminate to indicate the status of the supplies
within.
LED Color
Meaning
Neutral (unlit)
The lane or drawer is full and recognized, but not actively
in use by the system. The reagent, sample rack, or tip tray
is not being accessed by the system. You can remove the
supply in this area.
Steady Green
Do not remove. The reagent, sample rack, or tip tray is
actively in use by the system. The supply can be accessed
by the system.
Blinking Green
This sample lane, reagent position, or tip drawer is active
and ready for loading.
Steady Yellow
This lane is empty. This lane is not ready for sample rack
or reagent loading.
Blinking Yellow
The sample rack or reagent is loaded in this lane, but the
barcode could not be read by the system.
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System Overview
This section provides descriptions and locations of the major subsystems and components.
1
2
3
4
5
Workstation
Tip Drawers
Solid Waste Drawer
Sample Compartment
Reagent Compartment
6
7
8
9
10
Cuvette Loading Bin
Acid and Base Reagent Compartment
Waste Container (10 L)
DI Water Container (10 L)
Wash 1 Container (10 L)
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Systems are equipped with 7.5 L Waste, DI Water and Wash 1 containers.
1
2
3
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Waste Container (7.5 L)
DI Water Container (7.5 L)
Wash 1 Container (7.5 L)
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Power and Signal Connections to the Workstation
This section provides descriptions and locations of the power and signal connections to the
back of the computer.
1
2
3
Power cable for computer
Mouse
Keyboard-scanner adapter
4
5
6
Keyboard
Hand-held barcode scanner
Printer cable, USB (optional) - possible
parallel printer cable
Video signal monitor cable
7
8 Network cable
9 USB port
10 UBS communication cable to the
ADVIA Centaur CP system
11 Audio
12 Touchscreen signal cable
13 LIS
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Acid and Base Reagent Compartment
1
2
3
1
2
3
Acid and Base Reagent Compartment Door
Acid Bottle (R1)
Base Bottle (R2)
The acid and base reagent compartment is located on the left side of the system. This area
contains the acid and base reagents, which are used to trigger the chemiluminescent
reaction. Loading and unloading these 2 bottles are the only supplies procedures that you
cannot perform while the system is running. A warning message displays when the
number of tests available is running low.
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Tip Drawers
1
3
1
2
3
4
2
4
Tip Trays
LEDs
Tip Drawer
Orientation Tab
The 2 tip drawers are located on the left side of the front of the system. The
ADVIA Centaur CP system uses disposable sample tips to eliminate the possibility of
sample carryover. The 2 drawers can accommodate 2 tip trays each, for a total of 480
disposable tips (120 per tray).
The LEDs above each drawer indicate the status of the tip trays. A green LED indicates
that the tip tray is active and the system can use it. Even if the system is not processing
samples, the green LED remains on. If the tips are not assigned or all the tips are used, the
system automatically turns the green LED off. You can then access and replace the tip tray.
A tab on the instrument prevents incorrect placement by forcing the tip tray into the
correct position.
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Sample Compartment
2
1
3
5
1
2
3
4
5
4
Barcode Scanner
Lane Status LEDs
Barcode Scanning Beam
Sample Rack
Lane
The sample compartment is located directly to the right of the tip drawers, and can hold up
to seven racks. Each rack is capable of holding 12 sample tubes. Therefore, the system can
accommodate a total of 84 samples at a time. The sample compartment has seven lanes
that guide you to correctly insert the racks. On the system front cover, LEDs indicate the
status of each lane.
•
A steady green LED over a lane indicates that an active rack occupies that lane. A rack
is active when at least one sample tube has yet to be processed.
•
A steady yellow LED over a lane indicates that the lane is empty.
•
A neutral (unlit) LED over a lane indicates that an inactive rack occupies that lane. A
rack is inactive when all the tubes have been processed, or no test is scheduled for the
samples in the rack.
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When the sample compartment is opened, the workspace displays the Sample
Compartment screen, and a blinking green LED indicates the lane you should use for a
new rack. You can enter the rack into another position by first selecting the new lane on
the Sample Compartment screen.
While a sample rack is being loaded, the barcode scanner automatically reads the sample
IDs. The system automatically recalls appropriate scheduling information from the LIS or
worklist. If the system cannot read the barcode during insertion, a blinking yellow LED
above the lane will inform you of the problem.
Lane 7 in the sample compartment is the default lane for STAT testing. When this option is
active, any rack loaded in lane 7 is given first priority and processed almost immediately.
2
3
1
1
2
3
Sample Rack
Sample Tube
Tube-type Selector
Sample tubes are loaded onto 12-position universal racks. These racks can accommodate
multiple tube types. A tube type selector on the sample rack allows up to three types of
tubes to be used on the system at the same time.
You must load all the same type of sample tube onto a rack. Refer to Specifying Sample
Tube Types‚ page 6-34 for details on setting tube types for a sample rack.
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Reagent Compartment
6
5
4
3
1
2
1
2
3
Ancillary Reagent Position
Ancillary Reagent Tray
Ancillary Reagent Pack
4
5
6
Primary Reagent Pack
Primary Reagent Holder
Reagent Status LEDs
The reagent compartment is located directly to the right of the sample compartment, on
the right side of the front cover. This cooled area contains both primary and ancillary
reagents. Up to 15 primary reagents can be loaded. Up to 10 ancillary reagents can be
loaded in 2 trays, each containing 5 positions.
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The ADVIA Centaur CP system uses reagent packs that hold from 50-200 tests,
depending on the assay. Reagents are liquid and ready to use. Reagent packs can be
continuously loaded and unloaded during system operation.
1
2
3
1
Lite Reagent
2
Ancillary Well
3
Solid Phase
Each primary pack and ancillary pack has a unique barcode that the system uses to identify
the pack. The primary packs contain Solid Phase and Lite Reagent. A third compartment is
available for an additional reagent. The system tracks the inventory in each compartment
and calculates the remaining number of tests in the pack.
The ADVIA Centaur CP system uses the same primary reagent packs as the
ADVIA Centaur system.
A reagent is stable for the amount of time stated in that assay’s instructions for use. The
system tracks the onboard stability of a primary reagent packs. The assay definition
provided by Siemens Healthcare Diagnostics determines whether the onboard stability of
a primary reagent pack is calculated from the first time that the reagent pack is pierced, or
from the first time that the system reads the barcode after the reagent pack is placed on the
system.
For both primary and ancillary reagents, the front cover LEDs indicate the status, with the
same convention used for the sample racks:
•
A steady green LED over a lane indicates that an active pack occupies that lane. A
pack is active when at least one test is available, and tests for that assay have been
scheduled.
•
A steady yellow LED over a lane indicates that the lane is empty.
•
A neutral (unlit) LED over a lane indicates that an inactive pack occupies that lane. A
pack is inactive when no tests are available, or no tests have been scheduled for that
assay.
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When the reagent compartment is opened, the workspace displays the Primary Reagent
screen, and a blinking green LED indicates the position you should use for a new reagent
pack or ancillary tray. You can load the reagent pack or tray into another position by first
selecting the new position on the Primary or Ancillary Reagent screen. To access the
Ancillary Reagent screen, close the Primary Reagent screen and select the Ancillary
Reagent area from the workspace.
The barcode reader automatically scans the reagent pack barcode, recording the lot
number, expiration date, and pack inventory. If the system cannot read the barcode during
insertion, a blinking yellow LED above the lane will inform you of the problem.
You must manually mix the primary reagent packs before loading them on the reagent
holders in the primary reagent area of the reagent compartment. The reagent compartment
stores the reagents at 8° to 12°C. The primary reagent compartment mixes the packs to
keep the reagents in suspension. See Appendix C, Reagents Information, for more
information about handling reagents.
Each ancillary pack contains one ancillary reagent. The system tracks the volume in the
pack. A reagent is stable for the amount of time stated in that assay’s instructions for use.
Some ancillary packs are customer-fillable packs.
You load the ancillary reagent packs in the ancillary reagent area of the reagent
compartment. Two ancillary trays are in the reagent compartment. Each tray holds 5
ancillary reagents. The reagent compartment stores the reagents at a temperature of
8° to 12°C.
Solid Waste Drawer
The solid waste drawer is located beneath the sample compartment. The solid waste
drawer accommodates cuvettes and tips for up to 400 tests. This drawer can be emptied at
any time during system operation without interrupting sample processing.
Fluidics Area
Three containers are supplied to hold the DI water, wash 1 solution, and liquid waste. The
containers have a capacity of 10 liters, more than sufficient for the average daily operation
of the system. You can replenish the DI water and wash 1 solution and remove and empty
the waste while the system is in operation.
Reagent Shortage Window
The ancillary reagent volume shown in the reagent shortage window may not match the
volume shown on the ancillary reagent screen. The reagent shortage window shows the
volume of ancillary reagent needed to complete the worklist. The Ancillary Reagent
screen shows the volume of reagent available in the pack.
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Cuvette Hopper
The cuvette hopper is located on the right side of the system and can hold 400 cuvettes.
You can load cuvettes at any time during system operation. Use care when adding cuvettes
to the system. If you shake the bag or overfill the cuvette hopper, cuvettes may fall onto
the incubation ring and impede system operation.
The entire chemiluminescent reaction takes place in the small cuvette. See Test Sequence‚
page 1-26 for more information on this process.
System Interior
You can access the system interior by lifting the top cover. The system interior is where all
the main processing of the ADVIA Centaur CP system takes place, and where the
incubation ring, the probes, the wash station, and the luminometer can be accessed. When
the top cover is lifted, the probes stop. The ADVIA Centaur CP system uses several areas
while processing samples, as shown in the following figure.
7
5
6
1
2
9
8
10
3
4
1
2
3
4
5
Tip Drawers
Tip Eject Area
Sample Compartment
Reagent Compartment
Luminometer
6
7
8
9
10
Cuvette Elevator
Wash Block
Incubation Ring
Cuvette Loader
Cuvette Hopper
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Workstation
2
3
1
4
5
1
2
3
Touch Screen Monitor
Computer
Barcode Scanner
4
5
Mouse
Keyboard
Computer
The ADVIA Centaur CP computer controls system functions and processes data. The
computer is equipped with a CD-RW drive for software updates and enhancements. The
computer has several serial ports, as well as an Ethernet port that expands the
communication link between Siemens and your laboratory, allowing for enhanced remote
diagnostics and proactive service. The monitor, keyboard, mouse, and barcode scanner are
all connected to the computer.
Touch Screen Monitor
The ADVIA Centaur CP system utilizes a color touch screen monitor, which allows you to
point and select by using your finger. You can also use the mouse and keyboard to perform
all functions.
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Keyboard
The keyboard can be used to enter terms and numbers into fields. In addition, press the F1
function key to display or hide the online help system.
Mouse
The mouse can be used to navigate the system software – selecting buttons and tabs,
moving windows, and scrolling.
Barcode Scanner
The barcode scanner can be used to enter barcode information, such as the information on
Master Curve cards or Calibrator Assigned Value cards. Press the button on the scanner to
turn it on. To scan information, place the scanner on the top barcode of the Master Curve
card or Calibrator Assigned Value card, and then slowly move the scanner down the card
over the barcodes. The scanner beeps after successfully reading a barcode. The scanner
will automatically turn off after you are finished scanning.
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Software Overview
Workspace
1
2
3
4
5
Display Area
System and User Data Area
Taskbar
Task Buttons
Function Buttons
6
7
8
9
10
Help Button
Status and Time Display
Status Bar
Status Buttons
Event Log
The workspace provides access to all system functions and information necessary to
operate the system. The workspace is grouped into three areas: the display area, the
taskbar, and the status bar.
•
The display area (in the center of the workspace) shows the current active screen.
Screens include System, Results, Definition, Maintenance, Diagnostics, Setup, and
Help. When the software is launched, or when you close a screen, the System screen
displays.
•
The taskbar (along the top of the workspace) is used to access screens and windows
associated with specific tasks and functions. The task buttons are used to access
screens associated with specific tasks. When a task button is selected, the display area
shows that task screen. The function buttons are used to sign in, to start processing a
job, or to exit the system.
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•
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The status bar (along the bottom of the workspace) contains the Event Log button and
status buttons used to access screens and windows associated with the current status of
the system. The status buttons change color from neutral to yellow or red to indicate
that a system area requires attention.
Display Area
When no task screen is active, the display area shows the System screen. In the upper right
corner of the System screen (below the Sign In and Exit buttons), the System Status and
Time display provides the current status (for example, Ready) of the system and the
current time. For more information on the ADVIA Centaur CP system states, see the
Screen Help section of the online help system.
On the System screen, graphic images provide access to screens for the operating parts of
the instrument: the incubation ring image, the tip drawers, the sample compartment, the
ancillary reagent area, and the primary reagent area. You can access any of these screens
by selecting the image.
•
Select the incubation ring to access information about the samples that are currently in
process. The boxes are color-coded to provide you with the necessary information at a
glance. The boxes display the time to completion for the samples in process in minutes
and seconds. For more information on the details provided, see the Screen Help
section of the online help system.
•
Select a tip drawer to assign or withdraw tip trays.
•
Select the sample compartment to access information related to the sample racks, such
as the position occupied by a rack, available positions, tubes loaded on a rack, the
sample ID (SID) for each tube with assays, or the profile scheduled. This is also the
screen where you can manually schedule a test, if it is necessary. This screen
automatically opens when you open the sample compartment door to load or remove
sample racks.
•
Select the ancillary or primary reagent areas to access information related to the
ancillary and primary reagents. These areas contain important information about your
reagents, such as the lot numbers, pack numbers, tests available, expiration dates, and
onboard stability dates. For the ancillary reagents, a list of assays that are linked to
primary reagents is also displayed. You can also schedule calibrations from the
primary reagent screen.
NOTE: A yellow calibration status indicates that a calibration is not valid or the
calibration is expired. A neutral calibration status indicates the calibration is valid or
in the case of a primary reagent probe wash pack, not required.
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System and User Data Area
The system and user data area constantly displays the system identification number, the
current date, the name of the user who is currently logged onto the system, and the level of
the user. The system identification number is also available on the label on the side of the
instrument below the power cord. This number is required by the field service engineer if
you need to make a service call for the system.
Taskbar
The taskbar is located along the top of the workspace and contains task buttons, function
buttons, and the online help button. These buttons provide access to important screens and
windows necessary to operate the ADVIA Centaur CP system.
Task Buttons
When you select a task button, a screen displays with one or more section tabs. There are 5
buttons are available: Results, Definition, Maintenance, Diagnostics, and Setup. By
simply closing a screen and selecting another task button, you can navigate from screen to
screen.
•
The Results screen provides access to test, calibration, and control results and related
information. The information displayed can include the sample ID, the assay
processed, the time of the result, the dilution factor, the RLU, the result in
concentration, the unit, the interpretation, and flags that can be important for the
operator. You can sort your results based on the parameters provided. You can access
the ADVIA® QC using the Quality Control tab on the Results screen.
•
The Definition screen allows you to define and review calibrators, Master Curves, and
controls. ADVIA Centaur CP assays are calibrated through an 8- to 10-point Master
Curve provided with each lot of reagent. The Master Curve is scanned into the system
and is valid until the lot expiration date. This Master Curve is calibrated at
assay-dependent intervals with a 2 point re-calibration. The exception to this is
T-uptake, which uses a single point of calibration.
•
The Maintenance screen allows you to review, create, edit, perform, and monitor
maintenance tasks. In addition, the Maintenance Log tab provides a convenient view
of all maintenance tasks performed on the system.
•
The Diagnostics screen allows you to perform diagnostics and troubleshooting
procedures with the software. The Diagnostics screen is divided into 6 section tabs:
Ring, Luminometer, Washer, Prime, Probes, and Others. Each of these tabs has a
command area to perform system actions, and a status area to monitor the system
activities. Entering or exiting the Diagnostics screen causes the system to re-initialize.
•
The Setup screen allows you to define assays and profiles, set up physician
demographics, create and edit user accounts, set up your LIS interface settings, and
configure your system settings. Refer to System Setup‚ page 6-1 for more information
on setting system options.
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Function Buttons
When you select a function button, a window displays prompting some action related to
signing in and out of the software, starting and stopping sample processing, and exiting the
system software. When samples are processing, the Start button changes to the Stop
button.
Sign-in Button
If an operator is signed in, the system and user data area displays the operator’s user name
and security level. For more information on the ADVIA Centaur CP security levels, see
the Screen Help section of the online help system.
Exit Button
The Exit button provides you with the following options:
•
Exit the system software and return to the desktop
•
Exit the system software and restart the software
•
Exit the system software and shut down the computer
•
Back up system databases
Online Help Button
The online help button is located along the top of the workspace. The online help button
provides access to all operating instructions and information necessary to run the system.
When you select the online help button, the online help system displays Screen Help
information related to the current active screen. From there you can easily navigate to
other sections of the online help system to find all the information you need to operate the
system efficiently.
To access online help select the online help icon:
The online help system has 5 section tabs:
•
Screen Help - provides detailed descriptions of the screens, windows, and fields in
the system software.
•
Operator’s Guide - provides all the basic procedures required for operating the
system.
•
Troubleshooting - provides detailed event code information for the system.
•
Assays - provides access to all of the assay instructions for use documents.
•
Library - provides access to reference documents, including the Interface
Specification Guide, and version information for the system and software.
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To find information on a topic in the online help system, follow this procedure:
1. Select a section tab, for example, Screen Help.
2. Select a button.
For example, if you select Screen Help, you can select any of the following buttons:
•
Workspace
•
System
•
Results
•
Definition
•
Maintenance
•
Diagnostics
•
Setup
3. Select a topic from the Contents field.
Function Buttons
Each online help window contains function buttons on the right side of the screen.
•
Lock/Unlock - Locks the online help to a specific page. The current help screen page
remains active even if the online help is closed.
•
Home - Select this button to return to the home page of the Screen Help.
•
Print - Select this button to print the current help topic.
NOTE: Wait until the Print window closes before resuming operation. Selecting
another option while printing online help may cause the system to lockup.
•
Close - Select this button to close the online help system and return to the workspace.
Navigation Keys
To navigate between the online help system and the workspace follow this procedure:
1. Press the F1 key on your keyboard.
2. Select the left arrow to navigate to the previous page.
3. Select the right arrow to navigate to the next page.
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Exporting Logs
CAUTION
Do not export results or logs while the system is in process. If you export results or logs
when the system is in process, the system software may lock up. Ensure the system is in
the Ready state before you export results or logs.
Use this procedure to export logs:
1. Ensure the system is in the Ready state.
2. At workstation, select the online help icon.
3. Select the Troubleshooting.
4. Select Logs.
The Logs window opens.
5. Select the type of log file you want to export from the following:
•
Daily (*.log) - The daily log file. This file contains all the event messages that
appear in the event message window. Messages older than 30 days are moved to a
subfolder corresponding to that month, for example, yyyy-mm-dd.log (yyyy
represents the year, mm represents the month, and dd represents the day).
•
Serial (*.trw) - This log file contains the serial communication between the
computer and the analyzer. File names have the pattern SERxxxxx.trw. The
numbers are continuos starting at 00000.
•
Melias (*.trw) - This log file contains trace messages created by specific
instructions that were introduced by software developers for debugging and
testing purposes. File names have the pattern MELIASxxxxx.trw. The numbers
are continuous starting at 00000.
•
LIS (*.trc) - This log file contains low- and high-level communication between the
computer and the LIS. The list of files includes both r (record-protocol) and b
(byte-protocol) file types. File names have the pattern CiRxxxxx.trc and
CiBxxxxx.trc. In both cases, the i is a digit ranging from 2 to 4 indicating the
select communication port. The xxxxx numbers are continuous starting at 00000.
6. Select a Range. Indicate the range of records that you want to export, for example,
“last 30 days.” You can use the navigation buttons to navigate between months as
follows:
•
< - Previous month
•
> - Next month
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7. Select a file from the list. Files are listed by the file name, start (file creation date), and
end (last write operation to the file).
To select multiple files, press the Ctrl key on your keyboard while selecting the files.
•
Select the View button to view the file that you selected. Only one file can be
viewed at a time. All users can view LIS files. You must have access rights of FSE
or higher to view other files than the LIS files.
•
Select the Cancel button to cancel the operation and return to the Troubleshooting
tab.
8. Select Export.
The Export Logs Window opens.
9. Select a storage medium. You have the option of exporting files to a CD or a memory
stick.
Select an available drive for the memory stick from the list. The system automatically
selects the drive with the highest drive letter.
The amount of memory available for the selected device is displayed in the Available
Space field.
10. Select OK to begin the file export operation.
Select Cancel to cancel the operation and return to the Logs window.
Removing a Memory Stick
To safely remove a memory stick from the system, follow these procedures:
1. At the workspace, select Help.
2. Select the Troubleshooting tab.
3. Select Eject Memory Stick.
4. Select Close.
Status Bar
The status bar is located along the bottom of the workspace and provides access to all the
important system status. The status buttons change color to indicate the current status of
the system. The following list describes the status buttons from left to right.
•
The Event Log window displays the most recent 2 events. To access the Event Log
screen, select the Event Log button.
•
The Reagent Shortage window provides basic information about the reagent
inventory.
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•
The Reagent and Calibration Stability window provides information on primary and
ancillary reagents that have passed the onboard stability, with details about the lot,
number of tests available, position, and status of expired, on-system assay calibrations
(calibrations expire within 24 hours).
•
The Supplies window indicates when a particular supply needs replenishing. This
window also contains a button that allows you to restart the cuvette loader.
•
The Waste window indicates when the solid waste drawer or the liquid waste
container needs to be emptied. This window also contains a button that allows you to
indicate that the solid waste was emptied.
•
The Maintenance screen provides access to the maintenance schedule and the
maintenance log of past activities.
•
The Temperature and Voltage window allows you to monitor the temperatures and
voltages of system components.
Screens and Windows
You use screens and windows to perform tasks and review information. The screens and
windows are designed to have a common structure.
•
Each screen and window contains a title in the upper left corner.
•
Information tables display result, definition, maintenance, and other records. These
tables are used on many screens and windows.
•
You can sort records by selecting the column headings in the table, while the Search
field allows you to locate specific records.
•
Scroll buttons on the right side of the information tables allow you to scroll up or
down. You can scroll by one record, one page, or to the top or bottom of the table.
•
A checkbox on the right side of the information table allows you to select multiple
records.
•
The buttons on the bottom of the screens and windows perform actions or open related
windows.
Opening and Closing Windows
You can open and close windows as needed to perform system functions and access
information.
•
To open a task screen from the workspace, select a task button.
•
To open a status window from the workspace, select a status button.
•
To close a screen or window, select the Close, Save, Cancel, or OK button.
•
Where applicable, to open a Select Assay or Select Dilution window, select the
ellipsis (...) button.
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ADVIA Centaur CP Operator’s Guide: 1 Overview
You cannot actively work in multiple screens or windows. To interact with a new screen or
window, it is first necessary to close the active screen or window.
NOTE: You can access the Status windows and online help screens at any time.
Window Elements
Window elements allow you to make selections and interact with the windows.
•
Tables allow you to review information and to select records.
•
Dropdown lists allow you to select menu options.
•
Data fields allow you to enter or display information.
•
Scroll buttons allow you to display records that are not visible in the table.
•
Selection buttons allow you to select assays and dilutions, perform actions, and open
windows.
Test Sequence
This section explains the test sequence by describing (1) the steps you take to ensure that
all the necessary supplies are loaded, and (2) the path of a cuvette through the system. The
entire chemiluminescent reaction takes place in the small cuvette.
Before you begin, make sure that the system is in a Ready state. Make sure that all
supplies are loaded in the system:
1. Load cuvettes in the cuvette loading bin.
2. Load tips in the 2 tip drawers.
3. Verify that primary reagent and ancillary reagent packs are loaded.
4. Verify that the DI water and wash 1 solution are sufficient for daily operation.
5. Verify that the solid waste drawer beneath the sample compartment has been emptied.
6. Check the liquid waste, and empty it if necessary.
7. Verify that the acid and base reagents in the compartment on the left side of the system
contain sufficient reagent for your tests.
8. Load your samples into the lanes of the sample compartment ensuring that you use a
steady, even, continuous motion so that the system’s laser scanner can read the sample
barcodes.
9. The LIS queries the system for a workorder.
If an LIS is not connected to the system, you must manually enter a workorder.
10. At the workspace, select Start.
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The system moves a cuvette through the process as follows.
1. The system moves the cuvettes to the cuvette loader, which correctly positions the
cuvettes before they enter the incubation ring.
2. The cuvette loader releases the cuvettes into the incubation ring, a circular insulated
track, which is at a temperature of 37°C (98.6°F). The incubation ring advances the
cuvettes at 20-second intervals.
3. The sample probe picks up a sample tip to start the test sequence.
4. The probe aspirates a sample in the sample compartment and dispenses it into a
cuvette in the incubation ring.
5. The incubation ring moves the cuvette from the sample probe area to the reagent
probe area.
6. The reagent probe aspirates the primary or ancillary reagents from the packs in the
reagent compartment and dispenses the reagents into the cuvette in the incubation
ring.
The rinse station rinses the probe with distilled water after each reagent aspiration.
7. The patient sample and the necessary reagents are dispensed into the cuvette at the
appropriate time, according to the assay protocol. Various incubation protocols and
multiple reagent dispensing is available to obtain the most reliable results.
8. After reagents are added and incubated, the sample is separated and washed:
a. The incubation ring moves the cuvette to the wash station.
b. The magnetic particles are pulled to the side of the cuvette by magnets positioned
along the incubation ring.
c. The aspirate probes draw fluid out of the cuvette.
d. The wash station dispenses wash 1 into the cuvette to wash the magnetic particles.
If necessary, the system performs multiple subsequent washes and aspirations.
9. The incubation ring moves the cuvette to the acid probe, which dispenses acid reagent
into the cuvette.
10. The incubation ring moves the cuvette to the elevator, which lifts the cuvette from the
incubation ring into the luminometer.
11. The cuvette enters the luminometer, where the chemiluminescent reaction occurs and
is measured. The luminometer has three parts: a photomultiplier tube (PMT) with
photon-counting electronics, a base probe, and a waste probe.
a. The base probe dispenses base reagent into the cuvette.
b. The chemiluminescent reaction occurs.
c. The PMT measures the light emitted as relative light units (RLUs).
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ADVIA Centaur CP Operator’s Guide: 1 Overview
d. The workstation processes the data from the PMT and converts the RLUs into
results. The system can then send the results to an LIS or a printer.
e. The waste probe aspirates the waste fluid from the cuvette.
12. The cuvette drops into the solid waste drawer.
As cuvettes exit the incubation ring, the system continuously adds new cuvettes to the
incubation ring.
The test sequence is complete.
Technology
Chemiluminescence is a chemical reaction that emits energy in the form of light.1–5 When
used in combination with immunoassay technology, the light produced by the reaction
indicates the amount of analyte in a sample. Direct chemiluminescent reactions directly
measure the light energy without the use of added steps or amplifying molecules.6 The
ADVIA Centaur CP assays use acridinium ester (AE) as the chemiluminescent label,
since AE does not require the addition of a catalyst or substrate.6
Direct Chemiluminescence
Direct chemiluminescence using AE is easily automated and provides many benefits, such
as long reagent shelf life, fast reaction time, and assay sensitivity. The
ADVIA Centaur CP assays use the dimethyl form of AE because its stability allows long
reagent shelf life.6,8
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In ADVIA Centaur CP assays, AE is oxidized by hydrogen peroxide and the light
emission is maximized by changing the environment from acidic to basic. Oxidation of
AE occurs rapidly, with peak light emission occurring within one second. The rapid
reaction time and very low background make direct chemiluminescence with AE faster
than RIA or EIA methods.6,8
1,000,000
800,000
600,000
400,000
200,000
A
0
0
1
100
2
200
3
300
4
400
5
500
6
600
1
2
B
A
B
1
2
Light Intensity
Seconds
Acridinium Ester
Other Methods
The AE molecule is much smaller than the alkaline phosphatase molecule used in EIA
assays. This smaller size decreases blockage of binding sites, increases diffusion rates, and
increases the assay sensitivity.8
1
2
1
2
Alkaline Phosphatase (MW 68,000)
AE (MW 481)
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Antibody Binding Principles
Antibodies are proteins that are produced by the immune system in response to an antigen.
Antibodies are ideal for use in immunoassays because they can be produced to bind to
specific antigens. In immunoassays, the antigen is the analyte that is being measured.
2
3
1
1
2
3
Antigen
Binding Site
Antibody
AE can be covalently bound to an antibody without altering the ability of the antibody to
bind to an antigen. To measure an antigen, many ADVIA Centaur CP assays use
antibodies that are covalently bound to AE.
Paramagnetic Particles and Magnetic Separation
Paramagnetic particles (PMP) are iron oxide crystals that are attracted to a magnetic
field.7 In the ADVIA Centaur CP assays, PMP coated with antibody or antigen are called
Solid Phase.7 Coated PMP provide approximately 50 times the reactive surface area of
coated tubes or beads. 6
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During incubation, coated PMP in the cuvette bind to the target antigen or antibody. When
the cuvette is exposed to a magnetic field, the PMP bound to antigen or antibody are
drawn toward the magnets. While the magnets hold the PMP in place, sample and reagent
not bound to the coated PMP are washed away.
1
2
1
2
PMP
Antibody
Assay Reaction Formats
The ADVIA Centaur CP system directly measures the amount of light that the
chemiluminescent reaction emits. ADVIA Centaur CP assays use AE as the label in Lite
Reagent and PMP as the Solid Phase. The system uses a variety of formats to detect
antigens as well as antibodies. For more information about the reaction formats and
principles for specific assays, and for assay performance characteristics such as precision
and accuracy, refer to the Assay section of the online help system.
The ADVIA Centaur CP system applies the immunoassay binding principles of antibodies
using several formats:
•
sandwich format
•
competitive format
•
antibody-capture format
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ADVIA Centaur CP Operator’s Guide: 1 Overview
Sandwich Format
Sandwich formats use AE-labeled antibody in the Lite Reagent.
Lite Reagent, containing AE-labeled antibody, is added to the sample. The AE-labeled
antibody binds specifically to the analyte-specific antigen in the sample.
1
2
3
4
1
2
Acridinium Ester
Antibody
3
4
Analyte-specific Antigen in the Sample
Other Antigens
Solid Phase containing PMP, that are coated with antibody specific for the antigen in the
sample, is added. The cuvette is incubated at 37 ° C (98.6 ° F). PMP bind to the antigens
that are bound to AE-labeled antibody.
1
1
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The cuvette is exposed to a magnetic field, which draws PMP toward the magnets. While
the magnets hold PMP in place, sample and reagent not bound to PMP are washed away.
The cuvette now contains AE bound to antigen, which is bound to PMP by antibody.
2
1
3
1
2
3
Magnets
PMP-Antibody-Antigen-Antibody-AE Complex
Cuvette
Acid and base reagents are added to initiate the chemiluminescent reaction. The emission
of light is measured in relative light units (RLUs). Once the light produced from the
oxidation of AE is quantitated, the system calculates the concentration of antigen.
In a sandwich format, the analyte-specific antigen concentration in the sample and the
light emission in RLUs have a direct relationship. If more analyte-specific antigen
molecules are present in the sample, then more AE is present, and therefore light emission
is greater.
A
B
A
B
Light Emission (RLUs)
Analyte Concentration
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ADVIA Centaur CP Operator’s Guide: 1 Overview
Competitive Format
Competitive formats include:
•
AE-labeled antigen in the Lite Reagent
•
AE-labeled antibody in the Lite Reagent
AE-labeled Antigen
Lite Reagent, containing AE-labeled antigen, and Solid Phase, containing
antibody-labeled PMP, are added to the sample. The cuvette is incubated at 37 ° C
(98.6 ° F). The AE-labeled antigen competes with analyte-specific antigen in the sample
for limited binding sites on the antibody, which is bound to PMP.
If more analyte-specific antigen is present in the sample, then less AE-labeled antigen is
bound. Alternatively, if less analyte-specific antigen in the sample is present, then more
AE-labeled antigen is bound.
3
2
4
1
1
2
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Antibody
PMP
3
4
Analyte-specific Antigen in the Sample
AE-labeled Antigen
ADVIA Centaur CP Operator’s Guide: 1 Overview
1-35
The cuvette is exposed to a magnetic field, which draws PMP toward the magnets. While
the magnets hold PMP in place, sample and reagent not bound to PMP are washed away.
The cuvette now contains analyte-specific antigen from the sample and AE-labeled
antigen bound to PMP by antibody.
2
1
3
4
1
2
3
4
Magnets
PMP-Antibody-Antigen Complex
PMP-Antibody-Antigen-AE Complex
Cuvette
Acid and base reagents are added to initiate the chemiluminescent reaction. The emission
of light is measured in RLUs. Once the light produced from the oxidation of AE is
quantitated, the system calculates the concentration of the analyte.
If the sample has a low concentration of analyte-specific antigen, most binding sites on the
antibody are bound to AE-labeled antigen. This results in an elevated reading of RLUs
from the oxidation of AE.
If the sample has a high concentration of analyte-specific antigen, most binding sites on
the antibody are bound to antigen from the sample, and few sites are bound to AE-labeled
antigen. This results in a lower reading of RLUs from the oxidation of the AE.
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In a competitive assay with AE-labeled antigen, the concentration of antigen in the sample
and the light emission in RLUs have an inverse relationship.
A
B
A
B
Light Emission (RLUs)
Analyte Concentration
AE-labeled Antibody
Lite Reagent, containing AE-labeled antibody, and Solid Phase, containing
antigen-labeled PMP, are added to the sample. The cuvette is incubated at 37 ° C (98.6 ° F).
Antigen bound to PMP competes with analyte-specific antigen in the sample for limited
binding sites on AE-labeled antibody.
If more analyte-specific antigen is present in the sample, then less PMP-labeled antigen is
bound. Alternatively, if less analyte-specific antigen is present in the sample, then more
PMP-labeled antigen is bound.
2
1
3
1
2
3
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PMP-labeled Antigen
Analyte-specific Antigen in the Sample
ADVIA Centaur CP Operator’s Guide: 1 Overview
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The cuvette is exposed to a magnetic field, which draws PMP toward the magnets. While
the magnets hold PMP in place, sample containing analyte-specific antigen and reagent
not bound to PMP are washed away. The cuvette now contains PMP-antigen bound to AE
by antibody.
2
1
3
1
2
3
Magnets
PMP-Antigen-Antibody-AE Complex
Cuvette
Acid and base reagents are added to initiate the chemiluminescent reaction. The emission
of light is measured in RLUs. Once the light produced from the oxidation of AE is
quantitated, the system calculates the concentration of analyte.
If the sample has a low concentration of analyte-specific antigen, most binding sites on the
antibody are bound to PMP-labeled antigen. This results in an elevated reading of RLUs
from the oxidation of AE.
If the sample has a high concentration of analyte-specific antigen, most binding sites on
the antibody are bound to antigen from the sample, and few sites are bound to
PMP-labeled antigen. This results in a lower reading of RLUs from the oxidation of AE.
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In a competitive assay with AE-labeled antibody, the concentration of analyte in the
sample and the light emission in RLUs have an inverse relationship.
A
B
A
B
Light Emission (RLUs)
Analyte Concentration
Antibody-capture Format
The antibody-capture format is used when the substance being measured in the sample is
an antibody. The assay uses a reagent containing an additional antibody that is specifically
directed against the antibody in the sample.
Antibody-capture formats are usually characterized by 2 cycles of incubation and wash.
The purpose of the first incubation and wash is to remove excess interfering substances in
the sample. The purpose of the second incubation and wash is to measure the antibody in
the sample.
Antibody-capture assays can detect specific IgG antibody or IgM antibody in patient
samples. The following example is an antibody-capture assay that detects human IgM
antibody in a patient sample.
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Solid Phase, containing anti-human IgM antibody bound to PMP, is added to the sample.
The cuvette is incubated at 37 ° C (98.6 ° F). The IgM antibody in the sample binds to
anti-human IgM antibody bound to PMP.
1
2
1
2
Anti-human IgM Antibody bound to PMP
Human IgM Antibody in Sample
The cuvette is exposed to a magnetic field, which draws PMP toward the magnets. While
the magnets hold PMP in place, sample and reagent not bound to PMP are washed away.
The cuvette now contains IgM antibody from the sample captured by specific anti-human
IgM antibody, which is bound to PMP.
2
1
3
1
2
3
Magnets
PMP-Anti-lgM Antibody-IgM Complex
Cuvette
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ADVIA Centaur CP Operator’s Guide: 1 Overview
Lite Reagent, containing AE-labeled antigen, is added to the cuvette and incubated at
37 ° C (98.6 ° F). The AE-labeled antigen binds to the sample IgM antibody in the sample.
1
2
1
2
AE-labeled antigen binds to the human lgM antibody.
Cuvette
The cuvette is again exposed to a magnetic field, which draws PMP toward the magnets.
While the magnets hold PMP in place, reagent not bound to PMP is washed away. The
cuvette now contains AE-labeled antigen bound to sample IgM antibody, which is bound
to anti-human IgM antibody, bound to PMP.
2
1
3
1
2
3
Magnets
PMP-Anti-lgM Antibody-IgM-AE-labeled Antigen Complex
Cuvette
Acid and base reagents are added to initiate the chemiluminescent reaction. The emission
of light is measured in RLUs. Once the light produced from the oxidation of the AE is
quantitated, the system calculates the concentration of the analyte.
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In this example of an antibody-capture assay, the sample concentration and the light
emission have a direct relationship. If more sample IgM antibody is present, then more AE
is present, and therefore the light emission is higher.
A
B
A
B
Light Emission (RLUs)
Analyte Concentration
References
1. Whitehead TP, Kricka J, Carter JN, Thorpe G. Analytical luminescence: its potential
in the clinical laboratory. Clin Chem 1979; 25/9: 1531–1546.
2. Woodhead JS, Campbell AK, McCapra F, Beheshti I, Weeks I. Acridinium esters as
high specific-activity labels in immunoassays. Clin Chem 1983; 29/8: 1474–79.
3. Weeks I, Woodhead JS. Chemiluminescence immunoassays. J. Clin Immunoassay
1984; 7/1: 82–89.
4. Patel A, Morton MS, Woodhead JS, Ryall MET, McCapra F, Campbell AK. A new
chemiluminescent label for use in immunoassay. Biochem Soc Trans 1982; 10: 224–5.
5. Tietz NW. Fundamentals of clinical chemistry, 3rd ed. Philadelphia: W.B. Saunders
Company, 1987; 1010.
6. Kricka LJ. Chemiluminescence immunoassay. The immunoassay handbook, 1st ed.
New York: Stockton Press, 1994; 341–343.
7. Dudley R. The immunoassay handbook, 1st ed. New York: Stockton Press, 1994;
161–164.
8. Dudley R. Chemiluminescence immunoassay: an alternative to RIA. Lab Med 1990;
21/4; 216–221.
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2
Operating the System
Daily System Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
Starting and Stopping the System . . . . . . . . . . . . . . . . . . . . . . . 2-3
Starting the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Signing In to the System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Stopping or Pausing Sample Processing . . . . . . . . . . . . . . . . . . . . . . . . 2-4
Pausing Sampling. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-4
Stopping Sample Processing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-4
Turning the Audible System Alarm Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-5
Signing Out of the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-5
Exiting the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5
Turning the System Off. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8
Changing Your Password . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9
Managing Supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9
Replacing Acid and Base Reagents (R1 and R2) . . . . . . . . . . . . . . . . . 2-9
Viewing Available Acid and Base Volumes . . . . . . . . . . . . . . . . . . . . . 2-11
Loading Sample Tips . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-12
Withdrawing the Old Tip Trays at the Workspace . . . . . . . . . . . . . . . . . . . .2-13
Loading the New Tip Trays. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-13
Assigning the New Tip Trays at the Workspace . . . . . . . . . . . . . . . . . . . . . .2-15
Adding Cuvettes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-16
Emptying the Solid Waste Drawer . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-17
Emptying and Refilling the DI Water and Wash 1 Containers . . . . . . . 2-19
Emptying and Refilling the DI Water and Wash 1 Containers . . . . . . . . . . .2-20
Replenishing the DI Water and Wash 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-20
Emptying the Liquid Waste Container . . . . . . . . . . . . . . . . . . . . . . . . . 2-20
Monitoring and Managing Reagent Supplies. . . . . . . . . . . . . . 2-21
Loading Primary Reagent Packs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-22
Removing Primary Packs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-26
Loading Ancillary Reagent Packs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-27
Removing Ancillary Reagent Packs . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-31
Processing Samples. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-33
Loading Samples into Sample Racks. . . . . . . . . . . . . . . . . . . . . . . . . . 2-33
Setting Tube Types . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-35
Loading Sample Racks into the System. . . . . . . . . . . . . . . . . . . . . . . . 2-35
Removing Sample Racks from the System . . . . . . . . . . . . . . . . . . . . . 2-38
Removing a Sample Rack to Retrieve a Sample . . . . . . . . . . . . . . . . . 2-39
Ensuring the Final Results are Released . . . . . . . . . . . . . . . . . . . . . . . 2-39
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ADVIA Centaur CP Operator’s Guide: Contents
Scheduling Patient Samples . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-40
Scheduling Samples through the Sample Compartment Screen . . . . . 2-40
Scheduling Samples Using a Profile . . . . . . . . . . . . . . . . . . . . . . . . . . 2-41
Selecting a Dilution for a Sample Through
the Sample Compartment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-41
Manual Dilution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-42
Predefined Dilution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-42
Scheduling a Dilution Test Exclusively . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-43
Setting Replicates Through the Sample Compartment . . . . . . . . . . . . 2-43
Setting up Batch Orders Through the Sample Compartment. . . . . . . . 2-44
Checking Sample Status Through the Sample Compartment . . . . . . . 2-44
Scheduling a Worklist Using the Results Screen . . . . . . . . . . . . . . . . . 2-45
Scheduling Replicates Using a Worklist . . . . . . . . . . . . . . . . . . . . . . . . 2-45
Scheduling Dilutions Using a Worklist . . . . . . . . . . . . . . . . . . . . . . . . . 2-46
Downloading Orders Automatically from the LIS . . . . . . . . . . . . . . . . . 2-47
Downloading Orders Manually . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-47
Scheduling a Worklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-48
Scheduling a Worklist for Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-48
Scheduling a Control Bracketed Patient Sample . . . . . . . . . . . . . . . . . 2-49
Scheduling a Control Bracketed Control as a QC Sample . . . . . . . . . . 2-50
Closing a Bracket . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-50
Scheduling a Calibration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-50
Manually Discarding a Bracket . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-51
Automatically Discarding a Bracket . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-51
Entering STAT Samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-51
Deleting Results and Scheduled Tests . . . . . . . . . . . . . . . . . . . . . . . . . 2-52
Editing Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-52
Using Multicomponent Testing . . . . . . . . . . . . . . . . . . . . . . . . . 2-53
Scheduling Calibrations for a Multicomponent Test . . . . . . . . . . . . . . . . . . .2-53
Adding Control Definitions for a Multicomponent Test . . . . . . . . . . . . . . . . .2-53
Scheduling Controls for a Multicomponent Test . . . . . . . . . . . . . . . . . . . . . .2-54
Scheduling Patient Samples for Multicomponent Tests . . . . . . . . . . . . . . . .2-54
Cancelling a Multicomponent Test Using the LIS . . . . . . . . . . . . . . . . . . . . .2-56
Rerunning a Multicomponent Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-56
Repeating a Multicomponent Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-57
Calculating the Multicomponent Result and Reporting an Interpretation . . .2-57
Printing on Your Local Printer. . . . . . . . . . . . . . . . . . . . . . . . . . 2-61
Printing a Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-61
Printing Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-61
Automating the Printing of Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-61
Recalling Sample IDs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-62
Entering Sample IDs not Captured by the Barcode Reader. . . . . . . . . 2-62
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Contents-3
Entering Patient Demographic Information . . . . . . . . . . . . . . . 2-63
Entering Patient Demographic Information Through the Worklist . . . . 2-63
Entering Patient Demographic Information Through the Sample
Compartment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-64
Start Sampling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-64
Processing Samples in Batch Mode. . . . . . . . . . . . . . . . . . . . . . . . . . . 2-65
Managing Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-65
Results Tabs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-65
Sample Results Tabs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-65
Calibration Tabs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-66
Control Samples Tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-66
Viewing Workorders from the LIS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-66
Viewing Result Summaries. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-66
Viewing Result Details . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-66
Viewing (Filtering) Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-67
Viewing Pending Control Bracketed Results . . . . . . . . . . . . . . . . . . . . 2-67
Moving Results to the Historical Tab . . . . . . . . . . . . . . . . . . . . . . . . . . 2-68
Printing Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-68
Deleting Results and Scheduled Tests . . . . . . . . . . . . . . . . . . . . . . . . . 2-69
Exporting Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-70
Exporting Results to a CD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-71
Entering Comments for Patient Results . . . . . . . . . . . . . . . . . . . . . . . . 2-71
Rerunning Patient Samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-72
Automatically Scheduling a Rerun Test . . . . . . . . . . . . . . . . . . . . . . . . 2-72
Automatically Scheduling a Rerun Test in the Event of an Error . . . . . 2-72
Manually Scheduling a Rerun Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-72
Releasing the Hold Status for a Result. . . . . . . . . . . . . . . . . . . . . . . . . 2-73
Releasing the Hold Status for a Ratio Result . . . . . . . . . . . . . . . . . . . . 2-73
Editing Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-73
Entering an Offsystem Result. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-74
Downloading Orders. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-75
Processing Failed Samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-75
Responding to Depleted Reagent Volume . . . . . . . . . . . . . . . . . . . . . . 2-75
Moving Results to the Historical Tab . . . . . . . . . . . . . . . . . . . . . . . . . . 2-76
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ADVIA Centaur CP Operator’s Guide: Contents
2 Operating the System
Daily System Operation
When not in operation, the ADVIA Centaur CP system and workstation should be left on
and in the Ready state to ensure optimal system performance.
Procedure
•
Start the system, if required.
•
Starting the System.................................................................................... page 2-3
Sign in to the system.
•
Signing In to the System ........................................................................... page 2-3
Ensure that the solid waste drawer is empty.
•
Emptying the Solid Waste Drawer .......................................................... page 2-17
Ensure that the liquid waste container is empty.
•
Emptying the Liquid Waste Container .................................................... page 2-20
Ensure that sufficient tips for all tests to process are loaded on
the system.
•
Loading Sample Tips .............................................................................. page 2-12
Ensure that sufficient cuvettes for all tests to process are
loaded on the system.
•
Adding Cuvettes...................................................................................... page 2-16
Ensure that sufficient wash 1 solution and DI water for all tests
to process are loaded on the system.
•
Emptying and Refilling the DI Water and Wash 1 Containers................ page 2-19
Ensure that sufficient acid and base reagents for all tests to
process are loaded on the system.
•
Replacing Acid and Base Reagents (R1 and R2)...................................... page 2-9
Ensure that sufficient primary reagents for all tests to process
are loaded on the system.
•
Loading Primary Reagent Packs ............................................................. page 2-22
Ensure that sufficient ancillary reagents for all tests to
process are loaded on the system.
•
Loading Ancillary Reagent Packs ........................................................... page 2-27
Ensure that valid calibrations exist for all reagents.
•
Workflow to Process Calibrators............................................................... page 3-9
Ensure that any necessary control material was processed.
Workflow to Process Quality Control Samples....................................... page 3-22
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•
Load samples into sample racks.
•
Loading Samples into Sample Racks...................................................... page 2-33
Load the racks in the sample compartment.
•
Loading Sample Racks into the System.................................................. page 2-35
Assign assays to samples with profile, individually, or with LIS.
•
Scheduling Patient Samples .................................................................... page 2-40
Assign dilution, if required.
•
Selecting a Dilution for a Sample Through the Sample Compartment... page 2-41
Enter patient demographic information, if required.
•
•
Entering Patient Demographic Information ............................................ page 2-63
At the Results screen, check that all samples are pending, and that
the information for each sample is correct.
Viewing Result Summaries ..................................................................... page 2-66
Start sample processing.
Start Sampling ......................................................................................... page 2-64
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2-3
Starting and Stopping the System
Starting the System
Use this procedure to start the ADVIA Centaur CP system and workstation.
1. Turn the computer on.
2. On the Windows XP Welcome screen, select Lab.
3. Enter the password welcome.
The system software launches automatically if you are starting from the gray desktop.
4. Select the arrow key to sign in to the system.
5. Wait for the workspace to display.
6. After the workspace displays, move to the left side of the system, and press the power
switch to turn the system on.
Wait approximately 3 minutes while the system initializes.
NOTE: You must shut down and restart the system every time you restart the
ADVIA Centaur CP system software.
If the ADVIA Centaur CP instrument halts due to hardware issues, and the system
indicates that it is in the Halted mode, instead of rebooting the system, press the Init
button. This causes the system to reinitialize. The reinitializing process is faster than the
rebooting process and may resolve the issue sooner.
Signing In to the System
Use this procedure to sign in to the system. User names and passwords are case-sensitive.
There are four security levels of user access rights on the ADVIA Centaur CP system.
Some system functions are only available to a user with an appropriate level of security
(for example, selecting system options, entering comments, or editing test results). If you
will only be processing samples, you can sign in as a “Guest.” For more information on
the ADVIA Centaur CP access rights, see the Screen Help section of the online help
system.
1. At the workspace, select Sign In.
2. In the Sign In window, enter your user name.
3. Enter your password.
If you do not have a password, select the Sign in as Guest checkbox.
4. Select OK.
The system number (identifier), date, your user name, and security level are displayed
on the System and User Data Area.
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5. To process samples, see Test Sequence‚ page 1-26.
NOTE: After you select the Start button, the system determines the following:
•
Whether the remaining acid and base reagent volumes are sufficient for the
number of tests that have been ordered. A message displays if the levels of acid
and base are not sufficient to complete the tests ordered.
•
Whether there is sufficient space in the solid waste bin to accept the solid waste
that results from the tests ordered. A message displays if there is insufficient space
in the solid waste bin to complete the tests ordered.
If the acid and base reagent is short, or if there is not enough space in the waste bin to
accept the solid waste that results from the test ordered, the system displays a window
that includes the following message:
Do you want to start processing samples?
You must select OK or Cancel.
•
When you select OK, the system completes initialization/priming and proceeds to
process the scheduled worklist. The number of acid and base tests short is
displayed on the Shortage screen.
The system processes as many tests as possible with the available supplies.
Remaining tests are marked as Pending. You must replenish the necessary
supplies to complete the scheduled worklist or empty the solid waste bin.
•
When you select Cancel, the system returns to the Ready state. This gives you the
opportunity to replace the acid and base supplies or to empty the waste bin.
Scheduled orders return to Pending. You must select Start again.
After the message displays, the system does not start until you respond.
Stopping or Pausing Sample Processing
Pausing Sampling
Use this procedure to pause the sample probe.
1. At the workspace, select the sample compartment.
The Sample Compartment screen displays.
2. Select Pause.
After finishing the current action, the sample probe stops moving. The reagent probe
continues to function, and any samples that have already been dispensed are
processed.
On the Sample Compartment screen, the Pause button becomes the Resume button.
Stopping Sample Processing
Use this procedure to stop the sample and reagent probes.
While samples are processing, the Start button changes to a Stop button.
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2-5
At the workspace, select Stop. The button changes to a Start button.
After finishing the current action, the reagent and sample probes stop moving. Samples in
process, with all reagents already added, complete and results are generated.
Turning the Audible System Alarm Off
If the audible system alarm sounds, press the F11 function key to turn the alarm off.
See Setting Audible Alarms‚ page 6-38, for more information on setting audible alarms on
the system.
Signing Out of the System
Use this procedure to sign out of the system. It is important to sign out of the system at the
end of your shift, especially if your user profile has extended privileges.
