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Master Table of Contents - 2 CELL-DYN ® 3700 Operator’s Manual
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Master Table of Contents
Printer Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7Ticket Printer Installation Procedure . . . . . . . . . . . . . . . . 2-10
Sample Loader Set Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-12Instrument Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-15
Relocation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-19
Chapter 3: Principles of Operation
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-1
Sample Aspiration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-3
Sample Analysis Cycle Overview . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5
WBC Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5RBC/PLT Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6Reticulocyte Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6
Hemoglobin Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7Results Displayed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7Instrument Rinsed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7
WBC Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9
WIC/WOC Interaction . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9WIC Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10WOC Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-13WBC Differential Analysis . . . . . . . . . . . . . . . . . . . . . . . . 3-19WBC Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-25WBC Flagging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-26
RBC/PLT Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-27
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-27Electrical Impedance Measurements . . . . . . . . . . . . . . . . 3-27Coincidence Passage Correction . . . . . . . . . . . . . . . . . . . 3-27RER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-28Volumetric Metering . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-28RBC/PLT Measurement Process . . . . . . . . . . . . . . . . . . . . 3-29RBC Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-30RBC Flagging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-31Reticulocytes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-32PLT Measurement Process . . . . . . . . . . . . . . . . . . . . . . . . 3-32PLT Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-33Platelet Flagging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-34
Hemoglobin Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-35Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-35Hemoglobin Measurement Process . . . . . . . . . . . . . . . . . 3-35HGB Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-36
Operational Messages and Data Flagging. . . . . . . . . . . . . . . . . . . 3-37
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-37Interfering Substances . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-37Instrument Fault and Status Messages . . . . . . . . . . . . . . . 3-38Parameter Flagging Messages . . . . . . . . . . . . . . . . . . . . . . 3-39
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Introduction to WBC Flagging . . . . . . . . . . . . . . . . . . . . . 3-42Cell Populations and Flagging . . . . . . . . . . . . . . . . . . . . . 3-45
Flagging Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-49
WBC Descriptors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-49Suspect Parameter Flags . . . . . . . . . . . . . . . . . . . . . . . . . . 3-50Suspect Population Flags . . . . . . . . . . . . . . . . . . . . . . . . . 3-54Flagging Diagnostics Screen . . . . . . . . . . . . . . . . . . . . . . . 3-59Interpretive Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-60
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-63
Chapter 4: System Specification
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
CELL-DYN 3700SL System Specifications . . . . . . . . . . . . . . . . . . . 4-3
Physical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
Power Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4Operational Specifications . . . . . . . . . . . . . . . . . . . . . . . . . 4-6Bar Code Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7
CELL-DYN 3700CS System Specifications . . . . . . . . . . . . . . . . . . . 4-9
Physical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-9Power Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10Operational Specifications . . . . . . . . . . . . . . . . . . . . . . . . 4-11
Combined Specifications for the SL and CS Systems . . . . . . . . . 4-13
Measurement Specifications . . . . . . . . . . . . . . . . . . . . . . . 4-13Performance Specifications . . . . . . . . . . . . . . . . . . . . . . . 4-15Performance Characteristics . . . . . . . . . . . . . . . . . . . . . . . 4-20
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-25
Chapter 5: Operating Instructions
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
Instrument Logbook . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1Data Station Program Overview . . . . . . . . . . . . . . . . . . . . . 5-2Conventions Used in This Manual . . . . . . . . . . . . . . . . . . . 5-5Menu Flowcharts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6
Set Up Instructions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-13
Date/Time Soft Key . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-14Patient Limits Soft Key . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-16Reagent Log Soft Key . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-19QC Set Up Menu Soft Key . . . . . . . . . . . . . . . . . . . . . . . . 5-21Operation Set Up Soft Key . . . . . . . . . . . . . . . . . . . . . . . . 5-43Units Selection Soft Key . . . . . . . . . . . . . . . . . . . . . . . . . . 5-49Customize Report Soft Key . . . . . . . . . . . . . . . . . . . . . . . . 5-51
Routine Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-67
Run Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-68Run Screen Soft Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-74Sample Collection and Handling . . . . . . . . . . . . . . . . . . . 5-87
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Sample Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-89Instrument Start Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-92Sample Analysis Using the SL Model . . . . . . . . . . . . . . . . 5-92
Sample Analysis Using the CS Model . . . . . . . . . . . . . . . . 5-99Using The Work List . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-103Sample Analysis Using the Work List . . . . . . . . . . . . . . . 5-114
Using The Data Log. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-121
Data Log Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-122Data Log Set Up Procedures . . . . . . . . . . . . . . . . . . . . . . 5-135Data Review from the Data Log . . . . . . . . . . . . . . . . . . . 5-140
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-143
Chapter 6: Calibration
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-1
When to Calibrate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1Open and Closed Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2Calibration Methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3Calibration Materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3Calibration Procedural Summary . . . . . . . . . . . . . . . . . . . 6-11Conventions Used in this Chapter . . . . . . . . . . . . . . . . . . 6-11
Calibration Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-13
Calibration Menu Flowchart . . . . . . . . . . . . . . . . . . . . . . 6-13Calibration Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-14Open Sampler/Closed Sampler Soft Key . . . . . . . . . . . . . 6-15Print Soft Key . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-15Main Soft Key . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-16
Enter Factor Soft Key . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-16Calibration Log Soft Key . . . . . . . . . . . . . . . . . . . . . . . . . . 6-18
Auto-Calibrate Soft Key . . . . . . . . . . . . . . . . . . . . . . . . . . 6-19Pre-Calibration Procedures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-27
Calibration Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-27Pre-Calibration Procedures Checklist . . . . . . . . . . . . . . . . 6-29
Auto-Cal Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-33
Auto-Cal Sample Capacity . . . . . . . . . . . . . . . . . . . . . . . . 6-34 Auto-Cal Methodology . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-34Calibration Requirements for Auto-Cal . . . . . . . . . . . . . . 6-35
Auto-Cal Using Calibrator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-37
Starting Auto-Cal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-37Entering the Reference Values . . . . . . . . . . . . . . . . . . . . . 6-37Collecting the Calibration Data . . . . . . . . . . . . . . . . . . . . 6-38Calibration Factor Calculation . . . . . . . . . . . . . . . . . . . . . 6-40Determining Which Parameters Need Calibration . . . . . 6-41Calibrating All Parameters . . . . . . . . . . . . . . . . . . . . . . . . 6-43Calibrating Individual Parameters . . . . . . . . . . . . . . . . . . 6-44Completing Open Mode Calibration . . . . . . . . . . . . . . . . 6-44
Auto-Cal Calibration Criteria Worksheet . . . . . . . . . . . . . 6-45
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Auto-Cal Using Whole Blood. . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-47
Starting Auto-Cal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-47Entering the Reference Values . . . . . . . . . . . . . . . . . . . . . 6-48
