Bayer HealthCare Advia 70 Manual

Part No. 083D0001-01
ADVIA 70 Hematology System
Operator's Guide

A
Trademarks and Copyright
ADVIA, is a registered trademark of Bayer Corporation. TESTpoint and SETpoint are
trademarks of Bayer Corporation.
Microsoft, Windows, and Windows 2000 are registered trademarks of Microsoft
Corporation.
All other trademarks and service marks used in this document are the property of their
respective owners.
© 2001 Bayer Corporation. 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 Bayer Corporation.
WARNING
If theADVIA 70 Hematology System is used in a manner not specified by Bayer
Corporation, the protection provided by the equipment may be impaired. See Appendix B
for warning and hazard statements.

CONTENTS i
CONTENTS
CONTENTS .............................................................................................................i
FIGURES..............................................................................................................vii
SECTION 1 — INTRODUCTION.........................................................................1-1
Intended Use ............................................................................................................1-2
Reagents, Calibrators, and Controls.........................................................................1-3
General..............................................................................................................1-3
Damaged Containers......................................................................................... 1-4
ADVIA 70 Diluent...............................................................................................1-4
ADVIA 70 Lyse...................................................................................................1-4
ADVIA 70 KLEEN ..............................................................................................1-4
ADVIA 70 Sheath............................................................................................... 1-4
ADVIA 70 TESTpoint Controls and SETpoint Calibrators..................................1-5
Laboratory Precautions .....................................................................................1-5
Supplementary Data.................................................................................................1-5
Service Assistance....................................................................................................1-6
This Manual and Training .........................................................................................1-6
SECTION 2 — SETTING UP THE SYSTEM .......................................................2-1
Unpacking the System..............................................................................................2-2
Setting up the Autosampler (optional)................................................................2-3
Placement of the ADVIA 70 Hematology System .....................................................2-5
General Environment.........................................................................................2-5
Power Requirements.........................................................................................2-5
Space Requirements.........................................................................................2-6
Setting up the ADVIA 70 Hematology System ..........................................................2-6
ADVIA 70 Reagents...........................................................................................2-6
Supply Tubing Assemblies.................................................................................2-7
ADVIA 70 KLEEN ..............................................................................................2-7
ADVIA 70 Diluent...............................................................................................2-7
ADVIA 70 Sheath............................................................................................... 2-8

ii CONTENTS
ADVIA 70 Lyse...................................................................................................2-8
Waste ................................................................................................................2-8
Computer...........................................................................................................2-8
Computer Monitor..............................................................................................2-9
Printer (optional)................................................................................................ 2-9
Keyboard ...........................................................................................................2-9
Pointing Device..................................................................................................2-9
Starting the System ................................................................................................2-10
Software Configuration ...........................................................................................2-10
Auxiliary Menu ........................................................................................................ 2-11
Patient Ranges and Action Limits.................................................................... 2-13
Autorecount Feature........................................................................................2-15
Printer (optional).............................................................................................. 2-16
Transfer Settings .............................................................................................2-17
Date/Time and Regional Settings....................................................................2-18
Customize Report............................................................................................2-20
Wake Up and Shutdown..................................................................................2-23
Advanced Setup .............................................................................................. 2-24
Service ............................................................................................................2-24
SECTION 3 — SYSTEM PRINCIPLES ...............................................................3-1
General System Design............................................................................................3-2
Sequence of Operation............................................................................................. 3-2
Dilution Phase ...................................................................................................3-2
Counting Phase................................................................................................. 3-3
Rinse Phase ......................................................................................................3-4
Elements of Impedance Cell Counting .....................................................................3-5
Cell Counting and Sizing (RBC, Plt) .........................................................................3-7
Cell Counting (WBC) ..............................................................................................3-13
White Cell Differential .............................................................................................3-13
Hemoglobin Determination (Hgb) ...........................................................................3-17
Mean Cell Volume Determination (MCV)................................................................3-18

