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CELL-DYN 3000 System
OPERATOR’S MANUAL
LIST NO: 92420-01
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EXIT
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• Precautions, Limitations and Hazards
ENTIRE CONTENTS COPYRIGHT
ABBOTT LABORATORIES ABBOTT LABORATORIES 1993
ABBOTT PARK, IL 60064 U.S.A. PRINTED IN THE U.S.A.
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Master Table of Contents
Introduction
Chapter 1. System Description
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
System Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5
Analyzer Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6
Front Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6
Flow Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8
Left Side Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-12
Rear Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-15
Data Station . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-17
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-17
Data Station Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-17
Front Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-18
Right Side Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-19
Rear Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-20
Sample Loader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-22
Reagent System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-22
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-22
CELL-DYN Reagents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-23
Chapter 2. Installation
Proprietary Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2
Abbott Instrument Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3
Text Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5
Safety Icon Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6
Revision Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7
Manual Revision Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
Initial Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
Space Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
Waste Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Power Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Printer Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Graphics Printer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4
Ticket Printer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5
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Sample Loader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-8
Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-8
Mechanical and Electrical Setup . . . . . . . . . . . . . . . . . . . .2-8
Fluid Tubing Connection . . . . . . . . . . . . . . . . . . . . . . . . . .2-9
Tube Racks Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-10
Power On . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-11
Chapter 3. Principles of Operation
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-1
Sample Aspiration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-2
Sample Analysis Cycle Overview . . . . . . . . . . . . . . . . . . . . . . . . .3-2
Sample Segments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-2
WBC Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-2
RBC/PLT Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-3
Hemoglobin Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-3
Results Displayed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-3
Instrument Rinsed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-4
WBC Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-5
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-5
Introduction to Flow Cytometry . . . . . . . . . . . . . . . . . . . .3-6
Sheath Reagent . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-8
Detection with the Optical Bench . . . . . . . . . . . . . . . . . . .3-8
WBC Differential . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-10
WBC Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-15
WBC Flagging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-16
RBC/PLT Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-17
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-17
Electrical Impedance Measurements . . . . . . . . . . . . . . . .3-17
Coincidence Passage Correction . . . . . . . . . . . . . . . . . . .3-17
RER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-18
Volumetric Metering . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-18
RBC/PLT Measurement . . . . . . . . . . . . . . . . . . . . . . . . .3-19
RBC Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-20
PLT Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-22
Platelet Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-22
Platelet Flagging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-24
Hemoglobin Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-25
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-25
Hemoglobin Measurement Process . . . . . . . . . . . . . . . . .3-25
HGB Parameter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-25
HGB Flagging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-25
Operational Messages and Data Flagging . . . . . . . . . . . . . . . . . .3-26
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-26
Instrument Fault and Status Conditions . . . . . . . . . . . . . .3-26
Master Table of Contents - 2 CELL-DYN
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9140240E — May 1995
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Parameter Flagging Messages . . . . . . . . . . . . . . . . . . . . . . . . . . 3-27
Dispersional Data Alerts . . . . . . . . . . . . . . . . . . . . . . . . . 3-28
Suspect Parameter Flags . . . . . . . . . . . . . . . . . . . . . . . . . 3-28
Suspect Population Flags . . . . . . . . . . . . . . . . . . . . . . . . 3-31
Interpretive Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-33
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-35
Chapter 4. System Specifications
Physical Specifications — CELL-DYN 3000SL . . . . . . . . . . . . . 4-1
Power Specifications — CELL-DYN 3000SL . . . . . . . . . . . . . . . 4-2
Consumption . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
Operational Specifications — CELL-DYN 3000SL . . . . . . . . . . 4-3
Operating Environment . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
Complete Cycle Times . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
Approximate Aspiration Volumes (whole blood) . . . . . . . 4-3
Batch Size . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
Throughput . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
Collection Tube and Sample Volume . . . . . . . . . . . . . . . . 4-4
Bar Code Specifications — CELL-DYN 3000SL . . . . . . . . . . . . 4-5
Bar Code Format . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5
Bar Code Label Specifications . . . . . . . . . . . . . . . . . . . . . 4-5
Physical Specifications — CELL-DYN 3000CS . . . . . . . . . . . . . 4-6
Power Specifications — CELL-DYN 3000CS . . . . . . . . . . . . . . . 4-7
Consumption . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7
Operational Specifications — CELL-DYN 3000CS . . . . . . . . . . 4-8
Operating Environment . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-8
Complete Cycle Times . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-8
Approximate Aspiration Volumes (whole blood) . . . . . . . 4-8
Measurement Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-9
Measurement Channels . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-9
WBC and Differential . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-9
RBCs and PLTs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-9
HGB . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-9
Performance Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10
Background Counts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10
Precision . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10
Hemogram Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10
WBC Differential Parameters . . . . . . . . . . . . . . . . . . . . . 4-11
Linearity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11
Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-12
Hemogram Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . 4-12
WBC Differential Parameters . . . . . . . . . . . . . . . . . . . . . 4-12
Carryover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-13
CELL-DYN
3000 System Operator’s Manual
9140240E — May 1995
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Chapter 5. Operating Instructions
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-1
Data Station Program Overview . . . . . . . . . . . . . . . . . . . . . . . . . .5-1
Main Menu Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-2
Conventions Used in This Manual . . . . . . . . . . . . . . . . . .5-3
Procedure Date/Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-7
Procedure Patient Limit Sets . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-9
Procedure Reagent Log Entry . . . . . . . . . . . . . . . . . . . . . . . . . . .5-11
Procedure Deleting Entries . . . . . . . . . . . . . . . . . . . . . . .5-11
Procedure X-B Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-14
Range and Limit Entry and File Updating . . . . . . . . . . . . . . . . .5-16
QC Limits Entry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-16
Procedure QC File Setup . . . . . . . . . . . . . . . . . . . . . . . . .5-22
Procedure Customize QC Log Display . . . . . . . . . . . . . .5-25
Procedure Customize QC Log Printout . . . . . . . . . . . . . .5-29
Procedure Bar Code Set Up . . . . . . . . . . . . . . . . . . . . . . .5-31
Procedure Computer Setup . . . . . . . . . . . . . . . . . . . . . . .5-34
Procedure Units Selection . . . . . . . . . . . . . . . . . . . . . . . .5-36
Procedure Customize Display . . . . . . . . . . . . . . . . . . . . .5-38
Routine Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-51
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-51
Data Station Run Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-52
Data Station Run Screen . . . . . . . . . . . . . . . . . . . . . . . . .5-53
Status Box . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-54
Bulletin Line . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-55
Flagging Diagnostics Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-56
Data Station Run Screen Soft Keys . . . . . . . . . . . . . . . . . . . . . . .5-58
Procedure Resistant RBC . . . . . . . . . . . . . . . . . . . . . . . .5-66
Sample Collection and Handling . . . . . . . . . . . . . . . . . . . . . . . . .5-67
Anticoagulant . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-67
Sample Stability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-67
Sample Collection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-68
Interfering Substances . . . . . . . . . . . . . . . . . . . . . . . . . . .5-68
Sample Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-69
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-69
Operator ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-69
Sample Identification . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-69
Alerts and Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-70
Instrument Start Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-72
Sample Analysis on the CELL-DYN 3000SL . . . . . . . . . . . . . .5-73
Daily Quality Control Checks . . . . . . . . . . . . . . . . . . . . .5-74
Running Samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-77
Daily Shutdown . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-79
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Sample Analysis on the CELL-DYN 3000CS . . . . . . . . . . . . . . 5-80
Running Samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-81
Daily Shutdown . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-83
Using the Work List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-84
Work List Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-85
Work List Soft Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-87
Sample Analysis Using the Work List,
Sample Loader Instruments . . . . . . . . . . . . . . . . . . . 5-91
Sample Analysis with the Work List,
Closed Sampler Instruments . . . . . . . . . . . . . . . . . . . 5-96
Using the Data Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-101
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-101
Data Log Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-101
Data Log Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-111
Data Log Set Up Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-112
Customizing the Data Log Display . . . . . . . . . . . . . . . . 5-112
Procedure Customize Data Log Display . . . . . . . . . . . . 5-113
Standard Groups . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-114
Data Review from the Data Log . . . . . . . . . . . . . . . . . . . . . . . . 5-117
Scrolling Through the Data Log . . . . . . . . . . . . . . . . . . 5-117
Displaying a Record . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-117
Procedure Record Display . . . . . . . . . . . . . . . . . . . . . . 5-118
Editing a Record . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-119
Procedure Edit Specimen . . . . . . . . . . . . . . . . . . . . . . . 5-119
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-121
Chapter 6. Calibration
CELL-DYN
3000 System Operator’s Manual
9140240E — May 1995
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
Calibration Materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2
General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3
Calibration Procedural Guidelines . . . . . . . . . . . . . . . . . . . . . . . . 6-3
Conventions Used in this Chapter . . . . . . . . . . . . . . . . . . . . . . . . 6-4
Calibration Procedural Summary . . . . . . . . . . . . . . . . . . . . . . . . . 6-5
Whole Blood Calibration Guidelines . . . . . . . . . . . . . . . . . . . . . . 6-6
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-6
Sample Requirements for Fresh Whole Blood . . . . . . . . . 6-6
Determination of the Reference Values . . . . . . . . . . . . . . 6-6
Calibration Requirements for Fresh Whole Blood . . . . . . 6-7
Calibration Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-11
Auto-Cal Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-11
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-11
Auto-Cal Sample Capacity . . . . . . . . . . . . . . . . . . . . . . . 6-11
Auto-Cal Methodology . . . . . . . . . . . . . . . . . . . . . . . . . . 6-11
Calibration Requirements for Auto-Cal . . . . . . . . . . . . . 6-12
Calibration Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-13
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Master Table of Contents - 6
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Manual Calibration Overview . . . . . . . . . . . . . . . . . . . . . . . . . . .6-24
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-24
Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-24
Mode To Mode Calibration Overview . . . . . . . . . . . . . . . . . . . .6-25
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-25
Auto-Cal Mode to Mode Calibration . . . . . . . . . . . . . . . .6-25
Manual Mode to Mode Calibration . . . . . . . . . . . . . . . . .6-25
Mode to Mode Calibration Preparation . . . . . . . . . . . . . .6-26
Closed Mode Calibration Confirmation . . . . . . . . . . . . .6-26
Pre-Calibration Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-27
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-27
Calibration Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-27
Instrument Logbook . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-28
Open Mode Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-33
Auto-Cal Using The CELL-DYN Calibrator . . . . . . . . . . . . . . .6-33
Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-33
Starting Auto-Cal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-33
Entering the Reference Values . . . . . . . . . . . . . . . . . . . .6-33
Performing the Calibration . . . . . . . . . . . . . . . . . . . . . . .6-34
Calibration Factor Calculation . . . . . . . . . . . . . . . . . . . . .6-36
Determining Which Parameters Need Calibration . . . . .6-37
Calibration for All Parameters . . . . . . . . . . . . . . . . . . . . .6-39
Calibration for Individual Parameters . . . . . . . . . . . . . . .6-40
Completing Open Mode Calibration . . . . . . . . . . . . . . . .6-40
Auto-Cal Using Whole Blood Samples . . . . . . . . . . . . . . . . . . . .6-42
Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-42
Starting Auto-Cal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-42
Entering the Reference Values . . . . . . . . . . . . . . . . . . . .6-42
Performing the Calibration . . . . . . . . . . . . . . . . . . . . . . .6-43
Calibration Factor Calculation . . . . . . . . . . . . . . . . . . . . .6-45
Determining Which Parameters Need Calibration . . . . .6-46
Calibration for All Parameters . . . . . . . . . . . . . . . . . . . . .6-48
Calibration for Individual Parameters . . . . . . . . . . . . . . .6-49
Completing Whole Blood Open Mode Calibration . . . . .6-49
Manual Calibration — Open Mode . . . . . . . . . . . . . . . . . . . . . . .6-51
Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-51
Preparing for Manual Calibration . . . . . . . . . . . . . . . . . .6-51
Determining the Open Mode Mean . . . . . . . . . . . . . . . . .6-51
Calibration Factor Calculations . . . . . . . . . . . . . . . . . . . .6-52
Determining Which Parameters Need Calibration . . . . .6-53
Calibrating the Open Mode . . . . . . . . . . . . . . . . . . . . . . .6-55
Completing Manual Calibration . . . . . . . . . . . . . . . . . . .6-55
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Closed Mode Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-59
Mode To Mode Auto-Cal, Sampler Loader Procedure . . . . . . . . 6-59
Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-59
Determining Reference Values . . . . . . . . . . . . . . . . . . . . 6-59
Starting Auto-Cal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-59
Entering the Reference Values . . . . . . . . . . . . . . . . . . . . 6-60
Performing the Calibration . . . . . . . . . . . . . . . . . . . . . . . 6-61
Calibration Factor Calculation . . . . . . . . . . . . . . . . . . . . 6-63
Determining Which Parameters Need Calibration . . . . . 6-64
Calibration for All Parameters . . . . . . . . . . . . . . . . . . . . 6-66
Calibration for Individual Parameters . . . . . . . . . . . . . . . 6-67
Completing Mode to Mode Calibration . . . . . . . . . . . . . 6-67
Mode To Mode Auto-Cal, Closed Sampler Procedure . . . . . . . . 6-70
Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-70
Determining Reference Values . . . . . . . . . . . . . . . . . . . . 6-70
Starting Auto-Cal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-70
Entering the Reference Values . . . . . . . . . . . . . . . . . . . . 6-71
Performing the Calibration . . . . . . . . . . . . . . . . . . . . . . . 6-72
Calibration Factor Calculation . . . . . . . . . . . . . . . . . . . . 6-74
Determining Which Parameters Need Calibration . . . . . 6-75
Calibration for All Parameters . . . . . . . . . . . . . . . . . . . . 6-77
Calibration for Individual Parameters . . . . . . . . . . . . . . . 6-78
Completing Mode to Mode Calibration . . . . . . . . . . . . . 6-78
Manual Mode To Mode Calibration . . . . . . . . . . . . . . . . . . . . . . 6-81
Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-81
Preparing for Manual Mode to Mode Calibration . . . . . 6-81
Determining the Open Mode Mean . . . . . . . . . . . . . . . . 6-81
Determining the Closed Mode Mean . . . . . . . . . . . . . . . 6-82
Difference Calculation . . . . . . . . . . . . . . . . . . . . . . . . . . 6-82
Determining Which Parameters Need Calibration . . . . . 6-83
Calibration Factor Calculation . . . . . . . . . . . . . . . . . . . . 6-85
Calibrating the Closed Mode . . . . . . . . . . . . . . . . . . . . . 6-85
Completing Mode to Mode Calibration . . . . . . . . . . . . . 6-86
Post-Calibration Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-89
Quality Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-89
Calibration Back-Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-89
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-91
Chapter 7. Quality Control
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
Quality Control Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3
Quality Control Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-13
General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-13
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Chapter 8. Precautions, Limitations and Hazards
Limitations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-1
Location Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-1
Electrical Safety Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-2
Mechanical Safety Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . .8-3
Chemical Safety Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-3
Infection Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-3
Decontamination Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-4
Blood Samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-4
Spills . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-4
Reagent Storage and Handling . . . . . . . . . . . . . . . . . . . . . . . . . . .8-5
Laser Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-5
Printer Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-5
Sample Loader Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-6
Chapter 9. Maintenance
Running Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-13
Control Material . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-13
Mixing and Handling . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-13
Assay Verification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-14
Westgard Rules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-15
CELL-DYN 3000 Westgard Rules . . . . . . . . . . . . . . . . .7-15
X-B Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-18
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-18
Lower/Upper Acceptance Limits . . . . . . . . . . . . . . . . . . .7-18
Target Value . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-19
Action Limit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-19
Establishing the Target Value . . . . . . . . . . . . . . . . . . . . .7-19
Interpreting X-B Results . . . . . . . . . . . . . . . . . . . . . . . . .7-19
CELL-DYN Controls . . . . . . . . . . . . . . . . . . . . . . . . . . .7-19
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-21
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-1
Preventive Maintenance Schedule . . . . . . . . . . . . . . . . . . . . . . . . .9-3
Daily . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-3
Weekly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-3
Monthly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-3
As Required Maintenance . . . . . . . . . . . . . . . . . . . . . . . . .9-3
Special Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-4
Analyzer Flow Panel Components Diagram . . . . . . . . . . . . . . . . .9-4
Special Protocols Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-7
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Daily Maintenance Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . 9-13
Auto-Clean . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-13
Sample Loader Aspiration Needle . . . . . . . . . . . . . . . . . 9-15
Closed Sampler Aspiration Needle . . . . . . . . . . . . . . . . . 9-16
Weekly Maintenance Procedures . . . . . . . . . . . . . . . . . . . . . . . . 9-17
Shear Valve . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-17
Aspiration Peristaltic Pump Tubing . . . . . . . . . . . . . . . . 9-20
Sample Loader Tray, Racks and Safety Cover . . . . . . . . 9-22
Monthly Maintenance Procedures . . . . . . . . . . . . . . . . . . . . . . . 9-25
Reagent Syringes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-25
WBC Transfer Peristaltic Pump Tubing . . . . . . . . . . . . . 9-28
Air Filters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-29
Extended Auto-Clean . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-32
As Required Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-35
RBC/PLT Aperture Plate . . . . . . . . . . . . . . . . . . . . . . . . 9-35
Hemoglobin Flow Cell Manual Cleaning
Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-39
Vacuum Accumulator Cleaning Procedure . . . . . . . . . . . 9-41
Special Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-43
Closed Sampler Tube Retainer Adjustment . . . . . . . . . . . . . . . . 9-43
Preparation for Inactivity or Shipping . . . . . . . . . . . . . . . . . . . . 9-44
Repackaging for Shipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-46
Chapter 10. Troubleshooting
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1
Diagnostics Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-3
Diagnostics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-4
Troubleshooting Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-25
Introduction to Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . 10-25
Obtaining Technical Assistance . . . . . . . . . . . . . . . . . . . . . . . . 10-26
Troubleshooting Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-27
Power ON Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . 10-27
Power OFF Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . 10-28
Initializing the System . . . . . . . . . . . . . . . . . . . . . . . . . 10-28
Unclogging the Open Sample Aspiration Probe . . . . . . 10-30
Operator-Replaceable Components . . . . . . . . . . . . . . . . . . . . . 10-32
Operator-Replaceable Fuse . . . . . . . . . . . . . . . . . . . . . . 10-32
Checking or Changing the Analyzer Fuse . . . . . . . . . . 10-32
Sample Loader Aspiration Needle or Vent Needle . . . . 10-33
Aperture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-36
Syringes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-37
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Troubleshooting Tips and Techniques . . . . . . . . . . . . . . . . . . .10-38
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-38
Troubleshooting the Background Count . . . . . . . . . . . .10-38
Troubleshooting Reagent Problems . . . . . . . . . . . . . . . .10-39
Troubleshooting the “Incomplete
Aspiration-Sampling Error” Message . . . . . . . . . . .10-39
Troubleshooting RBC Clog and Flow Error
Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-40
Troubleshooting the WBC Flow Error Message . . . . . .10-40
Troubleshooting Imprecise or Inaccurate Data . . . . . . .10-41
Messages and Fault Conditions . . . . . . . . . . . . . . . . . . . . . . . . .10-43
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-43
Instrument Status Conditions . . . . . . . . . . . . . . . . .10-45
General Fault Conditions . . . . . . . . . . . . . . . . . . . .10-53
Sample-Related Fault Conditions . . . . . . . . . . . . . .10-67
Non-Functional Fault Conditions . . . . . . . . . . . . . .10-73
Chapter 11. Printer
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-1
Printing Graphics Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-1
Printing Tickets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-1
Loading Individual Tickets . . . . . . . . . . . . . . . . . . . . . . .11-2
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-5
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-6
Chapter 12. Sample Loader
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12-1
Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12-2
CELL-DYN Bar Code Labels . . . . . . . . . . . . . . . . . . . . .12-2
CELL-DYN Q Labels . . . . . . . . . . . . . . . . . . . . . . . . . . .12-2
Bar Code Label Placement . . . . . . . . . . . . . . . . . . . . . . .12-3
Sample Loader Components . . . . . . . . . . . . . . . . . . . . . . . . . . . .12-4
Sample Loader Operation Keyboard Keys . . . . . . . . . . . . . . . . .12-5
Operating Principles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12-7
Functional Description . . . . . . . . . . . . . . . . . . . . . . . . . .12-7
Function Sequence . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12-12
Routine Operating Procedures . . . . . . . . . . . . . . . . . . . . . . . . . .12-15
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12-15
Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12-15
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12-15
Master Table of Contents - 10 CELL-DYN
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Appendix A. Bar Codes
Introduction To Bar Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1
Bar Coding Function . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1
Understanding the Label “Code” . . . . . . . . . . . . . . . . . . A-2
Bar Code Types and Characteristics . . . . . . . . . . . . . . . . A-2
CELL-DYN 3000 Bar Code Specifications . . . . . . . . . . . . . . . . A-3
Bar Code Label Specifications . . . . . . . . . . . . . . . . . . . . A-3
CELL-DYN Bar Code Labels . . . . . . . . . . . . . . . . . . . . . A-4
CELL-DYN Q Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . A-4
Bar Code Label Placement . . . . . . . . . . . . . . . . . . . . . . . A-5
Acknowledgment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-6
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NOTES
Master Table of Contents - 12 CELL-DYN
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List of Figures
Figure 1.1: CELL-DYN 3000SL . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
Figure 1.2: CELL-DYN 3000CS . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
Figure 1.3: CELL-DYN 3000 System Components . . . . . . . . . . . 1-5
Figure 1.4: CELL-DYN 3000 Analyzer Front View . . . . . . . . . . 1-6
Figure 1.5: Analyzer Flow Panel Components . . . . . . . . . . . . . . 1-10
Figure 1.6: Analyzer Left Side Panel Components . . . . . . . . . . 1-13
Figure 1.7: Analyzer Rear Panel Components . . . . . . . . . . . . . . 1-15
Figure 1.8: Data Station Front Panel Components and
Standard Computer Keyboard . . . . . . . . . . . . . . . . . 1-17
Figure 1.9: Data Station Right Side Panel Components . . . . . . . 1-19
Figure 1.10: Data Station Rear Panel Components . . . . . . . . . . . . 1-20
Figure 2.1: Data Station Rear Panel . . . . . . . . . . . . . . . . . . . . . . . 2-6
Figure 2.2: Analyzer with Sample Loader . . . . . . . . . . . . . . . . . . 2-8
Figure 2.3: Sample Loader Tubing Connections . . . . . . . . . . . . . 2-9
Figure 2.4: Tube Rack Showing Label Placement Location . . . . 2-11
Figure 3.1: WBC Flow Cell . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7
Figure 3.2: WBC Light Scatter . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8
Figure 3.3: Optical Bench . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9
Figure 3.4: Mononuclear-Polymorphonuclear Scatter . . . . . . . . 3-11
Figure 3.5: Neutrophil-Eosinophil Scatter . . . . . . . . . . . . . . . . . 3-12
Figure 3.6: Mononuclear Scatter . . . . . . . . . . . . . . . . . . . . . . . . . 3-13
Figure 3.7: WBC Histograms . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-14
Figure 3.8: WBC Data and Scatterplots . . . . . . . . . . . . . . . . . . . 3-15
Figure 3.9: Volumetric Metering . . . . . . . . . . . . . . . . . . . . . . . . 3-18
Figure 3.10: RBC Data and Histogram . . . . . . . . . . . . . . . . . . . . . 3-20
Figure 3.11: PLT Data and Histogram . . . . . . . . . . . . . . . . . . . . . 3-23
Figure 5.1: Main Menu Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2
Figure 5.2: Setup Menu Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5
Figure 5.3: Date/Time Setup Screen . . . . . . . . . . . . . . . . . . . . . . . 5-6
Figure 5.4: Patient Limits Screen . . . . . . . . . . . . . . . . . . . . . . . . . 5-8
Figure 5.5: Diluent Log Screen . . . . . . . . . . . . . . . . . . . . . . . . . . 5-10
Figure 5.6: QC Setup Menu Screen . . . . . . . . . . . . . . . . . . . . . . 5-12
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Master Table of Contents - 14
Figure 5.7: X-B Setup Screen . . . . . . . . . . . . . . . . . . . . . . . . . . .5-13
Figure 5.8: QC Range Entry Screen . . . . . . . . . . . . . . . . . . . . . .5-17
Figure 5.9: QC Means/Limits Entry Screen . . . . . . . . . . . . . . . .5-18
Figure 5.10: Replicate ID Entry Screen . . . . . . . . . . . . . . . . . . . . .5-21
Figure 5.11: Lot Number Entry Screen . . . . . . . . . . . . . . . . . . . . .5-22
Figure 5.12: Customize QC Display Screen . . . . . . . . . . . . . . . . .5-24
Figure 5.13: Customize QC Display Screen
Showing Standard Groups . . . . . . . . . . . . . . . . . . . .5-26
Figure 5.14: Customize QC Printout Screen . . . . . . . . . . . . . . . . .5-28
Figure 5.15: Operation Setup Menu Screen . . . . . . . . . . . . . . . . .5-30
Figure 5.16: Bar Code Set Up Screen . . . . . . . . . . . . . . . . . . . . . .5-31
Figure 5.17: Computer Setup Screen . . . . . . . . . . . . . . . . . . . . . . .5-32
Figure 5.18: Units Selection Screen . . . . . . . . . . . . . . . . . . . . . . .5-35
Figure 5.19: Customize Displayed Report Screen . . . . . . . . . . . . .5-37
Figure 5.21: Customize Printout Header Screen . . . . . . . . . . . . . .5-43
Figure 5.24: Run Screen for Patient Samples . . . . . . . . . . . . . . . .5-52
Figure 5.25: Run Screen Showing Bulletin Line Message . . . . . .5-55
Figure 5.26: Flagging Diagnostics Screen . . . . . . . . . . . . . . . . . . .5-56
Figure 5.27: Work List Screen . . . . . . . . . . . . . . . . . . . . . . . . . . .5-58
Figure 5.28: Specimen Type Screen . . . . . . . . . . . . . . . . . . . . . . .5-60
Figure 5.29: Run Screen for Patient Samples . . . . . . . . . . . . . . . .5-61
Figure 5.30: Run Screen for a QC File . . . . . . . . . . . . . . . . . . . . .5-62
Figure 5.31: Run Screen for Background Counts . . . . . . . . . . . . .5-63
Figure 5.32: Run Screen for Electrical Background Counts . . . . .5-64
Figure 5.33: Run Screen for Resistant RBC . . . . . . . . . . . . . . . . .5-65
Figure 5.34: Work List Screen . . . . . . . . . . . . . . . . . . . . . . . . . . .5-85
Figure 5.35: Work List Setup Screen . . . . . . . . . . . . . . . . . . . . . .5-89
Figure 5.36: Data Log Screen . . . . . . . . . . . . . . . . . . . . . . . . . . .5-101
Figure 5.37: Display Specimen Screen . . . . . . . . . . . . . . . . . . . .5-103
Figure 5.38: Data Log Search Screen . . . . . . . . . . . . . . . . . . . . .5-105
Figure 5.39: Customize Display for Data Log Screen . . . . . . . . .5-106
Figure 5.40: Customize Display for Data Log Screen . . . . . . . . .5-107
Figure 5.41: Customize Printout for Data Log Screen . . . . . . . .5-109
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Figure 5.42: Data Log Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-111
Figure 5.43: Data Log Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-112
Figure 5.44: Customize Display for Data Log Screen . . . . . . . . 5-113
Figure 5.45: Customize Printout for Data Log Screen . . . . . . . . 5-115
Figure 5.46: Display Specimen Screen . . . . . . . . . . . . . . . . . . . . 5-117
Figure 5.47: Edit Specimen Screen . . . . . . . . . . . . . . . . . . . . . . . 5-119
Figure 6.1: Calibration Menu Screen Displaying
Open Mode Calibration Factors . . . . . . . . . . . . . . . . 6-13
Figure 6.2: Calibration Menu Screen Displaying
Closed Mode Calibration Factors . . . . . . . . . . . . . . . 6-14
Figure 6.3: Enter Whole Blood Factor Screen . . . . . . . . . . . . . . 6-15
Figure 6.4: Calibration Log Screen . . . . . . . . . . . . . . . . . . . . . . . 6-17
Figure 6.5: Auto-Calibration Screen for CELL-DYN 3000 . . . . 6-17
Figure 6.6: Whole Blood Auto-Cal Screen . . . . . . . . . . . . . . . . . 6-19
Figure 6.7: Whole Blood Auto-Cal Screen . . . . . . . . . . . . . . . . . 6-21
Figure 6.8: Whole Blood Auto-Cal Results Screen . . . . . . . . . . 6-21
Figure 6.9: Whole Blood Auto-Cal Results Screen . . . . . . . . . . 6-22
Figure 6.10: Calibrator Auto-Cal Screen . . . . . . . . . . . . . . . . . . . 6-23
Figure 7.1: QC Menu Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4
Figure 7.2: The X-B Display Screen (Data) . . . . . . . . . . . . . . . . . 7-5
Figure 7.3: The X-B Display Screen (Graph) . . . . . . . . . . . . . . . . 7-6
Figure 7.4: The View QC Log Screen . . . . . . . . . . . . . . . . . . . . . 7-7
Figure 7.5: The Levey-Jennings Menu Screen . . . . . . . . . . . . . . 7-10
Figure 7.6: View QC Log Screen (With Rejected Results) . . . . 7-11
Figure 7.7: Levey-Jennings Menu Screen Showing
Westgard Rule Violations . . . . . . . . . . . . . . . . . . . . . 7-16
Figure 9.1: Analyzer Flow Panel Components . . . . . . . . . . . . . . . 9-5
Figure 9.2: Special Protocols Screen . . . . . . . . . . . . . . . . . . . . . . 9-8
Figure 9.3: Special Protocols Screen 2 . . . . . . . . . . . . . . . . . . . . 9-10
Figure 9.4: Special Protocols: Process Complete Screen . . . . . . 9-12
Figure 9.5: Special Protocols: Auto-Clean Screen . . . . . . . . . . . 9-13
Figure 9.6: Shear Valve Assembly . . . . . . . . . . . . . . . . . . . . . . . 9-18
Figure 9.7: Aspiration Peristaltic Pump . . . . . . . . . . . . . . . . . . . 9-21
Figure 9.8: WBC Syringe Assembly . . . . . . . . . . . . . . . . . . . . . . 9-25
Figure 9.9: WBC Transfer Peristaltic Pump . . . . . . . . . . . . . . . . 9-28
Figure 9.10: Analyzer Left Side Panel . . . . . . . . . . . . . . . . . . . . . 9-30
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Master Table of Contents - 16
Figure 9.11: Data Station Rear Panel . . . . . . . . . . . . . . . . . . . . . .9-31
Figure 9.12: Special Protocols: Extended Auto-Clean Screen . . .9-33
Figure 9.13: Transducer Assembly — Levers Closed . . . . . . . . . .9-35
Figure 9.14: Transducer Assembly and Aperture Plate . . . . . . . . .9-37
Figure 9.16: Closed Sampler Module . . . . . . . . . . . . . . . . . . . . . .9-43
Figure 10.1: First Diagnostics Menu Screen . . . . . . . . . . . . . . . . .10-4
Figure 10.2: Operator Correctable Fault Report Screen . . . . . . . .10-5
Figure 10.3: Fatal Fault Report Screen . . . . . . . . . . . . . . . . . . . . .10-6
Figure 10.4: Fault Report – No Fault Pending Screen . . . . . . . . .10-7
Figure 10.5: Count Rate Summary Screen . . . . . . . . . . . . . . . . . .10-8
Figure 10.6: WBC Count Rate Data . . . . . . . . . . . . . . . . . . . . . . .10-9
Figure 10.7: WBC Count Rate Graph . . . . . . . . . . . . . . . . . . . . .10-10
Figure 10.8: Raw Data Summary Screen . . . . . . . . . . . . . . . . . .10-11
Figure 10.9: Second Diagnostics Menu Screen . . . . . . . . . . . . . .10-12
Figure 10.10: Pump Operation Screen . . . . . . . . . . . . . . . . . . . . .10-13
Figure 10.11: Pump Operation Screen — Vacuum ON . . . . . . . .10-14
Figure 10.12: Inhibit Pumps Screen . . . . . . . . . . . . . . . . . . . . . . .10-15
Figure 10.13: Vacuum Test Screen . . . . . . . . . . . . . . . . . . . . . . . .10-16
Figure 10.14: Third Diagnostics Menu Screen . . . . . . . . . . . . . . .10-17
Figure 10.15: Voltage Readings Screen . . . . . . . . . . . . . . . . . . . .10-18
Figure 10.16: Fourth Diagnostics Menu Screen . . . . . . . . . . . . . .10-19
Figure 10.17: Fifth Diagnostics Menu Screen
(CELL-DYN 3000SL) . . . . . . . . . . . . . . . . . . . . . .10-20
Figure 10.18: Auto-Sampler Version Screen . . . . . . . . . . . . . . . .10-21
Figure 10.19: Serial Test Screen . . . . . . . . . . . . . . . . . . . . . . . . . .10-22
Figure 10.20: Serial Test Transmit Message Screen . . . . . . . . . . .10-23
Figure 10.21: Open Sample Aspiration Probe . . . . . . . . . . . . . . . .10-31
Figure 10.22: Sample Loader Vent/Aspiration
Needle Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . .10-34
Figure 11.1: OKIDATA® MICROLINE® Printer . . . . . . . . . . . .11-3
Figure 11.2: Printer Carriage Shaft and Platen . . . . . . . . . . . . . . .11-5
Figure 12.1: Analyzer with Sample Loader . . . . . . . . . . . . . . . . . .12-1
Figure 12.2: Rack Movement . . . . . . . . . . . . . . . . . . . . . . . . . . . .12-2
Figure 12.3: Tube Labeling Requirements . . . . . . . . . . . . . . . . . .12-3
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Figure 12.4: Sample Loader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-4
Figure 12.5: Operation Keyboard . . . . . . . . . . . . . . . . . . . . . . . . . 12-5
Figure 12.6: Tower Stations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-8
Figure 12.7: Tube Racks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-10
Figure A.1: Bar Code Label Specifications . . . . . . . . . . . . . . . . . A-4
Figure A.2: Tube Labeling Requirements . . . . . . . . . . . . . . . . . . A-5
CELL-DYN
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9140240E — May 1995
Master Table of Contents - 17
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NOTES
Master Table of Contents - 18 CELL-DYN
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9140240E — May 1995
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List of Tables
Parameter Flagging Messages . . . . . . . . . . . . . . . . . 3-27
Interpretive Messages . . . . . . . . . . . . . . . . . . . . . . . . 3-34
Dimensions — CELL-DYN 3000SL . . . . . . . . . . . . . 4-1
Dimensions After Packaging for Shipment . . . . . . . . 4-1
Power Specifications . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
Dimensions — CELL-DYN 3000CS . . . . . . . . . . . . . 4-6
Dimensions After Packaging for Shipment . . . . . . . . 4-6
Power Specifications . . . . . . . . . . . . . . . . . . . . . . . . . 4-7
Parameters (N = 20) . . . . . . . . . . . . . . . . . . . . . . . . . 4-10
Precision of the WBC Differential Parameters . . . . . 4-11
Linearity Specifications . . . . . . . . . . . . . . . . . . . . . . 4-11
Table 4.10: Accuracy of Hemogram Parameters . . . . . . . . . . . . . 4-12
Table 4.11: Accuracy of WBC Differential Parameters . . . . . . . 4-12
Table 4.12: Carryover for WBC, RBC, HGB and PLT . . . . . . . . 4-13
Report Units. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-36
Calibration Criteria Chart . . . . . . . . . . . . . . . . . . . . . . 6-4
Calibration Procedural Summary . . . . . . . . . . . . . . . . 6-5
Calibration Criteria Chart . . . . . . . . . . . . . . . . . . . . . 6-37
Calibration Criteria Chart . . . . . . . . . . . . . . . . . . . . . 6-46
Calibration Criteria Chart . . . . . . . . . . . . . . . . . . . . . 6-53
Mode to Mode Calibration Criteria Chart . . . . . . . . 6-64
Mode to Mode Calibration Criteria Chart . . . . . . . . 6-75
Mode to Mode Calibration Criteria Chart . . . . . . . . 6-83
Table 10.1: Instrument Status Conditions . . . . . . . . . . . . . . . . . 10-46
Table 10.2: General Fault Conditions . . . . . . . . . . . . . . . . . . . . 10-54
Table 10.3: Sample-Related Fault Conditions . . . . . . . . . . . . . . 10-68
Table 10.4: Non-Functional Fault Conditions . . . . . . . . . . . . . . 10-74
Master Table of Contents - 19
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NOTES
Master Table of Contents - 20 CELL-DYN
3000 System Operator’s Manual
9140240E — May 1995
Foreword
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Introduction
Congratulations on becoming a proud operator of the
CELL-DYN® System. Using state-of-the-art technology we have designed your instrument so that it functions consistently and dependably on a day-to-day basis.
The CELL-DYN System is backed by dedicated professionals who excel in engineering, training, and technical expertise. As a valued customer, you will learn how to operate, maintain, and troubleshoot your system when you attend our training program at Abbott's California facility.
For your continuing service, we also provide telephone technical assistance, should you need additional information or assistance in diagnosing a problem. This service is available by calling the Abbott
Customer Support Center at 1 (800) CELL DYN or 1 (800) 235-5396.
Abbott Customer Support Specialists are available 7 days a week, 24 hours a day.
If a problem cannot be resolved by telephone, on-site support is offered by Abbott's Field Service Representatives. Our Field Service
Representatives are extensively trained in all aspects of Abbott instrumentation which assures proficiency in diagnosing, isolating and correcting problems.
Abbott Laboratories is dedicated to manufacturing the highest quality, most reliable instrumentation available. We look forward to serving your needs in any way possible.
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3000 System Operator’s Manual
9140240E — May 1995
1
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Proprietary Information
Entire contents of this manual copyright 1993, 1995 by Abbott
Laboratories. No part of this document may be reproduced, sorted, or transmitted in any form or by any means; electronic, mechanical, photocopied, recorded or otherwise without the prior written permission of Abbott Laboratories.
Abbott Laboratories' software programs are protected by copyright. All rights are reserved. This software was developed solely for use with
Abbott Laboratories equipment and for in vitro diagnostic applications as specified in the operating instructions.
This product contains software licensed from Microsoft Corporation.
All operating instructions must be followed. In no event shall Abbott be responsible for failures, errors, or other liabilities resulting from a customer's noncompliance with the procedures and precautions outlined herein.
The CELL-DYN 3000 instrument system is covered by one or more of the following U. S. Patents: 4,710,021; 4,726,237; 5,017,497; and
5,378,633.
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Abbott Instrument Warranty
For U. S. Customers Only
Abbott Laboratories warrants CELL-DYN 3000 Series Analyzers, sold by Abbott Sales Representatives (the "Instrument"), to be free from defects in workmanship and materials during normal use by the original purchaser. This warranty shall continue for a period of one (1) year, commencing twenty-one (21) days from the date of shipment to the original purchaser or until title is transferred from the original purchaser, whichever occurs first (the "Warranty Period").
If any defects occur during the Warranty Period, contact your Abbott
Customer Support Center immediately and be prepared to furnish
pertinent details concerning the defect, the Instrument model number 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 and within one week of occurrence
2.
Result from chemical decomposition or corrosion
3.
Are caused by customer or third party abuse, misuse, or negligence, or by failure to comply with any requirement or instruction 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 limited solely to the repair or (at
Abbott's sole discretion) replacement of the Instrument or any components thereof. In no event shall Abbott be liable for injuries sustained by third parties, incidental or consequential damages or lost profits. Replaced parts shall become the property of Abbott
Laboratories.
The foregoing is the sole warranty made by Abbott Laboratories regarding the Instrument and Abbott specifically disclaims all other warranties, expressed or implied, including the implied warranties of merchantability and of fitness for a particular purpose.
CELL-DYN® 3000 System Operator's Manual 3
9140240E — May 1995
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The CELL-DYN 3000 Series Hematology Systems are manufactured by Abbott Diagnostics, a wholly owned subsidiary of Abbott
Laboratories, Abbott Park, IL 60064, U.S.A. Please direct all inquiries concerning information in this manual to the foregoing address.
NOTE: Direct all inquiries regarding equipment problems to the Abbott Customer Support Center at
1 (800) CELL DYN or 1 (800) 235-5396 (U.S. customers only).
4 CELL-DYNE® 3000System Operation's Manual
9140240E — May 1995
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Text Conventions
The following text conventions are used in this manual:
INFORMATION
Note, Important
Screen or Menu display
Data entry field
Bulletin Message
Status Condition
Soft Keys*
PRESENTATION
INDENTED, ALL CAPITALS, BOLD
ALL CAPITALS, UNIVERSAL BOLD
<Within Brackets, Universal Bold,
Text matches screen>
Universal Bold, Text matches screen
ALL CAPITALS, UNIVERSAL
[UNIVERSAL BOLD, ALL
CAPITALS], Brackets
* In the menu descriptions given in Chapters 5 ,
the soft keys are also depicted as follows:
MAIN
MENU
SUB MENU
CELL-DYN
3000 System Operator’s Manual
9140240E — May 1995
5
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Safety Icon Conventions
DANGER: This icon is used in major hazard situations where an immediate hazard presents a threat of serious injury. This icon represents the highest level of any hazardous situation.
WARNING: Represents a hazard level between caution and danger. It denotes a clear and present danger.
CAUTION: Used in minor hazard situations where a nonimmediate or potential hazard or unsafe practice presents a lesser threat of injury. The caution icon and terminology may also alert the user to a situation that threatens equipment or performance.
WARNING: Potential Biohazard. Identifies the actual or potential presence of a biological hazard.
WARNING: Electrical Shock Hazard. Indicates possible danger from electrical shock.
6 CELL-DYN
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92420-01C
9140240D
9140240E
6/93
5/95
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Revision Status
Revision
9211420A Original Issue
9211420B
Date Pages Revised and Added
Not Applicable
Section 1-8: Heading added "1-8 Red Cell
Parameters"
Figures renumbered in Table of Contents
Name change from Unipath to Abbott and changed PN 9211420 to List No. 92420-01
All pages
All pages
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The Manual Revision Log on the next page is provided to document
revisions to this manual. The user should record the appropriate information and sign and date this log to provide a permanent record.
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Manual Revision Log
Revision* Date Incorporated Revision Incorporated By
____________________ ____________________ ________________________________________
____________________ ____________________ ________________________________________
____________________ ____________________ ________________________________________
____________________ ____________________ ________________________________________
____________________ ____________________ ________________________________________
____________________ ____________________ ________________________________________
____________________ ____________________ ________________________________________
____________________ ____________________ ________________________________________
____________________ ____________________ ________________________________________
____________________ ____________________ ________________________________________
____________________ ____________________ ________________________________________
____________________ ____________________ ________________________________________
____________________ ____________________ ________________________________________
____________________ ____________________ ________________________________________
____________________ ____________________ ________________________________________
____________________ ____________________ ________________________________________
____________________ ____________________ ________________________________________
____________________ ____________________ ________________________________________
____________________ ____________________ ________________________________________
____________________ ____________________ ________________________________________
*The revision is indicated by the letter following the part number given on the bottom of the page.