Collecting the Calibration Data . . . . . . . . . . . . . . . . . . . . 6-48Calibration Factor Calculation . . . . . . . . . . . . . . . . . . . . . 6-50Determining Which Parameters Need Calibration . . . . . 6-52Calibrating All Parameters . . . . . . . . . . . . . . . . . . . . . . . . 6-54Calibrating Individual Parameters . . . . . . . . . . . . . . . . . . 6-55Completing Whole Blood Open Mode Calibration . . . . . 6-55
Auto-Cal Calibration Criteria Worksheet . . . . . . . . . . . . . 6-57Manual Calibration Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-59
Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-60Manual Calibration Procedure — Open Mode. . . . . . . . . . . . . . . 6-61
Preparing for Manual Calibration . . . . . . . . . . . . . . . . . . 6-61Determining the Open Mode Mean . . . . . . . . . . . . . . . . . 6-61
Calibration Factor Calculations . . . . . . . . . . . . . . . . . . . . 6-62Determining Which Parameters Need Calibration . . . . . 6-63Calibrating the Open Mode . . . . . . . . . . . . . . . . . . . . . . . 6-65Completing Manual Calibration . . . . . . . . . . . . . . . . . . . 6-66Manual Calibration Worksheet . . . . . . . . . . . . . . . . . . . . 6-68
Mode To Mode Calibration Overview . . . . . . . . . . . . . . . . . . . . . 6-71
Auto-Cal Mode to Mode Calibration . . . . . . . . . . . . . . . . 6-71Manual Mode to Mode Calibration . . . . . . . . . . . . . . . . . 6-72Mode to Mode Calibration Preparation . . . . . . . . . . . . . . 6-72Closed Mode Calibration Confirmation . . . . . . . . . . . . . 6-72
Mode To Mode Auto-Cal Calibration
(Closed Sampler Only) . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-73Determining Reference Values . . . . . . . . . . . . . . . . . . . . . 6-73Starting Auto-Cal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-74Entering the Reference Values . . . . . . . . . . . . . . . . . . . . . 6-74Collecting the Calibration Data . . . . . . . . . . . . . . . . . . . . 6-75Calibration Factor Calculation . . . . . . . . . . . . . . . . . . . . . 6-77Determining Which Parameters Need Calibration . . . . . 6-78Calibrating All Parameters . . . . . . . . . . . . . . . . . . . . . . . . 6-80Calibrating Individual Parameters . . . . . . . . . . . . . . . . . . 6-81Completing Mode to Mode Calibration . . . . . . . . . . . . . . 6-82Optional Calibration Confirmation . . . . . . . . . . . . . . . . . 6-82Mode to Mode Auto-Cal Calibration Criteria Worksheet 6-83
Manual Mode to Mode Calibration (CS or SL) . . . . . . . . . . . . . . 6-85Preparing for Manual Mode to Mode Calibration . . . . . . 6-85Determining the Open Mode Mean . . . . . . . . . . . . . . . . . 6-85Determining the Closed Mode Mean . . . . . . . . . . . . . . . . 6-86Percent Difference Calculation . . . . . . . . . . . . . . . . . . . . 6-87Determining Which Parameters Need Calibration . . . . . 6-88Calibration Factor Calculation . . . . . . . . . . . . . . . . . . . . . 6-90Calibrating the Closed Mode . . . . . . . . . . . . . . . . . . . . . . 6-90
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Completing Mode to Mode Calibration . . . . . . . . . . . . . . 6-91Optional Calibration Confirmation . . . . . . . . . . . . . . . . . 6-91Manual Mode to Mode Calibration Worksheet . . . . . . . . 6-93
Post-Calibration Procedures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-95Quality Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-95Calibration Backup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-95
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-99
Chapter 7: Quality Control
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-1
Quality Control Menu Flowchart . . . . . . . . . . . . . . . . . . . . 7-2Quality Control Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3
X-B File Soft Key . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4View QC Log Soft Key . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-8
Quality Control Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-15Running Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-15Westgard® Rules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-17
X-B Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-20References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-27
Chapter 8: Hazards
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1Warning Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
Hazard Information and Precautions. . . . . . . . . . . . . . . . . . . . . . . 8-3
General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3Biohazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3Handling and Disposing of Biohazardous Materials . . . . . 8-4Chemical Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4Electrical Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5Physical and Mechanical Hazards . . . . . . . . . . . . . . . . . . . 8-6Laser Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-6
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-11
Chapter 9: Maintenance
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-1
Preventive Maintenance Schedule . . . . . . . . . . . . . . . . . . . 9-2 Analyzer Flow Panel Components Diagram . . . . . . . . . . . . 9-2Decontamination Procedures . . . . . . . . . . . . . . . . . . . . . . . 9-4
Special Protocols Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-5
Emptying the Transducers . . . . . . . . . . . . . . . . . . . . . . . . . 9-6Draining the Reagent Reservoirs . . . . . . . . . . . . . . . . . . . . 9-7
Accessing the Maintenance Log . . . . . . . . . . . . . . . . . . . . . 9-8 Accessing the Shear Valve . . . . . . . . . . . . . . . . . . . . . . . . . . 9-9
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Disabling/Enabling the Analyzer . . . . . . . . . . . . . . . . . . . . 9-9Special Protocols Screen #2 . . . . . . . . . . . . . . . . . . . . . . . 9-10
Maintenance Log Set Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-13
Interval Set Up Procedure . . . . . . . . . . . . . . . . . . . . . . . . . 9-15Update Maintenance Log Procedure . . . . . . . . . . . . . . . . 9-16
Daily Maintenance Procedures. . . . . . . . . . . . . . . . . . . . . . . . . . . 9-19
Auto-Clean . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-19Sample Loader Aspiration Needle . . . . . . . . . . . . . . . . . . 9-21Closed Sampler Aspiration Needle . . . . . . . . . . . . . . . . . . 9-22
Weekly Maintenance Procedures . . . . . . . . . . . . . . . . . . . . . . . . . 9-23
Shear Valve . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-23Sample Aspiration Peristaltic Pump Tubing . . . . . . . . . . . 9-26Sample Loader Tray, Racks, and Safety Cover . . . . . . . . . 9-27Extended Auto Clean . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-28
Monthly Maintenance Procedures. . . . . . . . . . . . . . . . . . . . . . . . 9-29
Reagent Syringes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-29 Analyzer Air Filters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-32WOC Transfer Peristaltic Pump Tubing . . . . . . . . . . . . . . 9-33Extended Auto-Clean . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-35
As Required. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-37
10-mL Reagent Syringe . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-37 Aperture Plates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-39Hemoglobin Flow Cell Manual Cleaning . . . . . . . . . . . . . 9-43Unclogging the Open Sample Aspiration Probe . . . . . . . 9-45Bar Code Reader Window . . . . . . . . . . . . . . . . . . . . . . . . . 9-46Flushing the “Y” Fitting — Open and Closed Modes . . . . 9-47
Special Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-51Closed Sampler Tube Retainer Adjustment(CS System Only) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-51
Preparation for Inactivity or Shipping . . . . . . . . . . . . . . . 9-52Repackaging for Shipment . . . . . . . . . . . . . . . . . . . . . . . . 9-54
Chapter 10: Troubleshooting
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1
Diagnostics Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-3
Diagnostics Menu Flowchart . . . . . . . . . . . . . . . . . . . . . . 10-4Troubleshooting Guide. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-27
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-27Troubleshooting Procedures . . . . . . . . . . . . . . . . . . . . . 10-29Replaceable Components . . . . . . . . . . . . . . . . . . . . . . . . 10-32List of Symptoms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-38Symptom Identification and Resolution . . . . . . . . . . . . 10-39List of Messages and Fault Conditions . . . . . . . . . . . . . . 10-66Messages and Fault Conditions . . . . . . . . . . . . . . . . . . . 10-68
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Chapter 11: Printers
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-1
Routine Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-3Graphics Printer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-3Ticket Printer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-3
Maintenance and Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . 11-5
Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-5Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-5
Chapter 12: Sample Loader
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-1
Bar Code Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12-3
CELL-DYN Bar Code Labels . . . . . . . . . . . . . . . . . . . . . . . 12-3
CELL-DYN Q Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-3Bar Code Label Placement . . . . . . . . . . . . . . . . . . . . . . . . 12-3
Sample Loader Components. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-5
Main Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-5Tower Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-7