CONTENTS iii
Hematocrit Determination (Hct) ..............................................................................3-18
Mean Cell Hemoglobin Determination (MCH).........................................................3-18
Mean Cell Hemoglobin Concentration Determination (MCHC)............................... 3-18
Red Cell Distribution Width (RDW).........................................................................3-19
Mean Platelet Volume Determination (MPV) ..........................................................3-19
Plateletcrit Determination (Pct)...............................................................................3-19
Platelet Distribution Width (PDW)...........................................................................3-19
Clog Detection ........................................................................................................3-20
Patient Action Limits and Normal Ranges...............................................................3-20
SECTION 4 — DAILY OPERATING PROCEDURES ..........................................4-1
Supplies and Accessories.........................................................................................4-2
Specimen Collection and Handling...........................................................................4-2
Startup ...................................................................................................................... 4-3
System Checks..................................................................................................4-3
Dry Startup ........................................................................................................4-3
Normal Startup ..................................................................................................4-4
Performing the Daily Quality Control Check .............................................................4-5
Open-Tube Sampling................................................................................................4-7
Running Samples in Sample Saver and Direct Patient Modes
without a Worklist ..............................................................................................4-7
Running Samples in Direct Patient Mode with a Worklist................................4-10
Running Stat Samples with a Worklist.............................................................4-12
Closed-Tube Sampling ...........................................................................................4-12
Using the Autosampler with a Worklist: No Barcode Reader...........................4-12
Using the Autosampler with a Worklist: Barcode Reader ................................4-14
Using the Autosampler without a Worklist (Barcode Reader Required)...........4-14
Running a Stat Sample in Autosampler Mode .................................................4-15
Shutdown................................................................................................................4-15
Shutdown without Wake Up.............................................................................4-16
Shutdown with Wake Up..................................................................................4-16

iv CONTENTS
SECTION 5 — DATA ARCHIVE ..........................................................................5-1
File System Description............................................................................................5-1
Data Archive ......................................................................................................5-1
Maintenance Log...............................................................................................5-2
System Log........................................................................................................5-2
SECTION 6 — DATALOG ...................................................................................6-1
General.....................................................................................................................6-2
Opening the Datalog................................................................................................. 6-2
Searching the Datalog ..............................................................................................6-3
Searching by Sequence Number.......................................................................6-4
Searching by Patient ID Number .......................................................................6-5
Searching by Patient Name...............................................................................6-6
Displaying Results ....................................................................................................6-7
Changing the Patient ID............................................................................................6-8
Transferring Data......................................................................................................6-9
Printing Data.............................................................................................................6-9
SECTION 7 — CALIBRATION PROCEDURES ..................................................7-1
General.....................................................................................................................7-1
When to Calibrate.....................................................................................................7-1
How to Calibrate the System ....................................................................................7-2
SECTION 8 — QUALITY CONTROL ..................................................................8-1
General.....................................................................................................................8-2
Quality Control System Organization........................................................................8-3
Selecting the Active Control Lot................................................................................8-4
Adding Controls to the System .................................................................................8-5
Setting Up a Quality Control File Using a Disk ..................................................8-5
Setting Up a Quality Control File Manually........................................................8-6
Deleting a Control Lot...............................................................................................8-7
Editing a Control File ................................................................................................ 8-7
Reviewing Quality Control Results ...........................................................................8-8
Levy-Jennings Charts........................................................................................8-8

CONTENTS v
Quality Control Results....................................................................................8-10
Submitting Control Data by Disk......................................................................8-12
 XBAnalysis ...........................................................................................................8-12
Establishing
 XBTarget Values........................................................................8-14
Activating
 XBAnalysis....................................................................................8-14
 XBAlert ..........................................................................................................8-14
Viewing or Printing
 XBGraphics ....................................................................8-15
Reviewing Sample Results..............................................................................8-15
Reviewing Batches..........................................................................................8-15
SECTION 9 — MAINTENANCE..........................................................................9-1
General.....................................................................................................................9-2
Maintenance Log ...................................................................................................... 9-3
Adding an Event to the Maintenance Log.......................................................... 9-3
Adding or Editing a Comment in the Maintenance Log ..................................... 9-4
Printing the Maintenance Log............................................................................9-4
Reagents ..................................................................................................................9-5
Changing Reagents...........................................................................................9-5
Priming Reagent Lines ......................................................................................9-7
Monthly or Pre-Calibration Cleaning.........................................................................9-7
Cleaning the Slide Valve....................................................................................9-7
Cleaning the WBC Aperture (No Disassembly) .................................................9-9
Semi-Annual Maintenance......................................................................................9-10
Cleaning the Apertures (Disassembly Required)............................................9-10
Annual Maintenance............................................................................................... 9-11
Additional Options................................................................................................... 9-11
SECTION 10 – TROUBLESHOOTING..............................................................10-1
General...................................................................................................................10-2
Overview of Troubleshooting ..................................................................................10-2
Alert or Symptom....................................................................................................10-2
Functional Alerts..............................................................................................10-2
System Message Alerts ................................................................................... 10-3