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9
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NOTES
10 CELL-DYN
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Chapter 1 Search
Book TOC
Go Back
System Description
Chapter Table of Contents
System Components
Analyzer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5
Data Station . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5
Analyzer Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6
Upper Front Cover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6
Lower Front Cover. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7
Status Indicator Panel. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7
Open Sample Aspiration Probe . . . . . . . . . . . . . . . . . . . . . 1-7
Touch Plate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7
Closed Sample Aspiration Module . . . . . . . . . . . . . . . . . . 1-7
Flow Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8
Sample Aspiration Peristaltic Pump . . . . . . . . . . . . . . . . . 1-8
Shear Valve Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8
Wash Block . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8
Syringe Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8
Waste Chambers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9
RBC/PLT Metering Assembly. . . . . . . . . . . . . . . . . . . . . 1-11
RBC/PLT Transducer Assembly . . . . . . . . . . . . . . . . . . . 1-11
HGB Flow Cell Assembly . . . . . . . . . . . . . . . . . . . . . . . . 1-11
WBC Transfer Peristaltic Pump. . . . . . . . . . . . . . . . . . . . 1-11
Overflow Chamber. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-12
WBC Mixing Chamber . . . . . . . . . . . . . . . . . . . . . . . . . . 1-12
HGB Mixing Chamber. . . . . . . . . . . . . . . . . . . . . . . . . . . 1-12
WBC Flow Cell Cover . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-12
Optical Bench Assembly . . . . . . . . . . . . . . . . . . . . . . . . . 1-12
Left Side Panel. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-12
Pinch Valves . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-13
Air Inlet Filters. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-13
Diluent Reservoir . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-13
Sheath Reservoir . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-14
Hemoglobin Lyse Reservoir . . . . . . . . . . . . . . . . . . . . . . 1-14
Normally Closed Valves . . . . . . . . . . . . . . . . . . . . . . . . . 1-14
Analyzer Serial Number Label . . . . . . . . . . . . . . . . . . . . 1-14
Analyzer Power Switch . . . . . . . . . . . . . . . . . . . . . . . . . . 1-14
Auto Sampler Connector . . . . . . . . . . . . . . . . . . . . . . . . . 1-14
Waste Sensor Connector . . . . . . . . . . . . . . . . . . . . . . . . . 1-14
Diluent Inlet Tube Connector . . . . . . . . . . . . . . . . . . . . . 1-14
Sheath Inlet Tube Connector . . . . . . . . . . . . . . . . . . . . . . 1-14
Hemoglobin Lyse Inlet Tube Connector . . . . . . . . . . . . . 1-15
Waste Outlet Tube Connector . . . . . . . . . . . . . . . . . . . . . 1-15
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3000 System Operator’s Manual
9140240E — May 1995
Table of Contents-1
Table of Contents
Table of Contents-2
Search Book TOC Go Back
Chapter 1
Rear Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-15
Fans. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-15
Line Frequency and Voltage Select Switch . . . . . . . . . . .1-15
Fuse. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-15
Analyzer Power Connector. . . . . . . . . . . . . . . . . . . . . . . .1-16
RS-232 Connector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-16
Data Station Connector. . . . . . . . . . . . . . . . . . . . . . . . . . .1-16
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-17
Data Station Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-17
Front Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-18
Video Display Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-18
Soft Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-18
Primary Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-18
Data Station Keyboard . . . . . . . . . . . . . . . . . . . . . . . . . . .1-18
Standard Computer Keyboard . . . . . . . . . . . . . . . . . . . . .1-19
Floppy Disk Drive . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-19
Right Side Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-19
Data Station Serial Number Label . . . . . . . . . . . . . . . . . .1-19
Contrast Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-20
Brightness Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-20
Power Switch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-20
Rear Panel. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-20
Fan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-21
Monitor Video Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-21
External Computer Port . . . . . . . . . . . . . . . . . . . . . . . . . .1-21
Analyzer Port . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-21
Graphics Printer Port . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-21
Ticket Printer Port . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-21
Keyboard Port. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-21
Data Station Power Receptacle. . . . . . . . . . . . . . . . . . . . .1-21
Computer Voltage Selector . . . . . . . . . . . . . . . . . . . . . . .1-21
Power Supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-21
Monitor Power Cord. . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-21
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-22
CELL-DYN Reagents. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-23
Diluent (L/N 99231-01) . . . . . . . . . . . . . . . . . . . . . . . . . .1-23
Hemoglobin Lyse (L/N 99411-01) . . . . . . . . . . . . . . . . . .1-23
Sheath (L/N 99311-01) . . . . . . . . . . . . . . . . . . . . . . . . . . .1-23
Shear Valve Lubricant (L/N 99630-01) . . . . . . . . . . . . . .1-23
Enzymatic Cleaner (L/N 99644-01) . . . . . . . . . . . . . . . . .1-23
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3000 System Operator’s Manual
9140240E — May 1995
Chapter 1
Introduction
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System Description
The CELL-DYN® 3000 is a multi-parameter, automated hematology analyzer designed for in vitro diagnostic use in clinical laboratories. The
Analyzer
Data Station
Analyzer
Pedestal
Sample Loader
Sample Loader Platform
Figure 1.1: CELL-DYN 3000SL
The CELL-DYN 3000SL is equipped with a separate Sample Loader module. The Sample Loader provides continuous automated closed sampling for up to 100 tubes without operator intervention.
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System Description
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Analyzer
Chapter 1
Data Station
Figure 1.2: CELL-DYN 3000CS
The CELL-DYN 3000CS is equipped with a built-in manual closed sample aspiration module referred to as the closed sampler. The closed sampler aspirates blood from a closed collection tube that has been inserted in the sampler module.
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Chapter 1
Intended Use
Search Book TOC Go Back System Description
The CELL-DYN 3000 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
MONO — Monocyte absolute count
%L — Lymphocyte percent
%M — Monocyte percent
EOS — Eosinophil absolute count
BASO — Basophil absolute count
%E — Eosinophil percent
%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
* Clinical significance has not been established for these parameters.
Therefore, they are not reportable.
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System Description
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NOTES
Chapter 1
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System Components
Analyzer Data Station
Figure 1.3: CELL-DYN 3000 System Components
The two main modules of the CELL-DYN 3000 are depicted in Figure
Analyzer
The Analyzer contains the hardware to aspirate, dilute and analyze each whole blood specimen.
Data Station
The Data Station contains the computer, video display monitor and keyboard.
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System Description
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Chapter 1
Analyzer Components
Front Panel
The components visible on the front of the Analyzer are depicted in
Figure 1.4. The functional description of each component follows.
Upper Front Cover
Shear Valve
Viewing Window
Status Indicator
Panel
1-6
Lower Front Cover
Figure 1.4:
Tube
Retainer
Closed Sample
Aspiration Module
Touch Plate
CELL-DYN 3000 Analyzer Front View
Upper Front Cover
The removable upper front cover protects the upper flow panel. It contains a window that allows the operator to view the shear valve. The cover is removed by lifting it up and away from the mounting brackets. A grounding wire provides electrical continuity for shielding purposes.
Disconnect the grounding wire to allow the cover to be placed on top of the instrument. Access to the upper flow panel is necessary to completely view the operation of the upper flow panel components and to perform certain maintenance procedures.
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Chapter 1 Search Book TOC Go Back System Description
Lower Front Cover
The removable lower front cover protects the lower flow panel. To remove the cover, first remove the upper front cover then disconnect the grounding wire from the clip mounted to the flow panel and lift up on the cover to free it from the mounting brackets. Access to the lower flow panel is necessary to view the action of the lower flow panel components and to perform certain maintenance procedures.
Status Indicator Panel
Three status indicator messages (illuminated by green, yellow and red
LEDs) indicate the status of the Analyzer. The status messages are:
• Ready (green light) — the Analyzer is ready to process a specimen
• Busy (yellow light) — the Analyzer is busy with a normal operational sequence
• Fault (red light) — the Analyzer is unable to process specimens due to an existing fault condition
Open Sample Aspiration Probe
The open sample aspiration probe is used to aspirate whole blood from an opened collection tube. The probe moves up into the wash block and remains there whenever the closed mode is selected.
Touch Plate
The touch plate is located directly behind the open sample aspiration probe. Pressing the touch plate starts the selected run cycle. If the closed sampler mode is selected (CELL-DYN 3000CS instrument), the cycle will begin only if a tube has been properly inserted in the holder.
Closed Sample Aspiration Module
The closed sample aspiration module is used to aspirate whole blood from a closed collection tube. It is activated when the closed sampler mode is selected (CELL-DYN 3000CS instrument). The module contains the following components:
• A holder for the closed collection tube
• A tube retainer to correctly position the tube in the holder
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1-7
Flow Panel
• The quick adjust levers which are located on either side of the tube retainer. The levers are used to raise or lower the tube retainer in order to securely hold the collection tube in the proper position
• The interlock switch located in the tube retainer prevents activation of the closed sampler until a collection tube is inserted properly
• A needle that 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 sampler cycle
The major components of the flow panel are depicted in Figure 1.5
functional description of each component follows.
Sample Aspiration Peristaltic Pump
The sample aspiration peristaltic pump is composed of a rotor and pump tube holder. It aspirates whole blood from either an open 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 valve isolates a precise volume of whole blood by means of a shearing action as the front and rear sections rotate.
The aspirated blood is isolated in three separate segments — one for the
WBC dilution, one for the HGB dilution and one for the RBC/PLT dilution.
Wash Block
The wash block rinses the outside of the open sample aspiration probe with Diluent. It air dries the probe and routes the external and internal rinses to the waste chamber.
Syringe Assembly
The syringe assembly contains a set of five syringes. The two HGB syringes are operated by the same stepper motor. The RBC Diluent,
WBC Sheath, and WBC Metering Syringes are each operated by a separate stepper motor.
• RBC Diluent syringe — delivers a specific volume of Diluent to transport the blood from the shear valve to the mixing chamber in the RBC/PLT transducer
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Chapter 1 Search Book TOC Go Back System Description
• HGB Diluent syringe — delivers a specific volume of Diluent to transport the blood from the shear valve to the HGB mixing chamber
• HGB Lyse syringe — dispenses a specific volume of Hemoglobin
Lyse into the HGB Mixing chamber at the same time as the diluted sample is dispensed into the HGB Mixing chamber
• WBC Sheath syringe — delivers a specific volume of Sheath reagent to transport the blood from the shear valve to the WBC
Mixing chamber
• WBC Metering syringe — injects a specific volume of the WBC dilution into the WBC flow cell
Waste Chambers
The waste chambers collect the waste liquid from the Analyzer flow panel.
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System Description
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Chapter 1
Figure 1.5:
1-10
Analyzer Flow Panel Components
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Chapter 1
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Search Book TOC Go Back System Description
RBC/PLT Metering Assembly
The RBC/PLT metering assembly contains a precision-bore glass tube with a set of optical detectors, one upper and one lower, mounted on it. It is used to meter a fixed volume of the RBC/PLT dilution to ensure that an accurate volume is counted during the RBC/PLT measurement portion of each cycle.
RBC/PLT Transducer Assembly
The RBC/PLT transducer assembly contains the fluidics and hardware required for accurate measurement of the diluted red blood cells and platelets. The primary components of this assembly are:
RBC/PLT aperture plate -The aperture is heat embedded into the aperture plate, which is inserted into a slot between the two transducer chambers.
RBC/PLT Transducer - The transducer contains two chambers. The mixing chamber on the left is used to mix the RBC/PLT dilution.
The counting chamber on the right contains the von Behrens plate used to prevent cells that have traversed the aperture from recirculating into the sensing zone.
Electrodes - There are two non-corrosive, electrically conductive plates, one positively charged and one negatively charged. One electrode is located in each transducer chamber. The electrodes conduct a constant current flow through the aperture during the
RBC/PLT measurement portion of each cycle.
HGB Flow Cell Assembly
The HGB flow cell assembly contains the following components:
• A fully enclosed (light-tight), flow-through glass cuvette
• An LED light source
• A bandwidth filter used to obtain the ICSH recommended wavelength of 540 nm
• A photodetector for measuring the light transmitted
WBC Transfer Peristaltic Pump
The WBC transfer peristaltic pump is composed of a rotor and a pump tube holder. It is used to transport the WBC dilution to the WBC flow cell area.
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Left Side Panel
Overflow Chamber
The overflow chamber is used to collect excess fluid from the mixing chambers.
WBC Mixing Chamber
The glass WBC mixing chamber is used to mix the WBC dilution.
HGB Mixing Chamber
The glass HGB mixing chamber is used to mix the HGB dilution.
WBC Flow Cell Cover
The WBC flow cell cover protects the WBC Flow Cell assembly, which contains the fluidics and hardware needed to hydrodynamically focus the
WBC sample stream (diluted WBCs). The primary components of this assembly are:
• Sample feed nozzle — a specifically designed tube used to deliver the WBC dilution into the sheath stream
• WBC flow cell — an optically clear quartz chamber with a central rectangular opening of a specific size, which flares out into a cone at the top of the flow cell
Optical Bench Assembly
The optical bench assembly contains the helium-neon laser, the WBC flow cell, the optics and the detectors required for the enumeration and differentiation of the white blood cells.
The components on the left side panel of the Analyzer are depicted in
. The functional description of each component follows.
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Chapter 1 Search Book TOC Go Back System Description
CELL-DYN
3000 System Operator’s Manual
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Analyzer
Power Switch
Auto
Sampler
Connector
Waste
Sensor
Connector
HGB Lyse
Inlet Tube
Connector
Diluent
Inlet Tube
Connector
Sheath
Inlet Tube
Connector
Pinch Valves
Air Inlet
Filter
Diluent
Reservoir
Sheath
Reservoir
Hemoglobin
Lyse
Reservoir
Air Inlet
Filter
Waste
Outlet Tube
Connector
Figure 1.6:
Analyzer Serial
Number Label
Normally
Closed Valves
Analyzer Left Side Panel Components
Pinch Valves
The pinch valves are used to control pressure and vacuum. The three pinch valves in the top row control the hydraulic pressure to the system.
The three pinch valves in the bottom row control the vacuum used to fill the reagent reservoirs.
Air Inlet Filters
A set of removable panels contains washable air inlet filters that are inserted into the left side panel from the front. The filters clean the air drawn into the Analyzer by the action of air circulation fans located on the rear panel.
Diluent Reservoir
The Diluent reservoir maintains the Diluent supply within the Analyzer.
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System Description
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Chapter 1
Sheath Reservoir
The Sheath reservoir maintains the Sheath reagent supply within the
Analyzer.
Hemoglobin Lyse Reservoir
The Hemoglobin Lyse reservoir maintains the Hemoglobin Lyse supply within the Analyzer.
Normally Closed Valves
The three normally closed valves prevent the reagents in the reservoirs from draining down into the Analyzer when the Analyzer power is turned
OFF.
Analyzer Serial Number Label
This label contains the manufacturer's serial number for the Analyzer.
Analyzer Power Switch
This is the main power switch for the Analyzer. It is used to power the instrument ON and OFF.
Auto Sampler Connector
The Auto Sampler Connector port is used to attach the serial interface cable from the optional Sample Loader.
Waste Sensor Connector
The Waste-Full sensor plug connects to the waste sensor connector port.
When the electrical sensor is tripped, the WASTE FULL message is generated and the READY status is inhibited until the situation is corrected. The Analyzer interprets a disconnected plug the same way as a full waste container. Therefore, if the waste is routed to a drain, a dummy plug must be inserted in the connector.
Diluent Inlet Tube Connector
This color-coded (red) port is used to connect the Diluent inlet tube with its associated cap, sinker and label.
Sheath Inlet Tube Connector
This color-coded (purple) port is used to connect the Sheath inlet tube with its associated cap, sinker and label.
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Chapter 1
Rear Panel
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9140240E — May 1995
Search Book TOC Go Back System Description
Hemoglobin Lyse Inlet Tube Connector
This color-coded (blue) port is used to connect the Hemoglobin Lyse inlet tube with its associated cap, sinker and label.
Waste Outlet Tube Connector
This color-coded (black) port is used to connect the waste outlet tube.
The components visible on the rear panel of the Analyzer are depicted in
Figure 1.7. The functional description of each component follows.
Line Frequency and Voltage
Select Switches
Fuse
Fans
Analyzer
Power
Connector
RS-232
Connector
Data
Station
Connector
Figure 1.7: Analyzer Rear Panel Components
Fans
A set of three fans cools the internal components of the Analyzer.
Line Frequency and Voltage Select Switch
These switches are used to select the line frequency and voltage for the
Analyzer.
Fuse
The AC line fuse protects the Analyzer from excess electrical current.
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System Description
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Chapter 1
Analyzer Power Connector
This receptacle is used to connect the main power cord to the Analyzer.
RS-232 Connector
This port is used by Abbott personnel.
Data Station Connector
This connector is used to attach the cable that provides communication between the Data Station and the Analyzer.
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Data Station
Overview
The Data Station contains the video display monitor, computer and keyboards. The CELL-DYN 3000 operations are controlled by high-speed microprocessors that monitor system status, perform the various analytical routines used by the instrument, perform diagnostic checks and store result data.
Serial data (ASCII format) may be output to a Laboratory Information
System (LIS) through an RS-232 connector. Data may be transmitted either automatically as samples are processed or by command of the operator. Parallel data may be output to an on-line printer.
Data Station Components
The components visible on the front and
right panels of the Data Station
. The full computer keyboard is also
shown.
Video Display Screen
Soft Keys
Primary Keys
Floppy Disk Drive
Data Station Keyboard
Standard Computer
Keyboard
Figure 1.8: Data Station Front Panel Components and Standard
Computer Keyboard
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System Description
Front Panel
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Chapter 1
Video Display Screen
A 14-inch diagonal, high-resolution video display screen with 16-color illumination displays all alphanumeric and graphic data.
Soft Keys
A row of eight unlabeled pressure-sensitive soft keys is located directly below the screen. Each key generates an audible tone when pressed and initiates a function defined by the screen label currently displayed directly above it.
Primary Keys
The pressure-sensitive primary keys are located directly below the soft keys. Each key generates an audible tone when pressed. These keys consist of the following numeric and special function keys:
• Numeric keys — a block of ten numeric keys, labeled from 0 to 9 and a decimal key which are used to enter numeric data
• ENTER key — stores entered numeric data and advances the cursor to the next entry location
• ESC key — allows the operator to escape (abort) data entry before it is completed
• Arrow keys — a set of four keys used to move the cursor in the direction depicted by each arrow
• Page Up key — used to display the previous screen of data that is stored in a log format, eliminating the need to scroll through data lines one by one
• Page Down key — used to display the next screen of data that is stored in a log format, eliminating the need to scroll through data lines one by one
• HELP key — not currently supported
Data Station Keyboard
The Data Station keyboard contains a complete set of pressure-sensitive alphabetic keys. It also contains a Backspace key, an Escape key, an
Enter key, a Comma key and a Space key. The keyboard folds up when it is not in use.
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Right Side Panel
Standard Computer Keyboard
The standard computer keyboard connects to the rear panel of the Data
Station and contains a complete set of alphabetic, numeric and special function keys used for data entry and manipulation. The F1 to F8 function keys on this keyboard correspond to the soft keys on the Data
Station.
Floppy Disk Drive
The floppy disk drive accepts 3.5-inch high-density diskettes. It is used to update the system software program and to download data.
The components located on the right side panel of the Data Station are depicted in Figure 1.9
. The functional description of each component
follows.
Data Station
Serial Number Label
Brightness Control
(Rear)
Contrast Control
(Front)
Power Switch
Figure 1.9: Data Station Right Side Panel Components
Data Station Serial Number Label
This label contains the manufacturer's serial number for the Data Station.
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Rear Panel
Contrast Control
This control adjusts the contrast of the video display screen.
Brightness Control
This control adjusts the brightness of the video display screen.
Power Switch
This is the main power switch for the Data Station.
The components located on the rear panel of the Data Station are depicted in Figure 1.10
. The functional description of each component
follows.
Fan
Monitor
Power Cord
Power Supply
Computer
Voltage
Selector
Monitor
Video
Cable
This Port
Not Used
Monitor Power
Receptacle
Data Station
Power
Receptacle
External
Computer
Port
Graphics
Printer
Port
Keyboard
Port
Video
Connector
Analyzer
Port
Figure 1.10: Data Station Rear Panel Components
Ticket Printer
Port
NOTE: Data Station output port location may vary. Refer to the output port labels on the back of the Data Station for correct connections.
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Chapter 1
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Fan
The fan cools the Data Station.
Monitor Video Cable
The monitor video cable provides video input to the monitor. It connects to the monitor video connector.
External Computer Port
The External Computer Port is used to interface the Data Station to a
Laboratory Information System (LIS).
Analyzer Port
The Analyzer Port is used to connect the cable that provides communication with the Analyzer.
Graphics Printer Port
This port is used to connect the printer cable when the printer is used to print data in a graphics format.
Ticket Printer Port
This port is used to connect the printer cable when the printer is used to print data in a ticket format.
Keyboard Port
This port is used to connect the standard computer keyboard.
Data Station Power Receptacle
This receptacle is used to connect the main power cord to the Data
Station.
Computer Voltage Selector
This switch sets the line voltage compatibility for the Data Station.
Power Supply
Supplies the power to operate the Data Station.
Monitor Power Cord
The monitor power cord supplies power to the monitor. It connects to the monitor power receptacle.
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System Description
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Chapter 1
Printer
Sample Loader
Reagent System
Introduction
The printer is discussed in detail in Chapter 11, Printer .
The Sample Loader is discussed in detail in Chapter 12, Sample Loader .
The reagent system is formulated specifically for the CELL-DYN 3000 instrument flow systems in order to provide optimal system performance.
Use of reagents other than those specified in this manual is not recommended as instrument performance can be affected. Each
CELL-DYN 3000 system is tested at the factory using the specified reagents and all performance claims were generated using these reagents.
Reagents must be stored at room temperature to ensure optimal performance. All reagents should be protected from direct sunlight, extreme heat and freezing during storage. Temperatures below 32°F
(0°C) may cause reagent layering that changes the tonicity and conductivity of the reagents. If any reagent has been frozen, it should not be used.
The reagent inlet tubes have a cap attached that minimizes evaporation and contamination during use. To ensure optimal performance and accurate results, use all reagents within the dating period indicated on the label.
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CELL-DYN Reagents
Diluent (L/N 99231-01)
CELL-DYN Diluent is formulated to:
• Dilute the RBCs, PLTs and Hemoglobin
• Maintain the stable diluted cell volume of each red cell and platelet during the count and sizing portion of the measurement cycle
• Provide acceptable background counts
Hemoglobin Lyse (L/N 99411-01)
CELL-DYN Hemoglobin Lyse is formulated to:
• Rapidly lyse the Red Blood Cells
• Convert hemoglobin to a modified hemiglobincyanide complex that is measurable at 540 nm. (The quaternary ammonium lysate participates as a chromogen.)
Sheath (L/N 99311-01)
CELL-DYN Sheath is formulated to:
• Dilute the WBCs
• Osmotically lyse the red cells
• Maintain the light scattering properties of the WBCs
• Serve as a sheath fluid for the hydrodynamic focusing process
• Provide sufficient wetting action to prevent accumulation of air bubbles in the WBC flow system
• Provide acceptable WBC background count
The following consumables are available:
Shear Valve Lubricant (L/N 99630-01)
CELL-DYN Shear Valve Lubricant is formulated to effectively lubricate the inner surfaces of the shear valve, which ensures smooth rotation and consistent valve alignment.
Enzymatic Cleaner (L/N 99644-01)
CELL-DYN Enzymatic Cleaner is formulated to effectively remove protein build-up within the instrument.
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System Description
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NOTES
Chapter 1
1-24
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Chapter 2 Search Book TOC Go Back
Installation
Chapter Table of Contents
Space Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
Waste Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Power Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Graphics Printer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4
Installation Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4
Ticket Printer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5
Installation Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5
Loading Individual Tickets in the Ticket Printer . . . . . . . 2-7
Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8
Mechanical and Electrical Setup . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8
Fluid Tubing Connection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9
Tube Racks Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-10
Power On . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11
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Table of Contents-1
Table of Contents Search Book TOC Go Back
NOTES
Chapter 2
Table of Contents-2
CELL-DYN
3000 System Operator’s Manual
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Chapter 2
Introduction
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Installation
Installation of the CELL-DYN® 3000 should be performed by an authorized Abbott representative to ensure that all system components are functioning correctly and to verify system performance.
NOTE: Installation of the Analyzer by an unauthorized or untrained person could result in damage to the system and may void the warranty. Never attempt to install the system without an authorized Abbott service representative present.
The remainder of this chapter gives general requirements for a successful
installation. Procedures are also included for installing the printer and
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Installation
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Chapter 2
Initial Preparation
Space Requirements
The instrument is shipped from the factory as follows:
CELL-DYN 3000SL
• Analyzer
• Data Station
• Sample Loader with accessories
• CELL-DYN 3000 Accessory Kit
• Printer
• Reagents, Calibrator, and Controls necessary for installation
CELL-DYN 3000CS
• Analyzer
• Data Station
• CELL-DYN 3000 Accessory Kit
• Printer
• Reagents, Calibrator and Controls necessary for installation
Approximately five linear feet of space is required on the counter top, and sufficient space is required beneath for Diluent, Hemoglobin Lyse,
Sheath, and waste container (if one is used).
Allow six inches of space behind and on the left side of the Analyzer for air flow. A constant circulating internal air stream is required to cool circuitry and components whenever the power is ON. Also allow six inches of space behind the Data Station for air flow. The Data Station may be placed in direct contact with the right side of the Analyzer. If possible, allow 24 inches of space above and to either side of the instrument for service access.
Locate the instrument:
• Away from direct sunlight
• Away from the path of a cooled or heated air outlet
• Far from a centrifuge, x-ray equipment, CRT, video terminal, computer or copier
• Place the reagents below the instrument.
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Chapter 2 Search Book TOC Go Back Installation
• The location should have nonporous, non-absorbing work surfaces and flooring which can be easily cleaned and disinfected using recommended procedures.
Waste Requirements
Allow room for a suitable waste container or position the instrument to permit the waste to be routed directly to a drain. Regulations on permissible substances, and their amounts, for disposal in public sewer systems vary from state to state and even community to community.
Customers are advised to be knowledgeable of all applicable local, state, and federal requirements, and the contents of their effluent streams, before disposal of waste in public sewer systems. Be sure that the waste outlet tube is secured in the drain hole.
Insert the waste full sensor plug (attached to the cap’s electrode wires) into the receptacle on the left side panel of the Analyzer labeled waste sensor. If the waste tube is placed directly into a drain, use a dummy plug in the receptacle, as the WASTE FULL alert will activate if no plug is inserted.
Power Requirements
Be sure that the system is located at the desired site before attempting any connections. Four power outlets are required for the CELL-DYN
3000SL and three are required for the CELL-DYN 3000CS. A grounded power outlet and voltage regulator may be necessary for optimum performance.
Printer Installation
Overview
Remove the printer from its shipping container and visually inspect it for damage. Find a suitable location adjacent to the Data Station. Be sure the printer power switch is in the OFF position. Retain the manuals shipped with the printer and store them in a convenient location.
NOTE: If the printer is placed on top of the Data Station, be sure that the paper does not restrict air flow to the rear panel fans.
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2-3
Graphics Printer
When interfaced with the CELL-DYN 3000, the printer can be configured as either a graphics printer for graphic reports or a ticket printer for blank or pre-printed tickets. The same model printer can be used for either configuration, but if both tickets and graphics reports are required two printers must be installed.
Follow installation instructions carefully to be sure that the printer is
connected to the correct port on the Data Station. (See Figure 2.1
convenience, general instructions are provided for loading individual pre-printed tickets in the ticket printer. For a detailed description of the printer components and operating instructions, refer to the manuals that accompany the printer.
Installation Procedure
To print the graphics report, the printer cable must be connected to the
graphics printer port on the rear of the Data Station .
1.
Assemble the printer as directed in the printer manual.
2.
Make sure that the printer power switch is OFF. Plug the power cord into the back of the printer and plug the other end into a grounded outlet.
3.
Make sure that the power to the Data Station is turned OFF.
Remove the interface cable (which looks like a power cord with two connectors) from the accessory kit and plug one end into the port on the rear of the printer. Fasten the wire clips to the connector for a secure connection.
4.
the connector for a secure connection.
5.
Install the ribbon as directed in the printer manual.
6.
Load the paper as directed in the printer manual.
NOTE: This printer is now configured for use as a graphics printer only. To print tickets, you must connect a printer to the ticket printer port.
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Ticket Printer
IMPORTANT: CELL-DYN 3000 software automatically controls and adjusts most print conditions for the graphics printer, including page width. Occasionally, a few settings may need to be changed in the printer's software for correct operation. If printing is not what you expect, refer to the printer manual for guidance in making adjustments. If you have additional questions or experience any problems, call the
Abbott Customer Support Center for assistance at 1 (800)
CELL DYN or
1 (800) 235-5396 (U.S. customers only).
Installation Procedure
The ticket printer is used to print result data on blank or pre-printed tickets. (Blank tickets are available in continuous tractor-feed sheets.
Pre-printed tickets are loaded individually.)
for customizing either type of printout.
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Graphics
Printer
Port
Ticket Printer
Port
Figure 2.1: Data Station Rear Panel
1.
Assemble the printer as directed in the printer manual.
2.
Make sure that the printer power switch is OFF. Plug the power cord into the back of the printer and plug the other end into a grounded outlet.
3.
Make sure that the power to the Data Station is turned OFF.
Remove the interface cable (which looks like a power cord with two connectors) from the accessory kit and plug one end into the port on the rear of the printer. Fasten the wire clips to the connector for a secure connection.
4.
Plug the other end of the interface cable into the ticket printer port on the Data Station. (See Figure 2.1.) Tighten the screws on the connector for a secure connection.
5.
Install the ribbon as directed in the printer manual.
6.
Load the blank, continuous-feed tickets as directed in the printer
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Chapter 2 Search Book TOC Go Back Installation
Loading Individual Tickets in the Ticket Printer
1.
Be sure that the printer is turned ON and the printer cable is connected to the ticket printer port on the back of the Data Station.
If the connection is incorrect, turn the Data Station power OFF, change the position of the cable and turn the power back ON.
2.
Set the ribbon cartridge headgap lever to adjust for the thickness of the tickets. Refer to the printer manual for detailed instructions.
3.
Move the paper selection lever to the rear position to select single-feed paper.
4.
Open the access cover and be sure the guide wire on the paper separator is pushed back into the locked position.
5.
Raise the separator to its upright position.
6.
Place a ticket on the paper separator and adjust the guides so that they barely touch the edges of the ticket.
7.
Pull the bail lever forward. The ticket will automatically feed into place. Release the bail lever.
8.
Be sure the printer is deselected (SEL indicator is not illuminated) and set the Top of Form by pressing and holding the TOF/QUIET key and pressing the FORM FEED key to move the ticket up or pressing the LINE FEED key to move the ticket down. (The ticket moves in very fine increments so it can be precisely positioned.)
NOTE: The ticket will only move down to a certain point to prevent potential ticket jams. Do not move the top of the page below the paper bail.
9.
Position the ticket so that the lower red line on the paper shield
(located between the print head and the paper) is positioned where the first line of printing should occur.
NOTE: When the top of form is set, the position is retained in the printer memory until it is reset.
10.
Press the SEL key to select the printer. The printer is now ready to print.
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Installation
Sample Loader
Installation
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Chapter 2
A metal pedestal is shipped with the CELL-DYN 3000SL. This pedestal has an attached platform for the Sample Loader. The pedestal is placed under the Analyzer and the Sample Loader is set on the platform.
Data Station
Analyzer
Analyzer Pedestal
Figure 2.2:
Sample Loader
Sample Loader Platform
Analyzer with Sample Loader
Mechanical and Electrical Setup
1.
Unpack the Sample Loader from its shipping container. Place it on the platform as shown in Figure 2.2.
2.
Remove the protective plastic and inspect the module for damage.
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Chapter 2 Search Book TOC Go Back Installation
Fluid Tubing Connection
3.
Remove the power cord from the sample loader accessory kit and inspect the cord and connector for damage. Connect the cord to the power connector on the right side panel. Plug the three- prong end into an available power outlet.
CAUTION: Do not turn the Sample Loader power ON.
Damage may result when the fluid tubing is not connected.
4.
Remove the Sample Loader interface cable (it looks like a power cord with two connectors) from the Sample Loader accessory kit and inspect it for damage. Connect the appropriate end of the cable to the port marked CH1 on the right side panel of the Sample
Loader and secure the screws. Connect the cable’s other end to the connector labeled Auto Sampler, on the left side panel of the
Analyzer. Secure the screws.
1.
Locate the four tubes banded together and extending from the lower front portion of the Analyzer flow panel; one tube is red, one tube is white, one is clear and one is blue.
Sample Aspiration
Tube (Translucent)
Aspiration Rinse
Tube (Clear)
Vent Rinse
Tube (White)
Aspiration
Waste Tube
(Red)
Vent Waste
Tube (Blue)
Figure 2.3: Sample Loader Tubing Connections
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2-9
Tube Racks Setup
2.
Connect the red tube (aspiration waste fluid) connector to the red tube attached to the lower port of the aspiration needle wash block.
3.
Connect the clear tube (aspiration rinse fluid) connector to the clear tube attached to the upper port of the aspiration needle wash block.
4.
Connect the blue tube (vent waste fluid) connector to the blue tube extending from the right side of the tower.
5.
Connect the white tube (vent rinse fluid) connector to the white tube extending from the right side of the tower.
6.
Locate a fifth tube, the translucent silicone tube (sample aspiration), extending from beside the open sample aspiration probe wash block on the Analyzer module.
7.
Then, locate the clear sample aspiration tube attached to the top of the aspiration needle and sticking out of the top of the tower.
8.
Connect these two tubes by inserting the end of the aspiration tube leading from the top of the aspiration needle into the silicone sample aspiration tube.
1.
Remove the 11 tube racks from the Accessory kit and inspect each for damage.
2.
Remove the bar code labels provided for the tube racks and inspect them for damage. Apply bar coded rack ID labels to the indented area on the side of each tube rack between tube positions 1 and 2.
Be sure the labels are positioned in the indentations. Apply the bar coded rack labels to the sides of the tube racks (in the area indicated) by starting at the top and working downward. Label
MUST reside inside recessed area provided. It is suggested that the racks be labeled 1–10 and the end rack be labeled 99.
3.
Apply the rack ID number label as shown in Figure 2.4
recessed area provided on the top of the rack.
4.
On one rack only, apply the end rack sensor label to the indented area on the side of the rack, and apply two end rack visual indicator labels to the indented areas on top of the rack. These labels will identify this rack as the end rack.
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Power On
5.
Place five racks in the open area to the left of the tower and five racks in the open area to the right of the tower. Push all of the right side racks toward the Analyzer. Pull all of the left side racks away from the Analyzer. All ten racks are required to be in place for proper operation.
NOTE: Be sure each rack is placed with its bar coded rack ID label and open slot facing toward the Analyzer.
NOTE: Liquid spills in the rack drive mechanism are a potential reason for failure of the rack to advance. Liquid spills that flow in the Sample Loader Control Panel could cause operational
failure. Notify the Customer Support Center for further
assistance.
Bar Coded
Position
ID Label
Black End Rack Visual Indicator Label
(END RACK ONLY)
Rack ID
Number
Label
Tube
Rack
Bar Coded Rack
ID Label
Orient Numbered End
DOWNWARD
Black End Rack Sensor Label
(END RACK ONLY)
Figure 2.4: Tube Rack Showing Label Placement Location
1.
Turn the Sample Loader power switch on the right side panel to
ON. When the initialization process is complete, the light above the
Sample Loader START key flashes. This indicates that the Sample
Loader is ready to start processing samples. The message AUTO
SAMPLER READY is displayed in the Data Station bulletin line.
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2.
Test Sample Loader operation by running several blood samples. If
3.
Confirm that the background count is acceptable before running
patient samples. (Refer to the Routine Operation section of
Chapter 5, Operating Instructions , for instructions for running background counts .)
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Chapter 3
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Principles of Operation
Chapter Table of Contents
Sample Analysis Cycle Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
Sample Segments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
WBC Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
RBC/PLT Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
Hemoglobin Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
Results Displayed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
Instrument Rinsed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4
WBC Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5
Introduction to Flow Cytometry . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6
Sheath Reagent . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8
Detection with the Optical Bench . . . . . . . . . . . . . . . . . . . . . . . . . 3-8
WBC Differential . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10
Mononuclear-Polymorphonuclear Separation . . . . . . . . . 3-10
Neutrophil-Eosinophil Separation . . . . . . . . . . . . . . . . . . 3-11
Mononuclear Separation . . . . . . . . . . . . . . . . . . . . . . . . . 3-12
Other Scatterplots. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-14
WBC Histograms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-14
MONO-POLY Histogram . . . . . . . . . . . . . . . . . . . . . . . . 3-15
LYM-BASO-MONO Histogram . . . . . . . . . . . . . . . . . . . 3-15
WBC Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-15
WBC Flagging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-16
RBC/PLT Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-17
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-17
Electrical Impedance Measurements . . . . . . . . . . . . . . . . . . . . . 3-17
Coincidence Passage Correction . . . . . . . . . . . . . . . . . . . . . . . . . 3-17
Volumetric Metering . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-18
RBC/PLT Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-19
RBC Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-20
RBC Count. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-20
MCV. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-20
HCT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-21
MCH. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-21
MCHC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-21
RDW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-21
RBC Flagging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-21
Table of Contents-1
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Chapter 3
PLT Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-22
Platelet Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-22
PLT Count . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-23
MPV . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-23
PCT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-23
PDW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-24
Platelet Flagging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-24
Hemoglobin Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-25
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-25
Hemoglobin Measurement Process . . . . . . . . . . . . . . . . . . . . . . .3-25
HGB Parameter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-25
HGB Flagging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-25
Operational Messages and Data Flagging . . . . . . . . . . . . . . . . . . . . .3-26
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-26
Instrument Fault and Status Conditions . . . . . . . . . . . . . . . . . . .3-26
Parameter Flagging Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-27
Dispersional Data Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-28
Suspect Parameter Flags . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-28
WBC Flags . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-29
RBC Flags. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-30
PLT Flags . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-30
Suspect Population Flags . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-31
WBC Flags . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-31
RBC Flags. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-33
PLT Flags . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-33
Interpretive Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-33
Table of Contents-2
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Chapter 3
Overview
Search Book TOC Go Back
Principles of Operation
The principles that the CELL-DYN® 3000 uses to measure, count, and calculate the hematologic parameters are discussed generally in the first section of this chapter. The parameters will be discussed individually and a detailed explanation of the theory used for parameter derivation in each of the three methods will be given in the last section.
The three independent measurement channels used in the
CELL-DYN 3000 are:
• The optical channel for determining the WBC count and differential data
• The impedance channel for determining the RBC and PLT data
• The Hemoglobin channel for determining the HGB data
During each instrument cycle, the sample is aspirated, diluted and mixed, and the measurements for each parameter are performed.
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3-1
Sample Aspiration
There are two modes of whole blood sample aspiration on the CELL-
DYN 3000. The operator selects the mode of aspiration from the Data
• The open sampler mode is used to aspirate the sample from a collection tube that has been opened and is held under the open sample aspiration probe.
• The manual closed sampler or automated Sample Loader mode is used to aspirate the blood directly from a collection tube by piercing the tube stopper.
The aspiration volumes are:
• Open Mode 170 µL ± 5%
• Closed Mode (CS) 230 µL ± 5%
• Sample Loader (SL) 350 µL ± 5%
Once the mode of aspiration is selected, the whole blood sample is aspirated into the Analyzer by the sample aspiration peristaltic pump.
The pump aspirates the sample through the shear valve. An optical sensor checks the integrity of the sample.
Sample Analysis Cycle Overview
NOTE: Sample and reagent volumes given in this section are stated as the nominal values. Slight differences between instruments may cause these volumes to vary. These differences are compensated for by factory-set internal dilution factors.
Sample Segments
The shear valve rotates in order to isolate three segments of the whole blood sample which has been aspirated through it. The segments are:
32 µL for the WBC dilution
0.64 µL for the RBC/PLT dilution
12 µL for the HGB dilution
WBC Analysis
1.
The WBC Sheath syringe dispenses 1.6 mL of WBC Sheath reagent through the shear valve where it picks up the 32 µL WBC segment.
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RBC/PLT Analysis
Hemoglobin Analysis
Results Displayed
2.
The sample segment and sheath are then routed to the WBC mixing chamber where the dilution is bubble mixed. The final dilution is
1:51.
3.
The action of the WBC peristaltic pump transfers the WBC dilution from the WBC mixing chamber to the sample feed nozzle in the
WBC flow cell.
4.
The WBC metering syringe injects 78 µL of the WBC dilution into the flow cell sheath stream.
5.
A laser beam is focused on the flow cell. As the sample stream intersects the laser beam, the light scattered by the cells is measured at four different angles.
1.
The RBC Diluent syringe dispenses 8.0 mL of Diluent through the shear valve, where it picks up the 0.64 µL RBC/PLT segment.
2.
The sample segment and diluent are then routed to the mixing chamber of the RBC/PLT transducer assembly, where the dilution is bubble mixed. The final dilution is 1:12,501.
3.
The dilution is pulled through the aperture by vacuum. The volumetric metering process ensures that 100 µL of the dilution are used for the measurement. Electrical impedance is used to count the RBCs and PLTs as they traverse the aperture.
1.
The 12 µL HGB sample segment is transported by 1.5 mL of
Diluent and 1.5 mL Hemoglobin Lyse reagent to the HGB mixing chamber. The 1:251 dilution is bubble mixed, then transferred to the HGB flow cell.
2.
In the flow cell, the absorbance of the sample is read at 540 nm.
The absorbance is directly proportional to the HGB concentration of the sample.
The flow cell is drained and filled with Hemoglobin Lyse reagent for a blank (reference) reading.
All data is transmitted to the Data Station for analysis. Results are
computed for all parameters and are displayed on the Data Station RUN
Screen . Results are also stored in a log format called the
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Principles of Operation
Instrument Rinsed
Search Book TOC Go Back
Chapter 3
1.
The open sample aspiration probe is rinsed internally and externally with Diluent.
2.
The needle used in either closed mode is rinsed internally and externally with Diluent.
3.
The WBC mixing chamber and WBC flow cell are rinsed with
Sheath.
4.
The RBC/PLT transducer assembly is rinsed with Diluent.
5.
The RBC/PLT metering tube is coated with Hemoglobin Lyse.
6.
The HGB mixing chamber and HGB flow cell are rinsed with
Hemoglobin Lyse.
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WBC Measurement
Overview
This section gives an overview of the WBC measurement. The details are
discussed in the sections covering the optical bench and the
The optical channel is used for the determination of WBC data. A 1:51 dilution of the sample is made with the Sheath reagent. The WBC metering syringe injects a metered volume of this dilution into the sheath stream. The sample stream is then hydrodynamically focused to align the cells in single file as they pass through the WBC flow cell, which is an optically clear quartz chamber. A vertically polarized helium neon laser is the light source.
The instrument measures the traditional forward angle light scatter (1—
3
°
, referred to as 0
°
) and orthogonal light scatter
(70—110
°
, referred to as 90
°
) parameters. Two additional scatters, narrow-angle light scatter (7—11
°
, referred to as 10
°
) and ninety-degree depolarized scatter (70—110
°
, referred to as 90
°
D), are measured. This is referred to as MAPSS™ (for multi-angle polarized scatter separation) technology. Various combinations of these four measurements are used to classify the WBC subpopulations and provide morphological flagging.