Operating Principles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-9
Functional Description . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-9Function Sequence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-12
Routine Operating Procedures. . . . . . . . . . . . . . . . . . . . . . . . . . 12-15
Operating Tips . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-15Other Chapters to Reference . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-17
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-17Set Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-17Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-17
Chapter 13: Veterinary Package
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-1
Principles of Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-3
The Animal Catalog . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-3Performance Characteristics. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-5
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-5Precision . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-5
Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-6Linearity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-7Carryover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-7Flagging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-8
Operating Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-9
Vet Package Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-10Routine Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-21
Run Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-21Selecting the Animal . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-22
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Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-27
Procedure: MCV or MPV Calibration . . . . . . . . . . . . . . . 13-28Pre-Calibration Procedures . . . . . . . . . . . . . . . . . . . . . . . 13-28
Determining the Calibration Factors for MCV and MPV 13-29Entering the Calibration Factor . . . . . . . . . . . . . . . . . . . 13-29
Quality Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-31
Adding New Animal Types . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-33
Adding a New Configuration File . . . . . . . . . . . . . . . . . . 13-34Customizing the Display . . . . . . . . . . . . . . . . . . . . . . . . 13-36Turning on the Gains Template . . . . . . . . . . . . . . . . . . . 13-37Preparing the Samples . . . . . . . . . . . . . . . . . . . . . . . . . . 13-38Running the Samples . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-38Determining the Variance . . . . . . . . . . . . . . . . . . . . . . . 13-39Baso Box Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-46
Vet Package Suggestions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-49
Examples of Customer-Defined Default Codes . . . . . . . 13-50Turning The Vet Package Off . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-53
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-55
Chapter 14: Reticulocyte Package
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-1
Principles of Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-7
Retic Menu Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-9
Turning the Reticulocyte Package ON and OFF . . . . . . . 14-10Retic Main Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-14
Retic Set Up Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-16Retic Data Log Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-30Data Review from the Retic Data Log . . . . . . . . . . . . . . 14-37Retic QC Log Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-39Retic Diagnostics Menu . . . . . . . . . . . . . . . . . . . . . . . . . 14-47Retic Special Protocols Menu . . . . . . . . . . . . . . . . . . . . . 14-52
Routine Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-55
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-55Retic Run Menu Flowchart . . . . . . . . . . . . . . . . . . . . . . . 14-56Retic Run Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-57Reticulocyte Specimens . . . . . . . . . . . . . . . . . . . . . . . . . 14-67
Quality Control Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-77
Control Material . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-77Mixing and Handling . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-78
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-79
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-79Operational Messages and Data Flagging . . . . . . . . . . . . 14-79High Background Counts . . . . . . . . . . . . . . . . . . . . . . . . 14-82
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-83
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Bibliography
Bibliography . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Bibliography-1
Appendix A: Bar Codes
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Appendix A-1Bar Coding Function . . . . . . . . . . . . . . . . . . . . . . Appendix A-1Understanding the Label Code . . . . . . . . . . . . . . Appendix A-2Bar Code Types and Characteristics . . . . . . . . . . Appendix A-3
Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Appendix A-5
Bar Code Label Formats . . . . . . . . . . . . . . . . . . . . Appendix A-5Bar Code Check Digit Formats . . . . . . . . . . . . . . Appendix A-5Bar Code Label Specifications . . . . . . . . . . . . . . . Appendix A-6CELL-DYN Bar Code Labels . . . . . . . . . . . . . . . . . Appendix A-7CELL-DYN Q Labels . . . . . . . . . . . . . . . . . . . . . . . Appendix A-7Bar Code Label Placement . . . . . . . . . . . . . . . . . . Appendix A-8
Acknowledgment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Appendix A-9
Appendix B: Parts List
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Appendix B-1
CELL-DYN 3700 Accessories . . . . . . . . . . . . . . . . Appendix B-1
Appendix C
Appendix C . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Appendix C-1
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List of Figures
Figure 1.1: CELL-DYN 3700SL System. . . . . . . . . . . . . . . . . . . . 1-1Figure 1.2: CELL-DYN 3700 System . . . . . . . . . . . . . . . . . . . . . 1-5Figure 1.3: CELL-DYN 3700CS System Analyzer Front View . . 1-6Figure 1.4: Analyzer Flow Panel Components . . . . . . . . . . . . . 1-9Figure 1.5: Analyzer Left Side Panel Components . . . . . . . . . 1-14Figure 1.6: Analyzer Rear Panel Components . . . . . . . . . . . . . 1-17Figure 1.7: Power Supply Module Voltage
Switch Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-18Figure 1.8: Data Station — Front View. . . . . . . . . . . . . . . . . . . 1-19Figure 1.9: Data Station — Rear Components . . . . . . . . . . . . . 1-21
Figure 1.10: Control Button – Front View. . . . . . . . . . . . . . . . 1-23Figure 1.11: Inputs Diagram . . . . . . . . . . . . . . . . . . . . . . . . . . 1-25Figure 1.12: Caution Label . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-28
Figure 2.1: Data Station Rear Components. . . . . . . . . . . . . . . . 2-8Figure 2.2: CELL-DYN 3700SL. . . . . . . . . . . . . . . . . . . . . . . . . 2-12Figure 2.3: Tube Rack Showing Label Placement Locations. . 2-13Figure 2.4: Left Side Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-16Figure 2.5: Front Flow Panel . . . . . . . . . . . . . . . . . . . . . . . . . . 2-18
Figure 3.1: Volumetric Metering . . . . . . . . . . . . . . . . . . . . . . . 3-11Figure 3.2: WOC Flow Cell . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-14
Figure 3.3: WBC Light Scatter . . . . . . . . . . . . . . . . . . . . . . . . . 3-15Figure 3.4: Optical Bench Assembly . . . . . . . . . . . . . . . . . . . . 3-17Figure 3.5: Mononuclear-Polymorphonuclear Scatter . . . . . . 3-20Figure 3.6: Neutrophil-Eosinophil Scatter. . . . . . . . . . . . . . . . 3-21Figure 3.7: Mononuclear Scatter . . . . . . . . . . . . . . . . . . . . . . . 3-22Figure 3.8: WBC Histograms . . . . . . . . . . . . . . . . . . . . . . . . . . 3-24Figure 3.9: WBC Data and Scatterplots . . . . . . . . . . . . . . . . . . 3-25Figure 3.10: Volumetric Metering . . . . . . . . . . . . . . . . . . . . . . 3-28Figure 3.11: RBC Data and Histogram. . . . . . . . . . . . . . . . . . . 3-30Figure 3.12: PLT Data and Histogram . . . . . . . . . . . . . . . . . . . 3-33Figure 3.13: Flagging Diagnostics Screen . . . . . . . . . . . . . . . . 3-41Figure 3.14: Scatterplot with Increased Stroma in the
N1 Region . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-43
Figure 5.1: Data Station. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2Figure 5.2: Main Menu Screen. . . . . . . . . . . . . . . . . . . . . . . . . . 5-3Figure 5.3: Set Up Menu Screen . . . . . . . . . . . . . . . . . . . . . . . 5-13Figure 5.4: Date/Time Set Up Screen. . . . . . . . . . . . . . . . . . . . 5-14Figure 5.5: Patient Limit Set Screen. . . . . . . . . . . . . . . . . . . . . 5-16Figure 5.6: Diluent Log Screen . . . . . . . . . . . . . . . . . . . . . . . . 5-19
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Figure 5.7: QC Set Up Menu Screen . . . . . . . . . . . . . . . . . . . . 5-21Figure 5.8: QC File Set Up (Lot Number Entry) Screen . . . . . 5-22Figure 5.9: QC File Set Up (Replicate ID Entry) Screen . . . . . 5-23
Figure 5.10: QC Range Entry Screen . . . . . . . . . . . . . . . . . . . . 5-27Figure 5.11: QC Means/Limits Entry Screen . . . . . . . . . . . . . . 5-28Figure 5.12: QC Means/Limits Entry Screen Showing
the Update From File Key . . . . . . . . . . . . . . . . . . . . . . . . . . 5-30Figure 5.13: Customize QC Display Screen. . . . . . . . . . . . . . . 5-32Figure 5.14: Customize QC Display Screen Showing