At the workspace, select Sign In. The Sign In window displays, and you are signed out of
the system.
When you sign out, samples that are in process will complete. However, a new user will
have to sign in before using the system. The Sign In window remains displayed until a
new user signs in.
Exiting the System
NOTE: Ensure that all system icons, for example the waste icon, are closed before you
attempt to exit the system software. If you attempt to exit the system software while a
system icon is open, you can experience a system failure that requires you to reboot the
system.
Use this procedure to do one of the following:
•
exit the system software and restart the software
•
exit the system software to the desktop
•
exit the system software and shut down the computer
NOTE: If you receive an error event that causes you to reboot the system, note that failure
to follow the recommended procedures to resolve error events may cause erroneous results
or safety hazards. If you have exhausted the procedural steps to resolve the issue and an
error event continues to display, call for technical assistance.
After you select your exit options, turn the instrument off (step 7).
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The Exit window allows you to create a backup prior to exiting the system.
1. At the workspace, select Exit.
2. At the first prompt, select Yes if you want to exit the system software.
3. The second prompt asks if you want to make a backup:
If you want to . . .
Then . . .
back up
select Yes.
exit without backing up system data
select No and proceed to step 6.
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2-7
4. If you are performing a system back up, select one of the following options:
If you want to backup . . .
Then . . .
•
•
•
•
•
•
•
•
•
•
•
•
•
select Data-backup. This option is used
for routine system backups.
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
All results
Assay definitions
Calibration
Definitions
Event messages
Event log
Flashcurves*
Instrument Coordinates
Instrument probe calibrations
LIS settings
System settings
User settings
All results (patient, calibrator,
controls)
Assay definitions
Automated maintenance procedures
Calibrations
Definitions (calibrator, control, master
Curve)
Error messages
Event log
Flashcurves*
Instrument Coordinates
Instrument probe calibrations
Internal software logs
LIS logs (if option is turned on)
LIS settings
Reports
System settings
User settings
select Troubleshooting. This option
allows you to send important backup
information to your local technical support
provider for analysis.
all of the above
select All. This option allows you to back
up everything on your system.
to a CD-ROM, rather than the directory
specified in System Settings
select the Write to CD-ROM checkbox.
* Flashcurves are only backed up if the Transmit Flashcurve option is active. The default
setting is inactive. Contact your technical service provider to change this setting.
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ADVIA Centaur CP Operator’s Guide: 2 Operating the System
Data backup is the default backup setting. You only need to perform the
Troubleshooting or All backups functions under the direction of your technical service
provider.
5. Select Continue.
NOTE: When exiting the system software, the message “Please Wait” appears on the
screen after you select Continue.
Once the Shutdown Computer, Restart Software and, Exit to Desktop buttons become
active, ignore the “Please Wait” message and select the appropriate button.
6. At the final prompt, select from the following options:
If you want to . . .
Then . . .
exit the system software, and shut down
the workstation
select Shutdown Computer.
restart the system software
select Restart Software.
exit the system software, and access the
desktop
select Exit to Desktop.
7. Turn the instrument off by turning the power switch off.
Turning the System Off
When not in operation, leave the ADVIA Centaur CP system and workstation on and in
the Ready state to ensure optimal system performance.
Use this procedure to turn the system off.
1. Ensure that the system is the in Ready state.
2. If the system will be off for more than 5 minutes, perform the following tasks:
a. Remove the sample racks and store the samples in an appropriate location.
b. Remove the primary and ancillary reagents and store them in an appropriate
location.
3. Press the power switch on the left side of the system.
4. Exit the system software.
When you exit the system, select the Shutdown Computer option. See Exiting the
System‚ page 2-5.
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2-9
Changing Your Password
Use this procedure to change your password.
1. At the workspace, select Setup.
2. Select the Users tab.
3. Select your user name.
4. Select Change Password.
The Change Password window displays.
5. Enter your old (or current) password.
6. Enter your new password.
7. Enter your new password again, and then select Save.
8. To return to the workspace, select Close.
Managing Supplies
Replacing Acid and Base Reagents (R1 and R2)
Use this procedure to replace acid and base reagents (R1 and R2) when they have
insufficient volume or have reached their expiration date.
WARNING
Avoid contact of acid and base reagents with skin and eyes. Acid and base reagents are
irritating to the skin. Wear suitable eye, face, and skin protection, which includes wearing
gloves, protective eye shield, and laboratory coat. In case of contact with the eyes, rinse
the eyes immediately with plenty of water and seek medical advice. In case of accident or
if you feel unwell, seek medical advice (if possible show the bottle label and Material
Safety Data Sheet). In case of accidental ingestion of reagent, call a physician
immediately.
CAUTION
Do not use reagents other than ADVIA Centaur systems reagents. Use of reagents other
than ADVIA Centaur systems reagents can cause erroneous results.
CAUTION
Do not perform this procedure while the system is processing samples. The system stops
sampling and the tests in process are not completed.
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For lot number control and optimum reagent performance, replace both reagents at the
same time. Acid and base reagents are for in vitro diagnostic use. Use acid and base
reagents until the expiration date stated on the bottle label or until 28 consecutive days
after loading the reagent on the system.
1
2
3
1
2
3
Acid and Base Reagent Compartment Door
Acid Reagent Bottle (R1)
Base Reagent Bottle (R2)
1. Make sure that the system is in a ready state.
2. Lift the acid and base reagent compartment door.
3. Remove the old reagent bottles.
4. Dispose of the remaining reagent in an appropriate receptacle.
5. Dispose of the old reagent bottles in an appropriate receptacle.
Do not pool any reagent from used acid and base reagent bottles.
6. Write the current date in the space provided on each new bottle.
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2-11
CAUTION
Ensure that the acid and base reagent bottles are installed in the correct positions. If they
are reversed, the chemiluminescent reaction will not occur correctly.
7. Remove each cap and place the new bottles in the compartment with the acid reagent
bottle (R1) on the left and the base reagent bottle (R2) on the right.
8. Lower the acid and base reagent compartment door. Ensure that the acid and base
sensors are within the bottles.
NOTE: Each time you open and close the acid and base reagent compartment door, a
message displays as follows:
Did you replace the Acid and Base bottles?
•
When you select Yes, the message window closes and the system resets to the
default value of tests.
•
When you select No, the message window closes and the number of tests
available remains unchanged.
Viewing Available Acid and Base Volumes
Use this procedure to view the acid (R1) and base (R2) reagents available on the system to
determine if there is sufficient volume to run your tests:
1. At the workspace, select Supplies (status icon on the status bar).
The system displays the estimated number of tests remaining in the acid and base
reagent bottles at the end of the current run.
2. Select Close to return to the workspace.
The acid reagent bottle and the base reagent bottle each have a sensor for measuring
reagent levels. The system displays the number of tests remaining based upon the lowest
sensor reading. The acid and base typically deplete at the same rate, but if priming with
acid or base, a volume level may be lower. For example, the acid reagent may show
neutral, but the base reagent may be yellow.
When there is not enough volume to complete the ordered tests, the system displays a
warning icon:
•
When a yellow warning displays, this indicates an 80% depletion in the acid and base
reagent supplies. A status message shows 180 tests remain. The system counts down
the remaining tests from this number.
•
When a red warning displays, this indicates there is not enough acid reagent or base
reagent to complete tests.
Replace the acid and base reagents. See Replacing Acid and Base Reagents (R1 and R2)‚
page 2-9.
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ADVIA Centaur CP Operator’s Guide: 2 Operating the System
Acid and Base Level Status While Ordering Tests
If you are processing samples and you select the Start button, the system checks the acid
and base reagent volumes against the number of tests ordered. The system displays a
message when the acid and base reagent levels are insuffient to complete the ordered tests.
If there is not enough acid and base reagent to complete the tests, the system displays a
message:
Volume of Acid and Base is not sufficient to complete the worklist; it is short by
n tests. Do you want to start processing samples?
Select OK or Cancel.
•
When you select OK, the system completes initialization/priming and proceeds to
process the scheduled worklist. The number of acid and base tests short display on
the Shortage screen.
If you choose to continue processing after the system displays the warning
message, the system processes as many tests as possible with the available
supplies. Remaining tests are marked as Pending. Replenish the necessary
supplies to complete the scheduled worklist.
•
When you select Cancel, the system returns to the Ready state. You can replace
the acid and base supplies. Scheduled orders return to Pending. You must select
Start again.
After the message displays, the system does not start processing until you respond.
NOTE: The system does not recalculate the reagent levels when you add a test after the
run has started.
Loading Sample Tips
Use this procedure to add new tips to the system.
CAUTION
Do not reuse sample tips or cuvettes. Reuse of sample tips and cuvettes can cause
erroneous results.
CAUTION
Do not open a tip drawer that is active, with a steady green LED above the lane, when the
system is in process. Withdraw the tip trays in the drawer using the Tip Drawer screen and
wait until the LED is neutral before you open the tip drawer. Opening a tip drawer when
the system is in process and the LED is green can cause lost results or mechanical damage
to the system.
For more information on the LEDs on the instrument cover, see LED Color Coding‚
page 1-4.
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2-13
Withdrawing the Old Tip Trays at the Workspace
If the LED is green, you must perform this procedure before you load new tip trays.
1. At the workspace, select the appropriate tip drawer.
The Tip Drawer screen displays.
2. On the left side of the Tip Drawer screen, select the position of the tip trays to replace.
3. Select Withdraw Tray.
4. To return to the workspace, select Close.
Loading the New Tip Trays
If the LED is neutral, you can perform this procedure.
1. Open the tip drawer.
The LED is blinking green.
2. Remove the old tip trays, and discard them in an appropriate container.
3. Open a new pack of tip trays:
a. Remove the strap from the tip tray bundle.
b. Separate the trays.
c. Store the remaining trays.
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4. Place a single tip tray in each position in the tip tray drawer.
Ensure that all tips fit in the drawer, and that the key on each tray is in the correct
position.
Figure 2-1
086D0320-01, Rev. 04
Lining up the Tip Tray in the Tip Drawer
ADVIA Centaur CP Operator’s Guide: 2 Operating the System
2-15
5. Lift the tray cover from the end with the hole, gently sliding the cover forward to
remove it.
1
1
Tip tray cover
Figure 2-2
Removing Tip Tray Cover
6. Snap the tray into place.
7. Discard the tip tray cover.
8. Close the tip drawer until it clicks into place.
The LED returns to neutral.
Assigning the New Tip Trays at the Workspace
Before you assign tips using the workspace, confirm that the screen display matches the
physical tips in the tip drawer.
1. At the workspace, select the appropriate tip drawer.
The Tip Drawer screen displays.
2. Select Set All to mark all tip positions in the tray as full.
NOTE: As the system uses sample tips, the system tracks tip removal. Full tip
positions are shown as blue and empty tip positions as white. However, you must
mark any empty tip positions when loading a tray that has missing tips.
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3. If necessary, select individual tip positions on the diagram to mark that position as
empty. You can select individual tips, or drag your finger or the mouse diagonally
across multiple positions to select an area.
When complete, the tip positions shown as full on the diagram of the tip tray should
correspond to the tips loaded on the system.
•
The top tip tray position corresponds to the tip tray at the back of the drawer.
•
The bottom tip tray position corresponds to the tip tray in the front of the drawer.
4. Select Assign Tray.
5. Select Close to return to the workspace.
Adding Cuvettes
Use this procedure to add new cuvettes to the system. You can fill the cuvette loading bin
at any time, even while the system processes samples. The cuvette loading bin holds up to
400 cuvettes, or 2 bags of cuvettes. Do not overfill the cuvette loading bin.
CAUTION
Do not reuse sample tips or cuvettes. Reuse of sample tips and cuvettes can cause
erroneous results.
When adding cuvettes to the system, gently pour the cuvettes into the cuvette holder. Do
not shake the cuvette bag. Do not overfill the cuvette bin.
Load the cuvettes in the cuvette loading bin toward the back edge of the system.
CAUTION
When loading cuvettes, do not allow them to bounce out of the bin onto the incubation
ring or the top of the reagent compartment. If any cuvettes do get out of the bin, open the
cover and remove them. Wait until the system is in a Ready state before you open the
cover.
If the system is processing when you open the cover, sample and reagent probes stop
moving. This stops the sample run.
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If the cuvette hopper indicator on the workspace is red, then system detected an empty
cuvette supply. Load cuvettes, and then restart the cuvette loader.
Use this procedure to restart the cuvette loader.
Indicator
Procedure
1. At the workspace, select the Supplies status button.
2. Select Restart Cuvette Loader.
3. Select Close.
Emptying the Solid Waste Drawer
Use this procedure to empty the solid waste drawer, which collects used sample tips and
cuvettes. The solid waste drawer holds waste for 400 tests. The system does not allow you
to schedule additional tests unless enough space is available in the solid waste drawer for
the solid waste that will be generated.
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Empty the solid waste drawer at the beginning of each day, and before extended operation.
Although you can empty the solid waste drawer while the system processes samples,
avoid any potential biohazardous conditions by emptying the solid waste drawer while the
system is in the Ready state.
BIOHAZARD
Wear personal protective equipment. Use universal precautions. Refer to Appendix A,
Safety Information, for recommended precautions when working with biohazardous
materials.
CAUTION
Do not reuse sample tips or cuvettes. Reuse of sample tips and cuvettes can cause
erroneous results.
1. Ensure that the system is in the Ready state.
2. Remove the solid waste drawer by grasping the handle and pulling the drawer out of
the system.
3. Dispose of the contents of the drawer in an appropriate receptacle.
4. Replace the solid waste drawer.
5. At the workspace, select the Waste status button.
6. Select Solid Waste Emptied.
Observe the message in the event log display of the workspace.
7. Select Close.
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Emptying and Refilling the DI Water and Wash 1 Containers
You can add DI water and wash 1 solution at any time, even while the system is processing
samples. The containers have a similar design and are distinguished by the color of the
caps. The DI water container has a blue cap, the wash 1 container has a white cap, and the
liquid waste container has a red cap.
CAUTION
Do not change the order of the caps on the containers. This can cause erroneous results or
damage to the system.
Do not disconnect fluid or sensor lines from the DI water or wash 1 containers when you
replenish fluids if the system is processing samples.
3
4
2
1
5
6
7
1
2
3
4
5
6
7
Liquid Waste Container Tubing and Sensor Mount
Liquid Waste Container Sensor Connection
DI Water and Wash 1 Tubing Connection
DI Water and Wash 1 Sensor Connector
Wash 1 Container
DI Water Container
Liquid Waste Container
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Emptying and Refilling the DI Water and Wash 1 Containers
1. Ensure that the system is in the Ready state.
2. Disconnect the container from the system:
a. Disconnect the tubing from the container and set it aside on lint-free tissues or
gauze to absorb drips.
b. Disconnect the sensor from the container.
c. Remove the cap from the container.
3. Dispose of the fluid into an appropriate receptacle.
4. Refill the container.
5. Re-install the container:
a. Replace the cap on the container.
b. Place the container back in position.
c. Connect the tubing to the container.
d. Connect the sensor to the container.
Replenishing the DI Water and Wash 1
You do not need to disconnect the DI water and wash 1 containers from the system to add
more fluid.
1. Remove the cap from the container.
2. Pour more fluid into the container.
3. Replace the cap.
Emptying the Liquid Waste Container
The system notifies you when the liquid waste is 80% full. This notification displays while
sufficient unused volume remains to allow tests in process in the incubation ring to
complete.
Empty the liquid waste container at the beginning of each day and before extended
operation. If the waste status icon is red, empty the liquid waste before you continue
processing samples, perform any maintenance or diagnostics procedures, or shut down or
restart the system. Although you can empty the liquid waste container while the system
processes samples, avoid any potential biohazardous conditions by emptying the liquid
waste container while the system is in the Ready state.
BIOHAZARD
Wear personal protective equipment. Use universal precautions. Refer to Appendix A,
Safety Information, for recommended precautions when working with biohazardous
materials.
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1. Disconnect the container from the system:
a. Disconnect the tubing from the container and set it aside on lint-free tissues or
gauze to absorb drips.
NOTE: If you are emptying the liquid waste while the system is not in Ready
state, place the tubing in a 2-liter container to collect any liquid waste that is
expelled from the system.
b. Disconnect the sensor from the container.
c. Remove the cap from the container.
2. Dispose of the waste into an appropriate receptacle.
3. Re-install the container:
a. Replace the cap on the container.
b. Place the container back in position.
c. Connect the tubing to the container.
d. Connect the sensor to the container.
Monitoring and Managing Reagent Supplies
Inventory for primary reagents is expressed in number of tests. Inventory for ancillary
reagents, diluents, and ancillary wash solutions is expressed in milliliters.
NOTE: Do not add reagent to reagent packs. Each reagent pack contains enough reagent
to process a predetermined number of tests. Each time the system accesses a reagent pack,
reagent inventory tracks the amount of reagent used. The system does not recognize
additional fluid placed in a reagent pack.
Typically, the system displays the number of tests remaining in a primary reagent pack and
the volume remaining for ancillary reagent pack. For Probe Wash 3 (PW3), a primary
reagent pack, the system displays both the test and volume information, but only the
volume information will decrease with use.
If you have multiple systems in your laboratory, record the following information before
you move a reagent pack from one system to another:
•
the number of tests remaining in a primary reagent pack
•
the volume remaining in an ancillary reagent pack
•
the stability information that displays on the Reagent and Calibration Stability
window
Enter this information in the appropriate fields in the Primary or Ancillary Reagent screen
when you load the reagents on a different system.
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Loading Primary Reagent Packs
Use this procedure to load primary reagent packs.
NOTE: To ensure optimal system productivity avoid keeping the reagent compartment
door open for more than 5 minutes at a time.
LASER WARNING
Do not look directly at the laser beam or at its reflection from a shiny surface. This may
cause damage to the eyes. Refer to Appendix A, Safety Information, for more information.
NOTE: Do not open the reagent compartment door and the sample compartment door
simultaneously. An interactive dialog window displays when a door is open. When 2
dialog windows are displayed simultaneously, one is obscured by the other. The system
waits for the user to respond to the obscured dialog and the system may lock up.
1. Open the reagent compartment door.
The Primary Reagent screen displays.
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2. Load the primary reagent packs.
For each pack, perform the following steps:
CAUTION
Ensure that reagent packs are level and loaded correctly. Reagent packs that are not level
and loaded correctly can cause the system to stop.
a. Rock the pack to premix the reagents.
See Appendix C, Reagents Information, for more information on handling
reagents. Some reagents require vigorous shaking before loading. Follow the
procedures in the assay instructions for use.
b. Select a position for the reagent pack.
The system default is to load reagents left to right. To change the position used for
loading, select a new position on the Primary Reagent screen. The position
numbers are noted on the reagent compartment door. You cannot select a position
with a pack already loaded, even if the system does not recognize the reagent
pack.
When the position becomes active and ready to accept a reagent pack, the LED
above the position blinks green. The LED above the position must show the
position as active to recognize the reagent. See LED Color Coding‚ page 1-4.
c. Pull the reagent holder toward you.
d. Load the pack on the reagent holder, loading the barcoded end of the pack first.
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e. Ensure that the indentation in the reagent pack fits correctly on the tab in the
reagent holder.
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f.
2-25
Push the reagent holder back.
The barcode for each reagent is scanned after that reagent holder is in place.
3. After loading the reagent pack, gently press down on the top of the pack to ensure it is
correctly seated on the reagent holder.
If the system does not recognize the barcode on the primary reagent pack, the system
displays question marks (???) on the Primary Reagent window for the lane where the
primary reagent pack is located. To manually enter the barcode for the primary
reagent, follow this procedure:
a. Open the compartment door and remove the primary reagent pack that
corresponds with the question marks from the reagent holder.
b. Write down the barcode from the pack.
c. Look for the steady yellow LED for that lane, replace the pack on the reagent
holder, and push it back into place.
d. Close the compartment door.
e. At the workspace, select the Primary Reagent area.
f.
At the Primary Reagent window, select the lane with the question marks.
Be sure to select the correct lane.
g. Enter the barcode from the pack in the Barcode field.
h. Change the input focus by selecting another field on the screen.
The system displays all the information for the primary reagent based upon its
master curve.
i.
Select Close.
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4. Confirm reagent details, and edit reagent volume on the Primary Reagent screen if the
pack was used on another system.
5. Close the reagent compartment door.
The Primary Reagent screen closes.
Removing Primary Packs
CAUTION
Do not remove a reagent pack that is active, with a steady green LED above the lane,
when the system is in process. Wait until the LED is neutral before you remove the pack.
Removing a reagent pack when the system is in process and the LED is steady green can
cause mechanical damage to the system.
For more information on the LEDs on the instrument cover, see LED Color Coding‚
page 1-4.
Use this procedure to remove primary reagent packs. Before disposing of a reagent, refer
to the appropriate assay instructions for use to identify any warnings or special
instructions that may apply.
NOTE: To ensure optimal system productivity, avoid keeping the reagent compartment
door open for more than 5 minutes at a time.
LASER WARNING
Do not look directly at the laser beam or at its reflection from a shiny surface. This may
cause damage to the eyes. Refer to Appendix A, Safety Information, for more information.
NOTE: Do not open the reagent compartment door and the sample compartment door
simultaneously. An interactive dialog window displays when a door is open. When 2
dialog windows are displayed simultaneously, one is obscured by the other. The system
waits for the user to respond to the obscured dialog and the system may lock up.
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1. Open the reagent compartment door.
2. Pull the reagent holder toward you.
3. Remove the reagent pack from the reagent holder.
4. Push the reagent holder back in.
5. Close the reagent compartment door.
The workspace screen displays.
Loading Ancillary Reagent Packs
NOTE: To ensure optimal system productivity, avoid keeping the reagent compartment
door open for more than 5 minutes at a time.
NOTE: Do not open the reagent compartment door and the sample compartment door
simultaneously. An interactive dialog window displays when a door is open. When 2
dialog windows are displayed simultaneously, one is obscured by the other. The system
waits for the user to respond to the obscured dialog and the system may lock up.
Use this procedure to load ancillary reagent packs.
1. Load the ancillary reagent packs onto an ancillary tray. For each pack, perform the
following steps:
a. Select a location for the pack.
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b. Load the barcoded end of the pack toward the barcodes on the tray.
c. Slide the pack into position, and push the pack forward until it snaps into place.
LASER WARNING
Do not look directly at the laser beam or at its reflection from a shiny surface. This may
cause damage to the eyes. Refer to Appendix A, Safety Information, for more information.
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2. Open the reagent compartment door.
The Primary Reagent screen displays.
3. To access the Ancillary Reagent screen, close the Primary Reagent screen and select
the ancillary reagent area on the workspace.
The system default is to load reagent trays left to right. To change the position used for
loading, select a new position on the Ancillary Reagent screen. The position numbers
are noted on the reagent compartment door.
When the position becomes active and ready to accept a reagent tray, the LED above
the position blinks green. The LED above the position must show the position as
active to recognize the reagents. See LED Color Coding‚ page 1-4.
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4. When the barcode scanner is on, slide the ancillary tray into the ancillary reagent area
until it snaps into place.
Slide the groove on the ancillary tray under the rivet on the side of the ancillary
reagent area. Use one continuous motion. The ancillary reagent barcodes are read as
the tray is inserted into the system. If the tray stops or reverses during its insertion, the
barcodes may be read incorrectly.
Figure 2-3
If the system does not recognize the barcode on the ancillary reagent pack, the
Ancillary Reagent screen displays with a blank ancillary reagent lane. The display is
the same whether the barcode is missing or the system in unable to read the barcode.
5. To enter the barcode manually, follow this procedure:
a. Remove the ancillary tray.
b. Remove the pack that corresponds to the blank lane.
c. Write down the barcode from the pack.
d. Put the pack back into the ancillary tray and reinsert the ancillary tray into the
compartment.
e. Close the ancillary reagent compartment door.
f.
At the workspace, select the Ancillary Reagent Area.
g. Select the lane.
h. Enter the barcode number from the pack in the Barcodes field.
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i.
Change the input focus by selecting another field on the screen.
The system displays all the information for the ancillary reagent.
j.
Select Close.
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6. Confirm reagent details, and edit reagent volume on the Ancillary Reagent screen if
the pack was used on another system.
7. Close the reagent compartment door.
The Ancillary Reagent screen closes.
Removing Ancillary Reagent Packs
CAUTION
Do not remove a reagent pack that is active, with a steady green LED above the lane,
when the system is in process. Wait until the LED is neutral before you remove the pack.
Removing a reagent pack when the system is in process and the LED is steady green can
cause mechanical damage to the system.
CAUTION
Do not remove an ancillary reagent pack that is needed for a mitigation until the system is
in the Ready state. The LED turns neutral for the reagent when the reagent is no longer
needed, but then flashes before and during the mitigation. It goes neutral again until it is
required for the next mitigation. Removing a reagent pack when the system is in process
can cause mechanical damage to the system.
For more information on the LEDs on the instrument cover, see LED Color Coding‚
page 1-4.
NOTE: Do not open the reagent compartment door and the sample compartment door
simultaneously. An interactive dialog window displays when a door is open. When 2
dialog windows are displayed simultaneously, one is obscured by the other. The system
waits for you to respond to the obscured dialog, and the system may lock up.
Use this procedure to remove ancillary reagent packs. Before disposing of a reagent, refer
to the appropriate assay instructions for use to identify any warnings or special
instructions that may apply.
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If it is necessary to remove an active ancillary tray during sample processing, on the
Ancillary Reagent screen, select the arrow button at the bottom of the lane. The arrow
button for a tray is active when the LED above the lane is steady green and the reagent
compartment door is opened. When the tray is replaced and the compartment door is
closed, sample processing resumes, and the arrow is no longer active.
NOTE: To ensure optimal system productivity, avoid keeping the reagent compartment
door open for more than 5 minutes at a time.
NOTE: Do not remove ancillary reagent packs that are required for mitigation washes
until the system is in the Ready State.
LASER WARNING
Do not look directly at the laser beam or at its reflection from a shiny surface. This may
cause damage to the eyes. Refer to Appendix A, Safety Information, for more information.
1. Open the reagent compartment door.
2. Pull the ancillary tray out of the reagent compartment.
3. Remove the reagent pack from the ancillary tray. If additional reagents remain on the
tray, return the tray to the compartment.
4. Close the reagent compartment door.
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Processing Samples
Loading Samples into Sample Racks
Several types of sample collection and loading vessels (sample tubes) can be used on the
ADVIA Centaur CP system. See Appendix D, Specifications for more information on tube
types available on the system.
Label the sample tube containing the patient sample with the appropriate barcode label.
See Appendix D, Specifications for more information on determining the required sample
volume.
BIOHAZARD
Wear personal protective equipment. Use universal precautions. Refer to Appendix A,
Safety Information, for recommended precautions when working with biohazardous
materials.
1. Position the barcode label vertically on the sample tube approximately 2 cm (0.8 in)
from the top.
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2. Move the tube-type selector on the rack to the correct position for the sample tubes
you are loading in the rack.
Tube selection assignments are made during system setup.
If you do not know the tube type for your sample tube, you must set the tube type. To
view and set the tube type, see Setting Tube Types‚ page 2-35.
Refer to Specifying Sample Tube Types‚ page 6-34 for details on setting tube
assignments. See Appendix D, Specifications, for more information on tube types
available on the system.
2
3
1
1
2
3
Sample Rack
Sample Tube
Tube-type Selector
3. Place the sample tubes in the rack.
4. Ensure that only one type of sample tube is in the rack and that the tube-type selector
is positioned correctly for that tube type.
Ensure that the barcode labels are clearly visible above or between the slots in the
rack.
CAUTION
Do not load capped sample tubes into the sample compartment. Ensure all caps are
removed from the sample tubes before loading the rack into the system. Leaving caps on
the tubes can cause mechanical damage to the system.
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Setting Tube Types
To set the tube type for your sample tubes, you must have Level 1 privileges. If you have
Level 1 access, use the following procedure to view and set the tube type for your sample
tubes:
1. Remove all sample racks from the sample compartment.
2. At the workspace, select Setup.
3. Select the System tab.
4. Select Tube Types.
5. At the Tube Types window, verify that your tube type is available and listed in the
Racks section as A, B, or C.
6. If the tube type is not available, select the appropriate tube type, select the appropriate
Assign to button, and then select OK.
7. Select Cancel.
8. Select Cancel to return to the workspace.
Loading Sample Racks into the System
LASER WARNING
Do not look directly at the laser beam or at its reflection from a shiny surface. This may
cause damage to the eyes. Refer to Appendix A, Safety Information, for more information.
1. Open the sample compartment door.
NOTE: Do not open the reagent compartment door and the sample compartment door
simultaneously. An interactive dialog window displays when a door is open. When 2
dialog windows are displayed simultaneously, one is obscured by the other. The
system waits for the user to respond to the obscured dialog and the system may lock
up.
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When you open the Sample Compartment door, wait a few seconds before you load a
sample rack into a lane until you can see the reflection of red light of the laser to the
right-hand side of the compartment wall. Do not look to the left of the Sample
Compartment (at the red laser beam).
The system default is to load sample racks left to right. To change the lane used for
loading, select a new lane on the Sample Compartment screen. The lane numbers are
noted on the sample compartment door. You cannot select a lane with a rack already
loaded, even if the system does not recognize the sample rack.
When the lane becomes active and ready to accept a sample rack, the LED above the
lane blinks green. The LED above the lane must show the lane as active to recognize
the sample rack. See LED Color Coding‚ page 1-4.
NOTE: When the LED displays a blinking green, wait a few seconds to ensure that
the barcode reader is completely activated.
2. Ensure that the groove at the bottom of the sample rack lines up with the guide on the
bottom of the sample compartment lane.
3. Slide the sample rack into the appropriate lane.
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Use one continuous, even motion (neither too fast nor too slow). The sample barcodes
are read as the rack is inserted into the system. If the rack stops or reverses during its
insertion, the barcodes may not be read.
4. Ensure that the sample rack is inserted correctly, and locked into place.
When the sample rack is inserted correctly, you can hear and feel it click into place.
Samples loaded into the STAT lane are automatically designated as STAT samples.
The default STAT lane is lane 7.
5. Close the sample compartment door.
If the LED goes to neutral (no light), then the rack is loaded correctly.
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Removing Sample Racks from the System
CAUTION
Do not remove a sample rack that is active, with a steady green LED above the lane, when
the system is in process. Wait until the LED is neutral before you remove the rack.
Removing a sample rack when the system is in process and the LED is steady green can
cause mechanical damage to the system.
CAUTION
Do not remove a sample rack that has Auto Rerun or Auto Reflex tests scheduled. The
sample LED indicator turns neutral before the final result is released. Removing a sample
rack when the system is in process can cause mechanical damage to the system.
For more information on the LEDs on the instrument cover, see LED Color Coding‚
page 1-4.
LASER WARNING
Do not look directly at the laser beam or at its reflection from a shiny surface. This may
cause damage to the eyes. Refer to Appendix A, Safety Information, for more information.
1. Open the sample compartment door.
2. Grasp the sample rack by the handle and remove the sample rack from the
compartment.
3. Close the sample compartment door.
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Removing a Sample Rack to Retrieve a Sample
If it is necessary to retrieve a sample while other samples in the rack are pending or in
process, ensure that you follow this procedure to safely remove the rack:
NOTE: It is recommended that you do not remove sample racks from the sample
compartment while the system is processing samples or waiting to rerun samples.
1. At the workspace, select the Sample Compartment.
2. In the Sample Compartment window, select Pause.
3. Remove the rack, complete the necessary action, and return the rack into the same
lane of the Sample Compartment.
4. Wait a few seconds, and then select Resume.
Ensuring the Final Results are Released
If Auto Rerun and/or Auto Reflex features are enabled in Setup>System, do not remove a
sample rack from the system until the final patient result has been released. The sample
LED indicator turns neutral before the final result is released. If the sample rack is
removed prematurely, the system does not perform the Auto Rerun or Auto Reflex
aspirations if required.
Use the following procedure to ensure that the final result is released:
1. At the workspace, select Results.
2. Select Today’s.
3. Determine that a result and interpretation is recorded.
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Scheduling Patient Samples
When you request a ratio test, the system automatically schedules all assays defined as
part of the ratio. The component assays are not displayed at the Sample Compartment
screen, only the ratio test is shown.
If you request a ratio test and also request an assay that is part of the ratio test, the system
performs the assay only once. The assay result is reported as both part of the ratio result,
and independently.
If a reflex test has been defined for an assay, you cannot remove samples tested against
that assay until processing is complete.
Scheduling Samples through the Sample Compartment
Screen
1. At the workspace, select the sample compartment.
2. Select the 12-position image of the sample rack.
3. Select the Sample ID field.
The samples are numbered 1 to 12. Number 1 is the sample at the back of the sample
compartment, and number 12 is the sample at the front of the sample compartment.
4. If no barcode is on the sample tube, select the sample type by toggling the sample
selection button.
The default is a routine patient sample smp. If the sample is a calibrator, select cal. If
the sample is a control, select ctrl.
NOTE: Samples loaded into the STAT lane are automatically designated as STAT
samples. You can also designate a sample as STAT by selecting the STAT button.
5. If no barcode label is on the sample tube, enter the SID.
NOTE: If the system cannot detect a sample tube, the sample position is grayed out
and the SID cannot be entered. Remove the rack and ensure that a tube is in the
position. Reinsert the rack.
It is not necessary to press Enter after entering the ID.
You can enter the sample ID manually or using the hand-held barcode scanner.
If entering SIDs manually adhere to the following restrictions:
086D0320-01, Rev. 04
•
You can enter up to 17 alphanumeric characters for the sample ID.
•
Use uppercase letters for SID entries that are downloaded by the CentraLink™ or
the LIS. SIDs containing lowercase letters are not recognized and remain pending.
•
Do not use the % symbol as part of the sample ID.
•
You can set the minimum and maximum sample ID for your laboratory. For
additional information, refer to Setting Minimum and Maximum Sample ID
Lengths‚ page 6-39.
ADVIA Centaur CP Operator’s Guide: 2 Operating the System
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NOTE: Review the SID entry thoroughly before you continue on to the next sample
field. Once you leave the sample field, you cannot go back and make a correction.
To correct an error in the SID entry, remove the sample rack from the system. Re-load
the rack, re-enter the SID, the test selection, dilutions and replicates for the sample
you are correcting. If necessary, re-enter the SIDs for the other samples in the rack.
The workorder information is secure for the other samples.
6. Select the assays or the profiles to process against the sample.
NOTE: You must select at least one test request.
7. Select Close.
Scheduling Samples Using a Profile
At the Sample Compartment screen, after you select the sample, select the profile (the list
of tests to run against the sample). When tests are scheduled for that sample using a
profile, the system no longer looks to the profile for instructions. If you later decide that
you do not want to schedule some of the tests in the profile, you must deselect the tests.
To deselect one or more tests, perform the following steps.
1. At the Sample Compartment screen, select the sample.
2. In the Assay Selection area, select the test you want to deselect.
The LED in the lower left-hand corner of the assay is turned off. The assay is
deselected.
Selecting a Dilution for a Sample Through the Sample
Compartment
The ADVIA Centaur CP system provides both automatic and user-requested dilution
options.
Automatic dilution options, such as diluting and retesting samples with results greater than
a specified concentration limit, and dilution profiles, which automatically schedule
multiple dilutions for an assay, are defined for a specific assay in the assay screens. Refer
to Assay and Dilution Profiles‚ page 6-26 for details.
If you have manually diluted the sample, you must enter the offline dilution factor before
you select any assays on the Sample Compartment screen. After you select an assay, you
cannot define offline dilutions for the sample.
If a dilution profile is scheduled for the sample, you cannot change the dilution factors.
User-requested dilutions are not available for samples scheduled using an LIS.
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You must dilute all samples with the ADVIA Centaur CP diluent specified for each assay.
Physiological saline or commercial albumin are not acceptable diluents for
ADVIA Centaur CP assays. Refer to the Assays section of the online help system for
specific dilution information.
Manual Dilution
If you run a sample and the result was, for example, above the accepted range (linearity),
then you can run the sample with an offline (manual) dilution.
Once the sample has resulted you cannot then enter a manual dilution for that SID. Use a
different SID for the manual dilution, or delete all the results related to that SID, and begin
again.
When you load a sample into the Sample Compartment and select a test, you cannot then
enter a manual dilution. Deselect the test.
Use this procedure to order an offline sample dilution:
1. At the workspace, select the sample compartment.
2. Select the sample.
3. Enter the offline dilution factor:
a. Select Dilute.
b. Enter the dilution factor in the Offline area.
The Undiluted button changes to show the offline dilution factor in a 1:X format.
c. Select Close Dilutions.
4. In the Assay Selection area, select the assays to run against the sample.
Predefined Dilution
If a system dilution is predefined (some assays do not have predefined onboard dilutions)
for selection, then use this procedure.
1. At the workspace, select the sample compartment.
2. Select the sample.
3. Select an assay.
4. Select Dilute.
5. In the Selected Requirements area, select the assay.
6. To run assigned dilutions, select from the available dilution factors.
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7. Define whether you will also process an undiluted sample:
If you want to . . .
Then . . .
run only diluted samples
select the Undil. button to clear it. If you
have diluted the sample offline, this button
shows the offline dilution factor entered in
step 5.
run both diluted samples and samples that
are not diluted by the system
leave the Undil. button as it is (Undil. is
selected by default). If you have diluted
the sample offline, this button shows the
offline dilution factor entered in step 5.
8. Select Close Dilutions.
Scheduling a Dilution Test Exclusively
If you order an exclusive dilution from Schedule Worklist, the system performs both a
diluted test and an undiluted test on the same patient sample.
Schedule an exclusive dilution test through the Sample Compartment window.
1. Load the patient sample.
2. At workspace, select the Sample Compartment.
3. Select the patient sample, select an assay to be diluted.
4. Select Dilute.
5. Select the dilution.
6. Deselect Undiluted.
7. Select Close Dilutions.
Setting Replicates Through the Sample Compartment
Replicates allows you to view and edit replicates for the assay you select. You specify
replicates from the Sample Compartment screen.
Use this procedure to order a sample replicate.
1. At the workspace, select the sample compartment.
2. Select a sample.
3. In the Assay Selection area, select the assays to run against the sample.
4. Select Replicates.
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5. In the Selected Requirements area, select the assay.
The assay name displays in the Replicates field.
The default replicate for the assay displays.
6. Use the up and down arrows next to the Replicates field to increase or reduce the
replicate number or use the keyboard to enter the number of replicates you want.
7. Select Close Replicates.
Final repeat replicate and any other test that autorepeats results will not cause additional
automatic reruns, such as a repeat for over dilution point greater than concentration, check
range, or final result rule.
The test will only repeat one time. Any result only autorepeats once as a result of any of
the user-defined range conditions. When repeat replicates is set, the final result does not
cause an autorepeat of the test, because the result is based on repeated tests.
Setting up Batch Orders Through the Sample Compartment
You can select all the samples and controls on a rack in the sample compartment to apply
assays, dilutions, or replicates to all samples on that rack at the same time.
When you finish loading the rack(s) into the instrument and close the door, the system
displays the Workspace screen.
1. At the workspace, select the sample compartment.
2. Select the sample rack.
3. Select Enable Batch Orders.
You cannot modify sample IDs in Batch Order mode. You cannot select individual
sample positions. You cannot run manually diluted samples in Batch Order mode.
4. Select the assays and profiles you want to run against every sample on the selected
rack.
If you select the STAT button in Batch Order mode, all the sample positions are
assigned the STAT priority.
5. Select Disable Batch Orders.
6. Select Close.
The system processes the samples.
Checking Sample Status Through the Sample Compartment
If any samples fail, the Sample Status button on the Sample Compartment screen turns
yellow. You can see the status of your samples including the results flag, which indicates
the reason for the failure, for example, Clot Detected or Calibrator Expired.
You can reprocess these samples once you correct the problem.
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You can check the status of a sample through the sample compartment.
1. At the workspace, select the sample compartment.
2. Select Sample Status.
The system displays the Reruns results display, which indicates the current status of
the samples that need to be rerun or need attention.
3. Select Close to exit the Results display.
4. Select Close to exit the Sample Compartment screen and return to the workspace.
NOTE: If you select Sample Status in the Sample Compartment window and select
Delete, Export, or Print, and then select OK or Cancel, an artifact field from a previous
window appears. The artifact field will not affect sample processing or results.
Use the cursor to select anywhere in the window, and the artifact field will disappear.
Scheduling a Worklist Using the Results Screen
You can create a worklist before loading your samples onto the system.
1. At the workspace, select Results.
The system displays the Today’s Results tab (the default).
2. Select Schedule Worklist.
3. Enter a sample ID.
4. Enter patient demographic information for the sample.
See the Screen Help section of the online help system for details.
5. Enter the offline dilution factor, if any.
6. Select the assays or profiles to process against the sample.
You can select dilutions or replicates if necessary.
7. To add another entry to the worklist, select Next.
8. To finish entering the worklist, select OK.
9. To return to the workspace, select Close.
Scheduling Replicates Using a Worklist
Replicates allows you to view and edit replicates for the assay you select.
1. At the workspace, select Results.
The system displays the Today’s Results tab (the default).
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2. Select Schedule Worklist.
The Patient tab is the default.
3. Enter a sample ID.
If you enter an SID that has patient demographics information, then the data fields fill
in automatically.
4. Enter demographic information (optional).
5. Enter a comment (optional).
6. Select an assay or use a profile from the Profile Selection area (for example, Profile)
to assign tests.
7. Select Replicates.
8. At the Assay Selection window, select an assay.
9. Enter a replicate number.
10. Select Close Replicates.
The system displays the Patient tab of the Schedule Worklist screen.
Assign replicates to assays one at a time. If you want to enter replicates for other tests,
follow steps 9 through 11 for each assay.
From the Patient screen, you can also schedule dilutions for the assays as described in
the next section.
11. To finish entering the worklist, select OK.
12. To return to the workspace, select Close.
Scheduling Dilutions Using a Worklist
Dilutions allows you to view and edit dilution data for the assay you select. You can enter
dilution information for the sample ID from the previous section, or you can enter a
dilution for a sample selected from one of the sample results displays.
Use this procedure to schedule dilutions using a worklist.
1. At the workspace, select Results.
The system displays the Today’s Results tab (the default).
2. Select Schedule Worklist.
The Patient tab is the default.
3. Enter a sample ID.
4. Enter demographic information (optional).
5. Enter a comment (optional).
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6. You can enter your own offline dilution ratio for a sample in the Offline Dilution area.
7. Select one or more assays or use a profile from the Profile Selection area (for example,
Profile) to assign tests.
The system performs both an undiluted test and a diluted test on the sample.
NOTE: If you choose to schedule an exclusive dilution test you must schedule it in the
Sample Compartment window. Refer to Scheduling a Dilution Test Exclusively‚
page 2-43.
8. Select Dilutions.
9. At the Assay Selection window, select an assay.
10. Select the standard dilution option(s) for that test or the Undil. button or both.
The system displays the standard dilutions defined in the test definition for the
selected assay.
If you entered your own offline dilution ratio for a sample, the system displays that
information in the Offline Dilution area. You cannot edit that information from this
area. You can edit this information from the Patient tab.
11. Select Close Dilutions.
12. At the Patient window, select Next to add dilutions to another entry.
13. To finish, select OK.
14. To cancel the dilution, select Cancel.
15. To return to the workspace, select Close.
Downloading Orders Automatically from the LIS
If a worklist is downloaded automatically from the LIS, the orders are added to the Results
tab. All information required to process the order can be downloaded from the LIS. The
order status is Pending. The sample status changes to In process when you select Start
or if the system is already running.
When the LIS sends orders for kit-type controls for control bracketed tests, the system
ignores the order.
User-requested dilutions are not available for samples scheduled using the LIS.
Downloading Orders Manually
Use the following procedure to download orders manually:
1. At the workspace, select Results.
2. Select the appropriate sample results tab.
3. Select Download Orders.
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Scheduling a Worklist
The Schedule Worklist screen provides 3 tabs: Patient, Control, and Brackets.
•
Use the Patient tab to enter patient samples to the worklist.
•
Use the Control tab to add controls to the worklist.
•
Use the Brackets tab to schedule a set of controls to process before and after specific
tests.
Scheduling a Worklist for Controls
The Schedule Worklist screen provides 2 tabs: Patient and Control. Use the Patient tab to
enter patient samples to the worklist. Use the Control tab to add controls to the worklist,
using the following procedure.
1. At the workspace, select Results.
The system displays the Today’s Results tab (the default).
2. Select Schedule Worklist.
3. Select the Control tab.
4. Select an assay.
5. Select one or more controls to process.
Note the barcode and target of the control. To select multiple controls, select and hold
the Ctrl key.
6. To schedule another set of controls, select Next.
7. Repeat steps 5 to 7 as necessary.
8. When all controls are scheduled, select OK.
NOTE: To add the tests to the worklist, select Next. To cancel only the last set of
controls that were scheduled, select Cancel.
You must delete any previously scheduled controls from the Results tab.
When the scheduled controls are loaded on the system, they run automatically.
9. To return to the workspace, select Close.
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Scheduling a Control Bracketed Patient Sample
Control Bracketing requires you to open a bracket and close a bracket for a specific test
and reagent lot. Control bracketing enforces the processing of these controls within a
specified time frame, called a control bracket. The system does not aspirate
control-bracketed samples until the start-of-bracket controls are successfully aspirated. In
addition, the system does not report control-bracketed patient sample results until the
end-of-bracket controls are successfully completed.
Laboratories can comply with procedural recommendations for certain tests that are
regulated very closely. The ADVIA Centaur CP system can perform tests with control
bracketing when the feature is enabled in the Assay Details window. This feature is
enabled by the manufacturer. If your laboratory does not require you to use this feature,
contact your local technical support provider or distributor to disable it.
Refer to Using Control Bracketing‚ page 6-11 for further information on setting up the
system with control bracketing.
Use the following procedure to schedule patient samples for specific assay testing required
by your laboratory. This type of assay testing requires you to schedule a complete set of
controls to open a bracket and close a bracket.
NOTE: If a control bracketed test is scheduled for repeat replicates, and the replicates are
aspirated in a different control bracket from the initial sample’s control bracket, and the
repeat replicates bracket fails, you must rerun the sample.
NOTE: Results are only reported, displayed, sent to the printer, or transmitted to the LIS if
both sets of controls are within their acceptable ranges.
1. At the workspace, select Results.
The system displays the Today’s Results tab (the default).
2. Select Schedule Worklist.
3. Select the Brackets tab.
4. Select an assay from the Test Name list to be processed in control bracketed mode.
The Lot field is populated with the corresponding control lot if the selected reagent is
lot locked.
NOTE: The Open Bracket button is only enabled if the following criteria is met:
•
The system is in the Ready or Running state.
•
A valid calibrated reagent lot is loaded and not expired.
•
All required control levels are loaded within the same sample rack.
Refer to Scheduling a Calibration for further information.
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5. Select the Open Bracket button to schedule the control levels that are to be processed
at the beginning of a patient sample run.
6. Load and process patient samples.
Refer to Loading Sample Racks into the System‚ page 2-35 for further information.
Scheduling a Control Bracketed Control as a QC Sample
If the control sample rack is already loaded in the sample compartment and you schedule a
control-bracketed control as a QC sample, not as an opening bracket, the results may stay
pending.
The control results remain pending if the control sample rack is already loaded in the
sample compartment when they are scheduled through Results > Schedule Worklist.
If the control sample rack is already loaded in the sample compartment, use the Sample
Compartment window to schedule the QC controls.
Closing a Bracket
The Closing Bracket button is only enabled if the following criteria is met:
•
The system is in the Ready or Running state.
•
A valid calibrated reagent lot is loaded and not expired.
•
Refer to Scheduling a Calibration‚ page 2-50 for further information.
•
All required control levels are loaded within the same sample rack.
NOTE: To force a bracket to be closed before it has aspirated, the controls must be loaded
within the same rack in the right-most lane of the sample compartment
NOTE: If the patient samples are not run within the allotted 24-hour time period from the
start-of-bracket controls until the end-of-bracket controls, the patient results are
automatically discarded.
1. Select the Close Bracket button to schedule the control levels that are to be processed
at the end of a patient sample run.
2. Select Close to return to the Results window.
Scheduling a Calibration
Select the Schedule Cal button to schedule a calibration for the selected reagent lot.
•
The button is enabled only if the primary reagent pack is selected and the associated
calibrator is onboard.
•
Selecting the button performs the same function as selecting the Calibrate button on
the Reagent Loading screen.
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Manually Discarding a Bracket
You can choose to discard a bracket manually.
NOTE: If an open bracket is discarded, all patient test results associated with it are
automatically discarded.
Select the Discard Bracket button to discard an open bracket. All patient results
associated with that bracket are discarded.
•
The button is enabled if there is a valid opening bracket.
•
The button is disabled if the system is processing control bracketed assays.
Automatically Discarding a Bracket
The ADVIA Centaur CP system automatically discards a bracket if any of the following
events occur.
NOTE: A warning message displays when a bracket it discarded.
•
Performing a maintenance procedure, either manually or automatically
•
Performing a diagnostics procedure
•
Scheduling a calibration for the reagent lot with a valid open bracket
•
Reagent calibration expires
•
Reagent Lot expires
•
Control Lot expires
•
Control results outside of the range specified by control definitions
•
Deleting a Master Curve definition for the reagent lot with an open control bracket
•
Deleting a control definition for an open control bracket
•
Deleting a calibrator definition for an open control bracket
•
Attempting to delete the results of any one of the active open control bracket results
Entering STAT Samples
When you load a sample scheduled as STAT in the sample compartment, the system
processes the sample before routine samples.
NOTE: If a control bracket is in the process of being aspirated, a STAT sample will not
run until the closing bracket has completed aspirating.
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There are 3 options for designating a sample as STAT:
•
Define a single lane as a STAT lane. Any sample loaded in the defined lane is
automatically designated as STAT. The default STAT lane is lane 7.
Refer to Changing the Designated STAT Lane‚ page 6-32 for details.
•
Use the STAT button in the Loading area to designate a sample as STAT (or you can
select STAT in Batch Mode). To designate a sample as STAT, select the sample, and
then select the STAT button. The sample selection button changes to an orange color,
and the “smp” designation is followed by an asterisk.
This option is only available when the sample has the status of Pending.
•
Schedule the sample as STAT through the LIS.
Deleting Results and Scheduled Tests
To ensure optimal system performance, do not retain more than 50,000 results in the
database. If you need to keep a copy of your results, export your results before you delete
them.
Use this procedure to delete results. You must have the appropriate level of security to
delete results.
1. At the workspace, select Results.
2. Select the appropriate results tab.
3. Select a record.
You can select a range of records by holding the Ctrl key down as you select the range
of records you want with the mouse.
4. Select Delete.
5. Choose Selected Records, Older than 30 Days, All Records, or a Range of records by
assay, sample ID, date, interpretations, or status, and enter the from and to selections.
6. Select OK.
7. To return to the workspace, select Close.
Detailed descriptions of the selection criteria are available in the Screen Help section of
the online help system.
Editing Results
Use this procedure to edit a result. You must have the appropriate level of security to edit
results. You cannot edit results for Infectious Disease assays.
1. At the workspace, select Results.
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2. Select the appropriate sample results tab.
See the Results Tabs section of this chapter for more information.
3. Select a result.
4. Select Details.
5. Select Edit.
6. Select a replicate result.
7. Enter a new value for the replicate result.
8. Enter a reason for the change.
You must enter a reason for the change to the result, otherwise the change is not saved.
9. Select Change.
10. Select Save.
11. Select Close.
12. To return to the workspace, select Close.
Using Multicomponent Testing
A multicomponent test uses the results from one or more standard tests or off-system tests
in a formula to provide a calculated result. The standard tests and off-system tests that are
used to determine a multicomponent result are referred to as component tests of the
multicomponent test.