The WBC count is determined by enumerating the number of occurrences above the computer-generated threshold in the 0
°
channel.
The information from all four measurements is used to differentiate the
WBCs into five subpopulations:
Neutrophils
Lymphocytes
Monocytes
Eosinophils
Basophils
The WBC data is presented graphically as scatterplots. It may also be presented in two histograms at operator request.
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Introduction to Flow Cytometry
The CELL-DYN 3000 uses flow cytometric techniques to analyze the
WBC subpopulations. This section gives a brief introduction to the
principles of flow cytometry .
2
“Flow cytometry is a process in which individual cells or other biological particles are made to pass in single file in a fluid stream by a sensor or
sensors which measure physical or chemical characteristics of the cells or particles .”
3
Flow cytometry enables the rapid screening of large numbers of cells beyond the capability of traditional methods and provides quantitative cell analysis at the single-cell level. The basic components of a flow cytometer include:
A sample collector and transporter
A flow system
A light source and focusing optics
Signal detectors
Data collection and storage
Data analysis and display
In a flow cytometer, the cell suspension is pumped from the specimen container through a sample tube into a special flow chamber with a small opening at the tip. The suspension is then injected into a stream of fastmoving, cell-free liquid (sheath fluid). Since the two liquids travel at different rates of speed, they do not intermingle. This is called laminar flow. The special geometry of the flow cell and the flow rate of the sheath fluid forces the cells into single file. This process is known as
hydrodynamic focusing. (See Figure 3.1
for a drawing of the WBC flow cell .)
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Various Angles of Scattered Light
Focused
Laser Beam
Sample Stream
Sheath Stream
Sample
Feed Nozzle
Figure 3.1: WBC Flow Cell
As the cells enter the flow laser intercept area they scatter the laser light at different angles, yielding information about cell size, internal structure, granularity and surface morphology. The optical signals the cells generate are detected and converted to electrical impulses which are then stored and analyzed by the computer.
Flow cytometers generally measure two angles of scatter. Forward angle light scatter is roughly a measure of cell size. Right angle (orthogonal) light scatter is primarily a measurement of internal granularity.
Combining the information from the two scatter measurements provides more accurate discrimination between cell populations than either single
for an example of the light scatter
measured by the CELL-DYN 3000.)
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Focused
Laser Beam
0
°
Scatter
10
°
Scatter
Various Angles of Scattered Light
90
°
Scatter
90
°
D Scatter
Figure 3.2: WBC Light Scatter
Sheath Reagent
The Sheath reagent is an integral part of the WBC analysis. White blood cells diluted in the Sheath reagent maintain cellular integrity close to their native state. The structure of the basophils changes slightly due to the water soluble nature of the basophilic granules.
The RBCs are also altered by the Sheath reagent. The RBCs are ruptured by hypo-osmotic shock. The RBC ghosts have the same refractive index as the Sheath reagent, thereby rendering them invisible to the laser.
Detection with the Optical Bench
optical bench is to detect the light scattered by the cells as they pass through the flow cell. The detection process is discussed in this section.
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Chapter 3
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Search Book TOC Go Back Principles of Operation
The light source is a vertically polarized 5 mW helium-neon laser with a wavelength of 632.8 nm. The laser beam passes through a cylindrical lens which changes the shape from a circle to an ellipse. The beam is then directed through a 125 µm slit which blocks the weaker outer edges.
This process yields a uniformly intense beam approximately 80 µm wide.
Consequently, the cell stream may wander slightly in the flow cell and yet still be exposed to the same light intensity. An imaging lens centers the focused laser beam onto the quartz flow cell.
The WBC metering syringe slowly injects 78 µL of the WBC dilution into the sheath stream in the WBC flow cell. The sample is hydrodynamically focused into a small stream approximately 30 µm in diameter. This focused stream aligns the diluted cells in single file as they pass through the sensing region, which allows them to be analyzed one at a time.
90
°
Light
Scatter
PMT
Front
Surface
Mirror
Cylindrical
Lens
700
µ m
Slit
90
°
Depolarized
Light Scatter
PMT Polarizer
(Horizontal)
Helium-Neon Laser
(632.8 nm) Polarized
Vertically
Beam
Splitter
10
°
Light
Scatter
Photodiode
Front
Surface
Mirror
125
µ m
Vertical
Slit
Imaging
Lens
WBC
Flow
Cell
Obscuration
Bar Perforated
Mirror
0
°
Light
Scatter
Photodiode
Optical Bench Figure 3.3:
Since the average WBC is much smaller than the focused laser beam, the cells do not scatter much laser light. If the remaining so-called axial light were allowed to reach the 0
°
detector, it would saturate the electronics.
Therefore, it is blocked from the detector by the obscuration bar. The forward angle scatter is directed to a perforated mirror. The 0
°
light scatter passes through the mirror to the 0
° photodiode detector. The 10
° light scatter is deflected off the mirror to the 10
° photodiode detector.
3-9
WBC Differential
The orthogonal scatter is directed through a 700 µm slit which blocks the scatter from the walls of the flow cell. A beam splitter then separates the orthogonal light scatter into two portions. One portion of the light is directed to the 90
° photomultiplier tube (PMT). The remaining light is directed through a horizontal polarizer. Only light that has changed polarization (depolarized) can pass through the polarizer to the 90
°
D
PMT. (PMTs are used because relatively little light is scattered at this high angle.)
The light signals collected by each detector are converted into electrical signals or pulses. The pulses are digitized based on intensity and sorted into 256 channels for each angle of light measured.
If a pulse falls above the hardware threshold (channel 23) in the 0
° detector, the cell counter counts the pulse and stores it for further evaluation. Pulses that fall below this threshold are not included in the count and therefore, are not included in the differential. If this raw count is estimated to be below a predetermined value, the instrument automatically continues to count WBCs for an extended count period.
The results from the two count periods are averaged.
The information from each detector is collected in list mode. This format stores the channel information from each of the four dimensions. The data is then used to determine the differential. Data can be stored in the list mode format. This data may be reconstructed into scatterplots at any time or analyzed by different algorithms as revisions are made.
The light scatter information is graphically presented in the form of dots on a scatterplot. (Data can also be presented in histograms, which are operator selectable.) The dots are plotted at a point determined by the intersection of the channel information designated on the X and Y axes.
For example, if a cell falls in channel 50 on the X axis and channel 50 on the Y axis, it is plotted at the intersecting point of the two channels.
The scatter information may be plotted in various combinations to yield different information.
Mononuclear-Polymorphonuclear Separation
The scatter information is plotted with the 90
°
scatter on the Y axis and the 10
°
scatter on the X axis. (The 90
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Two populations of cells are clearly seen on the display. The mononuclear cells fall in the cluster in the lower left corner of the scatterplot and the polymorphonuclear cells fall in the cluster above and to the right of them.
The instrument uses a dynamic threshold to determine the best separation between the two populations. Each cell is then identified as a MONO or a
POLY. Once each cell is identified, it retains this classification no matter where it appears on other scatterplots.
10
º
Complexity
Figure 3.4: Mononuclear-Polymorphonuclear Scatter
Neutrophil-Eosinophil Separation
The scatter information is plotted with the 90
°
D scatter on the Y axis and the 90
°
scatter on the X axis. (The 90
.) This scatterplot separates the polymorphonuclear cells. The
mononuclear cells have been identified and therefore do not interfere in the further classification of the polymorphonuclear cells.
Two populations of polymorphonuclear cells are clearly seen on the display. The neutrophils fall in the lower of the two clusters. The eosinophils fall in the upper cluster. The instrument uses a dynamic threshold to determine the best separation between the two populations.
Each cell is then classified as a NEUT or an EOS.
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All cells scatter a certain amount of 90
°
D light. The eosinophils scatter more 90
°
D light than any of the other cells because of the unique nature of granules they contain. This property of the eosinophils is used to positively identify them and thus clearly differentiate them from the neutrophil population.
90
°
Orthogonal
Figure 3.5: Neutrophil-Eosinophil Scatter
Mononuclear Separation
The scatter information is plotted with the 0
°
scatter on the Y axis and the 10
°
.) The mononuclear cells are plotted on this scatterplot. The
algorithm also uses the orientation of the neutrophil cluster to aid in classifying the mononuclears. Three populations of mononuclear cells are clearly seen on the display.
There are three populations of mononuclears because basophils are included in the mononuclear cluster. Typically, basophils are granulated cells and therefore more complex than the mononuclear cells. However, the basophilic granules are water soluble and dissolve in the Sheath reagent. Consequently, the degranulated basophil becomes a less complex cell that falls into the mononuclear cluster.
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Chapter 3 Search Book TOC Go Back Principles of Operation
The lymphocytes fall in the lowest large cluster. (The small population of cells below the lymphocytes contains particles that are unlikely to be
WBCs.) The basophils fall in the cluster above and slightly to the right of the lymphocytes. The monocytes fall in the cluster above the lymphocytes and basophils. The instrument uses dynamic thresholds to determine the best separation between the three main populations. Each cell is then classified as a LYMPH, a MONO or a BASO.
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10
°
Complexity
Mononuclear Scatter Figure 3.6:
Finally, the instrument evaluates the area below the lymphocyte cluster but above the hardware threshold (channel 23). Any particles that fall in this area are separated from the lymphocytes by a dynamic threshold.
The following cell types may be present in this region:
NRBCs
Unlysed RBCs
Giant PLTs
PLT clumps
All particles in this region are excluded from the WBC count and the differential.
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Other Scatterplots
90
°
/0
°
The scatter information is plotted with the 90
°
scatter on the Y axis and the 0
° scatter on the X axis.
90
°
D/0
°
The scatter information is plotted with the 90
°
D scatter on the Y axis and the 0
° scatter on the X axis.
90
°
D/10
°
The scatter information is plotted with the 90
°
D scatter on the Y axis and the 10
° scatter on the X axis.
All scatterplots may be displayed and printed at operator request.
WBC Histograms
The CELL-DYN 3000 can present the WBC scatter information as two histograms . (See Figure 3.7
.) These histograms may be displayed and
printed at the operator's request.
MONO-POLY LYM-BASO-MONO
Figure 3.7: WBC Histograms
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WBC Parameters
MONO-POLY Histogram
The scatter information is plotted in a histogram format with the relative number of cells on the Y axis and the mononuclear and polymorphonuclear size distribution data on the X axis.
LYM-BASO-MONO Histogram
The scatter information is plotted in a histogram format with the relative number of cells on the Y axis and the lymphocyte, basophil and monocyte size distribution data on the X axis.
The WBC data is generally displayed as depicted in Figure 3.8
numeric and graphic data are automatically displayed on the Data Station
RUN Screen in the format selected. After the WBC scatter information
has been plotted and the cells have been classified into the five subpopulations, the instrument determines the WBC count by enumerating the pulses above the dynamic threshold in the 0
° channel.
The algorithms then determine the WBC and the percent of cells in each subpopulation.
Figure 3.8: WBC Data and Scatterplots
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WBC Flagging
Once the WBC count is determined, the absolute number of cells in each subpopulation is calculated by multiplying that WBC count by the percentage. The results are expressed as follows:
WBC # x 10
3
/µL
NEU # x 10
3
/µL and %
LYM # x 10
3
/µL and %
MONO # x 10
3
/µL and %
EOS # x 10
3
/µL and %
BASO # x 10
3
/µL and %
The WBC subpopulations are further identified by the following colors:
Neutrophils — yellow
Lymphocytes — blue
Monocytes — magenta
Eosinophils — green
Basophils — white
The WBC scatter information is usually displayed in two scatterplots as shown in Figure 3.8
SIZE/COMPLEXITY: The size (0
°
scatter) information is plotted on the Y axis and the complexity (10
° scatter) information is plotted on the X axis.
DEPOL/ORTHOGONAL: The granularity (Depol 90
°
D scatter) information is plotted on the Y axis and the lobularity (Orthogonal 90
°
scatter) information is plotted on the
X axis.
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RBC/PLT Measurement
Overview
An impedance channel is used for the determination of RBC and PLT data. A 1:12,501 dilution of the sample is made with the Diluent. The cells are counted and sized using the Impedance method as they pass through the 60 x 72 µm aperture in the RBC/PLT transducer assembly.
Dynamic thresholding separates the PLTs from the RBCs. The 100 µL volume of sample dilution that is analyzed is precisely regulated by the
RBC/PLT metering assembly. Data is collected in 256 channels for both
RBCs and PLTs.
Electrical Impedance Measurements
RBCs and PLTs are counted and sized by the aperture impedance method. This method is based on the measurement of changes in electrical current which are produced by a particle, suspended in a conductive liquid, as it passes through an aperture of known dimensions.
An electrode is submerged in the liquid on either side of the aperture in order to create an electrical pathway through it.
As each particle passes through the aperture, a transitory change in the resistance between the electrodes is produced. This change produces a measurable electrical pulse. The number of pulses generated is indicative of the number of particles that traversed the aperture. The amplitude of each pulse is essentially proportional to the volume of the particle that produced it.
Each pulse is amplified and compared to internal reference voltage channels. These channels are delineated by calibrated size discriminators to accept only pulses of a certain amplitude. Thus, the pulses are sorted into various size channels according to their amplitude.
Coincidence Passage Correction
Two or more cells can enter the aperture sensing zone simultaneously during a measurement cycle. The resistance change created in this situation generates a single pulse with a high amplitude and increased pulse area. Thus, it appears that one large cell has passed through the aperture. Consequently, the cell count is falsely decreased. This count reduction, referred to as coincidence passage loss, is statistically predictable because it has a direct relationship to the effective volume of the aperture and the amount of dilution. Each total cell count for RBCs and PLTs is automatically corrected for coincidence passage loss.
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RER
Volumetric Metering
The RER (red cell editing ratio) is a process of pulse editing that is applied to the RBC pulses before the MCV is derived. The instrument compensates for the aberrant pulses produced by the non-axial passage of the RBCs through the aperture. These pulses are included in the RBC count but eliminated from the RBC sizing determination.
The CELL-DYN 3000 utilizes the volumetric metering process to regulate the count cycle and ensure that a precise volume of sample is used for the RBC/PLT measurement.
the detectors is set to precisely measure 100 µL. Hemoglobin Lyse is added to the metering tube to create a meniscus. When the RBC/PLT cycle is initiated, the liquid flows down the metering tube.
Meniscus
Upper Detector
(count initiated)
Count
Volume
Figure 3.9: Volumetric Metering
Lower Detector
(count completed)
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RBC/PLT Measurement
The count portion of the cycle is initiated when the meniscus reaches the upper detector. The count cycle stops when the meniscus reaches the lower detector. The amount of time required for the meniscus to travel from the upper to the lower detector is called the RBC count time. The computer also monitors the time it takes the meniscus to reach the upper detector once the RBC/PLT cycle is initiated. This is called the RBC upper metering time. (For convenience, these times are referred to as
“RBC” times. Both times actually monitor the RBC/PLT metering process.)
The RBC count time (CNT) and the RBC upper metering time (UMT) are automatically monitored to detect variation from the expected values.
Variation may be caused by debris in the aperture, vacuum fluctuation or air bubbles in the metering tube. If significant variation is detected, the
bulletin line on the Data Station RUN Screen displays the message RBC
METERING FAULT-CLOG or FLOW ERROR and the RBC and PLT data are suppressed.
At the end of each cycle, the RBC count time is displayed on the Data
Station RUN Screen to the right of the MPV result. If an RBC metering
fault was detected, one of two messages is displayed and printed: the
RBC CLOG message if either time is too slow or the RBC FLOW
ERROR message if either time is too fast. Both the RBC upper metering
time (UMT) and the RBC count time (CNT) are displayed and printed when an RBC metering fault occurs.
The 1:12,501 RBC/PLT dilution is delivered to the mixing chamber in the RBC/PLT transducer assembly where it is bubble mixed. A 100 µL metered volume of the dilution is drawn through the 60 x 72 µm aperture by vacuum. The RBCs and PLTs are counted by impedance. If the pulse generated is above the PLT lower threshold (1 fL), it is counted as a PLT.
If the pulse generated is above the RBC lower threshold (35 fL), it is counted as an RBC. There are 256 size channels for each of the parameters, each RBC size channel being equivalent to 1 fL and each
PLT size channel being equivalent to 0.137 fL.
The von Behrens Plate located in the RBC/PLT transducer counting chamber minimizes the effect of recirculating cells. As cells exit from the aperture, they tend to swirl around and may re-enter the sensing zone and be counted a second time, causing the counts to be falsely elevated.
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RBC Parameters
The RBC count is corrected for coincidence and the pulses are edited by the RER before the MCV is derived. The PLT pulses are analyzed by the
PLT algorithm as discussed in the PLT measurement section.
All numeric and frequency size distribution data are automatically
displayed on the Data Station RUN Screen in the format selected. The
size distribution data for the red cells is displayed graphically as a histogram. The size distribution data is plotted on the X axis. The relative number of cells is normalized and plotted on the Y axis. The RBC data are shown in Figure 3.10.
Figure 3.10: RBC Data and Histogram
RBC Count
The Red Blood Cell (RBC) count is directly measured, gives the number of RBCs and is expressed as follows:
RBC = # x 10
6
/µL
MCV
The Mean Corpuscular Volume (MCV) is the average volume of the individual red blood cells. The MCV is derived from the RBC size distribution data and is expressed in femtoliters.
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HCT
The Hematocrit (HCT) is the ratio of red blood cells to plasma and is expressed as a percentage of the whole blood volume. The HCT is calculated from the red blood cell count and the mean cell volume as follows:
HCT = (RBC x MCV)/10
MCH
The Mean Corpuscular Hemoglobin (MCH) is the average weight of hemoglobin contained in the red blood cell expressed in picograms. The
MCH is calculated from the RBC and the HGB as follows:
MCH = (HGB/RBC) x 10
MCHC
The Mean Corpuscular Hemoglobin concentration (MCHC) is the ratio of the weight of hemoglobin to the volume of the average red blood cell expressed in grams per deciliter. It is calculated from the HGB and the
HCT as follows:
MCHC = (HGB/HCT) x 100
RDW
Red Cell Distribution Width (RDW) is a measure of the heterogeneity of the RBC population. RDW is a coefficient of variation of the MCV expressed as a percent (%). The RDW is derived from the RBC histogram using the 20th and 80th percentiles.
RBC Flagging
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PLT Measurement
Platelet Parameters
Pulses counted in the RBC/PLT dilution between 1 and 35 fL are included in the PLT data. If the raw PLT count is estimated to be below a predetermined value, the instrument automatically continues to count
PLTs for an extended count period. The results from the two count periods are averaged. The PLT data is plotted as a histogram. An algorithm analyzes the histogram to eliminate interference and thus determine the lower and upper thresholds for the count.
If no interference is detected, the lower and upper thresholds are set at 2 and 30 fL respectively. If interference is detected, the thresholds float to determine the best separation between the interference and the PLT population. The lower threshold floats in the 1–3 fL region and the upper threshold floats in the 15–35 fL region. Once the thresholds have been determined, the PLT count is derived from the data between them.
Interference in the upper threshold region is generally caused by microcytic RBCs. Therefore, after the PLT upper threshold has been determined, the data between it and the RBC lower threshold is reevaluated. If the PLT upper threshold is less than 35 fL, the counts above it (but less than the RBC lower threshold) are added to the RBC count.
If the interference in either threshold region exceeds a predetermined limit, the PLT count is flagged accordingly. The flags are discussed in the last section of this chapter.
All numeric and frequency size distribution data are automatically displayed on the Data Station RUN Screen in the format selected. The size distribution data for the platelets is displayed graphically as a histogram with the size distribution data plotted on the X axis and the
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Figure 3.11: PLT Data and Histogram
PLT Count
The Platelet count is derived from the PLT histogram after the PLT data has been analyzed by the platelet algorithm. The PLT count is expressed as follows:
PLT = # x 10
3
/µL
MPV
The Mean Platelet Volume (MPV) is derived from the PLT histogram after the PLT count has been determined. The MPV is expressed in femtoliters.
PCT
The Plateletcrit (PCT) is the product of PLT and MPV and is analogous to the hematocrit. It is expressed in percent and is calculated as follows:
PCT = (PLT x MPV)/10
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Platelet Flagging
PDW
Platelet Distribution Width (PDW) is a measure of the heterogeneity of the PLT population. It is expressed as the geometric standard deviation.
NOTE: PCT and PDW are not reportable parameters.
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Hemoglobin Measurement
Overview
The HGB channel is used for the colorimetric determination of
Hemoglobin.
A 1:251 dilution of the sample is made with the diluent and the
Hemoglobin Lyse reagent in the HGB mixing chamber. The HGB concentration is measured using a modified hemiglobincyanide method.
A filtered LED with a wavelength of 540 nm is the light source. A photodetector measures the light that is transmitted.
Hemoglobin Measurement Process
The Hemoglobin Lyse reagent lyses the diluted red blood cells and converts the Hemoglobin that is released to a cyanide-containing pigment. The sample is transferred to the Hemoglobin flow cell where the Hemoglobin concentration is measured. The sample enters the flow cell from the bottom. This allows any bubbles present to float to the surface so they will not interfere with the reading.
The LED shines through the flow cell and a 540 nm narrow bandwidth filter onto a photodetector. The Hemoglobin concentration is directly proportional to the absorbance of the sample at 540 nm. Five separate
HGB readings are made on each sample and averaged to give the final
HGB sample reading. After the Hemoglobin readings have been made, the HGB flow cell is rinsed with Hemoglobin Lyse.
The rinse is drained and more HGB Lyse reagent is delivered to the HGB flow cell. A zero or blank reading is then obtained on the reagent to provide a reference to which the sample signal is compared. Five separate blank readings are made on each sample and averaged to give the final HGB reference reading.
The reference and sample readings are compared to determine the HGB concentration of the sample. The HGB result is expressed in grams of
Hemoglobin per deciliter of whole blood.
HGB Parameter
The Hemoglobin is directly measured and is expressed in grams of
Hemoglobin per deciliter of whole blood.
HGB Flagging
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Operational Messages and Data Flagging
Overview
Operational messages and data flags appear on the Data Station RUN
Screen , on printed reports and can be transmitted to a laboratory
computer system. The CELL-DYN 3000 monitors conditions and data criteria that may affect the displayed results and these messages and flags are used to alert the operator. Instructions for interpreting all flags, numeric, scatterplot and histogram data should be incorporated into the laboratory’s procedure and used to determine the need for further action and/or review of results. Messages are divided into the following categories:
Instrument Messages:
• Fault Conditions
• Status Conditions
Parameter Flagging Messages:
• Dispersional Data Alerts
• Suspect Parameter Flags
• Suspect Population Flags
• Interpretive Messages
Detailed descriptions of the messages in each of the categories are given in this section.
Instrument Fault and Status Conditions
The instrument fault and status conditions are discussed in detail in the
Troubleshooting Guide . These messages are displayed when the
instrument detects an inappropriate condition during specimen processing. When necessary, data is suppressed. When any of these
messages is displayed, refer to the Troubleshooting Guide for assistance.
Follow the instructions given and take the appropriate corrective action.
When the problem is corrected, repeat the specimen. If the problem cannot be corrected, contact the Abbott Customer Support Center for assistance at
1 (800) CELL DYN.
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Chapter 3 Search Book TOC Go Back Principles of Operation
Parameter Flagging Messages
Table 3.1 summarizes all of the parameter flagging messages by parameter and category. Detailed descriptions of the messages are given on the following pages.
Table 3.1: Parameter Flagging Messages
Parameter
WBC
Differential
NEU
LYM
MONO
EOS
BASO
RBC
HGB
MCV
RDW
PLT
MPV
Dispersional Data Alerts
Result displays in yellow if below lower limit
Result displays in magenta if above upper limit
Result underlined on graphics printout when limits exceeded
Result underlined on blank ticket when limits exceeded
Result marked with asterisk
(*) on preprinted ticket when results exceeded
Same as WBC
Suspect
Parameter
Flags
WBC
DIFF
(NLMEB)
Suspect
Population
Flags
Same as WBC
Same as WBC
RBC
HGB
LRI
URI
LURI
PLT
Interpretive
Messages
Leukopenia
Leukocytosis
BAND
IG
BLAST
VAR L
Neutropenia
Neutrophilia
Lymphopenia
Lymphocytosis
Monocytosis
Eosinophilia
Basophilia
RBC MORPH
NRBC
MPV
Suppressed
(not displayed or printed)
Anemia
Polycythemia
Microcytic RBC
Macrocytic RBC
Hypochromic
Hyperchromic
Anisocytosis
Thrombocytopenia
Thrombocytosis
Microcytic PLT
Macrocytic PLT
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Principles of Operation
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Chapter 3
Dispersional Data Alerts
These alerts are triggered by the numeric limits entered into the four
patient limit sets (see the Set Up Instructions section of Chapter 5 ,
Operating Instructions , for an explanation). If results for a parameter
exceed these limits, they are flagged on the screen and on the report.
Dispersional alerts are displayed or printed as follows:
Screen display: Result below lower limit shown in yellow
Result above upper limit shown in magenta
Results outside limits are underlined Graphic Report:
Blank Ticket: Results outside limits are underlined
Preprinted Ticket: Results outside limits are marked with an asterisk
Display and Print
Capacity Exceeded: Result displayed and printed as >>>
Specimens with results that exceed the linearity should be diluted with
Diluent according to the laboratory’s procedure and repeated. (Be sure to correct the results for the dilution factor used.)
NOTE: MCV, MCH, MCHC and MPV are unaffected by dilution.
CAUTION: When entering limits into the four patient limit sets, ensure that the upper and lower limits for each parameter
DO NOT EXCEED the Linearity Specifications, Chapter 4,
. This will ensure that any value that exceeds these
limits will be flagged for further review.
Suspect Parameter Flags
These flags are generated after the instrument evaluates the measured data for a particular parameter or group of parameters. The result may be suspect due to interfering substances or the inability of the instrument to measure a particular parameter due to a sample abnormality. The name of each flag, the location of the flag on the display, the cause of the flag and action to be taken are given in the following explanations.
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WBC Flags
WBC — displayed next to the WBC result
Cause:
1.
The count in a predefined region below the lymphocyte cluster on the size/complexity (0
°
/10
°
) scatterplot is >10% of the total WBC count.
2.
The count rate monitoring shows a decline in the count rate.
3.
The lymphocyte percent is greater than 60% and the position of the lymphocyte cluster is below a predefined region on the size/ complexity (0
°
/10
°
) scatterplot.
Action: Review a stained smear for the presence of NRBCs. Verify the
WBC count by an alternate method.
NOTE: When the WBC and NRBC flags are set concurrently,
RBCs resistant to the lytic action of the Sheath reagent may be present. Repeat the sample using the Resistant RBC specimen type. Specimens with suspected fragile WBC populations should not be run in the Resistant RBC mode.
DIFF (NLMEB) — displayed next to the BASO result
Cause:
1.
A default (preset) value or threshold was used to determine the five-part differential. This is typically due to the presence of abnormal cell clusters that the instrument cannot reliably discriminate between and therefore, a default threshold is selected.
The flag may also be caused by an abnormally low number of cells in a specific subpopulation.
2.
A declining kinetic rate for WBC.
Action: Examine a stained smear to verify the differential values.
NOTE: The DIFF flag is always accompanied by additional descriptive information, NLMEB, in parentheses. These letters indicate which subpopulation or group of subpopulations is suspect when the DIFF flag is displayed. (N=Neutrophils,
L=Lymphocytes, M=Monocytes, E=Eosinophils, B=Basophils.)
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RBC Flags
RBC
HGB — displayed next to RBC and HGB results (RBC and HGB are always displayed together)
Cause: The relationship of the RBC and the HGB data do not meet expected criteria.
Action: Repeat the sample. If the flag remains, verify the RBC and
HGB results.
PLT Flags
LRI (Lower Region Interference) — displayed next to the MPV result
Cause: Interference in the lower threshold region (1–3 fL) of the PLT histogram is greater than a predetermined limit. This is generally non-biologic interference. The flag may be caused by:
Debris (dirty aperture)
Contaminated reagent
Electronic noise
Microbubbles
Action:
within limits, repeat the specimen. If the flag persists, review a stained smear to determine the cause of the interference and confirm the PLT count.
URI (Upper Region Interference) — displayed next to the MPV result
Cause: Interference in the upper threshold region (15–35 fL) is greater than a predetermined limit. This is generally biologic interference. The flag may be caused by:
Microcytic RBCs
Schistocytes
Giant Platelets
Sickle Cells
Platelet Clumps
NOTE: A "bumpy" platelet histogram may indicate the presence of platelet clumps.
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Chapter 3 Search Book TOC Go Back Principles of Operation
Action: Review the MCV and the PLT histogram. If the MCV is low and/or the histogram indicates an overlap (poor separation at the upper discriminator) in the RBC and PLT populations, review a stained smear to determine the cause and confirm the
PLT count.
LURI (Lower and Upper Region Interference) — displayed next to the
MPV result
Cause: Interference is present in both the upper and lower regions of the PLT histogram.
Action: Follow the guidelines given above for the LRI and URI flags.
PLT — displayed next to PLT result
Cause: The relationship of the absolute PLT count and the PLT histogram did not meet the expected criteria.
Action: Repeat the sample. If the flag remains, verify the PLT count.
Suspect Population Flags
These flags are generated when the instrument’s evaluation of the measured data for a particular parameter or group of parameters indicates the possible presence of an abnormal subpopulation. A stained smear should be reviewed whenever a suspect population flag is present.
Therefore, instructions for interpreting these flags should be incorporated into the laboratory’s review criteria for abnormal samples.
NOTE: The word SUSPECT will be displayed and printed above any displayed WBC suspect population flags.
WBC Flags
BANDS — displayed next to the NEU result
Cause:
1.
The count in the region of scatter (on the 0
°
/10
°
plot) where bands are typically located is >12.5% of the total WBC count.
2.
The ratio of suspected bands to mature neutrophils is >50%.
3.
The CV of the neutrophil cluster on the 0
°
axis exceeds expected criteria.
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Chapter 3
Action: Review a stained smear and follow your laboratory's review criteria. When bands are present, they are included in the total neutrophil count.
IG (Immature Granulocyte) — displayed next to the NEU result
Cause: The count in the region of scatter (on the 0
°
/10
°
plot) where immature granulocytes are typically located is >3% of the total
WBC count.
Action: Review a stained smear and follow your laboratory's review criteria. When IGs are present, they are included in the total neutrophil count.
BLAST — displayed next to the LYM result
Cause:
1.
The count in the region of scatter (on the 90
°
/0
°
plot) where blasts are typically located is >1% of the total WBC count.
2.
The MONO % is >20% of the total WBC count.
3.
The MONO % is >3% of the total WBC count, and the standard deviation of the monocytes on the 0
°
axis exceeds expected criteria.
Action: Review a stained smear and follow your laboratory's review criteria. When blasts are present, they are included in the monocyte count.
VAR LYM — displayed next to the LYM result
Cause: The distribution of the lymphocyte cluster on the size/ complexity (0
°
/10
°
) scatterplot exceeds expected criteria.
Action: Review a stained smear and follow your laboratory's review criteria. When variant lymphocytes are present, they are included in the lymphocyte count.
NOTE: This flag may be displayed singly or in combination with the blast flag. If the flag is displayed with the blast flag, it is displayed as VLYM/BLAST.
NRBC — displayed next to the MONO result
Cause: The count in a predefined region below the lymphocyte cluster on the size/complexity (0
°
/10
°
) scatterplot is >2.9% of the total
WBC count.
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Interpretive Messages
Action: Review a stained smear for nucleated red blood cells, platelet aggregates, sickle cells, or other abnormal cell types and follow your laboratory's review criteria.
If NRBCs are present, they should be quantitated according to your laboratory's procedure; correction of the WBC count is not required, however.
When the NRBC and WBC flags are set concurrently, RBCs resistant to the lytic action of the sheath reagent may be present. Repeat the sample using the Resistant RBC specimen type.
RBC Flags
RBC MORPH — displayed next to the MCV result
Cause: One or more of the following parameters exceeds expected limits:
MCV <80 fL or >100 fL
MCH <25 pg or >34 pg
MCHC <29 g/dL or >37 g/dL
RDW > 18.5%
Action: Review a stained smear and follow your laboratory's review criteria.
PLT Flags
No MPV result displayed (data suppressed)
Cause: The PLT histogram did not meet expected criteria (non-log normal distribution).
Action: Review a stained smear for abnormal PLT morphology or the presence of PLT aggregates and follow your laboratory's review criteria. Verify the PLT count.
Interpretive messages appear only on the graphics report and are
Instructions , for an explanation). These messages are printed only when
the Interpretive Report option is selected on the CUSTOMIZE
. The Interpretive messages are summarized in
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Principles of Operation
Search Book TOC Go Back
Table 3.2: Interpretive Messages
Cause Message
WBC Messages
Leukopenia
Leukocytosis
Neutropenia
Neutrophilia
Lymphopenia
Lymphocytosis
Monocytosis
Eosinophilia
Basophilia
RBC Messages
Anemia
Polycythemia
Microcytic RBC
Macrocytic RBC
Hypochromic
Hyperchromic
Anisocytosis
PLT Messages
Thrombocytopenia
Thrombocytosis
Microcytic PLT
Macrocytic PLT result exceeds the lower limit for WBC result exceeds the upper limit for WBC result exceeds the lower limit for Neutrophil absolute number result exceeds the upper limit for Neutrophil absolute number result exceeds the lower limit for Lymphocyte absolute number result exceeds the upper limit for Lymphocyte absolute number result exceeds the upper limit for Monocyte absolute number result exceeds the upper limit for Eosinophil absolute number result exceeds the upper limit for Basophil absolute number result exceeds the lower limit for RBCs result exceeds the upper limit for RBCs result exceeds the lower limit for MCV result exceeds the upper limit for MCV result exceeds the lower limit for MCHC result exceeds the upper limit for MCHC result exceeds the upper limit for RDW result exceeds the lower limit for PLTs result exceeds the upper limit for PLTs result exceeds the lower limit for MPV result exceeds the upper limit for MPV
Chapter 3
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Chapter 3 Search Book TOC Go Back Principles of Operation
References
1.
ICSH, The Assignment of Values to Fresh Blood Used for
Calibrating Automated Cell Counters, Clinical and Laboratory
Hematology 1988, 10:203-212.
2.
Clinical Applications of Flow Cytometry, ASCP National Meeting,
Spring 1990.
3.
Shapiro, Howard, Practical Flow Cytometry, 1984.
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Principles of Operation
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NOTES
Chapter 3
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Chapter 4 Search Book TOC Go Back
System Specifications
Chapter Table of Contents
Physical Specifications — CELL-DYN 3000SL . . . . . . . . . . . . . . . . 4-1
Power Specifications — CELL-DYN 3000SL . . . . . . . . . . . . . . . . . . 4-2
Consumption . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
Operational Specifications — CELL-DYN 3000SL . . . . . . . . . . . . . . 4-3
Operating Environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
Complete Cycle Times . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
Approximate Aspiration Volumes (whole blood) . . . . . . . . . . . . 4-3
Batch Size . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
Throughput . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
Collection Tube and Sample Volume . . . . . . . . . . . . . . . . . . . . . . 4-4
Bar Code Specifications — CELL-DYN 3000SL . . . . . . . . . . . . . . . 4-5
Bar Code Format . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5
Bar Code Label Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5
Physical Specifications — CELL-DYN 3000CS . . . . . . . . . . . . . . . . 4-6
Power Specifications — CELL-DYN 3000CS . . . . . . . . . . . . . . . . . . 4-7
Consumption . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7
Operational Specifications — CELL-DYN 3000CS . . . . . . . . . . . . . . 4-8
Operating Environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-8
Complete Cycle Times . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-8
Approximate Aspiration Volumes (whole blood) . . . . . . . . . . . . 4-8
Measurement Specifications — CELL-DYN 3000SL and CS . . . . . . 4-9
Measurement Channels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-9
WBC and Differential . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-9
RBCs and PLTs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-9
Performance Specifications — CELL-DYN 3000SL and CS . . . . . . 4-10
Background Counts (acceptable up to limits listed) . . . . . . . . . . 4-10
Precision . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10
Hemogram Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10
WBC Differential Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11
Linearity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11
Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-12
Hemogram Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-12
WBC Differential Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-12
Carryover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-13
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Table of Contents-1
Table of Contents Search Book TOC Go Back
NOTES
Chapter 4
Table of Contents-2
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Chapter 4 Search Book TOC Go Back
System Specifications
Physical Specifications — CELL-DYN 3000SL
Table 4.1:
Height
Width
Depth
Weight
Dimensions
Analyzer
24" (61 cm)
30" (76 cm)
22" (56 cm)
190 lb (86 kg)
Data Station
24" (61 cm)
15" (38 cm)
22" (56 cm)
73 lb (33 kg)
Printer
6" (15 cm)
16.5" (41 cm)
14.5" (39 cm)
16.5 lb (7.5 kg)
Table 4.2:
Height
Width
Depth
Weight
Dimensions After Packaging for Shipment
Analyzer
36" (91 cm)
40" (102 cm)
30" (76 cm)
310 lb (141 kg)
Data Station
37" (94 cm)
21" (53 cm)
27" (69 cm)
134 lb (61 kg)
Printer
9.5" (24 cm)
21" (53 cm)
18.5" (46 cm)
21 lb (9.5 kg)
Sample Loader
17" (42 cm)
28" (71 cm)
11.5" (29 cm)
53 lb (24 kg)
Sample Loader
35" (89 cm)
21" (53 cm)
35" (89 cm)
200 lb (91 kg)
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4-1
System Specifications
Search Book TOC Go Back
Power Specifications — CELL-DYN 3000SL
Table 4.3:
Setting
100
120
220
240
Power Specifications
Analyzer Input Requirements
Range
90—110 VAC
110—130 VAC
200—240 VAC
220—250 VAC
Setting
120
240
Data Station Input Requirements
Range
90—130 VAC
180—260 VAC
Frequency
50/60 Hz
50/60 Hz
50/60 Hz
50/60 Hz
Frequency
50/60 Hz
50/60 Hz
Setting
115
230
Consumption
Setting
120
Printer Input Requirements
Frequency
50/60 Hz
Sample Loader Input Requirements
Range
90—130 VAC
190—240 VAC
Frequency
60 Hz
50 Hz
Analyzer:
Data Station:
Printer:
Sample Loader:
900 Watts
300 Watts
145 Watts
50 Watts
1395 Watts maximum (4760 BTU per hour)
Chapter 4
4-2
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Chapter 4 Search Book TOC Go Back System Specifications
Operational Specifications — CELL-DYN 3000SL
Operating Environment
Temperature
Relative Humidity
Patient Samples:
Room Temperature (15–30 o C)
Monocyte values exhibit a change at lower and higher temperatures. A 1.5% decrease is seen in the total monocyte percent at lower temperatures
(<18 o C). A 6% increase will be seen at higher temperatures.
Instrument: 15–30 o C
Background values for RBC and PLT may exhibit an increase at lower environmental temperatures (<18 o C).
10% to 85%, RHNC
Complete Cycle Times
Auto-Startup (from STANDBY)
Auto-Startup (from power OFF)
Run, Open mode
Approximately 5.5 minutes
Approximately 7 minutes*
Approximately 40 seconds
(READY to READY)
Approximately 49 seconds
7.5 minutes
Run, Sample Loader
Shutdown (to STANDBY)
* The laser requires a 15 minute warm up time. If the power has been
OFF longer than 5 minutes, wait 10 minutes after the Auto-Startup cycle is complete before processing samples.
Approximate Aspiration Volumes (whole blood)
Open mode
Sample Loader
170 µL
350 µL
Batch Size
1–100 tubes per batch
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4-3
System Specifications
Search Book TOC Go Back
Chapter 4
Throughput
Maximum throughput = 72 samples/hour
NOTE: Maximum throughput is achieved with normal samples that do not generate any instrument operational messages.
Collection Tube and Sample Volume
13 mm diameter x 75 mm high with a Hemoguard style closure
• Minimum sample volume = 1 mL (using the Sample Loader)
• Maximum sample volume = 3 mL (using the Sample Loader)
NOTE: The sample volume in the tube must be within the specified limits for adequate mixing and sampling.
4-4
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Bar Code Specifications — CELL-DYN 3000SL
Bar Code Format
The following formats with or without check digits are acceptable:
• Code 39
• Interleave 2 of 5
• Codabar
Bar Code Label Specifications
Bar code labels must meet the following specifications:
• Printed on good quality label stock
• 0.25-inch quiet zone on each end
• 0.01-inch minimum narrow bar width
• 2:1 wide to narrow bar ratio
• 0.5-inch minimum bar length
• 2-inch maximum label length
• 1.25-inch maximum label width
NOTE: Refer to Appendix A for complete information on bar code label formats ,
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System Specifications
Search Book TOC Go Back
Physical Specifications — CELL-DYN 3000CS
Table 4.4: Dimensions
Height
Width
Depth
Weight
Analyzer
24" (61 cm)
30" (76 cm)
22" (56 cm)
190 lb (86 kg)
Data Station
24" (61 cm)
15" (38 cm)
22" (56 cm)
73 lb (33 kg)
Table 4.5:
Height
Width
Depth
Weight
Dimensions After Packaging for Shipment
Analyzer
36" (91 cm)
40" (102 cm)
30" (76 cm)
310 lb (141 kg)
Data Station
37" (94 cm)
21" (53 cm)
27" (69 cm)
134 lb (61 kg)
Chapter 4
Printer
6" (15 cm)
16.5" (41 cm)
14.5" (39 cm)
16.5 lb (7.5 kg)
Printer
9.5" (24 cm)
21" (53 cm)
18.5" (46 cm)
21 lb (9.5 kg)
4-6
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Chapter 4 Search Book TOC Go Back
Power Specifications — CELL-DYN 3000CS
Table 4.6:
Setting
100
120
220
240
Power Specifications
Analyzer Input Requirements
Range
90—110 VAC
110—130 VAC
200—240 VAC
220—250 VAC
Frequency
50/60 Hz
50/60 Hz
50/60 Hz
50/60 Hz
Setting
120
240
Data Station Input Requirements
Range
90—130 VAC
180—260 VAC
Frequency
50/60 Hz
50/60 Hz
Consumption
Setting
120 VAC
Printer Input Requirements
Frequency
50/60 Hz
Analyzer:
Data Station:
900 Watts
300 Watts
Printer: 145 Watts
1345 Watts maximum (4590 BTU per hour)
System Specifications
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4-7
System Specifications
Search Book TOC Go Back
Chapter 4
Operational Specifications — CELL-DYN 3000CS
Operating Environment
Temperature
Relative Humidity
Patient Samples:
Room Temperature (15–30 o C)
Monocyte values exhibit a change at lower and higher temperatures. A 1.5% decrease is seen in the total monocyte percent at lower temperatures
(<18 o C). A 6% increase will be seen at higher temperatures.
Instrument: 15–30 o C
Background values for RBC and PLT may exhibit an increase at lower environmental temperatures (<18 o C).
10% to 85%, RHNC
Complete Cycle Times
Auto-Startup (from STANDBY)
Auto-Startup (from power OFF)
Run, Open mode
Approximately 5.5 minutes
Approximately 7 minutes*
Approximately 40 seconds
(READY to READY)
7.5 minutes Shutdown (to STANDBY)
* The laser requires a 15 minute warm up time. If the power has been
OFF longer than 5 minutes, wait 10 minutes after the Auto-Startup cycle is complete before processing samples.