Standard Groups . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-35Figure 5.15: Customize QC Printout Screen . . . . . . . . . . . . . . 5-37Figure 5.16: X-B Set Up Screen . . . . . . . . . . . . . . . . . . . . . . . . 5-40Figure 5.17: Operation Set Up Menu Screen. . . . . . . . . . . . . . 5-43Figure 5.18: Bar Code Set Up Screen. . . . . . . . . . . . . . . . . . . . 5-44Figure 5.19: Computer Set Up Screen . . . . . . . . . . . . . . . . . . . 5-46
Figure 5.20: Units Selection Screen. . . . . . . . . . . . . . . . . . . . . 5-49Figure 5.21: Customize Displayed Report Screen . . . . . . . . . . 5-52Figure 5.22: Customize Printed Report Screen for
Pre-Printed Tickets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-56Figure 5.23: Customize Printed Report Screen for
Blank Tickets. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-58Figure 5.24: Customize Printed Report Screen for the
Graphics Printer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-61Figure 5.25: Customize Printout Header Screen for the
Graphics Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-64Figure 5.26: Run Screen for Patient Samples . . . . . . . . . . . . . 5-68Figure 5.27: Run Screen for Auxiliary Samples . . . . . . . . . . . . 5-70Figure 5.28: Run Screen Showing Count Times and
Flagging Messages. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-73Figure 5.29: Run Screen Showing Flagging Messages,
RBC CLOG Message, and RBC Up Time . . . . . . . . . . . . . . . 5-73Figure 5.30: Run Screen Showing Bulletin Line Message . . . . 5-74Figure 5.31: Work List Screen . . . . . . . . . . . . . . . . . . . . . . . . . 5-75Figure 5.32: Specimen Type Screen. . . . . . . . . . . . . . . . . . . . . 5-77Figure 5.33: Run Screen for Patient Samples . . . . . . . . . . . . . 5-78Figure 5.34: Run Screen for a QC File. . . . . . . . . . . . . . . . . . . 5-79Figure 5.35: Run Screen for Background Counts . . . . . . . . . . 5-80Figure 5.36: Run Screen for Electrical Background Counts . . 5-81
Figure 5.37: Run Screen for Resistant RBC Specimen Type . . 5-82Figure 5.38: Auxiliary Specimen Type Screen. . . . . . . . . . . . . 5-83Figure 5.39: Run Screen for the Auxiliary Specimen Type . . . 5-85Figure 5.40: Work List Screen . . . . . . . . . . . . . . . . . . . . . . . . 5-104Figure 5.41: Work List Set Up Screen . . . . . . . . . . . . . . . . . . 5-108Figure 5.42: Data Log Screen. . . . . . . . . . . . . . . . . . . . . . . . . 5-121Figure 5.43: Display Specimen Screen . . . . . . . . . . . . . . . . . 5-124Figure 5.44: Data Log Search Screen . . . . . . . . . . . . . . . . . . . 5-126Figure 5.45: Data Log Screen Showing Reject From X-B Key 5-127
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Figure 5.46: Data Log Screen Showing Accept Into X-B Key 5-128Figure 5.47: Customize Display for Data Log Screen . . . . . . 5-129Figure 5.48: Customize Display Showing Standard Groups . 5-130
Figure 5.49: Customize Printout for Data Log Screen . . . . . 5-132Figure 5.50: Print Data Log Screen . . . . . . . . . . . . . . . . . . . . 5-134Figure 5.51: Customize Display for Data Log Screen
Showing Standard Groups . . . . . . . . . . . . . . . . . . . . . . . . 5-135Figure 5.52: Customize Printout for Data Log Screen
Showing Customized Print Group . . . . . . . . . . . . . . . . . . 5-138Figure 5.53: Display Specimen Screen . . . . . . . . . . . . . . . . . 5-140Figure 5.54: Edit Specimen Screen . . . . . . . . . . . . . . . . . . . . 5-142
Figure 6.1: Calibration Screen Displaying Open ModeCalibration Factors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-14
Figure 6.2: Calibration Menu Screen Displaying Closed
Mode Calibration Factors . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-15Figure 6.3: Enter Calibration Factor Screen . . . . . . . . . . . . . . 6-16Figure 6.4: Calibration Log Screen . . . . . . . . . . . . . . . . . . . . . 6-18Figure 6.5: Auto-Calibration Screen forCELL-DYN 3700CS System . . . . . . . . . . . . . . . . . . . . . . . . . . 6-19
Figure 6.6: Whole Blood Auto-Cal Screen. . . . . . . . . . . . . . . . 6-20Figure 6.7: Whole Blood Auto-Cal Screen. . . . . . . . . . . . . . . . 6-22Figure 6.8: Whole Blood Auto-Cal Results Screen . . . . . . . . . 6-23Figure 6.9: Whole Blood Auto-Cal Results Screenwith Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-24
Figure 6.10: Calibrator Auto-Cal Screen . . . . . . . . . . . . . . . . . 6-25Figure 6.11: Latex Auto-Cal Screen . . . . . . . . . . . . . . . . . . . . . 6-26
Figure 7.1: QC Menu Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3Figure 7.2: The X-B RBC Data Screen . . . . . . . . . . . . . . . . . . . . 7-4Figure 7.3: The X-B RBC Graphs Screen . . . . . . . . . . . . . . . . . . 7-5Figure 7.4: The X-B WBC Data Screen. . . . . . . . . . . . . . . . . . . . 7-6Figure 7.5: The X-B WBC Graphs Screen. . . . . . . . . . . . . . . . . . 7-7Figure 7.6: The View QC Log Screen. . . . . . . . . . . . . . . . . . . . . 7-8Figure 7.7: The Levey-Jennings Menu Screen . . . . . . . . . . . . . 7-11Figure 7.8: QC Log Screen With Rejected Results. . . . . . . . . . 7-12Figure 7.9: Levey-Jennings Menu Screen ShowingWestgard Rule Violations . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-18
Figure 8.1: Laser Hazard Label. . . . . . . . . . . . . . . . . . . . . . . . . . 8-8Figure 8.2: Laser Aperture and Warning Label Position -
Protective Cover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-8Figure 8.3: Laser Warning Label Position - Flow Panel. . . . . . . 8-9Figure 8.4: Class 2 Laser Caution Label. . . . . . . . . . . . . . . . . . . 8-9Figure 8.5: Class 2 Laser Caution Label Location . . . . . . . . . . . 8-9Figure 8.6: Laser Label, Rear Panel . . . . . . . . . . . . . . . . . . . . . 8-10Figure 8.7: Class 1 Laser Product Label Location . . . . . . . . . . 8-10
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List of Figures
Figure 9.1: Analyzer Flow Panel Components . . . . . . . . . . . . . 9-3Figure 9.2: Special Protocols Screen . . . . . . . . . . . . . . . . . . . . . 9-5Figure 9.3: Reagent Reservoir Screen . . . . . . . . . . . . . . . . . . . . 9-7
Figure 9.4: Special Protocols Screen 2. . . . . . . . . . . . . . . . . . . . 9-9Figure 9.5: Maintenance Log Screen . . . . . . . . . . . . . . . . . . . . 9-13Figure 9.6: Interval Set Up Screen . . . . . . . . . . . . . . . . . . . . . . 9-15Figure 9.7: Update Maintenance Log Screen. . . . . . . . . . . . . . 9-16Figure 9.8: Special Protocols: Auto-Clean Screen . . . . . . . . . . 9-19Figure 9.9: Shear Valve . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-23Figure 9.10: Sample Aspiration Peristaltic Pump . . . . . . . . . . 9-26Figure 9.11: WOC Syringes and Syringe Assembly . . . . . . . . . 9-29Figure 9.12: Analyzer Left Side Panel . . . . . . . . . . . . . . . . . . . 9-32Figure 9.13: WOC Transfer Peristaltic Pump . . . . . . . . . . . . . 9-33Figure 9.14: Special Protocols: Extended Auto-Clean Screen . 9-35Figure 9.15: von Behrens Transducer Assembly . . . . . . . . . . . 9-40
Figure 9.16: Transducer Assembly and Aperture Plate . . . . . . 9-41Figure 9.17: The von Behrens WIC Transducer, HGB Flow
Cell, and Solenoid 13 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-43Figure 9.18: Open Sample Aspiration Probe . . . . . . . . . . . . . . 9-45Figure 9.19: Flow Panel Open/Closed Mode Tubing . . . . . . . 9-48Figure 9.20: Closed Sampler Module . . . . . . . . . . . . . . . . . . . 9-51Figure 9.21: Analyzer Flow Panel: Accessing Normally
Closed Valves . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-52
Figure 10.1: First Diagnostics Menu Screen . . . . . . . . . . . . . . 10-5Figure 10.2: Operator Correctable Fault Report Screen . . . . . 10-6Figure 10.3: Fatal Fault Report Screen. . . . . . . . . . . . . . . . . . . 10-7
Figure 10.4: Fault Report — No Fault Pending Screen. . . . . . . 10-7Figure 10.5: Count Rate Summary Screen. . . . . . . . . . . . . . . . 10-8Figure 10.6: WOC Count Rate Data (Tabular Format) . . . . . . 10-9Figure 10.7: WOC Count Rate Graph . . . . . . . . . . . . . . . . . . 10-10Figure 10.8: Raw Data Summary Screen . . . . . . . . . . . . . . . . 10-11Figure 10.9: Second Diagnostics Menu Screen . . . . . . . . . . . 10-12Figure 10.10: Pump Operation Screen . . . . . . . . . . . . . . . . . 10-13Figure 10.11: Pump Operation Screen — Vacuum ON . . . . . 10-14Figure 10.12: Inhibit Pumps Screen . . . . . . . . . . . . . . . . . . . 10-15Figure 10.13: Vacuum Test Screen . . . . . . . . . . . . . . . . . . . . 10-16Figure 10.14: Drain Accumulators Screen. . . . . . . . . . . . . . . 10-17Figure 10.15: Third Diagnostics Menu Screen . . . . . . . . . . . 10-18Figure 10.16: Voltage Readings Screen . . . . . . . . . . . . . . . . . 10-19Figure 10.17: Fourth Diagnostics Menu Screen . . . . . . . . . . 10-20Figure 10.18: Fifth Diagnostics Menu Screen
(CELL-DYN 3700SL System) . . . . . . . . . . . . . . . . . . . . . . . 10-21Figure 10.19: Auto-Sampler Version Screen . . . . . . . . . . . . . 10-22Figure 10.20: Serial Test Screen. . . . . . . . . . . . . . . . . . . . . . . 10-23Figure 10.21: Serial Test Transmit Message Screen
Transmit Message . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-25
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List of Figures
Figure 10.22: Sample Loader Vent/Aspiration Needle Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-33
Figure 10.23: Sample Loader Vent/Aspiration Needle —
Tubing Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-34Figure 10.24: Volumetric Metering . . . . . . . . . . . . . . . . . . . . 10-50
Figure 12.1: Analyzer with Sample Loader . . . . . . . . . . . . . . . 12-1Figure 12.2: Rack Movement - Top View . . . . . . . . . . . . . . . . 12-2Figure 12.3: Tube Labeling Requirements. . . . . . . . . . . . . . . . 12-3Figure 12.4: Sample Loader . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-5Figure 12.5: Operation Keyboard . . . . . . . . . . . . . . . . . . . . . . 12-6Figure 12.6: Tower Stations. . . . . . . . . . . . . . . . . . . . . . . . . . . 12-7Figure 12.7: Tube Racks. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-10