Scheduling Calibrations for a Multicomponent Test
Schedule calibrations individually for all the component tests of a multicomponent test.
Adding Control Definitions for a Multicomponent Test
For information about adding Control Definitions, see Adding a New Quality Control
Definition‚ page 3-23.
NOTE: When adding a definition for a Multicomponent Test, the definition must include
all the components and the multicomponent test in the same definition.
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Scheduling Controls for a Multicomponent Test
Schedule the multicomponent control manually or by using the LIS. The system
automatically runs the controls for the component tests as they are selected in the
multicomponent control definition. For more information about interpreting result flags,
see Screen Help.
Use this procedure to add the multicomponent controls to the worklist:
1. At the workspace, select Results.
The system displays the Today’s Results tab (the default).
2. Select Schedule Worklist.
3. Select the Control tab.
4. Select a multicomponent test.
NOTE: If any one component of the multicomponent test is disabled, then the
multicomponent test is disabled.
5. When the controls display, select OK.
To return to the workspace, select Close.
Scheduling Patient Samples for Multicomponent Tests
Schedule patient samples for multicomponent tests using the following options:
•
Manually
•
LIS
•
As part of a test profile
•
As part of a batch
You can schedule the patient sample through a worklist or through the Sample
Compartment.
Scheduling a Multicomponent Test Using a Worklist
Use this procedure to schedule the multicomponent test for a patient sample from the
worklist:
1. At the workspace, select Results.
The system displays the Today’s Results tab (the default).
2. Select Schedule Worklist.
3. Select the Patient tab and enter patient information.
4. Select the multicomponent test.
NOTE: The system automatically schedules the component tests for the selected
multicomponent test.
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5. Select OK.
The system processes the samples. All the component tests must result within the time
limit.
NOTE: If you select all components of a multicomponent test, and 1 component does
not run within the time limit, the multicomponent result will not calculate and provide
a multicomponent test result. The individual components will result.
Scheduling a Multicomponent Test Through the Sample Compartment
Use this procedure to schedule the multicomponent test for a patient sample through the
sample compartment:
1. At the workspace, select the sample compartment.
2. Select the appropriate sample rack.
3. Select the Sample ID field.
The samples are numbered 1 to 12. Number 1 is the sample at the back of the sample
compartment, and number 12 is the sample at the front of the sample compartment.
4. If no barcode is on the sample tube, select the sample type by toggling the sample
selection button.
The default is a routine patient sample smp.
Samples loaded into the STAT lane are automatically designated as STAT samples.
You can also designate a sample as STAT by selecting the STAT button.
5. If no barcode label is on the sample tube, enter the SID.
NOTE: If the system cannot detect a sample tube, the sample position is grayed out
and the SID cannot be entered. Remove the rack and ensure that a tube is in the
position. Reinsert the rack.
It is not necessary to press Enter after entering the ID.
You can enter the sample ID manually or using the hand-held barcode scanner.
If entering SIDs manually adhere to the following restrictions:
•
You can enter up to 17 alphanumeric characters for the sample ID.
NOTE: If you are sending Sample ID to the LIS, the LIS truncates the SID after
13 characters.
•
Use uppercase letters for SID entries that are downloaded by the CentraLink or
the LIS. SIDs containing lowercase letters are not recognized and remain pending.
•
Do not use the % symbol as part of the sample ID.
•
You can set the minimum and maximum sample ID for your laboratory. For
additional information, refer to Setting Minimum and Maximum Sample ID
Lengths‚ page 6-39.
NOTE: Review the SID entry thoroughly before you continue on to the next sample
field. Once you leave the sample field, you cannot go back and make a correction.
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To correct an error in the SID entry, remove the sample rack from the system. Re-load
the rack, re-enter the SID, the test selection, dilutions and replicates for the sample
you are correcting. If necessary, re-enter the SIDs for the other samples in the rack.
The workorder information is secure for the other samples.
6. Select the multicomponent test to process the sample.
NOTE: You must select at least 1 test request.
7. Select Close.
If you select all components of a multicomponent test, and 1 component does not run
within the time limit, the multicomponent result will not calculate and provide a
multicomponent test result. The individual components will result.
Cancelling a Multicomponent Test Using the LIS
If you cancel a multicomponent test using the LIS, the system automatically cancels all the
component tests. You cannot cancel a component test individually if it is scheduled as part
of a multicomponent test.
If a component test is ordered individually, you can cancel the component test
individually.
Rerunning a Multicomponent Test
The system verifies the result time limits for all the components of a multicomponent test
before the system calculates the multicomponent test results. You can rerun a
multicomponent test with 8 hours. If a component exceeds the time limit, the system does
not calculate the multicomponent test result. Repeat the component test that exceeded the
time limit and then rerun the multicomponent test.
To manually schedule a rerun for a completed multicomponent test, you choose 1 of 2
procedures:
Procedure 1
1. At the workspace, select Results.
The system displays the Today’s Results tab (the default).
2. Select the appropriate Results tab.
See the Results Tabs‚ page 2-65 for more information.
3. Select the SID you want to rerun.
Verify that the samples are on the system or place the sample test tubes in a sample
rack and put the rack in the sample compartment.
4. Select Details.
5. Select Rerun All.
6. To return to the workspace, select Close.
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Procedure 2
1. At the workspace, select Results.
The system displays the Today’s Results tab (the default).
2. Select the appropriate Results tab.
See the Results Tabs‚ page 2-65 for more information.
3. Select the SID you want to rerun.
Verify that the samples are on the system or place the sample test tubes in a sample
rack and put the rack in the sample compartment.
4. Select Rerun.
5. Select OK.
Repeating a Multicomponent Test
If a component result of a multicomponent test exceeds the result time limit or is flagged
with an error, the system does not calculate the multicomponent test result.
To repeat the multicomponent test when one or more of the component test results exceeds
the time limit, follow this procedure:
1. At the Workspace, select Results.
2. Select the SID to repeat.
3. Select Details.
4. Select Repeat.
Calculating the Multicomponent Result and Reporting an
Interpretation
The following sections contain information regarding the calculation and interpretation of
a multicomponent result. The system uses additional criteria to calculate and interpret the
multicomponent result than existing ADVIA Centaur CP assays.
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Calculating the Multicomponent Result
The system calculates a multicomponent test result if the results of the component tests are
within the reportable dose limits.
The system also calculates a multicomponent test result according to these additional
conditions:
If . . .
And . . .
The system . . .
the result of a component
test is above the highest
limit of the component
assay’s reportable dose,
no other component
results are below the
lowest limit of their
reportable doses,
uses the highest
reportable dose limit
value in the formula to
calculate the
multicomponent result.
the result of a component
test is below the lowest
limit of the component
assay’s reportable dose,
no other component
results are above the
highest limit of their
reportable doses,
the result of a component
test is within the
component assay’s
reportable dose range,
one or more of the
component results are
lower or higher than the
linearity range,
uses the lowest reportable
dose limit value in the
formula to calculate the
multicomponent result.
• reports < or >
Linearity Range for
the component result
• uses the component
test result to calculate
the multicomponent
result.
NOTE: When manually calculating the multicomponent result, use the
manufacturer-recommended linearity value. If you do not use the
manufacturer-recommended linearity value, the multicomponent result may not match the
system calculation.
The system does not calculate a multicomponent test result according to these conditions:
If . . .
And . . .
The system . . .
the result of a component
test is above the highest
limit of the component
assay’s reportable dose,
one or more of the other
component results are
below the lowest limit of
their reportable doses,
does not calculate a
multicomponent result.
the result of a component
test is below the lowest
limit of the component
assay’s reportable dose,
one or more of the
component results are
above the highest limit of
their reportable doses,
does not calculate a
multicomponent result.
For more information about calculating a multicomponent result see Multicomponent
Tests‚ page 6-37.
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Interpreting the Multicomponent Result
The system determines an interpretation for the multicomponent result if the results of the
component tests are within the reportable dose limits.
An example of an interpretation range can be either of the following:
•
None to mild
•
Moderate
•
Severe
The system also assigns interpretations and reports results for the multicomponent test
according to these conditions:
If . . .
the result of a component test is above
the highest limit of the component
assay’s reportable dose, and the
multicomponent result is greater than or
equal to the lowest value of the most
severe interpretation range limit,
the result of a component test is below
the lowest limit of the component
assay’s reportable dose, and the
multicomponent result is less than the
highest value of the least severe
interpretation range limit,
The system . . .
• reports the results as > the lowest
value of the most severe
interpretation range limit
• assigns the most severe
interpretation
•
•
reports the results as < the highest
value of the least severe
interpretation range limit
assigns the least severe
interpretation
The user-defined interpretations are not used for the multicomponent result when the
component test results are higher or lower than the component assay ranges. The
maufacturer-defined interpretations are used.
Examples of Multicomponent Test Results for Component Test Results Outside the
Reportable Dose Range
Two examples of multicomponent test results when one or more of the component test
results are outside the reportable dose range for a multicomponent assay, XYZ, are as
follows:
a. Example: The result of the XA test, a component of the XYZ test, is less than the
lowest reportable dose limit for the XA test, 1.6 ng/ml. The system reports the XA
test result as < 1.6 ng/ml and uses 1.6 ng/ml to calculate an XYZ result.
The highest value of the least severe interpretation range limit for the XYZ test is
7.7. If the XYZ result is less than 7.7, the system reports the XYZ test result as
< 7.7 and assigns an interpretation of None to Mild.
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b. Example: The result of the XA test, a component of the XYZ test, is greater than
the highest reportable dose limit for the XA test, 1000 ng/ml. The system reports
the XA test result as > 1000 ng/ml and uses 1000 ng/ml to calculate an XYZ
multicomponent result.
The lowest value of the most severe interpretation range limit for the XYZ test
is 9.8. If the XYZ result is greater than 9.8, the system reports the results as > 9.8
and assigns an interpretation of Severe.
The system does not assign interpretations and does not report results for the
multicomponent test according to these conditions:
If . . .
the result of a component test is below
the lowest limit of the component
assay’s reportable dose, and the other
components results are above reportable
dose,
The system . . .
• reports Error
• assigns No calculation flag
• Interpretation fields are blank (no
interpretation)
one or more of the component test
results are higher than the highest limit
of the component assays’ reportable
dose, and one or more of the component
results are lower than the lowest limit of
their reportable doses,
•
•
•
reports Error
assigns No interpretation flag
Interpretation fields are blank (no
interpretation)
the results of a component test is above
the highest limit of the component
assay’s reportable dose, and the
multicomponent result is not greater
than or equal to the lowest value of the
most severe interpretation range limit,
•
•
•
reports Error
assigns No interpretation flag
Interpretation fields are blank (no
interpretation)
the component results are out of range
multicomponent test result is in range
•
•
reports Error
displays No interpretation in the
flag field
Interpretation fields are blank (no
interpretation)
reports lowest interpretation cutoff.
•
the results of all the component tests and
the multicomponent test is below the
highest limit of the component assay’s
reportable dose,
•
NOTE: If the multicomponent test flag is No interpretation, results are not sent to the LIS
and an event message will post to the x.
For more information about interpreting result flags, see the Screen Help.
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Printing on Your Local Printer
If you have a printer connected to the ADVIA Centaur CP system, you can print screens,
print reports, or automatically print results for samples that are being processed.
Printing a Screen
Use this procedure to print the contents of your workspace.
To print. . .
Then
the entire workspace,
press Ctrl+Prt Scr.
a selected area,
1. Select the area.
2. Press Ctrl+P.
Printing Results
Use this procedure to print results. You can print results from any of the Results screen.
1. At the workspace, select Results.
2. Select the appropriate results tab.
3. Select a sample ID or a range of sample IDs.
To select a range of records, hold the Ctrl key down as you select the range of records
you want to print with the mouse.
4. Select Print.
From the Selection area of the Print Results screen, you can choose Selected Record,
Today’s Records, All Records, or Range (of records).
If you choose to print a range of records, you can print by one of the following criteria:
Sample ID, Assay, Date, Interpretations, Status, or RunID.
Enter a date range indicating From: and To: to select a range of records to print.
You can choose to print one of the predefined reports from the Reports area of the
Print Result screen, for example, Summary with RLUs or Pending Results.
5. Select OK.
The records or predefined report prints on your default printer.
Automating the Printing of Results
If you need to print results as you process samples, use the following procedure.
1. At the workspace, select Setup.
2. Select the System tab.
3. At the System screen, for Runtime Reports, select On.
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4. Select Save.
As the system processes samples, when 8 samples have processed, a report of those
samples automatically prints on your local printer. When the system returns to the
Ready state, the last results of the sample run print on the last page of the report, even
if there are fewer than 7 records.
NOTE: Runtime reports may fail to contain 7 results per page if line wrapping is
caused by long patient names.
When the last result is the component of a ratio result, that last page prints a second
time. Review the Runtime Report carefully to ensure that the report contains a single
listing of the results.
If you need to print results before the system has processed 7 records, you can select
Force Printout from any of the Print windows available from the Results tabs. The
system prints the last page with whatever results are complete at that time.
The Force Printout option is available to you only if you have used the procedure
described above.
Recalling Sample IDs
Entering Sample IDs not Captured by the Barcode Reader
Use this procedure to recall the sample IDs loaded on the last rack of samples that was
removed from the system (for example, if the rack was removed to manually enter
unreadable barcodes). Selecting the Recall button displays the list of sample IDs for the
last rack removed and allows you to enter the SID of the sample tube whose barcode could
not be read.
Information scanned by the system is always preferred over that entered manually. For
example:
The system then reads the barcode correctly the second time around. The information read
by the system is kept, and the information you entered is discarded. If the barcode could
not be read the second time around, the system retains the information you entered.
1. If the sample compartment window is open and the green LED is not on, remove the
sample rack from the system.
2. Select Recall.
The lane indicator focuses on the lane where the last rack was removed.
The Recall window opens. Any sample IDs that were scanned or entered for the last
rack removed displays.
3. Enter any missing IDs in the appropriate field.
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4. Replace the sample rack.
The Recall window automatically closes. The information entered merges with the old
and new scans.
5. Close the sample compartment door.
Entering Patient Demographic Information
Entering patient demographic information is optional. You can enter or update patient
demographic information at the following times:
•
as you schedule samples in the worklist
•
as you schedule samples through the Sample Compartment screen
•
after you create the worklist
•
while samples are processing
The system displays the date when the last update to the patient demographic information
occurred. From the Results Details screen, view the Demographics area to see when the
information was updated (displayed as date and time).
Entering Patient Demographic Information Through the
Worklist
When you have a recurring need to access patient demographic information, use of a PID
(patient ID) reduces the possibility of data entry errors for sample orders you enter
manually.
Use this procedure to enter patient demographic information through the worklist.
1. At the workspace, select Results.
The system displays the Today’s Results tab (the default).
2. Select Schedule Worklist.
3. Enter the sample ID (SID), or scan the barcoded SID with the hand-held barcode
scanner.
4. Enter a patient ID (PID).
If you do not enter a PID, then the next time you make an entry for this patient, the
system does not recall the demographic information for this patient.
If you enter an existing PID, the system queries, “Is this the correct patient?” If the
patient demographics already exist for that PID in the system and you answered YES,
then the data fields fill in automatically.
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5. If no match is in the system, enter the patient information, and then select OK (if this
is the only entry you want to make at this time) or Next (if you want to make
additional entries).
NOTE: You must select at least one test for the patient.
NOTE: If the demographic information originated from the LIS, then you cannot edit
that information. If the demographic information was entered into the system
manually, then you can edit it.
You can enter comments for a patient sample, such as, “the serum is hemolyzed” or
“the patient is non-fasting.”
Entering Patient Demographic Information Through the
Sample Compartment
Use this procedure to enter patient demographic information through the Sample
Compartment screen.
1. At the workspace, select the sample compartment.
2. Select a sample rack.
3. Select a sample ID or enter a new sample ID.
4. Select the Patient button.
5. Enter the demographic information.
See the Screen Help section of the online help system for details.
6. Select OK.
7. Select Close.
Start Sampling
When all samples are pending, and necessary information is entered in the system, you can
begin sampling.
1. At the workspace, select Start.
NOTE: Refer to Signing In to the System‚ page 2-3 for additional messages and
conditions for starting the system.
2. Select OK.
The status for all samples loaded on the system with workorders changes from Pending to
In process. This schedules a place in the ring and provides a time when the result will
complete in the Pending Results tab. See the Screen Help section of the online help system
for details.
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If a STAT sample is in any of the new racks inserted into the system, then the system resets
all sample priorities when you add additional samples to the sample compartment.
Existing samples that are not processed may be assigned a new result time. This ensures
that new STAT samples are given top priority.
Processing Samples in Batch Mode
When scheduling patient samples in batch mode, you cannot have calibrators on that same
rack. Do not schedule calibrations in batch mode. If you have controls on a rack, you
cannot schedule replicates, dilutions, or STATs in the batch mode for that rack.
To enable batch orders for multiple racks, use the following procedure:
1. Put the racks into the sample compartment.
2. At the Sample Compartment screen, select Enable Batch Mode.
3. Select the rack from positions 1-7, and select the test or tests for that rack.
4. Continue to select racks and select the test or tests for the rack until you have selected
all the racks you want to process in batch mode.
5. Select Close.
6. Select Start.
Managing Results
Select the Results button to view the results display tabs. See the Screen Help section of
the online help system for details.
The following procedures use the Results button on the workspace to manage test results.
Results Tabs
Select the following tabs from the Results screen to view sample results, calibration lots,
and control samples.
Sample Results Tabs
•
Pending - Select the Pending tab to view the samples that are in process or waiting to
be processed on the system.
•
Today’s - Select the Today’s tab to view the samples for the current date.
•
STATs - Select the STATs tab to view samples you designated as urgent.
•
Reruns - Select the Reruns tab to view the samples that are still in the sample
compartment and require reprocessing.
•
Historical - Select the Historical tab to view all samples from previous days.
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Calibration Tabs
•
Current Calibrations - Select the Current Calibrations tab to view the current
calibration for the reagents that are on the system.
•
All Calibrations - Select the All Calibrations tab to view all calibrations.
Control Samples Tab
•
Quality Control - Select the Quality Control tab to access the ADVIA QC.
•
Brackets - Select the Brackets tab to access the status of control bracketed patient
worklist entries.
Viewing Workorders from the LIS
To view workorders received from the LIS, use the Pending tab on the Results screen, or
after you load the racks into the Sample Compartment, select Start, wait a short time, and
then view the Sample Compartment screen when the system displays the status,
“Running.”
Viewing Result Summaries
Use this procedure to view a summary of all sample, calibration, and QC results, such as
results, RLUs, and flags. You can also access various result management functions from
this window.
1. At the workspace, select Results.
The system displays the Today’s Results tab (the default).
2. Select the appropriate results tab.
A list of results displays. Associated status flags also display. See the Screen Help
section of the online help system for a full list of flags.
NOTE: The multicomponent result displays with the multicomponent score as well as the
standard results for the component assays.
Viewing Result Details
Use this procedure to view result details.
1. At the workspace, select Results.
The system displays the Today’s Results tab (the default).
2. Select the appropriate results tab.
3. Select a record.
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4. Select Details.
5. Select Close.
Detailed descriptions of the information provided are available in the Screen Help section
of the online help system.
Viewing (Filtering) Results
Use this procedure to view only results that meet selected criteria.
1. At the workspace, select Results.
The system displays the Today’s Results tab (the default).
2. Select the appropriate sample results tab.
See the Results Tabs section of this chapter for more information.
3. Select View.
4. Select a filter criteria.
5. Select OK.
Detailed descriptions of the selection criteria are available in the Screen Help section of
the online help system.
Viewing Pending Control Bracketed Results
View pending control bracketed results in the Results - Bracketing window.
1. At the workspace, select Results.
The system displays the Today’s Results tab (the default).
2. Select the Brackets tab.
3. Select a record.
4. Select Details.
5. Select Close.
Detailed descriptions of the information provided are available in the Screen Help section
of the online help system.
For additional information on control-bracketing, refer to Scheduling a Control Bracketed
Patient Sample‚ page 2-49.
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Moving Results to the Historical Tab
Select the Move to Historical button to transfer the selected records to the Historical tab.
This button is available on the Today’s tab. You can transfer the selected records, a range
of records, or all records.
Use this procedure to move sample results to the Historical tab:
1. At the workspace, select Results.
The system displays the Today’s Results tab (the default).
2. If the Today’s tab is not displayed, select the Today’s tab.
3. Select Move to Historical.
There are 3 options for transferring records: Selected Records, Range, or All.
By default, the selected records option is selected. Those records that you selected on
the Today’s tab are the records that are moved.
If you select a range of records, in the Records found area of the Move to Historical
window, in the By pulldown field, select one of the following:
•
By Date
•
Sample ID
•
Assay
•
Interpretations
•
Status
•
Run ID
NOTE: Only completed or failed sample results can be moved to the Historical tab.
4. Select OK.
5. To confirm that your selected results moved, select the Historical tab.
Confirm that the records that you selected were moved.
6. Select Close.
Printing Results
Use this procedure to print a summary of all or selected results, or details of all or selected
results. Results are printed to the default printer assigned to the system.
1. At the workspace, select Results.
The system displays the Today’s Results tab (the default).
2. Select the appropriate results tab.
3. Select a record (or multiple records).
4. Select Print.
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5. Choose one of the selection options and choose a report.
A variety of report types are available to you. Choose a summary or detail report.
•
If you choose any of the consolidated summary reports, the system consolidates
results by SID.
•
If you choose a consolidated summary report, and if PIDs are used, the system
consolidates by PID first, and then by SID.
6. Select OK.
7. To return to the workspace, select Close.
Detailed descriptions of the selection criteria and report types are available in the Screen
Help section of the online help system.
Deleting Results and Scheduled Tests
CAUTION
Do not delete results while the system is in process. If you use the delete option when the
system is in process, the system software may lock up. Ensure the sytem is in the Ready
state before you use the delete option.
Do not delete any of the following while the system is processing samples:
•
Patient results or workorders
•
Control results or workorders
•
Assay definitions
•
Maintenance
•
Profiles
•
Physicians
•
Users
Before you begin, ensure that you inserted a blank CD or a Read/Write CD that you want
to overwrite into the CD drive and closed the drive.
Use this procedure to delete results. You must have the appropriate level of security to
delete results.
1. Ensure the system is in the Ready state.
2. At the workspace, select Results.
The system displays the Today’s Results tab (the default).
3. Select the appropriate results tab.
4. Select a record.
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5. Select Delete.
6. Select OK.
7. To return to the workspace, select Close.
Detailed descriptions of the selection criteria are available in the Screen Help section of
the online help system.
Exporting Results
CAUTION
Do not export results or logs while the system is in process. If you export results or logs
when the system is in process, the system software may lock up. Ensure the system is in
the Ready state before you export results or logs.
Use this procedure to export results to an LIS or a file. ASTM and CSV formats are
available.
1. Ensure the system is in the Ready state.
2. At the workspace, select Results.
The system displays the Today’s Results tab (the default).
3. Select the appropriate sample results or control sample tab.
Refer to Results Tabs‚ page 2-65 for more information.
4. Select a record or a range of records.
5. Select Export.
6. Select either LIS or File.
7. If you are exporting to a file, enter the file location and the name of the file.
You can also use the File Location button to browse to the correct directory. We
recommend that you select D:\Archive\export\yourfilename. You can export results to
a CD. See the Screen Help section of the online help system for details.
8. Select Save.
9. Select OK.
10. To return to the workspace, select Close.
Detailed descriptions of the selection criteria are available in the Screen Help section of
the online help system.
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Exporting Results to a CD
CAUTION
Do not export results or logs while the system is in process. If you export results or logs
when the system is in process, the system software may lock up. Ensure the system is in
the Ready state before you export results or logs.
Use this procedure to export results to a CD.
1. At the workspace, select Results.
The system displays the Today’s Results tab (the default).
2. Select the appropriate sample results tab.
See the Results Tabs‚ page 2-65 in this chapter for more information.
3. Select a record or a range of records.
4. Insert a blank, writable CD into the drive or use a CD that you want to overwrite.
5. Select Export.
6. Select File.
7. Select Tab.
8. In the File location area, select your DVD/CD RW drive and enter a filename for the
data.
9. Select Save.
10. Select OK.
11. When the CD Writing Wizard displays, enter a name for the CD. Follow the CD
Writing Wizard prompts. Wait until Finished appears.
NOTE: Do not select the screen area outside the CD Writing Wizard window while
exporting. If you select the screen area while exporting, the wizard window is hidden.
When the CD completes, the CD automatically ejects.
Entering Comments for Patient Results
You can enter comments for a patient result, such as “the serum is hemolyzed” or “the
patient is non-fasting.”
1. At the workspace, select Results.
The system displays the Today’s Results tab (the default).
2. Select the appropriate sample results tab.
See the Results Tabs section of this chapter for more information.
3. Select a record.
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4. Select Details.
5. Select Comments.
6. In the Comments window, enter a comment.
You can enter up to 3 comments. Comments can contain up to 120 alphanumeric
characters. The system enters your user name and the date. You must sign into the
system with Level 2 permissions or higher to enter comments.
To enter comments for a sample, you must have manually entered patient
demographics for that sample.
7. Select Save.
8. Select Close.
Rerunning Patient Samples
Test repeats and reruns are scheduled before any other unaspirated tests. This can cause
the result time to change.
Automatically Scheduling a Rerun Test
When the Rerun button is active and you select it from any of the Results tabs, only those
patient samples with an assay that are not repeat replicates will rerun.
Automatically Scheduling a Rerun Test in the Event of an
Error
When your system is set up to repeat if a clot is detected or if a sample integrity error is
detected, the system automatically reschedules the sample test to repeat one time.
See Rerun a Sample if a Clot is Detected‚ page 6-36 or Rerun a Sample if a Sample
Integrity Error is Detected‚ page 6-36.
Manually Scheduling a Rerun Test
Use this procedure to manually schedule a repeat for a completed test. For information
about setting up automatic sample repeats, refer to Allowing Automatic Repeat and Reflex
of Samples‚ page 6-35.
1. At the workspace, select Results.
The system displays the Today’s Results tab (the default).
2. Select the appropriate Results tab.
See the Results Tabs‚ page 2-65 for more information.
3. Select the test or tests you want to rerun.
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4. Verify that the sample is on the system or place the sample test tube in a sample rack
and put it in the sample compartment.
5. Select Rerun.
6. Select OK.
7. To return to the workspace, select Close.
Releasing the Hold Status for a Result
If results are being held for review before being sent to the LIS, use this procedure to
release the hold status for a result. When the system releases the hold status for a result, it
automatically sends the result to an LIS if automatic transfer of results is defined for your
system.
1. At the workspace, select Results.
The system displays the Today’s Results tab (the default).
2. Select the appropriate sample results tab.
See the Results Tabs section of this chapter for more information.
3. Select the result you want to release.
4. Select Details.
5. Select Release.
6. Select Close.
7. To return to the workspace, select Close.
Releasing the Hold Status for a Ratio Result
If a ratio result is on hold and one of the component assays is also on hold, after you
release the hold on the ratio, the component assays is still on hold. Release the hold on the
ratio and the component assays separately. Refer to Releasing the Hold Status for a Result‚
page 2-73.
Editing Results
You must have the appropriate level of security to edit results. Use this procedure to edit a
result:
1. At the workspace, select Results.
The system displays the Today’s Results tab (the default).
2. Select the appropriate sample results tab.
See the Results Tabs section of this chapter for more information.
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3. Select a result.
4. Select Details.
5. Select Edit.
6. Select a result.
7. Enter a new value for the result.
8. Enter a reason for the change.
You must enter a reason why the result was changed.
9. Select Change.
10. Select Save.
11. Select Close.
12. To return to the workspace, select Close.
Entering an Offsystem Result
Use this procedure to enter the result for an offsystem test. Offsystem tests are handled in
the same way as system tests, and you must define and schedule before entering a result.
1. At the workspace, select Results.
The system displays the Today’s Results tab (the default).
2. Select the appropriate sample results tab.
See the Results Tabs section of this chapter for more information.
3. Select an offsystem test.
4. Select Details.
5. Select Edit.
6. Enter a value for the test result.
7. Enter a reason for the change.
8. Select Save.
9. Select Close.
10. To return to the workspace, select Close.
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Downloading Orders
Use this feature to download orders from the LIS:
1. At the workspace, select Results.
The system displays the Today’s Results tab (the default).
2. Select the appropriate sample results tab.
See the Results Tabs‚ page 2-65 section of this chapter for more information.
3. Select Download Orders.
Processing Failed Samples
If some of your samples fail, you must select the Rerun tab to view them. You should print
the pending results report before you remove the rack from the system. When the rack is
removed from the system, the list no longer displays.
Consolidate your patient samples for processing in a rack.
NOTE: If several of the pending tests are all for the same assay, verify that there is
sufficient reagent and confirm that a valid calibration exists for that assay. Ensure that you
look for a valid calibration in the Current Calibration and the All Calibration tabs.
Calibrate the assay if a valid calibration does not exist.
1. Insert the rack of samples for reprocessing, and select the failed samples.
2. Select Rerun. You do not have to select the pending samples, since they will
automatically rerun.
If the samples are in a new rack position and you rerun these samples, the new lane
position does not immediately display on the system. The change of position may not
display until you start the run.
Responding to Depleted Reagent Volume
If a reagent pack is empty and a Reagent Volume check error occurs for a sample, replace
the empty reagent pack with a pack from a lot with a valid calibration. The system
automatically reschedules the test.
NOTE: Do not remove the sample from the system when a Reagent Volume error occurs.
If the sample is removed from the system, the test has a Pending status.
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Moving Results to the Historical Tab
You can move results that are currently selected in a results window to the Historical tab.
Use this procedure to move selected results to the Historical tab:
1. At the workspace, select Results.
2. Select Today’s.
3. Select a single result, all the results listed on the display, or a range of results.
4. Select Move to Historical.
The system displays a window that displays your selections. You can confirm your
selection, modify the selection, or cancel.
5. Select OK.
6. To confirm that your selected results moved, select the Historical tab.
7. Confirm that your selected results moved.
8. Select Close.
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Calibration and Quality Control
Calibration Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
Master Curve Development . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
Two-point Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
Reference Serum Calibration for T Uptake. . . . . . . . . . . . . . . . . . . . . . . . . . .3-4
Calibration Evaluation Criteria . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4
Acceptable CV for the Low and High Calibrators . . . . . . . . . . . . . . . . . . . . .3-5
Ratio . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-5
Slope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-5
Low Cal and High Cal Deviation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-6
Defined Ranges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-6
Observed Ranges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-6
Retaining Calibrations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7
Autoexcluding Calibrator Replicates. . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9
Workflow to Process Calibrators . . . . . . . . . . . . . . . . . . . . . . . . 3-9
Scheduling Calibrators for a Control Bracketed Test . . . . . . . . . . . . . . . 3-9
Scheduling Calibrators for a Multicomponent Test . . . . . . . . . . . . . . . . 3-11
Entering Calibrator Information Manually . . . . . . . . . . . . . . . . . . . . . . . 3-11
Adding Calibrator Values. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-12
Adding a New Calibrator Definition. . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-12
Determining if an Assay Test Definition is Linked to
a Specific Calibrator Card . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-12
Using the Barcode Scanner . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-12
Using the Keyboard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-13
Verifying the Calibrator Reagent Code Matches the
Assay Test Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-13
Defining a Master Curve. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-13
Determining if an Assay Test Definition is Linked to
a Specific Master Curve Card . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-14
Using the Barcode Scanner . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-14
Using the Keyboard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-15
Verifying the Master Curve Reagent Code Matches
the Assay Test Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-15
Managing Calibration Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-15
Viewing Calibrations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-15
Viewing Calibration Result Summaries . . . . . . . . . . . . . . . . . . . . . . . . 3-16
Viewing Quality Controls by Status. . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-16
Viewing Calibration Result Details . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-17
Responding to a “HBs No Cal” Message . . . . . . . . . . . . . . . . . . . . . . . . . . .3-17
Viewing (Filtering) Calibration Results . . . . . . . . . . . . . . . . . . . . . . . . . 3-17
Printing Calibration Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-18
Excluding a Calibrator RLU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-18
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ADVIA Centaur CP Operator’s Guide: Contents
Waiving a Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-19
Accepting a Calibration that is in Verify State . . . . . . . . . . . . . . . . . . . . 3-20
Assigning a Calibration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-21
Quality Control Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-21
Workflow to Process Quality Control Samples . . . . . . . . . . . . . . . . . . . 3-22
Adding and Editing Quality Control Values . . . . . . . . . . . . . . . 3-23
Adding a New Quality Control Definition . . . . . . . . . . . . . . . . . . . . . . . 3-23
Editing a Quality Control Definition. . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-26
Deleting a Quality Control Definition. . . . . . . . . . . . . . . . . . . . . . . . . . . 3-26
Reloading a Quality Control Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-27
Running Automatically Scheduled Controls . . . . . . . . . . . . . . . . . . . . . . . . .3-27
Scheduling a Control from the Primary Reagent Window . . . 3-27
Defining a Control Definition for a Multicomponent Test. . . . . . . . . . . . 3-28
Scheduling Controls for Multicomponent Tests . . . . . . . . . . . . . . . . . . 3-28
Managing Quality Control Data . . . . . . . . . . . . . . . . . . . . . . . . . 3-28
Viewing Quality Control Summaries . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-28
Viewing Quality Control Details . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-29
Viewing (Filtering) Quality Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-29
Printing Quality Control. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-30
Deleting Quality Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-30
Exporting Quality Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-30
ADVIA QC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-31
086D0320-01, Rev. 04
3 Calibration and Quality Control
Calibration Overview
The ADVIA Centaur CP system uses a Master Curve and a two-point, operator-initiated
calibration to calibrate qualitative and quantitative assays. The Master Curve and the
two-point calibration method eliminate the need to measure a full standard curve or to
include a calibration each time the assay is performed. The exception to this is T-uptake,
which uses a single point of calibration.
Master Curve Development
The Master Curve is established by Siemens as part of the manufacturing process for each
assay lot number. Full standard curves are performed on lot numbers by measuring the
RLU response at multiple concentration levels. The standard concentrations and corrected
RLUs define the shape of the curve for a particular assay lot number.
Siemens uses reagents from a specific lot to generate a Master Curve by performing the
assay on standards of varying concentrations on multiple systems over several days. The
resulting standard curve determines the relationship between the defined analyte levels
and the RLUs. These concentrations and RLUs become the lot-specific Master Curve and
are provided as barcodes on the Master Curve card.
The Master Curve for a competitive assay has a negative slope, which indicates that the
analyte concentration is inversely proportional to the light emission in RLUs.
A
B
A
B
Light Emission (RLUs)
Analyte Concentration
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ADVIA Centaur CP Operator’s Guide: 3 Calibration and Quality Control
The Master Curve for a sandwich assay has a positive slope, which indicates that the
analyte concentration is directly proportional to the light emission in RLUs.
A
B
A
B
LIght Emission (RLUs)
Analyte Concentration
Two-point Calibration
To minimize instrument-to-instrument variability and variability due to environmental
factors and reagent age, a two-point calibration must be performed at regular intervals.
The calibration interval is assay-specific. Refer to the Assays section of the online help
system for assay-specific calibration intervals.
To perform a two-point calibration on the system, you process replicates for 2 calibrators
of known value. If the calibrators meet defined validity criteria, the system compares the
average RLUs for each calibrator to the Master Curve and determines a system-specific
formula. The system then adjusts the observed RLUs to the Master Curve according to this
formula:
adjusted RLUs = observed RLUs x defined slope + defined intercept
When patient samples or quality control samples are assayed using a quantitative assay,
the adjusted RLU value is matched to its corresponding analyte concentration using the
Master Curve.
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Qualitative assays have a cut-off point that remains constant for each lot number of
reagent. This cut-off is established during product development and is based on extensive
population studies. The antibody activity or analyte concentration associated with the
cut-off is assigned an index value of 1.0 for most assays.
NOTE: See the method IFUs for the assigned cut off values for the method.
A Master Curve consisting of 6 to 10 standards is based on the RLU relative to the cut-off.
The cut-off or index value is represented as a specific level on this Master Curve.
C
D
E
A
B
A
B
C
D
E
.
Frequency
Index
Nonreactive
Cutoff
Reactive
As with quantitative assays, the assay is calibrated using 2 calibrators of known value in
replicate. If the calibrators meet defined validity criteria, then the calibrator RLUs are
compared to the Master Curve and an instrument-specific correction formula is
determined. When patient or quality control samples are assayed, the RLUs read by the
system are adjusted by the formula derived from the 2 known calibrators. The sample
RLUs are compared to the calibration curve, and the RLU-associated index value is
determined, for example:
•
If the index value is greater or equal to 1.0, then the sample is considered as reactive to
the antibody or analyte tested.
•
If the index value is less than 1.0, then the sample is considered as nonreactive to the
antibody or analyte tested.
NOTE: See method-specific IFUs for the Interpretation of Results for that method.
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ADVIA Centaur CP Operator’s Guide: 3 Calibration and Quality Control
Reference Serum Calibration for T Uptake
The ADVIA Centaur CP T Uptake assay provides an indirect measure of the number of
unoccupied binding sites on thyroxine-binding proteins in a sample. In this assay, a direct
relationship exists between the RLUs detected by the system and the number of binding
sites available on the thyroxine-binding proteins. This results in a higher T Uptake ratio
when there are fewer free binding sites and a lower ratio when there are more free binding
sites.
The T Uptake Master Curve card provides only lot number and expiration date for the
assay reagents. A Master Curve is not necessary for the T Uptake assay because it is a
ratio test. The T Uptake assay compares the control and patient sample uptake results with
a euthyroid reference serum of known uptake, such as Calibrator A. The
ADVIA Centaur CP T Uptake assay uses Low Calibrator A as follows:
T Uptake Ratio = (Calibrator RLUs / Unknown RLUs) x reference serum factor
The reference serum factor is printed on the Calibrator Assigned Value card provided with
Calibrator A.
To report results as % T Uptake, the ADVIA Centaur CP system requires
a% T Uptake reference (normal) range. The system multiplies the T Uptake ratio by the
midpoint of the % T Uptake reference range to obtain % T Uptake results.
For example, if the % T Uptake reference range is defined as 25 to 35% (midpoint of 30)
and a sample has a T Uptake ratio of 0.82, the system calculates the % T Uptake as
follows:
0.82 x 30 = 24.6%
The system reports 24.6% as the % T Uptake.
Calibration Evaluation Criteria
The ADVIA Centaur CP system evaluates a calibration using values you enter from the
Master Curve card when you define a Master Curve for a reagent lot. The Master Curve
definition includes the standard concentrations and related RLUs and target values used by
the system to evaluate calibration data. Target values (ranges) are defined for acceptable
CV, ratio, slope, and calibrator deviation. The system determines a valid calibration based
on whether the calibration data is within these defined ranges and system calculated
observed ranges.
You can review the calibration evaluation criteria on the Master Curve Definition Details
screen. The following information is available. Details are provided in the sections below.
•
Slope is a comparison of high and low calibrator RLUs to the Master Curve.
•
Ratio is a comparison of low and high calibrator RLUs.
•
The deviations are a measure of how well the high and the low calibrator RLUs fit the
Master Curve.
•
CV is the precision of the calibrator replicates based on RLUs.
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•
Acceptable CV is the maximum CV that is acceptable for a valid calibration.
•
Critical Precision is a value used by the system to determine whether an outlier is too
far out to be automatically excluded.
Refer to the Assays section of the online help system for information about using
Calibration Evaluation Ranges to perform assay troubleshooting.
Acceptable CV for the Low and High Calibrators
The percent coefficient of variation (CV) of the individual calibrator replicates must not
exceed a defined acceptable value. This is the first criterion that the system checks after
performing a calibration.
Ratio
For sandwich assays, the ratio is the quotient obtained by dividing the difference between
the mean RLU value of the high calibrator and the mean RLU value of the low calibrator
by the mean RLU value of the low calibrator.
Ratio = (High Cal Mean RLU - Low Cal Mean RLU) / Low Cal Mean RLU
For competitive assays, the ratio is the quotient obtained by dividing the difference
between the mean RLU value of the low calibrator and the mean RLU value of the high
calibrator by the mean RLU value of the high calibrator.
Ratio = (Low Cal Mean RLU - High Cal Mean RLU) / High Cal Mean RLU
Slope
The slope describes the relationship of the RLUs expected from the Master Curve data to
the measured calibrator RLUs.
Slope = (High Cal Expected RLU - Low Cal Expected RLU) / (High Cal Measured RLU - Low Cal
Measured RLU)
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ADVIA Centaur CP Operator’s Guide: 3 Calibration and Quality Control
Low Cal and High Cal Deviation
These values are a relative measure of the deviation of the average RLUs of the low
calibrator and the high calibrator from the Master Curve.
2
3
1
A
B
A
B
1
2
3
RLUs
Concentration
Low Cal Deviation
High Cal Deviation
Master Curve
Defined Ranges
The defined ranges are the values for Slope, Ratio, Low Cal Deviation, and High Cal
Deviation you enter from the Master Curve card when you define a Master Curve for a
reagent lot. These values are always used by the system to evaluate calibrations, even
when the system provides observed ranges. Because these ranges are reagent lot specific,
the relatively narrow limits of the ranges ensure quality calibration monitoring.
Observed Ranges
After performing four valid calibrations for a reagent lot and calibrator lot combination,
the system calculates observed ranges for Slope, Ratio, Low Cal Deviation, and High Cal
Deviation. When subsequent calibrations are performed using the same reagent lot and
calibrator lot combination, the results are compared to the defined ranges from the Master
Curve definition and also to the observed ranges determined by the system. The observed
ranges are recalculated with each valid calibration.
Whenever a new reagent lot or calibrator lot is used, observed ranges do not apply until
four new valid calibrations are performed for the new reagent lot and calibrator lot
combination and new observed ranges are established.
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Because the observed ranges are specific for your system, they are narrower than the
defined ranges and therefore increase the quality of calibration monitoring over the
defined ranges. Whenever a calibration is outside of the observed ranges but within the
defined ranges, the calibration can be accepted by the operator.
The following figure shows both defined and observed ranges.
7
A
5
B
1
2
4
3
6
B
8
A
A
B
1–4
5
6
7
8
Defined Range
Observed Range
The first four valid calibrations of a reagent lot and calibrator lot combination.
The system calculates observed ranges after the fourth valid calibration.
A valid calibration because it is within the observed range.
An invalid calibration because it is outside of the defined range.
An invalid calibration because it is outside of the observed range.
Retaining Calibrations
You can use the Retain Calibration feature to calculate patient and control results with a
previously valid calibration if the TDef allows you to retain calibrations. This reduces
unnecessary adjustments from calibration to calibration that can cause minor calibration
drift or trends.
The Retain Calibration feature is assay dependant. Some assays do not support this
feature. You can choose to retain calibration information for a particular assay during
system setup. Refer to Defining Calibration Options‚ page 6-19 for details.
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ADVIA Centaur CP Operator’s Guide: 3 Calibration and Quality Control
When you select the Retain Calibration option, for the first 3 calibrations of a reagent lot
and calibrator lot combination, the system gathers statistical data and uses these
calibrations, to calculate results. The system then checks the fourth and subsequent
calibrations, and if the new calibration is statistically the same as the third calibration, it
retains the third calibration to calculate results. The new calibration has the status of
“Done.” This indicates that the previous “Valid” calibration is the one the system is using
to calibrate the method.
If a next valid calibration is statistically different, it is marked as “valid” and used to
calculate the method. Subsequent calibrations are checked against the last “Valid”
calibration, and if they are statistically the same, are marked “Done.” The calibration
interval expiration date is based on the date of the new calibration.
When you change the reagent or calibrator lot, the process starts over with 3, new, valid
calibrations.
A
B
1
2
4
3
5
6
7
B
A
A Defined Range
B Observed Range
1–4 The first four valid calibrations of a reagent lot and calibrator lot combination. The system
calculates observed ranges after the fourth valid calibration.
5 A valid calibration that is not statistically different from the fourth calibration, so the fourth
calibration is retained and used to calculate results. The calibration interval expiration date
is based on the date of this (fifth) calibration, which has the status of “Done.”
6 A valid calibration that is statistically different from the fourth calibration, so data from this
calibration is used to calculate results and set the calibration interval expiration date.
7 A valid calibration that is not statistically different from the sixth calibration, so the sixth
calibration is retained and used to calculate results. The calibration interval expiration date
is based on the date of this (seventh) calibration, which has the status of “Done.”
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Autoexcluding Calibrator Replicates
When Autoexclude Replicates is selected during system setup, the system evaluates the
calibrator results for all replicates and excludes replicates based on Master Curve
definition and assay definition parameters. This feature is turned on by default for all
assays. To evaluate calibrator replicates, the system performs the following steps:
1. The system checks the CV of the replicates.
2. If the CV of the replicates exceeds the defined Acceptable CV, the system checks for
an outlier.
3. If the system finds an outlier (replicate causing the unacceptable CV), it then checks
the critical precision.
The critical precision is a value in the Master Curve definition used by the system to
determine whether an outlier is too far out to be excluded.
•
If the deviation of an outlier does not exceed the critical precision limit, the
system excludes it and re-evaluates the calibration criteria.
•
If the deviation of an outlier exceeds the critical precision limit, the system cannot
exclude the replicate and the calibration is invalid.
The system excludes as many replicates as needed to obtain a valid calibration; however,
the system ensures that the minimum number of replicates defined in the assay definition
is included in the calibration.
You can choose to exclude calibrator replicates for a particular assay during system setup.
Refer to Defining Calibration Options‚ page 6-19 for details.
Workflow to Process Calibrators
Scheduling Calibrators for a Control Bracketed Test
Do not run calibrators in the middle of processing a control bracketed test; otherwise, the
patient test results are discarded.
To schedule a calibrator for a control bracketed test.
Refer to Scheduling a Calibration‚ page 2-50 for further information.
Calibrate an assay in the following instances:
•
the calibration interval expires
•
a calibration is invalid
•
you use a new lot of assay reagents
•
controls are repeatedly out of range
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ADVIA Centaur CP Operator’s Guide: 3 Calibration and Quality Control
1. Enter the calibrator information provided on the ADVIA Centaur CP calibrator
assignment value card.
Ensure you use the ADVIA Centaur CP card. If you do not use the correct card, the
system does not accept the values. See Adding a New Calibrator Definition‚
page 3-12.
2. Enter the Master Curve information from the cards provided with the primary reagent
packs.
Ensure you use the ADVIA Centaur CP side of the card. If you use the incorrect side
of the card, the system will not accept the values. See Defining a Master Curve‚
page 3-13.
3. Attach the Siemens-supplied barcode labels to the pour-off tubes.
See Loading Samples into Sample Racks‚ page 2-33.
4. Load the low and high calibrators into appropriate sample pour-off tubes that
accommodate the Siemens-supplied barcode labels.
See Loading Samples into Sample Racks‚ page 2-33.
5. Load the sample tubes into a sample rack.
See Loading Samples into Sample Racks‚ page 2-33.
6. Load the rack in the sample compartment.
See Loading Sample Racks into the System‚ page 2-35.
7. On the Sample Compartment screen, select the lane containing the sample rack with
the calibration material.
8. Select each calibrator and confirm the calibrator information.
See Entering Calibrator Information Manually‚ page 3-11.
9. To return to the workspace, select Close.
10. At the workspace, select the Ancillary Reagent Compartment and confirm that the
required ancillary and wash packs are loaded.
11. Select the Primary Reagent button on the Ancillary Reagent Compartment window.
12. Select the assay to calibrate.
13. Select Calibrate.
The system automatically begins sampling the calibrator material.
NOTE: The Calibrate button is active on the Primary Reagent Screen in the following
situations, but the text is grayed out:
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•
no calibrators are defined
•
no Master Curves are defined
•
no reagent is onboard
ADVIA Centaur CP Operator’s Guide: 3 Calibration and Quality Control
•
the calibration material for defined lots is expired
•
no calibrator material is in the sample compartment
3-11
If the Calibrate button is not active, enter the information, load the reagent, load the
calibrator material, or prepare unexpired calibrator material.
14. To return to the workspace, select Close.
15. If needed, check the time due for the calibration:
a. At the workspace, select Results.
b. Select the Current Calibration tab to view the status and Time Due stamp for the
assay you are calibrating.
c. Select Close.
Scheduling Calibrators for a Multicomponent Test
Schedule the calibrators for all the component assays of a multicomponent test
individually.
Entering Calibrator Information Manually
Use this procedure to enter calibrator information if the barcode is not scanned by the
system.
1. On the Sample Compartment screen, select the lane containing the sample rack with
the calibration material.
2. For each calibrator, perform the following steps:
a. Select the low calibrator.
b. Enter the sample ID of the calibrator.
c. If the sample selection button is not set to cal, toggle the Sample Selection button
to cal.
The calibrator information displays.
d. Check that the information is correct, and the calibrator level is set to Low.
Calibrator information automatically displays, including assay and concentration
information. The calibrator SIDs are defined during calibration definition. See
Adding a New Calibrator Definition‚ page 3-12.
e. Repeat steps a to d for the high calibrator.
3. To return to the workspace, select Close.
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ADVIA Centaur CP Operator’s Guide: 3 Calibration and Quality Control
Adding Calibrator Values
Adding a New Calibrator Definition
Use this procedure to add a new calibrator definition. Each Calibrator Kit includes a
Calibrator Assigned Value card that provides the calibrator values for each analyte in the
low and high calibrators. This is a two-sided card. Ensure you use the ADVIA Centaur CP
card. If you use the incorrect card, the system does not accept the values. You can use the
barcode scanner or, if necessary, the keyboard to enter the calibrator values.
Certain assay test definitions contain a specific reagent code that links the test definition to
a specific Calibrator Assigned Value card. If an assay is linked with a specific reagent
code in the test definition, an additional calibration card is supplied in the calibrator kit.
Determining if an Assay Test Definition is Linked to a Specific
Calibrator Card
Follow this procedure to determine if an assay calibrator is linked to a specific Master
Curve card and test definition:
1. At the workspace, select Setup.
2. Select the Assay tab.
3. Select an assay and select Details.
4. If the number in the Reagent Code box in the Assay Details window is greater than 0,
the assay is linked to a specific test definition.
NOTE: When scanning or entering a calibrator that is linked to an assay test definition,
ensure that the reagent code in the test definition matches the reagent code on the
calibrator card. If the reagent code does not match the system will reject the calibration
card. The system issues an error message.
Using the Barcode Scanner
1. At the workspace, select Definition.
2. Select the Calibrators tab.
3. Select Scan.
NOTE: Verify that the caps lock on the keyboard is disabled.
4. Use the hand-held barcode scanner to scan the barcodes on the ADVIA Centaur CP
side of the Calibrator Assigned Value card.
Scan the barcodes from top to bottom of the Calibrator Assigned Value card. The Scan
Calibrator window closes, and the Details screen displays.
The system makes an audible tone with each line that is scanned from the card.
When complete, the Calibrator Details screen displays.
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5. Ensure that the calibrator values are correct.
6. Select Close.
Using the Keyboard
1. At the workspace, select Definition.
2. Select the Calibrators tab.
3. Select Add.
4. Enter the calibrator name, lot number, and expiration date.
5. Enter the checksum.
6. Enter the calibrator values from the ADVIA Centaur CP side of the Calibrator
Assigned Value card:
a. Select an assay.
b. Enter the low conc value and the high conc value.
c. Select Add.
d. Repeat steps a through c for each assay.
e. Select Save.