Approximate Aspiration Volumes (whole blood)
Open mode 170 µL
Closed Sampler 230 µL
4-8
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Chapter 4 Search Book TOC Go Back System Specifications
Measurement Specifications — CELL-DYN 3000SL and CS
Measurement Channels
Impedance channel for both RBC and PLT
Laser Optics for WBC and Differential
Hemoglobin Absorbance
WBC and Differential
Method
Light Source
Wavelength
Dilution
Data Collection
Laser light scatter
Vertically polarized 5–10 mW helium neon laser
632.8 nm
1:51 of blood in sheath reagent
Four angles measured:
0
°
, 10
°
, 90
°
and 90
°
depolarized.
Data collected in 256 channels for each angle of light scatter.
RBCs and PLTs
Method
Aperture Size
Dilution
Data Collection
Aperture Impedance
60 µm (diameter) x 72 µm (length)
1:12,501 of blood in diluent
256 channels for RBCs, each RBC channel = 1 fL
256 channels for PLTs, each PLT channel = 0.137 fL
HGB
Method
Light Source
Wavelength
Dilution
Data Collection
Modified hemiglobincyanide
LED
540 nm
1:251 of blood in diluent and
Hemoglobin Lyse
Average of 5 absorbance readings for the blank, average of 5 absorbance readings for the sample dilution
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4-9
System Specifications
Search Book TOC Go Back
Chapter 4
Performance Specifications — CELL-DYN 3000SL and CS
Background Counts (acceptable up to limits listed)
WBC <0.50 K/µL
RBC
HGB
PLT
<0.05 M/µL
<0.20 g/dL
<10.0 K/µL
Precision
Samples that are used to verify precision specifications should have results that fall within the laboratory's normal range. These samples should not display any of the following suspect parameter flags:
WBC
LRI
URI
LURI
The stated precision values are applicable to the Open, Closed Sampler and Sample Loader modes.
Hemogram Parameters
Precision specifications for the hemogram parameters are given as the coefficient of variation (CV) of at least 20 determinations of the same sample.
Table 4.7: Precision of the Hemogram Parameters (N = 20)
Parameter
WBC
RBC
HGB
MCV
RDW
PLT
MPV
CV
<2.5%
<1.7%
<1.2%
<1.5%
<3.5%
<6.0%
<6.0%
4-10
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Chapter 4 Search Book TOC Go Back System Specifications
WBC Differential Parameters
Precision specifications for the WBC Differential parameters are given as a 95% confidence limit for a range of values for each of the WBC subpopulations.
Table 4.8: Precision of the WBC Differential Parameters
Cell Type
Neutrophil %
Lymphocyte %
Monocyte %
Eosinophil %
Basophil %
Range
42—65%
24—45%
3.6—11.0%
1.0—9.5%
0.5—1.3%
95% Confidence Limit
± 2.1%
± 3.2%
± 2.9%
± 1.2%
± 1.0%
Linearity
Table 4.9:
Parameter
WBC
RBC
HGB
MCV
PLT
MPV
Linearity specifications are determined by analyzing dilutions of a commercially available control material that contains no interfering substances and displays no suspect parameter flags. Specifications are determined by taking multiple measurements on each dilution to minimize the effect of imprecision. The stated limits are determined by regression analysis with the line going through the origin (0,0).
Linearity Specifications
Linear Range
0.0—99.9 K/ µL
0.00—7.00 M/ µL
2.5—24 g/dL
50—200 fL
0—999 K/ µL
5—20.0 fL
Acceptable Limits
(whichever is greater)
± 0.4 or 3.0%
± 0.1 or 2.5%
± 0.3 or 2.0%
± 3.0 or 3.0%
± 12.0 or 4.0%
± 1.0 or 6.0%
CELL-DYN
3000 System Operator’s Manual
9140240E — May 1995
4-11
System Specifications
Search Book TOC Go Back
Chapter 4
Accuracy
The CELL-DYN 3000 system can be calibrated to agree with reference values within the allowable calibration ranges. Both modes of operation,
Open and Closed (CS and SL) may be calibrated. Thus, it is possible to compensate for differences between modes due to differing aspiration pathways or operational sequences. When each mode is properly calibrated according to the directions given in this manual, bias between the modes is clinically insignificant.
Accuracy specifications are determined by correlation to reference values obtained from comparison analyzers or analysis by reference methodology. Samples that are used for correlation studies should not display any suspect parameter flags.
Hemogram Parameters
Table 4.10: Accuracy of Hemogram Parameters
Parameter
WBC
RBC
HGB
MCV
PLT
MPV
Correlation Coefficient
0.98
0.98
0.98
0.98
0.98
0.90
WBC Differential Parameters
Table 4.11: Accuracy of WBC Differential Parameters
Parameter
Neutrophil # and %
Lymphocyte # and %
Monocyte # and %
Eosinophil # and %
Basophil # and %
Correlation Coefficient
>0.92
>0.92
>0.80
>0.84
>0.30
4-12
CELL-DYN
3000 System Operator’s Manual
9140240E — May 1995
Chapter 4 Search Book TOC Go Back System Specifications
Carryover
Carryover is determined by running samples with high concentrations of
WBCs, RBCs, HGB and PLTs. Each sample is run in triplicate followed by three background cycles. The percent carryover is calculated using the following formula:
% Carryover
______ 3
x 100
Sample
3
- Background
3
Absolute Carryover = Background
1
- Background
3
Table 4.12:
Level
Carryover
(in % or
Absolute)
Carryover for WBC, RBC, HGB and PLT
WBC
90K/ µL
<1.0 % or
<0.1
RBC
6.9M/ µL
<1.0 % or
<0.03
HGB
20.6 g/dL
<1.0 % or
<0.1
PLT
721 K/ µL
<1.0 % or
<10
CELL-DYN
3000 System Operator’s Manual
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4-13
System Specifications
Search Book TOC Go Back
NOTES
Chapter 4
4-14
CELL-DYN
3000 System Operator’s Manual
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Chapter 5 Search Book TOC Go Back
Operating Instructions
Chapter Table of Contents
Data Station Program Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
Main Menu Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2
Conventions Used in This Manual . . . . . . . . . . . . . . . . . . . . . . . . 5-3
Setup Instructions
Procedure Date/Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-7
Procedure Patient Limit Sets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-9
Procedure Reagent Log Entry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-11
Procedure Deleting Entries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-11
Procedure X-B Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-14
Range and Limit Entry and File Updating . . . . . . . . . . . . . . . . . . . . 5-16
QC Limits Entry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-16
Procedure Range Entry . . . . . . . . . . . . . . . . . . . . . . . . . . 5-17
Procedure Means/Limits Entry . . . . . . . . . . . . . . . . . . . . 5-18
Procedure QC File Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-22
Procedure Lot Number Entry . . . . . . . . . . . . . . . . . . . . . 5-22
Procedure Replicate ID Entry . . . . . . . . . . . . . . . . . . . . . 5-23
Procedure Customize QC Log Display . . . . . . . . . . . . . . . . . . . . 5-25
Procedure Customize QC Log Display
(Standard Groups) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-27
Procedure Customize QC Log Printout . . . . . . . . . . . . . . . . . . . 5-29
Procedure Bar Code Set Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-31
Procedure Computer Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-34
Procedure Units Selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-36
Procedure Customize Display . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-38
Procedure Customize Graphics Report . . . . . . . . . . . . . . 5-43
Procedure Customize Graphics Header . . . . . . . . . . . . . 5-44
Procedure Customize Pre-Printed Ticket . . . . . . . . . . . . 5-46
Procedure Customize Blank Ticket . . . . . . . . . . . . . . . . . 5-48
Routine Operation
Data Station Run Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-52
Data Station Run Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-53
Status Box . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-54
Bulletin Line . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-55
Flagging Diagnostics Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-56
Data Station Run Screen Soft Keys . . . . . . . . . . . . . . . . . . . . . . . . . . 5-58
Procedure Resistant RBC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-66
Sample Collection and Handling . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-67
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3000 System Operator’s Manual
9140240E — May 1995
Table of Contents-1
Table of Contents
Table of Contents-2
Search Book TOC Go Back
Chapter 5
Anticoagulant . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-67
Sample Stability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-67
Sample Collection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-68
Interfering Substances . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-68
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-69
Operator ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-69
Sample Identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-69
Alerts and Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-70
Instrument Start Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-72
Sample Analysis on the CELL-DYN 3000SL . . . . . . . . . . . . . . . . . .5-73
Daily Start Up Procedure . . . . . . . . . . . . . . . . . . . . . . . . .5-73
Start Up Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-73
Sample Loader Operating Tips . . . . . . . . . . . . . . . . . . . .5-74
Daily Quality Control Checks . . . . . . . . . . . . . . . . . . . . . . . . . . .5-74
Open Mode QC Procedure . . . . . . . . . . . . . . . . . . . . . . .5-74
Closed Mode QC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-75
QC (with Q Labels) Procedure . . . . . . . . . . . . . . . . . . . .5-75
QC (without Q Labels) Procedure . . . . . . . . . . . . . . . . . .5-76
Running Samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-77
Open Mode Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-77
Open Mode Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . .5-77
Closed Mode Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . .5-78
Closed Mode Procedure . . . . . . . . . . . . . . . . . . . . . . . . . .5-78
Daily Shutdown . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-79
Sample Analysis on the CELL-DYN 3000CS . . . . . . . . . . . . . . . . . .5-80
Daily Start Up Procedure . . . . . . . . . . . . . . . . . . . . . . . . .5-80
Start Up Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-80
Daily Quality Control Checks . . . . . . . . . . . . . . . . . . . . .5-80
QC (Open or Closed Mode) Procedure . . . . . . . . . . . . . .5-81
Running Samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-81
Open Mode Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-81
Open Mode Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . .5-81
Closed Mode Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . .5-82
Closed Mode Procedure . . . . . . . . . . . . . . . . . . . . . . . . . .5-82
Daily Shutdown . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-83
Using the Work List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-84
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-84
Work List Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-85
Work List Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-86
Work List Soft Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-87
Work List Setup Procedure . . . . . . . . . . . . . . . . . . . . . . .5-90
Sample Analysis Using the Work List,
Sample Loader Instruments . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-91
Using the Work List with Bar Codes . . . . . . . . . . . . . . . .5-91
Sample Analysis Procedure . . . . . . . . . . . . . . . . . . . . . . .5-92
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3000 System Operator’s Manual
9140240E — May 1995
Chapter 5 Search Book TOC Go Back Table of Contents
Using the Work List Without Bar Codes . . . . . . . . . . . . 5-94
Sample Analysis Procedure . . . . . . . . . . . . . . . . . . . . . . 5-94
Running STAT Samples . . . . . . . . . . . . . . . . . . . . . . . . . 5-95
Sample Analysis with the Work List,
Closed Sampler Instruments . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-96
Using the Work List with Bar Code ON . . . . . . . . . . . . . 5-96
Sample Analysis Procedure . . . . . . . . . . . . . . . . . . . . . . 5-96
Using the Work List with Bar Code OFF . . . . . . . . . . . . 5-98
Sample Analysis Procedure . . . . . . . . . . . . . . . . . . . . . . 5-98
Running STAT Samples . . . . . . . . . . . . . . . . . . . . . . . . . 5-99
Using the Data Log
Data Log Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-101
Data Log Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-111
Data Log Set Up Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-112
Customizing the Data Log Display . . . . . . . . . . . . . . . . . . . . . . 5-112
Procedure Customize Data Log Display . . . . . . . . . . . . . . . . . . 5-113
Standard Groups . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-114
Procedure Customize Data Log Display
(Standard Groups) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-114
Customizing the Printout . . . . . . . . . . . . . . . . . . . . . . . 5-116
Procedure Customize Data Log Printout . . . . . . . . . . . 5-116
Data Review from the Data Log . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-117
Scrolling Through the Data Log . . . . . . . . . . . . . . . . . . . . . . . . 5-117
Displaying a Record . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-117
Procedure Record Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-118
Editing a Record . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-119
Procedure Edit Specimen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-119
CELL-DYN
3000 System Operator’s Manual
9140240E — May 1995
Table of Contents-3
Table of Contents Search Book TOC Go Back
NOTES
Chapter 5
Table of Contents-4
CELL-DYN
3000 System Operator’s Manual
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Chapter 5 Search Book TOC Go Back
Operating Instructions
Introduction
This chapter discusses the operation of the CELL-DYN® 3000. It is
divided into three sections: Set Up Instructions , Routine Operation
Using the Data Log . The chapter also includes an overview of the Data
Station computer program. The three major menus in the program that
are used for routine operation — Set Up
discussed in this chapter. The remaining parts of the program are discussed in the following chapters:
Data Station Program Overview
The Data Station menus are presented as key labels displayed across the bottom of the screen. Each menu is accessed by pressing the soft key located directly below the label. (From left to right, these soft keys correspond to keys F1–F8 on the standard computer keyboard.)
When the Data Station is powered ON, the MAIN MENU Screen , depicted in Figure 5.1
, is displayed. The key labels displayed across the
bottom of this screen are used to access all of the sub-menus that are available. The MAIN MENU keys are listed below.
MAIN MENU KEYS:
SETUP
RUN
DATA LOG
QC LOGS
CALIBRATION
DIAGNOSTICS
SPECIAL PROTOCOLS
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Main Menu Screen
Version #
The MAIN MENU Screen is divided into four sections. The upper lefthand corner shows the current version of the instrument software. The upper right-hand corner shows the current date and time, operator ID and the sequence number. The information in the upper right corner is displayed on every screen during operation.
CD 3000 MAIN MENU
Ready
Dec 08 1992
Operator ID
Sequence #
15:50
734
0067
SETUP RUN DATA LOG QC LOGS CALIBRA-
TION
DIAG-
NOSTICS
SPECIAL
PROTOCOLS
Figure 5.1: Main Menu Screen
NOTE: The cursor is positioned at the <OPERATOR ID> field when the MAIN MENU Screen is displayed. An operator ID of up to three alphanumeric characters may be entered. (An operator ID may also be entered from the main
Screen .) This operator ID will be displayed on all other screens
and printed on all reports.
The Status Box is displayed in the top center of the screen. This box appears on every screen to show the following:
• Menu in use
• Analyzer status
• Other applicable information such as report or file identity and any existing fault conditions
5-2
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Chapter 5 Search Book TOC Go Back Operating Instructions
The MAIN MENU key labels are displayed across the bottom of the screen.
Conventions Used in This Manual
Please refer to the introduction of this manual for a key to style
conventions used in this and other chapters.
CELL-DYN
3000 System Operator’s Manual
9140240E — May 1995
5-3
Operating Instructions
Search Book TOC Go Back
NOTES
Chapter 5
5-4
CELL-DYN
3000 System Operator’s Manual
9140240E — May 1995
Setup Instructions
This section discusses the options available when the [SETUP] key is pressed. (See Figure 5.2.) These options are used to configure the system according to the laboratory’s requirements. The function of each key is discussed and set up procedures are given where applicable.
SETUP MENU
Ready
Dec 08 1992
Operator ID
Sequence #
05:51
734
0067
SETUP
DATE/
TIME
PATIENT
LIMITS
REAGENT
LOG
QC SETUP
MENU
OPERATION
SETUP
UNITS
SELECTION
CUSTOMIZE
REPORT
MAIN
Figure 5.2: Setup Menu Screen
When the [SETUP] key is pressed, the following soft key labels are displayed:
CELL-DYN
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9140240E — May 1995
DATE/
TIME
DATE/TIME SETUP
Ready
Enter desired date display option and/or set date and time:
1 1 1: Month/Day/Year
2: Day/Month/Year
3: Year/Month/Day
4: Year/Day/Month
2
3
Date (Month/Day/Year): --/--/--
Time (00:00 to 23:59): --:--
Dec 08 1992
Operator ID
Sequence #
15:52
734
0067
RETURN
Figure 5.3: Date/Time Setup Screen
The [DATE/TIME] key is used to enter the date and time. This screen allows the operator to select the format for displaying the date and to change the date and time as required. Four different date formats are available. The numbers on the
DATE/TIME SETUP Screen shown in
correspond to the following numbered options:
1.
Display Format selection box:
1.
Month/Day/Year
2.
Day/Month/Year
3.
Year/Month/Day
4.
Year/Day/Month
2.
<DATE> entry field
3.
<TIME> entry field
5-6
CELL-DYN
3000 System Operator’s Manual
9140240E — May 1995
The desired format is selected by typing the corresponding number in the entry field displayed to the left of the list (1).
When the Enter key on the keyboard is pressed, the selected format is displayed in the <DATE> entry field (2) and the cursor moves to the entry position. After the date has been entered, the cursor moves to the <TIME> entry field (3).
Procedure Date/Time
1.
From the SETUP MENU Screen , press [DATE/TIME] to display
the
2.
Type the number of the desired format at the cursor.
3.
Press the Enter key on the keyboard to save the entry and advance to the <DATE> entry field.
4.
Type the date in the selected format using one or two digits.
Separate the day, month and year with a slash (/) or a period (.). The entry order of the date should conform to the date format just selected.
5.
Press the Enter key on the keyboard to save the entry and advance to the <TIME> entry field.
6.
Type the time in the 24-hour (military) time format using one or two digits. Separate the hours and minutes with a colon (:) or a period (.).
7.
Press the Enter key on the keyboard to save the entry.
8.
Press [RETURN] to return to the SETUP MENU Screen .
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Operating Instructions
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5-8
PATIENT
LIMITS
Chapter 5
LIMIT SET 1
Ready
WBC:
NEU:
LYM:
MONO:
EOS:
BASO:
RBC:
HGB:
HCT:
MCV:
MCH:
MCHC:
RDW:
PLT:
MPV:
PCT:
PDW:
LIMIT
SET 2
Lower Limits
0.0
0.0
4.04
12.2
4.6
2.0
0.6
0.0
K/uL
K/uL
K/uL
K/uL
K/uL
K/uL
M/uL g/dL
37.7
80.0
27.0
31.8
11.6
142
0.0
0.00
% fL pg g/dL
%
K/uL fL
%
0.0
10(GSD)
LIMIT
SET 3
LIMIT
SET 4
37.0
10.0
0.0
0.0
0.0
%N
%L
%M
%E
%B
Jun 30 1992
Operator ID
Sequence #
Upper Limits
10.2
6.9
3.4
0.9
0.7
0.2
6.13
18.1
K/uL
K/uL
K/uL
K/uL
K/uL
K/uL
M/uL g/dL
53.7
97.0
31.2
35.4
14.8
424.
99.9
9.99
% fL pg g/dL
%
K/uL fL
%
99.9
10(GSD)
80.0
50.0
12.0
7.0
2.5
%N
%L
%M
%E
%B
11:15
734
6799
PRINT RETURN
Figure 5.4: Patient Limits Screen
The [PATIENT LIMITS] key is used to enter upper and lower flagging limits for groups of patient samples. (For example, limits may be entered for adult males, adult females, neonates, etc.)
CAUTION: When entering the limits into the four (4) Patient
Limits Sets, ensure that the upper and lower limits for each parameter do not exceed the linearity claims. (Refer to the
linearity specifications in Chapter 4, System Specifications .)
This will ensure that any value that exceeds these limits will be flagged for further review.
The following soft key labels are displayed (see Figure 5.4) when the
[PATIENT LIMITS] key is pressed:
LIMIT SET 1
LIMIT SET 2
LIMIT SET 3
LIMIT SET 4
RETURN
CELL-DYN
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9140240E — May 1995
NOTE: The key label for the limit set displayed on the screen is not shown.
Four different sets of limits may be entered. Whenever a parameter result exceeds an entered limit, the result is displayed in color on the screen to alert the operator. Results displayed in yellow are below the limit and results displayed in magenta are above the limit. The flagged result is underlined on the graphics report and the blank ticket report. The flagged result is marked with an asterisk (*) on the pre-printed ticket report.
Procedure Patient Limit Sets
1.
From the
SETUP MENU , press [PATIENT LIMITS] to display
A Patient Limit Set is displayed on the screen. The set number
(Limit Set 1, Limit Set 2, etc.) is displayed in the Status Box. The other limit sets may be selected by pressing the appropriate soft key.
2.
Use the Arrow keys on the keyboard to move the cursor to the desired limit entry field and type the number.
3.
Press the Enter key on the keyboard to save the entry and automatically advance the cursor to the next entry position.
4.
Repeat steps 2 and 3 until all desired entries have been made.
5.
If desired, press [PRINT] to obtain a printout of the Limit Set.
NOTE: Retaining a hard copy of each Limit Set is recommended, as the screens do not display names or categories for the limit sets.
6.
Press the appropriate soft key to select another Limit Set and repeat steps 2–5 to enter the desired limits.
7.
Press [RETURN] to return to the SETUP MENU Screen .
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Operating Instructions
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Chapter 5
REAGENT
LOG
Package Size
--
--
--
--
20
20
--
--
--
--
Lot Number
013511
013511
---------
---------
---------
---------
---------
---------
---------
---------
DILUENT LOG
Ready
Expiration Date
02/28/93
02/28/93
--/--/--
--/--/--
--/--/--
--/--/--
--/--/--
--/--/--
--/--/--
--/--/--
Dec 17 1992
Operator ID
Sequence #
16:30
734
0630
Open Date
12/02/92
12/17/92
--/--/--
--/--/--
--/--/--
--/--/--
--/--/--
--/--/--
--/--/--
--/--/--
DELETE
ENTRY
HGB
LYSE LOG
SHEATH
LOG
LOG
RETURN
Figure 5.5: Diluent Log Screen
The [REAGENT LOG] key is used to enter current reagent information into the three reagent logs. The following soft key labels are displayed when the [REAGENT LOG] key is pressed:
DELETE ENTRY
DILUENT LOG
HGB LYSE LOG
SHEATH LOG
PRINT LOG
RETURN
NOTE: The key label for the reagent log displayed on the screen is not shown.
5-10
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3000 System Operator’s Manual
9140240E — May 1995
When the [REAGENT LOG] key is pressed, one of the logs is displayed
. (The name of the displayed log is indicated in the
Status Box). The other two logs may be displayed by pressing the appropriate soft key. Each log holds 10 entries. The following information may be entered for each reagent:
Package Size Lot Number
Expiration Date Open Date
Procedure Reagent Log Entry
1.
From the SETUP MENU , press [REAGENT LOG] to display a
2.
Use the soft key to select the appropriate reagent log if it is not displayed.
3.
Use the Arrow keys on the keyboard to move the cursor to the desired entry field.
4.
Type the appropriate information.
NOTE: Entries for each field of information are optional. Dates should be entered with a slash (/) or a period (.) separating the month, day and year.
5.
Press the Enter key on the keyboard to save the entry and advance the cursor.
6.
Repeat steps 3–5 until all desired entries have been made.
7.
If desired, press [PRINT LOG] to obtain a printout of the log.
8.
Press the appropriate soft key to select another reagent log and repeat steps 2–7 to enter data.
Procedure Deleting Entries
When the log is full (the log holds 10 entries), any new entry will replace the oldest entry. Print the logs when they are full for documentation purposes.
1.
From the
SETUP MENU , press [REAGENT LOG] to display a
2.
Move the cursor to the oldest entry in the log.
3.
Press [DELETE ENTRY]. The [COMPLETE DELETION] and
[RESTORE ENTRY] keys are displayed.
CELL-DYN
3000 System Operator’s Manual
5-11
9140240E — May 1995
QC SETUP
MENU
4.
Press [COMPLETE DELETION] to delete the selected entry and create a space at the bottom of the log.
5.
If desired, a new entry may then be made as directed in the above
Entry Procedure.
NOTE: New entries may also be made by typing over old entries without deleting them.
6.
Press [RETURN] to return to the main
QC SETUP MENU
Ready
Dec 08 1992
Operator ID
Sequence #
15:57
734
0067
File Name
5.
6.
7.
8.
1.
2.
3.
4.
FILE 1
FILE 2
FILE 3
FILE 4
FILE 5
FILE 6
FILE 7
FILE 8
9.
10.
FILE 9
FILE 10
# Specimens
0
0
0
0
0
0
0
0
0
0
15.
16.
17.
18.
11.
12.
13.
14.
19.
20.
File Name
FILE 11
FILE 12
FILE 13
FILE 14
FILE 15
FILE 16
FILE 17
FILE 18
FILE 19
FILE 20
Select a QC file with the arrow keys or enter a new file name.
# Specimens
0
0
0
0
0
0
0
0
0
0
X-B
SETUP
LAB ID
SETUP
QC
LIMITS
SET UP
QC FILE
CUSTOMIZE
DISPLAY
CUSTOMIZE
PRINTOUT
RETURN
Figure 5.6: QC Setup Menu Screen
The [QC SETUP MENU] key is used to display a list of the QC files
(see Figure 5.6) and the following soft key labels:
RETURN
5-12
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3000 System Operator’s Manual
9140240E — May 1995
Chapter 5
X-B
SETUP
Search Book TOC Go Back Operating Instructions
This section discusses the procedures that are used to set up the QC files.
The keys are discussed in the order they are used to set up a QC file.
Parameter
MCV
MCH
MCHC
1
Lower/Upper Limits
55.0/125.
fL
20.0/40.0
pg
24.0/44.0
g/dL
X-B SETUP
Ready
2
Target Value
90.0
fL
30.0
pg
34.0
g/dL
Dec 08 1992
Operator ID
Sequence #
3
Action Limit
16:10
734
0067
3.0 %
3.0 %
3.0 %
The X-B program is ON.
TURN
X-B OFF
PRINT RETURN
Figure 5.7: X-B Setup Screen
The [X-B SETUP] key is used to select the X-B SETUP Screen. (See
Figure 5.7.) This screen is used to enter upper and lower acceptance limits, target values and action limits for the X-B Moving Average QC
Program. The following soft key labels are displayed when the [X-B
SETUP] key is pressed:
TURN X-B ON or
TURN X-B OFF (The key label alternates between these two selections when the soft key is pressed.)
RETURN
CELL-DYN
3000 System Operator’s Manual
9140240E — May 1995
5-13
Procedure X-B Setup
The numbers on the X-B SETUP Screen shown in Figure 5.7
to the following numbered options:
1.
LOWER/UPPER LIMITS
The Lower and Upper Limits determine which patient results will be used in the X-B Moving Average calculation. Results that fall outside these limits are automatically excluded from the X-B calculations. These limits should be set widely to exclude grossly abnormal samples that would bias the calculation but should include at least 95% of the patient results.
2.
TARGET VALUE
The Target Value for X-B Analysis is similar to the assay value for a commercial control. It is derived from the patient population that is analyzed on the instrument.
NOTE: The default (preassigned) Target Values on the
X-B SETUP Screen shown in Figure 5.7
Target Values. Dr. Bull's Target Values are included in the X-B
Analysis section of Chapter 7, Quality Control .
3.
ACTION LIMIT
The Action Limit is the acceptable limit of variation around the target value.
NOTE: The X-B Program is discussed in detail in Chapter 7,
Quality Control , of this manual.
1.
From the QC SETUP MENU , press [X-B SETUP] to display the
2.
Use the Arrow keys on the keyboard to move the cursor to the desired entry field.
3.
Type the number(s) and press the Enter key on the keyboard to save the entry and advance the cursor to the next entry field.
4.
Repeat steps 2 and 3 until all entries have been made.
5.
If desired, press [PRINT] to obtain a printout of the entered values.
6.
Press [TURN X-B ON] to enable the program if this key label is displayed.
5-14
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3000 System Operator’s Manual
9140240E — May 1995
LAB ID
SETUP
7.
Press [RETURN] to return to the
NOTE: The X-B status is shown on the
DISPLAY SPECIMEN Screen below the Data Station Status
Box (for example, X-B: 10/IN or X-B: 13/OUT2). The number of specimens in the current X-B batch is noted (1-19). The status of the previous batch is displayed following this number. The status may be OUT, OUT2, or IN.
• OUT indicates that the mean of the previous batch was outside the action limits.
• OUT2 indicates that the mean of the last 2 or more completed batches fell outside the action limits.
• IN indicates that the mean of the previous batch was within the action limits.
The feature enabling the transfer of QC limits and data into a QC file from a floppy disk is not currently available. Therefore the following keys mentioned in this manual should not be used at this time: [LAB ID
SETUP], [LOAD FROM DISK], and [WRITE QC TO DISK].
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3000 System Operator’s Manual
5-15
9140240E — May 1995
Range and Limit Entry and File Updating
QC
LIMITS
The [QC LIMITS] key is used to display the QC MEANS/LIMITS
ENTRY Screen and the following soft key labels:
RANGE ENTRY or
MEANS/LIMITS (The key label alternates
between these two selections.)
UPDATE FROM FILE (This key label is displayed only when there are two or more results in the selected file.)
LOAD FROM DISK
RETURN
QC Limits Entry
QC Limits are entered by pressing the [QC LIMITS] key. This key is available on the
Two types of QC limits are available:
RANGE ENTRY — used to enter the upper and lower
flagging limits absolute numbers (see
MEANS AND LIMITS — used to enter the mean value and a ±
range value that defines the upper and
lower flagging limits (see Figure 5.9
If Range Entry is selected by pressing the [RANGE ENTRY] key, the current upper and lower limits for the selected file are displayed as described above. If Means/Limits entry is selected by pressing the
[MEANS/LIMITS] key, the current means and limits for the selected file are displayed as described above.
5-16
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3000 System Operator’s Manual
9140240E — May 1995
QC RANGE ENTRY
Ready
FOR NORM RD43 SL
MEANS/
LIMITS
WBC:
NEU:
LYM:
MONO:
EOS:
BASO:
RBC:
HGB:
HCT:
MCV:
MCH:
MCHC:
RDW:
PLT:
MPV:
PCT:
PDW:
Lower Limits
36.3
81.0
27.9
33.2
13.0
220.
6.0
0.21
14.5
0.0
0.0
4.20
13.1
6.9
3.5
2.4
0.6
K/uL
K/uL
K/uL
K/uL
K/uL
K/uL
M/uL g/dL
% fL pg g/dL
%
K/uL fL
%
10(GSD)
47.3
31.5
7.0
1.2
0.0
%N
%L
%M
%E
%B
UPDATE
FROM FILE
LOAD
FROM DISK
Jun 08 1992
Operator ID
Sequence #
Upper Limits
40.3
89.0
31.9
37.2
17.0
270.
10.0
0.23
15.9
0.4
0.2
4.50
13.9
8.5
4.3
3.0
1.0
K/uL
K/uL
K/uL
K/uL
K/uL
K/uL
M/uL g/dL
% fL pg g/dL
%
K/uL fL
%
10(GSD)
10:23
734
9110
55.3
37.5
13.0
5.2
2.0
%N
%L
%M
%E
%B
PRINT RETURN
Figure 5.8: QC Range Entry Screen
Procedure Range Entry
1.
Select a file from the
QC SETUP MENU Screen by using the
Arrow keys on the keyboard to move the cursor into the desired file.
2.
Press [QC LIMITS] to display the QC RANGE ENTRY Screen
for the selected file.
3.
Use the Arrow keys on the keyboard to move the cursor to the desired entry field.
4.
Type the numbers and press the Enter key on the keyboard to save each entry and advance the cursor to the next entry field.
5.
Repeat step 4 until all entries have been made.
6.
If desired, press [PRINT] to obtain a printout of the entered values.
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3000 System Operator’s Manual
5-17
9140240E — May 1995
7.
Press [RETURN] to save the entries and return to the QC SETUP
NOTE: When the entries are saved, the software checks to see if any entries would result in the upper limit being less than the lower limit. If this situation occurs, the limits are automatically reversed. The bulletin line displays the message:
LIMITS WERE EXCHANGED TO MAKE UPPER > LOWER
WBC:
NEU:
LYM:
MONO:
EOS:
BASO:
RBC:
HGB:
HCT:
MCV:
MCH:
MCHC:
RDW:
PLT:
MPV:
PCT:
PDW:
Means
K/uL
K/uL
K/uL
K/uL
K/uL
K/uL
M/uL g/dL
% fL pg g/dL
%
K/uL fL
%
10(GSD)
38.3
85.0
29.9
35.2
15.0
245.
8.0
0.22
15.2
0.2
0.1
4.35
13.5
7.7
3.9
2.7
0.8
RANGE
ENTRY
UPDATE
FROM FILE
LOAD
FROM DISK
51.3
34.5
10.0
3.2
QC MEANS/LIMITS ENTRY
Ready
FOR NORM RD43 SL
1.0
%N
%L
%M
%E
%B
May 18 1992
Operator ID
Sequence #
2.0
2.0
25.
2.0
0.4
2.0
4.0
2.0
0.2
0.2
0.1
0.15
Limits (+/-)
0.8
K/uL
0.4
0.3
K/uL
K/uL
K/uL
K/uL
K/uL
M/uL g/dL
% fL pg g/dL
%
K/uL fL
0.01
0.7
%
10(GSD)
4.0
3.0
3.0
2.0
1.0
%B
%N
%L
%M
%E
11:35
734
4300
PRINT RETURN
Figure 5.9: QC Means/Limits Entry Screen
Procedure Means/Limits Entry
1.
Select a file from the
QC SETUP MENU Screen by using the
Arrow keys on the keyboard to move the cursor into the desired file.
2.
Press [QC LIMITS] followed by [MEANS/LIMITS] to display the QC MEANS/LIMITS ENTRY Screen for the selected file.
3.
Use the Arrow keys on the keyboard to move the cursor to the desired entry field.
5-18
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3000 System Operator’s Manual
9140240E — May 1995
UPDATE
FROM FILE
4.
Type the numbers and press the Enter key on the keyboard to save each entry and advance the cursor to the next entry field.
5.
Repeat step 4 until all entries have been made.
6.
Press [RETURN] to save the entries and return to the
NOTE: When the entries are saved, the software checks to see if any entries would result in a negative number for the lower limit (e.g., mean = 1.0, limit = 2.0). If a negative number is found, the values are automatically edited to adjust the lower limit to zero. The bulletin line displays the message:
LIMITS WERE CHANGED TO CORRECT
OUT-OF-RANGE VALUES.
In the above example, the mean would be adjusted to 1.5 and the limit would be adjusted to 1.5.
7.
If desired, press [QC LIMITS] to return to the MEANS/LIMITS
ENTRY Screen and press [PRINT] to obtain a printout of the
entered values.
The [UPDATE FROM FILE] key is displayed on the
[UPDATE FROM FILE] key is pressed, the bulletin line displays the message USE CONFIRM UPDATE TO SET MEANS AND LIMITS
FROM QC FILE and the following soft key labels are displayed:
CONFIRM UPDATE
CANCEL UPDATE
These keys are used to confirm or cancel the Update from File command.
When the [CONFIRM UPDATE] key is pressed, the mean value for each parameter is computed from the values in the file. The parameter limits are set as follows:
WBC, PLT, RDW and MPV: ± 10% of the computed mean
NEU, LYM and MONO: ± 40% of the computed mean
Remaining Parameters: ± 5% of the computed mean
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3000 System Operator’s Manual
5-19
9140240E — May 1995
LOAD
FROM DISK
SETUP
QC FILE
The feature enabling the transfer of QC limits and data into a QC file from a floppy disk is not currently available. Therefore the following keys mentioned in this manual should not be used at this time: [LAB ID
SETUP], [LOAD FROM DISK], and [WRITE QC TO DISK].
The [SETUP QC FILE] key is used to configure the QC file. If the file is used for a commercial control, the lot number and expiration date may be entered by pressing the [LOT NUMBER] key. If the file is used for a patient control, the ID number of the control may be entered by pressing the [REPLICATE ID] key. This screen is also used to select the
Westgard Rules that will be applied to the QC data stored in the file. The following soft key labels are displayed when the [SETUP QC FILE] key is pressed:
REPLICATE ID or
LOT NUMBER (The key label alternates between these two selections.)
TOGGLE ON/OFF (This key label is present only when the cursor is in one of the Westgard
Rule Selection fields.)
RETURN
are shown in the procedures which follow. The numbers on the QC
correspond to the following numbered options:
1.
<REPLICATE ID> entry field (see the following figure )
This entry field is displayed when the [REPLICATE ID] key is pressed. This designation is intended for QC Files that are used for patient controls.
5-20
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3000 System Operator’s Manual
9140240E — May 1995
QC FILE SETUP
Ready
FOR Low
Dec 17 1992
Operator ID
Sequence #
16:36
734
0630
1 Replicate ID: ------------
WESTGARD RULE SELECTION:
ON RULE 1: Value outside 3 SD.
ON
ON
RULE 2:
RULE 3:
Two consecutive values outside SAME 2 SD.
Two consecutive values outside OPPOSITE 2 SD.
ON
ON
ON
RULE 4:
RULE 5:
RULE 6:
Two of three consecutive values outside SAME 2 SD.
Four consecutive values outside SAME 1 SD.
Ten consecutive values on SAME side of mean.
LOT
NUMBER
PRINT RETURN
Figure 5.10: Replicate ID Entry Screen
2.
<LOT NUMBER> and <EXPIRATION DATE> entry fields (see
These entry fields are displayed when the [LOT NUMBER] key is pressed. This designation is intended for QC Files that are used for commercial controls.
3.
WESTGARD RULE SELECTION:
RULE 1: Value Outside 3 SD
RULE 2: Two Consecutive values outside SAME 2 SD
RULE 3: Two Consecutive values outside OPPOSITE 2 SD
RULE 4: Two of Three Consecutive values outside SAME 2 SD
RULE 5: Four Consecutive values outside SAME 1 SD
RULE 6: Ten Consecutive values on SAME side of mean.
NOTE: Westgard Rules are discussed in detail in the Quality
Control chapter of this manual.
The Westgard Rule selections are available on either of the
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3000 System Operator’s Manual
5-21
9140240E — May 1995
QC FILE SETUP
Ready
FOR Low
Dec 17 1992
Operator ID
Sequence #
16:35
734
0630
Procedure QC File Setup
3
2
Lot Number: 12345
Expiration Date (Month/Day/Year): 11/30/92
WESTGARD RULE SELECTION:
ON RULE 1: Value outside 3 SD.
ON
ON
RULE 2:
RULE 3:
Two consecutive values outside SAME 2 SD.
Two consecutive values outside OPPOSITE 2 SD.
ON
ON
ON
RULE 4:
RULE 5:
Two of three consecutive values outside SAME 2 SD.
Four consecutive values outside SAME 1 SD.
RULE 6: Ten consecutive values on SAME side of mean.
REPLICATE
ID
PRINT RETURN
Figure 5.11: Lot Number Entry Screen
1.
Press [QC SETUP MENU] to display the QC SETUP MENU
Screen.
2.
Use the Arrow keys on the keyboard to move the cursor to the desired QC file.
3.
Type the desired alphanumeric file name. (Up to 12 characters may be entered.)
4.
Press the Enter key on the keyboard to save the entry and advance the cursor to the next QC file.
5.
Use the Arrow keys on the keyboard to move the cursor back into the selected file.
6.
Press [SETUP QC FILE] to display the QC FILE SETUP
Screen.
Procedure Lot Number Entry
1.
If necessary, from the QC FILE SETUP Screen, press
[LOT NUMBER] to display the <LOT NUMBER> and
<EXPIRATION DATE> entry fields.
5-22
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3000 System Operator’s Manual
9140240E — May 1995
2.
The cursor is in the <LOT NUMBER> entry field. Type the lot number and press the Enter key on the keyboard to save the entry and advance the cursor to the <EXPIRATION DATE> entry field.
3.
This is the same format selected on the
Screen . Separate the digits with a slash (/) or a period (.).
4.
Press the Enter key on the keyboard to save the entry and advance the cursor to the <WESTGARD RULE SELECTION> entry fields.
5.
Use the Arrow keys on the keyboard to position the cursor at the desired Westgard Rule.
6.
Press [TOGGLE ON/OFF] to enable the rule and advance the cursor.
7.
Repeat steps 5 and 6 until all desired rule selections have been made.
8.
If desired, press [PRINT] to obtain a printout of the entries.
9.
Press [RETURN] to return to the
Procedure Replicate ID Entry
1.
If necessary, from the
[REPLICATE ID] to display the <REPLICATE ID> entry field.
2.
The cursor is in the <REPLICATE ID> entry field. Type the
Replicate ID number (up to 12 alphanumeric characters may be entered) and press the Enter key on the keyboard to save the entry and advance the cursor to the <WESTGARD RULE
SELECTION> entry fields.
3.
Select the Westgard Rules as directed in the Lot Number Entry
CELL-DYN
3000 System Operator’s Manual
5-23
9140240E — May 1995
Operating Instructions
Search Book TOC Go Back
Chapter 5
CUSTOMIZE
DISPLAY
5-24
CUSTOMIZE QC DISPLAY
Ready
FOR FILE 1
Dec 08 1992
Operator ID
Sequence #
16:07
734
0067
Group 1:
Group 2:
Group 3:
Group 4:
WBC NEU LYM MONO EOS BASO
RBC HGB HCT MCV MCH MCHC RDW
PLT MPV UMT1 CNT1
WBC %N %L %M %E %B
WBC NEU LYM MONO EOS BASO
RBC HGB HCT MCV MCH MCHC RDW
PLT MPV
%N
PCT
%L
PDW
%M %E %B
UMT1 UMT2 CNT1 CNT2 EMPTY
SELECT
PARAMETER
STANDARD
GROUPS
RETURN
Figure 5.12: Customize QC Display Screen
The [CUSTOMIZE DISPLAY] key is used to customize the display of information in the QC logs. (See Figure 5.12.) The CUSTOMIZE QC
DISPLAY Screen and the following key labels are displayed when the
[CUSTOMIZE DISPLAY] key is pressed:
SELECT PARAMETER
STANDARD GROUPS
RETURN
The screen displays a matrix showing the groups of parameters that are currently selected. A list of all available parameters is displayed under the matrix. The following parameters are included in the list and may be displayed in the QC file if desired.
UMT1 and UMT2 — UMT1 is the RBC/PLT Upper Metering Time.
UMT2 is the RBC/PLT Upper Metering Time for an extended count.
CNT1 and CNT2 — CNT1 is the RBC/PLT Count Time. CNT2 is the RBC/PLT Count Time for an extended count.
EMPTY — Inserts an empty column in the QC Log File display.
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3000 System Operator’s Manual
9140240E — May 1995
On the
CUSTOMIZE QC DISPLAY Screen , Parameter Group 1 is
displayed (in the order indicated from left to right) on the first VIEW
QC LOG Screen. The remaining groups are displayed on subsequent screens that are accessed by pressing the Right Arrow key on the keyboard. The Left Arrow key is used to page back through the screens to the first screen.
The [STANDARD GROUPS] key is used to select a predetermined group of parameters that will be placed on a designated page. The display may be customized by selecting the individual parameters, standard groups of parameters or a combination of the two.
Procedure Customize QC Log Display
1.
Select a file from the QC SETUP MENU Screen by moving the
cursor to the desired file.
2.
Press [CUSTOMIZE DISPLAY] to display the CUSTOMIZE
QC DISPLAY Screen for the selected file.
3.
If necessary, press [CUSTOM PLACEMENT] to display the
CUSTOMIZE QC DISPLAY Screen and the [SELECT
PARAMETER] key.
4.
Use the Arrow keys on the keyboard to move the cursor to the desired parameter in the listing under the matrix.
5.
Press [SELECT PARAMETER]. The selected parameter is highlighted and the cursor moves to the first position in Group 1.
NOTE: The key label changes to [PLACE PARAMETER] and a [CANCEL SELECTION] key is displayed.
6.