Figure 13.1: Operation Set Up Menu Screen. . . . . . . . . . . . . . 13-9
Figure 13.2: Set Up Menu Screen . . . . . . . . . . . . . . . . . . . . . 13-11Figure 13.3: Animal Type Set Up Screen . . . . . . . . . . . . . . . . 13-12Figure 13.4: View Animal Type Set Up Screen . . . . . . . . . . . 13-13Figure 13.5: Animal Limit Set 1. . . . . . . . . . . . . . . . . . . . . . . 13-14Figure 13.6: Animal Type Catalog Screen . . . . . . . . . . . . . . . 13-16Figure 13.7: Catalog Contents, Animal Type Set Up Screen. 13-17Figure 13.8: Expected Ranges . . . . . . . . . . . . . . . . . . . . . . . . 13-18Figure 13.9: Run Screen for Animals. . . . . . . . . . . . . . . . . . . 13-21Figure 13.10: Animal Type Selection Screen. . . . . . . . . . . . . 13-22Figure 13.11: Specimen Type Screen. . . . . . . . . . . . . . . . . . . 13-23Figure 13.12: Dog Background Count. . . . . . . . . . . . . . . . . . 13-24Figure 13.13: Enter Calibration Factor Screen . . . . . . . . . . . 13-28
Figure 13.14: Add New Animal Type Screen. . . . . . . . . . . . . 13-34Figure 13.15: Customized Display for Adding New Animals 13-36Figure 13.16: Gains Template . . . . . . . . . . . . . . . . . . . . . . . . 13-37Figure 13.17: Target Locations for the Neutrophil and
Lymphocyte populations . . . . . . . . . . . . . . . . . . . . . . . . . 13-39Figure 13.18: Set Point Entry Screen. . . . . . . . . . . . . . . . . . . 13-44Figure 13.19: Baso Box Set Up. . . . . . . . . . . . . . . . . . . . . . . . 13-46
Figure 14.1: Operation Set Up Menu Screen withReticulocyte Package Disabled . . . . . . . . . . . . . . . . . . . . . . 14-10
Figure 14.2: Operation Set Up Menu Screen withReticulocyte Package Enabled. . . . . . . . . . . . . . . . . . . . . . 14-12
Figure 14.3: Reticulocyte Main Menu Screen . . . . . . . . . . . . 14-14Figure 14.4: Reticulocyte Set Up Screen . . . . . . . . . . . . . . . . 14-16Figure 14.5: Reticulocyte Patient Limits Screen . . . . . . . . . . 14-18Figure 14.6: Reticulocyte QC Set Up Screen . . . . . . . . . . . . . 14-19Figure 14.7: Retic QC Range Entry Screen . . . . . . . . . . . . . . 14-21Figure 14.8: Retic QC Means/Limits Screen . . . . . . . . . . . . . 14-22Figure 14.9: Retic Set Up QC Screen . . . . . . . . . . . . . . . . . . . 14-25
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Figure 14.10: Operation Set Up Menu Screen withReticulocyte Package Enabled. . . . . . . . . . . . . . . . . . . . . . 14-27
Figure 14.11: Reticulocyte Units Selection Screen . . . . . . . . 14-28
Figure 14.12: Reticulocyte Data Log Screen . . . . . . . . . . . . . 14-31Figure 14.13: Reticulocyte Display Specimen Screen . . . . . . 14-33Figure 14.14: Reticulocyte Data Log Search Screen . . . . . . . 14-35Figure 14.15: Reticulocyte Data Log Screen Showing the
Starting Reticulocyte Sequence Number Field. . . . . . . . . 14-36Figure 14.16: Reticulocyte Display Specimen Screen . . . . . . 14-37Figure 14.17: Reticulocyte QC Log Screen . . . . . . . . . . . . . . 14-39Figure 14.18: View Reticulocyte QC Log Screen. . . . . . . . . . 14-41Figure 14.19: The Reticulocyte Levey-Jennings Screen. . . . . 14-44Figure 14.20: View Reticulocyte QC Log Screen with
Rejected Results. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-45Figure 14.21: Reticulocyte Diagnostics Screen . . . . . . . . . . . 14-48
Figure 14.22: Reticulocyte Count Rate Summary Screen(Tabular Format). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-49
Figure 14.23: Reticulocyte Count Rate Summary Screen(Graphic Format) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-50
Figure 14.24: Reticulocyte Raw Data Summary Screen . . . . 14-51Figure 14.25: Reticulocyte Special Protocols Screen. . . . . . . 14-53Figure 14.26: Reticulocyte Run Screen . . . . . . . . . . . . . . . . . 14-57Figure 14.27: The First Reticulocyte Patient Specimen
Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-58Figure 14.28: The Second Reticulocyte Patient Specimen
Screen (Displayed When the Specimen ID is Found) . . . 14-59Figure 14.29: The Third Reticulocyte Patient Specimen
Screen (Displayed When the Specimen ID Found isMore Than Eight Hours Old) . . . . . . . . . . . . . . . . . . . . . . 14-60
Figure 14.30: The Fourth Reticulocyte Patient SpecimenScreen (Displayed When the Specimen ID Is Not Found) 14-61
Figure 14.31: The Reticulocyte Run Result Screen for aPatient Specimen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-62
Figure 14.32: Reticulocyte Run Result Screen for aQC Specimen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-65
Figure 14.33: Reticulocyte Run Result Screen for aBackground Specimen . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-66
Figure A.1: Bar Code Label Specifications . . . . . . . . .Appendix A-6Figure A.2: Tube Labeling Requirements . . . . . . . . .Appendix A-8
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List of Tables
List of Tables
Table 3.1: Parameter Flagging Messages . . . . . . . . . . . . . . . . . 3-39
Table 4.1: Dimensions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3Table 4.2: Power Specifications. . . . . . . . . . . . . . . . . . . . . . . . . 4-4Table 4.3: Dimensions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-9Table 4.4: Power Specifications. . . . . . . . . . . . . . . . . . . . . . . . 4-10Table 4.5: Precision of the Hemogram and ReticulocyteParameters (N = 31) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-16
Table 4.6: Precision of the WBC Differential Parameters. . . . 4-16Table 4.7: Linearity Specifications . . . . . . . . . . . . . . . . . . . . . 4-17Table 4.8: Accuracy of Hemogram Parameters . . . . . . . . . . . . 4-18
Table 4.9: Accuracy of WBC Differential Parameters . . . . . . . 4-19Table 4.10: Carryover for WBC, RBC, HGB, PLT and Retics. . 4-19Table 4.11: Typical Precision for Hemogram Parameters. . . . 4-20Table 4.12: Reference Range for Distributional Flagging . . . . 4-21Table 4.13: Reference Range for Morphologic Flagging. . . . . 4-21Table 4.14: Abnormalities Evaluated. . . . . . . . . . . . . . . . . . . . 4-22Table 4.15: Flagging Analysis Truth Table . . . . . . . . . . . . . . . 4-23Table 4.16: Analysis of False Negative Results . . . . . . . . . . . . 4-23
Table 5.1: Report Units . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-50
Table 6.1: Calibration Criteria. . . . . . . . . . . . . . . . . . . . . . . . . 6-41Table 6.2: Calibration Criteria. . . . . . . . . . . . . . . . . . . . . . . . . 6-51
Table 6.3: Calibration Criteria. . . . . . . . . . . . . . . . . . . . . . . . . 6-63Table 6.4: Mode to Mode Calibration Criteria . . . . . . . . . . . . 6-78Table 6.5: Mode to Mode Calibration Criteria . . . . . . . . . . . . 6-87
Table 7.1: Troubleshooting X-B RBC. . . . . . . . . . . . . . . . . . . . 7-23Table 7.2: Default (Preset) X-B WBC Values . . . . . . . . . . . . . . 7-25
Table 13.1: Precision . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-5Table 13.2: Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-6Table 13.3: Linearity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-7Table 13.4: Carryover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-7
Table 14.1: Potential Interfering Substances. . . . . . . . . . . . . 14-69
Table B.1: CELL-DYN 3700 Accessories Kit(List Number 06H88-01) . . . . . . . . . . . . . . . . . . . . . Appendix B-1
Table B.2: CELL-DYN 3700 Sample Loader Accessories Kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Appendix B-2Table B.3: CELL-DYN 3700 Optional Accessories . . . Appendix B-3Table B.4: CELL-DYN 3700 Calibrators andControls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Appendix B-4
Table B.5: CELL-DYN 3700 Reagents. . . . . . . . . . . . . Appendix B-4
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List of Tables
NOTES
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CELL-DYN ® 3700 System Operator’s Manual i
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Introduction
Foreword
We welcome you to the role of Operator of a CELL-DYN 3700
System. Your system, which includes state-of-the-art technology, isdesigned to function consistently and dependably from day today.
The CELL-DYN 3700 System is backed by dedicated professionalswho excel in engineering, medical technology, training, andservice. As part of the customer training program, we will teach
you to operate, maintain and troubleshoot your System.
Abbott Laboratories is dedicated to manufacturing the highestquality, most reliable instrumentation available. We look forwardto serving your needs in any way possible.
Customer ServiceUnited States: 1 (877) 4ABBOTT or 1 (877) 422-2688
Abbott Diagnostics DivisionCustomer Service200 Abbott Park Road
Abbott Park, IL 60064, USA
Canada: 1 (800) 387-8378
For customers outside the US, call your local Customer Service
Representative.
Intended Use
The CELL-DYN 3700 System is a multiparameter, automatedhematology analyzer designed for in vitro diagnostic use inclinical laboratories.
Proprietary Statement
The entire contents are copyright 2000, 2003, 2004, and 2007 by Abbott Laboratories. Abbott Laboratories’ software programs are
protected by copyright. All rights are reserved. This software wasdeveloped solely for use with Abbott Laboratories’ equipment andfor in vitro diagnostic applications as specified in the operatinginstructions. No part of this document may be reproduced, stored,or transmitted in any form or by any means (electronic,mechanical, photocopied, recorded, or otherwise) without theprior written permission of Abbott Laboratories.