Verifying the Calibrator Reagent Code Matches the Assay Test
Definition
Use this procedure to verify that the calibrator reagent code entered matches the assay test
definition:
1. At the workspace, select Definition.
2. Select the Calibrators tab.
3. Select an assay and select Details.
4. Ensure that the number in the Reagent Code box in the Calibrator Details window
matches the reagent code in the test definition.
Defining a Master Curve
Use this procedure to add Master Curve information for each new lot number of reagent.
Each ADVIA Centaur CP assay kit includes a Master Curve card that lists the analyte
concentration and the RLUs for each Master Curve point. This is a two-sided card. Ensure
you use the ADVIA Centaur CP side of the card. If you use the incorrect side of the card,
the system does not accept the values. You can use the barcode scanner for data entry, or if
necessary, use the keyboard to define the Master Curve.
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Certain assay test definitions contain a specific reagent code that links the test definition to
a specific Master Curve card. If an assay is linked with a specific reagent code in the test
definition, an additional Master Curve card is supplied in the assay kit.
Determining if an Assay Test Definition is Linked to a Specific Master
Curve Card
Follow this procedure to determine Master Curve Card if an assay test definition is linked
to a specific master curve:
1. At the workspace, select Setup.
2. Select the Assay tab.
3. Select an assay and select Details.
4. If the number in the Reagent Code box in the Assay Details window is greater than 0,
the assay is linked to a specific test definition.
NOTE: When scanning or entering a Master Curve card that is linked to an assay test
definition, ensure that the reagent code in the test definition matches the reagent code on
the Master Curve card. If the reagent code does not match the system rejects the Master
Curve. The system issues an error message.
Using the Barcode Scanner
1. At the workspace, select Definition.
2. Select the Master Curves tab.
3. Select Scan.
4. Use the hand-held barcode scanner to scan the barcodes on the ADVIA Centaur CP
side of the Master Curve card.
Scan the barcodes from top to bottom of the Master Curve card.
CAUTION
Do not select the OK button on the Scan Master Curve window. This saves incomplete
data.
The Scan Master Curve window automatically closes when the barcodes are scanned
correctly.
If the Scan Master Curve window remains open, do not select OK. Select Cancel and
rescan the barcodes on the Master Curve card in order from top to bottom. Ensure that the
Caps Lock feature on the keyboard is disabled. Do not at any time select OK at this
window.
After the Scan Master Curve window closes automatically, the Master Curve Details
window displays with the information in the appropriate field.
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5. Ensure that the calibrator values are correct.
6. At the Master Curve Details window, select Close.
Using the Keyboard
1. At the workspace, select Definition.
2. Select the Master Curves tab.
3. Select Add.
4. Enter the Master Curve details from the values on the ADVIA Centaur CP side of
Master Curve card.
See the Screen Help section of the online help system for additional information.
5. Select Save.
Verifying the Master Curve Reagent Code Matches the Assay Test
Definition
Use this procedure to verify that the Master Curve reagent code entered matches the assay
test definition:
1. At the workspace, select Definition.
2. Select the Master Curves tab.
3. Select an assay and select Details.
4. Ensure that the number in the Reagent Code box in the Details field of the Master
Curve Details window matches the reagent code in the test definition.
Managing Calibration Data
Viewing Calibrations
To view calibrations by a range of calibrator lot numbers, you should enter only the last 2
digits of the numeric portion of the calibrator lot number. For example, to see a list of
CA31, enter only 31.
Perform the following steps to view calibrations by lot number.
1. At the workspace, select Results.
2. Select the Current Calibrations tab.
NOTE: After 5 days, invalid and expired calibrations are moved to All Calibrations.
3. Select View.
4. Select Range, and then select Cal Lot from the pull down menu.
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5. Enter the numeric portion of the calibration lot number.
6. Select OK.
Viewing Calibration Result Summaries
Use this procedure to view a summary of calibration results, such as replicate results and
status messages. You can also access a summary of the calibration status from the
Calibrations screen. Results and flags for individual calibrator results are available in the
main Results screen.
Refer to the Assays section of the online help system for information on using calibration
evaluation ranges during calibration troubleshooting.
•
You can review the status message associated with a calibration.
•
You can view the calibration used to calculate results or the calibration used to set the
expiration date.
1. At the workspace, select Results.
2. Select the Current Calibrations tab.
NOTE: If a current calibration is invalid, check the All Calibrations tab to verify that
the tests are running against a valid calibrator that is not expired but had been run
earlier.
A list of calibration results displays. A number of calibration status flags may be shown.
Refer to the Screen Help section of the online help system for a full list of flags.
Viewing Quality Controls by Status
To view (filter) quality control results by status, perform the following steps:
1. At the workspace, select Results.
2. Select Quality Control.
3. Select View.
4. Select Range.
5. From the Range pulldown menu, select QC Status.
6. In the From field, enter one of the following options:
a. For “in” range results, enter either 1 or OK.
b. For “out” of range results, enter 0 or >2SD.
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7. In the To field, enter one of the following options:
a. For “in” range results, enter either 1 or OK.
b. For “out” of range results, enter 0 or >2SD.
8. Select OK.
Viewing Calibration Result Details
Use this procedure to view calibration result details.
1. At the workspace, select Results.
2. Select the Current Calibrations tab.
3. Select a calibration.
4. Select Details.
Result details are described in the Screen Help section of the online help system.
Responding to a “HBs No Cal” Message
If a patient sample is HBsAg reactive and qualifies for a confirmatory test, but the HBsAg
Confirmatory assay is not calibrated or HBsAg Confirmatory Rgt A and Rgt B reagents
are not on board, the system displays the message “HBs No Cal” in the Shortage Status
window even though a valid HBsAg assay calibration exists.
Ensure that all reagents, including Rgt A and Rgt B are on board the system. Verify the
status of the HBsAg Confirmatory assay calibration by selecting Results > Current
Calibration. If a valid HBsAg Confirmatory assay calibration does not exist on the system,
calibrate the HBsAg Confirmatory assay.
Viewing (Filtering) Calibration Results
Use this procedure to view only calibration results that meet selected criteria.
1. At the workspace, select Results.
2. Select the Current Calibrations tab.
3. Select View.
4. Select filter criteria.
5. Select OK.
A variety of selection criteria are available. See the Screen Help section of the online help
system for details.
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Printing Calibration Results
Use this procedure to print a summary of all or selected calibrations, or details of all or
selected calibrations. Calibrations are printed to the default printer assigned to the system.
1. At the workspace, select Results.
2. Select the Current Calibrations tab.
3. Select a calibration.
4. Select Print.
5. Select a report type (for example, Calibration Summary or Calibration Details).
6. Select OK.
7. Select Close to return to the workspace.
A variety of selection criteria and report types are available. See the Screen Help section
of the online help system for details.
Excluding a Calibrator RLU
If the calibration data is outside the Calibration Acceptance Criteria range and is not
accepted by the system, you can exclude one or more RLU replicates to bring the data into
range and achieve a valid calibration.
Use this procedure to manually exclude calibrator RLUs. You can only exclude RLUs for
calibrators that are invalid or in verify mode. You cannot exclude RLUs for valid
calibrations.
The system automatically recalculates the calibration data and rechecks the calibration
criteria. You can exclude RLUs only if there are more replicate results than the minimum
number of replicates defined in the assay definition. You may need to investigate further to
determine the cause of the outlier. The system autoexcludes calibrator RLUs by default, or
you can manually exclude them.
To set manual exclusion of RLUs, refer to Modifying Calculation Options for an Assay‚
page 6-18. You can manually exclude calibrator RLUs if Autoexclude Cal Replicates is
not selected in Setup and you have the appropriate level of security.
1. At the workspace, select Results.
2. Select the All Calibrations tab.
3. Select a calibration.
Look for the calibration with an Invalid status.
4. Select Details.
5. Review the calibrator RLUs.
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6. Select the calibrator RLU to be excluded in the table.
The table must have at least 2 values. If less than 2 valid values are in the table and
you select one, the system displays a message saying that you cannot exclude that
value. If 3 values are in the table, you can exclude one, and the system recalculates the
results.
An exclamation point (!) displays next to the excluded RLU, and the system
automatically recalculates all results.
7. If required, you can select the excluded RLU to reinclude an excluded calibrator RLU
in the calibration.
8. Select Close.
9. To return to the workspace, select Close.
Waiving a Calibration
CAUTION
Do not waive calibrations unnecessarily. Waiving Calibrations repeatedly may cause
misreported results.
In the event that a calibration expires while you are processing samples, rather than losing
your tests and materials, you can use this procedure to extend the interval for the expired
calibration. This allows you to recalibrate the assay. The waived calibration is good for 24
hours, which should be sufficient time to complete the testing.
The system calculates results for the samples and displays the results for the assay as
Waived.
You must have the appropriate level of security to waive a calibration and the ability to
waive calibrations must be defined in Assay > Details. For more information, refer to
Defining Calibration Options‚ page 6-19. Results are flagged as Reagent Expired if the
shelf stability has expired and the shelf stability setting in Assay > Details is set to Use
Beyond.
NOTE: Results are no longer flagged as Reagent Expired if the onboard stability (OBS)
has expired and the OBS setting in Assay > Details is set to Use Beyond. It is your
laboratory’s responsibility to monitor the OBS of your reagents if you set the OBS to Use
Beyond.
NOTE: Modify the reagent stability option to use the reagents beyond the opened or
onboard stability date if Siemens notifies you of a lot-specific date or obsolete extension.
Follow this procedure to extend the interval for the expired calibration:
1. At the workspace, select Setup.
2. Select the assay.
3. Select Details.
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4. Select Reagents.
5. Select the Use Beyond option for the primary reagent.
6. Select Save.
7. In the Assay Details window, select Calculation.
8. Select Calibration.
9. Select the Waive Calibration field box.
10. Select OK in the Calibration window.
11. Select OK in the Calculation window.
12. Select Save in the Assay Details window.
13. To return to the workspace, select Close.
Accepting a Calibration that is in Verify State
You can accept a calibration that falls outside of the observed range but is within the
defined range. The system calculates results for the samples and displays the results for
the assay as Cal Accepted. You must have the appropriate level of security to accept a
calibration in the verify state and the Accept Calibration option must be selected for the
assay in system setup. Refer to Defining Calibration Options‚ page 6-19 for additional
information on assay definition.
NOTE: Every result generated with an accepted calibration is flagged “Calibration
Accepted.”
1. At the workspace, select Results.
2. Select the Current Calibrations tab.
3. Select a calibration with the status “Verify.”
4. Select Details.
5. Select Accept Calibration.
6. Select Close.
7. To return to the workspace, select Close.
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Assigning a Calibration
Use this procedure to assign the next valid calibration to samples processed when no
calibration exists. The system calculates results for the samples and displays the results for
the test with a Cal Assigned flag. You must have the appropriate level of security to assign
a calibration to results and the Assign Calibration option must be selected for the assay in
assay setup. Refer to Defining Calibration Options‚ page 6-19 for additional information
on assay definition.
NOTE: If no valid calibration is on the system and you run patient samples, you must run
a valid calibration and assign it to samples within 5 hours of processing the samples.
1. At the workspace, select Results.
2. Select the Current Calibrations tab.
3. Select the most recent valid calibration for the assay.
4. Select Details.
5. Select Assign Calibration.
The system searches for RLU only results.
6. On the confirmation window, select OK.
7. Select Close.
8. To return to the workspace, select Close.
Quality Control Overview
The ADVIA Centaur CP system quality control features help you maintain comprehensive
records for your quality control program. The ADVIA Centaur CP system also interfaces
with the ADVIA QC software to help you identify shifts or trends that can indicate
changes in system, assay, or quality control material performance.
The ADVIA Centaur CP system maintains the following quality control statistics:
Parameter
Description
Mean
the mean of the included data point results
2SD
2 standard deviations for the data
CV
the percent coefficient of variation for the data
Low Limit
the lower limit of the control range
High Limit
the upper limit of the control range
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The ADVIA Centaur CP system has the data storage capability to:
•
define 300 controls
•
define 50 assays per control
For example, for Ligand Plus 1 you can define 50 assays including TSH-3, TSH, T3,
T4, FT3, FrT4, and TUp.
Quality control for quantitative assays monitors the reporting range for each assay,
including the medical decision points. It is recommended that you evaluate each new lot of
quality control material before placing the material into routine use.
NOTE: You can set up the ADVIA QC to monitor quality control using Westgard Rules.
Although qualitative assays have one medical decision point, qualitative assays on the
ADVIA Centaur CP system have a value associated with every result. The goals of quality
control for qualitative assays are to maximize accuracy, sensitivity, and specificity:
•
maximizing accuracy minimizes false positives and false negatives
•
maximizing sensitivity minimizes false negatives
•
maximizing specificity minimizes false positives
For qualitative assays, the ADVIA Centaur CP system reports the following 3 results:
•
RLUs associated with a sample result
•
index value
•
result interpretation
Use this procedure to schedule controls. As a minimum requirement, we suggest you assay
2 levels of quality control material for each assay on each day that samples are analyzed
for that assay. We also suggest you assay quality control samples when performing a
two-point calibration. Treat all quality control samples the same as patient samples. Refer
to your laboratory quality assurance program to ensure quality throughout the entire
testing process.
Workflow to Process Quality Control Samples
Use this procedure to schedule controls. As a minimum requirement, we suggest you assay
2 levels of quality control material for each assay on each day that samples are analyzed
for that assay. We also suggest you assay quality control samples when performing a
two-point calibration. Refer to the Assays section of the online help system for
assay-specific quality control recommendations.
1. Enter the control definitions from the information provided with the controls.
See Adding and Editing Quality Control Values‚ page 3-23.
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2. Load the quality control material into an appropriate sample pour-off tube that
accommodates the Siemens-supplied barcode label.
See Loading Samples into Sample Racks‚ page 2-33.
3. Put the barcode label on the tube.
4. Load the sample tube in a sample rack.
See Loading Samples into Sample Racks‚ page 2-33.
5. Load the rack in the sample compartment.
See Loading Sample Racks into the System‚ page 2-35.
6. If the control is defined on the system, and the sample tube is properly labelled, the
system automatically recognizes the sample as a control when it is loaded.
7. Perform the following steps to manually assign the control:
a. On the Sample Compartment screen, select the lane containing the sample rack
with the control material.
b. Select the control, and then manually enter the SID.
c. Toggle the sample selection button to ctrl, if necessary.
8. Select the assays or profiles for the sample.
9. Select Next Worklist to process the controls the next time Start is selected from the
workspace.
Leave this button unchecked when loading quality control material on the system for
scheduled quality control assays if you defined the quality control material to run
based on time or number of samples on the Control Definition screen.
10. If Next Worklist is selected, select Start from the workspace to begin sampling the
control material.
Adding and Editing Quality Control Values
Adding a New Quality Control Definition
Use this procedure to add a new control definition, which includes defining the assays for
the control and the expected control values for each assay.
NOTE: When adding a definition for a Multicomponent Test, the definition must include
all the components and the multicomponent test in the same definition.
1. At the workspace, select Definition.
2. Select the Controls tab.
3. Select Add.
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4. Enter a control name.
For Routine controls, enter up to 11 alphanumeric characters for the control name. For
ID Assay controls, enter 11 alphanumeric characters for the control name. Ensure that
you enter the ID Assay control name exactly as displayed on the assay assignment
sheet.
5. Select Routine or Kit in the Type field.
Routine controls are not provided with the assay reagent kits. Controls such as Ligand
Plus or Tumor Marker Plus are routine controls. ID Assay controls are kit controls and
are provided as part of specific assay reagent kits.
6. Enter the lot number and the expiration date.
The lot number and the expiration date are located on the quality control material
assay sheet. You must enter a lot number and an expiration date in order to save the
control definition.
You can enter 1 to 10 characters for the lot number.
Select or enter the date in the format defined in system Setup, for example
2004-10-28. Refer to Specifying the Date Format‚ page 6-33 for additional
information.
NOTE: The system supports multiple controls with the same name provided that the
lot numbers are unique. When you define a new control, the system permits you to
complete and save the definition only if the lot number is unique.
If the name you enter for a control already exists, you must re-enter a unique lot
number for the definition or select cancel.
7. Enter the level of the control in the Level field.
The system fills in the Control Barcode field with the control lot number preceded by
K. The Control Barcode can be up to 11 characters. If the control is a Routine type and
your Quality Control Barcodes are different than the lot number, you can edit the
Control Barcode field.
NOTE: If you are defining a control that does not have a leading K in the barcode,
select Control Barcode and edit that field to match the barcode of the control. You
can select Control Barcode only after entering the lot number.
8. Select the usage.
Usage
Meaning
Primary
This is a control in the lot that is currently in use (usually
for a year).
Parallel
Before the primary lot is replaced with a new lot, the new
lot is usually run in parallel with the primary lot.
Alternate
When troubleshooting is required, an alternate control is
usually used.
9. Enter the level of the control in the Level field.
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10. Enter the pool number.
You can enter up to eight characters for the pool number. If you use your own quality
control pools, you can assign a pool number.
11. In the fields below the table, select an assay name and enter the Quality Control
expected values:
If you want to . . .
Then . . .
enter low and high limits
enter the low and high expected value
limits from the expected values charts
provided by the quality control material
manufacturer.
The system automatically calculates the
mean and 2SD values when you select
Save.
enter mean and 2SD
enter the mean and 2SD values from the
expected values charts provided by the
quality control material manufacturer.
The system automatically calculates the
low and high limit values when you select
Save.
12. Enter the number of replicates.
13. To run a control according to a schedule, enter a frequency. If you do not enter a
frequency, you must schedule all controls manually. If you enter a frequency, you
must have controls on the system when they are due to run.
If you want to . . .
Then . . .
run a control for every X number of
samples run on the system
enter the frequency in samples.
run a control on a set schedule
enter the frequency in hours.
NOTE: Quality Control material that is
retained on the system for use according to
a set schedule may be subject to
degradation or evaporation. See the
Assays section of the online help system
for details.
14. Select Add.
NOTE: Ensure that you select all the component assays that are required in the
multicomponent control definition.
15. Repeat steps 11 through 14 for all assays for the control.
16. Select Save.
17. Repeat steps 3 through 16 to add additional control definitions.
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Editing a Quality Control Definition
Use this procedure to edit a Quality Control definition. You cannot delete assays from the
control definition.
•
edit the control expected values
•
add assays to a previously defined control
•
edit a pool number
•
change usage
1. At the workspace, select Definition.
2. Select the Controls tab.
3. Select a control name and a lot number.
4. Select Details.
5. Edit the Quality Control definition:
If you want to . . .
Then . . .
edit the control expected values
1. Select an assay in the table.
2. In the fields below the table, edit the
low and high limits, or edit the mean
and 2SD values.
3. Select Save.
add assays to a defined control
1. Select an assay.
2. In the fields below the table, enter the
low and high limits or enter the mean
and 2SD values.
3. Select Add.
edit a pool number
Edit the pool number. You can enter up to
eight digits for the pool number.
change usage
Select Primary, Parallel, or Alternate.
delete assays from a control definition
This option is not available to users.
6. Select Save.
Deleting a Quality Control Definition
1. At the workspace, select Definition.
2. Select the Controls tab.
3. Select a control name and a lot number.
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4. Select Delete.
5. Select OK.
Reloading a Quality Control Definition
If you accidentally delete a quality control definition, you must delete all associated
control results before re-entering the definition.
Use this procedure to reload a quality control definition that was deleted.
1. Remove any control samples from the Sample Compartment associated with the
control definition.
2. Delete all control results associated with the quality control definition that was
deleted.
3. Reload the control definition.
4. Reload any control samples associated with the control definition.
Running Automatically Scheduled Controls
If an automatic frequency is defined for a control, the control is not processed unless the
following conditions are met:
•
The control is loaded on the system.
•
The assay reagent is loaded on the system.
•
A patient sample to process against the assay is scheduled and loaded on the system.
•
The defined number of patient tests was processed or the time frame has elapsed.
For more information on defining automatic frequencies for controls, refer to Adding and
Editing Quality Control Values‚ page 3-23.
Scheduling a Control from the Primary Reagent Window
You can schedule a control for any reagent pack that is loaded on the system. If you are
currently running tests that use a reagent that is running low, you can run controls on
another loaded ReadyPack® that is not being used so that it will be available immediately
for processing samples when the first ReadyPack is depleted.
Use this procedure to schedule controls for one or more reagents:
1. At the workspace, in the display area select the Primary Reagent area.
2. On the Primary Reagent window, select the reagent pack for which you want to
schedule controls.
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3. In the Control section of the Primary Reagent window, select Run Control.
The system displays the Matching Controls screen, which displays a list of the Name,
Lot, Expiration Date, Barcode ID, Type, Assay, and Use now. In the Use now column,
a checkmark indicates the control that will run.
All controls in the list are automatically checked. You must uncheck a control in the
list if you do not want it to run.
If you do not want to run any of the controls, select Cancel.
4. Select OK.
5. Select Close.
When you close the window, all controls that displayed a checkmark on the Matching
Controls screen are scheduled to run. The system schedules controls for the selected
reagent or reagents only if there is a matched control loaded into the compartment.
6. Select Close.
Defining a Control Definition for a Multicomponent Test
Define a mulitcomponent control definition according to the section, Adding and Editing
Quality Control Values‚ page 3-23. Ensure that you select all the component assays that
are required in the multicomponent control definition.
Scheduling Controls for Multicomponent Tests
You can schedule the multicomponent test control directly. You do not have to schedule
the individual component test controls. The system automatically schedules controls for
all the component tests and schedules the multicomponent test. The results for the
individual component controls are sent to ADVIA QC.
The system uses the component control results to calculate the multicomponent result. The
multicomponent control result is sent to ADVIA QC and to the LIS.
Managing Quality Control Data
Viewing Quality Control Summaries
Use this procedure to review a summary of Quality Control results, such as results, flags
and Quality Control status. You can view a summary of the Quality Control results and
RLU information from the Quality Control screen. This screen provides a summary of
Quality Control status.
1. At the workspace, select Results.
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2. Select Quality Control tab.
A list of Quality Control results displays. A number of Quality Control status flags may
display. See the Screen Help section of the online help system for a full list of flags.
Viewing Quality Control Details
Use this procedure to view Quality Control result details.
1. At the workspace, select Results.
2. Select the Quality Control tab.
3. Select a record.
4. Select Details.
Quality control details are described in the Screen Help section of the online help system.
Viewing (Filtering) Quality Control
Use this procedure to view only results that meet selected criteria.
1. At the workspace, select Results.
2. Select the Quality Control tab.
3. Select View.
4. Select a filter criteria.
5. Select OK.
A variety of selection criteria are available. See the Screen Help section of the online help
system for details.
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Printing Quality Control
Use this procedure to print a summary of all or selected results, or details of all or selected
results. Results are printed to the default printer assigned to the system.
1. At the workspace, select Results.
2. Select the Quality Control tab.
3. Select one or more records.
4. Select Print.
5. Select a report type (for example, Quality Control Summary or Quality Control
Details).
6. Select OK.
7. To return to the workspace, select Close.
A variety of selection criteria and report types are available. See the Screen Help section
of the online help system for details.
Deleting Quality Control
Use this procedure to delete Quality Control results. You must have an appropriate level of
security to delete results. You can also delete Quality Control results from the Results tab.
1. At the workspace, select Results.
2. Select the Quality Control tab.
3. Select the column heading, for example, Control Name or Result.
4. Select the delete range to specify the control results to delete.
5. Select Delete.
6. Select OK.
7. Select Close.
A variety of selection criteria are available. See the Screen Help section of the online help
system for details.
Exporting Quality Control
Use this procedure to export Quality Control results to a CSV file.
1. At the workspace, select Results.
2. Select the Quality Control tab.
3. Select one or more records.
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4. Select Export.
5. Enter the file location, and the name of the file.
We recommend that you select D:\Archive\export\yourfilename.
You can also use the File Location button to browse to the correct directory, or you can
export the results to a CD.
6. Select OK.
7. Select Close to return to the workspace.
A variety of selection criteria are available. See the Screen Help section of the online help
system for details.
ADVIA QC
The ADVIA QC software automatically launches in the background when the
ADVIA Centaur CP system launches. Use ADVIA QC from within the
ADVIA Centaur CP system for real time or longer term evaluation of system and method
performance.
ADVIA QC software automates collecting control material results, calculating statistics,
assessing data for Quality Control violations, notifying you of Quality Control violations,
and reporting assessment results.
Refer to Transmitting QC Results to ADVIA QC‚ page 6-37 for information on disabling
automatic start of ADVIA QC.
If ADVIA QC has not been launched at system start, use this procedure to launch the
ADVIA QC software.
1. At the workspace, select Results.
2. Select the Quality Control tab.
3. Select ADVIA QC.
NOTE: The multicomponent assay score, for example, the ELF score, is sent to
ADVIA QC.
For more information, access online help from the ADVIA QC software.
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ADVIA Centaur CP Operator’s Guide: 3 Calibration and Quality Control
4
Maintenance
Managing Maintenance Tasks . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
Maintenance Frequency Checklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
Reviewing Maintenance Tasks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
Recording Maintenance Tasks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
Printing Maintenance Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
Defining Maintenance Tasks. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
Deleting Maintenance Tasks. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5
Importing and Exporting Maintenance Tasks . . . . . . . . . . . . . . . . . . . . . 4-5
Canceling a Maintenance Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6
Automated Maintenance Procedures . . . . . . . . . . . . . . . . . . . . . 4-6
Performing an Automated Daily Cleaning . . . . . . . . . . . . . . . . . . . . . . . 4-6
Aspirate Bubble Detector Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-8
Performing an Automated Weekly Cleaning. . . . . . . . . . . . . . . . . . . . . . 4-8
Performing an Automated Monthly Cleaning . . . . . . . . . . . . . . . . . . . . 4-10
Maintaining Compartments and Drawers. . . . . . . . . . . . . . . . . 4-13
Cleaning the Acid and Base Reagent Compartment . . . . . . . . . . . . . . 4-13
Cleaning the Solid Waste Drawer and Liner. . . . . . . . . . . . . . . . . . . . . 4-14
Cleaning the Sample Compartment . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-17
Cleaning the Sample Compartment Shutters . . . . . . . . . . . . . . . . . . . . 4-19
Cleaning the Sample Racks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-21
Cleaning the Reagent Compartment . . . . . . . . . . . . . . . . . . . . . . . . . . 4-22
Cleaning the Reagent Compartment Shutter . . . . . . . . . . . . . . . . . . . . 4-24
Maintaining System Containers . . . . . . . . . . . . . . . . . . . . . . . . 4-26
Cleaning the Wash 1 Container . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-26
Check Liquid Waste Valve . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-29
Maintaining the System Interior . . . . . . . . . . . . . . . . . . . . . . . . 4-30
Cleaning the Incubation Ring Cover. . . . . . . . . . . . . . . . . . . . . . . . . . . 4-30
Cleaning the Exterior of the Reagent Probe. . . . . . . . . . . . . . . . . . . . . 4-31
Cleaning the Exterior of the Waste Probe . . . . . . . . . . . . . . . . . . . . . . 4-32
Cleaning the Probe Rails . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-33
Maintaining the System Exterior . . . . . . . . . . . . . . . . . . . . . . . . 4-34
Cleaning the System Exterior . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-34
Cleaning the Workstation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-34
Performing Database Maintenance. . . . . . . . . . . . . . . . . . . . . . 4-35
Maintaining the System Database . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-35
Backing Up System Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-36
Restoring System Data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-37
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ADVIA Centaur CP Operator’s Guide: Contents
General Maintenance Tasks . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-37
Preparing the Cleaning Solution used on the System . . . . . . . . . . . . . 4-37
Performing an Automated System Prime . . . . . . . . . . . . . . . . . . . . . . . 4-37
Opening the Top Cover. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-38
Installation, Relocation and Extended System Downtime . . . . . . . . . . 4-38
Disabling Assays . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-38
Checking the Acid and Base Pumps . . . . . . . . . . . . . . . . . . . . . . . . . . 4-39
Replacing the Blue Peripump Tubing . . . . . . . . . . . . . . . . . . . . . . . . . . 4-41
Flushing Fluid from the Peripump Tubing . . . . . . . . . . . . . . . . . . . . . . . . . . .4-42
Tubing Replacement Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-43
Removing the Tubing Clamp Covers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-46
Priming the System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-47
Replacing the Gray Peripump Tubing. . . . . . . . . . . . . . . . . . . . . . . . . . 4-47
Flushing Fluid from the Peripump Tubing . . . . . . . . . . . . . . . . . . . . . . . . . . .4-47
Tubing Replacement Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-48
Removing the Tubing Clamp Covers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-50
Priming the System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-51
Clearing a Jam from the Cuvette Loader . . . . . . . . . . . . . . . . . . . . . . . 4-51
Removing the Cuvette Loader Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . .4-51
Preliminary Steps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-51
Removing the Cuvette Loader Assembly . . . . . . . . . . . . . . . . . . . . . . . . . .4-52
Replacing the Cuvette Loader Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . .4-57
Performing Dark Counts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-58
Repositioning the Aspirate Probe Tubing . . . . . . . . . . . . . . . . . . . . . . . 4-59
086D0320-01, Rev. 04
4 Maintenance
Managing Maintenance Tasks
Maintenance Frequency Checklist
Daily Maintenance Tasks
Performing an Automated Daily Cleaning................................................ page 4-6
Aspirate Bubble Detector Calibration ....................................................... page 4-8
Weekly Maintenance Tasks
Performing an Automated Weekly Cleaning ............................................ page 4-8
Cleaning the Incubation Ring Cover....................................................... page 4-30
Cleaning the Exterior of the Reagent Probe............................................ page 4-31
Cleaning the Exterior of the Waste Probe ............................................... page 4-32
Cleaning the Probe Rails ......................................................................... page 4-33
Monthly Maintenance Tasks
Performing an Automated Monthly Cleaning......................................... page 4-10
As-Needed Maintenance Tasks
Cleaning the Wash 1 Container............................................................... page 4-26
Preparing the Cleaning Solution used on the System ............................. page 4-37
Performing an Automated System Prime................................................ page 4-37
Recording Maintenance Tasks .................................................................. page 4-3
Reviewing Maintenance Tasks.................................................................. page 4-3
Printing Maintenance Reports................................................................... page 4-4
Defining Maintenance Tasks..................................................................... page 4-4
Deleting Maintenance Tasks ..................................................................... page 4-5
Importing and Exporting Maintenance Tasks ........................................... page 4-5
Cleaning the Acid and Base Reagent Compartment ............................... page 4-13
Cleaning the Solid Waste Drawer and Liner........................................... page 4-14
Cleaning the Sample Compartment ........................................................ page 4-17
Cleaning the Sample Compartment Shutters .......................................... page 4-19
Cleaning the Sample Racks..................................................................... page 4-21
Cleaning the Reagent Compartment ....................................................... page 4-22
Cleaning the Reagent Compartment Shutter........................................... page 4-24
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ADVIA Centaur CP Operator’s Guide: 4 Maintenance
Cleaning the System Exterior.................................................................. page 4-34
Cleaning the Workstation ........................................................................ page 4-34
Backing Up System Data ........................................................................ page 4-36
Restoring System Data............................................................................ page 4-37
Maintaining the System Database ........................................................... page 4-35
Checking the Acid and Base Pumps ....................................................... page 4-39
Replacing the Blue Peripump Tubing ..................................................... page 4-41
Replacing the Gray Peripump Tubing..................................................... page 4-47
Clearing a Jam from the Cuvette Loader ................................................ page 4-51
Performing Dark Counts ......................................................................... page 4-58
Repositioning the Aspirate Probe Tubing ............................................... page 4-59
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ADVIA Centaur CP Operator’s Guide: 4 Maintenance
4-3
Reviewing Maintenance Tasks
The ADVIA Centaur CP system monitors maintenance tasks and notifies you when a
scheduled task is due. The system notifies you through a color change on the Maintenance
status button and an Overdue icon next to the task on the Maintenance Schedule screen.
When a certification is due, contact your local technical support provider to schedule the
procedure as soon as possible.
The system provides a maintenance schedule for you to record the completion of
scheduled maintenance tasks. The system then uses this information to automatically
update the maintenance schedule with the next time the task is due.
At the workspace, the background of the Maintenance status button changes color to
indicate status.
•
Yellow indicates that a maintenance task is due or overdue.
•
Red indicates that an automated maintenance procedure did not finish.
You can select the Maintenance status button to access the Maintenance screen. You can
also access the Maintenance screen by selecting Maintenance on the taskbar.
You can display specific information at the Maintenance screen by selecting the
appropriate tab and sort combinations:
•
The tab you select determines the information the system displays. If you select
Maintenance Schedule, the system displays the scheduled maintenance tasks. If you
select Maintenance Log, the system displays a record of completed maintenance
tasks.
•
The sort option you select determines order in which the system displays the
scheduled tasks. For example, if you select Name, the system sorts and displays the
scheduled tasks in alphabetical order.
An historical log is maintained of all maintenance tasks performed on the system. The
system records the date, time, and cycle count when the task was completed and records
the user name of the operator.
Recording Maintenance Tasks
After performing a scheduled maintenance task, use this procedure to record the task as
complete. You can also enter and review comments.
1. At the workspace, select Maintenance.
2. Select a task.
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ADVIA Centaur CP Operator’s Guide: 4 Maintenance
3. Select Perform.
The system automatically enters your user name and calculates the date when the task
is due next.
You can also enter a comment in the Comment field, such as a note that indicates if the
maintenance was performed to correct a system problem.
4. Select OK.
5. Select Close to return to the workspace.
Printing Maintenance Reports
Use this procedure to print a report of either the scheduled maintenance for the system or
the maintenance log.
1. At the workspace, select Maintenance.
2. Select either tab:
•
Maintenance Schedule
•
Maintenance Log
3. Select Print.
4. Select a particular record, today’s records, or a range of records.
5. Select one of the report types (summary or detailed).
A variety of selection criteria and report types are available. See Screen Help section
of the online help system for details.
6. Select OK.
Defining Maintenance Tasks
Use this procedure to define maintenance tasks that are specific to your laboratory. These
tasks are part of the regular maintenance schedule. You must have a supervisor level of
security to define maintenance tasks.
You can change maintenance tasks to be performed more frequently but not less frequently
than the original settings.
1. At the workspace, select Maintenance.
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ADVIA Centaur CP Operator’s Guide: 4 Maintenance
4-5
2. On the Maintenance screen, you can define or edit a maintenance task:
If you want to . . .
Then . . .
define a maintenance task
1. Select Add.
2. Enter the name of the maintenance
task.
3. Enter or edit the appropriate
information.
edit a maintenance task
1. Select a task.
2. Select Details.
3. Enter or edit the appropriate
information.
4. Select Restore Default to return to the
maintenance definition originally
defined for your system.
3. Select OK.
Deleting Maintenance Tasks
Use this procedure to delete maintenance tasks you defined. You must have a supervisor
level of security to delete maintenance tasks.
1. At the workspace, select Maintenance.
2. Select a maintenance task you defined.
3. Select Delete.
4. Select OK.
Importing and Exporting Maintenance Tasks
Use this procedure to transfer user-defined maintenance tasks from system to system. You
must have a supervisor level of security to import or export maintenance tasks.
1. At the workspace, select Maintenance.
2. Select Export to export selected maintenance tasks to a file. Tasks can be transferred
or saved to a variety of media for transfer to other ADVIA Centaur CP systems.
3. Select Import to import maintenance tasks from a file.
4. Browse to the location of the maintenance file.
5. Select or name the file.
6. Select Open.
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ADVIA Centaur CP Operator’s Guide: 4 Maintenance
Canceling a Maintenance Procedure
When you cancel a maintenance procedure, wait a few minutes while the system
completes the current cycle of the procedure, and then you can resume operation. You
must repeat the procedure you canceled before you can run samples again.
Automated Maintenance Procedures
Before performing any automated cleaning procedure, ensure that you have sufficient
supplies and that the solid and liquid waste containers have sufficient space to complete
the maintenance procedure. Before you begin the automated maintenance task, empty the
solid waste bin and the liquid waste container. Make sure that all resources are full.
Otherwise, you may not be able to complete the maintenance task and you will have to run
it again.
Performing an Automated Daily Cleaning
Use this procedure to perform the automated daily maintenance. The automated daily
maintenance includes both system and operator tasks. Monitor the Perform Task window
carefully and follow the system prompts in the status window.
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4-7
The automated daily maintenance uses the DI water tubing only. Do not remove the DI
water sensor cable.
1
2
Cleaning Bottle
DI Water Container
BIOHAZARD
Wear personal protective equipment. Use universal precautions. Refer to Appendix A,
Safety Information, for recommended precautions when working with biohazardous
materials.
WARNING
When handling the cleaning solution, follow the appropriate chemical safety guidelines,
which include wearing gloves, laboratory coat, and safety glasses or protective face
shield.
1. Prepare cleaning solution in the 2-liter cleaning bottle.
See Preparing the Cleaning Solution used on the System‚ page 4-37.
2. Ensure that the system is in the Ready state.
3. At the workspace, select Maintenance, or select the Maintenance Status button.
4. Select Automated Daily Cleaning.
5. Select Perform.
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ADVIA Centaur CP Operator’s Guide: 4 Maintenance
6. When procedure 1 displays, prompting you to install the cleaning bottle, perform the
following steps:
a. Remove the tubing from the DI water container.
b. Connect the tubing to the 2-liter cleaning bottle containing the cleaning solution.
c. Select Accept.
7. When procedure 5 displays, prompting you to reinstall the DI water container,
perform the following steps:
a. Remove the tubing from the 2-liter cleaning bottle.
b. Reconnect the tubing to the DI water container.
c. Select Accept.
8. When procedure 9 displays, indicating that the task completed successfully, select OK.
The system is now ready to process samples.
Aspirate Bubble Detector Calibration
Use this procedure daily after you perform the automated daily cleaning procedure or if
you are seeing aspiration errors on the system event log.
1. Ensure that the system is in the Ready state.
2. At the workspace, select Maintenance, or select the Maintenance Status button.
3. Select Aspirate Probe Bubble Detector Calibration.
4. Select Perform.
The system displays a status message indicating that it is calibrating the aspiration
sensor. This takes approximately 5 minutes to complete.
The system status changes to Finished and Successful.
5. Select Cancel to stop the calibration.
6. When the procedure is complete, select OK.
Performing an Automated Weekly Cleaning
Use this procedure to perform the automated weekly maintenance. The automated weekly
maintenance includes both system and operator task. Monitor the Perform Task window
carefully and follow the system prompts in the status window. The automated weekly
maintenance uses the DI water tubing only.
BIOHAZARD
Wear personal protective equipment. Use universal precautions. Refer to Appendix A,
Safety Information, for recommended precautions when working with biohazardous
materials.
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4-9
WARNING
When handling the cleaning solution, follow the appropriate chemical safety guidelines,
which include wearing gloves, laboratory coat, and safety glasses or protective face
shield.
1. Prepare 2 liters of cleaning solution.
See Preparing the Cleaning Solution used on the System‚ page 4-37.
2. Ensure that the system is in the Ready state.
3. Disconnect the DI water container from the system:
a. Disconnect the tubing from the container and set it aside on lint-free tissues or
gauze to absorb drips.
b. Disconnect the sensor from the container.
c. Remove the cap from the container.
4. Dispose of the DI water into an appropriate receptacle.
5. Pour the cleaning solution into the DI water container.
6. Replace the cap on the DI water container.
7. Rock the container 10 times.
8. Let the container sit for 10 minutes.
9. Place the DI water container back in position.
10. At the workspace, select Maintenance.
11. Select Automated Weekly Cleaning.
12. Select Perform.
13. When procedure 1 displays, prompting you to install the DI water container
containing the cleaning solution, perform the following steps:
a. Connect the DI water tubing and the sensor to the DI water container containing
the cleaning solution.
b. Select Accept.
14. When procedure 5 displays, prompting you to empty, clean, and reinstall the DI water
container, perform the following steps:
a. Disconnect the tubing and sensor from the DI water container.
b. Dispose of the cleaning solution in an appropriate receptacle.
• Fill the container with approximately 3 liters of DI water.
• Rock the container at least 5 times.
• Dispose of the DI water in an appropriate receptacle.
• Repeat at least 3 times.
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ADVIA Centaur CP Operator’s Guide: 4 Maintenance
c. Refill the DI water container with fresh DI water.
d. Reconnect the tubing and sensor to the DI water container.
e. Select Accept.
15. When procedure 9 displays, indicating that the task completed successfully, select OK.
The system is now ready to process samples.
Performing an Automated Monthly Cleaning
Use this procedure to perform the automated monthly maintenance. The automated
monthly maintenance includes both system and operator task. Monitor the Perform Task
window carefully and follow the system prompts in the status window.
The automated monthly maintenance uses both the DI water tubing and the wash 1 tubing.
Do not remove either the DI water sensor cable or the wash 1 sensor cable.
1
2
3
Cleaning Bottle
Wash 1 Container
DI Water Container
BIOHAZARD
Wear personal protective equipment. Use universal precautions. Refer to Appendix A,
Safety Information, for recommended precautions when working with biohazardous
materials.
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4-11
WARNING
When handling the cleaning solution, follow the appropriate chemical safety guidelines,
which include wearing gloves, laboratory coat, and safety glasses or protective face
shield.
1. Prepare cleaning solution in the 2-liter cleaning bottle.
See Preparing the Cleaning Solution used on the System‚ page 4-37.
2. Ensure that the system is in the Ready state.
3. At the workspace, select Maintenance, or select the Maintenance Status button.
4. Select Automated Monthly Cleaning.
5. Select Perform.
6. When procedure 1 displays, prompting you to install the cleaning bottle, perform the
following steps:
a. Remove the tubing from the DI water container and connect it to the 2-liter
cleaning bottle.
b. Remove the tubing from the wash 1 container and connect it to the 2-liter cleaning
bottle.
c. Select Accept.
7. When procedure 6 displays, prompting you to fill the cleaning bottle with DI water,
perform the following steps:
a. Disconnect the DI water tubing from the 2-liter cleaning bottle.
b. Disconnect the wash 1 tubing from the 2-liter cleaning bottle.
c. Dispose of the cleaning solution in an appropriate receptacle.
d. Rinse the cleaning bottle and cap at least 3 times with DI water.
e. Fill the 2-liter cleaning bottle with DI water and attach the cap.
f.
Connect the DI water tubing to the 2-liter cleaning bottle.
g. Connect the wash 1 tubing to the 2-liter cleaning bottle.
h. Select Accept.
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ADVIA Centaur CP Operator’s Guide: 4 Maintenance
8. When procedure 10 displays, prompting you to reinstall the DI water and wash 1
containers, perform the following steps:
a. Remove the DI water tubing from the 2-liter cleaning bottle.
b. Remove the wash 1 tubing from the 2-liter cleaning bottle.
c. Empty the contents of the 2-liter cleaning bottle.
d. Connect the DI water tubing to the DI water container.
e. Connect the wash 1 tubing to the wash 1 container.
f.
Select Accept.
9. When procedure 13 displays, indicating that the task completed successfully, select
OK. The system is now ready to process samples.
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4-13
Maintaining Compartments and Drawers
Cleaning the Acid and Base Reagent Compartment
Use this procedure to clean the acid and base reagent compartment
1
2
3
1
2
3
Acid and Base Reagent Compartment Door
Acid Reagent Bottle (R1)
Base Reagent Bottle (R2)
WARNING
Avoid contact of acid and base reagents with skin and eyes. Acid and base reagents are
irritating to the skin. Wear suitable eye, face, and skin protection, which includes wearing
gloves, protective eye shield, and laboratory coat. In case of contact with the eyes, rinse
the eyes immediately with plenty of water and seek medical advice. In case of accident or
if you feel unwell, seek medical advice (if possible show the bottle label and Material
Safety Data Sheet). In case of accidental ingestion of reagent, call a physician
immediately.
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ADVIA Centaur CP Operator’s Guide: 4 Maintenance
CAUTION
Do not clean the sensors with alcohol or cleaning solution. Unevaporated fluid on the
sensors can cause erroneous results.
1. Ensure that the system is in the Ready state.
2. Open the acid and base reagent compartment door.
3. Remove the acid and base (R1 and R2) reagent bottles and set aside.
4. Carefully wipe the interior of the compartment (but avoid touching the sensors) with
an alcohol wipe.
5. Allow the compartment to dry.
CAUTION
Ensure that the acid and base reagent bottles are installed in the correct positions. If they
are reversed, the chemiluminescent reaction will not occur correctly.
6. Replace the acid and base (R1 and R2) reagent bottles.
7. Confirm that the bottles are in the correct positions (see Caution above).
8. Close the acid and base reagent compartment door.
Cleaning the Solid Waste Drawer and Liner
The solid waste drawer liner is designed to be cleaned and reused. Use this procedure to
clean the solid waste drawer and the solid waste drawer liner.
BIOHAZARD
Wear personal protective equipment. Use universal precautions. Refer to Appendix A,
Safety Information, for recommended precautions when working with biohazardous
materials.
WARNING
When handling the cleaning solution, follow the appropriate chemical safety guidelines,
which include wearing gloves, laboratory coat, and safety glasses or protective face
shield.
1. Prepare cleaning solution.
See Preparing the Cleaning Solution used on the System‚ page 4-37.
2. Ensure that the system is in the Ready state.
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4-15
3. Grasp the solid waste drawer handle and pull the drawer out of the analyzer.
4. Dispose of its contents in a container approved for biohazardous waste.
5. Grasp the right side of the liner and pull the liner back and out of the drawer.
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ADVIA Centaur CP Operator’s Guide: 4 Maintenance
6. Clean the inside of the liner:
a. Wipe the interior and exterior of the liner with lint-free tissues or gauze saturated
with cleaning solution.
b. Wipe the interior and exterior of the liner with lint-free tissues or gauze saturated
with water.
c. Dry the liner thoroughly.
7. If required, clean the inside of the solid waste drawer with cleaning solution:
a. Wipe the interior and exterior of the drawer with lint-free tissues or gauze
saturated with cleaning solution.
b. Wipe the interior and exterior of the drawer with lint-free tissues or gauze
saturated with water.
c. Dry the drawer thoroughly.
8. Reinstall the solid waste drawer liner in the solid waste drawer.
9. Reinstall the drawer in the analyzer.
Ensure that it fits tightly.
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4-17
Cleaning the Sample Compartment
Use this procedure to clean the sample compartment when it becomes difficult to load
sample racks or if the rails in the compartment look dirty.
3
1
2
1
2
3
Sample Compartment Door
Sample Lanes
LEDs
BIOHAZARD
Wear personal protective equipment. Use universal precautions. Refer to Appendix A,
Safety Information, for recommended precautions when working with biohazardous
materials.
WARNING
When handling the cleaning solution, follow the appropriate chemical safety guidelines,
which include wearing gloves, laboratory coat, and safety glasses or protective face
shield.
WARNING
Do not clean the sample compartment while the probe is accessing samples. Injury can
result.
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ADVIA Centaur CP Operator’s Guide: 4 Maintenance
1. Prepare cleaning solution.
See Preparing the Cleaning Solution used on the System‚ page 4-37.
2. Ensure that the system is in the Ready state.
LASER WARNING
Do not look directly at the laser beam or at its reflection from a shiny surface. This may
cause damage to the eyes. Refer to Appendix A, Safety Information, for more information.
3. Open the sample compartment door.
4. Remove any sample racks.
5. Wipe the surfaces of the sample compartment with lint-free tissues or gauze saturated
with cleaning solution.
6. Wipe the surfaces of the sample compartment with lint-free tissues or gauze saturated
with water.
7. Dry the sample compartment thoroughly.
8. Close the sample compartment door.
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Cleaning the Sample Compartment Shutters
Clean the sample compartment shutters when shutter errors occur or splatter is visible on
the shutters. Use this procedure to clean the sample compartment shutters.
1
2
3
Sample Compartment Shutters
Bottom Shutter
Cam Screw
BIOHAZARD
Wear personal protective equipment. Use universal precautions. Refer to Appendix A,
Safety Information, for recommended precautions when working with biohazardous
materials.
WARNING
When handling the cleaning solution, follow the appropriate chemical safety guidelines,
which include wearing gloves, laboratory coat, and safety glasses or protective face
shield.
1. Prepare cleaning solution.
See Preparing the Cleaning Solution used on the System‚ page 4-37.
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2. Ensure that the system is in the Ready state.
LASER WARNING
Do not look directly at the laser beam or at its reflection from a shiny surface. This may
cause damage to the eyes. Refer to Appendix A, Safety Information, for more information.
3. Open the sample compartment door.
4. Remove any sample racks.
5. Turn power to the system off.
See Turning the System Off‚ page 2-8.
6. Open the top cover.
See Opening the Top Cover‚ page 4-38.
7. Carefully lift the probe up to its highest point, to a safe position.
Move the probe by pushing on the probe arm.
•
Push the sample probe vertical arm up and to the left back of the system.
•
Push the reagent probe up and to the right back of the system.
8. Remove the sample compartment shutter.
The sample shutter has 3 pieces. Remove each piece in turn.
a. Slide the top piece of the shutter forward until the tabs are under the slots in the
side panels.
b. Lift out the shutter.
c. Repeat steps a and b for the other 2 pieces of the shutter.
9. Wipe the shutter pieces with lint-free tissues or gauze saturated with cleaning solution.
10. Wipe the shutter pieces with lint-free tissues or gauze saturated with water.
11. Dry the shutter pieces thoroughly.
12. Reinstall the shutter:
a. Position the bottom piece of the shutter until the tabs are under the slots in the side
panels.
b. Lower the shutter into position.
c. Slide the shutter back into position.
d. Repeat steps a – c for the other 2 pieces of the shutter.
13. Close the top cover.
14. Restart the system.
See Starting the System‚ page 2-3.
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Cleaning the Sample Racks
Clean the sample racks if they look dirty or the system has trouble loading them. Use this
procedure to clean the sample racks.
BIOHAZARD
Wear personal protective equipment. Use universal precautions. Refer to Appendix A,
Safety Information, for recommended precautions when working with biohazardous
materials.
WARNING
When handling the cleaning solution, follow the appropriate chemical safety guidelines,
which include wearing gloves, laboratory coat, and safety glasses or protective face
shield.
1. Prepare cleaning solution.
See Preparing the Cleaning Solution used on the System‚ page 4-37.
2. Wipe the racks with cotton swabs saturated with cleaning solution.
3. Wipe the racks with cotton swabs saturated with water.
4. Allow the racks to dry.
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Cleaning the Reagent Compartment
Clean the reagent compartment, primary reagent pack holders, and ancillary reagent pack
trays when it becomes difficult to load reagent packs or when it has become dirty.
1
2
3
1
2
3
Primary Reagent Holder
Reagent Shelf
Primary Reagent Doors
BIOHAZARD
Wear personal protective equipment. Use universal precautions. Refer to Appendix A,
Safety Information, for recommended precautions when working with biohazardous
materials.
WARNING
When handling the cleaning solution, follow the appropriate chemical safety guidelines,
which include wearing gloves, laboratory coat, and safety glasses or protective face
shield.
WARNING
Do not clean the reagent compartment while the probe is accessing reagents. Injury can
result.
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1. Prepare cleaning solution.
See Preparing the Cleaning Solution used on the System‚ page 4-37.
2. Turn the instrument off.
3. Open the reagent compartment door.
4. Remove the reagent packs from the reagent compartment and refrigerate them.
5. Wipe excess water from the reagent compartment.
6. Wipe the surface of the compartment with cotton swabs saturated with cleaning
solution.
7. Wipe the surfaces of the reagent compartment with lint-free tissues or gauze saturated
with water.
8. If reagent has spilled onto the primary reagent holders, wipe the reagent pack holders
with lint-free tissues or gauze saturated with water.
9. Dry the reagent compartment thoroughly.
10. Turn the system on.
11. If necessary, clean the ancillary reagent trays:
a. Wipe the trays with lint-free tissues or gauze saturated with cleaning solution.
b. Wipe the trays with lint-free tissues or gauze saturated with water.
c. Dry the trays thoroughly.