If necessary, use the Arrow keys on the keyboard to move the cursor to the desired location and press [PLACE PARAMETER].
NOTE: When the [PLACE PARAMETER] key is pressed, the selected parameter is displayed in the position indicated by the cursor and the cursor is then advanced to the next parameter in the listing under the matrix.
7.
Repeat steps 4–6 until all selections have been made.
8.
If desired, press the Print Screen key on the keyboard to obtain a printout of the selected groups.
9.
Press [RETURN] to return to the QC SETUP MENU Screen .
10.
Repeat this procedure to customize the display for other QC logs.
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3000 System Operator’s Manual
5-25
9140240E — May 1995
Operating Instructions
Search Book TOC Go Back
Chapter 5
STANDARD
GROUPS
CUSTOMIZE QC DISPLAY
Ready
FOR FILE 1
Dec 08 1992
Operator ID
Sequence #
16:07
734
0067
Group 1:
Group 2:
Group 3:
Group 4:
WBC NEU LYM MONO EOS BASO
RBC HGB HCT MCV MCH MCHC RDW
PLT MPV PCT PDW
WBC %N % L %M %E %B
WBC NEU LYM MONO EOS BASO
RBC HGB HCT MCV MCH MCHC RDW
PLT MPV PCT PDW
%N % L %M %E %B
UMT1 UMT2 CNT1 CNT2 EMPTY
WBC
GROUP
RBC
GROUP
PLT
GROUP
DIFF
GROUP
LATEX
SET
CUSTOM
PLACEMENT
RETURN
Figure 5.13: Customize QC Display Screen Showing Standard Groups
Predetermined groups of parameters, called Standard Groups, may be selected by pressing the [STANDARD GROUPS] key. Figure 5.13 shows the CUSTOMIZE QC DISPLAY Screen with the standard groups displayed. When the [STANDARD GROUPS] key is pressed, the following soft key labels are displayed:
WBC GROUP
RBC GROUP
PLT GROUP
DIFF GROUP
LATEX SET
CUSTOM PLACEMENT*
RETURN
*This key is used to return to the CUSTOMIZE QC DISPLAY Screen for operator-selected placement.
5-26
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3000 System Operator’s Manual
9140240E — May 1995
LATEX
SET
Procedure Customize QC Log Display
(Standard Groups)
1.
Select a file from the
QC SETUP MENU Screen by moving the
cursor to the desired file.
2.
Press [CUSTOMIZE DISPLAY] to display the CUSTOMIZE
QC DISPLAY Screen for the selected file.
3.
Press [STANDARD GROUPS] to display the
DISPLAY Screen and key labels for Standard Groups.
4.
Use the Arrow keys on the keyboard to move the cursor to the desired group (1–4) location.
NOTE: This number indicates the order in which the group of parameters will be displayed (Group 1 on the first screen, Group
2 on the second, etc.).
5.
Press the soft key corresponding to the desired parameter group.
This group is displayed in the position indicated by the cursor.
6.
Repeat steps 4 and 5 until all desired groups have been selected.
7.
If desired, press the Print Screen key on the keyboard to obtain a printout of the configuration.
8.
Press [RETURN] to return to the QC SETUP MENU Screen .
9.
Repeat this procedure to select standard groups for other QC logs.
The [LATEX SET] key is available from the CUSTOMIZE QC
DISPLAY Screen for Standard Groups. This key is used to customize the
QC file to store information generated by latex particles. Information is stored for each of the four angles of scatter which are used to determine the differential. This key is intended for Abbott Service personnel.
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3000 System Operator’s Manual
5-27
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Operating Instructions
Search Book TOC Go Back
Chapter 5
CUSTOMIZE
PRINTOUT
CUSTOMIZE QC PRINTOUT
Ready
FOR Normal
Dec 17 1992
Operator ID
Sequence #
16:49
734
0630
WBC %N %L %M %E %B RBC HGB HCT MCV MCH MCHC
RDW PLT MPV UMT1 CNT1
WBC NEU
RBC HGB
LYM
HCT
MONO EOS
MCV MCH
BASO
MCHC RDW
PLT MPV
%N
PCT
%L
PDW
%M %E %B
UMT1 UMT2 CNT1 CNT2
SELECT
PARAMETER
STANDARD
SELECTION
RETURN
Figure 5.14: Customize QC Printout Screen
The [CUSTOMIZE PRINTOUT] key is used to customize the printout format for the QC logs. (See Figure 5.14.) The following soft key labels are displayed when the [CUSTOMIZE PRINTOUT] key is pressed:
SELECT PARAMETER
STANDARD SELECTION
RETURN
The CUSTOMIZE QC PRINTOUT Screen displays the group of parameters that is currently selected. A list of all available parameters is displayed under the group. The following parameters are included in the list and may be printed in the QC Log if desired:
UMT1 and UMT2 — UMT1 is the RBC/PLT Upper Metering
Time. UMT2 is the RBC/PLT Upper
Metering Time for an extended count.
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CNT1 and CNT2 — CNT1 is the RBC/PLT Count Time. CNT2 is the RBC/PLT Count Time for an extended count.
The [STANDARD SELECTION] key is used to automatically arrange the parameters in a predetermined print group.
Procedure Customize QC Log Printout
1.
Select a file from the
QC SETUP MENU Screen by moving the
cursor to the desired file.
2.
Press [CUSTOMIZE PRINTOUT] to display the CUSTOMIZE
QC PRINTOUT Screen for the selected file.
3.
Use the Arrow keys on the keyboard to move the cursor to the desired parameter in the list under the printout group.
4.
Press [SELECT PARAMETER]. The selected parameter is highlighted and the cursor moves to the first position in the group.
NOTE: The key label changes to [PLACE PARAMETER] and a [CANCEL SELECTION] key is displayed.
STANDARD
SELECTION
5.
If necessary, use the Arrow keys on the keyboard to move the cursor to the desired location and press [PLACE PARAMETER].
NOTE: When the [PLACE PARAMETER] key is pressed, the selected parameter is displayed in the position indicated by the cursor and the cursor then advances to the next parameter in the list under the printout group.
6.
Repeat steps 3–5 until all entries have been made.
7.
If desired, press the Print Screen key on the keyboard to obtain a printout of the configuration.
8.
Press [RETURN] to return to the QC SETUP MENU Screen.
9.
Repeat this procedure to customize the printout for other QC logs.
When the [STANDARD SELECTION] key is pressed, the parameters are automatically arranged in the predetermined print group shown in
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Operating Instructions
Search Book TOC Go Back
Chapter 5
OPERATION SETUP MENU
Ready
Dec 08 1992
Operator ID
Sequence #
16:11
734
0067
OPERATION
SETUP
BARCODE
SETUP
COMPUTER
SETUP
RETURN
Figure 5.15: Operation Setup Menu Screen
The OPERATION SETUP MENU Screen (see Figure 5.15) allows the operator to configure the transmission to an on-line computer. The following soft key labels are displayed when the [OPERATION
SETUP] key is pressed:
BAR CODE SETUP
COMPUTER SETUP
RETURN
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BAR CODE SET UP
Ready
Dec 08 1992
Operator ID
Sequence #
16:12
0068
1
OFF
Bar Code Symbology (1=CODE39, 2=I2OF5, 3=CODABAR)
Bar Code Check Digit
SET UP
BAR CODE
SETUP
Procedure Bar Code Set Up
Figure 5.16: Bar Code Set Up Screen
The [BAR CODE SETUP] key is used to select the type of bar code to be read and to enable or disable the check digit option for a specific bar code. (See Figure 5.16.) If the check digit option is enabled, the Analyzer reads only the type of bar code selected. If the option is disabled, the
Analyzer reads all three types of bar codes.
NOTE: For more information about check digits and bar codes,
refer to Appendix A, Bar Codes .
1.
From the
OPERATION SETUP MENU Screen , press [BAR
CODE SETUP] to display the BAR CODE SETUP Screen.
2.
Type the number for the type of bar code that will be used:
1 — Code 39
2 — Interleaf 2 of 5
3 — Codabar
Press the Enter key on the keyboard to save the entry and advance the cursor.
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3000 System Operator’s Manual
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9140240E — May 1995
3.
Press [TOGGLE ON/OFF] to enable or disable the check digit.
NOTE: The [TOGGLE ON/OFF] key is displayed only when the cursor is positioned next to BAR CODE CHECK DIGIT.
4.
Press [SETUP] to return to the OPERATION SETUP Screen .
COMPUTER SETUP
Ready
Dec 08 1992
Operator ID
Sequence #
16:13
734
0070
3
4
5
1
2
OFF
OFF
OFF
OFF
1
0
OFF
8
0.3
9600
Auto-transmission of ALERTED parameter data
Auto-transmission of NON-ALERTED parameter data
Auto-transmission of ALERTED graph data
Auto-transmission of NON-ALERTED graph data
Transmission CTS enabled
Transmission Data bits (7, 8)
Transmission Stop bits (1, 2)
Transmission Parity (0=None, 1=Odd, 2=Even)
Transmission time out (0.1 to 9.9)
Computer Baud Rate (300, 600, 1200, 2400, 4800, 9600)
COMPUTER
SETUP
REINIT
INTERFACE
STOP
TRANSMISS
TOGGLE
ON/OFF
RETURN
Figure 5.17: Computer Setup Screen
The [COMPUTER SETUP] key is used to display the COMPUTER
SETUP Screen (see Figure 5.17) and the following soft key labels:
REINIT INTERFACE
STOP TRANSMISS
TOGGLE ON/OFF
RETURN
The CELL-DYN 3000 can transmit data to an on-line computer
(Laboratory Information System). Data may be transmitted automatically as each sample is run or at the operator’s request. The CELL-DYN 3000 also can receive patient information transmitted to it by the on-line computer.
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REINIT/
INTERFACE
STOP
TRANSMISS
TOGGLE
ON/OFF
The
COMPUTER SETUP Screen is used to configure the transmission
format to meet the requirements of the Laboratory Information System or on-line computer. Instructions for using this option are given after the following description of the soft keys.
The [REINIT INTERFACE] key is used to initialize the RS-232 interface for the displayed transmission configuration after it is entered.
The interface is automatically initialized whenever the [STOP
TRANSMISS] key is pressed.
NOTE: Refer to the Interface Specification for complete information on interfacing or calling Customer Support Center at
1 (800) CELL DYN.
The [STOP TRANSMISS] key stops the current data transmission to the on-line computer. When the [STOP TRANSMISS] key is pressed, the following soft key labels are displayed:
CONFIRM STOP
CANCEL STOP
These keys confirm or cancel the Stop Transmission command.
The [TOGGLE ON/OFF] key enables or disables the first five options in the list displayed on the COMPUTER SETUP Screen.
The numbers on the COMPUTER SETUP Screen shown in Figure 5.17
correspond to the following numbered options:
1.
Auto-transmission of ALERTED parameter data
When this option is enabled, a report is automatically transmitted to the LIS for any sample with flagged parameter results.
2.
Auto-transmission of NON-ALERTED parameter data
When this option is enabled, a report is automatically transmitted to the LIS for any sample without flagged parameter results.
3.
Auto-transmission of ALERTED graphic data
When this option is enabled, histograms and scatterplots are automatically transmitted to the LIS for any sample with flagged results.
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Procedure Computer Setup
4.
Auto-transmission of NON-ALERTED graphic data
When this option is enabled, histograms and scatterplots are automatically transmitted to the LIS for any sample without flagged results.
5.
The remaining options are configured according to the requirements of the LIS:
Transmission CTS enabled
Transmission Data bits (7, 8)
Transmission Stop bits (1, 2)
Transmission Parity (0=None, 1=Odd, 2=Even)
Transmission time out (0.1 to 9.9)
Computer Baud Rate (300, 600, 1200, 2400, 4800, 9600)
The numbers in parentheses after the options indicate the selections available.
NOTE: Refer to the Interface Specification for complete information on interfacing or call the Customer Support Center at 1 (800) CELL DYN.
1.
From the
OPERATION SETUP MENU Screen , press
[COMPUTER SETUP] to display the
2.
For the first five options on the list, use the Arrow keys on the keyboard to move the cursor to the desired selection and press
[TOGGLE ON/OFF] to enable or disable the selection.
NOTE: The [TOGGLE ON/OFF] key is displayed when the cursor is positioned in any of the first five entry fields.
3.
For the last five options on the list, type the appropriate information and press the Enter key on the keyboard to save the entry and advance the cursor.
4.
When all the information has been entered, press [REINIT
INTERFACE] to initialize the interface for the selected configuration.
5.
If desired, press the Print Screen key on the keyboard to obtain a printout of the configuration.
6.
Press [RETURN] to return to the OPERATION SETUP MENU
7.
Press [RETURN] to return to the SETUP MENU Screen .
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Chapter 5 Search Book TOC Go Back Operating Instructions
UNITS SELECTION
Ready
Dec 08 1992
Operator ID
Sequence #
16:16
734
0070
Parameters
WBC:
RBC:
HGB:
HCT:
RDW:
PLT:
PCT:
USA
K/uL
M/uL g/dL
%
%
K/uL
%
SI
G/L
T/L g/L
L/L
%CV
G/L mL/L
SI MOD
10e9/L
10e12/L mmol/L
L/L
%CV
10e9/L mL/L
MIXED
10e3/uL
10e6/uL g/L
%
%CV
10e3/uL
%
UNITS
SELECTION
USA
UNITS
SI
UNITS
SI MOD
UNITS
MIXED
UNITS
SELECT
UNITS
RETURN
Figure 5.18: Units Selection Screen
The [UNITS SELECTION] key selects the report units for the indicated parameters. Units may be selected for each parameter individually or a set of units may be selected by pressing the appropriate soft key. (See
Figure 5.18.) The following soft key labels are displayed when the
[UNITS SELECTION] key is pressed:
USA UNITS
SI UNITS
SI MOD UNITS
MIXED UNITS
SELECT UNITS
RETURN
The units selected by each of the soft keys are shown on the screen
display in Figure 5.18. The following table shows an example of the
same sample displayed with each of the four units selections.
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9140240E — May 1995
5-35
TABLE 5.1: Report Units
Parameter
USA SI SI MOD MIXED
Value Units Value Units Value Units Value Units
WBC* 5.32 K/µL 5.32 G/L 5.32 10e9/L 5.32 10e3/µL
RBC 5.15 M/µL 5.15 T/L 5.15 10e12/L 5.15 10e6/µL
HGB 16.2 g/dL 162 g/L 10.1*** mmol/L 162 g/L
HCT 47.6 % 0.476 L/L 0.476 L/L 47.6 %
MCV 92.3 fL 92.3 fL 92.3 fL 92.3 fL
MCH 31.5 pg 31.5 pg 1.96 fmol 31.5 pg
MCHC 34.1 g/dL 341 g/L 21.2 mmol/L 341 g/L
RDW 12.5 % 12.5 %CV 12.5 %CV 12.5 %CV
PLT 323 K/µL 323 G/L 323 10e9/L 323 10e3/µL
MPV 8.26 fL 8.26 fL 8.26 fL 8.26 fL
PCT 0.267 % 2.67 mL/L 2.67 mL/L 0.267 %
PDW** 17.5 10GSD 17.5 10GSD 17.5 10GSD 17.5 10GSD
* The absolute values for NEU, LYM, MONO, EOS and BASO are reported in the same units as the WBC
** Report Unit is Geometric Standard Deviation
*** Conversion factor based on MW of hemoglobin of 16,000.
Procedure Units Selection
1.
From the
SETUP MENU Screen , press [UNITS SELECTION].
2.
Press the appropriate soft key to select the desired units. The group of selected units is highlighted on the screen.
OR
3.
For individual unit selection, use the Arrow keys on the keyboard to move the cursor to the desired units.
4.
Press [SELECT UNITS] to enter the selection. The chosen selection is highlighted on the display.
5.
Use the Arrow keys on the keyboard to move the cursor to the next unit to be selected.
6.
Repeat steps 3-5 until all selections have been made.
7.
If desired, press the Print Screen key on the keyboard to obtain a printout of the selected units.
8.
Press [RETURN] to return to the SETUP MENU Screen .
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CUSTOMIZE
REPORT
CUSTOMIZE
DISPLAY
The [CUSTOMIZE REPORT] key is used to customize the displayed and printed report. Three options are available:
CUSTOMIZE DISPLAY
CUSTOMIZE PRINTOUT
CUSTOMIZE HEADER
The [CUSTOMIZE REPORT] key may also be accessed from the
DISPLAY SPECIMEN Screen in the Data Log.
When the [CUSTOMIZE REPORT] key is pressed, the screen that was used for the last entry is displayed. For ease of explanation, each option is discussed individually.
ON WBC
ON NEU ON %N
O N LYM ON %L
ON MONO ON %M
ON EOS ON %E
ON BASO ON %B
ON RBC
ON HGB
ON HCT
O N MCV
ON MCH
ON MCHC
ON RDW
ON PLT
O N MPV
CUSTOMIZE DISPLAYED REPORT
Ready
PARAMETER SET 1 SELECTED
May 11 1992
Operator ID
Sequence #
Size-Cmp Scatter
Orthognl Scatter
10 deg-90 deg
0 deg-90 deg
10 deg-Depol
0 deg-Depol
L-B-M Histogram
M-P Histogram
RBC Histogram
PLT Histogram
Empty
11:09
734
3452
Size-Cmp Scatter Orthognl Scatter
PARAM
SET 2
PARAM
SET 3
PARAM
SET 4
RBC Histogram PLT Histogram
CUSTOMIZE
PRINTOUT
CUSTOMIZE
HEADER
SELECT
GRAPH
SETUP
Figure 5.19: Customize Displayed Report Screen
The CUSTOMIZE DISPLAYED REPORT Screen appears (see
Figure 5.19) for the indicated parameter set, and the following soft key labels are displayed when the [CUSTOMIZE DISPLAY] key is pressed:
PARAM SET 1*
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9140240E — May 1995
PARAM SET 2*
PARAM SET 3*
PARAM SET 4*
CUSTOMIZE PRINTOUT
CUSTOMIZE HEADER or
CANCEL GRAPH (This key label alternates between these two selections when [SELECT GRAPH] is pressed.)
SELECT GRAPH or
PLACE GRAPH or
TOGGLE PARAMETER (The key label alternates among these three selections when the soft key is pressed.)
SETUP
* The soft key for the displayed parameter set is not displayed.
Using the [PARAM SET "X"] key, the display may be customized for four different sets of parameters. Up to 20 individual parameters and up to four scatterplots and/or histograms may be displayed in each set. (An
“empty” selection may be used to “blank” the scatterplot or histogram display at the selected position.) The screen is divided into two sections.
Individual parameters are listed in the left section and the scatterplots and histograms are listed in the right section.
Procedure Customize Display
1.
From the
SETUP MENU Screen , press [CUSTOMIZE
REPORT] and if necessary, press [CUSTOMIZE DISPLAY] to display a parameter set.
2.
If desired, press [PARAM SET "X"] to select a different parameter set.
3.
Use the Arrow keys on the keyboard to move the cursor to the desired parameter in the list displayed on the left section of the screen.
4.
Press [TOGGLE PARAMETER] to turn the display OFF or ON and advance the cursor to the next parameter. The cursor moves through the entire list of parameters in this section of the screen and, when at the bottom, returns to the top of this list.
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CUSTOMIZE
PRINTOUT
NOTE: The [TOGGLE PARAMETER] key is displayed only when the cursor is positioned in the list of individual parameters displayed on this section of the screen.
5.
When all parameter selections have been made, move the cursor to the top of the parameter list and use the Arrow keys on the keyboard to move the cursor to the desired scatterplot or histogram listed on the left side of this section of the screen.
6.
Press [SELECT GRAPH] to select it. The scatterplot or histogram name is highlighted and the cursor moves to the lower left-hand corner of a display position. The key label changes to [PLACE
GRAPH] and the [CANCEL GRAPH] key is displayed.
7.
If necessary, use the Arrow keys on the keyboard to move the cursor to the desired display position.
8.
Press [PLACE GRAPH] to display the selection at the indicated position.
9.
The cursor moves through the entire list of scatterplots and
histograms. Repeat steps 3 –8 until all desired selections have been
made for the current Parameter Set.
10.
If desired, press the Print Screen key on the keyboard to obtain a printout of the selected Parameter Set.
11.
Press [PARAM SET "X"] to select another Parameter Set and repeat steps 3–10 to customize the display for it.
12.
Press [SETUP] to return to the
.
The [CUSTOMIZE PRINTOUT] key is used to customize the printout for the Graphics Printer or the Ticket Printer. For ease of explanation, the two printer types are discussed individually. Specific instructions are given for customizing a report from the Graphics Printer or for a blank or pre-printed ticket from the Ticket Printer. When the [CUSTOMIZE
PRINTOUT] key is pressed, some of the soft key labels change with the type of printer that is selected. The following soft key labels are displayed when the key is pressed:
GRAPHICS PRINTER or
TICKET PRINTER (The key label alternates between these two selections when the soft key is pressed.)
CUSTOMIZE DISPLAY
STOP PRINTING
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Operating Instructions
CUSTOMIZE
DISPLAY
STOP
PRINTING
TOGGLE
ON/OFF
Search Book TOC Go Back
Chapter 5
CUSTOMIZE HEADER
TOGGLE ON/OFF
SETUP
RESTORE HEADER
BLANK HEADER
(Displayed after other keys are pressed.)
(Displayed after other keys are pressed.)
When the [TICKET PRINTER] key is pressed, the following soft key label is also displayed:
BLANK TICKET or
PRE-PRNTD TICKET (The key label alternates between these two selections.)
When the [CUSTOMIZE PRINTOUT] key is pressed, the screen that was used for the last entry is displayed. A brief description of the function of the soft keys is given in this section. For ease of explanation, the keys are grouped according to the type of printer selected.
The [CUSTOMIZE DISPLAY] key is used to customize the display as discussed in the preceding section.
The [STOP PRINTING] key is used to stop printing that is in progress.
When the [STOP PRINTING] key is pressed, the following soft key labels are displayed:
CONFIRM STOP
CANCEL STOP
These keys confirm or cancel the stop printing command. If [CONFIRM
STOP] is pressed, the print buffer (the memory area where the material is stored while awaiting printing) is cleared and the bulletin line displays the message:
PRINTING STOPPED. RESET PAPER TO THE TOP OF THE
PAGE
The [TOGGLE ON/OFF] key enables or disables the option selected by the position of the cursor. The key label is not displayed when a numeric entry is required.
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The [SETUP] key is used to return to the SETUP Menu Screen .
SETUP
GRAPHICS
PRINTER
CUSTOMIZE PRINTED REPORT
Ready
Dec 08 1992
Operator ID
Sequence #
16:58
734
0630
6
7
4
5
1
2
3
8
9
10
11
OFF
OFF
OFF
OFF
OFF
OFF
OFF
OFF
OFF
OFF
66
GRAPHICS PRINTER
AUTO-PRINT results for ALERTED specimens
AUTO-PRINT results for NON-ALERTED specimens
Print graphs for ALERTED specimens only
Print PCT, PDW results
Print X-B Program status
Print Interpretive Report
Print Limits Report
Print Manual Differential Grid for ALERTED specimens
Print Manual Differential Grid for NON-ALERTED specimens
Suppress WBC, RBC, HGB, or PLT value if its flag is set
Line-feeds per page for graphics printer (1 to 99)
TICKET
PRINTER
CUSTOMIZE
DISPLAY
STOP
PRINTING
CUSTOMIZE
HEADER
TOGGLE
ON/OFF
SETUP
Figure 5.20: Customize Printed Report Screen for the Graphics Printer
When the [GRAPHICS PRINTER] key is pressed, the CUSTOMIZE
PRINTED REPORT Screen for the Graphics Printer is displayed. The numbers on the CUSTOMIZE PRINTED REPORT Screen shown in
Figure 5.20 correspond to the following numbered options:
1.
AUTO-PRINT results for ALERTED specimens
When this option is enabled, a report is automatically printed for any sample with flagged results.
2.
AUTO-PRINT results for NON-ALERTED specimens
When this option is enabled, a report is automatically printed for any sample without flagged results.
3.
Print graphs for ALERTED specimens only
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9140240E — May 1995
When this option is enabled, scatterplots and histograms are printed only for samples with flagged results.
4.
Print PCT, PDW results
When this option is enabled, the results for PCT and PDW are printed on the report.
NOTE: Clinical significance has not been established for these parameters. Therefore, they are not reportable.
5.
Print X-B Program status
When this option is enabled, the status of the X-B program is printed on the report.
6.
Print Interpretive Report
When this option is enabled, the Interpretive Report messages are printed on the report. These messages are generated when results exceed the Patient Limits and/or instrument-generated flags are
7.
Print Limits Report
When this option is enabled, the Patient Limits set that was applied to the results is printed on the report.
8.
Print Manual Differential Grid for ALERTED specimens
When this option is enabled, a grid that can be used to report a manual Differential is printed on the report for any specimen that is flagged.
9.
Print Manual Differential Grid for NON-ALERTED specimens
When this option is enabled, a grid that can be used to report a manual Differential is printed on the report for any specimen that is not flagged.
10.
Suppress WBC, RBC, HGB, or PLT value if its flag is set.
When this option is enabled, flagged results are not displayed on the RUN Screen or in the Data Log.
11.
Line-feeds per page for graphics printer (1 to 99)
This option is used to select the size of the printed report.
(A graphics report typically has 66 lines.)
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Procedure Customize Graphics Report
1.
From the CUSTOMIZE REPORT Screen if necessary, press
[GRAPHICS PRINTER] to display the
PRINTED REPORT Screen for the Graphics Printer.
2.
Use the Arrow keys on the keyboard to move the cursor to the desired selection.
3.
Press [TOGGLE ON/OFF] to enable or disable the selection.
4.
Repeat steps 2 and 3 until all selections have been made.
5.
A numeric entry is required for the <LINE-FEEDS PER PAGE
FOR GRAPHICS PRINTER> field. Type the desired number of line-feeds in the entry field and press the Enter key on the keyboard to save the entry and advance the cursor. (An 8 1/2" x 11" sheet of paper has 66 lines per page.)
6.
If desired, press the Print Screen key on the keyboard to obtain a printout of the selections.
7.
If desired, press [SETUP] to return to the
or continue with the following procedure for customizing the header.
CUSTOMIZE PRINTOUT HEADER
Ready
Dec 17 1992
Operator ID
Sequence #
16:58
734
0630
Please enter the number of lines for the customize header (0..4) : 0
Print current Date/Time and Software Version : OFF
......................1......................2......................3......................4......................5......................6......................7....................
RESTORE
HEADER
BLANK
HEADER
CUSTOMIZE CUSTOMIZE
DISPLAY PRINTOUT
Figure 5.21: Customize Printout Header Screen
SETUP
CELL-DYN
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9140240E — May 1995
CUSTOMIZE
HEADER
The [CUSTOMIZE HEADER] key is used to customize the header for
the graphics report. (See Figure 5.21
.) Any report printed in a graphics
format will be printed with this header. The following soft key labels are displayed when the [CUSTOMIZE HEADER] key is pressed:
RESTORE HEADER
BLANK HEADER
CUSTOMIZE DISPLAY
CUSTOMIZE PRINTOUT
SETUP
The [BLANK HEADER] key is used to erase the current header.
BLANK
HEADER
RESTORE
HEADER
The [RESTORE HEADER] key is used to restore the header to the previous entry. This key is only functional immediately after a new header has been entered. Once a new header is entered and the
CUSTOMIZE PRINTOUT HEADER Screen has been exited, the
previous header is removed from the memory.
Procedure Customize Graphics Header
1.
From any CUSTOMIZE PRINTED REPORT Screen , press
[CUSTOMIZE HEADER] to display the
2.
Type the desired number of lines for the header in the indicated field. The header can include up to four lines.
3.
Press the Enter key on the keyboard to save the entry and advance to the next entry field.
4.
Press [TOGGLE ON/OFF] to enable or disable the PRINT
CURRENT DATE/TIME AND SOFTWARE VERSION option and advance the cursor to the next entry field.
5.
Type the information to be displayed on the first line of the header.
Each line holds 77 characters. (Existing information may be typed over or an existing header may be deleted by pressing the [BLANK
HEADER] key.)
NOTE: The numbers displayed above the header box on the screen indicate the position of the header on the printed page. For example, centering the header/information under the number 4 centers the header on the page.
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TICKET
PRINTER
6.
Press the Enter key on the keyboard to save the entry and advance the cursor.
7.
Repeat steps 5 and 6 for each line of the header.
8.
Press [SETUP] to return to the SETUP MENU Screen .
Two options are available when the [TICKET PRINTER] key is pressed:
PRE-PRNTD TICKET or
BLANK TICKET (The key label alternates between these two selections when the soft key is pressed.)
The [PRE-PRNTD TICKET] key is used to customize the printed report for a preprinted ticket. The [BLANK TICKET] key is used to customize the printed report for a blank ticket.
CUSTOMIZE PRINTED REPORT
Ready
Dec 18 1992
Operator ID
Sequence #
08:58
734
0630
1 OFF
2
3
4
OFF
OFF
OFF
TICKET PRINTER - PRE-PRINTED TICKET
AUTO-PRINT results for ALERTED specimens
AUTO-PRINT results for NON-ALERTED specimens
Print PCT, PDW results
BLANK
TICKET
GRAPHICS
PRINTER
CUSTOMIZE
DISPLAY
STOP
PRINTING
CUSTOMIZE
HEADER
TOGGLE
ON/OFF
SETUP
Figure 5.22: Customize Printed Report Screen for Pre-Printed Tickets
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9140240E — May 1995
PRE-PRNTD
TICKET
When the [PRE-PRNTD TICKET] key is pressed, the CUSTOMIZE
PRINTED REPORT Screen is displayed. The numbers on the screen
correspond to the following numbered options:
1.
TICKET PRINTER — PREPRINTED TICKET
When this option is enabled, the ticket printer is configured for a preprinted ticket. (The blank ticket option is automatically turned
OFF.)
2.
AUTO-PRINT results for ALERTED specimens
When this option is enabled, results for flagged specimens are automatically printed as tickets are inserted in the printer. Flagged results are marked with an asterisk (*).
3.
AUTO-PRINT results for NON-ALERTED specimens
When this option is enabled, results for specimens that are not flagged are automatically printed as tickets are inserted in the printer.
4.
Print PCT, PDW results
When this option is enabled, the PCT and PDW are printed on the ticket.
NOTE: Clinical significance has not been established for these parameters. Therefore, they are not reportable.
Procedure Customize Pre-Printed Ticket
1.
From the CUSTOMIZE PRINTED REPORT Screen , if
necessary, press [PRE-PRNTD TICKET] to display the
CUSTOMIZE PRINTED REPORT Screen for the Ticket Printer
using pre-printed tickets.
2.
Use the Arrow keys on the keyboard to move the cursor to the desired option.
3.
Press [TOGGLE ON/OFF] to enable or disable the selected option.
4.
Repeat steps 2 and 3 until all selections have been made.
5.
If desired, press the Print Screen key on the keyboard to obtain a printout of the selections.
6.
Press [SETUP] to return to the SETUP MENU Screen .
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3000 System Operator’s Manual
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Chapter 5 Search Book TOC Go Back Operating Instructions
1
ON
4
5
2
3
8
9
6
7
OFF
OFF
OFF
OFF
OFF
OFF
OFF
68
10 2
CUSTOMIZE PRINTED REPORT
Ready
Dec 18 1992
Operator ID
Sequence #
TICKET PRINTER - BLANK TICKET
AUTO-PRINT results for ALERTED specimens
AUTO-PRINT results for NON-ALERTED specimens
Print PCT, PDW results
Print Limits Report
Print Specific Alerts
Print Manual Differential Grid for ALERTED specimens
Print Manual Differential Grid for NON-ALERTED specimens
Line-feeds per page for ticket printer (1 to 99)
Number of lines for the customize ticket header (0 to 2)
...................1...................2...................3...............
08:57
734
0630
BLANK
TICKET
RESTORE
HEADER
PRE-PRNTD
TICKET
GRAPHICS
PRINTER
CUSTOMIZE
DISPLAY
STOP
PRINTING
CUSTOMIZE
HEADER
TOGGLE
ON/OFF
SETUP
Figure 5.23: Customize Printed Report Screen for Blank Tickets
When the [BLANK TICKET] key is pressed, the CUSTOMIZE
PRINTED REPORT Screen for blank tickets is displayed. The numbers on the screen shown in Figure 5.23 correspond to the following numbered options:
1.
TICKET PRINTER — BLANK TICKET
When this option is enabled, the Ticket Printer is configured for a blank ticket. (The pre-printed ticket option is automatically turned
OFF.)
2.
AUTO-PRINT results for ALERTED specimen
When this option is enabled, a ticket is automatically printed for any sample with flagged results. Flagged results are indicated by the letters “AL” (for alert) on the printout when the PRINT
SPECIFIC ALERTS option is turned OFF (see number 6 below).
Results that exceed Patient Limits are underlined on the printout.
3.
AUTO-PRINT results for NON-ALERTED specimens
When this option is enabled, a report is automatically printed for any sample without flagged results.
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3000 System Operator’s Manual
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5-47
4.
Print PCT, PDW results
When this option is enabled, the results for PCT and PDW are printed on the report.
NOTE: Clinical significance has not been established for these parameters. Therefore, they are not reportable.
5.
Print Limits Report
When this option is enabled, the Patient Limits set that was applied to the results is printed on the report.
6.
Print Specific Alerts
When this option is enabled, the specific flag (BAND, LRI, etc.) replaces the “AL” on the printout.
7.
Print Manual Differential Grid for ALERTED specimens
When this option is enabled, a grid that can be used to report a manual Differential is printed on the report for any specimen that is flagged.
8.
Print Manual Differential Grid for NON-ALERTED specimens
When this option is enabled, a grid that can be used to report a manual Differential is printed on the report for any specimen that is not flagged.
9.
Line-feeds per page for ticket printer (1 to 99)
This option is used to select the size of the printed report. (A blank ticket typically has 68 lines.)
10.
Number of lines for the customize ticket header (0 to 2)
This option is used to select the number of lines for the header on the blank ticket. The numbers across the top of the header can be used to center the header information on the ticket. Centering the information under the number 2 centers it on the ticket.
Procedure Customize Blank Ticket
1.
From the CUSTOMIZE PRINTED REPORT Screen , if
necessary, press [BLANK TICKET] or [TICKET PRINTER] to display the
CUSTOMIZE PRINTED REPORT Screen for the
blank ticket.
2.
Use the Arrow keys on the keyboard to move the cursor to the desired selection.
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3.
Press [TOGGLE ON/OFF] to enable or disable the selection.
4.
Repeat steps 2 and 3 until all selections have been made.
5.
A numeric entry is required for the <LINE-FEEDS PER PAGE
FOR TICKET PRINTER> field (a blank ticket typically has 68 lines) and the <NUMBER OF LINES FOR THE CUSTOMIZE
TICKET HEADER> field.
6.
Type the desired number of line-feeds in the entry field and press the Enter key on the keyboard to save the entry and advance the cursor.
7.
Type the desired number of lines for the header and press the Enter key on the keyboard to save the entry and advance the cursor.
8.
Type the first line of the header and press the Enter key on the keyboard to save the entry and advance the cursor. Each line holds
35 characters. If desired, type a second line and press the Enter key on the keyboard to save the entry and advance the cursor.
9.
If desired, press the Print Screen key on the keyboard to obtain a printout of the selections.
10.
Press [SETUP] to return to the
CELL-DYN
3000 System Operator’s Manual
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Operating Instructions
Search Book TOC Go Back
NOTES
Chapter 5
5-50
CELL-DYN
3000 System Operator’s Manual
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Introduction
Routine Operation
This section contains information and procedures that are recommended for the routine operation of the CELL-DYN 3000. The Sample Analysis
section gives instructions for running samples on both the Sample Loader
and Closed Sampler versions of the CELL-DYN 3000. For convenience,
instructions for running samples in the Open Mode are included in each
section. Refer to Chapter 12, Sample Loader , for a complete description
of Sample Loader and to Appendix A, Bar Codes , for information on the
use of bar code labels.
MENU is the same for both versions of the instrument.
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Operating Instructions
Search Book TOC Go Back
Chapter 5
Data Station Run Menu
5-52
RUN
1
4
5
2
3
Next ID___________ Auto
Patient___________
Sex(M/F):- DOB:--/--/--
Dr_________________
Param Set: 1
WBC
NEU
LYM
Limits: 3
K/uL
MONO
EOS
BASO
%N
%L
%M
%E
%B
XB: 13/IN
Z
E
S
I
RUN
Ready
COMPLEXITY RBC
HGB
HCT
MCV
MCH
MCHC
RDW
M/uL g/dL
% fL pg g/dL
%
PLT
MPV
CLEAR
ORIFICE
K/uL fL
WORK
LIST
PLT
SPECIMEN
TYPE
CUSTOMIZE
REPORT
CHANGE
SAMPLER
TICKET
Dec 18 1992
Operator ID
Sequence #
Open Sampler
D
E
P
O
L
ORTHOGONAL
09:43
734
0630
RBC
REPORT
MAIN
Figure 5.24: Run Screen for Patient Samples
The [RUN] key is used to display the Data Station RUN Screen. (See
Figure 5.24.)
The following soft key labels are displayed when the [RUN] key is pressed:
CLEAR ORIFICE or
CLEAR FAULT ( The key label alternates between these two selections when the soft key is pressed.)
WORK LIST
SPECIMEN TYPE
CUSTOMIZE REPORT
CHANGE SAMPLER or
TOGGLE AUTO ID (The key label changes to
[TOGGLE AUTO ID] when the cursor is positioned at the Auto ID location.)
PRINT TICKET
PRINT REPORT
MAIN
CELL-DYN
3000 System Operator’s Manual
9140240E — May 1995
Data Station Run Screen
The Upper Left Corner of the Data Station RUN Screen for patient
samples displays the following data entry fields on lines 1–5:
1.
NEXT ID This field is used to enter the ID number for the next sample to be run. (Up to 12 characters may be entered.) If the Auto Increment feature is active,
AUTO is highlighted at the end of the field. Refer to
the discussion in the Sample Identification section of the Sample Analysis section in Chapter 5 for
more information about this feature.
2.
PATIENT This field is used to enter the patient’s name or identification. (Up to 16 or characters may be entered.)
NOTE: If "patient" is not the selected specimen type, then a different data entry field appears on line 2.
• "Res RBC" replaces "PATIENT" when Resistant RBC is selected.
• "QC Filename" replaces "PATIENT" when QC Specimen is selected. The number of runs in the QC file and total file space are displayed to the right of the type as in the following example: 31/120.
• "Background" replaces "PATIENT" when Background is selected.
• "ELEC BKGND" replaces "PATIENT" when Electrical
Background is selected.
3.
SEX (M/F): These fields are used to enter the sex andDOB: --
/--/-- birth date of the patient.
4.
Dr. This field is used to enter the name of the patient’s physician. (Up to 22 characters may be entered.)
XB: If the XB analysis is enabled, the XB file status is displayed to the right of the <DR> entry field.
5.
PARAM:/ These fields display the number (1–4) of the
LIMITS: Parameter and Limit sets that will be applied
to the sample results.
NOTE: The Parameter and Limit sets applied to the sample may be changed after the sample has been run. Refer to the
description of the Data Log [EDIT SPECIMEN] key given in the
“ Using the Data Log ” section of this chapter.
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Status Box
The Status Box is displayed in the Top Center of the Data Station RUN
Screen . It contains the following information:
• Menu in use
• The Status of the Analyzer — the READY, NOT READY and
FAULT messages are displayed here
• Report or File identity for results currently displayed
The Top Right Corner of the Data Station RUN Screen displays the
following information:
• Current date and time
• Operator ID — Identification of the current operator
• Sequence # — Automatically incremented as samples are run
• Selected Sampler mode — Open Sampler or Closed Sampler
The Center Section of the Data Station RUN Screen displays the results.
A list of the parameters and results is displayed on the left side.
Scatterplots and histograms are displayed on the right side. The area between the parameter data and the graphic data is used to display flagging messages. Examples of the count times and some of the
flagging messages are shown in Figure 5.25
A detailed explanation of all flagging messages is given in Chapter 3,
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Chapter 5
Bulletin Line
Search Book TOC Go Back Operating Instructions
The Bulletin Line is displayed immediately above the key labels.
Messages appear in this line to identify status or fault conditions. An example of a Bulletin Line message is shown in Figure 5.25.
Next ID _________Auto
Patient_____________
Sex(M/F):- DOB:--/---/--
Dr_____________
Param
WBC: 4.9
NEU: 3.0
LYM: 1.5
Limits: 1
K/uL
60.0
31.0
%N
%L BLAST
MONO: 0.3
EOS: 0.1
BASO: 0.1
6.2
%M
1.0
%E
1.8
%B
RUN
Cleaning RBC orifice
XB: 7/IN
SUSPECT
S
I
Z
E
RBC: M/uL
HGB: 14.3
g/dL
HCT:
MCV:
% fL
MCH:
MCHC:
RDW: pg g/dL
%
PLT:
MPV:
COMPLEXITY
K/uL fL
WORK
LIST
CLOG
UT:4.11
CT:7.00
RBC
RBC METERING FAULT - CLOG
SPECIMEN
TYPE
CUSTOMIZE
REPORT
CHANGE
SAMPLER
TICKET
Dec 18 1992
Operator ID
Sequence #
Open Sampler
D
E
P
O
L
09:43
734
0630
ORTHOGONAL
REPORT
PLT
MAIN
Figure 5.25: Run Screen Showing Bulletin Line Message
CELL-DYN
3000 System Operator’s Manual
9140240E — May 1995
5-55
Spec ID
Sequence #
FLAGGING DIAGNOSTICS
Ready
SUSPECT
BAND FLAG ESTIMATE BAND
REGION %: X.X%
IG FLAG ESTIMATE IG
REGION %: X.X%
BLAST FLAG ESTIMATE BLAST
REGION %: X.X%
VAR LYM FLAG ESTIMATE VAR
LYM
REGION %: X.X%
Z
E
S
I
May 28 1993
Operator ID
Sequence #
Closed Sampler
D
E
P
O
L
16:10
----
COMPLEXITY ORTHOGONAL
BULLETIN LINE
PLT RBC
REPORT
RETURN
Figure 5.26: Flagging Diagnostics Screen
Flagging Diagnostics Screen
The FLAGGING DIAGNOSTICS Screen can be accessed from the
DISPLAY SPECIMEN Screen from the
LOG Screen , by pressing the PAGE DOWN key on the Data Station
keypad or the computer keyboard. To return to the
DISPLAY SPECIMEN Screen , press the PAGE UP key or RETURN
key on the Data Station key pad or the computer keyboard.
If the FLAGGING DIAGNOSTICS Screen is accessed from the
Screen , while the instrument is continuing to process specimens, the
FLAGGING DIAGNOSTICS Screen does not update with the new specimen information.
The printout of the FLAGGING DIAGNOSTICS Screen obtained by pressing the [PRINT REPORT] soft key or the PRINT SCREEN key on the computer keyboard will be in the horizontal (landscape) format.
NOTE: This information is provided for laboratory use only.
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The Spec ID and Sequence Number for the specimen displayed appears in the upper left hand corner of the display and printout. The information in the upper right hand corner displays the current operational status of the Analyzer. This includes the current date, time, operator ID, current specimen sequence number and sampler status (Open or Closed).