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Patent Statement
The CELL-DYN 3700 instrument system is covered by one or more
of the following US Patents: 4,710,021; 4,726,237; 5,378,633;5,510,267; 5,733,784; 5,017,497; 5,958,781; and 6,740,527.
Instrument Disclaimer
All operating instructions must be followed. In no event shall Abbott be responsible for failures, errors, or other liabilitiesresulting from customers’ noncompliance with the proceduresand precautions outlined herein.
Abbott has designed the CELL-DYN 3700 System components foroptimal performance. Substitution of reagents, calibrators,
controls, and components manufactured by other companies mayadversely affect the performance of the Analyzer.
Pictorial Disclaimer
All samples (printouts, graphics, displays or screens, etc.) are forinformation and illustration purposes only and shall not be usedfor clinical or maintenance evaluations.
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Abbott Instrument Warranty
For US Customers Only
Abbott Laboratories warrants CELL-DYN 3000 Series Analyzers,
sold by Abbott Sales Representatives, to be free from defects inworkmanship and materials during normal use by the originalpurchaser excluding items subject to wear and tear and whichrequire replacement during normal use as a matter of course. Thiswarranty shall continue for a period of one (1) year, commencingtwenty-one (21) days from the date of shipment to the originalpurchaser or until title is transferred from the original purchaser,whichever occurs first (the “Warranty Period”).
If any defects occur during the Warranty Period, contact AbbottDiagnostics Customer Service immediately and be prepared tofurnish pertinent details concerning the defect, the modelnumber, and the serial number.
Warranty support is provided twenty-four (24) hours a day, seven(7) days a week for all CELL-DYN 3000 Series customers.
This Warranty does not cover defects or malfunctions which:
1. Are not reported to Abbott during the Warranty Period andwithin one week of occurrence.
2. Result from chemical decomposition or corrosion.
3. Are caused by customer or third-party abuse, misuse, ornegligence, or by failure to comply with any requirement orinstruction contained in the applicable Abbott Operator’s
Manual.4. Result from maintenance, repair, or modification performed
without Abbott’s authorization.
Abbott’s liability for all matters arising from the supply,installation, use, repair, and maintenance of the Instrument,whether arising under this Warranty or otherwise, shall be limitedsolely to the repair or (at Abbott’s sole discretion) replacement ofthe instrument or of components thereof. In no event shall
Abbott be liable for injuries sustained by third parties, incidentalor consequential damages, or lost profits. Replaced parts shallbecome the property of Abbott.
THE FOREGOING IS THE SOLE WARRANTY MADE BY ABBOTTREGARDING THE INSTRUMENT; AND ABBOTT SPECIFICALLYDISCLAIMS ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED,INCLUDING THE IMPLIED WARRANTIES OF MERCHANTABILITY
AND OF FITNESS FOR A PARTICULAR PURPOSE.
CELL-DYN 3700 Hematology Systems are manufactured by AbbottDiagnostics Division, Abbott Laboratories, 200 Abbott Park Road,
Abbott Park, IL 60064, USA. Please direct all inquiries concerninginformation in this manual to the foregoing address.
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Safety Agency Approvals
UL 61010A-1 Approved
CSA C22.2 No. 1010.1 Approved
IEC 1010-1 Approved
Trademark Statements
CELL-DYN, and CELL-DYN HemCal are registered trademarks of Abbott Laboratories.
MAPSS is a trademark of Abbott Laboratories.
CONTRAVES, COULTER, EPSON, EPSON STYLUS, HEMOGARD,Luer-Lok, MICROLINE, OKIDATA, PLEXIGLAS, TEFLON, TYGON,VACUTAINER, and Westgard are not trademarks of AbbottLaboratories.
SymbolsThe symbols listed below are used on CELL-DYN labeling,including the instrument, reagents, calibrators, controls, and thismanual. Please note that Warning and Caution symbols andstatements are in this manual in Chapter 8: Hazards.
In Vitro Diagnostic Directive 98/79/EC
Legal Manufacturer Abbott Laboratories Abbott Park, Il 60064 USA
Authorized Representative ABBOTTMax-Planck-Ring 265205 Wiesbaden, Germany
General Instrument Symbols
Alternating Current Input
Protective Conductor (Ground) Terminal
Off
ON
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Specific Instrument Symbols
Alternating CurrentInput
Model Number
Alarm Monitor
Auto Loader Pause
Auto Sampler Peristaltic Pump
Busy Power
Communications Port 1 RBC Metering Assembly
Communications Port 2RBC Transducer
Assembly
Data Station Ready
Emergency Stop Repeat
Fault Reset
Frequency Revision
FusesRecommendedSpecification 232
Hard Disk Drive Service Disk
Hemoglobin Flowcell Set-up Disk
High Speed Serial Link Serial Number
Initialize Solenoid
Installation Disk Start
Keyboard Test Interface
Line Frequency Select Touch
Line Voltage Select Waste
First Parallel Printer Port Waste Chamber 1
Second Parallel PrinterPort
Waste Chamber 2
Manual Mode Waste Sensor
Maximum PowerWBC Impedance CountMetering Assembly
Mixing ChamberWBC ImpedanceCount Transducer
Assembly
AC INPUT MODEL
ALARM MONITOR
AUTO LOADER PAUSE
AUTO SAMPLER PERISTALTIC PUMP
BUSY POWER
COM 1 RBC METERING
COM 2 RBC TRANSDUCER
DATA STATION READY
E/STOP REPEAT
FAULT RESET
FREQUENCY REV
FUSES RS232
HDD SERVICE DISK
HGB FLOWCELL SET-UP DISK
HSSL SN
INIT SOL
INSTALLATION DISK START
KEYBOARD TEST INTERFACE
LINE FREQ SELECT TOUCH
LINE VOLTAGE SELECT WASTE
LPT1 WASTE CHAMBER 1
LPT2 WASTE CHAMBER 2
MAN WASTE SENSOR
MAX POWER WIC METERING
MIXING CHAMBER WIC TRANSDUCER
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System
Whole Blood Control, Low
Whole Blood Control, Normal
Whole Blood Control, High
Whole Blood Control, Tri-Level
Whole Blood Calibrator
Whole Blood Control
Miscellaneous
Legal Manufacturer
Manufacturer
Consult instructions for use
Date of Manufacture
Authorized Representative
For In Vitro Diagnostic Use
List Number
Separate collection for electrical and electronic equipment waste per
Directive 2002/96/EC in the European Union
Calibrator/Control related
SYSTEM
WB CONTROL L
WB CONTROL N
WB CONTROL H
WB CONTROL TRI-LEVEL
WB CAL
WB CONTROL
EC REP
IVD
REF
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viii CELL-DYN ® 3700 System Operator’s Manual
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Instrument Labeling
The following labels are affixed to the CELL-DYN 3700 System:
Current CELL-DYN customer’s instruments are CE Marked to theEuropean Electro-Magnetic Compliance (EMC) and Low-VoltageDirectives and have the following labels:
Laser Label, Front Panel
Laser Label, Rear Panel
Serial Number Label, Rear Panel
AVOID DIRECT EXPOSURE TO BEAM.NICHT DIREKT IN DEN LASERSTRAHL BLICKEN.
EVITER TOUTE EXPOSITION DIRECTE AU FAISCEAU LASER.
NO SE EXPONGA DIRECTAMENTE AL RAYO LASER.EVITARE OGNI ESPOSIZIONE DIRETTAAL RAGGIO.
LASER LIGHT WHEN OPEN.BEI OFFENER ABDECKUNG TRITT
LASERSTRAHLAUS.RAYON LASER SI OUVERT.
RADIACION LASER SI SE ABRE.LUCE LASER SE APERTO.
DANGER
GEFAHR DANGERPELIGRO PERICOLO
PN 9230701D
Class l Laser Product
per
lEC 825-1[1993]PN 9230702A
ABBOTT DIAGNOSTICS A wholly owned subsidiary of Abbott Laboratories
Abbott Park IL. 60064
THIS PRODUCT CONFORMS TOTHE APPLICABLE REQUIREMENTS
OF 21 CFR SUBCHAPTER J AT THE DATE OF MANUFACTURE
MANUFACTURED DATE
MODELNO.
SERIAL NO.
L IS T N O. RE V
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Voltage Label, Rear Panel
CE Label
Solution Container Label, Rear Panel
WARNING
WARNUNG
MISEEN GARDE
ADVERTENCIA
AVVERTENZA
: SET FOR 120 VOLTSWhen operation at other line voltage is required, refer to operation manual for detailed instructions.
: FUER 120 VOLT EINGESTELLTIst der Betrieb mit einer anderen Netzspannung erforderlich, entnehmen Sie die genauen
Anweisungen der Bedienungsanleitung.: PARAMETRE POUR UTILISATION SUR 120 VOLTS
Si une utilisation à une tension de réseau différente est requise, reportez-vous au ManuelTechnique pour de plus amples informations.