12. When the system is in the Ready state, return the reagent packs to the reagent
compartment.
NOTE: Some settling of the Solid Phase reagents can occur.
13. Ensure that reagents are resuspended before resuming normal operation.
See Appendix C, Reagents Information, for information on checking for settled Solid
Phase material and mixing reagent packs by hand.
14. Close the reagent compartment door.
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Cleaning the Reagent Compartment Shutter
Clean the reagent compartment shutter when reagent compartment shutter errors occur or
splatter is visible on the shutter. When you clean the reagent compartment shutter, use an
alcohol swab.
1
2
4
3
1
2
3
4
Guide Slots
Reagent Shutter
Cam Pin
Guide
BIOHAZARD
Wear personal protective equipment. Use universal precautions. Refer to Appendix A,
Safety Information, for recommended precautions when working with biohazardous
materials.
WARNING
When handling the cleaning solution, follow the appropriate chemical safety guidelines,
which include wearing gloves, laboratory coat, and safety glasses or protective face
shield.
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Use this procedure to clean the reagent compartment shutter.
1. Prepare cleaning solution.
See Preparing the Cleaning Solution used on the System‚ page 4-37.
2. Ensure that the system is in the Ready state.
LASER WARNING
Do not look directly at the laser beam or at its reflection from a shiny surface. This may
cause damage to the eyes. Refer to Appendix A, Safety Information, for more information.
3. Remove the reagent packs from the reagent compartment and refrigerate them.
4. Turn power to the system off.
See Turning the System Off‚ page 2-8.
5. Open the top cover.
See Opening the Top Cover‚ page 4-38.
6. Push on the reagent probe vertical arm to raise the probe until it is clear of the rinse
station.
7. Push the reagent probe assembly to one side by pushing the probe arm to the right
back.
8. Remove the reagent shutter:
a. Lift the shutter from the cam pin.
b. Slide the shutter to the left until the guide slots are under the guides.
c. Lift out the shutter.
9. Wipe the shutter components with lint-free tissues or gauze saturated with cleaning
solution.
10. Wipe the shutter components with lint-free tissues or gauze saturated with water.
11. Dry the shutter components thoroughly.
12. Wipe the surface under the shutter with lint-free tissues or gauze saturated with
cleaning solution.
13. With a cotton swab saturated with water, clean the slots in the surface under the
reagent shutter.
14. Wipe the surface under the shutter with lint-free tissues or gauze saturated with water.
15. Dry the surface under the shutter thoroughly.
16. Install the shutter by sliding it to the right until the guide slots are under the guides.
17. Drop the shutter cover into the shutter area, over the cam pin.
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18. Close the top cover.
19. Restart the system.
See Starting the System‚ page 2-3.
20. When the system is in the Ready state, return the reagent packs to the reagent
compartment.
Maintaining System Containers
Cleaning the Wash 1 Container
Use this procedure to clean the wash 1 container.
1
2
3
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DI Water and Wash 1 Tubing Connection
DI Water and Wash 1 Sensor Connection
Wash 1 Container
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BIOHAZARD
Wear personal protective equipment. Use universal precautions. Refer to Appendix A,
Safety Information, for recommended precautions when working with biohazardous
materials.
WARNING
When handling the cleaning solution, follow the appropriate chemical safety guidelines,
which include wearing gloves, laboratory coat, and safety glasses or protective face
shield.
1. Prepare cleaning solution.
See Preparing the Cleaning Solution used on the System‚ page 4-37.
2. Ensure that the system is in the Ready state.
3. Disconnect the wash 1 container from the system:
NOTE: When you remove the container from the system, place it where the tubing
will not leak on the floor.
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a. Disconnect the tubing from the container and set it aside on lint-free tissues or
gauze to absorb drips.
1
Disconnect DI water tubing.
b. Disconnect the sensor from the container.
1
Disconnect DI water sensor.
c. Remove the cap from the container.
4. Dispose of the remaining wash 1 solution in an appropriate receptacle.
Do not re-use wash 1 solution.
5. Pour approximately 2000 mL of cleaning solution into the wash 1 container.
6. Place the cap on the container tightly.
WARNING
Do not rock the container unless the cap is installed. Injury can result.
7. Rock the container 10 times.
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8. Let the container sit for 10 minutes.
9. Dispose of the cleaning solution in an appropriate receptacle.
CAUTION
Do not leave residual cleaning solution in the container after performing the cleaning
procedure. Ensure that the wash 1 container is rinsed thoroughly and filled with fresh
wash 1 solution. Residual cleaning solution in the container tubing can affect assay
performance.
10. Rinse the wash 1 container and cap with DI water:
a. Fill the container with approximately 3 liters of DI water.
b. Replace the cap on the container.
c. Rock the container at least 5 times.
d. Dispose of the DI water in an appropriate receptacle.
e. Repeat steps a to d at least 3 times.
11. Refill the container with fresh wash 1 solution.
12. Re-install the container:
a. Replace the cap on the container.
b. Place the container back in position.
c. Connect the tubing to the container.
1
2
Reconnect DI water tubing.
Reconnect the sensor.
d. Connect the sensor to the container.
Check Liquid Waste Valve
When you empty the liquid waste container, inspect the liquid waste valve. If any build up
is on the underside of the valve, remove the build up using a cotton swab.
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BIOHAZARD
Wear personal protective equipment. Use universal precautions. Refer to Appendix A,
Safety Information, for recommended precautions when working with biohazardous
materials.
Maintaining the System Interior
Cleaning the Incubation Ring Cover
Clean the reagent dispense position and the sample dispense position of the incubation
ring cover when significant splattering is present. Use this procedure to clean the
incubation ring cover.
BIOHAZARD
Wear personal protective equipment. Use universal precautions. Refer to Appendix A,
Safety Information, for recommended precautions when working with biohazardous
materials.
WARNING
When handling the cleaning solution, follow the appropriate chemical safety guidelines,
which include wearing gloves, laboratory coat, and safety glasses or protective face
shield.
1. Prepare cleaning solution.
See Preparing the Cleaning Solution used on the System‚ page 4-37.
2. Ensure that the system is in the Ready state.
3. Turn power to the system off.
See Turning the System Off‚ page 2-8.
4. Open the top cover.
See Opening the Top Cover‚ page 4-38.
5. Carefully lift the probe up to its highest point, to a safe position.
Move the probe by pushing on the probe arm.
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•
Push the sample probe vertical arm up and to the left back of the system.
•
Push the reagent probe up and to the right back of the system.
ADVIA Centaur CP Operator’s Guide: 4 Maintenance
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CAUTION
Ensure that no cleaning solution or water enters cuvettes through the dispense holes in the
incubation ring. Cleaning solution or water in the incubation ring can cause erroneous
results.
6. Carefully wipe the incubation ring cover with lint-free tissues or gauze saturated with
cleaning solution.
7. Carefully rinse the incubation ring cover with lint-free tissues or gauze saturated with
water.
8. Dry the incubation ring cover thoroughly.
9. Close the top cover.
10. Restart the system.
See Starting the System‚ page 2-3.
Cleaning the Exterior of the Reagent Probe
Use this procedure to clean the exterior of the reagent probe.
BIOHAZARD
Wear personal protective equipment. Use universal precautions. Refer to Appendix A,
Safety Information, for recommended precautions when working with biohazardous
materials.
WARNING
When handling the cleaning solution, follow the appropriate chemical safety guidelines,
which include wearing gloves, laboratory coat, and safety glasses or protective face
shield.
1. Turn power to the system off.
See Turning the System Off‚ page 2-8.
2. Open the top cover.
See Opening the Top Cover‚ page 4-38.
3. Carefully lift the probe up to its highest point, to a safe position.
Move the probe by pushing on the probe arm.
4. Check the probe for damage and to ensure that it is not bent.
5. Use a gentle downward motion to wipe the probe with an alcohol wipe.
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6. Move the probe back over the waste bowl.
Move the probe by pushing on the probe arm.
7. Close the top cover.
8. Restart the system.
See Starting the System‚ page 2-3.
Cleaning the Exterior of the Waste Probe
Use this procedure to clean the exterior of the waste probe.
BIOHAZARD
Wear personal protective equipment. Use universal precautions. Refer to Appendix A,
Safety Information, for recommended precautions when working with biohazardous
materials.
WARNING
Ensure that you use care when working with the probe. The probe tip is sharp and can
cause skin punctures.
CAUTION
Ensure that the probe is completely dry before starting system operation. Unevaporated
alcohol on the probe can cause erroneous results.
Use this procedure to clean the waste probe to prevent waste probe movement errors.
1. Turn power to the system off.
See Turning the System Off‚ page 2-8.
2. Open the top cover.
See Opening the Top Cover‚ page 4-38.
3. Wipe the probe with an alcohol wipe.
4. Close the top cover.
5. Restart the system.
See Starting the System‚ page 2-3.
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Cleaning the Probe Rails
Clean the probe rails regularly to prevent probe movement errors. Use this procedure to
clean the probe rails.
BIOHAZARD
Wear personal protective equipment. Use universal precautions. Refer to Appendix A,
Safety Information, for recommended precautions when working with biohazardous
materials.
1. Turn power to the system off.
See Turning the System Off‚ page 2-8.
2. Open the top cover.
See Opening the Top Cover‚ page 4-38.
3. Wipe the probe rails with an alcohol wipe.
4. Allow the rails to dry before resuming system operation.
5. Close the top cover.
6. Restart the system.
See Starting the System‚ page 2-3.
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Maintaining the System Exterior
Cleaning the System Exterior
Use this procedure to clean the system exterior.
BIOHAZARD
Wear personal protective equipment. Use universal precautions. Refer to Appendix A,
Safety Information, for recommended precautions when working with biohazardous
materials.
1. Using lint-free tissues or gauze saturated with water, perform the following steps:
a. Carefully wipe down the top cover.
b. Clean the system grasp points for the door and compartment handles.
c. Carefully wipe the exterior covers.
2. Dry all the surfaces thoroughly.
Cleaning the Workstation
Use this procedure to clean the workstation.
BIOHAZARD
Wear personal protective equipment. Use universal precautions. Refer to Appendix A,
Safety Information, for recommended precautions when working with biohazardous
materials.
WARNING
When handling the cleaning solution, follow the appropriate chemical safety guidelines,
which include wearing gloves, laboratory coat, and safety glasses or protective face
shield.
1. Prepare cleaning solution.
See Preparing the Cleaning Solution used on the System‚ page 4-37.
2. Carefully wipe the keyboard, mouse, monitor, and computer with lint-free tissues or
gauze dampened with cleaning solution.
3. Carefully wipe the keyboard, mouse, monitor, and computer with lint-free tissues or
gauze dampened with water.
4. Dry the components thoroughly.
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Performing Database Maintenance
Before running the Database Cleanup maintenance procedure, make sure that all samples
completed their run. Look at the Results tabs to determine if any samples are still pending.
Allow the ones that you need to start and complete, and then remove the sample racks
from the instrument. Any samples that are not complete at the time you run the Database
Cleanup procedure may be deleted during the process.
When you perform the Database Cleanup procedure, any pending tests change to “Failed.”
Delete these failed tests according to this procedure:
1. At the Workspace, select Results.
2. Select the Today’s tab.
3. Select the failed test.
4. Select Delete.
If your database contains approximately 22,000 results, it may take several minutes for the
cleanup task to complete. The interface is not locked. Take no action and allow the
procedure to complete.
When you backup the database, if an error message displays stating that the data cannot be
written to the CD, try the procedure again with a new CD. Check to see that the disk you
are using is a writable disk, that the disk is not defective, or that the disk is not full.
For more information regarding database maintenance, refer to the system online help,
Screen Help.
Maintaining the System Database
To ensure optimal system performance, for average system usage, you should clear results
from the database every month. System with greater than average usage should use the
following procedure more often. Typically, you would use this procedure monthly to
maintain the system database.
1. Export all results older than 30 days.
See Exporting Results‚ page 2-70.
2. Delete all results older than 30 days.
See Deleting Results and Scheduled Tests‚ page 2-69.
NOTE: In addition to maintaining the ADVIA Centaur CP database, it is recommended
that you backup you ADVIA QC database regularly. Refer to the ADVIA QC online help
system for details on how to backup and restore the ADVIA QC database.
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Backing Up System Data
You must have sufficient user rights to back up system data. System backup functionality
is available during system shutdown. See Exiting the System‚ page 2-5 for complete
information on backup options.
Use the following procedure to create a data backup of your system.
1. At the workspace, select Exit.
2. At the first prompt, asking if you want to exit the system software, select Yes.
3. At the second prompt, asking if you want to make a backup, select Yes.
4. Select Data-backup.
Of the 3 options for backups, Data-backup is the default. Use this option for routine
backups.
5. If you want to back up to a CD, select Write to CD-ROM.
6. Insert a CD into the CD tray.
7. Select Continue.
A window displays for a CD Writing Wizard.
The system backs up the information to the default directory D:\Archive\data. You can
change the default directory. To specify the directory where the ADVIA Centaur CP
system will write the backup file, refer to Setting System Backup Information‚
page 6-39.
8. Enter a CD name.
NOTE: The name can be anything you want, for example, the system serial number or
the date of the backup.
9. Select the checkbox for Close the wizard after the files have been written.
10. Select Next.
The CD Writing Wizard window automatically closes and the CD ejects when the
backup is complete.
11. When the backup is complete, select one of the following options for exiting:
•
Shutdown computer
•
Restart Software
•
Exit to desktop
12. Turn the instrument off.
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Restoring System Data
If you need to restore your system data, contact your technical support provider for
assistance.
General Maintenance Tasks
Preparing the Cleaning Solution used on the System
Use this procedure to prepare the cleaning solution used to perform system maintenance.
Cleaning solution is stable for seven days after preparation.
BIOHAZARD
Wear personal protective equipment. Use universal precautions. Refer to Appendix A,
Safety Information, for recommended precautions when working with biohazardous
materials.
WARNING
When handling the cleaning solution, follow the appropriate chemical safety guidelines,
which include wearing gloves, laboratory coat, and safety glasses or protective face
shield.
1. Carefully pour a container of ADVIA Centaur CP Cleaning Solution Concentrate into
the cleaning bottle, or other appropriate container.
2. Add enough DI water to the bottle or container to bring the total volume of cleaning
solution to 2 liters.
Performing an Automated System Prime
Perform this procedure on an as-needed basis or under the following conditions:
•
If you see that there are large air bubbles in the wash lines
•
If you have not run the system for a prolonged period
Use this procedure to perform an automated system prime. It takes approximately 10
minutes to complete.
1. Ensure that the system is initialized and in the Ready state.
2. At the workspace, select Maintenance.
3. Select Automated System Prime.
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4. Select Perform.
The system displays status indicating (1) the priming of the wash station and
luminometer probes, and then (2) the priming of the reagent probe tubing.
The system status changes to Finished and Successful.
5. When the procedure is complete, select OK.
Opening the Top Cover
Use this procedure to open the system cover.
WARNING
Do not perform maintenance tasks on the system interior with the system power turned on.
Ensure that the system power is turned off before performing these tasks. Some system
components can move unexpectedly and injury can result.
1. Ensure that the system has completed all sample processing and is in the Ready state.
Lifting the top cover stops all probes, and cancels all tests pending on the system.
2. Grasp the handle on the front of the cover and lift the top cover.
Installation, Relocation and Extended System Downtime
CAUTION
Do not install, remove from service, or move your ADVIA Centaur CP system.
Unauthorized movement, extended downtime, or installation can damage your system and
void your warranty and/or service contract. Unauthorized movement can also affect your
instrument calibrations. A Siemens technical support provider should install, remove from
service, or relocate your ADVIA Centaur CP system.
The system should be left on at all times. The system doors and drawers should be kept
closed at all times (except when required by the procedure being performed).
Contact Siemens or your technical support provider when you receive your
ADVIA Centaur CP system if you need to relocate your system within your facility, or if
you need to turn your system off for an extended period.
Disabling Assays
After disabling and enabling an assay, you must shut down and restart the
ADVIA Centaur CP software application for it to take affect. You must also perform a
daily, weekly, or monthly cleaning procedure as appropriate for that day.
Do not rerun Infectious Disease assays or controls that are set to repeat replicates. Use a
new workorder to schedule the repeat replicate assays or controls.
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Checking the Acid and Base Pumps
BIOHAZARD
All products or objects that come in contact with human or animal body fluids should be
handled, before and after cleaning, as if capable of transmitting infectious diseases.
Wear facial protection, gloves, and protective clothing.
The operator should follow the recommendations to prevent the transmission of infectious
agents in health-care settings as recommended by the Clinical and Laboratory Standards
Institute (formerly NCCLS) in Protection of Laboratory Workers from Occupationally
Acquired Infections; Approved Guideline - Third Edition. 2005. CLSI Document
M29-A3. This document contains complete information on user protection and it can be
used as reference material for instructions on laboratory safety.
WARNING
Avoid contact of acid and base reagents with skin and eyes. Acid and base reagents are
irritating to the skin. Wear suitable eye, face, and skin protection, which includes wearing
gloves, protective eye shield, and laboratory coat. In case of contact with the eyes, rinse
the eyes immediately with plenty of water and seek medical advice. In case of accident or
if you feel unwell, seek medical advice (if possible show the bottle label and Material
Safety Data Sheet). In case of accidental ingestion of reagent, call a physician
immediately.
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Figure 4-1
1
2
Acid and Base Pumps
Acid Pump
Base pump
1. Turn the instrument off.
2. Check the acid and base pumps for signs of leakage.
3. Observe whether or not the tubing connectors and tubing show signs of liquid coming
from the pumps.
If crystallization appears on the tubing connectors or on the base plate directly beneath
the pumps, then there is now or has been a leak.
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4. Using a lint-free tissue or piece of gauze, perform the following steps:
a. Carefully wipe around the tubing connector of the base rotary pump (the pump
with the blue tubing at the bottom of the pump).
Remove the tissue or gauze and determine if it is wet.
BIOHAZARD
Do not re-use the same tissue or gauze for the base pump and acid pump.
Cross-contamination between acid and base solutions can cause a chemical reaction.
b. Discard the used tissue or gauze.
c. Using another clean, lint-free tissue or piece of gauze, carefully wipe around the
tubing connector of the acid rotary pump (the pump with the white tubing at the
bottom of the pump).
d. Remove the tissue or gauze and determine if it is wet.
e. Discard the used tissue or gauze.
5. If there is a leak, try to eliminate the leak by tighten the tubing fitting at the base of the
pump with the leak using your fingers.
NOTE: Do not overtighten the fitting.
6. Inspect the shaft of the pumps (the part of the pumps that is closest to the back wall of
the instrument) for leaks using another clean, lint-free tissue or gauze.
7. If there is a leak, tighten the fitting at the back of the pump that is leaking using your
fingers.
NOTE: Do not overtighten the fitting.
8. If leak continues after you have tighten all the fittings, call your local technical
support provider for assistance.
9. Follow the established safety guidelines for your laboratory in disposing of the used
tissue or gauze.
Replacing the Blue Peripump Tubing
There are 2 peripumps in the instrument. The blue peripump distributes water across the
aspirate probes and rinse blocks. The gray peripump aspirates wash from the wash station,
luminometer, and aspirate probes.
BIOHAZARD
Wear personal protective equipment. Use universal precautions. Refer to Appendix A,
Safety Information, for recommended precautions when working with biohazardous
materials.
The blue peripump is divided into 2 segments. Replace the tubing on the rear segment
first, and then work on the front segment.
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Flushing Fluid from the Peripump Tubing
Before you begin to replace the tubing, use the following steps to flush the residual water
from the tubing:
1. Remove all sample racks from the sample compartment.
2. Remove and refrigerate the reagents and ancillary reagents.
You will have to resuspend the reagents when you reintroduce them into the
instrument after you complete the tubing replacement procedure.
3. Wait until the system is in a Ready state, and then turn the instrument off.
4. Open the top cover of the instrument.
5. Pull the inlet tubing connectors out to the left, and disconnect the inlet tubing
connectors on the blue peripump.
Figure 4-2
1
Disconnect of the Inlet Tubing Connectors
Inlet tubing connector
6. Close the top cover of the instrument.
The system displays a message that indicates that system communications have been
interrupted.
7. Turn the instrument on.
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8. Select Close.
The system initializes. This can take several minutes.
9. When the status on the workspace changes to Ready, select Start.
10. At the system message, “Do you want to start processing samples?,” select OK.
The status on the workspace changes to Running. The system initializes and primes.
This process can take approximately 5 minutes.
NOTE: During system initialization, do not use the system for any other purpose.
When the system prime is complete, the tubing is free of liquid.
Tubing Replacement Procedure
To replace the peripump tubing, use the following steps:
1. Turn the instrument off.
2. Open the top cover of the instrument.
WARNING
Ensure that you use care when working with the probe. The probe tip is sharp and can
cause skin punctures.
3. Grasp the sample probe by the probe housing and avoid grasping the probe by its tip.
4. Carefully raise the sample probe up, push it all the way back, and then push it gently
to the right side of the instrument until it stops.
Figure 4-3
1
Movement of the Sample Probe
Sample probe housing
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ADVIA Centaur CP Operator’s Guide: 4 Maintenance
5. The blue peripump has 2 segments, and each segment has a clamp cover. Squeeze the
side tabs of the tubing clamp cover at the rear of the pump first, and lift the clamp
straight up.
This exposes the pump tubing for replacement.
Figure 4-4
1
2
3
086D0320-01, Rev. 04
Location of the Blue Tubing Clamps
Inlet tubing connector
Tubing clamp cover
Outlet tubing connector
ADVIA Centaur CP Operator’s Guide: 4 Maintenance
4-45
6. Set the clamp aside.
Figure 4-5
1
2
3
4
Installation of the Tubing Assemblies
Inlet tubing connection
Pump segment tubing connectors
Pump segment tubing
Outlet tubing connection
7. Unscrew the inlet tubing connector and outlet tubing connector.
NOTE: Notice that the inlet tubing is larger than the outlet tubing. Do not reposition
or transpose the inlet and outlet tubing.
8. Pull the pump segment tubing connectors out to the sides of the pump.
9. Lift the tubing from the groove on the top of the rear segment of the pump from the
right side, and then from the left side.
10. Insert the new tubing into inlet side of the pump, and then screw and tighten the inlet
tubing to the connector, making it snug.
11. Insert the new tubing into outlet side of the pump, and then screw and tighten the
outlet tubing to the connector, making it snug.
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ADVIA Centaur CP Operator’s Guide: 4 Maintenance
12. Fit the tubing into the groove at the top of the rear segment of the pump with your
fingers, ensuring that it lies smoothly within the groove.
You will not be able to see the groove at the top of the pump. You must feel it with
your fingertips and position the tubing carefully within the groove.
NOTE: If the tubing is misaligned, it will be damaged by the installation of the tubing
clamp and will not work properly.
NOTE: The connectors must be really tight to avoid leaks. Ensure that you do not
loosen the connectors as you withdraw your hands from the pump.
13. Carefully align and push the pump segment tubing connectors back into place.
When the pump segment tubing connectors are properly aligned, you will hear them
click into place.
14. Position the clamp so that it is level and in line with the track at the bottom of the
pump, align the tubing connector with the slot, and press downward to snap it into the
locked position.
NOTE: If the sides of the tubing clamp cover remain compressed inward, push
downward on the top of the tubing clamp cover.
The sides of the tubing clamp cover will spring outward to align with the sides of the
pump.
15. Repeat the tubing and clamp replacement steps for the front segment of the pump.
16. Close the instrument cover.
17. Turn the instrument on.
The system displays a communication error.
18. Select Close.
If the system displays a message that indicates that the peristaltic pump could not home,
then use the steps described in, Removing the Tubing Clamp Covers‚ page 4-46.
Otherwise, proceed to Priming the System‚ page 4-47.
Removing the Tubing Clamp Covers
If the instrument fails to initialize, remove the tubing clamp covers and retry the
initialization.
1. Turn the instrument off.
2. Open the top cover of the instrument.
3. Remove the tubing clamp covers from both segments of the blue peripump.
4. Close the top cover of the instrument.
5. Turn the instrument on.
6. The system displays a communication error. Select Close.
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7. When the system is in a Ready state, select Start.
The system initializes and primes.
8. Turn the instrument off.
9. Open the top cover of the instrument.
10. Replace the tubing clamp covers on both segments of the pump.
11. When all the segment tubing has been replaced, close the top cover of the instrument.
12. Turn the instrument on.
13. The system displays a communication error. Select Close.
14. When the system is in a Ready state, select Start.
The system initializes and primes.
Priming the System
1. When the system is in a Ready state, select Start.
The system reinitializes and primes.
2. When the peripump tubing replacement is complete, resume normal operation.
Replacing the Gray Peripump Tubing
There are 2 peripumps in the instrument. The gray peripump aspirates wash from the wash
station, luminometer, and aspirate probes. The blue peripump distributes water across the
aspirate probes and rinse blocks.
The gray peripump is divided into 3 segments. Replace the tubing on the rear segment
first, and then work your way forward to the front segment.
BIOHAZARD
Wear personal protective equipment. Use universal precautions. Refer to Appendix A,
Safety Information, for recommended precautions when working with biohazardous
materials.
Flushing Fluid from the Peripump Tubing
Before you begin to replace the tubing, use the following steps to flush the residual water
from the tubing:
1. Remove all sample racks from the sample compartment.
2. Remove and refrigerate the reagents and ancillary reagents.
You will have to resuspend the reagents when you reintroduce them into the
instrument after you complete the tubing replacement procedure.
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ADVIA Centaur CP Operator’s Guide: 4 Maintenance
3. Wait until the system is in a Ready state.
4. Select Start.
5. At the system message, “Do you want to start processing samples?,” select OK.
The status on the workspace changes to Running. The system initializes and primes.
This process can take approximately 5 minutes.
NOTE: During system initialization, do not use the system for any other purpose.
When the system prime is complete, the tubing is free of liquid.
Tubing Replacement Procedure
To replace the peripump tubing, use the following steps:
1. Turn the instrument off.
2. Open the top cover of the instrument.
WARNING
Ensure that you use care when working with the probe. The probe tip is sharp and can
cause skin punctures.
3. Grasp the sample probe by the probe housing, and avoid grasping the probe by its tip.
4. Carefully raise the sample probe up, push it all the way back, and then push it gently
to the right side of the instrument until it stops.
Figure 4-6
1
086D0320-01, Rev. 04
Movement of the Sample Probe
Sample probe housing
ADVIA Centaur CP Operator’s Guide: 4 Maintenance
4-49
5. The gray pump has 3 segments, and each segment has a clamp cover. Squeeze the side
tabs of the tubing clamp cover at the rear of the pump first, and lift the clamp straight
up.
This exposes the pump tubing.
6. Set the clamp aside.
Figure 4-7
1
2
3
4
Installation of the Tubing Assemblies for the Gray Pump
Outlet tubing
Tubing connector
Pump segment tubing
Inlet tubing
7. Pull the inlet side of the tubing out to the side of the pump, and pull the inlet tubing
connector from that side.
NOTE: Notice that the inlet tubing is smaller than the outlet tubing. Do not reposition
or transpose the inlet and outlet tubing.
8. Lift the tubing from the groove on the top of the rear segment of the pump from the
right side.
9. Pull the outlet side of the tubing to the side of the pump and pull the outlet tubing
connector from that side.
10. Pull the tubing off the connectors to remove it.
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ADVIA Centaur CP Operator’s Guide: 4 Maintenance
11. Insert the new tubing into inlet side of the pump, and then attach the inlet tubing to the
connector, making it snug.
12. Place the tubing in the groove on the top of the pump, first from the right side and then
from the left side.
13. Insert the new tubing into outlet side of the pump, and then attach the outlet tubing to
the connector, making it snug.
14. Fit the tubing into the groove at the top of the rear segment of the pump with your
fingers, ensuring that it lies smoothly within the groove.
You will not be able to see the groove at the top of the pump. You must feel it with
your fingertips and position the tubing carefully within the groove.
NOTE: If the tubing is misaligned, it will be damaged by the installation of the tubing
clamp and will not work properly.
15. Align the tubing clamp with tubing track of the rear segment of the pump.
16. Position the clamp so that it is level and in line with the track at the bottom of the
pump, and press downward to snap it into the locked position.
NOTE: If the sides of the tubing clamp cover remain compressed inward, push
downward on the top of the tubing clamp cover.
The sides of the tubing clamp cover will spring outward to align with the sides of the
pump.
17. Repeat the tubing and clamp replacement steps for the front 2 segments of the pump.
18. When all the segment tubing has been replaced, close the instrument cover.
19. Turn the instrument on.
The system displays a communication error.
20. Select Close.
If the system displays a message that indicates that the peristaltic pump could not home,
then use the steps described in, Removing the Tubing Clamp Covers‚ page 4-50.
Otherwise, proceed to Priming the System‚ page 4-51.
Removing the Tubing Clamp Covers
If the instrument fails to initialize, remove the tubing clamp covers and retry the
initialization.
1. Turn the instrument off.
2. Open the top cover of the instrument.
3. Remove the tubing clamp covers from the 3 segments of the gray peripump.
4. Close the top cover of the instrument.
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5. Turn the instrument on.
6. The system displays a communication error. Select Close.
7. When the system is in a Ready state, select Start.
The system initializes and primes.
8. Turn the instrument off.
9. Open the top cover of the instrument.
10. Replace the tubing clamp covers on the 3 segments of the pump.
11. Close the top cover of the instrument.
12. Turn the instrument on.
13. The system displays a communication error. Select Close.
14. When the system is in a Ready state, select Start.
The system initializes and primes.
Priming the System
1. When the system is in a Ready state, select Start.
The system reinitializes and primes.
2. When the peripump tubing replacement is complete, resume normal operation.
Clearing a Jam from the Cuvette Loader
Use the following procedure to clear a cuvette that is lodged in the cuvette loader
assembly.
Removing the Cuvette Loader Assembly
Preliminary Steps
1. Exit the ADVIA Centaur CP system software to desktop.
2. On the left side of the system, turn the instrument off.
CAUTION
Ensure that the probes are in the safe position to avoid damage to the probes while lifting
the sample and reagent probes assembly.
3. Open the top cover of the instrument.
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ADVIA Centaur CP Operator’s Guide: 4 Maintenance
4. Move the sample and reagent probes to a safe position.
WARNING
Ensure that you use care when working with the probe. The probe tip is sharp and can
cause skin punctures.
NOTE: Grasp the sample probe by the probe housing, and avoid grasping the probe
by its tip.
a. Carefully raise the sample probe up, pull it all the way forward, and then push it
gently to the left side of the instrument until it stops.
b. Carefully raise the reagent probe up, and pull it all the way forward, and then push
it gently to the center of the instrument until it stops
Removing the Cuvette Loader Assembly
WARNING
Ensure that you use care when working in this area. Some surface edges are sharp and can
cause skin cuts and abrasions.
1. Loosen the thumb screw (shown in Figure 4-8 Cuvette Loader Assembly), until the 2
pins on the side of the cover clear their seat, and then remove the cuvette slide cover.
Leave the thumb screw attached to the cuvette slide cover.
2. Remove and discard all loose cuvettes in the cuvette slide.
3. Disconnect the ribbon cable to the cuvette loader by pushing the 2 tabs outward.
The cable ejects.
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4. Using a Phillips screwdriver, loosen the front captive screw, and then remove the
cuvette loader assembly by lifting it slightly and pulling it forward.
Figure 4-8
1
2
3
4
5
6
7
Cuvette Loader Assembly
Cuvette slide
Slide cover
Thumb screw
Lever arm
Front captive screw
Front locator pin
Ribbon cable
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ADVIA Centaur CP Operator’s Guide: 4 Maintenance
5. Turn the cuvette loader assembly upside down and remove any cuvettes that are still in
the chute.
Figure 4-9
1
Detached Cuvette Loader Assembly
Cuvette chute
When you turn the assembly upside down, loose cuvettes can fall out of the cuvette
chute.
6. Turn the cuvette loader assembly right side up.
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4-55
7. Lift the lever arm, and turn the sensor wheel to dislodge additional cuvettes.
Figure 4-10
1
2
Cuvette Loader Assembly with Lever Arm Raised
Lever arm
Home sensor CAM wheel
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ADVIA Centaur CP Operator’s Guide: 4 Maintenance
8. Use an implement (for example, a cotton swab, a mixing stick, or a clean, unused
sample tip) to drag cuvettes forward, and then turn the home sensor CAM wheel until
the cuvette drops out of the base of the assembly.
Figure 4-11
1
2
3
4
Cuvette Loader Assembly with Implement for Dragging Cuvettes
Lever arm in the raised position
Implement to pull cuvette forward (for
example, empty, unused sample tip)
Cuvette lodged inside the assembly
Home sensor CAM wheel
The dislodged cuvette drops out of the bottom of the cuvette loader assembly.
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ADVIA Centaur CP Operator’s Guide: 4 Maintenance
Figure 4-12
1
2
3
4-57
Final Cuvette Removed from the Cuvette Loader Assembly
Lever arm in the down position
Home sensor CAM wheel
Dislodged cuvette
9. Hold the assembly at an angle and turn the sensor wheel to remove any cuvettes that
remained in the assembly.
10. Inspect the assembly and verify that no cuvettes remain lodged inside the assembly.
Replacing the Cuvette Loader Assembly
1. Verify that the sensor wheel turns freely on the cuvette loader assembly.
2. Insert several test cuvettes and verify that cuvette loader assembly operates correctly.
3. Remove and discard any test cuvettes.
4. Replace the cuvette loader assembly:
a. Place the rear of the cuvette loader over the rear cuvette loader mounting pin, push
back until it engages, and then slide the cuvette loader assembly forward towards
the front to lock it in place.
b. Insert the front of the cuvette loader over the front locator pin.
c. Install the cuvette slide cover into the slot.
d. Locate the 2 pins on the slide cover, and then tighten the thumb screw.
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ADVIA Centaur CP Operator’s Guide: 4 Maintenance
e. Using a Phillips screwdriver, tighten the front captive screw to secure the cuvette
loader assembly.
f.
Re-install the ribbon cable using the guide tracks, and push until the tabs lock into
place.
2
1
Figure 4-13
1
2
Incubation Ring
Front locator pin
Rear cuvette loader mounting pin
5. Close the top cover.
6. Turn the instrument on.
7. Start the ADVIA Centaur CP software, and log on as Level 1.
8. When the system is in a Ready state, select Start.
The system initializes and primes.
9. Process a sample to ensure that there are no jams in the cuvette loader assembly.
Performing Dark Counts
Performing dark counts is a diagnostic tool that enables you to determine if there is a
problem with the luminometer.
Use the following steps to perform the dark counts:
1. At the workspace, select Diagnostics.
2. In response to the system message, “Are you sure you want to enter the Diagnostics
mode?” select Yes.
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3. Select the Luminometer tab.
4. Within the Dark Count Test section on the left side of the window, enter the number of
replicates (6 is the recommended number of replicates), and select with or without
cuvettes.
NOTE: If you enter a number greater than 1, then the mean RLU is the average of the
dark counts.
Values appear automatically in the Dark Counts section on the right side of the
window.
5. Compare the dark counts value displayed in the Dark Counts section of the window to
system recommendation (less than 300 RLUs).
6. Select Close to exit Diagnostics.
7. At the system message, select Yes to exit Diagnostics and return to the workspace.
If the dark count values are outside the ranges recommended (the value displayed is more
than 300), then record the value, and contact your local technical support provider.
Repositioning the Aspirate Probe Tubing
The aspirate probe tubing passes through the bubble detector clamps. The sensor requires
a clear spot on the tubing to detect bubbles. If the tubing is smudged or scratched, you may
have to wipe the tubing or move the tubing slightly up or down within the bubble detector
clamps.
Use the following procedure to reposition the aspirate probe tubing.
BIOHAZARD
Wear personal protective equipment. Use universal precautions. Refer to Appendix A,
Safety Information, for recommended precautions when working with biohazardous
materials.
1. Turn the instrument off.
2. Open the top cover of the system.
NOTE: Grasp the sample probe by the probe housing, and avoid grasping the probe
by its tip.
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ADVIA Centaur CP Operator’s Guide: 4 Maintenance
3. Carefully raise the sample probe, push it all the way back, and then push it gently to
the right side of the instrument until it stops.
Figure 4-14
1
086D0320-01, Rev. 04
Movement of the Sample Probe
Sample probe housing
ADVIA Centaur CP Operator’s Guide: 4 Maintenance
4-61
4. Open the tubing clamp cover by pulling on the right side to release the tubing.
The clamp cover opens like a door.
Figure 4-15
1
Aspirate Probe Tubing Clamps
Tubing clamp
5. Using a lint-free tissue or piece of gauze, wipe the tubing.
6. Reposition the tube higher or lower (enough to clear the kink in the tubing) within the
clamp.
NOTE: Ensure that the tubing is fully seated within the groove of the clamp.
NOTE: Ensure that you do not crimp or kink the tubing within the clamp.
7. Close the clamp cover.
When the clamp cover locks into place, there is an audible click.
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5
Troubleshooting Principles and Diagnostics
Troubleshooting Principles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
Monitoring the Event Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
Troubleshooting an Event. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2
Using the View Feature on the Event Log Screen . . . . . . . . . . . . . . . . . . . . .5-2
Responding to a Database Almost Full Message. . . . . . . . . . . . . . . . . . 5-3
Performing an Emergency Stop . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3
Recovering from a System Power Failure or System Lockup . . . . . . . . 5-3
Recovering from a Software Failure . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4
Recovering from a Facility Power Failure. . . . . . . . . . . . . . . . . . . . . . . . 5-5
When Power Fails. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-5
When Power is Restored . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-5
Enabling Remote Access . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6
Viewing the Status of Remote Access . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6
Diagnostics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-7
Recovering from a System Halt while in Diagnostics . . . . . . . . . . . . . . . 5-7
Initializing the Incubation Ring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-7
Emptying the Incubation Ring. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-8
Filling the Incubation Ring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-8
Emptying and Refilling the Incubation Ring . . . . . . . . . . . . . . . . . . . . . . 5-9
Initializing the System Probes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-10
Homing the Probes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-10
Homing the Entire System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-11
Performing Dark Counts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-11
Priming Individual System Fluids . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-11
Testing the Sample Probe for Clogs . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-12
Testing the Reagent Probe to Verify the Bubble Detector . . . . . . . . . . 5-12
Testing the Sample Barcode Scanner . . . . . . . . . . . . . . . . . . . . . . . . . 5-13
Testing the Primary Reagent Barcode Scanner . . . . . . . . . . . . . . . . . . 5-14
Scanning the Ancillary Pack . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-14
Calibrating the Solid Waste Bin Sensor . . . . . . . . . . . . . . . . . . . . . . . . 5-15
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ADVIA Centaur CP Operator’s Guide: Contents
5 Troubleshooting Principles and Diagnostics
This chapter contains information about troubleshooting and system diagnostics
procedures.
Troubleshooting Principles
Monitoring the Event Log
An event is a system activity or error recorded by the system in the Event Log. Events are
designed to provide you and your technical support provider with detailed information
necessary to understand system activity and status. Each event contains a unique event
code, the date and time of the event, the event message, the origin of the event, and the
severity level of the event. The historical log is maintained for the last 10,000 entries.
The event severity is indicated by one of 2 unique icons:
Icon
Meaning
Message (no icon)
Warning, Critical Error (yellow)
Problem, Fatal Error (red)
The Event Log icon, located on the left side of the status bar, displays the most recent 2
events. The Event Log button changes color to indicate the current status of the system.
•
Neutral indicates that the system is operating correctly.
•
Yellow indicates that a system warning condition has occurred. The system continues
to operate but requires your attention.
•
Red indicates that a system failure condition has occurred. The system stops operating
and requires your attention.
To view the full list of events, select the Event Log button on the workspace. You can
select an event from the list, and the select Details to view the online help for that event
including any corrective actions procedure associated with the event.
NOTE: Failure to follow the recommended procedures to resolve error events may cause
erroneous results or safety hazards. If you have exhausted the procedural steps to resolve
the issue and an error event continues to display, call for technical assistance.
An event can have a flag associated with it, to provide additional information about the
source.
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ADVIA Centaur CP Operator’s Guide: 5 Troubleshooting Principles and Diagnostics
•
S indicates that the event occurred during a service call.
•
D indicates the event was generated during an automatically initiated self-diagnostic
routine.
•
R indicates the event was generated during remote access.
Troubleshooting an Event
Most events do not require you to perform any action. Some events, however, identify a
problem or error in the system or software that require you to perform some
troubleshooting action. Use this procedure to troubleshoot an event using the system
Event Log.
For more information on the flags and codes used in the Event Log, see the Screen Help
section of the online help system.
1. At the workspace, select the Event Log button.
2. Select the event you want to troubleshoot.
In the event log display, the last event displayed may not be the issue. Look for related
events and events that occurred recently.
3. Select Details.
The event page for the event displays in the Troubleshooting section of the online help
system indicating possible causes and corrective actions.
4. Carefully read the message (and related messages), description, possible causes, and
corrective actions.
5. Take the appropriate actions.
6. If you cannot resolve the problem with the information provided, contact your local
technical support provider.
Using the View Feature on the Event Log Screen
When you use the View button on the Event Log screen, you must enter the full text for
the severity level, for example, “Critical Error” or “Fatal Error.” If you enter “Critical” or
“Fatal,” the list does not display the set of events for those severity messages.
Alternatively, you can enter the associated numeric value for that severity level, for
example, 3 for Critical Error or 4 for Fatal Error, to see the messages you want to display.
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5-3
Refer to the following table for a complete list of severity levels and associated codes.
Severity Level
Severity Code
0
Message
1
Warning
2
Problem
3
Critical Error
4
Fatal Error
Responding to a Database Almost Full Message
The system displays messages when the database is almost full.
Perform the database maintenance procedure according to Maintaining the System
Database‚ page 4-35.
Performing an Emergency Stop
If you need to stop all system mechanics, press the power switch on the left side of the
system.
Recovering from a System Power Failure or System Lockup
If the ADVIA Centaur CP system lost power, or stops functioning, perform the following
procedure:
1. On the left side of the instrument, press the power switch to turn the instrument off.
2. Wait 5 seconds.
3. Press the power switch again to turn the instrument on.
4. Ensure that the instrument begins to initialize.
If the system does not restart, perform the following procedure:
a. On the left side of the instrument, press the power switch to turn the instrument
off.
b. At the workspace, exit the system software, and shut down the computer.
c. Wait 5 seconds.
d. Press the power button on the computer to turn the computer on.
e. Sign in as Lab and enter the password.
The ADVIA Centaur CP software automatically starts the log in process.
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ADVIA Centaur CP Operator’s Guide: 5 Troubleshooting Principles and Diagnostics
f.
If the system software does not automatically launch, select the
ADVIA Centaur CP icon on the desktop to start the software.
g. If the system does not restart after a second attempt, contact your technical
support provider.
5. Sign in to the system.
See Signing In to the System‚ page 2-3.
6. Wait for the workspace to display.
7. After the workspace displays, press the power switch on the left side of the instrument
to turn the instrument on.
8. Re-introduce the ancillary reagents.
9. Re-introduce the sample racks.
10. Reset the tips.
11. Reorder the tests necessary to complete the work orders not completed during the
power failure.
12. If the problem persists, contact your local technical support provider.
Recovering from a Software Failure
If the ADVIA Centaur CP system software becomes frozen or does not respond, use the
following corrective actions.
Problem
Corrective Action
The system software appears to be
frozen.
Use a mouse or keyboard, or touch the
monitor, to see if the software responds.
You are unable to perform an action on
the monitor.
Check the connections for your mouse or
keyboard.
You are unable to perform an action on
the monitor or with the keyboard or
mouse.
1. Press and hold down the power button
on the computer for approximately 10
seconds until it turns off.
2. Turn the instrument off.
3. Press the power button on the computer
to restart the computer, restart the
software, and sign in to the software.
4. Restart the instrument.
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Problem
Corrective Action
A Debug error has occurred.
1. Press and hold down the power button
on the computer for approximately 10
seconds until it turns off.
2. Turn the instrument off.
3. Press the power button on the computer
to restart the computer, restart the
software, and sign in to the software.
4. Restart the instrument.
You cannot resolve your problem.
Contact your technical support provider.
Recovering from a Facility Power Failure
When Power Fails
If a facility power failure occurs, perform the following procedure:
1. Remove the sample racks and store the samples in an appropriate location.
2. Remove the primary and ancillary reagents and store them in an appropriate location.
3. If possible, ensure that the system and workstation power switches are turned off
before facility power is restored.
When Power is Restored
Once the facility power is restored, perform the following procedure:
1. Turn the computer on. If the system software does not launch automatically, select the
ADVIA Centaur CP icon on the desktop to start the software.
2. Sign in to the system.
See Signing In to the System‚ page 2-3.
3. Wait for the workspace to display.
4. After the workspace displays, press the power switch on the left side of the system to
turn the system on.
5. Wait approximately 5 minutes while the system initializes.
6. Reload the primary and ancillary reagents.
7. Reload the samples.
8. Reassign the tips.
9. Reorder the tests necessary to complete the work orders not completed during the
power failure.
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Enabling Remote Access
To enable remote access, use the following procedure:
1. At the workspace, select Setup.
2. Select the Users tab.
3. Select Start Remote Session.
Viewing the Status of Remote Access
To view the status of a remote access session, use the following procedure:
1. At the workspace, select Setup.
2. Select the Options tab.
The state of the shared connections displays in the Current State field.
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Diagnostics
The Diagnostics screen allows you to perform diagnostics procedures to analyze some of
the hardware components of the system.
The Diagnostics screen displays 6 tabs as follows:
•
Ring
•
Luminometer
•
Washer
•
Prime
•
Probes
•
Others
Each of these tabs has a command area to perform system actions, and a status area to
monitor the system activities. Entering or exiting the Diagnostics screen causes the system
to re-initialize.
To access the Diagnostics mode, at the workspace, select the Diagnostics tab.
For more information about Diagnostics, refer to the Screen Help section of the online
help system.
Recovering from a System Halt while in Diagnostics
If it is possible to select the Others tab in Diagnostics, use the following procedure:
1. At the Diagnostics screen, select Others.
2. In the Home area of the Others Tab, select System.
3. If this clears the system halt, resume your activity.
If the above procedure does not correct the problem, use this procedure to recover from a
system halt while in Diagnostics:
1. At the Diagnostics screen, select Close.
2. At the workspace, select Diagnostics to reenter the Diagnostics screen.
3. Resume your activity.
Initializing the Incubation Ring
You may need to verify that the incubation ring is functioning correctly or that no external
contamination occurred.
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Use this procedure to initalize the incubation ring:
1. At the workspace, select Diagnostics.
2. Select Yes to enter Diagnostics.
3. Select the Ring tab.
4. Select Initialize Ring.
The status of the ring initialization displays in the Status area. The system displays a
status of Complete when the initalization is finished.
5. Select Close when the system completes the procedure.
6. Select Yes to exit Diagnostics.
The system initializes when exiting Diagnostics.
Emptying the Incubation Ring
If an error has occurred or you have a dirty cuvette in the ring due to a system failure, you
may have to empty the incubation ring of all cuvettes. If a system failure or power outage
occurred, use this procedure to ensure that incubation ring is in a clean state before you
proceed with sample processing. This procedure can take approximately 10 minutes to
complete.
Use this procedure to empty the incubation ring of cuvettes:
1. At the workspace, select Diagnostics.
2. Select Yes to enter Diagnostics.
3. Select the Ring tab.
4. In the Cuvettes area, select Empty Ring.
The status of the emptying of the incubation ring displays in the Status area. The
system displays a status of Complete when the process is finished.
5. Select Close when the system completes the procedure.
6. Select Yes to exit Diagnostics.
Filling the Incubation Ring
If an error has occurred, you may have to fill the incubation ring. Use this procedure only
if the ring is completely empty.
NOTE: The system automatically fills the incubation ring with cuvettes when the system
initializes. Do not use this procedure if you plan to initialize the system as this will waste
supplies.
This procedure can take approximately 10 minutes to complete. Ensure that there is a
sufficient supply of cuvettes loaded in the system before you begin.
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Use this procedure to fill the incubation ring with clean cuvettes:
1. At the workspace, select Diagnostics.
2. Select Yes to enter Diagnostics.
3. Select the Ring tab.
4. In the Cuvettes area, select Fill Ring.
The status of the filling of the incubation ring displays in the Status area. The system
displays a status of Complete when the process is finished.
5. Select Close when the system completes the procedure.
6. Select Yes to exit Diagnostics.
Emptying and Refilling the Incubation Ring
If an error related to the incubation ring occurred, you may have to empty and refill the
incubation ring.
NOTE: The system automatically fills the incubation ring with cuvettes when the system
initializes. Do not use this procedure if you plan to initialize the system as this will waste
supplies.
This procedure can take approximately 20 minutes to complete. Ensure that there is a
sufficient supply of cuvettes loaded in the system before you begin.
Use this procedure to empty the cuvettes from the incubation ring, and then automatically
refill it with clean cuvettes:
1. At the workspace, select Diagnostics.
2. Select Yes to enter Diagnostics.
3. Select the Ring tab.
4. In the Cuvettes area, select Empty and Fill Ring.
The status of the emptying and refilling of the incubation ring displays in the Status
area. The system displays a status of Complete when the process is finished.
5. Select Close when the system completes the procedure.
6. Select Yes to exit Diagnostics.
The system initializes when exiting Diagnostics.
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ADVIA Centaur CP Operator’s Guide: 5 Troubleshooting Principles and Diagnostics
Initializing the System Probes
If the system does not return the sample probe and reagent probe to their home position
following an error condition, you can initialize the probes.
Use this procedure to initialize the system probes:
1. At the workspace, select Diagnostics.
2. Select Yes to enter Diagnostics.
3. Select the Luminometer tab.
4. In the Command Initialize area, select Probes.
The system resets the probes to their home position. The system homes the incubation
ring, the ring loader, the waste probe, the luminometer router, the wash probe
aspiration needles, and checks the tip eject on the sample probe.
5. Select Close when the system completes the procedure.
6. Select Yes to exit Diagnostics.
The system initializes when exiting Diagnostics.
Homing the Probes
If you are need to home the sample probe or the reagent probe, or if you are already in
Diagnostics and need to return the probes to their home position without leaving
Diagnostics, use this procedure:
1. At the workspace, select Diagnostics.
2. Select Yes to enter Diagnostics.
3. Select the Probes tab.
4. To home the sample probe, in the Command Sample Probe area, select Home.
The sample probe moves to its home position.
5. To home the reagent probe, in the Command Reagent Probe area, select Home.
The reagent probe moves to its home position.
6. Select Close when the system completes the procedure.
7. Select Yes to exit Diagnostics.
The system initializes when exiting Diagnostics.
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Homing the Entire System
If you need to home the system without leaving Diagnostics, use this procedure:
1. At the workspace, select Diagnostics.
2. Select Yes to enter Diagnostics.
3. Select the Others tab.
4. In the Home area, select System.
This moves the individual subsystems to their primary positions to ensure that the
system starts from the proper state after performing system tests. This does not move
the wash diluters or the pumps for the acid and base to their primary positions.
Performing Dark Counts
The cuvettes are cycled into the luminometer and past the photomultiplier tube (PMT)
when the dark count readings are recorded. Readings are displayed at the Dark Counts
displays area on the Luminometer tab.
Performing dark counts is a diagnostic tool that enables you to determine if there is a
problem with the luminometer.
For procedural information regarding performing dark counts, refer to Performing Dark
Counts‚ page 4-58.