The data displayed on the left side of the
Screen and printout provide supplemental information regarding the
suspect population flags for BAND, IG, VAR LYM, VLYM/BLAST and
NRBC. The word SUSPECT will also appear above the suspect
population flags as it does on the RUN and
Screens . The number of cells found in each region associated with the
suspect population flag is displayed as a percentage of the total WBC value. The region percentages displayed on the
DIAGNOSTICS Screen are used as criteria for the suspect population
flags displayed on the RUN Screen and the
Screen , thus providing additional information as to potential severity of the
flag.
The graphs located on the right side of the FLAGGING
DIAGNOSTICS Screen are determined by the parameter set which had
been selected for the specimen displayed. The parameter set is indicated on the
DISPLAY SPECIMEN Screen . On the most
current 2000 specimens in the Data Log, the parameter set can be edited after the sample has been processed using the [EDIT SPECIMEN] soft key on the
NOTE: These data are provided for laboratory use only. The information may be incorporated into your laboratory's review criteria and guidelines. Whenever a morphological flag is displayed, a stained smear should be reviewed.
CELL-DYN
3000 System Operator’s Manual
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Operating Instructions
Search Book TOC Go Back
Chapter 5
Data Station Run Screen Soft Keys
A brief description of the function of each key is given in this section.
Instructions for running samples and using the Work List are given in the
Sample Analysis sections of this chapter.
CLEAR
ORIFICE
CLEAR
FAULT
The [CLEAR ORIFICE] key is used to initiate a special cleaning sequence that flushes the RBC/PLT aperture to remove obstructions. The sequence takes approximately 35 seconds. When the [CLEAR
ORIFICE] key is pressed, the message CLEANING RBC ORIFICE is displayed in the Status Box.
The [CLEAR ORIFICE] key label changes to [CLEAR FAULT] whenever a system fault occurs (e.g., Diluent Empty). This key is used to clear the fault message and return the Analyzer to the “Ready” status after corrective action has been taken.
NOTE: A message describing the fault appears in the bulletin line. A list of fault conditions and corrective action is given in
Chapter 10, Troubleshooting , of this manual.
Work List OFF
797
798
799
800
793
794
795
796
Bar Code On
# 4-DIGIT
BAR CODE
1793
1794
1795
1796
1797
1798
1799
1800
SPECIMEN
ID
WORK LIST
Ready
Dec 18 1992
Operator ID
Sequence #
09:48
734
0630
SPECIMEN
NAME
LIMIT PARAM STATUS RACK-TUBE
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
WORK LIST
ON
BAR CODE
OFF
INSERT/
DELETE
DELETE
ALL
PURGE
COMPLETED
WORK LIST
SET UP
WORK LIST
RETURN
Figure 5.27: Work List Screen
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3000 System Operator’s Manual
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WORK
LIST
This key is used to display the WORK LIST Screen . (See Figure 5.27
The following soft key labels are displayed when the [WORK LIST] key is pressed:
WORK LIST ON or
WORK LIST OFF (The key label alternates
between these two selections.)
BAR CODE ON or
BAR CODE OFF (The key label alternates
between these two selections.)
INSERT/DELETE
DELETE ALL
PURGE COMPLETED
WORK LIST SET UP
PRINT WORK LIST
RETURN
The Work List is used to preassign sample identification, display and print criteria for samples that will be run. It is essentially a list of samples
(including the preassigned information) that the operator intends to run on the instrument. The Work List may be used with or without bar code labels on the tubes. The functions of the Work List keys are described in
the Sample Analysis: Using the Work List section of this chapter.
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3000 System Operator’s Manual
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9140240E — May 1995
Operating Instructions
Search Book TOC Go Back
Chapter 5
SPECIMEN
TYPE
SPECIMEN TYPE
Ready
Dec 18 1992
Operator ID
Sequence #
09:55
734
0630
File Name
5.
6.
7.
8.
1.
2.
3.
4.
Low
Normal
High low normal high
Replicate
FILE 8
9.
10.
FILE 9
FILE 10
# Specimens
0
0
0
0
11
13
0
0
0
0
15.
16.
17.
18.
11.
12.
13.
14.
19.
20.
File Name
Patient
FILE 12
FILE 13
FILE 14
FILE 15
FILE 16
FILE 17
LOW 11
NORMAL 11
HIGH 11
Press QC SPECIMEN key to select QC FILE at cursor position.
# Specimens
0
0
0
0
30
0
0
0
0
0
PATIENT QC
SPECIMEN
BACK-
GROUND
ELECTRICL
BACKGRND
LATEX RESISTANT
RBC
RUN
Figure 5.28: Specimen Type Screen
The [SPECIMEN TYPE] key is used to select the type of specimen that will be run. (See Figure 5.28.) When the [SPECIMEN TYPE] key is pressed, the screen displays a list of the QC files and the following soft key labels:
PATIENT
QC SPECIMEN
BACKGROUND
ELECTRICAL BACKGRND
LATEX
RESISTANT RBC
RUN
The function of each key is discussed in this section.
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3000 System Operator’s Manual
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Chapter 5 Search Book TOC Go Back Operating Instructions
PATIENT
Next ID___________Auto
Patient ___________
Sex(M/F):- DOB:--/--/--
Dr ___________________
Param Set: 1 Limits: 3
WBC: K/uL
NEU:
LYM:
%N
%L
MONO:
EOS:
BASO:
%M
%E
%B
RBC:
HGB:
HCT:
MCV:
MCH:
MCHC:
RDW:
M/uL g/dL
% fL pg g/dL
%
PLT:
MPV:
CLEAR
ORIFICE
K/uL fL
WORK
LIST
XB: 13/OUT2
S
I
Z
E
RUN
Ready
COMPLEXITY
PLT
SPECIMEN
TYPE
CUSTOMIZE
REPORT
CHANGE
SAMPLER
TICKET
Dec 18 1992
Operator ID
Sequence #
Open Sampler
D
E
P
O
L
ORTHOGONAL
09:51
734
0630
RBC
REPORT
MAIN
Figure 5.29: Run Screen for Patient Samples
The [PATIENT] key is used to display the RUN Screen for patient samples. (See Figure 5.29.) Patient identification and demographics may be entered on the RUN Screen after this key is pressed. Results from this run option are stored in the Data Log.
CELL-DYN
3000 System Operator’s Manual
9140240E — May 1995
5-61
Operating Instructions
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Chapter 5
QC
SPECIMEN
Type Low
Param Set: 1
11/120
RUN
Ready
Dec 18 1992
Operator ID
Sequence #
Open Sampler
09:53
734
0630
WBC:
NEU:
LYM:
MONO:
EOS:
BASO:
RBC:
HGB:
HCT:
MCV:
MCH:
MCHC:
RDW:
PLT:
MPV:
CLEAR
ORIFICE
M/uL g/dL
% fL pg g/dL
%
K/uL
%N
%L
%M
%E
%B
K/uL fL
WORK
LIST
S
I
Z
E
COMPLEXITY
PLT
SPECIMEN
TYPE
CUSTOMIZE
REPORT
CHANGE
SAMPLER
TICKET
D
E
P
O
L
ORTHOGONAL
RBC
REPORT
MAIN
Figure 5.30: Run Screen for a QC File
This key is used to select a QC file designated by the position of the cursor on the screen. After the cursor is moved to the desired file, the
[QC SPECIMEN] key is pressed to display the RUN Screen for the selected file. (See Figure 5.30.) Results from this run option are stored in the selected file and in the Data Log and are automatically excluded from the X-B Analysis.
NOTE: The selected QC file is identified on the same line (line
2) as the Patient entry field. It will also be identified in the Status
Box after the sample has been run.
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Chapter 5 Search Book TOC Go Back Operating Instructions
BACK-
GROUND
RBC:
HGB:
HCT:
MCV:
MCH:
MCHC:
RDW:
PLT:
MPV:
Type BACKGROUND
Param Set: 1
WBC:
NEU:
LYM:
MONO:
EOS:
BASO:
K/uL
%N
%L
%M
%E
%B
M/uL g/dL
% fL pg g/dL
%
K/uL fL
CLEAR
ORIFICE
WORK
LIST
S
I
Z
E
RUN
Ready
COMPLEXITY
PLT
SPECIMEN
TYPE
CUSTOMIZE
REPORT
CHANGE
SAMPLER
TICKET
Dec 18 1992
Operator ID
Sequence #
Open Sampler
D
E
P
O
L
ORTHOGONAL
09:51
734
0630
RBC
REPORT
MAIN
Figure 5.31: Run Screen for Background Counts
The [BACKGROUND] key is used to select the run mode and display the RUN Screen for background counts. (See Figure 5.31.) Results from this run option are identified by the designation BACKGROUND in the data log and are automatically excluded from the X-B analysis.
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9140240E — May 1995
5-63
Operating Instructions
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Chapter 5
ELECTRICL
BACKGRND
LATEX
RBC:
HGB:
HCT:
MCV:
MCH:
MCHC:
RDW:
PLT:
MPV:
Type ELEC BKGND
Param Set: 1
WBC:
NEU:
LYM:
MONO:
EOS:
BASO:
K/uL
%N
%L
%M
%E
%B
M/uL g/dL
% fL pg g/dL
%
K/uL fL
CLEAR
ORIFICE
S
I
Z
E
RUN
Ready
COMPLEXITY
Dec 18 1992
Operator ID
Sequence #
Open Sampler
PLT
WORK
LIST
SPECIMEN
TYPE
CUSTOMIZE
REPORT
CHANGE
SAMPLER
TICKET
D
E
P
O
L
ORTHOGONAL
09:52
734
0630
RBC
REPORT
MAIN
Figure 5.32: Run Screen for Electrical Background Counts
The [ELECTRICL BACKGRND] key is used to select the run mode for Electrical Background Counts and display the RUN Screen for them.
(See Figure 5.32.) Electrical backgrounds are used to check for electrical interference in the system. (Aperture current is turned OFF during this cycle.) Results from this run option are identified by the designation
ELEC BKGND in the data log and are automatically excluded from the
X-B analysis.
The [LATEX] key is used to select the run mode for latex particles and display the RUN Screen for them. This key is used by Abbott service personnel.
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Chapter 5
RESISTANT
RBC
Search Book TOC Go Back Operating Instructions
The [RESISTANT RBC] key is used to initiate the Resistant RBC cycle.
This cycle is used to process samples containing RBCs that are resistant to the lytic action of the Sheath reagent. The sample is held in the WBC mixing chamber for approximately 15 seconds longer than the normal mixing time. The extra time enhances the osmotic lysing effect of the
Sheath reagent and reduces interference from the lytic-resistant RBCs.
NOTE: The interference caused by these RBCs frequently generates WBC and NRBC flags. The Resistant RBC cycle reduces the number of these flags generated. Normal samples run in the Resistant RBC Mode will have an increase in the false positive band flag rate.
NOTE: Specimens with suspected fragile WBC populations should not be run in the Resistant RBC Mode.
The key is available only when the Open Mode is selected.
Next ID___________Auto
ResRBC___________
Sex(M/F):- DOB:--/--/--
Dr__________________
Param: 1 Limits: 1
WBC: K/uL
NEU:
LYM:
MONO:
EOS:
BASO:
%N
%L
%M
%E
%B
RBC:
HGB:
HCT:
MCV:
MCH:
MCHC:
RDW:
M/uL g/dL
% fL pg g/dL
%
PLT:
MPV:
CLEAR
ORIFICE
K/uL fL
WORK
LIST
S
I
Z
E
RUN
Ready
COMPLEXITY
RBC
SPECIMEN
TYPE
CUSTOMIZE
REPORT
CHANGE
SAMPLER
TICKET
May 03 1995
Operator ID
Sequence #
Open Sampler
D
E
P
O
L
08:05
112
740
ORTHOGONAL
REPORT
PLT
MAIN
Figure 5.33: Run Screen for Resistant RBC
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Procedure Resistant RBC
1.
If necessary, from the RUN Screen , press [CHANGE SAMPLER]
to select the Open Mode.
2.
Press [SPECIMEN TYPE] followed by [RESISTANT RBC] to select the Resistant RBC cycle.
3.
Enter the appropriate Patient ID information on the line labeled Res
RBC.
4.
Run the sample in the Open mode.
5.
When the cycle is complete, press [SPECIMEN TYPE] followed by [PATIENT] to return to the normal RUN cycle.
The [CUSTOMIZE REPORT] key is discussed in the Setup
Instructions section of this chapter.
CUSTOMIZE
REPORT
CHANGE
SAMPLER
TICKET
REPORT
The [CHANGE SAMPLER] key is used to select the Open or Closed mode of operation. When the key is pressed, the mode changes from the mode currently selected to the other operating mode. The Status Box displays the message:
SELECTING OPEN MODE or SELECTING CLOSED MODE
When the cursor is positioned on the word AUTO (at the end of the
<NEXT ID> entry field), the key label changes to [TOGGLE AUTO
ID]. This key enables (word AUTO is highlighted) or disables the auto
The [PRINT TICKET] key is used to print a report on a ticket when the
Ticket Printer is connected to the Data Station. The report is printed on
the type of ticket that is selected from the CUSTOMIZE PRINTED
The [PRINT REPORT] key is used to print a graphics report when the
Graphics Printer is connected to the Data Station.
The [MAIN] key is used to return to the MAIN MENU Screen .
MAIN
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Chapter 5 Search Book TOC Go Back Operating Instructions
Sample Collection and Handling
WARNING: Potential Biohazard. Consider all clinical specimens and controls, calibrators, etc. that contain human blood or serum as potentially infectious. Use established, good laboratory working practices when handling these samples. Wear gloves, lab coats and suitable eye protection and follow other biosafety practices as specified in the OSHA Bloodborne
Pathogen Rule or other equivalent biosafety procedures.
Anticoagulant
All performance claims given in this manual were generated from samples collected in K
3
EDTA. Samples collected in K
2
EDTA,
Na
2
EDTA, Heparin, Sodium Citrate or Lithium EDTA may be run with no adverse effect on the instrument. Certain results may be affected by the use of these anticoagulants. Therefore, each laboratory should develop protocols for handling samples collected in these anticoagulants.
Sample Stability
Fresh whole blood samples are recommended. The ICSH defines a fresh blood sample as one processed within four hours after collection.
The hemogram parameters, RBC, HGB, HCT, MCV, MCH, MCHC,
RDW, PLT and MPV are stable (±5%) for up to 24 hours after collection.
The total WBC is stable (±5%) for up to 12 hours after collection. The stability of the total WBC decreases to ±7% at 24 hours after collection.
The WBC Differential parameters NEU, LYM, MONO, EOS and BASO are stable (±10%) for up to 12 hours after collection. An increase in false positive suspect population flags may be seen on samples processed before 30 minutes or after 4 hours from the collection time.
Stability studies indicate that samples exhibit increased stability when they are stored at room temperature rather than stored in the refrigerator.
The stability of capillary samples collected in micro collection containers may vary depending on the microtainer manufacturer. Refer to the manufacturer’s package insert for stability claims.
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Sample Collection
Interfering Substances
All samples should be collected using proper technique and following the tube manufacturer’s recommendations.
NOTE: For additional information on collecting venous and capillary samples, refer to NCCLS Standards, H3-A3
1 and H4-
A3
2
.
The recommended tube for the Sample Loader is a 13 x 75 mm tube with a hemoguard closure that draws 3 mL of blood. The sample volume in this tube ensures proper mixing by the Sample Loader.
A minimum of 250 µL should be collected for micro-collection samples.
This ensures an adequate amount of blood for the Open Mode (170 µL) aspiration.
The CELL-DYN 3000 has been designed to detect and flag samples that contain interfering substances. The following list indicates the substances that may interfere with the listed parameters.
WBC: NRBCs, lytic-resistant RBCs, PLT clumps, cryoglobulin and cryofibrinogen, fragile WBCs
RBC: Elevated WBC count, increased numbers of giant
PLTs, autoagglutination, in vitro hemolysis
HGB: Elevated WBC count, increased plasma substances
(triglycerides, bilirubin, in vivo hemolysis), lyticresistant RBCs
MCV: Elevated WBC count, hyperglycemia, in vitro hemolysis, increased numbers of giant PLTs
PLT: WBC fragments, in vitro hemolysis, microcytic RBCs, cryoglobulins, PLT clumping, increased numbers of giant PLTs
For a detailed description of the flags that are generated, refer to the
Operational Messages and Data Flagging section of Chapter 3, Principles of Operation .
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Sample Analysis
Introduction
Operator ID
Sample Identification
This section explains how samples are run on the Sample Loader and
Closed Sampler instruments. Samples should not be run until the instrument has been properly started up and daily QC checks have been performed. For convenience, directions for Daily Start Up and QC are given in each section. Directions for running samples in the Open mode are also included in each section.
Samples may be analyzed whenever the READY message is displayed in
the Status Box on the Data Station RUN Screen . Samples should be well-
mixed (a rotary mixer is preferred
3
) before they are run in the Open or
Closed mode on the CELL-DYN 3000CS version. The Sample Loader automatically mixes the samples before aspiration. However, samples must be well-mixed before they are placed in the Sample Loader racks.
The operator should enter an Operator ID before running samples. The operator ID is displayed on all screens and printed on the graphics report and the blank ticket report. It is also retained in the QC Logs and the
Data Log.
The operator ID may be entered from the MAIN Screen or the
CALIBRATION Screen . When either screen is selected, the cursor is
positioned in the <OPERATOR ID> entry field. Type up to three alphanumeric characters and press the Enter key on the keyboard to save the ID number.
Sample Identification is entered in the upper left corner of the Data
Station RUN Screen . These entry fields are made available by pressing
[SPECIMEN TYPE] followed by [PATIENT].
1.
A Sample ID number of up to 12 characters may be entered in the
<NEXT ID> entry field.
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Alerts and Indicators
2.
An Auto Increment feature is available that automatically increments the sample ID number by 1 each time a sample is run. It is selected by moving the cursor to the word AUTO displayed at the end of the <NEXT ID> entry field. The [CHANGE
SAMPLER] key changes to [TOGGLE AUTO ID]. Press the
[TOGGLE AUTO ID] key to turn the feature ON or OFF. If the word AUTO is highlighted, the feature is enabled. Enabling this feature automatically increments the ID number after the first entry is made.
NOTE: Up to 12 characters may be entered, but the auto increment feature is limited by the number of characters currently entered. The number changes to zeros when the maximum value is reached. For example, if a three-digit ID number is entered, the number changes from 999 to 000. If a five-digit number is entered, the number changes from 99999 to
00000. Therefore, leading zeros should precede the number to maximize the use of this feature.
3.
The remaining patient demographic information may be entered at the operator’s discretion.
4.
The results are displayed and printed using Parameter set 1 and
Patient Limit set 1 if no changes are made in these entry fields.
When the results are displayed (but before the next sample is run), other parameter and limits sets may be displayed by moving the cursor to the appropriate field and typing the desired number.
NOTE: When the results are stored in the Data Log, other
parameter and limits sets may be selected by using the [EDIT
SPECIMEN] key. Refer to the Using the Data Log section of
this chapter for complete instructions.
This section describes information displayed on the screen as the samples are analyzed and/or when reports are printed.
NOTE: This section does not discuss how to interpret parameter flags, which are displayed after the sample is run.
Refer to Chapter 3, Principles of Operation , for detailed
explanations of each flag.
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• Results that fall outside the range of the selected limit set are displayed in color. Yellow indicates that the result exceeded the lower limit and magenta indicates that the result exceeded the upper limit. These results are underlined on the graphics and blank ticket printouts. They are indicated by an asterisk on a preprinted ticket.
• Results that exceed the display and print capacity are indicated by
>>>> in place of the result.
• If an RBC/PLT metering fault occurs, results are suppressed for the affected parameters and the appropriate CLOG or FLOW
ERROR message is displayed. The upper metering and count times are also displayed. These messages and times are also printed in the graphics report.
NOTE: A complete explanation of metering faults is given in
Chapter 3, Principles of Operation .
• If a WBC flow error occurs, results are suppressed for the WBC and Differential and the WBC FLOW error message is displayed.
• The message SAMPLING ERROR-INCOMPLETE
ASPIRATION is displayed on the Bulletin line if insufficient sample was detected during aspiration. SAMPLING ERROR is displayed on the screen and “SAMPLING ERR” is printed on the graphics report to the right of the MCHC. The same message is printed to the right of the WBC on the preprinted ticket.
"SAMPLING ERROR" is printed above the list of parameters on the blank ticket.
NOTE: The Sample Loader automatically stops if four consecutive Sampling Errors or Metering Faults occur. The message AUTO SAMPLER CONSECUTIVE DATA FAULT is displayed on the Bulletin line.
• The [CLEAR FAULT] key is displayed and a message (e.g.,
DILUENT EMPTY) appears in the Status Box on the Data Station if a fault condition is detected. The word “Fault” on the Analyzer status indicator is illuminated in red. The Status Box displays the message FAULT: SEE DIAG or SEE SPECIAL to direct the operator to the DIAGNOSTICS or SPECIAL PROTOCOLS menu for further instructions.
NOTE: After the problem has been corrected, press [CLEAR
FAULT] to resume operation.
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Instrument Start Up
The Analyzer and Data Station power switches should be left ON at all times. The instrument has been designed to automatically maintain itself when it is idle. If the instrument is idle for five minutes, a cleaning cycle is automatically initiated. If the instrument is idle for four hours, an automatic Shutdown cycle is initiated. The instrument is placed in the
STANDBY mode at the end of the automatic Shutdown cycle.
Power to the Printer may be left ON or OFF at the operator’s discretion.
Refer to Chapter 11, Printer , for complete instructions for printer
operation.
Power to the Sample Loader may be left ON or OFF at the operator’s
discretion. Refer to Chapter 12, Sample Loader , for complete
instructions for Sample Loader operation.
A complete procedure for powering the system ON or
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Sample Analysis on the CELL-DYN 3000SL
Daily Start Up Procedure
The automatic Start Up cycle is designed to prime the flow system and run background counts whenever the STANDBY or INITIALIZED
message appears in the Status Box on the Data Station RUN Screen . The
cycle takes approximately 3.5 minutes and is activated by pressing the
[RUN] or [PRIME] key. (The [PRIME] key will be displayed instead of the [CLEAR ORIFICE] key if the instrument goes into STANDBY
Before beginning this procedure, ensure that power to all components is ON.
The power to the Analyzer should always be ON.
Start Up Procedure
1.
Be sure that the word “Ready” on the Analyzer status indicator panel is illuminated in green and the READY message is displayed
in the Status Box on the Data Station RUN Screen .
2.
If the Status Box on the Data Station RUN Screen displays
STANDBY or INITIALIZED, press [RUN] or [PRIME] to initiate the automatic Start Up cycle.
3.
Be sure that all 10 racks are in the sample loader tray (5 on each side) and the safety cover is in place.
4.
Turn the Sample Loader power switch ON. When the Sample
Loader initialization cycle is completed, the indicator on the
Sample Loader Start key blinks and the Bulletin line on the Data
Station RUN Screen displays the message
AUTO-SAMPLER READY.
5.
When the automatic start up cycle is completed, a background count is automatically performed and the Open mode is selected.
6.
Verify that the background counts are acceptable. If the background counts are unacceptable, repeat the background cycle.
If the counts are still unacceptable, troubleshoot accordingly as directed in the Troubleshooting Guide.
NOTE: Backgrounds may be repeated by pressing the touch plate.
7.
When the background counts are acceptable, perform the daily
Quality Control checks as directed in the following section.
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Sample Loader Operating Tips
1.
All Sample Loader tubing must be connected before turning on the
Sample Loader, initializing it, or changing modes.
2.
All samples must be properly mixed before they are placed in the
Sample Loader racks.
3.
If a tube has multiple labels on it, spin the tube by hand after it is put in a rack to be sure it will spin freely and therefore mix
properly. (Refer to Chapter 12, Sample Loader , for labeling
requirements.)
Daily Quality Control Checks
Quality Control checks (which confirm calibration) should be performed on a daily basis according to the laboratory’s protocol. Commercial control materials should be properly warmed and mixed according to the manufacturer’s recommendations. Patient controls should be handled according to the laboratory’s protocol.
Open Mode QC Procedure
1.
From the RUN Screen , press [SPECIMEN TYPE].
2.
Move the cursor to the desired QC file and press [QC
SPECIMEN].
3.
If necessary, press [CHANGE SAMPLER] to select the Open mode.
4.
Run the control.
NOTE: Refer to the Running Samples section following the QC
procedures for complete instructions for running samples.
5.
Verify that the results are acceptable.
NOTE: Out of control results are displayed in color.
6.
If the results are unacceptable, repeat the run. If the results are still unacceptable, obtain a new bottle of the control, be sure that it is warmed and mixed properly, and again repeat the run. If the results are still unacceptable, run the other levels of control material. If the results on all levels are unacceptable, troubleshoot accordingly as
directed in the Troubleshooting Guide .
7.
When the control results are acceptable, patient samples may be analyzed.
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Closed Mode QC
QC samples may be run on the Sample Loader using the “Q Labels,” which are bar code labels provided with the Sample Loader. Each label is designated Qx, where x indicates the file number. If these labels are placed on the control tubes, the results are automatically transmitted to the file indicated by the label. QC samples may also be run on the
Sample Loader without these labels.
NOTE: Be sure the Work List is OFF before beginning these
procedures. If necessary, refer to the Work List section of this
chapter for instructions.
QC (with Q Labels) Procedure
1.
Label each control tube with the Q label that indicates the desired
QC file.
2.
Be sure that the word “Ready” on the Analyzer status indicator panel is illuminated in green and the READY message is displayed
in the Status Box on the Data Station RUN Screen .
3.
Place the labeled tubes in the Sample Loader end rack and load the rack in the Sample Loader tray.
4.
If necessary, press [RUN] to display the RUN Screen .
5.
If necessary, press [CHANGE SAMPLER] to select the Closed mode.
6.
Be sure that all 10 racks (5 on each side) and the safety cover are in place and press the Start key on the Sample Loader.
7.
The Sample Loader reads the Q label and transmits the results to the appropriate QC file.
8.
When all controls have been run, press [MAIN] followed by [QC
LOGS].
9.
Use the Arrow keys on the keyboard to move the cursor to the desired file.
10.
Press [VIEW QC LOG] to display the QC log.
11.
Verify that the results are acceptable.
NOTE: Out of control results are displayed in color.
12.
Repeat steps 8–10 for all controls that were run.
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13.
If the results are unacceptable, repeat the run. If the results are still unacceptable, obtain a new tube of control, be sure that it is warmed and mixed properly according to the manufacturer’s recommendations and again repeat the run. If the results are still unacceptable, run the other levels of control material. If the results on all levels are unacceptable, troubleshoot accordingly as directed
in the Troubleshooting Guide .
14.
When the control results are acceptable, patient samples may be analyzed.
QC (without Q Labels) Procedure
1.
From the RUN Screen , press [SPECIMEN TYPE].
2.
Use the Arrow keys on the keyboard to move the cursor to the appropriate QC file and press [QC SPECIMEN].
3.
If necessary, press [CHANGE SAMPLER] to select the Closed mode.
4.
Place the controls in the Sample Loader end rack in the order in which they are to be run.
5.
Be sure that all 10 racks (5 on each side) and the safety cover are in place and press the Start key on the Sample Loader.
NOTE: If all QC data is going to the same file, steps 6–10 may be skipped.
6.
After the first control is aspirated, press the Pause key on the
Sample Loader.
7.
After the results are displayed, press [SPECIMEN TYPE].
8.
Use the Arrow keys on the keyboard to move the cursor to the file for the next control to be run and press [QC SPECIMEN].
9.
Press the Start key on the Sample Loader.
10.
Repeat steps 6–9 until all levels of controls have been run.
11.
When all of the controls have been run, press [MAIN] followed by
[QC LOGS].
12.
Use the Arrow keys on the keyboard to move the cursor to the desired file.
13.
Press [VIEW QC LOG] to display the QC log.
14.
Verify that the results are acceptable.
NOTE: Out of control results are displayed in color.
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Running Samples
15.
Repeat steps 12–14 for all levels of controls that were run.
16.
If the results are unacceptable, repeat the run. If the results are still unacceptable, obtain a new tube of control, be sure that it is warmed and mixed properly and again repeat the run. If the results are still unacceptable, run the other levels of control material. If the results on all levels are unacceptable, troubleshoot accordingly as
directed in the Troubleshooting Guide .
17.
When the control results are acceptable, patient samples may be analyzed.
Open Mode Analysis
The Open Sampler Mode aspirates the sample from an opened collection tube. OPEN SAMPLER is displayed in the upper right corner of the
Data Station RUN Screen when this mode is selected. The open sample
aspiration probe is available only when this mode is selected.
Open Mode Procedure
1.
If necessary, from the
RUN Screen press [CHANGE SAMPLER]
to select the Open mode.
2.
Be sure that the word “Ready” is illuminated on the Analyzer status indicator panel and READY is displayed in the Status Box on the
WARNING: Potential Biohazard. Follow established biosafety practices when performing maintenance, service or troubleshooting procedures. Wear gloves, lab coat, and suitable
eye protection. Refer to Chapter 8, Precautions, Limitations and
Hazards , for additional information.
3.
Open the sample tube and immerse the open sample aspiration probe in the well-mixed sample.
4.
Press the touch plate located behind the probe to start the cycle.
The word “Busy” on the Analyzer status indicator panel is illuminated in yellow. The Status Box on the
messages to indicate the various stages of the cycle.
5.
Remove the tube when the beep sounds. The probe moves up through the wash block to clean it.
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6.
When the cycle is completed, the probe moves down, the word
“Ready” on the Analyzer status indicator panel is illuminated in
green and the results are displayed on the Data Station RUN
7.
If automatic report printing has been specified, a report is printed according to the options selected during set up. If this has not been specified, a report may be printed by pressing [PRINT REPORT].
8.
Repeat this procedure for subsequent samples.
Closed Mode Analysis
The Closed Sampler Mode on Sample Loader instruments aspirates the sample from a closed collection tube that has been placed in a Sample
Loader rack and loaded into the Sample Loader. CLOSED SAMPLER
is displayed in the upper right corner of the Data Station RUN Screen
when this mode is selected. The bulletin line displays the message
AUTO-SAMPLER READY and the Sample Loader Start key indicator blinks when the Sample Loader is ready. The probe is retracted when this mode is selected.
NOTE: The last group of samples in a run should be placed in the Sample Loader rack known as the end rack, which automatically signals the Analyzer to stop processing. This rack has black labels on the top and a black bar on the left edge.
Closed Mode Procedure
1.
Be sure that the word “Ready” on the Analyzer status indicator panel is illuminated in green and READY is displayed in the Status
Box on the
Screen . The bulletin line should display the message
AUTO-SAMPLER READY.
2.
If necessary, from the RUN Screen press [CHANGE SAMPLER]
to select the Closed Mode.
3.
Place the well-mixed samples in the Sample Loader racks in the order in which they are to be run.
NOTE: The racks and tube positions are identified by the bar code label on the rack and indicated as R(n)T(n). These numbers appear as the Sample ID number if bar code labels are not used.
(If the Work List is used, the Sample ID number is taken from it.
Refer to the Work List section of this chapter for more
information.)
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Chapter 5
Daily Shutdown
Search Book TOC Go Back Operating Instructions
4.
Place the racks in the Sample Loader tray with the slotted side facing the Analyzer.
NOTE: All 10 racks must be in the tray (5 on each side) for the
Sample Loader to operate.
5.
Put the Sample Loader safety cover in place.
NOTE: The Sample Loader will not operate without the safety cover.
6.
Press the START key on the Sample Loader.
7.
The Sample Loader automatically processes all the samples.
Processing stops when the end rack is finished.
It is not necessary to perform a Daily Shutdown procedure as the instrument automatically goes into a STANDBY mode if it has been idle for four hours. If desired, the operator may place the instrument in the
STANDBY state by pressing [SPECIAL PROTOCOLS], followed by
[MORE], followed by [DAILY SHUTDOWN].
When the key is pressed or when the automatic shutdown is initiated, the cycle:
• Rinses the flow system
• Sets the timer control that periodically opens all of the solenoid valves to prevent pinched tubing
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Sample Analysis on the CELL-DYN 3000CS
Daily Start Up Procedure
The automatic Start Up cycle is designed to prime the flow system and run the background counts whenever the STANDBY or INITIALIZED
message appears in the Status Box on the Data Station RUN Screen . The
cycle takes approximately 3.5 minutes and is activated by pressing the
[RUN] or [PRIME] key. (The [PRIME] key will be displayed instead of the [CLEAR ORIFICE] key if the instrument goes into STANDBY
Before beginning this procedure, ensure that power to all components is
ON. The power to the Analyzer should always be ON.
Start Up Procedure
1.
Be sure that the word “Ready” on the Analyzer status indicator panel is illuminated in green.
2.
If the Status Box on the Data Station RUN Screen displays
STANDBY or INITIALIZED, press [RUN] or [PRIME] to initiate the automatic Start Up cycle.
3.
When the cycle is complete, a background count is automatically performed and the Open mode is selected.
4.
Verify that the background counts are acceptable. If the background counts are unacceptable, repeat the background cycle.
If the counts are still unacceptable, troubleshoot accordingly as
directed in the Troubleshooting Guide .
NOTE: Backgrounds may be repeated by pressing the touch plate.
5.
When the background counts are acceptable, perform the daily
Quality Control checks as directed in the following section.
Daily Quality Control Checks
Quality Control checks (which confirm calibration) should be performed on a daily basis according to the laboratory’s protocol. Commercial control materials should be properly warmed and mixed according to the manufacturer’s recommendations. Patient controls should be handled according to the laboratory’s protocol.
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Running Samples
QC (Open or Closed Mode) Procedure
1.
From the Data Station RUN Screen , press [SPECIMEN TYPE].
2.
Move the cursor to the desired QC file and press [QC
SPECIMEN].
3.
If necessary, press [CHANGE SAMPLER] to select the desired mode.
4.
Run the control.
NOTE: Refer to the Running Samples section following this
procedure for complete instructions for running samples.
5.
Verify that the results are acceptable.
NOTE: Out of control results are displayed in color.
6.
If the results are unacceptable, repeat the run. If the results are still unacceptable, obtain a new bottle of the control, be sure that it is warmed and mixed properly and again repeat the run. If the results are still unacceptable, run the other levels of control material. If the results on all levels are unacceptable, troubleshoot accordingly as
directed in the Troubleshooting Guide .
7.
When the control results are acceptable, patient samples may be analyzed.
Open Mode Analysis
The Open Sampler Mode aspirates the sample from an opened collection tube. OPEN SAMPLER is displayed in the upper right corner of the
Data Station RUN Screen when this mode is selected. The open sample
aspiration probe is available only when this mode is selected.
Open Mode Procedure
1.
If necessary, from the Data Station RUN Screen press [CHANGE
SAMPLER] to select the Open mode.
2.
Be sure that the word “Ready” is illuminated on the Analyzer status indicator panel and READY is displayed in the Status Box on the
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3.
Open the well-mixed sample tube and immerse the open sample aspiration probe in the sample.
4.
Press the touch plate located behind the probe to start the cycle.
The word “Busy” on the Analyzer status indicator panel is
illuminated in yellow. The Status Box on the Data Station RUN
Screen displays messages to indicate the various stages of the
cycle.
5.
Remove the tube when the beep sounds. The probe moves up through the wash block to clean it.
6.
When the cycle is completed, the probe moves down, the word
“Ready” on the Analyzer status indicator panel is illuminated in
green and the results are displayed on the Data Station RUN
7.
If automatic report printing has been specified, a report is printed according to the options selected during Set Up. If this has not been specified, a report may be printed by pressing [PRINT REPORT].
8.
Repeat this procedure for subsequent samples.
Closed Mode Analysis
The Closed Sampler Mode on Closed Sampler (CS) instruments aspirates the sample from a closed collection tube that has been inserted in the Closed Sampler module. CLOSED SAMPLER is displayed in the
upper right corner of the Data Station RUN Screen when this mode is
selected. The probe is retracted when this mode is selected.
CAUTION: Damage to the instrument can occur if tubes are incorrectly placed in the Closed Sampler module. Be certain to invert sample tubes and place the stoppered end down into the
Closed Sampler module.
Closed Mode Procedure
1.
Be sure that the word “Ready” is illuminated on the Analyzer status indicator panel and READY is displayed in the Status Box on the
2.
If necessary, from the Data Station RUN Screen press [CHANGE
SAMPLER] to select the Closed mode.
3.
Invert the well-mixed sample and place the stoppered end down into the Closed Sampler module. Push the end of the tube securely into the tube retainer.
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Daily Shutdown
NOTE: The touch plate will not operate if the tube is not seated
correctly. (If necessary, refer to the Special Procedures section in
Chapter 9, Maintenance , for instructions for adjustment of the
4.
Press the touch plate located behind the probe to start the cycle.
The word “Busy” on the Analyzer status indicator panel is illuminated in yellow.
5.
Remove the tube when the beep sounds.
6.
When the cycle is completed, the word “Ready” on the Analyzer status indicator panel is illuminated in green and the results are
displayed on the Data Station RUN Screen .
7.
Repeat this procedure for subsequent samples.
It is not necessary to perform a Daily Shutdown procedure as the instrument automatically goes into a STANDBY state if it has been idle for four hours. If desired, the operator may place the instrument in the
STANDBY state by pressing [SPECIAL PROTOCOLS], followed by
[MORE], followed by [DAILY SHUTDOWN].
When the key is pressed or when the automatic shutdown is initiated, the cycle:
• Rinses the flow system
• Sets the timer control that periodically opens all of the solenoid valves to prevent pinched tubing
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Using the Work List
Introduction
The Work List is used to preassign sample identification, display and print criteria for samples that will be run. It is essentially a list of samples
(including the preassigned information) that the operator intends to run on the instrument. A Work List can be downloaded from a host computer to the CELL-DYN 3000. The use of the Work List is optional.
Detailed discussions of using the Work List with and without bar coded samples are provided in this section. Instructions are also given for handling STAT samples with and without bar code labels.
As the samples are processed, the Work List is accessed and the entered
information is displayed on the Data Station RUN Screen with the results
stored in the Data Log. The information is also printed on the report. The
Work List may be used with or without bar code labels on the tubes.
CAUTION: If bar code labels are not used, samples must be processed in the same order in which the information is listed on the Work List.
The following bar code symbologies may be used:
• Codabar, Interleaved 2 of 5 or Code 39
These bar code labels are generated by the user and are typically used when the bar code number is the Sample ID number.
• CELL-DYN 4-Digit Bar Code (Code 39)
These bar code labels are available for the Sample Loader and may be used for sample identification when the bar code number is not the same as the Sample ID number. This option must be selected in the Work List Set Up.
NOTE: Refer to Appendix A, Bar Codes , for complete
information on the use of bar code labels.
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Work List Menu
WORK
LIST
The [WORK LIST] key is displayed on the Data Station RUN Screen .
The
WORK LIST Screen and the following soft key labels are displayed
when the [WORK LIST] key is pressed:
WORK LIST ON or
WORK LIST OFF (The key label alternates between these two selections.)
BAR CODE ON or
BAR CODE OFF (The key label alternates between these two selections.)
INSERT/DELETE
DELETE ALL
PURGE COMPLETED
WORK LIST SETUP
PRINT WORK LIST
RETURN
1 Work List ON WORK LIST
Ready
2
3
4
1
2
5
6
Bar Code ON
3 4
#
5 6
4-DIGIT SPECIMEN SPECIMEN
BAR CODE ID NAME
123456
234567
345678
456789
567890
Jones, Mary
Smith, John
White, Bob
Black, Sue
Green, Kermit
1
1
1
1
1
1
Jul 07 1992
Operator ID
Sequence #
12:09
734
0330
7 8 9 10
LIMIT PARAM STATUS RACK-TUBE
1
1
1
1
1
1
N
A
F
WORK LIST
OFF
BAR CODE
OFF
INSERT/
DELETE
DELETE
ALL
PURGE
COMPLETED
WORK LIST
SET UP
WORK LIST
RETURN
Figure 5.34: Work List Screen
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Work List Screen
The
WORK LIST Screen is depicted in Figure 5.34
. The numbers on the screen shown in Figure 5.34
correspond with the following numbered
options:
1.
WORK LIST
The status of the Work List (OFF or ON) is displayed in this field.
2.
BAR CODE
The status of the Bar Code selection (OFF or ON) is displayed in this field.
3.
#
The sequential number of the Work List entries is displayed in this field. The Work List holds 800 entries. When the Work List is full, existing entries must be deleted before additional entries can be made.
4.
4-DIGIT BAR CODE
If this type of bar code was selected from the WORK LIST
SETUP Screen and the Bar Code is ON, the bar code number must
be entered in this field.
5.
SPECIMEN ID
A bar code number, sample identification number or name may be entered in this field. Up to 12 characters may be entered. The
sample is identified on the Data Station RUN Screen , in the Data
Log and on the printed report using the information entered in this field.
NOTE: An entry must be made in this field to create a Work
List.
6.
SPECIMEN NAME
The name entered in this field should be associated with the identification number entered in the Specimen ID field. Up to 16 characters can be entered in this field.
7.
LIMIT
This field is used to enter the number of the Patient Limit Set that will be used for flagging the sample. If no entry is made, the default
(preselected) Patient Limit Set is used.
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Work List Soft Keys
WORK LIST
ON
8.
PARAM
This field is used to enter the number of the Parameter Set that will be used for the sample. If no entry is made, the default
(preselected) Parameter Set is used.
9.
STATUS
As the samples are processed, the status is indicated in this field.
The operator cannot enter information in this field. The following codes are displayed:
N — Non-Alerted
The sample was not flagged in any way.
A — Alerted
The sample was flagged because results exceeded the selected Patient Limits or because a morphological flag was generated.
F — Fault
A metering fault or a sampling error message was generated as the sample was processed, either with or without the Sample Loader. A mixing error message was generated as the sample was processed (only when using the Sample Loader).
10.
RACK-TUBE
As samples are processed on the Sample Loader, the Rack number and Tube number (position of the tube in the rack) are displayed in this field. The operator cannot enter information in this field. The display shows RnTn
(n indicates the number of the rack or tube).
The function of each of the soft keys displayed on the
Screen is discussed in the following section.
The [WORK LIST ON] key is used to turn on the feature. The key label changes to [WORK LIST OFF] when the Work List feature is enabled.
The upper left-hand corner of the display indicates the status of the Work
List.
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Operating Instructions
BAR CODE
ON
INSERT/
DELETE
INSERT
DELETE
DELETE
ALL
PURGE
COMPLETED
Search Book TOC Go Back
Chapter 5
The [BAR CODE ON] key is used to create a Work List for samples that are identified with bar code labels. The key label changes to [BAR
CODE OFF] when the Bar code feature is enabled. The upper left corner of the display indicates the status of the Bar Code feature.
When the [INSERT/DELETE] key is pressed, the following soft key labels are displayed:
INSERT
DELETE
The [INSERT] key is used to insert a line of information into the Work
List. The line is inserted at the cursor position and the remainder of the
Work List is moved down one space.
The [DELETE] key is used to delete a line of information from the Work
List. (When information is deleted, the line remains blank.) When the
[DELETE] key is pressed, the following soft key labels are displayed:
CONFIRM DELETION
CANCEL DELETION
These keys are used to confirm or cancel the Delete command.
The [DELETE ALL] key is used to delete all data from the Work List.