: CONFIGURADO PARA 120 VOLTIOSSi se necesita otra tensión diferente a la indicada, consulte el Manual de Operaciones parainstrucciones más detalladas.
: CONFIGURATO PER 120 VOLTSe la tensione è di voltaggio diverso, fare riferimento alle istruzioni dettagliate nel Manuale diImpiego. PN 9230003
CAUTION: DO NOT HANDLESOLUTION CONTAINERUNLESS PROPERLYPROTECTED. REFER TOOPERATOR’S MANUAL FORINSTALLATION PROCEDURE.
PN 9230334
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New CELL-DYN customer’s instruments are CE Marked to theEuropean In Vitro Diagnostic Directive, which encompasses therequirements of the EMC and Safety Directives, and have thefollowing labels:
Laser Label, Front Panel
Laser Label, Rear Panel
Serial Number Label, Rear Panel
Biological Risk Label, Touch Plate
CAUTION –
CLASS 3B LASER LIGHT WHEN OPEN.
AVOID EXPOSURE TO BEAM.PN 9230701
CLASS 1 LASER PRODUCTPN 9230702
ABBOTT DIAGNOSTICS DIVISIONAbbott Laboratories
Abbott Park IL, 60064 USATHIS PRODUCT CONFORMS TO
THE APPLICABLE REQUIREMENTSOF 21 CFR SUBCHAPTER J AT THE DATE
OF MANUFACTURE
DATE OF MANUFACTURE
MADE IN U.S.A. PN 9230308 REV G
PN 9231446
Biological Risk
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CELL-DYN ® 3700 System Operator’s Manual xiii
9140320E — September 2004
Conventions Used in This Manual
Soft keys are also depicted as follows in margins and flowcharts:
The following conventions are used in this manual:
Information Presentation Examples
Note, Caution, Warning ALL CAPS, BOLDFACE NOTE:
Bulletin message, status, or otherscreen display
MONOSPACE FONT,
BOLDFACE
Ready
Data entry field
Menu names SANS SERIF FONT, ALL CAPS, SET UP
Soft key names [SANS SERIF FONT, ALL CAPS,BRACKETS]
[SET UP]
References to other text Bold: Bold & Italics Chapter: Title,Subsection: Heading
MAIN MENU
KEYS
SUBMENU
KEYS
TOGGLE
KEYS
TOGGLE
KEYS
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Flowchart Conventions
Menus are shown as square-cornered rectangles in the flowcharts,and soft keys are shown as round-cornered rectangles:
The Page Down key is depicted as follows:
When procedures are depicted in flowcharts, shaded boxes andbold lines indicate which soft keys to press:
MAIN MENU
Ready
SET UP RUN DATA LOG QUALITY
CONTROLRETIC
DATA LOG
PageDown
MAIN MENU
Ready
PATIENT REAGENT
LOG
QC SET
UP MENUOPERATION
SET UP
SET UP RUN DATA LOG QUALITY
TURN ON
VET PKG
TURN ON
RETIC PKGBAR CODE
SET UP
CONTROL
LIMITS
RETICDATA LOG
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CELL-DYN ® 3700 System Operator’s Manual xv
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Safety
The CELL-DYN 3700 System has been designed to minimize
hazards to the operator. Operation, maintenance, and servicing ofhematology systems may expose individuals to potential safetyand health hazards. All work must be performed in accordancewith procedures described in the CELL-DYN Operator’s Manual oras directed by an Abbott Representative. For detailed Safetyinformation refer to Chapter 8: Hazards.
Warnings are inserted in this manual to alert personnel topotential hazards. The standard warning conventions includingsignal words (e.g., Caution) and symbols are described in Chapter8: Hazards.
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xvi CELL-DYN ® 3700 System Operator’s Manual
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Revision Status
Document ControlNumber(s)
RevisionDate
Section(s)Revised
Pages Revisedand Added
Original Issue(9140320A)
12/98 Not Applicable Not Applicable
9140320B 3/99 Chapter 10Chapter 14
10-75, 10-76,14-1, 14-2, 14-25,14-26,14-29, 14-30, 14-39, 14-40,14-43, 14-44, 14-59, 14-60,14-61, 14-62, 14-67, 14-68,14-71, 14-72, 14-75, 14-76,14-77, 14-78, 14-85, 14-86,Revision Status viii.
9140320C 11/00 All All
9140320D 6/03 Master Table ofContents All
Foreword All
1: SystemDescription
1-6 through 1-9; 1-11; 1-17through 1-24; 1-27
2: Installation 2-1; 2-3 through 2-5; 2-14
3: Principles ofOperation
3-36
4: SystemSpecifications
4-5 through 4-7; 4-11; 4-23
5: Operating
Instructions
5-7; 5-9 and 5-10; 5-12; 5-50;
5-67; 5-88 through 5-91; 5-93through 5-95; 5-98 through5-102; 5-119; 5-121; 5-143
6: Calibration 6-3; 6-26; 6-40
7: Quality Control 7-17; 7-25
8: Hazards All
9: Maintenance 9-3 and 9-4; 9-23 and 9-24;9-27 through 9-54
10: Troubleshooting 10-32; 10-35 and 10-36;10-58; 10-60; 10-68; 10-85
12: Sample Loader 12-6 and 12-7; 12-1113: VeterinaryPackage
13-44 and 13-45; 13-47;13-52
14: Reticulocyte 14-1; 14-3; 14-69; 14-71through 14-75, 14-77 and14-78; 14-81
Appendix A All
Appendix B New
Index New
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9140320E — September 2004
9140320E 9/2004 Master Table ofContents
All
Foreword All
1: SystemDescription
1-1; 1-6; 1-9; 1-24 through1-27
2: Installation 2-1; 2-3; 2-5; 2-9; 2-12 and2-13; 2-15
3: Principles ofOperation
3-36 through 3-49; 3-55 and3-56
4: SystemSpecifications
4-6; 4-11; 4-17; 4-19
5: OperatingInstructions
5-17 through 5-19; 5-50; 5-87through 5-89; 5 103; 5-110;5-123
6: Calibration 6-1; 6-3; 6-30; 6-35; 6-38;6-53; 6-57; 6-64; 6-68 and6-69; 6-79; 6-82 and 6-83;6-89 and 6-90; 6-92 through6-96
7: Quality Control 7-15 through 7-19; 7-23;7-26
9: Maintenance 9-2 and 9-3; 9-19 and 9-20;9-23; 9-26 and 9-27; 9-29 and9-30; 9-32 through 9-34;9-36 and 9-37; 9-40; 9-43;9-45 and 9-46; 9-48; 9-52;9-54
10: Troubleshooting 10-23; 10-25; 10-28; 10-32;10-34 through 10-37; 10-42;10-57 and 10-58; 10-60through 10-65; 10-76; 10-78through 10-87
11: Printers 11-4; 11-6; 11-13
12: Sample Loader 12-1 and 12-3
13: VeterinaryPackage 13-8
14: Reticulocyte 14-14; 14-32 through 14-34;14-69; 14-71; 14-82
Appendix A 7 and 8
Appendix B 1 and 2; 4
Appendix C New
Document ControlNumber(s)
RevisionDate
Section(s)Revised
Pages Revisedand Added
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9140320F — April 2007
Revision Log
Instructions: Use this log to provide a permanent record to verify that revised chapter(s) and/orpage(s) have been added to this manual.
1. Record the document control number of the revised section in the first column. You will find thenumber in the footer. Make an entry for each chapter you receive and place in the manual.
2. Record the revision date, also found in the footer, in the second column.3. Record the current CELL-DYN 3700 System software version in the third column.4. Write your initials or signature in the fourth column to verify that you have placed the revised
page(s) in the manual.5. Record the date that you added the revised section to the manual in the fifth column.
DocumentControlNumber
RevisionDate
SoftwareVersion
Revision Incorporated
byDate
Incorporated
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xx CELL-DYN ® 3700 System Operator’s Manual
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NOTES
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CELL-DYN ® 3700 System Operator’s Manual 1-1
9140320E — September 2004
Chapter 1 System Description
SystemDescription
Overview
The CELL-DYN 3700 System is a multi-parameter, automatedhematology analyzer designed for in vitro diagnostic use inclinical laboratories. The instrument has two versions: theCELL-DYN 3700SL System with an automated Sample Loader andthe CELL-DYN 3700CS System with a manual Closed Sampler.
Figure 1.1: CELL-DYN 3700SL System
The CELL-DYN 3700SL System is equipped with an automatedSample Loader module. The Sample Loader provides continuousclosed sampling for up to 100 tubes at a time. (See the precedingfigure.)
The CELL-DYN 3700CS System is equipped with a built-in manualClosed Sample Aspiration Module referred to as the ClosedSampler. The Closed Sampler aspirates blood from a closed
collection tube that has been inserted in the Closed SamplerModule.