Priming Individual System Fluids
Use this procedure to manually prime individual fluid components of the system:
1. At the workspace, select Diagnostics.
2. Select Yes to enter Diagnostics.
3. Select the Prime tab.
4. In the Channels area, select the box for the individual system fluid lines connected to
the pumps.
•
Acid
•
Base
•
Wash 1
•
Reagent Probe
5. In the Replicates field, set the number of repetitions.
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ADVIA Centaur CP Operator’s Guide: 5 Troubleshooting Principles and Diagnostics
6. Select Prime.
The status of the priming displays in the Status area. The system displays a status of
Complete when the priming is finished.
You can select Stop to cancel the priming.
7. Select Close when the system completes the procedure.
The system refills the incubation ring with clean cuvettes.
8. Select Yes to exit Diagnostics.
The system initializes when exiting Diagnostics.
Testing the Sample Probe for Clogs
If the event log displays event messages indicating that there is a sample integrity error,
you may have to verify that the sample probe is not clogged.
Use this procedure to check for sample probe clogs:
1. At the workspace window, select the Diagnostics tab.
2. Select Yes to enter Diagnostics.
3. Select the Probes tab.
4. In the Sample Probe area of the Command section, select Air Test.
5. On the Sample Probe Air Test window, select Start Pump.
6. Observe the reading in the display area of the Diagnostics tab.
NOTE: Acceptable values for the calibration range are between 25% and 40%. A low
value, for example, 16%, indicates a clog in the sample probe.
•
If the air test passed, exit Diagnostics and continue normal operations.
•
If the air test failed, contact your local technical support provider.
7. Select OK when the system completes the procedure.
8. Select Yes to exit Diagnostics.
The system initializes when exiting Diagnostics.
Testing the Reagent Probe to Verify the Bubble Detector
If the event log displays event messages indicating that there are volume check errors or
TAG aspiration errors, you may have to run the system sensor test for the reagent probe.
Use this procedure to verify the reagent probe sensor is functioning correctly:
1. At the workspace window, select the Diagnostics tab.
2. Select Yes to enter Diagnostics.
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3. Select the Prime tab.
4. In the channels area, select the box for the Reagent Probe.
This will ensure that you won’t have bubbles in the line before you run the system
sensor test.
5. Select the Probes tab.
6. In the Reagent Probe area of the Command section, select Sensor Test.
7. Select Run Test.
The reagent probe moves to the reagent probe rinsing station and begins the test. The
system displays a message indicating Pass or Fail.
•
If the sensor test passed, exit Diagnostics and continue normal operations.
•
If the sensor test failed, contact your local technical support provider.
8. Select Exit when the system completes the procedure.
9. Select Close.
10. Select Yes to exit Diagnostics.
The system initializes when exiting Diagnostics.
Testing the Sample Barcode Scanner
If you are not certain that the sample barcode scanner is functioning correctly, use this
procedure to test the scanner:
1. At the workspace window, select the Diagnostics tab.
2. Select Yes to enter Diagnostics.
3. Select the Others tab.
4. Open the sample compartment.
5. Remove the sample rack.
6. Enter a number to change the lane number where the scanner is focused for the
Sample scanner to test the ability of the barcode scanner to read the barcode on the
specified lane (1–7).
7. Select Sample.
8. Insert the sample rack in the selected lane.
9. Close the sample compartment.
10. Select Close when the system completes the procedure.
11. Select Yes to exit Diagnostics.
The system initializes when exiting Diagnostics.
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ADVIA Centaur CP Operator’s Guide: 5 Troubleshooting Principles and Diagnostics
Testing the Primary Reagent Barcode Scanner
If you are not certain that the sample barcode scanner is functioning correctly, use this
procedure to test the scanner:
1. At the workspace window, select the Diagnostics tab.
2. Select Yes to enter Diagnostics.
3. Select the Others tab.
4. Open the primary reagent compartment.
5. Remove the reagent pack.
6. Enter a number to change the lane number where the scanner is focused for the
Primary Reagent scanner to test the ability of the barcode scanner to read the barcode
on the specified lane (1–15).
7. Select Primary Reagent.
8. Insert the pack in the selected lane.
Reagent information appears in the Status frame.
9. Close the primary reagent compartment.
10. Select Close when the system completes the procedure.
11. Select Yes to exit Diagnostics.
The system initializes when exiting Diagnostics.
Scanning the Ancillary Pack
Use this procedure to verify that the ancillary reagent compartment scanner is functioning
appropriately:
1. At the workspace window, select the Diagnostics tab.
2. Select Yes to enter Diagnostics.
3. Select the Others tab.
4. Open the ancillary reagent compartment.
5. Remove the ancillary rack.
6. Select the lane (1 or 2).
7. Select Ancillary Reagent.
8. Insert rack in selected lane.
Ancillary information appears in the Status frame.
9. Close the ancillary reagent compartment.
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10. Select Close when the system completes the procedure.
11. Select Yes to exit Diagnostics.
The system initializes when exiting Diagnostics.
Calibrating the Solid Waste Bin Sensor
If the event log displays event messages indicating that the waste bin is full after you
empty it, you may have to calibrate the waste bin sensor.
Use the following procedure to calibrate the waste bin sensor:
1. Ensure that the solid waste bin is empty.
2. At the workspace, select Diagnostics.
3. Select Yes to enter Diagnostics.
4. Select the Others tab.
5. In the Solid Waste area, select Calibrate sensor.
The solid waste bin emitter and receiver are calibrated based on no optical
interference in the solid waste bin.
The system displays the Solid waste sensor calibration window with the message,
“Remove any cuvette in front of the sensor!”
6. Verify that no cuvette is blocking the sensor.
7. Remove any cuvette that is blocking the sensor, and then select Continue.
8. When the calibration is complete, select Yes.
9. Select Close when the system completes the procedure.
10. Select Yes to exit Diagnostics.
The system initializes when exiting Diagnostics.
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6
System Setup
Assay Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
Defining Ratio and Off-system Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
Defining or Editing Ratio Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-1
Defining or Editing Off-System Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-4
Deleting Ratio or Off-System Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-6
Multicomponent Assays . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-6
Setting Conditions for Multicomponent Tests . . . . . . . . . . . . . . . . . . . . . . . . .6-7
Procedural Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-8
Modifying General Options for an Assay . . . . . . . . . . . . . . . . . . . . . . . . 6-8
Setting Anonymous Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-11
Modifying the Patient Replicates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-11
Using Control Bracketing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-11
Modifying the Reagent Stability Options for an Assay . . . . . . . . . . . . . 6-13
Modifying Evaluation, Repeat, and Reflex Ranges . . . . . . . . . . . . . . . 6-14
Defining Evaluation Ranges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-14
Defining Ranges for Flagging and Automatic Sample Repeats . . . . . . . . . .6-15
Defining Check Ranges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-15
Defining Linearity Ranges. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-16
Defining Repeats for the Concentration and Index Calculation Ranges. . . .6-17
Defining Reflex Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-17
Defining Reflex Tests for Reference Ranges . . . . . . . . . . . . . . . . . . . . . . .6-18
Defining Reflex Tests for User Interpretation Options . . . . . . . . . . . . . . . . .6-18
Modifying Calculation Options for an Assay . . . . . . . . . . . . . . . . . . . . . 6-18
Defining General Calculation Options. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-19
Defining Calibration Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-19
Defining User Interpretation Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-21
Viewing System Interpretations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-22
Defining Result Formats . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-22
Modifying Dilution Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-23
Change the Display Order of Dilution Options . . . . . . . . . . . . . . . . . . . . . . .6-23
Defining Automatic Dilutions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-24
Unlocking a Disabled Assay . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-25
Profile Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-26
Assay and Dilution Profiles. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-26
Defining or Editing an Assay Profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-26
Defining a Dilution Profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-27
Deleting a Profile or Dilution Profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-27
Physicians . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-28
Defining Physician Profiles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-28
Deleting a Physician Profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-28
086D0320-01, Rev. 04
Contents-2
ADVIA Centaur CP Operator’s Guide: Contents
Users . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-29
Defining User Profiles. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-29
Deleting a User Profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-29
Setting Your Password . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-29
LIS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-30
System Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-30
Setting the Sample Scheduling Mode . . . . . . . . . . . . . . . . . . . . . . . . . 6-30
Setting the Priority of Sample Scheduling of a Test . . . . . . . . . . . . . . . 6-31
Setting the Total STAT Sample Scheduling Mode . . . . . . . . . . . . . . . . 6-31
Changing the Designated STAT Lane . . . . . . . . . . . . . . . . . . . . . . . . . 6-32
Setting the System Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-32
Specifying the Date Format . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-33
Specifying the Time Format . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-33
Specifying the Decimal Point . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-33
Setting the Language for the System . . . . . . . . . . . . . . . . . . . . . . . . . . 6-33
Setting the Language for the Online Help . . . . . . . . . . . . . . . . . . . . . . 6-33
Specifying Sample Tube Types . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-34
Adding Headers to Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-35
Allowing Automatic Repeat and Reflex of Samples . . . . . . . . . . . . . . . 6-35
Allow Automatic Repeat of Samples. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-35
Allow Automatic Reflex of Samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-35
Rerun a Sample if a Clot is Detected . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-36
Rerun a Sample if a Sample Integrity Error is Detected . . . . . . . . . . . . . . . .6-36
Quality Control Using ADVIA QC . . . . . . . . . . . . . . . . . . . . . . . 6-36
Changing User Units in ADVIA QC . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-36
Viewing Out of Range QC Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-36
Transmitting QC Results to ADVIA QC. . . . . . . . . . . . . . . . . . . . . . . . . 6-37
Multicomponent Tests. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-37
Transmitting QC Results to an LIS . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-37
Transmit Flashcurve . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-37
Audible Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-38
Setting Audible Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-38
Turning Off the Audible Alarms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-38
Miscellaneous System Settings . . . . . . . . . . . . . . . . . . . . . . . . 6-39
Setting Minimum and Maximum Sample ID Lengths . . . . . . . . . . . . . . 6-39
Automatically Printing Sample Results. . . . . . . . . . . . . . . . . . . . . . . . . 6-39
Setting System Backup Information . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-39
Setting System Handling of Expired Calibrations . . . . . . . . . . . . . . . . . 6-40
086D0320-01, Rev. 04
6 System Setup
Assay Definition
On the ADVIA Centaur CP system, you can add, delete, and modify all parameters for
user-defined ratio and off-system tests. For standard assays, as well as other assays
defined by Siemens, you can modify assay parameters such as the result units, the number
of decimal places for results, and the number of sample replicates. You can unlock
disabled assays that become available for use in your region.
You cannot add or delete definitions for assays defined by Siemens.
In order to change assay options for a particular assay a reagent pack cannot be loaded on
the system for that assay. The pack should be removed, the assay changed, and then the
pack reloaded.
Defining Ratio and Off-system Tests
Defining or Editing Ratio Tests
You can define the ratio tests for calculated parameters, for example, free thyroxine index
(FTI) and red blood cell folate (RBC folate). The ADVIA Centaur CP system calculates
the FTI and RBC folate values using direct measurement, equations, and off-system tests.
See the Assays section of the online help system for specific parameters for each assay.
The formula to calculate ratio tests is: [(A-B)/C] x D = ratio
When you request a ratio test, the system automatically schedules all assays defined as
part of the ratio. The component assays are not displayed as selected on the Sample
Compartment screen, only the ratio test is shown as selected. However, the components
are scheduled.
There is an 8 hour expiration time on ratio assays. If you schedule a ratio that has assays
that were run more than 8 hours ago, the ratio will run and fail. At the Result screen,
examine the component parts of the ratio and determine how old they are. To avoid a
failed result, when you run a ratio, ensure that the assays that make up the ratio are less
than 8 hours old before you request the ratio. If they are more than 8 hours old, delete the
component assay results and schedule the ratio.
If you request a ratio test and also request an assay that is part of the ratio test, the system
performs the assay only once. The assay result is reported as both part of the ratio result
and independently.
When you edit a component of a ratio test, the system automatically recalculates the ratio
test result and reports the result with an Edited flag.
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If you create a custom assay ratio, and the calculated result is less than 0, a negative result
is displayed.
No action is necessary. The result is negative.
Use this procedure to define or edit ratio tests:
1. At the workspace, select Setup.
2. Select the Assay tab.
3. Define or edit a ratio test:
If you want to . . .
Then . . .
define a ratio test
select Add Ratio.
edit a ratio test
select a ratio test, and then select Details.
4. In the Add Ratio or Ratio Details window, enter or edit the parameters:
If you want to . . .
Then . . .
enter the name of the test
enter the name in the Diagnostic Name
field.
NOTE: When you fill in the Diagnostic
Name field, the Display, Print and LIS
Name fields will be filled with the same
information. However, you can edit the
other fields afterward.
NOTE: It is recommended that you are
consistent and use all upper case letters
when entering a ratio name and an LIS
code. Ratio names and LIS codes are case
sensitive.
If you create several ratios with the same
LIS code, for example, Ratio1, ratio1,
RATIO1, when you later enter Ratio1
instead of ratio1, the system will only run
the Ratio1.
enter the name that displays on user
interface buttons and fields
enter the name in the Display Name field.
enter the name that prints on reports
enter the name in the Print Name field.
enter the code sent to the LIS/LMS for an
assay
enter the code in the LIS/LMS code field.
select the units
select a unit of measure (if required).
report results without the patient name or
PID
select Anonymous.
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If you want to . . .
Then . . .
review the result before the system reports
the result
select Hold Results.
enter a reference range
enter the low limit and the high limit.
NOTE: When you fill in the Diagnostic Name field, the Display, Print, and LIS Name
fields will be populated with the same information. You can edit these other fields
afterward.
It is recommended that you are consistent and use all upper case letters when entering a
ratio name and an LIS code. Ratio names and LIS codes are case sensitive.
If you create several ratios with the same LIS code, for example, Ratio1, ratio1, RATIO1,
when you later enter Ratio1 instead of ratio1, the system will only run the Ratio1.
NOTE: Use the formula displayed above the variable entry fields to define each ratio test.
5. Enter the variables for the formula:
The formula to calculate ratio tests is: [(A-B)/C] x D =
If you want . . .
Then . . .
the system to use an assay result in the
calculation
1. Select Assay from the list in the first
field next to the appropriate variable.
2. Select the ellipsis (...) button next to
the first field.
3. Select an assay from the Select Assay
window.
4. Select OK.
The assay displays in the second field
next to the appropriate variable.
to enter a number for the variable
1. Select Variable from the list in the
first field next to the appropriate
variable.
2. Enter a value in the second field next
to the variable.
Examples:
a. RBC Folate = [(FOLATE - 0)/ HCT] × 3150
Enter the following variables for an RBC Folate:
• A = Assays, FOL
• B = Variable, 0
• C = Assays, HCT (off system)
• D = Variable, 3150
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b. FTI = [(T4 - 0)/ 100] × % Uptake
Enter the following variables for FTI:
• A = Assays, T4
• B = Variable, 0
• C = Variable, 100
• D = Assays, TUp (%)
6. Select Format to edit up to 5 measurement ranges, and the number of decimal places
reported for each range.
See Defining Result Formats‚ page 6-22, for more information on defining formats.
7. Select User Interpretation to enter up to four optional measurement ranges and the
label that you want the system to use for results within each range.
See Defining User Interpretation Options‚ page 6-21, for more information on
defining optional user interpretation ranges.
8. Select OK.
Defining or Editing Off-System Tests
Use this procedure to define or edit an off-system test. An off-system test is a test that the
ADVIA Centaur CP system does not perform, but can report or use in a ratio test
calculation. For example, you can define hematocrit as an off-system test if you want the
system to calculate RBC folate.
NOTE: Off system results are not sent to the LIS.
1. At the workspace, select Setup.
2. Select the Assay tab.
3. Define or edit an off-system test:
If you want to . . .
Then . . .
define an off-system test
select Add Off-System.
edit an off-system test
select an off-system test, and then select
Details.
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4. Enter or edit the appropriate information.
If you want to . . .
Then . . .
enter the name of the test
enter the name in the Diagnostic Name
field.
When you fill in the Diagnostic Name
field, the Display, Print and LIS Name
fields will be filled with the same
information. However, you can edit the
other fields afterward.
NOTE: It is recommended that you be
consistent and use all upper case letters
when entering an off system name and an
LIS code. Off system names and LIS
codes are case-sensitive.
If you create several off system names
with the same LIS code, for example,
Xxxx1, xxxx1, XXXX1, when you later
enter Xxxx1 instead of xxxx1, the system
will only run the Xxxx1.
enter the name that displays on user
interface buttons and fields
enter the name in the Display Name field.
enter the name that prints on reports
enter the name in the Print Name field.
enter the code sent to the LIS/LMS for an
assay
enter the code in the LIS/LMS code field.
select the units
select a unit of measure.
enter a reference range
enter the low limit and the high limit.
5. Select Format to edit up to 5 measurement ranges, and the number of decimal places
reported for each range.
See Defining Result Formats‚ page 6-22 for more information on defining Formats.
6. Select OK.
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Deleting Ratio or Off-System Tests
Use this procedure to delete ratio and off-system tests. You are only allowed to delete
user-defined ratio and off-system tests.
NOTE: If an off system test is within a ratio, first delete the off system test, and then
delete the ratio.
1. At the workspace, select Setup.
2. Select the Assay tab.
3. Select a ratio or off-system test.
4. Select Delete.
5. Select OK.
Multicomponent Assays
The system uses the results from 2 or 5 standard tests or off-system tests in a formula to
calculate a multicomponent test result. The standard tests and off-system tests that are
used to determine a multicomponent result are referred to as component tests of the
multicomponent test. The formula is included in the multicomponent test definition. The
formula consists of a constant, coefficients, and test results. These are referred to as
variables in the Test-Multicomponent Definition window.
The following is an example of a formula used to calculate a result for a multicomponent:
Result = A + B x 1n(C) + D x 1n(E) + F x 1n(G) + H x 1n(I) + J X 1n(K) + L
Where A = constant
B, D, F, H, J = constant coefficients
C, E, G, I, K = test results from component assays
L = constant or assay
Variables A through K are set by the manufacturer and cannot be customized.
Variable L is available depending on the manufacturer settings in the multicomponent test
definition. The default value of variable L is 0. Variable L can be either of the following:
•
A test result of an off–system test
•
A numeric value
There are no result time limits applied to a test result that is used as variable L in the
multicomponent formula. The system calculates the multicomponent result using the
variable l element after all component test results are complete. For more information
about off-system tests, refer to Defining or Editing Off-System Tests‚ page 6-4.
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Setting Conditions for Multicomponent Tests
Specific conditions apply for a component of a multicomponent assay. This section
describes the following conditions or settings:
•
Result time limit
•
Units
•
Conversion factors
•
Patient Replicates
•
Autorepeat
•
Reflex
Result Time Limit
The result time limit for each component assay is set by the manufacturer. The result time
measurement begins when the result becomes available. If a sample is repeated, the time
measurement begins when the repeat component result is available.
If a result time limit expires for any of the components of a multicomponent test, the
system does not calculate a multicomponent result. For example, XA is a component of
the multicomponent test XYZ. If the XA test result time limit expires, the system does not
calculate an XYZ result.
The system retains result time limits for all component results of a multicomponent test
after a reboot. These conditions apply to patient tests and control tests.
Units
The user units and the master curve units must be the same for all component assays that
are defined in a multicomponent test definition. If a multicomponent assay is enabled, you
cannot change the user units for the component assays.
If you run component tests individually, you may change the user units. Disable the
multicomponent assay before changing the user units of a component assay you intend to
run individually.
Conversion Factors
The conversion factors must be the same for all component assays that are defined in a
multicomponent test definition. If a multicomponent assay is enabled, you cannot change
the conversion factors for the component assays. If you run component tests individually,
you may change the conversion factors. Disable the multicomponent assay before
changing the conversion factors of a component assay you intend to run individually.
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Replicates
A component assay may have more than one replicate selected in the test definition. When
a multicomponent test is ordered, the system runs one replicate of each component test
regardless of the replicate settings in the test definition.
Autorepeating a Component Assay
If the repeat option is enabled for a component assay for a multicomponent test and the
test result falls in the repeat range, the system repeats the component test and holds the
results of the other component tests. The repeated result is used to calculate the
multicomponent result.
The system runs one repeat replicate for each component test regardless of the replicate
settings in the test definition.
Reflexing
The rules regarding reflex testing are specific for a multicomponent assay. A component
test may reflex to a multicomponent test. If the component test result meets the reflex
criteria, the system schedules the multicomponent test and all component tests, including
the component test that initiated the reflex test. The multicomponent test result is
calculated using the second result of the component test that initiated the reflex
multicomponent test.
A component assay, when ordered within a multicomponent assay, cannot reflex to itself.
A multicomponent assay cannot be a component of a multicomponent or ratio assay.
Procedural Notes
You cannot order a multicomponent test in rack ID mode. You cannot create a dilution
profile for a multicomponent assay. The following options must be disabled for
components of a multicomponent assay:
•
Control Bracketing
•
Reuse Result Rule
Modifying General Options for an Assay
Use this procedure for the following reasons or under the following conditions:
•
to update the display name, print name, and the LIS code of the assay
•
to update the number of patient replicates and the acceptable CV
•
if results will be anonymous
•
if results will be held for review
•
to update the priority of an assay
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NOTE: You must remove the primary reagent pack from the system before you modify
the assay.
1. At the workspace, select Setup.
2. Select the Assay tab.
3. Select an assay.
4. Select Details.
5. Enter or edit the parameters:
If you want to . . .
Then . . .
change the name that displays on user
interface buttons and fields
enter the name in the Display Name field.
NOTE: If you change the Assay Display
Name and save the change, the system
displays the changes correctly. If you
change the Display Name again, an error
message displays indicating that the LIS
code is invalid.
To avoid this error message, you must
delete the Assay Display Name in the LIS,
and then change the Assay Display Name
to the original name. Then the error does
not display.
change the name that prints on reports
enter the name in the Print Name field.
enter or change the LIS/LMS code for an
assay
enter the code in the LIS/LMS code field.
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If you want to . . .
Then . . .
add or remove the assay from those
available in the lab
select Enable/Disable.
NOTE: Do not disable an assay unless all
pending workorders for that assay are
deleted.
• Selecting Enable/Disable removes the
assay from all button selection areas.
• You can not disable assays that are
part of a ratio, combination assay, or
within a profile.
• After disabling and enabling an assay
you must shut down and restart the
ADVIA Centaur CP software
application for it to take affect. You
must also perform a daily, weekly, or
monthly cleaning procedure as
appropriate for that day.
NOTE: You cannot disable the HBsAg
confirmatory (Conf) assay directly as you
would other assays. To disable Conf, you
must disable both Rgt A and Rgt B.
change the number of times the assay will
be repeated against a patient sample
edit the patient replicates.
NOTE: The HBsAg confirmatory (Conf)
assay can only be scheduled with 1
replicate regardless of the replicate
number selected.
change the acceptable percent variation
between results for each replicate
edit the Patient Acceptable CV field.
report results without the patient name or
PID
select Anonymous.
review the result before the system reports
the result
select Hold Results.
set the priority for an assay
edit the Priority field
NOTE: The Display, Print, and LIS Name fields default to the Diagnostic Name provided
by Siemens. However, you can edit these fields. Refer to the notes in the table above for
guidelines about editing these fields.
Additional setup options are available by selecting Reagents, Ranges, Calculation, or
Sample Dilution. Detailed setup procedures for each of these options are described below.
NOTE: You cannot edit the Diagnostics Name, Version, Product Code, and Sample
Volume fields.
6. Select Save.
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Setting Anonymous Results
Use this procedure to define an assay so that the system reports results without patient
names or identification numbers (PIDs). You can use this option when results require a
high level of confidentiality. You can set anonymous reporting for Siemens-defined
assays, and ratio tests.
NOTE: If this option is selected for any assay performed against a sample, the system
saves all results for that sample without a patient name or PID.
1. At the workspace, select Setup.
2. Select the Assay tab.
3. Select an assay.
4. Select Details.
5. Select Anonymous.
6. Select Save.
Modifying the Patient Replicates
Use this procedure to modify the number of times an assay is performed against patient
samples:
1. At the workspace, select Setup.
2. Select the Assay tab.
3. Select an assay.
4. Select Details.
5. Edit the number of patient replicates.
6. Select Save.
Using Control Bracketing
Control Bracketing requires you to open a bracket and close a bracket for a specific test
and reagent lot. Control bracketing enforces the processing of these controls within a
specified timeframe, called a control bracket. The system does not process samples until
the start-of-bracket controls are successfully aspirated. In addition, the system does not
report sample results until the end-of-bracket controls are successfully completed.
Laboratories can comply with procedural recommendations for certain tests that are
regulated very closely. The ADVIA Centaur CP system can perform tests with control
bracketing when the feature is enabled in the Assay Details window. This feature is
enabled by the manufacturer. If your laboratory does not require you to use this feature,
contact your local technical support provider or distributor to disable it.
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NOTE: Control Bracketing is not available for multicomponent assays. Control
Bracketing cannot be activated for individual components of a multicomponent assay.
Refer to Scheduling a Control Bracketed Patient Sample‚ page 2-49 for further
information on using control bracketing.
NOTE: If a test has control bracketing enabled and the system is in the Ready state, you
can edit the time interval, in hours, from the time that the start-of-bracket control set
produces acceptable results to the time that you want to see a control reminder.
Use this procedure to view if an assay is set up to be processed using control bracketing or
to modify the reminder:
1. At the workspace, select Setup.
2. Select an assay.
3. Select Details.
The Assay Details window displays.
NOTE: If you do not wish to use control bracketing, your local technical support provider
or distributor can disable it.
4. Confirm that the enabled option is selected if you want to process the assay in the
control bracketing mode.
5. View the number of controls to use in a bracket in the Levels field.
6. View the Timeout field for the maximum allowable time in hours between the start
and end-of-bracket controls, as defined by the manufacturer.
NOTE: The time interval is from the time that the start-of-bracket control set produces
acceptable results to the time that you see a reminder to schedule and process the
end-of-bracket controls.
7. When the system issues the Reminder, you must process the end-of-bracket controls
immediately or any retained patient test results will be discarded.
8. At the Reminder field, enter the time interval in hours.
A Reminder for a control bracketed test is a system reminder message to schedule and
process the end-of-bracket controls. This reminder helps prevent discarding retained
patient test results. Retained patient test results are patient test results that are not
reported by the system until the system processes an end-of-bracket set of controls
with acceptable results.
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Modifying the Reagent Stability Options for an Assay
If you . . .
Then . . .
want the system to remind you to schedule
and process the end-of-bracket controls,
enter a value greater than 0 and less than
the value in the Timeout field.
do not want the system to remind you to
schedule and process the end-of-bracket
controls,
enter 0.
If Siemens notifies you of a lot-specific date or obsolete extension, you can use this
procedure, if necessary, to modify the reagent stability option and use reagents beyond the
onboard and shelf stability dates (provided that the option is not locked). This option is
available only for certain assays. If the option is locked, the field is gray.
When you use this procedure to modify the stability option of a reagent, the results
generated are flagged with a Reagent Expired message.
NOTE: For primary reagent packs, changing the stability for the Lite Reagent also
changes the stability for the ancillary as well as the solid phase reagents.
1. At the workspace, select Setup.
2. Select the Assay tab.
3. Select an assay.
4. Select Details.
5. Select Reagents.
6. For each reagent associated with the assay, select the stability options.
If you want to . . .
Then . . .
define use of reagents beyond the opened
or onboard stability date
select Use Beyond from the Onboard
Stability menu.
define use of reagents only within the
opened or onboard stability date
select Do Not Use Beyond from the
Onboard Stability menu.
define use of reagents beyond the
unopened (shelf) stability date
select Use Beyond from the Shelf
Stability menu.
define use of reagents only within the
unopened (shelf) stability date
select Do Not Use Beyond from the Shelf
Stability menu.
NOTE: If you select the Use Beyond menu option, see the Assays section of the online
help system for assay-specific information.
7. Select Save.
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Modifying Evaluation, Repeat, and Reflex Ranges
You can define reference ranges for your patient population, result interpretations for
results within a certain range, and reflex tests for samples with certain results.
NOTE: The Auto Rerun and Auto Reflex options must be selected on the System tab for
automatic repeat or reflex tests to be scheduled. See Allowing Automatic Repeat and
Reflex of Samples‚ page 6-35, for details on allowing Auto Rerun and Auto Reflex.
Defining Evaluation Ranges
Use this procedure to define the ranges for your patient population. Enter the range
established by your laboratory or the expected values provided in the Assays section of the
online help system. The system displays flags for results outside the defined ranges. You
can also use evaluation ranges to set reflex tests. See Defining Reflex Tests‚ page 6-17, for
details on setting reflex tests.
1. At the workspace, select Setup.
2. Select the Assay tab.
3. Select an assay.
4. Select Details.
5. Select Ranges.
6. Select the checkbox next to the first evaluation range.
7. You can enter or edit reference ranges for different patient populations. Use the range
established in your laboratory or the one provided in the Assays section of the online
help system.
If you want to enter or edit . . .
Then . . .
the name of the reference range, such as
Child or Adult
enter the name of the range.
the low limit or the high limit for the
reference range
enter the low limit or the high limit.
the gender
select M for male or F for female. If you
select both male and female, the
evaluation range is used for both sexes.
the age range
enter the low and high ends of the range.
Age range is entered in years. If the age is
less than one year, enter a percentage of a
year.
8. If required, define reflex tests for results that are outside the reference ranges. See
Defining Reflex Tests for Reference Ranges‚ page 6-18.
9. Select OK.
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Defining Ranges for Flagging and Automatic Sample Repeats
You can define the result ranges that you want to repeat, such as samples outside the check
range, or linearity. You can also choose to repeat samples outside the concentration
calculation range or index calculation range on the Master Curve card.
You can flag and repeat, or flag only for the following ranges:
• check range low/high limit
• linearity range low/high limit, repeat above/below
You can flag and repeat for the following ranges:
• concentration range above/below
• index range above/below
NOTE: The Auto Rerun and Auto Reflex options must be selected on the System tab for
automatic repeat or reflex tests to be scheduled. See Allowing Automatic Repeat and
Reflex of Samples‚ page 6-35 for details on allowing Auto Rerun and Auto Reflex.
Defining Check Ranges
A check range flag displays when the results are all within the defined range. Make sure
you set the low range limit for a check range to a value greater than 0, for example, 0.001.
Use this procedure to set the check range:
1. Select Setup.
2. Select Assay tab.
3. Select the assay.
4. Select Details.
5. Select Ranges.
6. Set the low limit of the check range to a value greater than 0, for example, 0.001.
Use this procedure to define the check range for an assay and if the assay repeats on
samples with results that are outside of this range. The system always flags samples
outside of the defined range. You do not need to define both a low and a high value for the
check range.
A check range is a range above and below which a result is repeated to verify its accuracy.
For example, if you have an assay whose reference range is 5–12 ng/dL, you may want to
repeat all results below 4 and above 15. The low limit of the check range is 4 and the high
limit of the check range is 15.
CAUTION
Do not change the check range values for the infectious disease assays. They should
remain as stated in the Instructions for Use (IFU).
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Enter or edit the low and high limits of the check range. The system always flags results
that are outside the check range limits.
7. To repeat assays based on the low limit of the check range, select the repeat if...
checkbox under the low limit:
If you want to repeat if results are . . .
Then . . .
less than the low limit of the check range
select Repeat if <.
greater than or equal to the low limit of the
check range
select Repeat if >=.
8. To repeat assays based on the high limit of the check range, select the repeat if...
checkbox under the high limit:
If you want to repeat if results are . . .
Then . . .
less than or equal to the high limit of the
check range
select Repeat if <=.
greater than the high limit of the check
range
select Repeat if >.
9. To repeat assays on samples with results inside a defined “hot zone” (above the low
limit of the check range, but below the high limit of the check range):
•
Select Repeat if >= in the Check Range area for the low limit.
•
Select Repeat if <= in the Check Range area for the high limit.
Defining Linearity Ranges
Use this procedure to set flagging and sample repeat for samples outside a linearity range.
Linearity is a range above and below which the assay is no longer linear or sensitive. You
can find this range in the product insert or you can define your own -specific linear range.
You can also repeat assays on samples with results that are outside of this range. The
system will always flag samples outside of the defined range. You do not need to define
both a low and a high value for the linearity range.
1. At the workspace, select Setup.
2. Select the Assay tab.
3. Select an assay.
4. Select Details.
5. Select Ranges.
6. Enter or edit the low limit and high limit of linearity. The system always flags results
that are outside the linearity limits.
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7. Define if you want to repeat assays on samples with results outside the linearity limits:
If you want to repeat if results are . .
Then . . .
less than the low limit of linearity
select Repeat If Below in the Linearity
Range area.
greater than the high limit of linearity
select Repeat If Above in the Linearity
Range area.
8. Select OK.
Defining Repeats for the Concentration and Index Calculation Ranges
Use this procedure to repeat assays on samples with results above or below the
concentration or index calculation range on the Master Curve card:
1. At the workspace, select Setup.
2. Select the Assay tab.
3. Select an assay.
4. Select Details.
5. Select Ranges.
6. Define if you want the system to repeat assays when results are outside the
concentration or index calculation range on the Master Curve card:
If you want the system to . . .
Then . . .
automatically repeat an assay when results
are below the concentration calculation
range
select Repeat if Below Concentration
Range.
automatically repeat an assay when results
are above the concentration calculation
range
select Repeat if Above Concentration
Range.
automatically repeat an assay when results
are below the index calculation range
select Repeat if Below Index Range.
automatically repeat an assay when results
are above the index calculation range
select Repeat if Above Index Range.
7. Select OK.
Defining Reflex Tests
Reflex tests are supplemental assays or profiles that are scheduled in response to low or
high results. You can define a reflex test that the system schedules automatically if a result
is outside a reference range or within an interpretation range.
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NOTE: You must select the Auto Rerun or Auto Reflex option on the System tab for
automatic repeat or reflex tests to be scheduled. See Allowing Automatic Repeat and
Reflex of Samples‚ page 6-35 for details on allowing Auto Rerun and Auto Reflex.
Defining Reflex Tests for Reference Ranges
Use this procedure to define a reflex test that the system schedules automatically if an
assay result is outside a reference range. To define a reference range, see Defining
Evaluation Ranges‚ page 6-14.
You can select a reflex test only if the assay definition for the reflex test is defined on the
system. If a reflex test has been defined for an assay, you cannot remove samples
processed against that assay until all results are reported.
1. At the workspace, select Setup.
2. Select the Assay tab.
3. Select an assay.
4. Select Details.
5. Select Ranges.
6. Select Auto Reflex.
NOTE: You must have at least one reference range defined to set reflex tests.
7. On the Auto Reflex window, select the reflex test for the low limit or the high limit of
the range:
a. For each named range, select the ellipsis (...) button next to the Schedule If Below
field, or the Schedule If Above field.
b. Select an assay to be run against the sample.
For each reflex test, you can only select a single assay to perform.
c. Select OK.
d. The assay displays in the appropriate field.
8. Select OK.
Defining Reflex Tests for User Interpretation Options
A user result interpretation is a label that you want the system to use for results within a
certain range, such as reactive or nonreactive. For detailed information on setting User
Interpretation ranges, and the reflex tests associated with them, refer to Defining User
Interpretation Options‚ page 6-21.
Modifying Calculation Options for an Assay
You can modify the parameters that the ADVIA Centaur CP system uses to calculate and
report results. In addition, you can set the settings used for the calibration of the system.
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Defining General Calculation Options
Use this procedure to define general calculation options for assays. General calculation
options are used to adjust the system results to match those of another system that uses
different methodology. When the slope and intercept are modified, the system adjusts the
curve by the designated changes before reporting a result.
1. At the workspace, select Setup.
2. Select the Assay tab.
3. Select an assay.
4. Select Details.
5. Select Calculation.
If you want to . . .
Then . . .
define a new unit for the assay result
select a user unit.
enter the factor required to convert the
master curve unit to the user unit
enter a conversion factor.
modify the Master Curve slope used in
reporting results
enter a slope.
modify the Master Curve intercept used in
reporting results
enter an intercept.
6. Select OK.
Defining Calibration Options
Use this procedure to review or edit calibration options, such as the calibration interval,
for each assay. You cannot set all options for some assays. Refer to Calibration Overview‚
page 3-1 for more information about performing calibrations.
NOTE: For Infectious Disease assays, some fields cannot be edited and these fields are
grayed out.
1. At the workspace, select Setup.
2. Select the Assay tab.
3. Select an assay.
4. Select Details.
5. Select Calculation.
6. Select Calibration.
7. Complete the appropriate tasks.
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NOTE: The number of calibrator replicates in the Minimum Replicates field and the
system limits for a retained calibration in the Retained Cal Limit field are established
at the time of manufacture. You can only enter a number of replicates that is greater
than the default defined by the manufacturer. You can only enter an interval that is less
than the default defined by the manufacturer.
If you want to . . .
Then . . .
define the number of calibrator replicates
to perform the first time a calibrator lot is
used
enter a number in the New Lot Replicates
field.
This number must be larger or equal to the
number of replicates for Current Lot
Replicates and Minimum Replicates
fields.
New Lot
define the number of calibrator replicates
to perform for the current lot
Current Lot
Minimum
enter a number in the Current Lot
Replicates field.
This number must be smaller or equal to
the number of replicates in the New Lot
Replicator field and larger or equal to the
number of replicates in the Minimum
Replicates field.
New Lot
Current Lot
Minimum
Minimum Replicates field
This field is not user editable.
define the maximum number of days
between calibrations of the assay
enter a number in the Calibration Interval
Days field.
define the maximum number of hours
between calibrating of the assay
enter a number in the Calibration Interval
Hours field. You can set the stability in
days or hours, but not both.
allow the completion of tests already in
process, and enable the system to allow
you to use a previous calibration that has
expired (that will extend usage for an
additional 24 hours)
select Waive Calibration.
enable the system to allow you to accept a
calibration that falls outside the observed
range but within the defined range
select Accept Calibration.
enable the system to allow you to assign a
valid calibration to RLU-only results
select Assign Calibration.
enable the system to automatically use
data from a previous calibration when new
calibration values are almost
mathematically identical to previous
values
select Retain Calibration.
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If you want to . . .
Then . . .
enable the system to automatically exclude
a calibrator replicate result when it is
outside of the defined ranges for precision
select Autoexclude Cal Replicates.
define the parameters that define if a
calibration will be retained
edit the Retain Cal Limit T and Retain Cal
Limit RLU fields.
8. Select OK.
Defining User Interpretation Options
Use this procedure to define labels that you want the system to use for results within a
certain range, such as reactive or nonreactive. You can define up to four custom result
interpretations for your laboratory in addition to the result interpretations defined by the
manufacturer.
1. At the workspace, select Setup.
2. Select the Assay tab.
3. Select an assay.
4. Select Details.
5. Select Calculation.
6. Select User Interpretation.
7. Enter the number of thresholds (1, 2, or 3).
8. Enter the threshold values.
The number of threshold values available is based on the number of thresholds.
9. Enter the threshold interpretation names. The number of threshold interpretation
names available is based on the number of thresholds.
10. Select an optional reflex test, if any, for each threshold interpretation:
a. For each named range, select the ellipsis (...) button next to the Assays to
Schedule field.
b. Select an assay to be run against the sample.
For each reflex test, you can only select a single assay to perform.
c. Select OK.
The assay displays in the appropriate field.
NOTE: For reflex tests to be run, the Auto Reflex checkbox must be selected on
the System tab. See Allow Automatic Reflex of Samples‚ page 6-35.
11. Select OK.
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Viewing System Interpretations
Use this procedure to view the Siemens predefined interpretations for results:
1. At the workspace, select Setup.
2. Select the Assay tab.
3. Select an assay.
4. Select Details.
5. Select Calculation.
6. Select System Interpretation to view the interpretations defined by the manufacturer.
7. Select Cancel.
Defining Result Formats
Use this procedure to define the number of decimal places used when reporting results:
1. At the workspace, select Setup.
2. Select the Assay tab.
3. Select an assay.
4. Select Details.
5. Select Calculation.
6. Select Format.
7. Enter Measurement Ranges.
You can define up to 5 measurement ranges.
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8. Edit the number of decimal places for each range.
To add decimal places, press any key. Press the key once for each decimal place
required. You can report from zero to 3 decimal places for each range.
Some examples of format ranges are:
Low
High
Format
Example
0
< 0.2
#.###
Results in this range are reported with 3 digits
after decimal point, for example, 0.123, 0.030,
or 0.009.
0.2
<1
#.##
Results in this range are reported with 2 digits
after decimal point, for example, 0.23, 0.30, or
0.99.
1
< 100
##.#
Results in this range are reported with 1 digits
after decimal point. For example, 23.0, 1.3, or
99.
##
Results in this range are reported without
digits after decimal point, for example, 123 or
1299.
100
Modifying Dilution Options
•
You can change the display order of the Siemens-defined dilution options defined for
use in your laboratory.
•
You can define automatic dilution options for certain assays, which dilute samples
with results greater than a specified concentration.
•
You can define dilution options for specific samples. Refer to Operating the System‚
page 2-1 and for more information about diluting individual samples.
Change the Display Order of Dilution Options
Use this procedure to set the dilution options available in your laboratory:
1. At the workspace, select Setup.
2. Select the Assay tab.
3. Select an assay.
4. Select Details.
5. Select Sample Dilution.
6. Select a dilution.
7. Select Up to move the dilution up in the display order.
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8. Select Down to move the dilution down the display order.
9. Select OK.
NOTE: The Confirmatory assay (Conf) always displays last in the assay list though it is
not last in the TDef summary.
Defining Automatic Dilutions
Use this procedure to define dilutions that the system schedules automatically if an assay
result is outside specified range:
1. At the workspace, select Setup.
2. Select the Assay tab.
3. Select an assay.
4. Select Details.
5. Select Ranges.
6. Select Auto Dilution.
NOTE: The Dilution Point, Overdilution Point, or Auto-Dilution fields may not be
available depending on the displayed assay.
NOTE: If you define a dilution point, you must also define an overdilution point and
auto dilution. If an auto dilution is not defined, the system does not have enough
information to automatically dilute a sample. If an overdilution point is not defined,
the system does not have enough information to check the diluted result.
7. In the Dilution Point field, enter the concentration above which you want the system
to perform an automatic dilution.
If the result is above the concentration limit that you enter in this field, the system
flags the result and automatically schedules a dilution.
8. In the Overdilution Point field, enter the concentration below which you do not want
the system to determine a result for the specific dilution.
The overdilution point should be equal to or greater then the low limit of the linearity
range specified on the Ranges window. If no low limit is defined, the overdilution
point should be equal to the sensitivity limit of the assay, as reported in the product
instruction in the Assays section of the online help system.
The overdilution point provides an indication that the sample should have been diluted
at a lower level or not at all. The system compares the uncorrected diluted
concentration to the value displayed in the Overdilution Point field. If the
concentration is below the overdilution point, the system does not report a result for
the sample.
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For example, if the overdilution point for ThCG is 5.0 mIU/mL (IU/L) and the
uncorrected result is 4.5 mIU/mL (IU/L) on a sample diluted 1:200, the system does
not determine a result for the sample because the concentration is below the specified
concentration. The system flags the result and does not schedule or repeat the assay.
To obtain a result, you can process the sample undiluted or diluted at a lower level,
such as 1:5.
9. Select the ellipsis (...) button next to the Auto Dilution field to select a dilution factor.
10. Select a dilution.
11. Select OK.
Unlocking a Disabled Assay
Certain assays are disabled and locked by the manufacturer pending approval for use by
the regulatory authority in your region. When the software is installed your local service
provider sets the region for which your system is governed.You are not able to use the
disabled assay until you are advised to enable and unlock the assay.
Once the approval for use is granted in your region, the Release key password to unlock
the assay is communicated to you in a customer bulletin.
Use this procedure to unlock an assay:
1. At the workspace select Setup.
2. Select the assay.
3. Select Details.
4. In the Assay Details window, select Enable.
5. An Enter Release Key dialog box opens. Enter the release key password in the Release
Key box.
6. Select OK.
Once the assay is unlocked, you can enable and disable the assay in the Test Definition as
needed. Refer to Modifying General Options for an Assay‚ page 6-8.
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Profile Definition
Assay and Dilution Profiles
Defining or Editing an Assay Profile
Use this procedure to define and delete assay profiles, which allow you to schedule
multiple assays for a sample. For example, if you define a thyroid profile, select all of the
thyroid assays that you want to include in the profile.
1. At the workspace, select Setup.
2. Select the Profile Definition tab.
If you want to . . .
Then . . .
add an assay profile
select Add Profile.
create a new profile by copying an existing
profile
1. Select an existing profile from the list.
2. Select Copy.
view or change an existing profile
1. Select an existing profile from the list.
2. Select Details.
3. Enter or edit the profile name.
You are allowed 1 to 10 characters.
4. Enter or edit the LIS name.
You are allowed 1 to 8 characters. The LIS name cannot contain spaces.
5. Select the assays you want in the profile.
6. Select Use as Default Profile to run the selected assays against any sample that does
not have a work order.
7. Select Save.
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Defining a Dilution Profile
Use this procedure to define a dilution profile that allows you to schedule multiple
dilutions via the LIS for an assay:
1. At the workspace, select Setup.
2. Select the Profile Definition tab.
If you want to . . .
Then . . .
add a dilution profile
select Add Dilution Profile.
create a new profile by copying an existing
profile
1. Select an existing dilution profile from
the list.
2. Select Copy.
view or change an existing profile
1. Select an existing dilution profile from
the list.
2. Select Details.
3. In the Profile area, enter the name.
You are allowed 1–10 characters.
4. Enter the LIS code.
You are allowed 1–8 characters. The LIS name cannot contain spaces.
It is recommended that you are consistent and use all upper case letters when entering
a profile name and an LIS code. Profile names and LIS codes are case sensitive.
If you create several profiles with the same LIS code, for example, Prof1, prof1,
PROF1, when you later enter Prof1 instead of prof1, the system will only run the
Prof1.
5. Select the assay you want to dilute.
6. Select the available dilution factors.
Only dilution factors previously defined by Siemens are available.
7. Select Undiluted to also run the assay against an undiluted sample.
8. Select Save.
Deleting a Profile or Dilution Profile
Use this procedure to delete a profile or dilution profile:
1. At the workspace, select Setup.
2. Select the Profile Definition tab.
3. Select an existing profile or dilution profile from the list.
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4. Select Delete.
5. On the Delete window, select OK.
Physicians
Defining Physician Profiles
Use this procedure to add or edit a physician profile:
1. At the workspace, select Setup.
2. Select the Physicians tab.
If you want to . . .
Then . . .
add a physician profile
select Add.
create a new profile by copying an existing
profile
1. Select an existing profile from the list.
2. Select Copy.
view or change an existing profile
1. Select an existing profile from the list.
2. Select Details.
3. Enter the information. See the Screen Help section of the online help system for
details on these fields.
4. Select Save.
Deleting a Physician Profile
Use this procedure to delete a physician profile:
1. At the workspace, select Setup.
2. Select the Physicians tab.
3. Select a profile from the list.
4. Select Delete.
5. On the Delete window, select OK.
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Users
Defining User Profiles
Use this procedure to add or edit a user profile. You can only add or edit users whose
rights are equal to or less than your own rights:
1. At the workspace, select Setup.
2. Select the Users tab.
If you want to . . .
Then . . .
add a user profile
select Add.
view or change an existing profile
1. Select an existing profile from the list.
2. Select Details.
3. If you are adding a new profile, add the user name.
User names must contain between 5 and 10 characters. You cannot edit existing user
names.
4. Add or change the user rights.
5. Enter and confirm a password.
Passwords must contain at least 5 characters, and are case sensitive.
6. Select Save.
Deleting a User Profile
Use this procedure to delete a user profile. You can only delete users whose security levels
are equal to or less than your own rights.
1. At the workspace, select Setup.
2. Select the Users tab.
3. Select a profile from the list.
4. Select Delete.
5. On the Delete window, select OK.
Setting Your Password
If you forget your password, use this procedure to change your password:
1. At the workspace, select Setup.
2. Select the Users tab.
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3. Select your user name.
4. Select Details.
5. Enter your new password.
6. Enter your new password again, and then select Save.
7. Select Close to return to the workspace.
LIS
For information on configuring your system to your LIS, see the ADVIA Centaur CP
Interface Specification Guide.
System Settings
Setting the Sample Scheduling Mode
Use this procedure to select the order in which the system aspirates samples. The system
aspirates samples in the most efficient order possible, either by the individual racks, by the
whole compartment, or by test. You may also select how STATs are scheduled.
Typically, the system schedules the sample processing by aspirating the sample with the
longest incubation time first.
•
When you schedule by rack, the system starts with the leftmost rack and processes the
test with the longest incubation time first, then the next longest, and so forth. When
the system has processed all tests from that rack, it starts to process the next rack. The
system indicates that you can remove the processed rack and replace it with another
rack if there are no reruns or reflex tests on the first rack.
•
When you schedule by compartment, the system starts processing the test with the
longest incubation, and then it aspirates the next longest incubation time across all
racks. When you schedule by compartment, it may take longer to retrieve a rack
because all racks may be in use. The system does not finish one full rack at a time.
•
When you schedule by Test, the system schedules tests according to priority
assignments. The system can control the order that tests are scheduled according to
priority. You can assign a priority ranging from 1 to 10, where 1 is the highest priority,
for up to 10 individual assays. Two or more assays can have the same priority
assignment.
A test with a priority assignment is scheduled before a test that has no priority
assignment. If more than one assay has the same priority assignment, the system
schedules the longest running assay first. Repeat replicate and rerun samples with
priority assignments are scheduled before routine patient tests.
Refer to Setting the Priority of Sample Scheduling of a Test‚ page 6-31.
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1. At the workspace, select Setup.
2. Select the System tab.
If you want to . . .
Then . . .
schedule sampling for each rack
individually
select Rack.
schedule sampling for all sample racks
loaded in the sample compartment
select Compartment.
schedule sampling for all tests according
to priority assignment
select Test.
3. Select Save.
Setting the Priority of Sample Scheduling of a Test
NOTE: Once the system is processing, the assay priority cannot be changed. Edit the
priority of an assay when the system is in Ready.
Use this procedure to set test priority on the system:
1. Remove the primary pack from the system.
2. At the workspace, select Setup.
3. Select an assay.
4. Select Details.
5. Enter a value for 1 to 10 in the Priority field box.
6. Select Save.
Setting the Total STAT Sample Scheduling Mode
Use this procedure to select the order in which the system aspirates STAT tests. The
system schedules STAT samples by Total STAT tests.
When you schedule by Total STAT, the system schedules all the tests ordered on a STAT
sample tube before scheduling tests from other STAT sample tubes.
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The Total STAT option is applicable to test priority, compartment and rack mode.
Refer to Setting the Sample Scheduling Mode‚ page 6-30.
1. At the workspace, select Setup.
2. Select the System tab.
3. Select Save.
NOTE: When you schedule by Test, the system schedules tests according to priority
assignments. The system does not schedule all the tests ordered on the STAT sample tube
if there are other STAT samples existing on the system with tests of higher priority
assignments.
For more information about setting test priority, refer to Setting the Priority of Sample
Scheduling of a Test‚ page 6-31.
Changing the Designated STAT Lane
The default STAT lane is lane 7. Any sample loaded in the defined lane is automatically
designated as STAT.
Use this procedure to designate a single lane for STAT samples only:
1. At the workspace, select Setup.
2. Select the System tab.
3. Select the lane that you want to designate as the STAT lane from the drop down menu.
If you do not want to reserve a lane for STAT use only, select None.
If no STAT lane is specified, you can designate individual samples as STAT during
sample loading or through the LIS.