When the [DELETE ALL] key is pressed, the following soft key labels are displayed:
CONFIRM DELETION
CANCEL DELETION
These keys are used to confirm or cancel the Delete All command.
The [PURGE COMPLETED] key is used to delete all Work List entries for samples that have been successfully run (marked with an N or A in the Status field) through the Analyzer. When the [PURGE
COMPLETED] key is pressed, the Bulletin line displays the message:
ALL SPECIMENS MARKED WITH ‘N’ OR ‘A’ WILL BE PURGED
The following soft key labels are displayed:
CONFIRM
CANCEL
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WORK LIST
SETUP
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Search Book TOC Go Back Operating Instructions
These keys are used to confirm or cancel the Purge Completed command.
NOTE: The Purge Completed option is not available when the
Bar Code feature is OFF.
WORK LIST SETUP
Ready
Dec 18 1992
Operator ID
Sequence #
10:09
734
0630
1 1 Bar Code ID associated with :
1 = 4-digit bar code
2 = Laboratory Specimen ID
2 OFF Specimen Name entry selected
3
4
OFF
1
Limit Set entry selected
Default Limit Set (1..4)
5
6
OFF
1
Parameter Set entry selected
Default Parameter Set (1..4)
TOGGLE
ON/OFF
RETURN
Figure 5.35: Work List Setup Screen
The [WORK LIST SETUP] key is used to display the WORK LIST
SETUP Screen shown in Figure 5.35. The numbers on the screen shown in Figure 5.35 correspond to the following numbered options:
1.
Bar Code ID associated with:
1 = 4-digit bar code
2 = Laboratory Specimen ID
This field is used to specify the type of bar code that will be used when the Bar Code is ON. If option 2 is selected, the bar code number must be entered in the Specimen ID field.
2.
Specimen Name entry selected
This field is used to specify whether a specimen name will be entered in the Work List.
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WORK LIST
RETURN
3.
Limit Set entry selected
This field is used to specify which Patient Limits are assigned to each sample. The Default Limit Set (see option 4) is used if no specification is made.
4.
Default Limit SET (1...4)
This field is used to specify the default (preassigned) Limit Set that is automatically assigned to each sample unless otherwise indicated in the Work List.
5.
Parameter Set entry selected
This field is used to specify which Parameter Set is assigned to each sample. The Default Parameter Set (see option 6) is used if no specification is made.
6.
Default Parameter Set (1...4)
This field is used to specify the default (preassigned) Parameter Set that is automatically assigned to each sample unless otherwise indicated in the Work List.
The [PRINT WORK LIST] key is used to print the Work List.
The [RETURN] key is used to return to the Data Station RUN Screen .
Work List Setup Procedure
1.
From the Data Station RUN Screen , press [WORK LIST]
followed by [WORK LIST SETUP] to display the
2.
Select the type of bar code that will be used:
Type 1 to use the CELL-DYN Series 4-digit bar code
Type 2 to use a laboratory-generated bar code
Press the Enter key on the keyboard to save the selection and advance the cursor.
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3.
If desired, press [TOGGLE ON/OFF] to select a Specimen Name entry. The cursor advances to the next entry field.
4.
If desired, press [TOGGLE ON/OFF] to select a Limit Set entry.
The cursor advances to the <DEFAULT LIMIT SET> entry field.
5.
If desired, select a Limit Set to be used as the default (preassigned) set by typing the number of the desired Limit Set and pressing the
Enter key on the keyboard.
NOTE: If no selection is made, Limit Set 1 will be used as the default Limit Set.
6.
If desired, press [TOGGLE ON/OFF] to select a Parameter Set entry. The cursor advances to the <DEFAULT PARAMETER
SET> entry field.
7.
If desired, select a Parameter Set to be used as the default
(preassigned) set by typing the number of the desired Parameter Set and pressing the Enter key on the keyboard.
NOTE: If no selection is made, Parameter Set 1 will be used as the default Parameter Set.
Sample Analysis Using the Work List
,
Sample Loader Instruments
NOTE: The Work List is active in the Closed Mode only on the
Sample Loader version of the CELL-DYN 3000.
Using the Work List with Bar Codes
The Sample Loader has a built-in bar code reader that automatically
reads a bar code label placed on the tube. Refer to Appendix A for a
complete discussion of bar code labels and instructions for correct placement of the labels on the tubes.
When the Bar Code ON option is selected, the bar code labeled samples may be run in any order after the Work List has been created.
When bar code labels are used on the CELL-DYN 3000SL and the Work
List is active, the instrument reads the bar code label and searches the
Work List for that bar code number. When the number is found, the
entered information is displayed on the Data Station RUN Screen and
stored in the Data Log. If no entry is found, the sample is identified in the
Data Log by “Bar Code Number/B,” as in the following example:
123456/B.
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When a laboratory-generated bar code number is used (Laboratory
Specimen ID option selected in the Work List Set Up), this number must be typed in the Work List <SPECIMEN ID> field. The samples are
identified on the Data Station RUN Screen and in the Data Log by this
number.
When a CELL-DYN 4-digit bar code label is used (4-digit bar code option selected in the Work List Set Up), the 4-digit number must be entered in the Work List <4-DIGIT BAR CODE> field, and a specimen
ID number must be entered in the Work List <SPECIMEN ID> field.
Samples are identified on the Data Station RUN Screen and in the Data
Log by the information entered in the Work List <SPECIMEN ID> field for that 4-digit bar code number.
The Work List is accessed randomly as the samples are processed.
Sample identification is made by matching the bar code number on the tube to the information entered in the Work List for that bar code number.
The Work List information is used to identify the sample on the Data
Station RUN Screen and in the Data Log.
NOTE: Special “Q Labels” are available to identify QC samples. QC samples should not be entered in the Work List.
The Q label identifies the sample as a QC sample and the results are automatically transmitted to the appropriate file.
Sample Analysis Procedure
1.
Follow the instructions in the Work List Set Up Procedure to
configure the Work List.
2.
If necessary, from the main WORK LIST Screen , press [WORK
LIST ON] to enable the Work List.
3.
If necessary, press [BAR CODE ON] to enable the bar code function.
4.
When a laboratory-generated bar code label is used, the bar code number must be entered in the <SPECIMEN ID> entry field.
NOTE: When the CELL-DYN 4-digit bar code label is being used, type the number in the <4-DIGIT BAR CODE> entry field. When data entry is completed for the entry fields on that line and the Enter key is pressed, the cursor returns to the next
<4-DIGIT BAR CODE> entry field and the number automatically increments by one digit. The cursor remains in this field until the Enter key is pressed again to save the entries and advance the cursor.
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5.
Type the appropriate sample identification information in the
<SPECIMEN ID> and <SPECIMEN NAME> (if selected) entry fields on the Work List. Press the ENTER key on the keyboard to save the entry in each field and advance the cursor.
6.
If selected, type the appropriate information in the <LIMIT> and
<PARAM> entry fields. Press the ENTER key on the keyboard to save the entry in each field and advance the cursor.
NOTE: If no entries are made in these fields, the default selections are used.
7.
After the information for all samples has been entered, place them in the Sample Loader racks. Samples may be placed in the racks in any order since the bar code label is used to identify them.
NOTE: The last group of samples should be placed in an end rack so the Sample Loader will stop when all the samples have been processed.
8.
Install the Sample Loader safety cover.
9.
Press [RETURN] to return to the Data Station RUN Screen .
10.
Press [SPECIMEN TYPE] followed by [PATIENT].
11.
If necessary, press [CHANGE SAMPLER] to select the Closed
Mode.
12.
Press the START key on the Sample Loader.
NOTE: Samples may be run with the
displayed. As the samples are processed, the status of each sample is displayed in the <STATUS> field on the Work List.
Additional entries may be made to the Work List while processing takes place.
13.
The samples are automatically processed in the order in which they were placed in the racks. The Sample Loader automatically stops when processing is finished if the last samples were placed in an end rack.
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Using the Work List Without Bar Codes
When the Bar Code OFF option is selected, samples must be run in the order in which the information has been entered in the Work List, since the Work List is accessed sequentially as the samples are processed.
NOTE: Special “Q Labels” are available to identify QC samples. QC samples should not be entered in the Work List.
The Q label identifies the sample as a QC sample and the results are automatically transmitted to the appropriate file.
Sample identification is made from the information entered in the
<SPECIMEN ID> field on the Work List. If no entries are made in the
<SPECIMEN ID> field, the Sample Loader identifies the sample by the rack and tube number (position of the tube in the rack). The identification is displayed as RnTn.
CAUTION: If a Sample Loader fault occurs that necessitates initialization of the Sample Loader, remove all samples that have been processed before restarting the Sample Loader. If these samples are not removed, misidentification of the remaining samples will occur.
Sample Analysis Procedure
1.
Follow the instructions in the Work List Set Up Procedure to
configure the Work List.
2.
If necessary, from the main
WORK LIST Screen , press [WORK
LIST ON] to enable the Work List.
3.
If necessary, press [BAR CODE OFF] to disable the bar code function.
4.
Type the appropriate sample identification information in the
<SPECIMEN ID> and <SPECIMEN NAME> (if selected) entry fields on the Work List. Press the Enter key on the keyboard to save the entry in each field and advance the cursor.
5.
If selected, type the appropriate information in the <LIMIT> and
<PARAM> entry fields. Press the Enter key on the keyboard to save the entry in each field and advance the cursor.
NOTE: If no entries are made in these fields, the default selections are used.
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6.
After the information for the sample is entered, place the sample in a Sample Loader rack. Subsequent samples should be placed in the racks in the order in which the sample information is entered into the Work List.
NOTE: The last group of samples should be placed in an end rack so the Sample Loader stops automatically when all the samples have been processed.
7.
When all entries have been made, place the racks in order in the
Sample Loader and install the safety cover.
8.
Press [RETURN] to return to the Data Station RUN Screen .
9.
Press [SPECIMEN TYPE] followed by [PATIENT].
10.
If necessary, press [CHANGE SAMPLER] to select the Closed mode.
11.
Press the START key on the Sample Loader.
NOTE: Samples may be run with the
displayed. As the samples are processed, the status of each sample is displayed in the <STATUS> field on the Work List.
Additional entries may be made to the Work List while processing takes place.
12.
The samples are automatically processed in the order they are placed in the racks. The Sample Loader automatically stops when processing is finished if the last samples were placed in an end rack.
Running STAT Samples
It is recommended that STAT samples be run in the Open Mode as directed in the following procedure:
1.
Press the PAUSE key on the Sample Loader. The Sample Loader stops after processing of the sample in progress is completed.
2.
From the WORK LIST Screen , press [RETURN] to return to the
3.
From the Data Station RUN Screen , press [CHANGE
SAMPLER] to select the Open mode.
NOTE: The Work List is not active in the Open mode on the
CELL-DYN 3000SL.
4.
Type the Specimen ID in the <NEXT ID> field and press the Enter key on the keyboard to save it.
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5.
Run the sample in the Open mode.
6.
When the cycle is completed, press [CHANGE SAMPLER] to select the Closed mode.
7.
Press the START key on the Sample Loader. Processing resumes with the next sample to be run.
Sample Analysis with the Work List,
Closed Sampler Instruments
The Work List may be used in the Open and Closed modes on the Closed
Sampler version of the CELL-DYN 3000. On CS instruments, use of the
Work List is identical in both modes so they are discussed together.
Using the Work List with Bar Code ON
When the Bar Code ON option is selected, the Laboratory Specimen ID option should always be selected in the Work List Set Up. The 4-Digit
Bar Code option should not be used.
When the Bar Code ON option is selected, the bar code labeled samples may be run in any order after the Work List has been created. The specimen ID number on the tube can be entered manually in the <NEXT
ID> entry field on the Data Station RUN Screen . Samples are identified
in the Data Log by this number.
The Work List is accessed randomly as the samples are processed.
Sample identification is made by matching the Specimen ID number
Station RUN Screen and in the Data Log.
NOTE: QC samples should not be entered in the Work List. To
run QC samples turn the Work List OFF and refer to the “ Daily
QC Checks for the CS ” section of this chapter for instructions
for running QC samples.
Sample Analysis Procedure
1.
Follow the instructions in the
to configure the Work List.
NOTE: Be sure to select the Laboratory Specimen ID option on
2.
From the main WORK LIST Screen , press [WORK LIST ON] to
enable the Work List.
3.
Press [BAR CODE ON] to enable the bar code function.
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4.
Type the appropriate sample identification information in the
<SPECIMEN ID> and <SPECIMEN NAME> (if selected) entry fields on the Work List. Press the Enter key on the keyboard to save the entry in each field and advance the cursor.
5.
If selected, type the appropriate information in the <LIMIT> and
<PARAM> entry fields. Press the Enter key on the keyboard to save the entry in each field and advance the cursor.
NOTE: If no entries are made in these fields, the default selections are used.
6.
After the information for the sample is entered, place the sample in a rack or on a mixer. Subsequent samples should be placed in the rack or on the mixer in the order in which the information is entered into the Work List.
7.
When all entries have been made, press [RETURN] to return to the
8.
Press [SPECIMEN TYPE] followed by [PATIENT].
9.
If necessary, press [CHANGE SAMPLER] to select the desired mode.
10.
Type the sample ID number in the <NEXT ID> entry field on the
Data Station RUN Screen . Press the Enter key on the keyboard to
save the number. The corresponding Work List information for that
ID number will be displayed in the appropriate fields.
11.
Run the well-mixed sample in the desired mode.
NOTE: Samples may be run in any order as long as the sample
ID number is entered in the <NEXT ID> entry field before the sample is run. Modifications to the Work List should be made only when the Data Station is in the READY state.
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Using the Work List with Bar Code OFF
When the Bar Code OFF option is selected, the samples must be run in the order in which the information has been entered in the Work List, since the Work List is accessed sequentially as the samples are processed. The sample identification number must be entered in the
Work List <SPECIMEN ID> field. The number entered in the Work List
<SPECIMEN ID> field is used to identify the sample on the Data
Station RUN Screen and in the Data Log.
CAUTION: If a sample needs to be repeated, turn the Work
List OFF before running the sample again. When the repeat run is completed, turn the Work List ON and continue to process samples in the order in which they were entered in the Work List.
NOTE: QC samples should not be entered in the Work List. To
run QC samples, turn the Work List OFF and refer to the “ Daily
QC Checks for the CS ” section of this chapter for instructions
for running QC samples.
Sample Analysis Procedure
1.
Follow the instructions in the Work List Set Up Procedure to
configure the Work List.
2.
From the main
WORK LIST Screen , press [WORK LIST ON] to
enable the Work List.
3.
If necessary, press [BAR CODE OFF] to disable the bar code function.
4.
Type the appropriate sample identification information in the
<SPECIMEN ID> and <SPECIMEN NAME> (if selected) entry fields on the Work List. Press the Enter key on the keyboard to save the entry in each field and advance the cursor.
5.
If selected, type the appropriate information in the <LIMIT> and
<PARAM> entry fields. Press the Enter key on the keyboard to save the entry in each field and advance the cursor.
NOTE: If no entries are made in these fields, the default selections are used.
6.
After the information for the sample is entered, place the sample in a rack or on a mixer. Subsequent samples should be placed in the rack or on the mixer in the order in which the information is entered into the Work List.
7.
When all entries have been made, press [RETURN] to return to the
8.
Press [SPECIMEN TYPE] followed by [PATIENT].
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9.
If necessary, press [CHANGE SAMPLER] to select the desired mode.
10.
Run the well-mixed samples in the order in which the information was entered in the Work List.
NOTE: If desired, samples may be run with the WORK LIST
Screen displayed. Modifications to the Work List should be made
only when the Data Station is in the READY state.
Running STAT Samples
Turn the Work List OFF before running a STAT sample. When the STAT sample run is completed, turn the Work List ON and continue to process samples in the order in which they were entered in the Work List.
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Operating Instructions
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NOTES
Chapter 5
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Using the Data Log
Introduction
Data Log Menu
The Data Log stores all data and demographic information in a log format for the last 10,000 cycles run on the CELL-DYN 3000. The record information is stored chronologically by sequence number.
Scatterplots and histograms are stored for the most current 2,000 records.
The first part of this section gives a brief description of the Data Log
Menu keys. The Data Log Set Up portion gives instructions for
The function of each of the soft keys in the Data Log Menu is discussed in this section.
DATA LOG
Ready
USE < OR > FOR MORE DATA
Apr 30 1993
Operator ID
Sequence #
12:57
734
3080
Seq Specimen ID
B 2621
2622
2623
2624
2625
2626
2627
2628
2629
2630
2631
2632
2633
2634
2635
2636
9100
R8 T5
R1 T3
BACK-
GROUND
LOW
LOW
NORMAL
HIGH
LOW
NORMAL
HIGH
PATIENT
PATIENT
PATIENT
WBC NEU LYM MONO EOS BASO
6.7
4.4
1.6
0.4
0.1
0.2
6.7
4.4
2.0
0.2
0.1
0.0
6.7
4.4
1.7
0.3
0.1
0.2
3.9
2.1
1.1
0.3
0.3
0.0
0.0
2.7
7.7
8.0
18.8
2.7
7.4
18.1
12.9
12.5
12.9
12.7
1.8
4.6
4.8
10.5
1.7
4.3
10.3
8.5
8.3
8.6
8.4
0.5
2.0
2.0
5.7
0.5
2.1
5.4
3.3
3.0
3.0
3.3
0.3
0.7
0.8
1.7
0.2
0.6
1.7
0.7
0.7
0.8
0.6
0.1
0.2
0.2
0.3
0.1
0.2
0.3
0.4
0.4
0.4
0.4
0.1
0.2
0.3
0.5
0.0
0.2
0.4
0.1
0.1
0.1
0.1
Date Time Op
O04/05/93 11:11 abc
O04/05/93 11:18 abc
K04/05/93 11:25 abc
C04/05/93 11:30 abc
O04/05/93 12:53 abc
O04/05/93 12:54 abc
O04/05/93 12:56 abc
O04/05/93 12:59 abc
O04/05/93 13:00 abc
C04/05/93 13:04 abc
C04/05/93 13:05 abc
C04/05/93 13:06 abc
C04/05/93 13:12 abc
C04/05/93 13:14 abc
C04/05/93 13:16 abc
O04/05/93 13:18 abc
Seq Specimen ID WBC NEU LYM MONO EOS BASO Date Time Op
EDIT
ID
DISPLAY
SPECIMEN
FIND
SPECIMEN
REJECT
FROM X-B
CUSTOMIZE
DATA LOG
TRANSMIT
DATA
DATA LOG
MAIN
Figure 5.36: Data Log Screen
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DATA
LOG
EDIT
ID
When the [DATA LOG] key is pressed, the
following soft key labels are displayed:
EDIT ID*
DISPLAY SPECIMEN
FIND SPECIMEN
REJECT FROM X-B**
CUSTOMIZE DATA LOG
TRANSMIT DATA
PRINT DATA LOG
MAIN
* This key is displayed only if the cursor is positioned next to a
patient record. (See Figure 5.36
** This key is displayed if the sequence number of the patient
record is preceded by a B. (See Figure 5.36
The [EDIT ID] key is used to edit the Specimen ID from the
. When the [EDIT ID] key is pressed, the cursor moves into the <SPECIMEN ID> field and all key labels are blank. Edits are saved by pressing the Enter key on the keyboard.
NOTE: The [EDIT ID] key is available only when the cursor is positioned next to a Patient Record. It is not available for
Background or QC records.
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DISPLAY
SPECIMEN
Spec ID R5 T1
Patient_____________
Sex(M/F):- DOB:--/---/--
Dr_____________
Param Set: 1 Limits: 1
WBC: 5.9 K/uL
NEU: 3.2 54.0
%N
LYM: 2.0 33.7
%L
MONO: 0.6 9.8 %M
EOS: 0.1 1.9 %E
BASO: 0.0 0.5 %B
RBC: 5.29 M/uL
HGB: 16.0 g/dL
HCT: 47.8 %
MCV: 90.3 fL
MCH: 30.3 pg
MCHC: 33.6 g/dL
RDW: 13.2 %
DISPLAY SPECIMEN
Ready
Sequence # 2856
S
I
Z
E
Dec 18 1992
Operator ID
Sequence #
Open Sampler
D
E
P
O
L
09:43
734
0630
COMPLEXITY ORTHOGONAL
PLT: 229. K/uL
MPV: 8.9 fL CT:6.35
RBC PLT
PREVIOUS
SPECIMEN
NEXT
SPECIMEN
EDIT
SPECIMEN
CUSTOMIZE
REPORT
TRANSMIT
SPECIMEN
TICKET
REPORT
RETURN
Figure 5.37: Display Specimen Screen
The [DISPLAY SPECIMEN] key is used to display the results for the record indicated by the cursor position. (See Figure 5.37.) The following soft key labels are displayed when the [DISPLAY SPECIMEN] key is pressed:
PREVIOUS SPECIMEN*
NEXT SPECIMEN**
EDIT SPECIMEN
CUSTOMIZE REPORT
TRANSMIT SPECIMEN
PRINT TICKET
PRINT REPORT
RETURN
* This key is not displayed when the first specimen in the log is on the screen.
** This key is not displayed when the last specimen in the log is on the screen.
NOTE: The
FLAGGING DIAGNOSTICS Screen is displayed
by pressing the Page Down key.
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PREVIOUS
SPECIMEN
NEXT
SPECIMEN
EDIT
SPECIMEN
CUSTOMIZE
REPORT
TRANSMIT
SPECIMEN
TICKET
REPORT
RETURN
The [PREVIOUS SPECIMEN] key is used to display the results for the sequence number preceding the one currently displayed without returning to the main DATA LOG Screen.
The [NEXT SPECIMEN] key is used to display the results for the sequence number following the one currently displayed without returning to the main DATA LOG Screen.
The [EDIT SPECIMEN] key is used to edit patient demographic information for the selected record. It may also be used to edit and display the results with a Parameter or Patient Limit set different from the one currently displayed. The following soft key labels are displayed when the [EDIT SPECIMEN] key is pressed:
CONFIRM
CANCEL
These keys are used to confirm or cancel the edits. The Bulletin line displays the message PRESS CONFIRM TO SAVE CHANGES OR
CANCEL TO CANCEL CHANGES. When the [CONFIRM] key is pressed, the edited record is displayed.
The [CUSTOMIZE REPORT] key is used to customize the
STATION RUN Screen display, header and printout
Set Up Instructions section of this chapter.
The [TRANSMIT SPECIMEN] key is used to transmit the displayed report to a Laboratory Information System or on-line computer.
The [PRINT TICKET] key is used to print a ticket (in the currently selected format) for the displayed record.
The [PRINT REPORT] key is used to print a graphics report (in the currently selected format) at the displayed record.
The [RETURN] key is used to return to the main
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Chapter 5 Search Book TOC Go Back Operating Instructions
FIND
SPECIMEN
REJECT
FROM X-B
SEQ # :
SPEC ID:
NAME :
DATA LOG SEARCH
Ready
Seq Specimen ID
4648HIGH 46 SL
4649HIGH 46 SL
4650HIGH 46 SL
4651LOW RD 43 SL
4652LOW RD 43 SL
4653LOW RD 43 SL
4654NORM RD 43 SL
4655NORM RD 43 SL
4656NORM RD 43 SL
4657HIGH RD 43 SL
4658HIGH RD 43 SL
4659HIGH RD 43 SL
WBC RBC HGB MCV PLT RDW
19.7
5.02
16.4
93.0
501.
15.7
19.3
4.92
16.2
92.8
480.
15.8
18.7
4.95
16.2
92.9
489.
15.4
3.2
2.08
6.1
85.2
45.
15.8
3.1
2.10
6.1
84.6
46.
15.3
3.1
2.08
6.1
84.3
45.
15.6
7.7
4.50
13.5
86.9
228.
16.7
8.0
4.54
13.6
86.9
221.
16.3
7.7
4.53
13.8
87.1
221.
16.6
21.0
5.36
18.0
96.1
444.
14.3
20.2
5.23
17.8
96.3
467.
14.0
20.3
5.25
17.8
96.0
477.
14.3
MPV
7.8
7.9
7.9
8.4
8.0
8.1
7.9
7.9
7.9
7.5
7.6
6.8
Apr 30 1993
Operator ID
Sequence #
15:23
734
4659
Date Time Op
C04/30/93 09:58 734
C04/30/93 09:59 734
C04/30/93 09:59 734
C04/30/93 10:02 734
C04/30/93 10:03 734
C04/30/93 10:05 734
C04/30/93 10:07 734
C04/30/93 10:10 734
C04/30/93 10:11 734
C04/30/93 10:13 734
C04/30/93 10:14 734
C04/30/93 10:14 734
Seq Specimen ID
WBC RBC HGB MCV PLT RDW MPV Date Time Op
Figure 5.38: Data Log Search Screen
The [FIND SPECIMEN] key is used to locate a particular record by entering the Specimen ID number, Sequence number, or Patient Name for the desired record. When this key is pressed, the DATA LOG
SEARCH Screen is displayed. (See Figure 5.38.) If the record is not found in the Data Log, the bulletin line displays the message: NO
ENTRY FOUND.
NOTE: If patient name is used, the name must be typed exactly as it was originally entered.
If the cursor is positioned at a sample identified with a “B” preceding the sequence number (indicating that the results are included in the X-B analysis), the [REJECT FROM X-B] key label is displayed. (See
.) When the [REJECT FROM X-B] key is pressed, the
sample is marked with an “R” following the Specimen ID, the results are excluded from the X-B analysis (the “B” is deleted) and the key label changes to [ACCEPT INTO X-B].
If the [ACCEPT INTO X-B] key is pressed, the “R” is deleted, the “B” is displayed and results are now included in the X-B analysis.
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Operating Instructions
CUSTOMIZE
DATA LOG
Search Book TOC Go Back
Chapter 5
NOTE: If all samples are rejected from the current X-B batch, it is not possible to accept any of them back into the X-B analysis.
CUSTOMIZE DISPLAY
Ready
FOR DATA LOG
Dec 18 1992
Operator ID
Sequence #
10:29
734
0630
Group 1:
Group 2:
Group 3:
Group 4:
WBC NEU LYM MONO EOS BASO
RBC HGB HCT MCV MCH MCHC RDW
PLT MPV UMT1 CNT1
WBC %N %L %M %E %B
WBC NEU LYM MONO EOS BASO
RBC HGB HCT MCV MCH MCHC RDW
PLT
UMT1
MPV
%N
PCT
%L
PDW
%M
UMT2 CNT1 CNT2
%E %B
EMPTY
SELECT
PARAMETER
STANDARD CUSTOMIZE
GROUPS PRINTOUT
RETURN
Figure 5.39: Customize Display for Data Log Screen
The [CUSTOMIZE DATA LOG] key is used to customize the Data Log display. The CUSTOMIZE DISPLAY FOR DATA LOG Screen (see
Figure 5.39) and the following soft key labels are displayed when the
[CUSTOMIZE DATA LOG] key is pressed:
SELECT PARAMETER or
PLACE PARAMETER (The key alternates between these two selections.)
STANDARD GROUPS or
CUSTOM PLACEMENT (The key alternates between these two selections.)
CUSTOMIZE PRINTOUT
RETURN
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SELECT
PARAMETER
PLACE
PARAMETER
CANCEL
SELECTION
The CUSTOMIZE DISPLAY FOR DATA LOG Screen displays a
matrix showing the four parameter groups and a list of the available parameters. Parameter group 1 is displayed (in the order indicated from left to right) on the first
DATA LOG Screen . The remaining groups are
displayed on subsequent screens that are accessed by pressing the Right
Arrow key on the keyboard. The Left Arrow key is used to page back through the screens to the first screen.
The [SELECT PARAMETER] key is used to select a parameter designated by the cursor. When the key is pressed, the selected parameter is highlighted, the label changes to [PLACE PARAMETER] and a
[CANCEL SELECTION] key is displayed.
The [PLACE PARAMETER] key is used to display the parameter in the location indicated by the position of the cursor.
The [CANCEL SELECTION] key is used to cancel the selection and display the [SELECT PARAMETER] key.
CUSTOMIZE DISPLAY
Ready
FOR DATA LOG
Dec 18 1992
Operator ID
Sequence #
10:30
734
0630
Group 1:
Group 2:
Group 3:
Group 4:
WBC NEU LYM MONO EOS BASO
RBC HGB HCT MCV MCH MCHC RDW
PLT MPV PCT PDW
WBC %N %L %M %E %B
WBC NEU LYM MONO EOS BASO
RBC HGB HCT MCV MCH MCHC RDW
PLT MPV PCT PDW
%N % L %M %E %B
UMT1 UMT2 CNT1 CNT2 EMPTY
WBC
GROUP
RBC
GROUP
PLT
GROUP
DIFF
GROUP
CUSTOM
PLACEMENT
CUSTOMIZE
PRINTOUT
RETURN
Figure 5.40: Customize Display for Data Log Screen
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STANDARD
GROUPS
Predetermined groups of parameters, called Standard Groups, may be
selected by pressing the [STANDARD GROUPS] key. Figure 5.40
shows the
CUSTOMIZE DISPLAY FOR DATA LOG Screen with the
standard groups displayed. The following soft key labels are displayed when the [STANDARD GROUPS] key is pressed:
WBC GROUP
RBC GROUP
PLT GROUP
DIFF GROUP
CUSTOM PLACEMENT*
CUSTOMIZE PRINTOUT
RETURN
* The [CUSTOM PLACEMENT] key is used to return to the
CUSTOMIZE DISPLAY FOR DATA LOG Screen for
operator-selected placement.
shows the WBC Group placed in GROUP 1, the RBC Group
placed in GROUP 2, the PLT Group placed in GROUP 3 and the Diff
Group placed in GROUP 4.
When each soft key is pressed, the designated parameter group is placed in the position indicated by the cursor.
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CUSTOMIZE
PRINTOUT
SELECT
PARAMETER
CUSTOMIZE PRINTOUT
Ready
FOR DATA LOG
Dec 18 1992
Operator ID
Sequence #
10:31
734
0630
WBC %N %L %M %E %B RBC HGB HCT MCV MCH MCHC
RDW PLT MPV UMT1 CNT1
WBC NEU LYM MONO EOS BASO
RBC HGB HCT MCV MCH MCHC RDW
PLT MPV PCT PDW
%N %L %M %E %B
UMT1 UMT2 CNT1 CNT2
SELECT
PARAMETER
STANDARD
SELECTION
RETURN
Figure 5.41: Customize Printout for Data Log Screen
The [CUSTOMIZE PRINTOUT] key is used to customize the printout format of the Data Log. (See Figure 5.41.) The following soft key labels are displayed when the [CUSTOMIZE PRINTOUT] key is pressed:
SELECT PARAMETER or
PLACE PARAMETER (The key alternates between these two selections.)
STANDARD SELECTION
RETURN
The
CUSTOMIZE PRINTOUT FOR DATA LOG Screen shows the
order (from left to right) in which the indicated parameters will be printed.
The [SELECT PARAMETER] key is used to select a parameter designated by the cursor. When the key is pressed, the selected parameter is highlighted, the label changes to [PLACE PARAMETER] and a
[CANCEL SELECTION] key is displayed.
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9140240E — May 1995
PLACE
PARAMETER
CANCEL
SELECTION
STANDARD
SELECTION
RETURN
TRANSMIT
DATA
DATA LOG
The [PLACE PARAMETER] key is used to display the parameter in the location indicated by the position of the cursor.
The [CANCEL SELECTION] key is used to cancel the selection and display the [SELECT PARAMETER] key.
The [STANDARD SELECTION] key is used to configure the printout
in the predetermined print group shown in Figure 5.41
. When the key is pressed, the print group is changed to the Standard Selection.
The [RETURN] key is used to return to the main DATA LOG Screen
.
The [TRANSMIT DATA] key is used to transmit a record to a
Laboratory Information System or on-line computer. When the
[TRANSMIT DATA] key is pressed, the screen prompts the operator to enter the starting and ending sequence numbers (from the lowest to the highest) for the desired transmission. Records may be transmitted singly or in batches as designated by the sequence number(s).
The [PRINT DATA LOG] key is used to print the Data Log. When the
[PRINT DATA LOG] key is pressed, the screen prompts the operator to enter the starting and ending sequence numbers (from the lowest to the
highest) for the desired printout. (See Figure 5.42
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Chapter 5 Search Book TOC Go Back Operating Instructions
Data Log Codes
Starting Sequence #:
Seq Specimen ID
3037 CD3019A-03
3038 CD3019A-04
3039 CD3019A-05
3040 CD3019A-06
3041 CD3019A-07
3042 CD3019A-08
3043 CD3019A-09
3044 CD3019A-10
3045 low
3046 normal
3047 high
3048 high
3049 7
E 3050
E 3051
E 3052
8
9
10
Seq Specimen ID
DATA LOG
Ready
USE < OR > FOR MORE DATA
WBC NEU LYM MONO EOS BASO
8.2
5.6
0.5
1.2
0.1
0.8
8.1
5.3
1.5
0.8
0.1
0.3
8.2
5.5
0.7
1.0
0.1
0.9
8.4
5.6
1.8
0.7
0.1
0.2
8.2
5.5
1.7
0.7
0.1
0.2
8.1
5.5
1.7
0.7
0.1
0.1
8.1
5.4
1.4
0.8
0.1
0.4
8.3
5.4
1.7
0.8
0.1
0.2
2.8
2.0
0.4
0.2
0.1
0.0
7.7
4.8
1.8
0.8
0.2
0.1
18.4
10.0
2.5
3.2
0.4
2.2
18.8
10.2
2.7
2.7
0.5
2.7
5.5
3.1
1.8
0.5
0.1
0.0
5.5
3.0
1.9
0.4
0.1
0.1
7.9
5.3
2.0
0.4
0.1
0.0
6.5
2.2
3.6
0.5
0.1
0.1
WBC NEU LYM MONO EOS BASO
Apr 30 1993
Operator ID
Sequence #
12:58
734
3080
Date Time Op
O04/29/93
O04/29/93
O04/29/93
O04/29/93
O04/29/93
O04/29/93
O04/29/93
O04/29/93
O04/29/93
O04/29/93
O04/29/93
C04/29/93
C04/29/93
C04/29/93
C04/29/93
C04/29/93
11:35 nla
11:36 nla
11:36 nla
11:38 nla
11:39 nla
11:40 nla
11:41 nla
11:42 nla
13:06 nla
13:08 nla
13:09 nla
13:10 nla
13:18 nla
13:19 nla
13:19 nla
13:20 nla
Date Time O p
Figure 5.42: Data Log Screen
The following letters are displayed in the Data Log in the column immediately preceding the date (see Figure 5.42):
O — Sample was run in the Open mode
C — Sample was run in the Closed mode
N — Incomplete aspiration in the Open mode
I — Incomplete aspiration in the Closed mode
K — RBC/PLT metering fault (Clog or Flow Error)
M — Mixing error on the Sample Loader
R — Sample was run in the Resistant RBC mode
B — Blood detected in Sample Loader sample aspiration line
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5-111
DATA LOG
Ready
USE < OR > FOR MORE DATA
Apr 30 1993
Operator ID
Sequence #
12:57
734
3080
B
Seq Specimen ID
2621
2622
2623
2624
2625
2626
2627
2628
2629
2630
2631
2632
2633
2634
2635
2636
9100
R8 T5
R1 T3
BACK-
GROUND
LOW
LOW
NORMAL
HIGH
LOW
NORMAL
HIGH
PATIENT
PATIENT
PATIENT
WBC NEU LYM MONO EOS BASO
6.7
6.7
6.7
3.9
4.4
4.4
4.4
2.1
1.6
2.0
1.7
1.1
0.4
0.2
0.3
0.3
0.1
0.1
0.1
0.3
0.2
0.0
0.2
0.0
18.8
2.7
7.4
18.1
0.0
2.7
7.7
8.0
12.9
12.5
12.9
12.7
1.8
4.6
4.8
10.5
1.7
4.3
10.3
8.5
8.3
8.6
8.4
0.5
2.0
2.0
5.7
0.5
2.1
5.4
3.3
3.0
3.0
3.3
0.3
0.7
0.8
1.7
0.2
0.6
1.7
0.7
0.7
0.8
0.6
0.1
0.2
0.2
0.3
0.1
0.2
0.3
0.4
0.4
0.4
0.4
0.1
0.1
0.1
0.0
0.2
0.4
0.1
0.1
0.2
0.3
0.5
Date Time Op
O04/05/93 11:11 abc
O04/05/93 11:18 abc
K04/05/93 11:25 abc
C04/05/93 11:30 abc
O04/05/93 12:53 abc
O04/05/93 12:54 abc
O04/05/93 12:56 abc
O04/05/93 12:59 abc
O04/05/93 13:00 abc
C04/05/93 13:04 abc
C04/05/93 13:05 abc
C04/05/93 13:06 abc
C04/05/93 13:12 abc
C04/05/93 13:14 abc
C04/05/93 13:16 abc
O04/05/93 13:18 abc
Seq Specimen ID WBC NEU LYM MONO EOS BASO Date Tim e Op
DISPLAY
SPECIMEN
FIND
SPECIMEN
CUSTOMIZE
DATA LOG
TRANSMIT
DATA
DATA LOG
MAIN
Figure 5.43: Data Log Screen
Data Log Set Up Procedures
The Data Log may be configured to display and print results in the order selected by the operator. This section gives instructions for Customizing the Display and Printout.
Customizing the Data Log Display
The
CUSTOMIZE DISPLAY FOR DATA LOG Screen displays a
matrix showing the four groups of parameters that will be consecutively
displayed on the four Data Log screens. ( Figure 5.44
Groups in the matrix.) A list of all available parameters is displayed under the matrix. The parameters are selected from the list and placed in the desired group to customize the display.
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CUSTOMIZE DISPLAY
Ready
FOR DATA LOG
Dec 18 1992
Operator ID
Sequence #
10:57
734
0630
Group 1:
Group 2:
Group 3:
Group 4:
WBC NEU LYM MONO EOS BASO
RBC HGB HCT MCV MCH MCHC RDW
PLT MPV PCT PDW
WBC %N %L %M %E %B
WBC NEU LYM MONO EOS BASO
RBC HGB HCT MCV MCH MCHC RDW
PLT MPV PCT PDW
%N %L %M %E %B
UMT1 UMT2 CNT1 CNT2 EMPTY
SELECT
PARAMETER
STANDARD
GROUPS
CUSTOMIZE
PRINTOUT
RETURN
Figure 5.44: Customize Display for Data Log Screen
The display may be customized by selecting the individual parameters,
Standard Groups of parameters or a combination of the two. In addition to the usual Hematologic parameters, the following parameters may also be displayed in the Data Log:
UMT1 and UMT2 — UMT1 is the RBC/PLT Upper Metering Time.
UMT2 is the RBC/PLT Upper Metering Time for an extended count.
CNT1 and CNT2 — CNT1 is the RBC/PLT Count Time. CNT2 is the
RBC/PLT Count Time for an extended count.
EMPTY — Inserts an empty column in the display.
Procedure Customize Data Log Display
1.
From the main
DATA LOG Screen , press [CUSTOMIZE DATA
LOG] to display the CUSTOMIZE DISPLAY FOR DATA LOG
2.
If necessary, press [CUSTOM PLACEMENT] to display the
CUSTOMIZE DISPLAY FOR DATA LOG Screen and key
labels for custom placement.
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9140240E — May 1995
Standard Groups
3.
Use the Arrow keys on the keyboard to move the cursor to the desired parameter in the listing under the matrix.
4.
Press [SELECT PARAMETER]. The selected parameter is highlighted and the cursor moves to the first position in Group 1.
NOTE: The key label changes to [PLACE PARAMETER] and a [CANCEL SELECTION] key is displayed.
5.
If necessary, use the Arrow keys on the keyboard to move the cursor to the desired location and press [PLACE PARAMETER].
NOTE: When the [PLACE PARAMETER] key is pressed, the selected parameter is displayed in the position indicated by the cursor and the cursor is then advanced to the next position in the group.
6.
Repeat steps 3–5 until all selections have been made.
7.
If desired, press the Print Screen key on the keyboard to obtain a printout of the selected groups.
8.
Press [RETURN] to return to the DATA LOG Screen .
9.
The Data Log is displayed configured with the selected parameters.
The Data Log display may also be customized with predetermined groups (Standard Groups) of parameters using the [STANDARD
shows the WBC Group placed in GROUP 1,
the RBC Group placed in GROUP 2, the PLT Group placed in GROUP 3 and the Diff Group placed in GROUP 4.
Procedure Customize Data Log Display
(Standard Groups)
1.
From the main
DATA LOG Screen , press [CUSTOMIZE DATA
LOG] to display the CUSTOMIZE DISPLAY FOR DATA LOG
2.
Press [STANDARD GROUPS] to display the CUSTOMIZE
DISPLAY FOR DATA LOG Screen and key labels for Standard
Groups.
3.
Use the Arrow keys on the keyboard to move the cursor to the desired group (1– 4) location.
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NOTE: This number indicates the order in which the group of parameters will be displayed (Group 1 on the first screen, Group
2 on the second, etc.).
4.
Press the soft key corresponding to the desired parameter group.
This group is displayed in the position indicated by the cursor.
5.
Repeat steps 3 and 4 until all desired groups have been selected.
6.
If desired, press the Print Screen key on the keyboard to obtain a printout of the configuration.
7.
Press [RETURN] to return to the DATA LOG Screen .
8.
The Data Log is displayed configured with the standard groups of parameters.
CUSTOMIZE PRINTOUT
Ready
FOR DATA LOG
Dec 18 1992
Operator ID
Sequence #
10:31
734
0630
WBC %N %L %M %E %B RBC HGB HCT MCV MCH MCHC
RDW PLT MPV UMT1 CNT1
WBC NEU LYM MONO EOS BASO
RBC HGB HCT MCV MCH MCHCRDW
PLT MPV PCT PDW
%N % L %M %E %B
UMT1 UMT2 CNT1 CNT2
SELECT
PARAMETER
STANDARD
SELECTION
Figure 5.45: Customize Printout for Data Log Screen
RETURN
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Customizing the Printout
The
CUSTOMIZE PRINTOUT FOR DATA LOG Screen (see
) shows the group of parameters that will be printed on a Data
Log printout. A list of the available parameters is displayed under the group. The parameters are selected from the list and placed in the desired position to customize the printout. In addition to the usual Hematologic parameters, the following parameters may also be printed in the Data
Log:
UMT1 and UMT2 — UMT1 is the RBC/PLT Upper Metering
Time. UMT2 is the RBC/PLT Upper
Metering Time for an extended count.
CNT1 and CNT2 — CNT1 is the RBC/PLT Count Time.
CNT2 is the RBC/PLT Count Time for an extended count.
Procedure Customize Data Log Printout
1.
From the main DATA LOG Screen , press [CUSTOMIZE DATA
LOG] followed by [CUSTOMIZE PRINTOUT].
2.
Use the Arrow keys on the keyboard to move the cursor to the desired parameter in the list displayed under the printout group.
3.
Press [SELECT PARAMETER]. The selected parameter is highlighted and the cursor moves to the first position in the group.
NOTE: The key label changes to [PLACE PARAMETER] and a [CANCEL SELECTION] key is displayed.
4.
If necessary, use the Arrow keys on the keyboard to move the cursor to the desired location and press [PLACE PARAMETER].
NOTE: When the [PLACE PARAMETER] key is pressed, the selected parameter is displayed in the position indicated by the cursor and the cursor then advances to the next parameter in the list displayed under the printout group.