Insert Color Photo
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1-2 CELL-DYN ® 3700 System Operator’s Manual
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System DescriptionOverview Chapter 1
NOTES
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CELL-DYN ® 3700 System Operator’s Manual 1-3
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Chapter 1 System Description
Intended Use
The CELL-DYN® 3700 System generates the following hematologic
measurements on EDTA-anticoagulated whole blood:
WBC — White Blood Cell or Leukocyte count
NEU — Neutrophil absolute count %N — Neutrophil percent
LYM — Lymphocyte absolute count %L — Lymphocyte percent
MONO — Monocyte absolute count %M — Monocyte percent
EOS — Eosinophil absolute count %E — Eosinophil percent
BASO — Basophil absolute count %B — Basophil percent
RBC — Red Blood Cell or Erythrocyte count
HGB — Hemoglobin concentration
HCT — Hematocrit
MCV — Mean Corpuscular Volume
MCH — Mean Corpuscular Hemoglobin
MCHC — Mean Corpuscular Hemoglobin Concentration
RDW — Red Cell Distribution Width
PLT — Platelet or Thrombocyte count
MPV — Mean Platelet Volume
PDW*— Platelet Distribution Width
PCT* — Plateletcrit
RETIC % — Reticulocyte Percent
RETIC ABS — Reticulocyte Absolute
IRF — Immature Reticulocyte Fraction
* Clinical significance has not been established for these parameters.
Therefore they are not reportable in the U.S. They are provided for
laboratory use only.
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1-4 CELL-DYN ® 3700 System Operator’s Manual
9140320C — November 2000
System DescriptionIntended Use Chapter 1
NOTES
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CELL-DYN ® 3700 System Operator’s Manual 1-5
9140320F — April 2007
System DescriptionChapter 1 System Components
System Components
The two main modules of the CELL-DYN 3700 System are depictedin the following two figures. (The Sample Loader Module includedwith the CELL-DYN 3700SL System is illustrated and described inChapter 2: Installation and Chapter 12: Sample Loader .)
Figure 1.2: CELL-DYN 3700 System
Analyzer:
The Analyzer contains the hardware to aspirate, dilute, andanalyze each whole blood specimen.
Data Station:
The Data Station contains a Flat Panel Display Monitor, aKeyboard, and a CPU (Central Processing Unit).
Analyzer Data Station
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1-6 CELL-DYN ® 3700 System Operator’s Manual
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System DescriptionSystem Components Chapter 1
Analyzer
Overview
The Analyzer is the central unit of the CELL-DYN 3700 System. Itaspirates and dilutes whole blood specimens, transports andanalyzes the prepared dilutions, and rinses fluidic components inpreparation for the next specimen. Except for those componentsdirectly related to the Closed Sample Processing Method(automated or manual), the CELL-DYN 3700CS System andCELL-DYN 3700SL System are identical. In the description ofcomponents on the following pages, those components applicableto only one of the systems will be identified as such. A completedescription of the automated Sample Loader can be found inChapter 12: Sample Loader .
Front Panel
The components visible on the front of the Analyzer are depictedin the following figure. The functional description of eachcomponent follows.
Figure 1.3: CELL-DYN 3700CS System Analyzer Front View
Left Front Cover Viewing Window
Status Indicator Panel
Right Front Cover
TubeRetainer
Closed Sample Aspiration Module
Touch Plate
Open
AspirationProbe
Sample
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System DescriptionChapter 1 System Components
Left Front Cover
The removable Left Front Cover protects the Left Flow Panel. Toremove the cover, lift up on the cover to free it from themounting brackets. A grounding wire provides electricalcontinuity for shielding purposes. Disconnect the groundingwire. Access to the Left Flow Panel is necessary to view the actionof the Flow Panel components and to perform certainmaintenance procedures.
Right Front Cover
The removable Right Front Cover protects the Right Flow Panel. Itcontains a window that allows the operator to view the ShearValve. The cover is removed by lifting it up, disconnecting theground wires, and lifting away from the mounting brackets.
Access to the Right Flow Panel is necessary to view the operationof the components and to perform certain maintenanceprocedures.
Status Indicator Panel
Three status indicator messages (illuminated by green, yellow, andred LEDs) indicate the status of the Analyzer. The status messages are:
• Ready (green light) — The Analyzer is ready to process aspecimen.
• Busy (yellow light) — The Analyzer is busy with a normaloperational sequence.
• Fault (red light) — The Analyzer is unable to processspecimens due to an existing faultcondition.
Open Sample Aspiration Probe
The Open Sample Aspiration Probe aspirates whole blood from anopened collection tube. The Wash Block moves down to the endof the probe and remains there whenever the Closed Mode isselected.
Touch Plate
The Touch Plate is located directly behind the Open Sample Aspiration Probe. Pressing the Touch Plate starts the selected runcycle for both the Open Mode and Closed Mode on theCELL-DYN 3700CS System. If the Closed Sampler Mode is selectedon the CS instrument, the cycle will begin only if a tube has beenproperly inserted in the holder. On the CELL-DYN 3700SL System,the Touch Plate is used for Open Mode only.
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1-8 CELL-DYN ® 3700 System Operator’s Manual
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System DescriptionSystem Components Chapter 1
Closed Sample Aspiration Module(CELL-DYN 3700CS System Only)
The Closed Sample Aspiration Module aspirates whole blood froma closed collection tube. It is activated when the Closed SamplerMode is selected. The module contains the following components:
• A Holder holds the closed collection tube.
• A Tube Retainer correctly positions the tube in the holder.
• Two Quick Adjust Levers located on either side of the TubeRetainer are used to raise or lower the Tube Retainer in orderto securely hold the collection tube in the proper position.
• An Interlock Switch located in the Tube Retainer preventsactivation of the Closed Sampler until a collection tube is
inserted properly.• A Needle pierces the collection tube stopper, vents vacuum
or pressure from inside the tube, aspirates the whole blood,and is retracted and rinsed at the end of each Closed Samplercycle.
Automated Sample Loader Module(CELL-DYN 3700SL System Only)
See Chapter 12: Sample Loader for information about the SampleLoader Module.
Flow PanelThe major components of the Flow Panel are depicted in thefollowing figure. The functional description of each componentfollows.
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CELL-DYN ® 3700 System Operator’s Manual 1-9
9140320E — September 2004
System DescriptionChapter 1 System Components
.
Figure 1.4: Analyzer Flow Panel Components
A e r o s o l
F i l t e r
W O C M i x i n g
C h a m b e r W O
C F l o w
C e l l C o v e r
W O C T r a n s f e r
P e r i s t a l t i c P u m p
v o n B e h r e n s
T r a n s d u c e r
A s s e m b l y
W a s t e
C h a m b e r 1
R B C / P L T
M e t e r i n g
A s s e m b l y
V a c u u
m
A c c u m
u l a t o r
D r a i n
L i n e
W I C M e t e r i n g
A s s e m b l y
W a s t e
C h a m b e r 2
S a m p l e A s p i r a t i o n
P e r i s t a l t i c P u m p
S h e a r V a l v e
A s s e m b l y
W O C
M e t e r i n g S y r i n g e
( c o n t a
i n s S h e a t h R e a g e n t )
W O C S h e a t h S y r i n g e
( c o n t a i n s S h e a t h R e a g e n t )
H G B / W I C L y
s e S y r i n g e
( c o n t a i n s H G
B / W I C L y s e )
H G B / W I C D i l u e n t S y r i n g e
( c o n t a i n s D i l u e n t )
R B C / P L T D i l u e n
t S y r i n g e
( c o n t a i n s D i l u e n
t ) W a s h
B l o c k
O p e n
S a m p l e
A s p i r a t i o n
P r o b e
T o u c h
P l a t e
O p t i c a l
B e n c h
A s s e m b l y
R B C / P L T
D i l u e n t
O v e r p r e s s u r e
S e n s o r
R B C / P L T
v o n B e h r e n s
T r a n s d u c e r
A s s e m b l y
W I C
O v e r f l o w
C h a m b e r
A . C . C .
I n t e r l o c k S w i t c h
N o r m a l l y
C l o s e d
V a l v e s
M o u n t i n g
B r a c k e t
M o u n t i n g
B r a c k e t
M o u n t i n g
B r a c k e t
H G B
F l o w C e l l
G r o u n d i n g
W i r e C l i p
G
r o u n d i n g
W
i r e C l i p
M o
u n t i n g
B r a c k e t
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1-10 CELL-DYN ® 3700 System Operator’s Manual
9140320C — November 2000
System DescriptionSystem Components Chapter 1
Sample Aspiration Peristaltic Pump
The Sample Aspiration Peristaltic Pump is composed of a rotorand pump tube holder. It aspirates whole blood from either anopen or closed collection tube into the Shear Valve. The pump
action is controlled by the Touch Plate and an optical detector.
Shear Valve Assembly
The three-piece ceramic Shear
Recommended