4. Select Save.
Setting the System Time
Use this procedure to define the system time:
1. At the workspace, select Setup.
2. Select the System tab.
3. In the Display Format area, select the Clock field.
4. Enter or edit the correct time.
5. Select Apply.
6. Select Save.
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Specifying the Date Format
Use this procedure to define the system date:
1. At the workspace, select Setup.
2. Select the System tab.
3. In the Display Format area, select a format from the Date Format dropdown menu.
4. Select Save.
Specifying the Time Format
Use this procedure to define the format used to display the system time:
1. At the workspace, select Setup.
2. Select the System tab.
3. In the Display Format area, select a format from the Time Format dropdown menu.
4. Select Save.
Specifying the Decimal Point
Use this procedure to define the decimal type used on the system:
1. In the Display Format area, select a format from the Decimal Point drop-down menu.
2. Select Save.
Setting the Language for the System
Use this procedure to specify the language for the system display:
1. At the workspace, select Setup.
2. Select the System tab.
3. In the Display Format area, select a language from the Language drop-down menu.
4. Select Save.
5. Exit and restart the software and the instrument.
Setting the Language for the Online Help
Use this procedure to specify the language for the online help system display:
1. At the workspace, select Setup.
2. Select the System tab.
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3. In the Display Format area, select a language from the Help Language drop-down
menu.
4. Select Save.
5. Exit and restart the software and the instrument.
Specifying Sample Tube Types
Use this procedure to specify up to 3 types of sample tubes to use on the system at any one
time. Refer to Pre-Set Tube Types‚ page D-6 for the list of tube types accepted by the
system.
NOTE: This option is not available if sample racks are in the sample compartment.
CAUTION
Ensure that the tube type selector on each sample rack points to the correct tube type as
defined on this window. If the tube type selector points to an incorrect tube type, the
system can experience problems with sample handling and system errors can result.
1. At the workspace, select Setup.
2. Select the System tab.
3. Select Tube Types.
4. On the Tube Types window, select up to 3 types of sample tubes.
5. Select a tube type from the list on the left.
6. Select Assign to A, Assign to B, or Assign to C.
When you load samples, use the tube type selector on the rack to indicate the tube type
you are loading. Refer to Loading Samples into Sample Racks‚ page 2-33 for more
information on loading samples.
7. On the Tube Types window, select OK.
8. On the System tab, select Save.
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Adding Headers to Reports
Use this procedure to define the information displayed on the top of reports:
1. At the workspace, select Setup.
2. Select the Laboratory tab.
3. Select Report Format.
4. Enter up to 3 lines of information for the report heading.
You can enter up to 70 characters per line.
5. Select Save.
Allowing Automatic Repeat and Reflex of Samples
The ADVIA Centaur CP system can automatically run repeat or reflex tests on qualifying
samples. Use the following 2 options to allow the system to run repeat or reflex tests on
samples that meet the criteria specified through the Assay Definition screens. Refer to
Modifying Evaluation, Repeat, and Reflex Ranges‚ page 6-14 for more information on
defining criteria for repeat and reflex tests.
NOTE: If a control bracketed test is scheduled for repeat replicates, and the replicates are
aspirated in a different control bracket from the initial sample’s control bracket, and the
repeat replicates bracket fails, you must rerun the sample.
Allow Automatic Repeat of Samples
Use this procedure to allow the system to run repeat tests on samples that meet the criteria
defined through the Assay Setup screens:
1. At the workspace, select Setup.
2. Select the System tab.
3. In the Options area, select the Auto Rerun checkbox.
4. Select Save.
Allow Automatic Reflex of Samples
Use this procedure to allow the system to run reflex tests on samples that meet the criteria
defined through the Assay Setup screens:
1. At the workspace, select Setup.
2. Select the System tab.
3. In the Options area, select the Auto Reflex checkbox.
4. Select Save.
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Rerun a Sample if a Clot is Detected
Use this procedure to allow the system to rerun a test on a sample if the system detects a
clot:
1. At the workspace, select Setup.
2. Select the System tab.
3. In the Options area, select the Repeat if Clot Detected checkbox.
4. Select Save.
Rerun a Sample if a Sample Integrity Error is Detected
Use this procedure to allow the system to rerun a test on a sample if the system detects a
sample integrity error:
1. At the workspace, select Setup.
2. Select the System tab.
3. In the Options area, select the Repeat if Sample Integrity Error Detected checkbox.
4. Select Save.
Quality Control Using ADVIA QC
Changing User Units in ADVIA QC
If your laboratory uses ADVIA QC, after you change the user units in the
ADVIA Centaur CP for an assay, you must then close out of the control files in
ADVIA QC for each active control for that assay.
Viewing Out of Range QC Status
The QC status displays yellow, which means 0 (Out) or not color, which means 1 (In).
To view QC results that are out of range, use the following procedure:
1. At the Quality Control tab, select View.
2. On the View Results window, select Range.
3. Select QC status, From 0 to 0.
4. Select OK.
The QC results that are out of range (yellow) display.
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Transmitting QC Results to ADVIA QC
Use this procedure to automatically transmit all quality control results to the ADVIA QC
software. If you do not set this option, quality control results will not be sent. If you set
this option all results will be sent, without user review.
1. At the workspace, select Setup.
2. Select the System tab.
3. In the Options area, select the Transmit QC Results to ADVIA QC checkbox.
4. Select Save.
Multicomponent Tests
When controls are ordered on a multicomponent test, the ADVIA Centaur CP system
automatically orders controls on the individual component test and the calculated
multicomponent score. Component test controls and calculated multicomponent test are
sent to ADVIA QC.
Transmitting QC Results to an LIS
Use this procedure to automatically transmit all quality control results to the LIS. If you do
not set this option, quality control results will not be sent. If you set this option all results
will be sent, without user review.
Multicomponent control results are sent to the LIS.
1. At the workspace, select Setup.
2. Select System.
3. In the Options area, select the Transmit QC Results to LIS checkbox.
4. Select Save.
Transmit Flashcurve
This option is not user-accessible.
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Audible Alarms
Setting Audible Alarms
Siemens has defined a number of events that can trigger audible alarms. Use this
procedure to turn on audible alarms:
1. At the workspace, select Setup.
2. Select the Options tab.
3. In the Enable Audible Alarms for Severity area, select the event severity level for
event messages that trigger audible alarms as follows:
•
Warning (lowest level)
•
Problem
•
Critical
•
Fatal (highest level)
An audible alarm sounds for events that match the severity level or levels you select.
When you select a level, for example, Problem, the system automatically selects all
levels higher than that level for you as well.
If you select Problem, the system automatically checks Critical and Fatal.
4. In the Repetitions area, select either of the following:
•
Continuous
•
Repeat for (some number of) seconds between 1 and 50
NOTE: The Continuous option is unchecked by default. If you select the Repeat for
option, enter a value, for example, 40 so the system alarm sounds for 40
seconds for those events that match the severity levels you selected above.
5. Select Save.
Turning Off the Audible Alarms
If you want to silence all audible alarms, use the following procedure:
Use this procedure to turn off audible alarms:
1. At the workspace, select Setup.
2. Select the Options tab.
3. In the Enable Audible Alarms for Severity area, make no selection.
When no severity level is checked, no audible alarms will sound.
4. Select Save.
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ADVIA Centaur CP Operator’s Guide: 6 System Setup
6-39
Miscellaneous System Settings
Setting Minimum and Maximum Sample ID Lengths
Use this procedure to set the minimum and maximum sample ID lengths for your
laboratory.
1. At the workspace, select Setup.
2. Select the System tab.
3. In the Sample ID Length area, enter the minimum and maximum sample ID lengths.
•
The minimum sample length can be set from 4–8 characters.
•
The maximum sample length can be set from 11–17 characters.
4. Select Save.
Automatically Printing Sample Results
Use this procedure to enable the automatic printing of sample reports to your local printer:
1. At the workspace, select Setup.
2. Select the System tab.
3. In the Runtime Report area, select On.
When 7 samples have processed, a report of those samples automatically prints on
your local printer. When the system returns to the Ready state, the last results of the
sample run print on the last page of the report, even if there are fewer than 7 records.
When the last result is the component of a ratio result, that last page prints a second
time. Review the Runtime Report carefully to ensure that the report contains a single
listing of the results.
If you enable this option, the Force Printout option is available to you from the Print
Results feature of the Results tabs.
4. Select Save.
Setting System Backup Information
Use this procedure to set the backup directory and filename information for the System
Backup File. System backup is available while exiting the system. System restore is
available during system sign in. Refer to Backing Up System Data‚ page 4-36 and
Restoring System Data‚ page 4-37 for more information about system backup and restore
procedures.
1. At the workspace, select Setup.
2. Select the System tab.
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ADVIA Centaur CP Operator’s Guide: 6 System Setup
6-40
3. In the Backup and Restore area, enter the backup directory where the system will put
system backup files.
•
To have the system automatically generate a backup file name, select Yes to
Autogenerate Backup Filename. Siemens recommends using this setting.
•
To specify the name of the backup file, select No, and then specify a file name.
4. Select Save.
Setting changes do not take effect until you exit the system software.
Setting System Handling of Expired Calibrations
Use this procedure to set system behavior if a calibration expires while the system is
actively processing samples.
1. At the workspace, select Setup.
2. Select the System tab.
3. In the Calibration Expired Summary area, select Change.
4. Select one of the following options:
•
Display a warning message but continue processing all samples until the end of
the current work list.
•
Stop sample aspirations, but complete all samples in process.
5. Select Save.
086D0320-01, Rev. 04
Appendixes
Appendix A: Safety Information
Appendix B: Warranty
Appendix C: Reagents Information
Appendix D: Specifications
Appendix E: Supplies
Appendix F: Symbols
Appendix G: Contacts
Appendix H: Glossary
Appendix I: Index
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ADVIA Centaur CP Operator’s Guide: Appendixes
Appendix A: Safety Information
Protecting Yourself from Biohazards
This information summarizes the established guidelines for handling laboratory
biohazards. This summary is based on the guidelines developed by the Centers for Disease
Control, the Clinical and Laboratory Standards Institute Document M29-A3, Protection of
Laboratory Workers from Occupationally Acquired Infections, and the Occupational
Safety and Health Administration’s Bloodborne Pathogens Standard.1–3
Use this summary for general information only. It is not intended to replace or supplement
your laboratory or hospital biohazard control procedures.
By definition, a biohazardous condition is a situation involving infectious agents
biological in nature, such as the hepatitis B virus, the human immunodeficiency virus, and
the tuberculosis bacterium. These infectious agents may be present in human blood and
blood products and in other body fluids.
The following are the major sources of contamination when handling potentially
infectious agents:
•
needlesticks
•
hand-to-mouth contact
•
hand-to-eye contact
•
direct contact with superficial cuts, open wounds, and other skin conditions that may
permit absorption into subcutaneous skin layers
•
splashes or aerosol contact with skin and eyes
To prevent accidental contamination in a clinical laboratory, strictly adhere to the
following procedures:
•
Wear gloves while servicing parts of the instrument that have contact with body fluids
such as serum, plasma, urine, or whole blood.
•
Wash your hands before going from a contaminated area to a noncontaminated area,
or when you remove or change gloves.
•
Perform procedures carefully to minimize aerosol formation.
•
Wear facial protection when splatter or aerosol formation are possible.
•
Wear personal protective equipment such as safety glasses, gloves, lab coats or aprons
when working with possible biohazard contaminants.
•
Keep your hands away from your face.
•
Cover all superficial cuts and wounds before starting any work.
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ADVIA Centaur CP Operator’s Guide: A
•
Dispose of contaminated materials according to your laboratory’s biohazard control
procedures.
•
Keep your work area disinfected.
•
Disinfect tools and other items that have been near any part of the instrument sample
path or waste area with 10% v/v bleach.
•
Do not eat, drink, smoke, or apply cosmetics or contact lenses while in the laboratory.
•
Do not mouth pipet any liquid, including water.
•
Do not place tools or any other items in your mouth.
•
Do not use the biohazard sink for personal cleaning such as rinsing coffee cups or
washing hands.
To prevent needlestick injuries, needles should not be recapped, purposely bent, cut,
broken, removed from disposable syringes, or otherwise manipulated by hand.
References
1. Centers for Disease Control. 1988. Update: Universal precautions for prevention of
transmission of human immunodeficiency virus, hepatitis B virus and other
bloodborne pathogens in healthcare settings. MMWR, 37:377–382, 387, 388.
2. Clinical and Laboratory Standards Institute (formerly NCCLS). Protection of
Laboratory Workers from Occupationally Acquired Infections; Approved Guideline Third Edition. CLSI Document M29-A3.[ISBN 1-56238-567-4]. Clinical and
Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne,
Pennsylvania 19087-1898 USA, 2005).
3. Federal Occupational Safety and Health Administration. Bloodborne Pathogens
Standard. 29 CFR 1910. 1030.
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A-3
Protecting Yourself from Barcode Scanner Lasers
To avoid damage to the eyes, never look directly at the laser beam or at its reflection from
a shiny surface. Never point a hand-held barcode scanner at anyone.
Some field service procedures require the removal of the protective housings that prevent
human access to the laser radiation. The removal of this protective housing may change
the classification of the laser. All field service procedures must be followed precisely.
Only Siemens-trained field service personnel should perform procedures related to laser
assemblies.
The laser optical assemblies in the ADVIA Centaur CP ancillary and sample barcode
scanner, use laser diode modules that have a maximum power output of ≤ 1.3 mW and a
pulse duration of 70μs, at 650-690 nm. The ADVIA Centaur CP system is classified as a
Class 1 laser product.
These classifications are defined by the Food and Drug Administration (FDA) Center for
Devices and Radiological Health (CDRH) regulations 21 CFR 1040.10 and 1040.11.
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ADVIA Centaur CP Operator’s Guide: A
The laser labels are positioned on the instrument as shown below.
086D0320-01, Rev. 04
Appendix B: Warranty
Limited System Warranty and Service Delivery Policy
Siemens Healthcare Diagnostics and its authorized distributors may provide customers
who acquire new Siemens instruments with a limited warranty either in a specific
agreement or in standard language on their invoices. This limited warranty is designed to
protect customers from the cost associated with repairing instruments that exhibit
malfunctions due to defects in materials and/or workmanship during the warranty period.
Siemens, at its election, will provide warranty service either by providing repair service of
the instrument on site, or by exchanging the defective instrument or component, subject to
the limitations and exclusions set forth in Replacement of Parts and Warranty and Service
Exclusions below. Repairs, replacements or exchanges of instruments or components
provided during the warranty or any additional service period, will not extend the
warranty or service period beyond the initially agreed upon period.
When the customer calls for service, the Siemens representative or authorized distributor
will inform the customer of the type of service available for the customer’s instrument,
and will instruct the customer as to how to obtain that service.
Warranty Period
The limited warranty period generally commences upon installation of the original
instrument at the customer’s location and extends for a period of one year thereafter,
unless otherwise specifically agreed to by and between Siemens (or its authorized
distributors) and customer in a writing signed by duly authorized representatives of both
parties (sales representatives are generally not authorized representatives of
Siemens Healthcare Diagnostics for these purposes).
Additional Service Period
The customers, with some exceptions, may purchase additional service coverage beyond
any initial warranty period as part of the original instrument acquisition for second or
subsequent years beyond the original installation date. The customer’s original Purchase
Invoice or appropriate Agreement Addendum must indicate the term in months for
additional service coverage.
Service During Normal Hours
The customer may obtain service for instruments during normal business hours by
contacting the nearest Siemens location or authorized distributor. See Appendix G,
Contacts for a list of Siemens locations.
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Extent of a Service Call
Warranty or service calls generally include on-site repair or exchange of instruments or
components, travel to the location of the instrument, and on-site labor during normal
business hours. A warranty or service call is initiated by the customer by following the
instructions on how to obtain service for the customer’s instrument. The service call is
considered complete when any defects in material or workmanship have been corrected by
repair or replacement and the instrument conforms to the applicable specifications. When
service is complete, the customer will receive a copy of the documentation detailing all
work performed by the Siemens representative or authorized distributor.
Service Outside Normal Hours
Customers, with some exceptions, may also request service to be delivered or an exchange
to be initiated outside normal business hours, including evenings, weekend days, or
nationally observed holidays, by contacting the nearest Siemens location or authorized
distributor. Service performed outside normal hours is subject to a surcharge unless the
customer has in place a service product option that provides service at the time requested.
Replacement of Parts
In performing service, Siemens or its authorized distributors will provide appropriate parts
to repair the instrument, or will arrange for the exchange of the instrument or affected
parts, at no charge with the exception of certain parts or subassemblies that are considered
Customer Maintenance Items. Customer Maintenance Items include, but are not limited
to, the following items: lamps, electrodes or sensors (which are covered by a separate
warranty), reagents, calibrators, controls, paper, and pens. Consult the appropriate system
operator’s manuals for a complete list of Customer Maintenance Items for any specific
model of instrument.
Design Changes and Retrofitting of Instruments
Siemens reserves the right to change the design or construction of specific models of
instruments at any time without incurring any obligation to make such changes available
to individual customers or instruments. If Siemens notifies customers of a change that
improves the performance or reliability of their instrument, and requests to retrofit that
instrument, the customer must agree to allow Siemens or an authorized distributor, at
Siemens’ expense, to retrofit components or make design changes, which will not
adversely affect the instrument’s performance characteristics.
Key Operator Designation
Each customer will designate a key operator who will be available to Siemens
representatives to describe instrument malfunctions by telephone and/or to perform simple
adjustments and corrections as requested. If a key operator is not designated or is
unavailable when the customer requests service, the delivery of service may be delayed.
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OSHA Requirements (US only)
When service is required at a customer location, the customer must provide the Siemens
representative with adequate facilities that comply with the regulations of the Secretary of
Labor under the Occupational Safety and Health Act (OSHA) of 1970, as amended.
Warranty and Service Exclusions
The following exclusions are in addition to any exclusions provided for in any written
warranty or service agreement.
IF ANY OF THE FOLLOWING EVENTS OCCUR, THE WARRANTY OR SERVICE
PROVISIONS DO NOT APPLY:
•
Repairs or modifications have been made to the instrument by someone other than an
authorized Siemens representative.
•
The instrument has been operated using accessories and supplies other than Siemens
brand accessories, or consumable supplies and/or reagents not having the same grade,
quality, and composition as defined in the system operator’s manuals.
•
Siemens has notified customers of a change that improves the performance or
reliability of their instrument and customer has not agreed to retrofit or make design
changes to the instrument.
•
Customer did not purchase the instrument from Siemens or one of its authorized
distributors.
•
The instrument has not been installed within 90 days of shipment to the customer’s
facility unless otherwise specified.
•
The customer has not performed appropriate customer maintenance procedures, as
outlined in the system operator’s manuals.
•
The instrument has been misused or used for a purpose for which it was not intended.
•
The instrument has been damaged in transit to the customer or damaged by the
customer while moving or relocating it without supervision by a Siemens
representative.
•
Damage was caused by floods, earthquakes, tornadoes, hurricanes, or other natural or
man-made disasters.
•
Damage was caused by Acts of War, vandalism, sabotage, arson, or civil commotion.
•
Damage was caused by electrical surges or voltages exceeding the tolerances outlined
in the system operator’s manuals.
•
Damage was caused by water from any source external to the instrument.
•
The customer has purchased an alternative agreement whose terms of warranty or
service supersede these provisions.
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ADVIA Centaur CP Operator’s Guide: B
Siemens or its authorized distributors will invoice customers, at current standard labor
and parts rates, for instruments repaired to correct damage or malfunctions due to any of
the reasons listed above.
Other than as stated above, there are no other warranties, express or implied WITH
RESPECT TO THE INSTRUMENT, ITS SALE TO THE CUSTOMER, ITS LEASE
TO THE CUSTOMER, OR THE sale OF THE INSTRUMENT to the customer at
the expiration or termination of THE LEASE agreement.
Siemens Healthcare Diagnostics specifically disclaims any and all implied warranties
of merchantability OR fitness for a particular Use or purpose.
Siemens Healthcare Diagnostics’ liability for breach of any warranty or service
agreement shall be limited only to the repair or replacement of defective equipment
and shall not include any damages of any kind, whether direct, indirect, incidental,
contingent, or consequential. Siemens shall not be liable for delay FROM ANY
CAUSE in providing repair OR EXCHANGE service.
ANY LIMITATIONS OR OTHER PROVISIONS NOT CONSISTENT WITH
APPLICABLE LAW IN PARTICULAR JURISDICTIONS OR A SPECIFIC
WRITTEN AGREEMENT DO NOT APPLY TO CUSTOMERS IN THOSE
JURISDICTIONS OR SUBJECT TO THOSE AGREEMENTS.
086D0320-01, Rev. 04
Appendix C: Reagents Information
Reagent Handling
This appendix describes handling requirements for the following ADVIA Centaur CP
reagents.
WARNING
When handling the reagents, follow the appropriate chemical safety guidelines, which
include wearing gloves, laboratory coat, and safety glasses or protective face shield.
CAUTION
Do not use reagents other than ADVIA Centaur systems reagents. Use of reagents other
than ADVIA Centaur systems reagents can cause erroneous results.
Primary Reagent Packs
•
Unpierced
•
Pierced
Ancillary Reagent Packs
•
Unpierced
•
Pierced
Primary Reagent Packs
During storage the particles in the Solid Phase reagent settle at the bottom of the primary
reagent pack. These particles must be resuspended homogeneously before use to provide
maximum reagent and assay efficiency.
Mix all primary reagent packs by hand before loading them onto the system. You can hold
and mix up to six reagent packs at a time. It is important to minimize foaming. Perform the
following mixing procedure gently to resuspend the particles. Do not shake the primary
reagent pack unless stated to do so in the product instructions.
Unpierced
NOTE: For detailed information about preparing ADVIA Centaur CP CEA reagents for
use, refer to Loading Reagents in the ADVIA Centaur CP CEA product instructions.
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ADVIA Centaur CP Operator’s Guide: C
For all other assays, use this procedure if the primary reagent pack is unpierced.
1. With the film side up, hold the reagent pack loosely at the ends with the thumb and
index or middle finger of each hand.
2. Carefully raise one end of the pack 90° so that the pack is in a vertical position.
90°
3. Carefully return the pack to a horizontal position.
4. Carefully raise the other end of the pack 90° so that the pack is again in a vertical
position.
5. Carefully return the pack to a horizontal position.
6. Repeat steps 2 through 5 a minimum of 20 times or until the following conditions are
met:
•
no material is visible on the bottom of the pack.
•
no large aggregates are visible floating inside the pack.
Adjust the mixing speed to minimize foaming.
7. Mix 5 to 10 times more to ensure complete mixing.
8. Load the unpierced primary reagent pack onto the system.
When testing is complete you may remove the reagents from the system or leave them on
the system. If you remove the reagents, cover the pierced film area of the primary reagent
pack with self-sealing laboratory film and place the pack in the reagent storage tray at
2° to 8°C. Store pierced primary reagent packs upright in the storage tray to minimize
spillage. Follow the pierced primary reagent pack procedure before placing the reagent
pack back on the system. Reagents left on a system with the power on are automatically
mixed by the system and do not require further mixing.
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Pierced
CAUTION
Do not use this procedure for pierced ADVIA Centaur CP CEA reagent packs. Discard
pierced ADVIA Centaur CP CEA reagent packs that have been removed from the system.
Mixing open ADVIA Centaur CP CEA reagent packs can cause contact with harmful
substances. For detailed information about preparing ADVIA Centaur CP CEA reagents
for use, refer to Loading Reagents in the ADVIA Centaur CP CEA instructions for use.
For all other assays, use this procedure if the primary reagent pack is pierced.
1. Press gently on the self-sealing laboratory film that covers the pierced film area while
mixing.
This prevents reagent leakage.
2. With the film side up, hold the reagent pack loosely at the ends with the thumb and
middle finger of each hand.
3. From a horizontal position, carefully raise one end of the pack 45°.
45°
4. Carefully return the pack to a horizontal position.
5. Carefully raise the other end of the pack 45°.
6. Carefully return the pack to a horizontal position.
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ADVIA Centaur CP Operator’s Guide: C
7. Repeat steps 3 through 6 a minimum of 20 times or until the following conditions are
met:
•
no material is visible on the bottom of the pack.
•
no large aggregates are visible floating inside the pack.
Adjust the mixing speed to minimize foaming.
8. Mix 5 to 10 times more to ensure complete mixing.
9. Remove the self-sealing laboratory film and load the pierced reagent pack onto the
system.
When testing is complete you may remove the reagents from the system or leave them on
the system. If you remove the reagents, cover the pierced film area of the primary reagent
pack with self-sealing laboratory film and place the pack in the reagent storage tray at
2° to 8°C. Store pierced primary reagent packs upright in the storage tray to minimize
spillage. Follow the pierced primary reagent pack procedure before placing the reagent
pack back on the system. Reagents left on a system with the power on are automatically
mixed by the system and do not require further mixing.
NOTE: If reagent mixing is turned off, but reagent cooling remains on, remove all
primary reagent packs from the system and check for solid phase settling. Mix all primary
reagent packs following the unpierced/pierced primary reagent pack procedures and place
the reagent packs back on the system. Verify reagent performance based on acceptable
quality control results or by criteria established for your laboratory.
If reagent cooling is turned off for longer than 2 hours, remove the primary reagent packs
from the system and store at 2° to 8°C. Mix all primary reagent packs following the
unpierced/pierced primary reagent pack procedures before placing the reagent packs back
on the system. Verify reagent performance based on acceptable quality control results or
by criteria established for your laboratory.
NOTE: The onboard stability of a primary reagent pack is calculated from the time that
the system reads the barcode after the reagent pack is placed on the system for the first
time. If a pack is removed from the system, it is recommended that you reload the pack
onto the same system. If you load the reagent pack onto a different system, you must track
onboard stability and you must adjust reagent test inventory to account for tests previously
removed from the pierced reagent pack while on the other system.
Ancillary Reagent Packs
Unpierced
Gently invert ancillary reagent packs several times before loading them into the ancillary
reagent tray. It is important to minimize foaming. Do not shake the ancillary reagent pack.
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When testing is complete you may remove the reagents from the system or leave them on
the system. If you remove the reagents, cover the pierced film area of the ancillary reagent
pack with self-sealing laboratory film and store the pack at 2° to 8°C. Store pierced
ancillary reagent packs upright to minimize spillage. Follow the pierced ancillary reagent
pack procedure before placing the reagent pack back on the system.
Pierced
Use this procedure if the ancillary reagent pack is pierced.
1. Press gently on the self-sealing laboratory film that covers the pierced film area while
mixing.
This prevents reagent leakage.
2. Gently invert the pack several times.
3. Remove the self-sealing laboratory film and load the pierced ancillary reagent pack
onto the system.
When testing is complete you may remove the reagents from the system or leave them on
the system. If you remove the reagents, cover the pierced film area of the ancillary reagent
pack with self-sealing laboratory film and store the pack at 2° to 8°C. Store pierced
ancillary reagent packs upright to minimize spillage. Follow the pierced ancillary reagent
pack procedure before placing the reagent pack back on the system.
Do not add reagent to ancillary reagent packs. Each ancillary reagent pack contains
enough reagent to process a predetermined number of tests. Each time the system accesses
an ancillary reagent pack, reagent volume inventory tracks the amount of reagent used
until the pack is empty. The system does not recognize additional fluid placed in an
ancillary reagent pack.
NOTE: If reagent cooling is turned off for longer than 2 hours, remove the ancillary
reagent packs from the system and store at 2° to 8°C Mix all ancillary reagent packs
following the unpierced/pierced ancillary reagent pack procedures before placing the
reagent packs back on the system. Verify reagent performance based on acceptable quality
control results or by criteria established for your laboratory.
NOTE: The onboard stability of an ancillary reagent pack is calculated from the time that
the pack is first pierced. If a pierced pack is removed from the system, it is recommended
that you reload the pack onto the same system. If you load the reagent pack onto a
different system, you must track onboard stability and you must adjust reagent volume
inventory to account for any reagent previously removed from the pierced reagent pack
while on the other system.
Ancillary Pack Usage
Ancillary pack usage is not prioritized. The system uses ancillary packs from left to right
and from back to front. Manage your system supplies with this in mind.
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Reagent Water Quality
Introduction
Water quality is an important consideration in the laboratory because it can significantly
affect the outcome of laboratory procedures and the measurement of patient samples.
This document provides an overview of reagent water quality guidelines as specified by
the Clinical Laboratory and Standards Institute (CLSI, formerly NCCLS).1 Use these
guidelines to evaluate the reagent water quality in your laboratory and to determine the
best method for obtaining the water quality you need.
Good laboratory practices suggest that you establish a protocol that supports the
manufacturer’s requirement for the instrument to:
•
ensure optimum performance of automated laboratory instruments
•
eliminate water quality as a source of problems when troubleshooting
•
help you to meet requirements for state and federal laboratory certification
What is Reagent Water?
Reagent water is laboratory water that meets specifications for clinical laboratory use.2,3
The CLSI has defined 3 grades of reagent water:
•
Type I, the highest grade
•
Type II, the intermediate grade
•
Type III, the lowest grade
NOTE: The ADVIA Centaur CP supports the use of Type I and Type II grade reagent
water.
The following table lists the CLSI specifications for the 3 types of reagent water. Use this
information to determine the water quality in your laboratory. Refer to the CLSI
guidelines for common laboratory uses of Type I, Type II, and Type III reagent water.
Specification
Type I
Type II
Type III
Maximum bacterial
content colony forming
units per mL (CFU/mL)*
10 (preferably bacteria
free)
1000
not applicable
pH
not applicable
not applicable 5.0 – 8.0
Minimum resistivity
(megohm/centimeter at
25 º C)†
10 (inline measurement
by sensor or resistor)
1.0
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Specification
Type I
Type II
Type III
Maximum
silicate
(mg/L)‡
0.05
0.1
1.0
Particulate matter (µm)§
smaller than 0.22 µm
(water is passed through a
0.22 µm filter)
not applicable not applicable
Organic compounds**
pretreat with activated
carbon
or distillation
or reverse osmosis
not applicable not applicable
*
Bacterial content: The number of colony forming units in water. Bacterial content is a water
contaminant you measure to determine water quality.
†
Resistivity: The ability of water to resist electrical conduction due to the ion content. Resistivity is
the standard test measurement for determining water quality. The higher the resistivity, the lower the
ion content and the better the water quality.
‡
Silicates: Compounds you remove to produce Type I reagent water.
§
Particulate matter: Undissolved (insoluble) substances larger than 0.22 µm are removed by the filter.
**
Organic compounds: Compounds you remove to produce Type I reagent water.
Purifying Water
As with all diagnostic testing procedures, good laboratory practices suggest that you
establish a protocol that supports the manufacturer’s requirements for selecting the
appropriate type of reagent water. You can then produce reagent water in your laboratory
by setting up and maintaining a water purification system which uses the purification
methods described in the following table.
The following table describes some of the typical laboratory water purification methods.
Method
Description
Distillation
Changes water from liquid to vapor and leaves behind
impurities such as particulates and bacteria
Deionization
Uses synthetic resins to remove ionized impurities by ion
exchange
Reverse Osmosis
Forces water under pressure through a semipermeable
membrane to remove dissolved solids and organic
impurities
Adsorption
Uses activated carbon, clays, silicates, or metal oxides to
remove organic impurities
Filtration
Forces water through a semipermeable membrane to
remove insoluble matter, emulsified solids, pyrogens, and
micro organisms
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The quality of the reagent water you produce depends on the quality of the water you start
with (source water), and the performance of your water purification system.
To produce the type of water you require, you may need a purification system that uses a
combination of methods. For example, if you want to produce Type I water, you need a
system that uses adsorption to remove organic impurities, deionization to remove ionized
impurities, and filtration to remove particulates.
The illustration displays a water purification system that combines adsorption,
deionization, and filtration to produce Type I water.
3
4
5
2
6
1
10
9
7
8
Pump
Source Water
Check Valve
Flow Controller
Resistivity Indicator is set for Type I water according to the manufacturer’s
recommendations.
6 Valve
7 This filter removes particles, emulsified solids, pyrogens, and micro-organisms.
8 Type I Water Output
9 Ion Exchange
10 Carbon
1
2
3
4
5
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Maintaining Water Quality
You can ensure that the reagent water supply in your laboratory consistently meets CLSI
guidelines by:
•
storing reagent water properly
•
testing for resistivity and contamination
•
maintaining your water purification system
Establishing procedures for maintaining reagent water quality is also required for
laboratory inspection and accreditation by the College of American Pathologists (CAP).4
Storing Reagent Water
Type I reagent water cannot be stored. Use it immediately after you produce it because it
degrades quickly and no longer meets Type I reagent water specifications. Additionally,
you cannot purchase Type I reagent water because its purity is not reliable.
Store Type II and Type III reagent water in glass or polyethylene bottles. Use it as soon as
possible after preparation to reduce the risk of contamination by microorganisms.
Testing Reagent Water
To monitor water quality and detect problems with your water purification system, test
reagent water regularly for resistivity and bacterial contamination. You may also want to
send reagent water out of the laboratory periodically for independent evaluation. Record
your test results and any corrective action.
Refer to the CLSI specifications for information about recommended water testing
methods.1
Maintaining your Purification System
Efficient operation and regularly scheduled maintenance of your water purification system
is the key to optimizing the performance of the system and consistently obtaining reagent
quality water. Preventative maintenance reduces the chance of the purification system
introducing additional contaminants into source water and ensures that reagent water
retains its purity when it is introduced into the laboratory instrument.
The following are suggested guidelines for maintaining water purification systems to
ensure smooth operation and prevent system problems.
For Customized Water Systems:
•
Change filters on carbon or membrane filter systems as required.
•
Use a recirculating pump to optimize performance and reduce contamination.
•
Filter the source water before treatment in reverse osmosis systems, and recirculate
deionizers in closed loops to extend resin life.
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ADVIA Centaur CP Operator’s Guide: C
For Distillation Systems:
•
Check the water vessels regularly for the presence of a slippery film.
•
Clean and disinfect the vessels as required with an agent that rinses well, such as
H2O2.
•
Clean the boiler regularly to remove deposits.
•
Test routinely for contamination.
For complete information about operation and maintenance requirements for your water
purification system, refer to the manufacturer’s specifications.
Problems Caused by Water
Using water that does not meet CLSI guidelines can cause problems with clinical
laboratory systems. Some common problems include:
•
contamination of system components
•
inaccurate patient and calibration results
•
out-of-range quality control results
•
deterioration of lyophilized quality control material
•
color changes and poor stability and performance of reagents
These problems can be caused by failure to use the appropriate type of reagent water,
bacterial contamination, and inadequate maintenance of the water purification system.
Refer to the troubleshooting section in your system manual for more detailed information
about problems caused by water that does not meet reagent water specifications.
References
1. Clinical and Laboratory Standards Institute (formerly NCCLS). Preparation and
Testing of Reagent Water in the Clinical Laboratory; Approved Guideline- Third
Edition. NCCLS document C3-A3 (ISBN 1-56238-336-1). Clinical and Laboratory
Standards Institute, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania
19087-1898 USA, 1997.
2. Tietz, Norbert W. Fundamentals of clinical chemistry, 3rd ed. Philadelphia: W.B.
Saunders Company; 1987. 1010 p.
3. Kaplan, Lawrence A. Pesce, Amadeo J. Clinical Chemistry; theory, analysis, and
correlation, 2nd edition. St. Louis: C.V. Mosby Company; 1989. 1212 p.
4. College of American Pathologists, Laboratory General Inspection Checklist Section 1,
Quality of water, p. 8. Northfield, IL. 1989.
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ADVIA Centaur CP Operator’s Guide: C
C-11
SI Unit Conversion Factors
This appendix provides the SI (system international) unit conversion factors,
which convert Mass/IUPAC units to SI units.
NOTE: Do not enter an SI conversion factor for T Uptake. The system does not accept an
SI conversion factor for this test.
CAUTION
Do not enter values in SI units when you enter Master Curve data or calibrator assigned
values. Doing this may cause erroneous results.
If you report results in SI units, enter the appropriate units and conversion factor for each
test in System Settings. See Chapter 6, System Setup for details on changing units.
Assay
Mass/IUPAC Units
SI Units
Conversion Factor
AFP
ng/mL
IU/mL
0.83
BNP
pg/mL
pmol/L
0.289
CEA
ng/mL
µg/L
1
CKMB
ng/mL
nmol/L
0.0125
Digoxin
ng/mL
nmol/L
1.28
Estradiol-6
pg/mL
pmol/L
3.67
Ferritin
ng/mL
pmol/L
2.20
Folate-2
ng/mL
nmol/L
2.265
Folate-BA
ng/mL
nmol/L
2.265
FrT4
ng/dL
pmol/L
12.9
FSH
mIU/mL
IU/L
1
FT3
pg/mL
pmol/L
1.54
Homocysteine
µmol/L
µmol/L
1
LH
mIU/mL
IU/L
1
Myoglobin
ng/mL
µg/L
1
PRGE
ng/mL
nmol/L
3.18
Prolactin
ng/mL
µIU/mL
21.2
PSA
ng/mL
µg/L
1
cPSA
ng/mL
µg/L
1
T3
ng/mL
nmol/L
1.54
T4
µg/dL
nmol/L
12.9
Testosterone
ng/dL
nmol/L
0.0347
Total hCG
mIU/mL
IU/L
1
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ADVIA Centaur CP Operator’s Guide: C
Assay
Mass/IUPAC Units
SI Units
Conversion Factor
Troponin I (cTnI)
ng/mL
µg/L
1
TSH
µIU/mL
mIU/L
1
TSH-3
µIU/mL
mIU/L
1
VB12
pg/mL
pmol/L
0.7378
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ADVIA Centaur CP Operator’s Guide: C
C-13
System Fluids
The fluids described in the table below are for in vitro diagnostic use only. Use the fluids
until the expiration date stated on the bottle labels.
•
Use acid and base reagents until the expiration date stated on the bottle label or until
28 consecutive days after loading the reagent on the system.
•
Use wash 1 solution until the expiration date stated on the bottle or until one month
after loading the solution on the system.
•
Use prepared cleaning solution within 7 days after preparation.
Dispose of acid and base reagents and cleaning solution using approved disposal
techniques for hazardous corrosive liquid wastes. Dispose of acid and base reagents in
accordance with local, state, and federal regulations. Refer to the Material Safety Data
Sheets for each material for additional information.
Siemens is not responsible for the performance of the ADVIA Centaur CP system when
reagents other than acid and base reagents are used.
WARNING
Avoid contact of acid and base reagents with skin and eyes. Acid and base reagents are
irritating to the skin. Wear suitable eye, face, and skin protection, which includes wearing
gloves, protective eye shield, and laboratory coat. In case of contact with the eyes, rinse
the eyes immediately with plenty of water and seek medical advice. In case of accident or
if you feel unwell, seek medical advice (if possible show the bottle label and Material
Safety Data Sheet). In case of accidental ingestion of reagent, call a physician
immediately.
Fluid Name
Volume
Ingredients
Storage
Usage
Acid Reagent (R1)
300 mL
1000 tests/bottle
0.5% hydrogen
peroxide
0.1 N nitric acid
4–25 º C
18–30º C
Base Reagent (R2)
300 mL
1000 tests/bottle
< 0.25 N sodium
hydroxide and
surfactant
4–25 º C
18–30º C
Wash 1 Reagent
1500 mL
phosphate buffered
saline (pH 7.2)
with < 0.1%
sodium azide and
surfactant
4–25 º C
18–30º C
Cleaning Solution
Concentrate
titered*
~52.5 g/L sodium
hypochlorite
2–8 º C
18–30º C
* Volume adjusted to account for variations in strength.
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C-14
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ADVIA Centaur CP Operator’s Guide: C
Appendix D: Specifications
System Specifications
This section summarizes the design specifications for the ADVIA Centaur CP system.
Safety Certifications
Refer to the DECLARATION OF CONFORMITY for the ADVIA Centaur CP system.
Contact your technical support provider or distributor for a copy.
Electromagnetic Compatibility (EMC)
Refer to the DECLARATION OF CONFORMITY for the ADVIA Centaur CP system.
Contact your technical support provider or distributor for a copy.
086D0320-01, Rev. 04
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ADVIA Centaur CP Operator’s Guide: D
System Dimensions
Dimension
Value
Depth
74 cm (29.0 in)
Height
82 cm (32 in) cover closed
110 cm (43 in) cover open
Width
110 cm (43 in)
Weight
170 kg (375 lb)
Workstation Dimensions
Dimension
Value
Depth
61 cm (24 in)
Height
56 cm (22 in)
Width
38 cm (15 in)
Weight
16 kg (35 lb)
Environmental Specifications
Specification
Value
Ambient Operating
Temperature
18.0–30.0 º C
Relative Humidity
20%–85%, non-condensing, actively controlled
Storage Temperature
0.0–50.0 º C
Indoor Use Only
Altitude
up to 3000 meters
Ventilation
1709 BTU
IEC 1010-1 Installation Category II
IEC 1010-1 Equipment Classification Class I
IEC 1010-1 Pollution Degree 2
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ADVIA Centaur CP Operator’s Guide: D
D-3
Specification
Value
Radio Frequency
Emissions
This equipment has been tested and found to comply with
the limits for a Class A digital device, pursuant to both
Part 15 of the FCC rules and the radio interference
regulations of the Canadian Department of
Communication. These limits are designed to provide
reasonable protection against harmful interference when
equipment is operated in a commercial environment.
This equipment generates, uses and can radiate radio
frequency energy and may cause harmful interferences to
radio communications, if not installed and used in
accordance with the instruction manuals. Operation of
this equipment in a residential area is likely to cause
harmful interferences. In which case, the user will be
required to correct the interferences at his expense.
Electrical Requirements
Requirement
Value
Electrical Rating
100 to 240VAC ± 10% ~8A
Power Requirements
50/60Hz
086D0320-01, Rev. 04
D-4
ADVIA Centaur CP Operator’s Guide: D
Tube Types
This section lists:
•
the primary sample tubes, sample transfer cups, transfer tubes, and microsample
containers you can use on your system,
•
the settings used to specify which types are currently in use,
•
and the minimum sample volume supported by each tube type.
You can specify up to 3 tube types to use on your system at any one time. Refer to
Specifying Sample Tube Types‚ page 6-34 for more information on specifying tube types
on your system.
The + symbol before the tube type indicates that it needs to be placed into a holder before
loading it into the sample rack. Ensure that translucent plastic sample tubes have barcode
labels or a printed label facing the barcode reader when the tubes are loaded onto the
system.
All sample tubes used for the ADVIA Centaur CP system are intended to be used one time
only.
WARNING
Do not reuse the Siemens Universal Cup Adapter without removing the barcode. Ensure
that the barcode label on the adapter matches the correct patient sample. If the cup adapter
barcode does not match the correct patient sample, the system may report incorrect
results.
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ADVIA Centaur CP Operator’s Guide: D
D-5
Sample Volume Requirements
For assays processed on the ADVIA Centaur CP system, the minimum required sample
volume for a reportable result depends on the sample volume for the assay, the sample
volume needed to prime the sample tip, and the volume of unusable sample for the sample
container.
Determining Minimum Sample Volume
Use this information to calculate the minimum required volume (MRV) for a reportable
result. The sample volume for each assay is specified in the assay instructions for use.
Refer to the table in Pre-Set Tube Types‚ page D-6, to determine the tip prime volume and
the unusable volume for the specific tube type and sample volume.
•
For a single replicate of one test, use the following formula:
Sample Volume + Tip Prime Volume + Unusable Volume = MRV
For example, for a TSH-3 scheduled in a 13x100-mm bottom tube, the values
are as follows:
200 µL + 20 µL + 300 µL = 520 µL
•
For multiple replicates of one test, use the following formula:
(Sample Volume + Tip Prime Volume) × No. of Replicates + Unusable Volume
= MRV
For example, for 2 replicates of a T4 scheduled in a 16x100-mm tube, the values are
as follows:
(25 µL + 10 µL) × 2 + 300 µL = 370 µL
•
For multiple tests scheduled for a sample, use the following formula:
Sum of (Sample Volume + Tip Prime Volume) for all replicates for all tests
+ Unusable Volume = MRV
For example, for 2 replicates of a TSH-3 and 3 replicates of a T4 scheduled
in a Siemens Sample Cup, the values are as follows:
(200 µL + 20 µL) × 2 +(25 µL + 10 µL) × 3 + 150 µL = 695 µL
086D0320-01, Rev. 04
D-6
ADVIA Centaur CP Operator’s Guide: D
Pre-Set Tube Types
The ADVIA Centaur CP system is pre-set to accept the following tube types.
Supported Tubes or Geometry in
Manufacturer
mm
For use with 100-mm sample racks
Tube Setting
Sample
Volume
Tip Prime
Volume
Unusable
Volume
Various Round
Bottom
13x100
100 mm-13x100
≤ 50 μL
> 50 μL
10 μL
20 μL
≤ 300 μL
≤ 300 μL
Various Round
Bottom
16x100
100 mm-16x100
≤ 50 μL
> 50 μL
10 μL
20 μL
≤ 300 μL
≤ 300 μL
SiemensCup
14x100
100 mm-SiemensCup
≤ 50 μL
> 50 μL
10 μL
20 μL
≤ 50 μL
≤ 150 μL
+Greiner Minicollect
11x40
100 mm-Greiner_
Minicollect
≤ 50 μL
> 50 μL
10 μL
20 μL
≤ 50 μL
≤ 50 μL
+Hitachi
13x38
100 mm-Hitachi
≤ 50 μL
> 50 μL
10 μL
20 μL
≤ 50 μL
≤ 50 μL
+Terumo-CAPIJECT
7x45
100 mm-TerumoCAPIJECT
≤ 50 μL
> 50 μL
10 μL
20 μL
≤ 50 μL
≤ 50 μL
Sarstedt
15x92
100 mm-15x92Monovette
≤ 50 μL
> 50 μL
10 μL
20 μL
≤ 300 μL
Sarstedt
16x92
100 mm- 16.5x92Monovette
≤ 50 μL
> 50 μL
10 μL
20 μL
≤ 300 μL
For use with 65-mm sample rack
+BD Microtainer with
Microgard Closure
10x45
65 mm-10x45-BDMicrotainer
≤ 50 μL
> 50 μL
10 μL
20 μL
≤ 50 μL
≤ 50 μL
Various round bottom
tubes
12x75
65 mm-12x75
≤ 50 μL
> 50 μL
10 μL
20 μL
≤ 300 μL
≤ 300 μL
+EZee-Nest
1mL
Ezee-Nest
cup
65 mm-Ezee-Nest13
≤ 50 μL
> 50 μL
10 μL
20 μL
≤ 50 μL
≤ 50 μL
Various Round
bottom tubes
13x75
65mm-13x75
≤ 50 μL
> 50 μL
10 μL
20 μL
≤ 300 μL
≤ 300 μL
Various Round
Bottom tubes
16x75
65mm-16x75gel
≤ 50 μL
> 50 μL
10 μL
20 μL
≤ 300 μL
≤ 300 μL
Sarstedt Flat Bottom
15x75
65mm-15x75Monovette
≤ 50 μL
> 50 μL
10 μL
20 μL
≤ 300 μL
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ADVIA Centaur CP Operator’s Guide: D
D-7
The following ADVIA Centaur CP pre-set tube types use the Universal cup adapter or the
Microtainer tube holder.
Supported Tubes or
Universal Cup
Manufacturer
Adapter
For use with 100-mm sample racks
Microtainer Tube
Holder
Part number
+Greiner Minicollect
yes
same as above
+Hitachi
yes
same as above
+Terumo-CAPIJECT
yes
same as above
For use with 65-mm sample racks
+BD Microtainer with
Microgard Closure
+Ezee-Nest13
yes
Manufacturer specific
yes
NOTE: The + symbol before the tube type indicates that it needs to be placed into a holder before loading
it into the sample rack.
NOTE: Ensure that you use BD Microcontainer with Microgard Closure tubes on the system. The BD
Microtainer with Microgard Closure tubes are compatible with 65 mm sample racks that have a one-piece
spring and include lot numbers of 2006 and higher. Contact your sample tube manufacturer for more
information about tube extenders that are compatible with BD Microcontainer with Microgard Closure
tubes.
086D0320-01, Rev. 04
D-8
086D0320-01, Rev. 04
ADVIA Centaur CP Operator’s Guide: D
Appendix E: Supplies
The following is a list of supplies identified with the REF number and part numbers to
assist in the ordering process.
Description
REF
Part Number
DI Water Container (7.5 L)
10638186
086-0332-02
Wash 1 Container (7.5 L)
10638184
086-0329-02
Waste Container (7.5 L)
10284242
086-0325-01
Cleaning Bottle
10284264
086-0335-01
Sample Racks 65 mm
10321984
086-0168-01
Sample Racks 100 mm
10320160
086-0169-01
Ancillary Reagent Trays
10328174
086-0094-01
Solid Waste Drawer
10330484
086-0119-01
Solid Waste Drawer Liner
10318686
086-0121-01
Acid and Base (R1 and R2) Reagent Kit
(2 x 30 mL)
10313526
00497043
Acid and Base (R1 and R2) Reagent Kit
(2 x 1500 mL)
10310026
112219
Cleaning Solution Concentrate (12 x 70 mL)
10310041
112748
Wash 1 Solution (2 x 2500 mL)
10319550
112351
Tubing Set, Blue 2 Channel, Peristaltic Pump
10324201
086-0162-01
Tubing Set, Gray 6 channel, Peristaltic Pump
10329151
086-0164-01
Tip Trays (package of 6480 tips)
10309547
078-K139-01
Cuvettes (package of 3000)
10309546
078-K138-01
Laser Printer (Lexmark E460dn -110 V)
10469854
664-1782-01
Laser Printer (Lexmark E460dn - 220 V)
10469855
664-1783-01
Inkjet Printer (Lexmark Z845 100/240 V)
4533362
527-5167-04
Cable USB Communication, 3-Meter
10317475
527-5158-02
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E-2
086D0320-01, Rev. 04
ADVIA Centaur CP Operator’s Guide: E
Appendix F: Symbols
This section describes the symbols that can display on the exterior of the
ADVIA Centaur CP system or on the system packaging. The symbols on the system
provide you with the location of certain components and with warnings for proper
operation. The symbols on the system packaging provide you with other important
information. For information on the symbols that can display on the ADVIA Centaur CP
reagent packaging and labelling, see the related assay instruction for use.
Symbol
Description
This symbol is used for both Warnings and Cautions.
• A Warning indicates the risk of personal injury or loss
of life if operating procedures and practices are not
correctly followed.
• A Caution indicates the possibility of loss of data or
damage to or destruction of equipment if operating
procedures and practices are not strictly observed.
This symbol alerts you to a biohazard.
This symbol alerts you to the risk of exposure to lasers.
This symbol alerts you to a potential electrical hazard.
This symbol indicates a moving component that can cause
injury.
This symbol indicates compliance with the restriction of
hazardous substances used in electrical or electronic
equipment.
This symbol indicates that the input electricity is
alternating current.
This symbol identifies the location of a protective earth
(GND) conductor terminal.
This symbol identifies the location of a fuse.
This symbol identifies the location of a power connector.
086D0320-01, Rev. 04
F-2
ADVIA Centaur CP Operator’s Guide: F
Symbol
Description
This symbol identifies the location of a computer
connection.
This symbol indicates that this equipment is classified as
Waste Electrical and Electronic Equipment under the
European WEEE Directive. It must be recycled or
disposed of in accordance with applicable local
requirements.
This symbol indicates the main power switch.
This symbol indicates that the main power supply is on.
This symbol indicates that the main power supply is off.
This symbol indicates where primary reagent packs are
loaded or removed.
This symbol indicates where ancillary reagent packs are
loaded or removed.
This symbol indicates the sample loading area.
This symbol indicates the STAT entry.
This symbol indicates where sample tips are loaded.
