Hema Cell Dine

8/20/2019 Hema Cell Dine

1/792


2/792

Master Table of Contents - 2 CELL-DYN ® 3700 Operator’s Manual

9140320F — April 2007

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


3/792

CELL-DYN ® 3700 Operator’s Manual Master Table of Contents - 3

9140320F — April 2007


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


4/792


9140320F — April 2007


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


5/792


9140320F — April 2007


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


6/792


9140320F — April 2007


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


7/792


9140320F — April 2007


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


8/792


9140320F — April 2007


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


9/792


9140320F — April 2007


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


10/792


9140320F — April 2007


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


11/792

CELL-DYN ® 3700 Operator’s Manual Master Table of Contents-11

9140320F — April 2007

List of Figures

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


12/792

Master Table of Contents-12 CELL-DYN ® 3700 Operator’s Manual

9140320F — April 2007

List of Figures

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


13/792


9140320F — April 2007

List of Figures

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


14/792


9140320F — April 2007

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


15/792


9140320F — April 2007

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


16/792


9140320F — April 2007

List of Figures

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


17/792


9140320F — April 2007

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


18/792


9140320F — April 2007

List of Tables

NOTES


19/792

CELL-DYN ® 3700 System Operator’s Manual i

9140320F — April 2007

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.


20/792

ii CELL-DYN ® 3700 System Operator’s Manual

9140320F — April 2007

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.


21/792

CELL-DYN ® 3700 System Operator’s Manual iii

9140320F — April 2007

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.


22/792

iv CELL-DYN ® 3700 System Operator’s Manual

9140320F — April 2007

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


23/792

CELL-DYN ® 3700 System Operator’s Manual v

9140320E — September 2004

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


24/792


25/792

CELL-DYN ® 3700 System Operator’s Manual vii

9140320F — April 2007

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


26/792

viii CELL-DYN ® 3700 System Operator’s Manual


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


27/792

CELL-DYN ® 3700 System Operator’s Manual ix


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


28/792

x CELL-DYN ® 3700 System Operator’s Manual

9140320F — April 2007

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


29/792


30/792


31/792

CELL-DYN ® 3700 System Operator’s Manual xiii


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


32/792

xiv CELL-DYN ® 3700 System Operator’s Manual


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


33/792

CELL-DYN ® 3700 System Operator’s Manual xv


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.


34/792

xvi CELL-DYN ® 3700 System Operator’s Manual


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


35/792

CELL-DYN ® 3700 System Operator’s Manual xvii


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


36/792


37/792

CELL-DYN ® 3700 System Operator’s Manual xix

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


38/792

xx CELL-DYN ® 3700 System Operator’s Manual

9140320F — April 2007

NOTES


39/792

CELL-DYN ® 3700 System Operator’s Manual 1-1


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


40/792

1-2 CELL-DYN ® 3700 System Operator’s Manual

9140320C — November 2000

System DescriptionOverview Chapter 1

NOTES


41/792


9140320C — November 2000

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.


42/792


9140320C — November 2000

System DescriptionIntended Use Chapter 1

NOTES


43/792


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


44/792



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


45/792


9140320D — June 2003


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.


46/792


9140320D — June 2003


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.


47/792




.

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


48/792


9140320C — November 2000


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

Documents

Hema Cell Dine