vi CONTENTS
Hematology Flags............................................................................................10-7
APPENDIX A — SYSTEM SPECIFICATIONS ................................................... A-1
Operating Characteristics .........................................................................................A-2
Parameters Reported ........................................................................................A-2
Scientific Principles............................................................................................A-3
Sampling Features....................................................................................................A-3
Volume Required for Each Analysis...................................................................A-3
Dilution Ratios ...................................................................................................A-3
Cell Counting Aperture Size ..............................................................................A-3
Cycle Time.........................................................................................................A-3
Waste Analysis ..................................................................................................A-3
Performance Specifications......................................................................................A-4
Computer Hardware .................................................................................................A-5
Processor and Memory .....................................................................................A-5
Display...............................................................................................................A-5
Input/Output Support .........................................................................................A-5
Printer (optional equipment) ..............................................................................A-5
Software Characteristics...........................................................................................A-6
Operating Systems............................................................................................A-6
Software Features .............................................................................................A-6
Alerts .................................................................................................................A-7
Physical Characteristics............................................................................................A-9
Reagents and Controls Required ......................................................................A-9
Power Requirements.........................................................................................A-9
Operating Environment......................................................................................A-9
Dimensions........................................................................................................A-9
Weight ...............................................................................................................A-9
Regulatory Compliance ..........................................................................................A-10

FIGURES vii
APPENDIX B — OPERATIONAL HAZARDS, PRECAUTIONS, AND
LIMITATIONS...................................................................................................... B-1
General.....................................................................................................................B-2
Documentation .........................................................................................................B-3
Electrical Hazards.....................................................................................................B-3
Instrument Precautions.............................................................................................B-3
Reagent Precautions ................................................................................................B-3
Maintenance Precautions .........................................................................................B-4
Calibration Precautions.............................................................................................B-4
Procedural Precautions and Limitations ...................................................................B-5
Results Limitations....................................................................................................B-5
Limitations of the Hct Determination..................................................................B-6
Limitations of the Platelet Count........................................................................B-7
Interpretation of Results............................................................................................B-7
APPENDIX C — BIBLIOGRAPHY..................................................................... C-1
APPENDIX D — ABBREVIATIONS ................................................................... C-1
FIGURES
SECTION 2 — SETTING UP THE SYSTEM
Figure 2-1 Rear Panel View..................................................................................... 2-2
Figure 2-2 Removing the Slide Valve.......................................................................2-3
Figure 2-3 Left Side of the Autosampler .................................................................. 2-4
Figure 2-4 Premix Cuvette.......................................................................................2-4
Figure 2-5 UPS Receptacles ...................................................................................2-5
Figure 2-6 Main Menu............................................................................................2-10
Figure 2-7 Auxiliary menu ...................................................................................... 2-11
Figure 2-8 Patient Range - Action Limits Window..................................................2-13
Figure 2-9 Set/Review Patient Range ...................................................................2-14
Figure 2-10 Set/Review Action Limits .................................................................... 2-15

viii FIGURES
Figure 2-11 Printers Window..................................................................................2-16
Figure 2-12 Transfer Settings Box ......................................................................... 2-17
Figure 2-13 Date and Time Properties...................................................................2-18
Figure 2-14 Regional Settings ...............................................................................2-19
Figure 2-15 Laboratory Information Window..........................................................2-20
Figure 2-16 Misc Information Window ...................................................................2-21
Figure 2-17 Customer Report Setup Dialog Box ...................................................2-22
Figure 2-18 Wake Up / Shutdown Dialog Box........................................................2-23
SECTION 3 — SYSTEM PRINCIPLES
Figure 3-1 Dilution Schematic Diagram...................................................................3-3
Figure 3-2 Impedance Counting System RBC/Plt....................................................3-6
Figure 3-3 RBC/Plt Counting System – Counting in Process ..................................3-8
Figure 3-4 RBC/Plt Counting System – Counting Complete....................................3-9
Figure 3-5 RBC/PLT Counting System – Rinsing Silencer ....................................3-10
Figure 3-6 RBC/Plt Counting System – Backflush Aperture .................................. 3-11
Figure 3-7 RBC/Plt Counting System – Cycle Complete .......................................3-12
Figure 3-8 WBC Differential – Flow Cytometer Scheme........................................3-14
Figure 3-9 Flow Cytometer – Hydrodynamic Focused Cell Monofile.....................3-15
Figure 3-10 WOC Sample Dilution – Injection System ...........................................3-16
Figure 3-11 WOC Scattergrams.............................................................................3-17
SECTION 4 — DAILY OPERATING PROCEDURES
Figure 4-1 Main Menu..............................................................................................4-3
Figure 4-2 Startup Shutdown Window ..................................................................... 4-4
Figure 4-3 Run Menu...............................................................................................4-7
Figure 4-4 Results Window......................................................................................4-9
Figure 4-5 Worklist Menu.........................................................................................4-9
Figure 4-6 Edit Worklist Window............................................................................4-10
Figure 4-7 Add Patient Window ............................................................................. 4-11
SECTION 6 — DATALOG
Figure 6-1 Datalog Menu.........................................................................................6-2
Figure 6-2 Datalog Search Window.........................................................................6-3