This symbol identifies the system fluid bottle for Acid
reagent.
This symbol identifies the system fluid bottle for Base
reagent.
This symbol identifies the system fluid bottle for wash 1
solution.
This symbol identifies the water bottle.
086D0320-01, Rev. 04
ADVIA Centaur CP Operator’s Guide: F
Symbol
F-3
Description
This symbol identifies the lid that provides access to the
liquid waste bottle.
This symbol indicates that the product has a temperature
limitation. In this example, you need to store the product
between 2-8 ° C.
This symbol indicates that there is a stacking limit for this
product. In this example, you cannot stack more than four
products on top of one another.
This symbol indicates an in vitro diagnostic device or an
in vitro diagnostic medical device.
This symbol indicates that you should consult instructions
for use.
This symbol indicates that the product is fragile and you
need to handle it with care.
This symbol indicates that you should keep the product
dry.
This symbol indicates the number used for ordering a part
or product.
This symbol indicates the serial number of a part or
product.
This symbol indicates the revision letter of a part or
product.
This symbol indicates the name and location of the
product manufacturer.
This symbol indicates the date of manufacture of the
product.
This symbol indicates the manufacturer’s authorized
representative within the European community.
This symbol indicates that the product or container should
be oriented in the direction of the arrows.
This symbol indicates not to use the product if the
package is damaged.
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F-4
ADVIA Centaur CP Operator’s Guide: F
Symbol
Description
This symbol is intended to encourage recycling.
This symbol is intended to facilitate recycling of
corrugated materials. The number is licensed in Germany
and printed on corrugated shippers.
This symbol indicates that the package is printed with soy
ink.
This symbol indicates that the product complies with the
applicable directives of the European Union.
This symbol indicates that the product is CSA approved
for safety (United States and Canada).
The following laser safety labels display on the exterior of the ADVIA Centaur CP
system.
Label
Description
This label indicates that the product is a
Class 2 laser product, with potential
exposure to a laser beam.
This label indicates that the system is a
Class 1 laser product.
This label indicates that the product
complies to the appropriate regulations.
This label indicates the position of the
laser beam.
086D0320-01, Rev. 04
Appendix G: Contacts
For technical assistance contact your local support provider. For customer service or
additional information contact your local technical support distributor.
086D0320-01, Rev. 04
G-2
086D0320-01, Rev. 04
ADVIA Centaur CP Operator’s Guide: G
Appendix H: Glossary
Ab
See antibody.
AC
Alternating current.
accept
Function used to indicate that a value is valid.
acceptable CV
Highest acceptable percent coefficient of variation among
the replicates of the calibrators, controls, or patient
samples. The system flags results higher than this value.
acid and base
compartment
Compartment containing the acid and base reagent bottles.
acid reagent bottle
Bottle containing the acid reagent used to trigger the
chemiluminescent reaction (labeled R1).
acid probe
Device that dispenses acid reagent into a cuvette to
resuspend the magnetic particles and prepare the
acridinium ester for light emission.
acid reagent
Solution of 0.5% hydrogen peroxide and 0.1N nitric acid
that is added to the magnetic particles in the cuvette after
the wash cycle and reacts with the acridinium ester at a low
pH. This readies the acridinium ester for light emission.
acridinium ester
Chemical tag responsible for the flash when base reagent is
added to the acidified magnetic particle/analyte/AE
mixture in the cuvette. Abbreviation: AE.
activate
Function used to enable a test or a pack for full use on the
system.
active
Available for full use on the system.
active test
Test from the menu that is enabled for use on the system.
AE
See acridinium ester.
Ag
See antigen.
analyte
Substance of unknown concentration in a sample.
ancillary reagent
Additional reagents required for an assay, such as
Releasing Agent, DTT, or sample diluent.
ancillary reagent area
Area of the reagent compartment where the operator loads
and unloads ancillary packs.
ancillary reagent pack
Container for the additional reagents required for an assay,
such as Releasing Agent, DTT, or sample diluent.
ancillary tray
Two sliding trays inside the reagent compartment used to
hold 5 ancillary reagent packs each.
086D0320-01, Rev. 04
H-2
ADVIA Centaur CP Operator’s Guide: H
antibody
Protein (immunoglobulin molecule) produced by the body
in response to the presence of an antigen. Antibodies are
used as part of the body’s resistance to disease.
Abbreviation: Ab.
antibody-capture assay
Antibody-antigen reaction in which the antibody of
unknown concentration in a sample is captured by an
additional antibody specifically directed against it. The
additional antibody is bound to Solid Phase. Excess
interfering substance is washed from the sample. Antigen
labeled with acridinium ester is added and binds with the
captured antibody from the sample. The measurable signal
produced by the reaction is directly proportional to the
concentration of antibody in the sample.
antigen
Substance that stimulates the production of and combines
specifically with corresponding antibodies. Abbreviation:
Ag. See also immunogen.
archive
Process of removing data from the system memory and
storing it on external media.
aspirate probe
Device used to draw fluid from the cuvette. There are four
aspirate probes: aspirate probes 1, 2, 3, and 4.
assay
Generic term that refers to the chemical analysis for a
specific analyte in a sample. Each assay possesses a unique
test protocol. Also called test.
assay format
Sequence of events during an assay, including incubation
time, wash and aspirate cycles, and addition of reagents.
automatic dilutions
1. Dilutions performed by the system when a result
exceeds the dilution point defined on the Ranges window.
2. Dilutions performed by the system when scheduled by
the operator on the Dilutions window.
background
Electronic signal of the photomultiplier tube (PMT) in the
absence of light.
back up
Process of copying the data files contained on the system
hard disk to an appropriate media.
barcode
Encoded information that is read by an optical scanner.
barcode label
Label containing encoded information that is placed on
sample tubes.
barcode scanner
Device that scans and decodes information from a barcode
label. The system barcode scanners include: the sample/
ancillary barcode scanner, the hand-held barcode scanner,
and the reagent barcode scanner.
086D0320-01, Rev. 04
ADVIA Centaur CP Operator’s Guide: H
H-3
base reagent
Solution of < 0.25N sodium hydroxide. Base reagent is
dispensed into the cuvette in the luminometer. The pHshift
and accompanying electron excitation cause the
chemiluminescent reaction.
base reagent bottle
Bottle that contains the base reagent used to trigger the
chemiluminescent reaction (labeled R2).
base reagent probe
Device that dispenses base reagent into a cuvette causing
the chemiluminescent reaction.
baud rate
Speed of data transmission in bits per second (bps)
between the system and a remote device.
bidirectional interface
Interface configuration allowing information to be
transferred to and from another device.
bps
Bits per second.
buffer
1. Solution composed of a weak acid or base and its salt
that is used for controlling ionic strength. Buffers maintain
the pH of a solution.
2. Data storage used to compensate for differences in
information flow rate or in the time that events occur when
data is transmitted between devices.
calibration
The use of two samples of known concentrations that you
process on your system. The calibration data is then used to
normalize your system against a stored master curve. The
system calculates results from the normalized curve.
calibration curve
Data that normalizes the system against stored Master
Curve data for the tested analyte. The calibration data
compensates for current running conditions and instrument
variability. The system calculates the required sample dose
from the normalized curve.
calibration data
Details of the calibration including the SID, concentration,
RLU, CV, and flags for the low and high calibrators.
calibration interval
Number of days or hours between required calibrations.
calibrator
Solution that contains a known concentration or a known
reactivity of one or more analytes and that provides a
reference for converting measured signals into
concentrations. Calibrators are analyzed with reagents to
obtain calibration data points. See calibration data.
Calibrator Assigned
Values card
Card that contains the calibrator information for a specific
lot of calibrators. The card contains the lot number and
expiration date, and the high and low calibrator values for
each analyte contained in the calibrator. This information is
on the card in text and barcodes for you to enter in the
system.
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cancel
Function used to ignore changes made at a window.
CD
Compact disk.
CD drive
Device that writes information to, and reads information
from, a CD.
central processing unit
Main printed circuit board of a computing system that
interprets instructions and directs the system operations.
Abbreviation: CPU.
character parity
Transmission setting used to check for transmission errors
between the system and a remote device. This setting must
be the same at the system and the remote device to
maintain compatibility between the systems.
check digit
Digit at the end of the barcode used to verify that the
barcode was correctly scanned.
check range
Value entered in the test definition beyond which the
operator can program the system to automatically repeat
tests. Also called alert range or action range.
checksum
1. Variable, two-digit, hexadecimal number that is part of
the data link message frames and supports error detection.
2. Variable hexadecimal number that ensures the Master
Curve and the Calibrator definition values entered are
valid.
chemiluminescence
Oxidation reaction of an organic chemical compound. The
chemiluminescent reaction emits light.
chemiluminescent
immunoassay
Assay that uses an antibody-antigen reaction to determine
the presence of an analyte. The amount of analyte is
quantitated by a chemiluminescent reaction.
chemiluminescent
reaction
Light-emitting chemical transformation caused by the
oxidation of an organic chemical compound.
cleaning bottle
Bottle containing the cleaning solution.
cleaning solution
Solution used for system cleaning.
closed bracket
The set of controls that follow a control bracketed assay.
See control bracketing.
coefficient of variation
Percent coefficient of variation among the replicates for a
sample. Abbreviation: CV.
communication port
Serial RS-232 port on the system that can connect the
system to an external, remote device, such as an LIS or a
data management system.
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competitive assay
1. Antibody-antigen reaction in which the antigen (Ag) of
unknown concentration in a sample and a labeled antigen
in an assay reagent compete for a limited amount of
antibody (Ab) in an assay reagent. The measurable signal
produced by the Ab/labeled-Ag reaction is inversely
proportional to the unknown concentration of Ag in the
sample.
2. Antibody-antigen reaction in which the antibody of
unknown concentration in a sample and a labeled antibody
in an assay reagent compete for a limited amount of
antigen in an assay reagent. The measurable signal
produced by the Ag/labeled-Ab reaction is inversely
proportional to the unknown concentration of Ab in the
sample.
completed assay
Assay for which a valid result was generated or for which
all required sample aspirations are complete. Required
reagent aspirations may not have completed.
computer
Workstation component that controls system functions and
processes data. Also called the central processing unit
(CPU).
Conc.
See concentration.
concentration
Amount of analyte measured. Abbreviation: Conc.
confidence interval
Statistical value that describes how likely the statistical
results are to be accurate.
configuration
Settings of software and hardware.
context-sensitive screen
help
Information related to the operator’s current task,
accessible without interrupting the current task.
continuous level sensing
Measurement of a wide range of resolvable fluid levels.
continuous operation
Operation allowing the system to process samples without
interruptions to add or remove samples, empty containers,
or replenish supplies (not including acid and base
reagents).
control
Quality control material used to determine if the system is
reporting valid results.
control bracketed assay
Certain assays are required to be preceded and followed by
a set of controls. See control bracketing.
control bracketed sample
A sample that requires an open control bracket and a closed
control bracket before results are released. See control
bracketing.
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control bracketing
Laboratories can comply with procedural
recommendations for certain assays that are regulated very
closely. These assays are required to be preceded and
followed by a set of controls. The patient results are
released only if the starting controls and the closing
controls complete successfully and are within range. The
system performs tests with control bracketing when the
feature is enabled in the Assay Details window.
control value range
Range of acceptable results established by the quality
control material manufacturer. The control value range is
provided in the assay manual.
corrective action
Activity performed by the operator to solve a problem.
CPU
See central processing unit.
cut-off point
Medical decision point for a qualitative assay. Results
above the cut-off point are reported with a different
qualitative interpretation than those below the cut-off
point.
cuvette
Plastic, disposable container that holds the reaction
mixture on the system. The chemiluminescent reaction
occurs inside the cuvette.
cuvette loading bin
Receptacle that holds the cuvettes.
CV
See coefficient of variation.
cycle count
Number of times the sample probe picks up a sample tip.
dark count
Electronic background signal of the photomultiplier tube
(PMT) in the absence of light.
data bits
Number of bits (7 or 8) transmitted as a byte between a
system and a remote device.
DC
Direct current.
default value
Value defined and preset by Siemens.
define
Establish a value for a variable or symbol, or establish
what the variable represents.
DI water
Deionized water used for rinsing the system components.
DI water container
Receptacle containing the DI water.
delete
Function used to remove an object, such as a file, from the
database.
demographics
Information about a patient or sample such as name,
identification number, date of birth, sex, location, and
physician.
designated STAT lane
Sample compartment lane defined by the operator in which
all samples are treated as STAT samples.
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diluent
Protein-based solution used to dilute a sample.
dilution setpoint
Value that indicates the concentration beyond which the
system dilutes the sample and repeats the test.
disable
1. Command or condition that does not allow a specific
event to proceed.
2. Function used to remove a test from the menu.
disabled assay
Certain assays are disabled and locked by the manufacturer
pending approval for use by the regulatory authority in
your region.
display area
Workspace area containing the current active screen.
ELF
Enhanced Liver Fibrosis assay intended to be used as an
aid in the diagnosis of liver fibrosis in patients with signs
and symptoms of chronic liver disease.
ELF Algorithm
The mathematical formula used to calculate the ELF score.
ELF Score
The result of an algorithm combining the concentrations of
3 assays; HA, PIIINP, and TIMP-1 on a given patient
sample that is used in conjunction with other laboratory
findings and clinical assessments as an aid in the diagnosis
and the assessment of the severity of liver fibrosis.
ELF Test
A test consisting of the results of 3 assays; HA, PIIINP, and
TIMP-1, and the calculation of the ELF score from those
results.
enable
1. Command or condition that permits a specific event to
proceed.
2. Function used to add a test to the menu.
equivocal
Interpretation of a qualitative assay for which a definitive
result is not possible. Certain qualitative assays have
equivocal zones that are established as a range on either
side of the cut-off point. Also called indeterminate.
event
System occurrences such as a manual operation or an error
recorded by the system in the event log.
event log
List of system occurrences (events) including errors, from
the most recent to the oldest.
expiration date
Date beyond which the manufacturer does not guarantee
correct performance of the reagent or material.
firmware
Software that the system downloads to the control unit.
flag
Remark or message about the status of a result. Flags are
displayed next to results on screens and windows, and on
printed reports.
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flash
Short burst of light produced during the chemiluminescent
reaction when acridinium ester is oxidized. Acridinium
ester is oxidized when the pH rapidly changes from acidic
to basic with the addition of base reagent.
front cover LEDs
Light-emitting diodes (LEDs) on the front cover above the
tip drawers, sample compartment, and reagent
compartment that indicate the status of the supplies within.
function buttons
Taskbar buttons that access functionality such as starting,
stopping, or exiting the system software.
fuse
Device that protects components against over current.
hand-held barcode
scanner
Device that allows the operator to scan barcodes to enter
data into the system.
hard disk drive
Device that stores data and contains all system
programming.
hardware
Physical components of the system.
host query
System interface setup that specifies that the system
request a remote device such as an LIS to upload requests
or information.
ICMA
See immunochemilumi-nometric assay.
ID
Identification. Used in SID (sample identification) and PID
(patient identification).
immunoassay
Chemical test that uses an antibody-antigen reaction to
determine the presence of a specific analyte or to quantify a
specific analyte. The test measures an antibody or an
antigen.
immunochemiluminometric assay
Type of sandwich assay in which the measurable signal
produced by the reagent-labeled antibody-antigen reaction
is proportional to the unknown concentration of antigen or
antibody in a sample. See also sandwich assay.
Abbreviation: ICMA.
immunogen
Substance of appropriate size and species specificity
which, when introduced to the body, stimulates the
production of antibodies. An immunogen can be an antigen
or a hapten conjugated to a large protein.
inactivate
Function used to limit the use of a test or a pack on the
system.
inactive
Not available for full use on the system.
inactive test
Test that is not enabled for use on the system.
include
Function used to add a value for consideration with other
values.
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incubation ring
Area where cuvettes are incubated at 37C to prepare the
sample and reagent for the chemiluminescent reaction. The
incubation ring also positions the cuvettes for sample and
reagent dispenses and magnetic particle washes and
resuspensions. Also called ring.
index
Qualitative result that represents the relative concentration
of an analyte based on a cutoff.
intercept
Factor used with slope to correlate the assay results with
another method. You obtain the intercept and the slope
from a regression equation based on method comparison
studies.
keyboard
Workstation component that allows the operator to type
information or to respond to a system prompt.
label
Substance coupled to an antigen or antibody that provides
the measurement signal for an immunoassay.
laboratory information
system
Laboratory computer system that can be interfaced to the
system. Abbreviation: LIS.
LED
See light-emitting diode.
Levey-Jennings charts
Charts used to graphically display quality control data
points for evaluation against a required mean and standard
deviation.
light count
Measured electronic signal of the photomultiplier tube
(PMT) during the chemiluminescent reaction.
light emitting diode
Electronic device made from semiconductor materials that
emits light when current flows through it. Abbreviation:
LED.
link
Method of directly accessing information or data.
LIS
See laboratory information system.
LIS code
Alphanumeric code that identifies a test, profile, or
calibrator to a hospital or laboratory computer.
Lite Reagent
Assay reagent containing antibody or antigen labeled with
acridinium ester in buffer.
lot-to-date QC data
Quality control mean, standard deviation (SD), number of
points (n), and coefficient of variation (CV) collected
during the time the lot is in use on the system.
luminometer
Subassembly and component of the system where the
chemiluminescent reaction is measured. Also called lumo.
lumo
See luminometer.
lyophilized material
Liquid material that is freeze-dried to a powder for long
term stability.
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manual dilution
Dilution of a sample made before placing the sample on the
system.
Master Curve
Multi-point curve that Siemens generates for each lot of
Solid Phase and Lite Reagent for a particular test. The
Master Curve is the reference curve used to convert a
measured signal into sample concentration. Calibration
data normalizes the system against stored Master Curve
data for the tested analyte.
monoclonal antibody
Antibody produced through the fusion of a myeloma cell
and a B lymphocyte. Antibodies produced by a single
fusion event have identical structure, affinity, and
specificity for a given antigen.
mouse
Workstation component that allows the operator to perform
actions on the user interface screens and windows.
n
1. Total number of observations. Used in calculating the
mean.
2. Number of points.
nonreactive
Below the cut-off limit for a reactive result. Abbreviation:
Nr.
normal range
See reference range.
Nr.
See nonreactive.
observed limits
Range calculated by the system for each test after the
fourth valid calibration of a reagent and calibrator lot
combination. The system uses data from additional valid
calibrations of the reagent and calibrator lot combination to
continually recalculate this range.
off-system test
Test that is not run on the system but whose results are
entered in the result database and printed on a patient
report. You can use off-system test results in ratio tests.
open bracket
The set of controls that precedes a control bracketed assay.
See control bracketing.
Pack ID
Identification code contained in the barcode on a reagent
pack that the system recognizes as unique to that pack.
paramagnetic particles
Magnetic particles used in the Solid Phase reagent.
Abbreviation: PMP.
patient identification code
Unique code that identifies the patient from whom a
sample is obtained. Abbreviation: PID.
pending samples
Samples for which tests are scheduled and in process, but
not complete.
pending tests
Tests that are scheduled or in process, but not complete.
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H-11
photomultiplier tube
Sensitive photodetector that captures individual photons of
light. Abbreviation: PMT.
photon
Unit of light; quantum of radiant energy.
placed
Tests that are scheduled and on the system, but are not in
process.
PID
See patient identification.
PMP
See paramagnetic particles.
PMT
See photomultiplier tube.
polyclonal antibody
Antibody produced through injection of antigen into
animals.
power socket
Connects the system to the main facility power via a power
cable.
power supply
Electronic subsystem that converts the AC voltages in the
power line to the DC voltages used inside the system.
power switch
Turns the system on and off.
pretreatment
Process that occurs to prepare a sample for testing.
primary reagent area
Area of the reagent compartment where the operator loads
and unloads primary reagent packs.
primary reagent pack
Contains the Solid Phase and Lite Reagent.
primary sample tube
Tube used to collect patient blood samples by
venipuncture.
prime
Function that prepares the system fluid lines.
priority
The system can control the order that tests are scheduled
according to priority.
profile
Group of tests.
prompt
Questions, instructions, or commands that help you
complete the current task.
pump
Device that transfers fluids.
QC
See quality control.
quality control
Process of verifying the performance of the system using
products containing specific analytes within a
predetermined concentration range. Abbreviation: QC.
quality control material
Product containing one or more specific analytes with a
predetermined concentration range or reactivity used to
verify the performance of the system.
quality control sample
Protein-based product containing specific analytes within a
predetermined concentration range used to verify the
performance of the systems.
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query timeout
Maximum time interval required for a remote device to
respond to a query from the system.
Rack Type ID
The unique code that identifies which tube type a rack can
use.
random access
Mode of operation in which the system processes samples
for multiple assays.
ratio definition
Formula used to calculate the results of a ratio test.
ratio test
Test results calculated using the results of other tests.
raw data
Total photon count that the system received for a flash.
reagent code
Certain assay test definitions contain a specific reagent
code that links the test definition to a specific Master Curve
card and Calibrator Assigned Value card.
reagent compartment
Compartment containing the ancillary and primary
reagents.
reagent probe
Device that aspirates reagents from the reagent packs and
dispenses them into cuvettes.
reagent probe rinsing
station
Device that helps clean the reagent probe.
reagent water
Water that meets specification for clinical laboratory use.
reference number
A unique number associated with each Siemens product.
The number is used when ordering the product.
reference range
Range of values for each assay from a defined population.
Reference ranges can also exist for various pathological
states.
relative light unit
Counts generated when the PMT detects light during the
chemiluminescent reaction. Abbreviation: RLU.
replicate
Number of times that a sample is performed for a
scheduled test.
results
Dose concentration, ratio cutoff, or qualitative answer
(positive, negative, reactive, nonreactive) for an assay
performed on a sample.
ring
See incubation ring.
RLU
See relative light unit.
rocker tray
Device that keeps reagents in suspension by rocking the
reagent packs.
sample
Specimen used for testing such as a patient sample, control,
or calibrator.
sample compartment
Compartment designed to accommodate 7 sample racks.
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sample cup
H-13
Disposable container that holds patient, control, or
calibrator samples.
sample identification code Unique code that identifies each sample. Abbreviation:
SID.
sample probe
Device that picks up a sample tip and then aspirates a
sample and dispenses it into a cuvette.
sample rack
Device used to present sample tubes to the system. Each
rack can accommodate 12 sample tubes.
sample rack lane
One of seven positions inside the sample rack compartment
designated for sample racks. Lane 7 is the default STAT
lane.
sandwich assay
Antibody-antigen reaction in which the antigen of
unknown concentration in a sample is sandwiched between
antibody bound to solid phase and antibody labeled with
acridinium ester. The measurable signal produced by the
reaction is directly proportional to the concentration of
antigen in the sample.
save
Function used to add an object to the database or to include
updates to an object in the database.
SD
See standard deviation.
search
Function used to locate an item in a list.
sensor
Device that detects changing states of a component.
shutter
Device that covers the reagent compartment, and opens to
provide the reagent probe access to the reagents.
SI units
International system for units of measure.
SID
See sample identification.
sign in
Accessing the system software by entering a user name.
slope
Factor used along with intercept to correlate the assay
results with results from another method. You obtain the
slope and the intercept from a regression equation based on
method comparison studies.
software
Computer instructions that generate and carry out
commands to control system operation.
Solid Phase
Assay reagent consisting of paramagnetic particles
covalently bound to antigen or antibody suspended in a
buffer.
sort
Function used to change the order of items in a list.
stability
Degree of a reagent’s resistance to chemical change or
degradation.
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standard deviation
The positive square root of the variance. A measure of
scatter used to determine quality control ranges.
Abbreviation: SD.
startup
Events that occur when the system uses the software to
initialize the hardware.
STAT
Test given the highest priority (from the Latin statum
meaning immediately).
status
Information about the current operating condition of the
system.
status bar
Workspace area used to access screens and windows
associated with the current status of the system.
stop bits
Number of data bits that maintain synchronization between
the system and a remote device during data transmission.
symbology
Set of rules for encoding information in a barcode.
syngo
Syngo is a messaging and communications framework that
provides a means to exchange data between an instrument
and Real Time Informatics (RTI) applications, between an
instrument and Real Time Solutions (RTS) applications,
and between an instrument and an LIS (laboratory
information system). Syngo allows the remote viewing,
interpretation, intervention by your local service provider,
data management, and middleware capability.
system clock
Twenty-four hour clock that the system uses to monitor
various system functions.
taskbar
Workspace area used to access screens and windows
associated with specific tasks and functions.
thermistor
Device that changes resistance with temperature changes.
tip
Plastic device designed to pick up patient sample from a
sample tube.
tip drawers
Two drawers designed to accommodate a total of 4 tip
trays.
tip eject area
Area into which the sample probe ejects used sample tips
into the waste drawer.
tip tray
Tray containing 120 sample tips.
top cover
Hinged interlocked component that covers the system.
touch-screen monitor
Workstation component that allows the operator to interact
with the system software by pointing and selecting with a
finger.
troubleshooting
Determining the cause of a system or assay performance
problem.
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H-15
tube-type selector
Selector on the sample rack that allows you to define a
tube-type for that rack.
two-point calibration
Assay calibration that uses two known concentrations to
normalize the Master Curve for current operating
conditions.
update
Function used to overwrite information with new
information.
user interface
Point of interaction or communication between the system
software and the operator.
valid
Acceptable (refers to calibration results).
view
Function used to limit the items that display in a list.
waive
Function that allows you to use an expired calibration.
wash 1 container
Receptacle containing the wash 1 solution.
wash 1 solution
Solution used to wash away the unbound material in the
cuvettes.
waste container
Receptacle for liquid waste. Also called the liquid waste
container.
waste drawer
Receptacle for solid waste (cuvettes and tips). Also called
the solid waste drawer.
waste drawer liner
Removable plastic liner fitted inside the waste drawer.
waste probe
Device that aspirates waste from the cuvette after it is
processed.
window
Workspace element displayed above the current screen.
worklist
List of scheduled patient samples, controls, and calibrators,
including identification and requested tests for each entry.
workspace
User interface that provides access to all system functions
and information necessary to operate the system.
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Appendix I: Index
Numerics
2-point calibration 3-2
A
acceptable CV, calibrators 3-5
accepting a calibration 3-20, 6-20
acid and base
checking the pumps 4-39
reagent compartment 1-8
viewing volumes 2-11
acid reagent
composition C-13
acridinium ester 1-29, 1-31
adding
acid and base 2-9
control requests 3-22
controls 3-23
cuvettes 2-16
ADVIA Centaur CP system
interior view 1-15
system components 1-5
topview figure 1-15
ADVIA QC
quality control 6-36
software 3-31
transmitting 6-37
viewing out of range status 6-36
AE antibody binding 1-30
AE-labeled antibody 1-36
alarm
setting audible alarms 6-38
severity 6-38
turning off the audible system alarm 2-5, 6-38
All calibrations tab 2-66
alternating current (electricity) symbol F-1
ancillary probe
cleaning 4-31
ancillary reagent
loading packs 2-27
pack handling C-4
removing packs 2-31
anonymous results 6-11
defining 6-6, 6-11
antibody 1-30
AE-labeled 1-32
antibody binding principles 1-30
antibody-capture assay 1-31, 1-38
antibody-capture format 1-38
antigen 1-30, 1-32
aspirate probes 1-27
bubble detector calibration 4-8
repositioning the tubing 4-59
aspirating waste fluid 1-28
assay
antibody-capture 1-31
calculation options 6-18
competitive 1-31, 1-34
options 6-8
options, reagent stability 6-13
reaction formats 1-31
reaction time 1-31
sandwich 1-31
technology 1-31
assigned value card
calibrator values 3-12
assigning
calibrations 3-21, 6-20
new tip trays 2-15
audible alarms 6-38
autoexclude, calibrator replicates 3-9
automated system prime 4-37
automatic
printing sample results 6-39
reflex of samples 6-35
repeat of samples 6-35
automatic sample repeats
concentration calculation range 6-17
defining 6-15
index calculation range 6-17
automating
daily cleaning 4-6
monthly cleaning 4-10
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printing of results 2-61
running scheduled controls 3-27
weekly cleaning 4-8
autoscheduling, daily cleaning procedure 4-4
B
backup 2-6
routine system backup 2-7
setting backup directory 6-39
system data 4-36
writing to CD-ROM 2-7, 4-35
barcode
ancillary reagent manually enter 2-30
lot-specific 3-1
manually enter primary reagent 2-25
manually enter sample ID 2-40, 2-55
primary pack 1-13
scanner 3-14
scanner lasers A-3
testing the primary reagent scanner 5-14
base reagent
composition C-13
batch orders 2-44
biohazard
protecting yourself A-1
symbol F-1
brackets
control bracketing 2-66
using control bracketing 6-11
bubble detector, testing the reagent probe 5-12
C
calculating the multicomponent result 2-58
calibration
acceptable CV 3-5
accepting 3-20
accepting invalid 6-20
assigning 3-12, 3-21, 6-20
autoexclude calibrator replicates 3-9
calibrator deviation 3-6
defined ranges 3-6
defining options 6-19
086D0320-01, Rev. 04
evaluation criteria 3-4
HBs no cal 3-17
master curve 3-1
observed ranges 3-6
printing results 3-18
ratio 3-5
reagent code 3-12, 3-13, 3-14
result details 3-17
result summaries 3-16
retained 3-7
retaining 6-20
slope 3-5
T uptake 3-4
two-point 3-1, 3-2
viewing results 3-17
waiving 3-19
waiving a calibration 3-19
waiving expired 3-19, 6-20
calibration data
replicate results 3-15
review 3-15
status messages 3-15
calibrator
acceptable CV (low and high) 3-5
adding 3-12
autoexcluding a replicate 6-21
barcode scanner 3-12
defining values 3-12
display at worklist 3-20
excluding RLU 3-18
scheduling 3-9
calibrator reagent code and test definition 3-13
canceling a multicomponent test 2-56
capacity
cuvette 1-3
cuvette waste 1-3
fluid waste 1-3
for supplies 1-3
reagent water 1-3
sample tip trays 1-3
Index-3
caution symbol F-1
CD backup of data 2-7
changing designated STAT lane 6-32
changing your password 2-9
checking
acid and base pumps 4-39
sample status 2-44
checking sample status 2-44
chemiluminescent
immunoassay 1-30
cleaning
ancillary probe 4-31
automating daily cleaning 4-6
automating monthly cleaning 4-10
automating weekly cleaning 4-8
exterior of reagent probe 4-31
primary reagent compartment 4-17, 4-22
reagent compartment 4-22
reagent compartment shutter 4-24
reagent pack holders 4-17, 4-22
sample compartment 4-17
sample compartment shutters 4-19
solid waste drawer and liner 4-14
wash 1 container 4-26
water and waste containers 4-26
cleanup database 4-35
clogs
testing for sample probe clogs 5-12
closing
a bracket 2-50
windows 1-25
color coding for LEDs 1-4
compartment
acid and base reagent 1-8
reagent 1-12
sample 1-10
competitive assay 1-31, 1-34
competitive format 1-34
computer
barcode scanner 1-17
components 1-16
keyboard 1-17
mouse 1-17
shutdown 2-8
touch screen 1-16
concentration calculation ranges
automatic repeats 6-17
consult instructions for use symbol F-3
contacts G-1
container orientation symbol F-3
containers
DI water 2-19
liquid waste 2-20, 4-26
wash 1 2-19
control bracket
automatically discarding a bracket 2-51
closing 2-50
discarding 2-51
scheduling a QC sample 2-50
scheduling calibrators 3-9
scheduling patient samples 2-49
using control bracketing 6-11
control definition, deleting 3-26
Control Definitions
multicomponent test 2-53
controls
adding control requests 3-22
defining 3-23, 3-26
defining new 3-23
deleting from a QC definition 3-26
editing 3-26
entering expected values 3-23
name 3-24
running automatically scheduled controls 3-27
scheduling a worklist 2-48
scheduling requests 3-22
086D0320-01, Rev. 04
Index-4
conversion factors, SI C-11
correct an error in the SID entry 2-41, 2-56
CSA approved for safety symbol F-4
current calibration tab 2-66
cut-off point, qualitative assays 3-3
cuvettes
adding 2-16
filling loading bin 2-16
hopper 1-15
waste bin 1-28
waste fluid 1-28
D
daily cleaning
automated 4-6
procedure, autoscheduling 4-4
dark counts, performing 5-11
database
almost full 5-3
cleanup procedure 4-35
date of manufacture symbol F-3
Debug error 5-5
decimal point 6-33
default STAT lane 2-37
defined ranges
for calibration 3-6
defined validity criteria
qualitative assay 3-3
quantitative assay 3-2
defining
anonymous results 6-6, 6-11
assay profile 6-26
automatic sample repeats 6-15
calibration options 6-19
calibrator replicates 6-20
calibrator values 3-12
check ranges 6-15
linearity 6-16
maintenance activities 4-4
master curve using keyboard 3-13, 3-15
off-system tests 6-4
086D0320-01, Rev. 04
opened stability 6-13
overdilution concentration 6-24
physician profiles 6-28
profiles 6-26
ratio tests 6-1
reflex tests 6-18
repeats for the concentration calculation
ranges 6-17
result formats 6-22
sensitivity 6-16
user interpretation options 6-21
user profile 6-29
deleting
control definition 3-26
maintenance tasks 4-5
physician profile 6-28
profile 6-27
quality control 3-30
ratio or off-system tests 6-6
results 2-52, 2-69
scheduled tests 2-69
tests from a QC definition 3-26
user profile 6-29
depleted reagent volume 2-75
deviation for calibrators 3-6
DI water
container 2-19
emptying container 2-20
replenishing 2-20
diagnostics 5-7
priming system fluids 5-11
recovering from a system halt in
Diagnostics 5-7
remote access 5-6, 5-14
scanning ancillary pack 5-14
diluting a sample
through the sample compartment 2-41
dilutions
dilution only 2-42
manual 2-42
options 6-23
Index-5
scheduling 2-46
scheduling worklist 2-46
direct chemiluminescence 1-28
display area 1-19
do not use if the package is damaged symbol F-3
downloading
orders from LIS 2-75
E
editing
control definition 3-26
QC expected values 3-26
results 2-52, 2-73
electrical hazard symbol F-1
electrical requirements D-3
emergency stop 5-3
emptying
DI container 2-19, 2-20
incubation ring 5-8
liquid waste container 2-20
solid waste drawer 2-17
wash 1 container 2-19, 2-20
emptying and filling
incubation ring 5-9
encourage recycling symbol F-4
entering
calibrator information manually 3-11
comments for patient results 2-71
expected values, quality control 3-23
offsystem results 2-74
patient demographics 2-63
patient demographics through the sample
compartment 2-64
patient demographics through the worklist 2-63
sample IDs 2-62
STAT samples 2-51
European Union compliance symbol F-4
evaluation criteria for calibration 3-4
evaluation ranges 6-14
event
flags 5-1
log 5-1
severity 5-1
status 5-1
Event Log button 5-1
excluding a calibrator replicate automatically 6-21
excluding a calibrator RLU 3-18
exit 1-21
Exit button 1-21
exiting 2-5
expected values, entering QC 3-23
expired
calibration, waiving 3-19
system fluids C-13
exporting
logs 1-23
maintenance tasks 4-5
quality control 3-30
results 2-70
results to a CD 2-70, 2-71
F
features 1-2
filling the incubation ring 5-8
filtering results 2-67
final results, released 2-39
flags
calibration data 3-18
events 5-1
fluidics area 1-14
fluids
acid and base reagents 2-9
DI water 2-19
expiration C-13
priming 5-11
wash 1 2-19
force printout option 2-62
formula for master curves 3-2
fragile symbol F-3
front cover
LEDs for primary and ancillary reagents 1-13
LEDs for sample lanes 1-10
086D0320-01, Rev. 04
Index-6
lifted, the probes stop 1-15
function buttons 1-21
K
H
L
hazardous substances used in electrical or
electronic equipment symbol F-1
Help 1-21
Historical tab 2-65
hold status for a ratio result 2-73
Home
home page of the Screen Help 1-22
homing
the probes 5-10
the system 5-11
I
importing, maintenance tasks 4-5
in vitro diagnostic device symbol F-3
incubation ring 1-15
add cuvettes 1-28
emptying 5-8
emptying and filling 5-9
filling 5-8
initializing 5-7
magnets 1-27
temperature 1-27
index value
nonreactive 3-3
qualitative assays 3-3
reactive 3-3
initializing
incubation ring 5-7
system probes 5-10
Interpreting the Multicomponent Result 2-59
invalid calibration
accepting 6-20
086D0320-01, Rev. 04
keep the product dry symbol F-3
label, chemiluminescent 1-29
lanes, sample compartment lanes 1-11
LEDs
color coding 1-4
front cover 1-10, 1-13
lid for the liquid waste bottle symbol F-3
light emission 1-29
liquid waste container 2-20
LIS
(laboratory information system) 6-30
loading
ancillary reagent packs 2-27
new tip trays 2-13
sample racks 2-33, 2-35
sample tips 2-12
location
of a computer connection symbol F-2
of a fuse symbol F-1
of a power connector symbol F-1
logs, exporting 1-23
lot-specific barcodes, master curve 3-1
luminometer 1-15
M
magnetic separation 1-30
magnets 1-27
main power supply
is off symbol F-2
is on symbol F-2
main power switch symbol F-2
maintaining
cuvette loading bin 2-16
Reagents 1 and 2 2-9
system containers 4-26
water quality C-9
maintenance
database 4-35
Index-7
database cleanup 4-35
printing reports 4-4
status button 4-3
maintenance tasks 4-3
defining 4-4
deleting 4-5
exporting 4-5
importing 4-5
recording 4-3
manual dilution 2-42
manufacturer’s representative for Europe
symbol F-3
master curve
calibration 3-1
card, barcodes 3-1
defining 3-13
development 3-1
entering calibrator information manually 3-11
formula 3-2
qualitative assays 3-3
quantitative assays 3-1, 3-2
relative light units 3-13
scanning 3-14
specific lot 3-1
standard concentrations 3-1
standard curve 3-1
mixing primary reagent packs C-1
modifying sample replicates for automatic
repeats 6-15
monthly cleaning 4-10
Move to Historical button 2-68
moving component symbol F-1
multicomponent testing 2-53
scheduling a multicomponent test through the
sample compartment 2-55
scheduling a multicomponent test using a
worklist 2-54
scheduling calibrators 3-11
N
name and location of manufacturer symbol F-3
name of a control 3-24
navigation keys 1-22
O
observed ranges, for calibration 3-6
off system tests 6-4
online help button 1-21
opening windows 1-25
ordering a part symbol F-3
ordering supplies E-1
overdilution concentration
defining 6-24
overview 1-5
quality control overview 3-21
software overview 1-18
P
paramagnetic particles 1-30, 1-31
password
changing 2-9
setting 6-29
patient demographic information (PID) 2-63
entered through the sample compartment 2-64
patient replicates 6-11
Pause 2-39
pausing sampling 2-4
pending tab 2-65
performing dark counts 5-11
power
failure 5-3, 5-5
restored 5-5
preheater, temperature 1-28
primary pack barcode 1-13
primary reagent
LED status 1-13
loading 1-14
pack information C-1
packs 2-22
removing packs 2-26, 2-31
086D0320-01, Rev. 04
Index-8
screen 1-14
primary reagent compartment 1-5, 1-15
cleaning 4-17, 4-22
priming
automated system prime 4-37
individual system fluids 5-11
principles
antibody binding 1-30
printed with soy ink symbol F-4
printing
automating the printing of results 2-61
calibration results 3-18
force printout 2-62
maintenance reports 4-4
quality control 3-30
results 2-61, 2-68
runtime results 2-61
screen 2-61
to a local printer 2-61
probes
homing 5-10
initializing 5-10
processing samples 2-33
failed samples 2-75
profile definition 6-26
protecting yourself from biohazards A-1
protective earth (GND) conductor terminal
symbol F-1
pumps
checking acid and base pumps 4-39
replacing blue peripump tubing 4-41
replacing gray peripump tubing 4-47
purifying water C-7
Q
QC definition, editing 3-26
QC principle, qualitative assay 3-22
qualitative assay
cut-off point 3-3
index value 3-3
master curve 3-3
086D0320-01, Rev. 04
two-point calibration 3-3
quality control
adding and editing 3-23
deleting 3-30
deleting controls 3-26
deleting tests 3-26
editing control definitions 3-26
exporting 3-30
overview 3-21
printing 3-30
results, transmitting to LIS 6-37
samples 3-22
tab 2-66
viewing 3-29
viewing details 3-29
viewing summaries 3-28
quality control definition
adding controls 3-23
editing expected values 3-26
reloading a control definition 3-27
selecting tests for 3-23
quality control values
adding 3-23
editing 3-23
quantitative assay
calibration 3-1
master curve 3-1
two-point calibration 3-1
user-initiated calibration 3-1
quantitative two-point calibration. See two-point
calibration.
R
range
concentration calculation 6-17
patient population 6-14
reference 6-14
ratio
for sandwich assays 3-5
hold result 2-73
hold status 2-67
Index-9
ratio tests
defining 6-1
reagent
cleaning compartment shutter 4-24
cleaning pack holders 4-17
cleaning reagent compartment 4-22
cleaning reagent compartment shutter 4-24
cleaning the exterior of the probe 4-31
compartment 1-12
defining opened stability 6-13
handling C-1
managing supplies 2-21
monitoring supplies 2-21
packs 1-13
primary reagent packs 2-22
replacing acid and base 2-9
shortage window 1-14
volume error 2-75
water 1-5, 1-6
water quality C-6
Reagent 1
composition 2-9
locating 2-9
replacing 2-9
Reagent 2
composition 2-9
locating 2-9
replacing 2-9
reagent code 3-15
assay test definition 3-13
master curve match assay test definition 3-15
reagent pack
cleaning holders 4-22
empty 2-73
reagent probe
verify the bubble detector 5-12
reagent stability 6-13
Reagents 1 and 2
replacing 2-9
rebooting the system. See Starting and Stopping
the System.
recovering
from a software failure 5-4
from a system power failure 5-3
system lockup 5-3
recycling of corrugated materials symbol F-4
reference ranges
reflex tests 6-18
reference serum calibration
T uptake 3-4
reflex tests
defining 6-18
reference ranges 6-18
releasing hold status for a result 2-73
reloading a quality control definition 3-27
remote access
viewing status 5-6
removing
ancillary reagent packs 2-31
primary reagent packs 2-26
racks from the system 2-38
repeating a multicomponent test 2-57
repeating samples
concentration calculation range 6-17
index calculation range 6-17
replacing
acid and base reagents 2-9
blue peripump tubing 4-41
gray peripump tubing 4-47
Reagents 1 and 2 2-9
replenishing
acid and base 2-9
DI water 2-20
sample tips 2-12
wash 1 2-20
replicates
scheduling 2-45
setting through the sample compartment 2-43
reports
headers 6-35
printing maintenance reports 4-4
086D0320-01, Rev. 04
Index-10
printing runtime results 2-61
rerunning tests 2-56, 2-72
reruns tab 2-65
restoring system data 4-37
results
automatic printing 2-61
deleting 2-52, 2-69
editing 2-52, 2-73
entering comments 2-71
entering offsystem results 2-74
exporting 2-70
exporting to a CD 2-71
filtering 2-67
printing 2-61, 2-68
releasing hold status 2-73
reporting without patient names or PIDs 6-6,
6-11
summaries 2-66
tabs 2-65
viewing 2-67
viewing result details 2-66
viewing summaries 2-66
Resume 2-39
retained calibration 3-7
retaining a calibration 6-20
revision letter of a part symbol F-3
rinse stations
cleaning 4-24
risk of exposure to lasers symbol F-1
runtime report 2-61
ratio result 2-62
S
sample
checking status 2-44
checking status through the sample
compartment 2-44
diluting a sample 2-41
entering IDs 2-62
entering STATs 2-51
loading racks 2-33
loading racks into the system 2-35
086D0320-01, Rev. 04
minimum volume D-5
pausing 2-4
processing 2-33
removing racks from the system 2-38
scheduling patient samples 2-40
scheduling through the sample
compartment 2-40
stopping 2-4
tube types 6-34, D-4
volume requirements D-5
sample compartment 1-10
checking sample status 2-44
cleaning 4-17, 4-19
diluting a sample 2-41
setting batch orders 2-44
setting replicates 2-43
sample ID
(SID) 2-62
lengths 6-39
sample loading area symbol F-2
sample probe
testing for clogs 5-12
sample racks
loading 2-35
removing 2-38
removing to retrieve sample 2-39
sample scheduling mode 6-30
sandwich assay 1-31
sandwich format 1-31
scanning
ancillary pack 5-14
calibrator 3-12
master curve 3-14
scanning barcodes 3-14
scheduled tests
deleting 2-69
scheduling
a worklist 2-48
calibrator 3-9
calibrators for a control bracketed test 3-9
control bracketed control 2-49
Index-11
control bracketed control as a QC sample 2-50
control bracketed patient sample 2-49
control bracketed sample 2-49
control requests 3-22
dilution exclusively 2-43
dilutions 2-46
dilutions using a worklist 2-46
manually rerun a test 2-56, 2-72
multicomponent test through the sample
compartment 2-55
patient samples 2-40
qc sample 2-50
replicates using a worklist 2-45
samples through the sample compartment 2-40
samples using a profile 2-41
worklist 2-48
worklist for controls 2-48
worklist using the Results Screen 2-45
worklist using the results screen 2-45
scheduling calibrators for a multicomponent
test 2-53
scheduling controls for a multicomponent
test 2-54
scheduling patient samples for a multicomponent
tests 2-54
screens and windows 1-25
sensitivity
defining 6-16
separation
bound from free 1-33
serial number symbol F-3
service, under warranty B-1
setting
alarm severity 6-38
batch orders 2-44
date format 6-33
language 6-33
online help language 6-33
password 6-29
replicates 2-43
report headers 6-35
STAT sample mode 6-31
system response to expired calibrations 6-40
system time 6-32
test priority 6-31
tube type 2-35
shutdown 2-8
SI unit conversion factors C-11
sign-in 2-3
as Guest 2-3
button 1-21
slope for calibrations 3-5
software failure 5-4
solid waste
calibrating the sensor in the bin 5-15
drawer 1-14
drawer cleaning 4-14
emptying 2-17
specifications D-1
stacking limit symbol F-3
standard concentrations
master curve 3-1
start
sampling 2-64
the system 2-3
STAT entry symbol F-2
STATs
default STAT lane 2-37
entering 2-51
tab 2-65
status bar 1-24
Stop, system 5-3
stopping
emergency stop 5-3
sampling 2-4
system 2-5
supplies 1-3
capacity 1-3
managing supplies 2-9
ordering E-1
reagent 2-21
viewing acid and base supplies 2-11
086D0320-01, Rev. 04
Index-12
symbols F-1
alternating current (electricity) F-1
biohazard F-1
caution F-1
consult instructions for use F-3
container orientation F-3
CSA approved for safety F-4
date of manufacture F-3
do not use if the package is damaged F-3
electrical hazard F-1
encourage recycling F-4
European Union compliance F-4
fragile F-3
in vitro diagnostic device F-3
keep the product dry F-3
lid for the liquid waste bottle F-3
location of a computer connection F-2
location of a fuse F-1
location of a power connector F-1
main power supply is off F-2
main power supply is on F-2
main power switch F-2
manufacturer’s representative for Europe F-3
moving component F-1
name and location of manufacturer F-3
ordering a part F-3
printed with soy ink F-4
protective earth (GND) conductor F-1
recycling of corrugated materials F-4
restriction of hazardous substances used in
electrical or electronic equipment F-1
revision letter of a part F-3
risk of exposure to lasers F-1
sample loading area F-2
serial number F-3
stacking limit F-3
STAT entry F-2
system fluid bottle for Acid reagent F-2
system fluid bottle for Base reagent F-2
system fluid bottle for wash 1 solution F-2
temperature limitation F-3
086D0320-01, Rev. 04
warning F-1
water bottle F-2
WEEE European Directive F-2
where ancillary reagent packs are loaded or
removed F-2
where primary reagent packs are loaded or
removed F-2
where sample tips are loaded F-2
system
backup information 6-39
backups 2-6
description 1-1
dimensions D-2
emergency stop 5-3
exiting 2-5
features 1-2
homing 5-11
interior 1-15
overview 1-5
priming 5-11
shutdown 2-8
signing in 2-3
signing in as Guest 2-3
signing out 2-5
starting 2-3
stop 5-3
stop probes 1-15
turning off 2-8
warranty B-1
system and user data area 1-20
system data
backup 4-36
restoring 4-37
system fluid bottle
for Acid reagent symbol F-2
for Base reagent symbol F-2
for wash 1 solution symbol F-2
system fluids
expiration C-13
priming 5-11
Index-13
system lookup 5-3
system probes
homing 5-10
initializing 5-10
T
T uptake
calculating result 3-4
ratio test 3-4
reference serum calibration 3-4
tab
All calibrations results 2-66
current calibration results 2-66
historical results 2-65, 2-68, 2-76
pending results 2-65
quality control results 2-66
reruns results 2-65
STATs results 2-65
Today’s results 2-65
task buttons 1-20
taskbar 1-20
technology 1-28
temperature limitation symbol F-3
tests
deleting from a QC definition 3-26
deleting scheduled tests 2-69
rerun tests 2-56, 2-72
sequence 1-26
tip drawers 1-9
tip trays
assigning new tip trays 2-15
loading new tip trays 2-13
withdrawing old tip trays 2-13
tips
loading sample tips 2-12
Today’s tab 2-65
top cover
opening 4-38
troubleshooting
an event 5-2
creating a backup for service 2-7
event flags 5-1
event log 5-1
event severity 5-1
tube types 6-34
preset D-6
selector illustration 2-34
setting 2-35
turning off
audible system alarms 2-5, 6-38
system 2-8
two-point calibration 3-2
adjusted signal 3-2, 3-3
defined validity criteria 3-2, 3-3
instrument specific correction formula 3-3
qualitative assays 3-3
quantitative assay 3-1, 3-2
user-initiated 3-1
type
tube 6-34
U
unlocking a disabled assay 6-25
user interface workstation 1-16
V
verifying state for calibration 3-20
viewing
pending control bracketed results 2-67
quality control data 3-29
quality control details 3-29
quality control summaries 3-28
result details 2-66
results 2-67
summary information 2-66
system interpretations 6-22
waiting control bracketed results 2-49, 2-67
086D0320-01, Rev. 04
Index-14
W
waiving calibrations 3-19, 6-20
warning symbol F-1
warranty B-1
wash 1
cleaning container 4-26
container 2-19, 4-26
emptying container 2-20
replenishing 2-20
wash block 1-15
waste 1-3
emptying liquid waste 2-20
solid waste drawer 1-14
waste container cleaning 4-26
waste fluid from cuvette 1-28
waste probe 1-28
water
maintaining quality C-9
problems caused by water C-10
purifying C-7
water bottle
cleaning 4-26
symbol F-2
WEEE European Directive symbol F-2
weekly cleaning 4-8
where ancillary reagent packs are loaded or
removed symbol F-2
where primary reagent packs are loaded or
removed symbol F-2
where sample tips are loaded symbol F-2
windows 1-25
closing 1-25
elements 1-26
opening 1-25
opening and closing 1-25
worklist 2-46
entering patient demographics 2-63
scheduling 2-45, 2-48
scheduling a multicomponent test 2-54
scheduling controls 2-48
scheduling replicates 2-45
086D0320-01, Rev. 04
workspace
computer interface 1-18
display area 1-19
Exit button 1-21
function buttons 1-21
online help button 1-21
sign-in button 1-21
status bar 1-24
system and user data area 1-20
task buttons 1-20
taskbar 1-20
workstation 1-16
dimensions D-2