5.
Repeat steps 2–4 until all selections have been made.
6.
If desired, press the Print Screen key on the keyboard to obtain a printout of the configuration.
7.
Press [RETURN] twice to return to the DATA LOG Screen .
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Chapter 5 Search Book TOC Go Back Operating Instructions
Data Review from the Data Log
Scrolling Through the Data Log
The Page Up and Page Down keys may be used to rapidly scroll through the records stored in the Data Log. Press the Page Up key to scroll backward and press the Page Down key to scroll forward.
Displaying a Record
Results may be displayed for all 10,000 records stored in the Data Log.
Scatterplots and histograms are available for the last 2,000 records only.
A record is displayed by positioning the cursor at the record in the Data
Log listing and pressing [DISPLAY SPECIMEN]. The Status Box indicates DISPLAY SPECIMEN on results displayed (or printed) from the Data Log record. (See Figure 5.46.)
Spec ID 7
Patient___________
Sex(M/F):- DOB:--/--/--
Dr_________________
Param Set: 1 Limits: 1
WBC: 6.7
K/uL
NEU: 3.8
LYM: 2.4
56.7
35.4
%N
%L
MONO: 0.4
EOS: 0.1
BASO: 0.0
6.4
%M
0.9
%E
0.6
%B
RBC: 4.73
M/uL
HGB: 13.6
g/dL
HCT: 41.2
%
MCV: 87.1
fL
MCH: 28.8
pg
MCHC: 33.1
g/dL
RDW: 13.2
%
DISPLAY SPECIMEN
Ready
Sequence # 2346
S
I
Z
E
COMPLEXITY
Dec 18 1992
Operator ID
Sequence #
Open Sampler
PLT:
MPV:
402.
K/uL
9.1
fL CT: 6.40
RBC
PREVIOUS
SPECIMEN
NEXT
SPECIMEN
EDIT
SPECIMEN
CUSTOMIZE
REPORT
TRANSMIT
SPECIMEN
TICKET
D
E
P
O
L
13:11
734
0630
ORTHOGONAL
REPORT
PLT
RETURN
Figure 5.46: Display Specimen Screen
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Procedure Record Display
1.
From the
MAIN MENU Screen , press [DATA LOG].
2.
If the desired record is not displayed on the screen, press [FIND
SPECIMEN] to display the DATA LOG SEARCH Screen .
3.
Use the Arrow keys on the keyboard to move the cursor to the desired identifier: Sequence number, Specimen ID number or
Name.
4.
Type the appropriate information and press the Enter key on the keyboard to start the search.
NOTE: If necessary, you may press the Escape (ESC) key or the Enter key on the keyboard to exit from the search function
and return to the DATA LOG Screen .
5.
If the requested record is available, the screen displays the Data
Log page containing it. (The cursor is located at the sequence number of the record.)
6.
Press [DISPLAY SPECIMEN] to display the RUN Screen for the
selected record.
7.
If desired, press [PRINT REPORT] to obtain a printout.
8.
The [PREVIOUS SPECIMEN] or [NEXT SPECIMEN] key may now be used to display records listed in the Data Log which are adjacent to the one currently displayed.
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Editing a Record
The Patient Demographics and the Parameter and Patient Limits Sets may be edited for each record. (See Figure 5.47.)
Spec ID
7
Patient_____________
Sex(M/F):- DOB:--/---/--
Dr_____________
Param Set: 1 Limits: 1
WBC: 6.7 K/uL
NEU: 3.8 56.7
%N
LYM: 2.4 35.4
%L
MONO: 0.4 6.4 %M
EOS: 0.1 0.9 %E
BASO: 0.0 0.6 %B
RBC: 4.73 M/uL
HGB: 13.6 g/dL
HCT: 41.2 %
MCV: 87.1 fL
MCH: 28.8 pg
MCHC: 33.1 g/dL
RDW: 13.2 %
PLT: 402. K/uL
MPV: 9.1 fL
CONFIRM
EDIT SPECIMEN
Ready
Sequence # 2346
Dec 18 1992
Operator ID
Sequence #
Open Sampler
13:11
734
0630
Z
E
S
I
D
E
P
O
L
COMPLEXITY ORTHOGONAL
CT:6.40
RBC PLT
CANCEL
Figure 5.47: Edit Specimen Screen
Procedure Edit Specimen
1.
From the MAIN MENU Screen , press [DATA LOG].
2.
Locate the desired record and press [DISPLAY SPECIMEN] followed by [EDIT SPECIMEN].
3.
Use the Arrow keys on the keyboard to move the cursor to the line that will be edited and type the appropriate information. Press the
Enter key on the keyboard to save the entry.
4.
Press [CONFIRM] to display the RUN Screen for the edited
result.
5.
If desired, press [PRINT REPORT] to obtain a printout.
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Operating Instructions
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NOTES
Chapter 5
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References
1.
NCCLS Standard H3-A3, Procedure for the Collection of
Diagnostic Blood Specimens by Venipuncture—Third Edition;
Approved Standard (1991).
2.
NCCLS Standard H4-A3, Procedure for the Collection of
Diagnostic Blood Specimens by Skin Puncture—Third Edition;
Approved Standard (1991).
3.
ICSH, Protocol for Evaluation of Automated Blood Cell Counters,
Clinical and Laboratory Hematology 1988, 10:203, 212.
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Operating Instructions
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NOTES
Chapter 5
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Chapter 6 Search Book TOC Go Back
Calibration
Chapter Table of Contents
General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3
Calibration Procedural Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3
Conventions Used in this Chapter . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4
Calibration Procedural Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5
Whole Blood Calibration Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . 6-6
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-6
Sample Requirements for Fresh Whole Blood . . . . . . . . . . . . . . . 6-6
Determination of the Reference Values . . . . . . . . . . . . . . . . . . . . 6-6
Calibration Requirements for Fresh Whole Blood . . . . . . . . . . . . 6-7
Calibration Overview
Auto-Cal Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-11
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-11
Auto-Cal Sample Capacity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-11
Auto-Cal Methodology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-11
Calibration Requirements for Auto-Cal . . . . . . . . . . . . . . . . . . . 6-12
Calibration Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-13
Manual Calibration Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-24
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-24
Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-24
Mode To Mode Calibration Overview . . . . . . . . . . . . . . . . . . . . . . . 6-25
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-25
Auto-Cal Mode to Mode Calibration . . . . . . . . . . . . . . . . . . . . . 6-25
Manual Mode to Mode Calibration . . . . . . . . . . . . . . . . . . . . . . 6-25
Mode to Mode Calibration Preparation . . . . . . . . . . . . . . . . . . . 6-26
Closed Mode Calibration Confirmation . . . . . . . . . . . . . . . . . . . 6-26
Pre-Calibration Procedures
Calibration Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-27
Instrument Logbook . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-28
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Table of Contents-1
Table of Contents Search Book TOC Go Back
Chapter 6
Open Mode Procedures
Auto-Cal Using The CELL-DYN Calibrator . . . . . . . . . . . . . . . . . . .6-33
Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-33
Starting Auto-Cal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-33
Entering the Reference Values . . . . . . . . . . . . . . . . . . . . . . . . . .6-33
Performing the Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-34
Calibration Factor Calculation . . . . . . . . . . . . . . . . . . . . . . . . . .6-36
Determining Which Parameters Need Calibration . . . . . . . . . . .6-37
Calibration for All Parameters . . . . . . . . . . . . . . . . . . . . . . . . . .6-39
Calibration for Individual Parameters . . . . . . . . . . . . . . . . . . . . .6-40
Completing Open Mode Calibration . . . . . . . . . . . . . . . . . . . . . .6-40
Auto-Cal Using Whole Blood Samples . . . . . . . . . . . . . . . . . . . . . . .6-42
Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-42
Starting Auto-Cal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-42
Entering the Reference Values . . . . . . . . . . . . . . . . . . . . . . . . . .6-42
Performing the Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-43
Calibration Factor Calculation . . . . . . . . . . . . . . . . . . . . . . . . . .6-45
Determining Which Parameters Need Calibration . . . . . . . . . . .6-46
Calibration for All Parameters . . . . . . . . . . . . . . . . . . . . . . . . . .6-48
Calibration for Individual Parameters . . . . . . . . . . . . . . . . . . . . .6-49
Completing Whole Blood Open Mode Calibration . . . . . . . . . . .6-49
Manual Calibration — Open Mode . . . . . . . . . . . . . . . . . . . . . . . . . .6-51
Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-51
Preparing for Manual Calibration . . . . . . . . . . . . . . . . . . . . . . . .6-51
Determining the Open Mode Mean . . . . . . . . . . . . . . . . . . . . . . .6-51
Calibration Factor Calculations . . . . . . . . . . . . . . . . . . . . . . . . . .6-52
Determining Which Parameters Need Calibration . . . . . . . . . . .6-53
Calibrating the Open Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-55
Completing Manual Calibration . . . . . . . . . . . . . . . . . . . . . . . . .6-55
Closed Mode Procedures
Mode To Mode Auto-Cal, Sampler Loader Procedure . . . . . . . . . . .6-59
Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-59
Determining Reference Values . . . . . . . . . . . . . . . . . . . . . . . . . .6-59
Starting Auto-Cal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-59
Entering the Reference Values . . . . . . . . . . . . . . . . . . . . . . . . . .6-60
Performing the Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-61
Calibration Factor Calculation . . . . . . . . . . . . . . . . . . . . . . . . . .6-63
Determining Which Parameters Need Calibration . . . . . . . . . . .6-64
Calibration for All Parameters . . . . . . . . . . . . . . . . . . . . . . . . . .6-66
Calibration for Individual Parameters . . . . . . . . . . . . . . . . . . . . .6-67
Completing Mode to Mode Calibration . . . . . . . . . . . . . . . . . . .6-67
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Mode To Mode Auto-Cal, Closed Sampler Procedure . . . . . . . . . . . 6-70
Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-70
Determining Reference Values . . . . . . . . . . . . . . . . . . . . . . . . . . 6-70
Starting Auto-Cal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-70
Entering the Reference Values . . . . . . . . . . . . . . . . . . . . . . . . . . 6-71
Performing the Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-72
Calibration Factor Calculation . . . . . . . . . . . . . . . . . . . . . . . . . . 6-74
Determining Which Parameters Need Calibration . . . . . . . . . . . 6-75
Calibration for All Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . 6-77
Calibration for Individual Parameters . . . . . . . . . . . . . . . . . . . . . 6-78
Completing Mode to Mode Calibration . . . . . . . . . . . . . . . . . . . 6-78
Manual Mode To Mode Calibration . . . . . . . . . . . . . . . . . . . . . . . . . 6-81
Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-81
Preparing for Manual Mode to Mode Calibration . . . . . . . . . . . 6-81
Determining the Open Mode Mean . . . . . . . . . . . . . . . . . . . . . . 6-81
Determining the Closed Mode Mean . . . . . . . . . . . . . . . . . . . . . 6-82
Difference Calculation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-82
Determining Which Parameters Need Calibration . . . . . . . . . . . 6-83
Calibration Factor Calculation . . . . . . . . . . . . . . . . . . . . . . . . . . 6-85
Calibrating the Closed Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-85
Completing Mode to Mode Calibration . . . . . . . . . . . . . . . . . . . 6-86
Post-Calibration Procedures
Calibration Back-Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-89
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Table of Contents-3
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NOTES
Chapter 6
Table of Contents-4
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Chapter 6
Introduction
Search Book TOC Go Back
Calibration
The CELL-DYN® 3000 is calibrated at the factory just prior to shipment.
An Abbott Field Service Representative will assist the operator in confirming this calibration during instrument installation. Calibration may be performed with a commercial calibrator or fresh whole blood samples.
Only the directly measured parameters WBC, RBC, HGB, MCV, PLT and
MPV may be calibrated.
The instrument is very stable and should not require frequent recalibration when it is operated and maintained according to the recommendations in this manual. On-board quality control programs are designed to provide continual monitoring and confirmation of instrument calibration. The laboratory should make the decision to recalibrate based on the performance of the
CELL-DYN 3000 in these quality control programs. The programs include statistical computations and Westgard Rules for commercial or patient controls and monitoring of patient samples for the RBC parameters using
Bull’s moving average program (X-B).
The calibration of the CELL-DYN 3000 should be confirmed on a regular basis according to the requirements governing quality control in your laboratory. In keeping with good laboratory practices, this should include daily confirmation on each shift and following a reagent lot number change. Confirmation of calibration is also recommended following the replacement of any major instrument component (e.g., the shear valve) that could affect calibration. Calibration may be confirmed by running appropriate commercial controls or by using fresh whole blood samples that were analyzed on a reliably calibrated Hematology analyzer or by reference methodology.
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Calibration
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Chapter 6
Calibration Materials
WARNING: Potential Biohazard. Consider all clinical specimens and controls, calibrators, etc. that contain human blood or serum as potentially infectious. Use established, good laboratory working practices when handling these samples. Wear gloves, lab coats and suitable eye protection and follow other biosafety practices as specified in the OSHA Bloodborne
Pathogen Rule or other equivalent biosafety procedures.
Three calibration materials can be used to calibrate the
CELL-DYN 3000:
• CELL-DYN Calibrator
Calibration with CELL-DYN Calibrator is most efficiently performed by calibrating the Open mode. The Closed mode is then calibrated to correlate with the Open mode using fresh whole blood samples.
• Fresh Whole Blood
Calibration with fresh whole blood is accomplished by performing multiple analyses of each sample by acceptable reference methodology and calculating the mean reference value for each parameter. The same samples are analyzed on the CELL-DYN
3000 in the Open mode. The Closed mode is then calibrated to correlate with the Open mode using another set of fresh whole
blood samples. A detailed discussion of Whole Blood Calibration
is given in the next section.
• Latex Particles
Latex Particles are used to calibrate the Mean Platelet Volume. This function is only used by Abbott Service Representatives.
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Chapter 6 Search Book TOC Go Back Calibration
General Information
The CELL-DYN 3000 has three modes of operation:
• Open mode
• Closed mode — Sample Loader version
• Closed mode — Closed Sampler version
NOTE: Each CELL-DYN 3000 has only one closed mode of operation.
Both the Open and Closed modes must be calibrated individually. For convenience, the Open mode is calibrated first and the Closed mode is then referenced to it. There are several ways to accomplish the total calibration, depending on the preference of the user. The following
Calibration Procedural Guidelines section provides a quick reference guide to the remainder of the chapter.
Calibration Procedural Guidelines
Two methods may be used to calibrate the CELL-DYN 3000:
• Auto-Cal — automatic calibration program incorporated in the
Data Station software
• Manual Calibration — an alternative to Auto-Cal
The instrument’s Open mode is calibrated with the calibration material of choice, using the method of choice. The Closed mode is then calibrated to correlate with fresh whole blood samples using the Mode to Mode
Calibration method of choice. The Calibration Overview section of this
chapter contains an overview for each method of calibration and gives a detailed explanation of how to use it. Review the appropriate overview before beginning the selected calibration procedure.
The selected calibration procedure may indicate that the calibration for some or all of the parameters is acceptable. Therefore, each procedure includes specific criteria that are used to determine which parameters require calibration. The criteria are:
• Validation Range —
• Calibration Range —
Calibration not required
Calibration is required
• Calibration Limit — Do not calibrate, possible instrument problem exists
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Calibration
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Chapter 6
Complete instructions for using these criteria and a Calibration Criteria
Chart are included with each procedure to facilitate the decision. The chart is depicted in Table 6.1.
WBC
RBC
HGB
MCV
PLT
Table 6.1: Calibration Criteria Chart
Validation Range
Cal Not Required
<1.5%
<1.0%
<1.0%
<1.0%
<3.0%
Calibration Range
Cal Required
>1.5% but < 10%
>1.0% but < 10%
>1.0% but < 10%
>1.0% but < 10%
>3.0% but < 15%
Calibration Limit
Do Not Cal
>10%
>10%
>10%
>10%
>15%
The calibration procedures have been divided into subsections that consist of a series of easy-to-follow steps. Always follow the entire procedure unless specifically directed to skip to another section.
Worksheets are provided at the end of each procedure to assist in determining which parameters require calibration. For manual calibration, worksheets may be used to assist in making the necessary calculations. These worksheets may be duplicated as needed.
NOTE: Always complete the Pre-Calibration procedures before
beginning any calibration.
Conventions Used in this Chapter
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Calibration Procedural Summary
Table 6.2: Calibration Procedural Summary
Step Choices
1. Read appropriate overview Auto-Cal Calibration
Manual Calibration
Mode to Mode Calibration
2. Complete Pre-Calibration
Procedures
3. Open Mode Calibration
Procedures
4. Closed Mode Calibration
Procedures
Choose ONE:
Auto-Cal Using Commercial Calibrator
Auto-Cal Using Fresh Whole Blood*
Manual Calibration*
Choose ONE:
Auto-Cal Mode to Mode Calibration for
CELL-DYN 3000SL
Auto-Cal Mode to Mode Calibration for
CELL-DYN 3000CS*
Manual Mode to Mode Calibration for
CELL-DYN 3000SL OR CS*
5. Complete Post-Calibration
Procedures
* Be sure to read the
Whole Blood Calibration Guidelines section of this chapter for
complete information on fresh whole blood sample requirements.
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Calibration
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Chapter 6
Whole Blood Calibration Guidelines
Introduction
Calibration with Fresh Whole Blood Samples is an alternative to calibration with a Commercial Calibrator. This section explains the determination of reference values and gives requirements for Whole
Blood Samples and calibration with them.
Sample Requirements for Fresh Whole Blood
The following requirements should be observed for fresh whole blood samples used for calibration:
1.
The ICSH recommends that fresh samples be less than four hours old.
1 Sample age must not exceed eight hours at the conclusion of the calibration procedure.
2.
All parameter values should be within the laboratory’s normal range. The following ranges are programmed for the reference values that may be entered in the Auto-Cal program. Results exceeding these limits cannot be entered.
WBC
RBC
2.0
2.00
–
–
25.0
6.50
K/
µ
L
M/
µ
L
HGB 4.0
– 24.0
g/dL
MCV
PLT
70.0
– 100.0
50.0
– 600.0
fL
K/
3.
All cellular morphology must be normal.
µ
L
4.
No known interfering substances should be present (e.g., lipemia, icterus, drugs).
5.
All samples must be properly collected in the EDTA anticoagulant used by the laboratory.
6.
Each tube should contain at least 90% of the nominal collection volume of blood.
1
Determination of the Reference Values
Reference values for Whole Blood Calibration should be determined according to the following International Committee for Standardization in Hematology (ICSH) recommendations.
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WBC, RBC and PLT
Reference values may be determined using multiple counts from a certified hemocytometer or from a reliably calibrated hematology analyzer.
Hemoglobin
Reference values may be determined using either the Reference
Cyanmethemoglobin Method or a reliably calibrated hemoglobinometer or hematology analyzer.
NOTE: DO NOT attempt to calibrate the CELL-DYN 3000 with a hemoglobin standard designed for the calibration of specific Reference Cyanmethemoglobin Methods. The instrument uses a Modified Hemiglobincyanide Method which is not designed to analyze these standards directly.
MCV
Hematocrit Reference Values may be determined from the Reference
Microhematocrit. RBC Reference Values may be determined by using multiple counts from a certified hemocytometer or from a reliably calibrated hematology analyzer. The MCV can be calculated from the
Reference HCT and RBC Values.
NOTE: Reference Microhematocrit Values may be determined by multiple analyses using the NCCLS Method for Packed Cell
Volume (PCV). Use only plain (non-anticoagulated) capillary tubes. Be certain to verify the proper operation of the microhematocrit centrifuge and the timer as recommended by
NCCLS (National Committee for Clinical Laboratory
Standards).
Calibration Requirements for Fresh Whole Blood
Minimum requirements for Whole Blood Calibration are described in the following list.
1.
A minimum of five samples is required for adequate Whole Blood
Calibration.
2.
Samples must be assayed at least in triplicate by reference methodology and on the CELL-DYN 3000.
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Calibration
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Chapter 6
3.
No more than two hours should elapse between the
CELL-DYN 3000 run and the assay by reference methodology. If samples are run on the CELL-DYN 3000 first, assay by reference methodology should be completed within one hour. (Certain reference methodologies are sensitive to RBC swelling caused by in vitro deoxygenation.)
4.
Mean values should be calculated for each parameter for each sample from the reference assay results. These mean parameter values can then be entered in the Auto-Cal program as reference values for each sample.
NOTE: A worksheet is provided on the following page. This worksheet may be used to assist with the calculation of the parameter reference means and may be duplicated as needed.
5.
If Auto-Cal is not being used, the mean parameter values should be averaged to obtain the cumulative mean value for each parameter.
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Chapter 6 Search Book TOC Go Back Calibration
Whole Blood Calibration Reference Values Worksheet
Date:___________________________________Parameter:_______________________________________
Technologist:____________________________Method:_________________________________________
________________________________________________________________________________________
Sample ID 1 2 3 4
Reference Assays
5 6 7 8 9 10 Mean
CELL-DYN
3000 System Operator’s Manual
9140240E — May 1995
Cumulative Parameter Mean
6-9
Calibration
Search Book TOC Go Back
NOTES
Chapter 6
6-10
CELL-DYN
3000 System Operator’s Manual
9140240E — May 1995
Chapter 6 Search Book TOC Go Back Calibration
Calibration Overview
Auto-Cal Overview
Introduction
The Auto-Cal program provides an automated calibration method that prepares the CELL-DYN 3000 for calibration, calculates new calibration factors and calibrates the instrument. The Auto-Cal program allows calibration with Commercial Calibrators or whole blood samples. Auto-
Cal may be performed in the following modes:
• Open mode
• Closed mode
Auto-Cal Sample Capacity
Auto-Cal accepts up to ten consecutive sample runs in the Open Mode
(up to five in the Closed Mode) on up to ten different samples, as indicated:
Auto-Cal Program Sample Capacity
Maximum number of
Consecutive Runs
Auto-Cal Methodology
Specimen Type
Whole Blood
Commercial
Calibrator
* SL: Sample Loader
** CS: Closed Sampler
Maximum Number of
Specimens
10
10
Open
10
10
Closed SL* or
Closed-CS**
5
5
The Auto-Cal program automatically computes a calibration factor based on all acceptable data. (New factors are calculated using 1.00 as the reference.)
NOTE: Because the instrument uses 1.00 as the reference, results generated in the Auto-Cal mode may not correlate with results previously seen in the run mode. This DOES NOT indicate a problem.
CELL-DYN
3000 System Operator’s Manual
9140240E — May 1995
6-11
Calibration
Search Book TOC Go Back
Chapter 6
New calibration factors are computed for each parameter by comparing each mean to the reference value entered for that sample. If more than one sample is used, factors are computed for each parameter from each of the samples. All of these factors are averaged to obtain the final calibration factor for a given parameter.
The program computes the percent difference between the existing calibration factor and the new one it computed. The operator decides whether to accept the new factors based on criteria derived from CELL-
DYN 3000 performance specifications.
Calibration Requirements for Auto-Cal
The Open mode should be calibrated with the CELL-DYN Calibrator.
The Closed mode is then calibrated to correlate with the Open mode using fresh, normal whole blood samples. In order to achieve an accurate calibration, follow the appropriate requirements as listed below:
• Calibrator Calibration
The Calibrator should be cycled for a minimum of 5 consecutive runs and a maximum of 10 consecutive runs in the Open mode.
• Whole Blood Calibration
At least five different, fresh, normal Whole Blood Samples should be used. Each sample must be cycled for a minimum of three consecutive runs. Whole blood samples may be run in the Open or
Closed mode.
NOTE: Refer to the Whole Blood Calibration Guidelines
section of this chapter for detailed instructions for selecting and processing whole blood samples.
• Closed Mode Calibration
Ten normal whole blood samples should be used. After the Open mode has been calibrated, each sample is cycled once in the Open mode. The results from these samples are then used to calibrate the
Closed mode.
NOTE: Complete directions for calibration of the Closed mode
are given in the Mode to Mode Calibration Overview and the
Mode to Mode Calibration procedures sections of this chapter.
6-12
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Chapter 6
Calibration Menu
CALIBRA-
TION
Search Book TOC Go Back Calibration
The CALIBRATION MENU Screen (Figures 6.1 and
from the MAIN MENU Screen by pressing the [CALIBRATION] key.
The CALIBRATION MENU Screen displays the current calibration
factors for the mode indicated, the calibration method used, the date and time the factors were entered and the operator ID.
The following soft key labels are displayed:
ENTER FACTOR
CALIBRATN LOG
AUTO-CALIBRATE
OPEN SAMPLER or
CLOSED SAMPLER (Key label alternates between these two selections when the soft key is pressed.)
MAIN
CALIBRATION
Ready
May 11 1992
Operator ID
Sequence #
10:30
734
4100
Open Sampler
Current Whole Blood Factors:
Parameter
WBC
RBC
HGB
MCV
PLT
MPV
Method
CALIBRATOR
CALIBRATOR
CALIBRATOR
CALIBRATOR
CALIBRATOR
FACTORY
Factor
1.008
1.071
1.124
0.985
1.028
1.000
Date
04/29/92
04/29/92
04/29/92
04/29/92
04/29/92
03/02/92
Time
10:38
10:38
10:38
10:38
10:38
8:38
Operator
C03
C03
C03
C03
C03
C03
ENTER
FACTOR
CALIBRATN
LOG
Figure 6.1:
AUTO-
CALIBRATE
CLOSED
SAMPLER
PRINT MAIN
Calibration Menu Screen Displaying Open Mode
Calibration Factors
CELL-DYN
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9140240E — May 1995
6-13
Calibration
Search Book TOC Go Back
Chapter 6
CALIBRATION
Ready
May 11 1992
Operator ID
Sequence #
10:30
734
4100
Closed Sampler
Current Whole Blood Factors:
Parameter
WBC
RBC
HGB
MCV
PLT
MPV
Method
WHOLE BLOOD
WHOLE BLOOD
WHOLE BLOOD
WHOLE BLOOD
WHOLE BLOOD
FACTORY
Factor
1.056
1.060
1.136
0.985
1.039
1.000
Date
04/30/92
04/30/92
04/30/92
04/30/92
04/30/92
03/02/92
Time
16:59
16:59
16:59
16:59
16:59
11:41
Operator
C03
C03
C03
C03
C03
C03
OPEN
SAMPLER
ENTER
FACTOR
CALIBRATN
LOG
AUTO-
CALIBRATE
OPEN
SAMPLER
PRINT MAIN
Figure 6.2: Calibration Menu Screen Displaying Closed Mode
Calibration Factors
The function of each key is discussed briefly in this section. The Auto-
Cal Calibration Procedures provide detailed instructions for using the
Auto-Cal program.
NOTE: For ease of explanation, the key labels may not always be discussed in the order in which they appear on the screen.
The [OPEN SAMPLER/CLOSED SAMPLER] key is used to display
the current calibration factors for the mode selected (see Figures 6.1
and 6.2).
NOTE: The key is labeled for the sampler mode that is NOT currently displayed.
The [PRINT] key is used to print the Current Whole Blood Factors
displayed on the CALIBRATION MENU Screen .
6-14
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9140240E — May 1995
Chapter 6
MAIN
ENTER
FACTOR
RESTORE
FACTORS
Search Book TOC Go Back Calibration
The [MAIN] key is used to return to the MAIN MENU Screen .
The [ENTER FACTOR] key displays the ENTER WHOLE BLOOD
FACTOR Screen showing the current Open and Closed Calibration
Factors (See Figure 6.3). Calibration factors may be changed on this screen by moving the cursor to the desired position, typing the new factor and pressing the Enter key on the keyboard. The following soft key labels are displayed:
RESTORE FACTORS
RESET ALL TO 1.00
RETURN
The [RESTORE FACTORS] key is used to restore the previous calibration factors. This key is only active immediately after factors have been changed.
ENTER WHOLE BLOOD FACTOR
Ready
May 11 1992
Operator ID
Sequence #
10:34
734
4100
Parameter
WBC
RBC
HGB
MCV
PLT
MPV
(Factor Range)
(0.70..1.30)
(0.80..1.20)
(0.70..1.30)
(0.70..1.30)
(0.70..1.30)
(0.70..1.30)
Open Sampler
Factor
1.008
1.071
1.124
0.985
1.028
1.000
Closed Sampler
Factor
1.056
1.060
1.136
0.985
0.939
1.000
RESTORE
FACTORS
RESET ALL
TO 1.00
Figure 6.3: Enter Whole Blood Factor Screen
RETURN
CELL-DYN
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9140240E — May 1995
6-15
Calibration
RESET
ALL TO 1.00
RETURN
CALIBRATN
LOG
OPEN
SAMPLER
LOG
RETURN
AUTO-
CALIBRATE
6-16
Search Book TOC Go Back
Chapter 6
The [RESET ALL TO 1.00] key is used to reset all of the calibration factors to 1.00.
The [RETURN] key is used to return to the CALIBRATION MENU
The [CALIBRATN LOG] key is used to display the CALIBRATION
) for the Open or Closed mode. The following
soft key labels are displayed when the [CALIBRATN LOG] key is pressed:
OPEN SAMPLER or
CLOSED SAMPLER (Key label alternates between these two selections)
PRINT LOG
RETURN
The [OPEN SAMPLER/CLOSED SAMPLER] key is used to display the calibration log for the selected mode.
NOTE: The key is labeled for the sampler mode that is NOT currently displayed.
The [PRINT LOG] key is used to print the Calibration Log for the displayed mode.
The [RETURN] key is used to return to the CALIBRATION MENU
The [AUTO-CALIBRATE] key is used to access the Auto-Calibration
program. The AUTO-CALIBRATION Screen ( Figure 6.5
following soft key labels are displayed:
WHOLE BLOOD
CALIBRATR
LATEX
CHANGE SAMPLER
RETURN
CELL-DYN
3000 System Operator’s Manual
9140240E — May 1995
Chapter 6 Search Book TOC Go Back Calibration
CALIBRATION LOG
Ready
Aug 11 1992
Operator ID
Sequence #
10:35
734
4100
Open Sampler
Date
04/28/92
Time
14:45
OpID WBC RBC HGB MCV PLT MPV
734 1.010(A) 1.070(A) 1.120(A) 0.990(A) 1.030(A) 1.000(F)
Comments: CALIBRATION TO CALIBRATOR-LOT CD3012. INSTRUMENT INSTALLATION
08/02/92 11:41 734 1.010(A) 1.130(E) 1.120(A) 1.010(E) 1.130(E) 1.000(F)
Comments: RBC/PLT APERTURE REPLACED.
Figure 6.4: Calibration Log Screen
AUTO-CALIBRATION
Ready
Open Sampler
Open sampler is selected. To calibrate using the closed sampler, first press the CHANGE SAMPLER key.
To proceed, press the key for the specimen type being used (WHOLE BLOOD, CALIBRATOR, or LATEX).
CLOSED
SAMPLER
LOG
RETURN
May 11 1992
Operator ID
Sequence #
10:30
734
4100
WHOLE
BLOOD
CALIBRATR LATEX
Figure 6.5:
CHANGE
SAMPLER
RETURN
Auto-Calibration Screen for CELL-DYN 3000
CELL-DYN
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9140240E — May 1995
6-17
Calibration
CHANGE
SAMPLER
RETURN
WHOLE
BLOOD
EDIT
REF VAL
Search Book TOC Go Back
Chapter 6
The [CHANGE SAMPLER] key is used to change the sample aspiration mode of the Analyzer from the currently selected mode that is indicated on the screen.
The [RETURN] key is used to return to the CALIBRATION MENU
The [WHOLE BLOOD] key is used to display the WHOLE BLOOD
). This screen accesses the Auto-Cal
program that is used to calibrate the instrument with fresh Whole Blood
Samples. The WHOLE BLOOD AUTO-CAL Screen and the following
soft key labels are displayed:
EDIT REF VAL
START AUTO-CAL
QUIT AUTO-CAL
CLEAR REF VALS
PRINT SUMMARY
RETURN
CONFIRM SELECTION
CANCEL SELECTION
(This key appears only if
Auto-Cal was last performed with a Calibrator.)
(This key appears only if
Auto-Cal was last performed with a Calibrator.)
These keys are used to confirm or cancel the Whole Blood Auto-
Cal selection.
The bulletin line displays the message:
PRESS CONFIRM SELECTION TO CLEAR PREVIOUS
AUTO-CAL REFERENCE VALUES.
The [EDIT REF VAL] key is used to edit the displayed reference value indicated by the position of the cursor. The key deletes the existing value and the cursor remains in position for the new entry.
6-18
CELL-DYN
3000 System Operator’s Manual
9140240E — May 1995
Chapter 6 Search Book TOC Go Back Calibration
WHOLE BLOOD AUTO-CAL
Ready
May 11 1992
Operator ID
Sequence #
10:01
734
4100
Open Sampler
Enter reference value for each parameter to be calibrated: (up to 10 specimens)
Spec ID # of runs WBC RBC HGB
CAL#01
CAL#02
(1 to 10)
1
3
(2.0-25.0)
7.30
----
(2.00-6.50)
4.24
----
(4.0-24.0)
12.9
----
MCV
(70.0-100.)
90.0
----
PLT
(50.0-600.)
244.
----
CLEAR
REF VALS
SUMMARY
RETURN
CELL-DYN
3000 System Operator’s Manual
9140240E — May 1995
EDIT
REF VAL
START
AUTO-CAL
QUIT
AUTO-CAL
CLEAR
REF VALS
SUMMARY
RETURN
Figure 6.6: Whole Blood Auto-Cal Screen
The [CLEAR REF VALS] key is used to clear the reference values used in previous calibrations before entering new values. The following soft key labels are displayed when the [CLEAR REF VALS] key is pressed:
CONFIRM CLEAR
CANCEL CLEAR
These keys are used to confirm or cancel the Clear Reference Values command.
The [PRINT SUMMARY] key is used to print the entered reference values.
The [RETURN] key is used to return to the AUTO-CALIBRATION
6-19
Calibration
START
AUTO-CAL
CONTINUE
AUTO-CAL
INTERRUPT
AUTO-CAL
QUIT
AUTO-CAL
6-20
RETURN
Search Book TOC Go Back
Chapter 6
The [START AUTO-CAL] key starts the Auto-Cal program by initiating three background counts.
The [CONTINUE AUTO-CAL] key is displayed after the background
counts are completed as shown in Figure 6.7
NOTE: The key label changes to [INTERRUPT AUTO-CAL] after the key is pressed.
The WHOLE BLOOD AUTO-CAL RESULTS Screen (see Figure 6.8
and the following soft key labels are displayed when the [CONTINUE
AUTO-CAL] key is pressed:
INTERRUPT AUTO-CAL
QUIT AUTO-CAL
RETURN
The [INTERRUPT AUTO-CAL] key is used to interrupt (pause) the
Auto-Cal program.
The [QUIT AUTO-CAL] key is used to exit from the Auto-Cal program before it is completed. When the [QUIT AUTO-CAL] key is pressed, the bulletin line displays the message: ALL EXISTING DATA AND
RESULTS WILL BE CLEARED. The following soft key labels are displayed:
CONFIRM QUIT
CANCEL QUIT
These keys are used to confirm or cancel the Quit Auto-Cal command.
The [PRINT] key is used to print the
The [RETURN] key is used to return to the reference value entry screen.
CELL-DYN
3000 System Operator’s Manual
9140240E — May 1995
Chapter 6 Search Book TOC Go Back Calibration
WHOLE BLOOD AUTO-CAL
Ready
May 11 1992
Operator ID
Sequence #
10:01
734
4100
Open Sampler
Enter reference value for each parameter to be calibrated: (up to 10 specimens)
Spec ID # of runs WBC RBC HGB
CAL#01
CAL#02
(1 to 10)
3
3
(2.0-25.0)
7.30
----
(2.00-6.50)
4.24
----
(4.0-24.0)
12.9
----
MCV
(70.0-100.)
90.0
----
PLT
(50.-600.)
244.
----
EDIT
REF VAL
Figure 6.7:
CONTINUE
AUTO-CAL
QUIT
AUTO-CAL
CLEAR
REF VALS
SUMMARY
RETURN
Whole Blood Auto-Cal Screen
SPEC ID CAL#01-01
NO. OF RUNS 3
WHOLE BLOOD AUTO-CAL
Ready for Calibration
May 11 1992
Operator ID
Sequence #
10:30
734
4100
Open Sampler
Parameter
WBC
RBC
HGB
MCV
PLT
Value
7.30
4.24
12.9
90.0
244.
RUN1
RESULTS FOR SPECIMEN #1
Spec 1
RUN2 RUN3 Factor
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
Mean
Factor
----
----
----
----
----
Factor
%Diff
----
----
----
----
----
CELL-DYN
3000 System Operator’s Manual
9140240E — May 1995
Figure 6.8:
INTERRUPT
AUTO-CAL
QUIT
AUTO-CAL
Whole Blood Auto-Cal Results Screen
PRINT RETURN
6-21
Calibration
Search Book TOC Go Back
Chapter 6
The [REPEAT SPECIMEN] key (see Figure 6.9) is displayed when the first run of the first specimen is completed. This key is used to delete all results (runs) for the current specimen.
NOTE: This key deletes all results for all runs of the current specimen. It does not delete one run only.
SPEC ID CAL#01-01
NO. OF RUNS 3
WHOLE BLOOD AUTO-CAL
Ready for Calibration
May 11 1992
Operator ID
Sequence #
10:30
734
4100
Open Sampler
Parameter
WBC
RBC
HGB
MCV
PLT
Value
7.30
4.24
12.9
90.0
244.
RUN1
RESULTS FOR SPECIMEN #1
RUN2 RUN3
Spec 1
Factor
7.42
4.39
----
----
----
----
0.980
0.970
13.0
91.0
254.
----
----
----
----
----
----
0.990
0.990
0.960
Mean
Factor
----
----
----
----
----
Factor
%Diff
----
----
----
----
----
CALIBRATR
6-22
REPEAT
SPECIMEN
INTERRUPT
AUTO-CAL
QUIT
AUTO-CAL
PRINT RETURN
Figure 6.9: Whole Blood Auto-Cal Results Screen
The [CALIBRATR] key is used to display the
). This screen accesses the Auto-Cal
program that is used to calibrate the instrument with a commercial calibrator. The following soft key labels are displayed:
EDIT REF VAL
START AUTO-CAL
QUIT AUTO CAL
CLEAR REF VALS
PRINT SUMMARY
RETURN
CELL-DYN
3000 System Operator’s Manual
9140240E — May 1995
LATEX
These soft keys have the same functions as described for the WHOLE
NOTE: If Auto-Cal was last performed with a calibrator, the following key labels are displayed when the [WHOLE
BLOOD] key is pressed:
CONFIRM SELECTION
CANCEL SELECTION
These keys are used to confirm or cancel the Whole Blood Auto-Cal selection. The bulletin line displays the message:
PRESS CONFIRM SELECTION TO CLEAR PREVIOUS
AUTO-CAL REFERENCE VALUES.
The [LATEX] key is used to display the LATEX AUTO-CAL Screen.
This screen accesses the Auto-Cal program for MPV calibration with latex particles which is used by Abbott service personnel.
CALIBRATOR AUTO-CAL
Ready
May 11 1992
Operator ID
Sequence #
10:01
734
4100
Open Sampler
Enter reference value for each parameter to be calibrated: (up to 10 specimens)
Spec ID # of runs WBC RBC HGB MCV PLT
(1 to 10) (4.6-10.2) (3.00-5.50) (10.0-15.5) (85.0-97.0) (150.-400.)
CAL#01 10 7.90 4.46 13.2 85.4 257.
CAL#02 3 ---- ---- ---- ---- ----
EDIT
REF VAL
START
AUTO-CAL
QUIT
AUTO-CAL
CLEAR
REF VALS
SUMMARY
RETURN
Figure 6.10: Calibrator Auto-Cal Screen
CELL-DYN
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Calibration
Search Book TOC Go Back
Chapter 6
Manual Calibration Overview
Introduction
The Open mode of the CELL-DYN 3000 may be calibrated without using the Auto-Cal program. CELL-DYN Calibrator or whole blood samples may be used for Manual Calibration. Whole blood samples
should meet the requirements outlined in the Whole Blood Calibration
section of this chapter.
Manual Calibration is accomplished by running the calibrator or whole blood samples into a control file and using the parameter means to manually compute the calibration factors.
The new calibration factors are then entered manually from the
CALIBRATION MENU . Worksheets are
provided at the end of the procedure for use in making the calculations.
These worksheets may be duplicated as needed.
Guidelines
• The CELL-DYN Calibrator must be warmed and mixed according to the directions given in the package insert and run 5—10 times.
• If using whole blood samples:
• A minimum of five different, fresh, whole blood samples must be used for this procedure.
• Samples must be assayed a minimum of three times by reference methodology and on the CELL-DYN 3000.
• No more than two hours should elapse between the reference run and the CELL-DYN 3000 run.
NOTE: Refer to the Whole Blood Calibration section of this
chapter for detailed information about the requirements for whole blood samples.
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Chapter 6 Search Book TOC Go Back Calibration
Mode To Mode Calibration Overview
Introduction
The Open mode of the CELL-DYN 3000 is calibrated with either a commercial calibrator or fresh whole blood samples. The Closed mode is calibrated to match the Open mode using 10 different, fresh, normal whole blood samples. Samples used for Mode to Mode calibration
should meet the requirements outlined in the Whole Blood Calibration
section of this chapter.
Single replications of 10 samples can be used because calibration differences between modes are usually very small. Samples may be run more than once if desired but samples should be run the same number of times in each mode. Calibration of the Closed mode with fewer than 10 samples is not recommended because it may introduce a bias between the modes.
Worksheets are provided at the end of each procedure to assist in determining which parameters require calibration. For manual calibration, worksheets may be used to assist in making the necessary calculations. These worksheets may be duplicated as needed.
Auto-Cal Mode to Mode Calibration
After the Open mode has been calibrated or Open mode calibration is confirmed, each sample is run one time in the Open mode. For ease of identification, samples should be run as patient samples.
The Open mode values for each sample are entered as the reference values in the Auto-Cal program for the Closed mode. The samples are then run in the Closed mode. The factor percent difference computed by the Auto-Cal program is used to determine which Closed mode parameters require calibration.
Manual Mode to Mode Calibration
After the Open mode has been calibrated or Open mode calibration is confirmed, the samples are run into quality control files in the Open and
Closed modes.
The automatically calculated parameter means from each mode are used to manually compute the calibration bias and the new calibration factors.
The new calibration factors are then entered manually from the ENTER
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6-25
Calibration
Search Book TOC Go Back
Chapter 6
Mode to Mode Calibration Preparation
1.
Confirm the calibration of the Open mode before calibrating the
Closed mode.
2.
Select 10 different fresh, whole blood samples that meet the following requirements:
• Each sample should have sufficient volume to be run once in the Open mode and twice in the Closed mode. Therefore, try to select full 13 x 75 mm, 3mL tubes.
• Samples must be less than eight hours old at the completion of the procedure. If possible, select samples that are less than four hours old.
• All parameter values should be within the laboratory’s normal range.
Closed Mode Calibration Confirmation
An optional confirmatory step is included at the end of the Mode to
Mode Calibration procedures which use whole blood samples. After
Closed mode calibration is completed, instructions are given for rerunning the whole blood samples that were used for calibration. These
“post-calibration results” are then used to verify the accuracy of the
Closed mode calibration. Closed mode calibration may also be confirmed by running Commercial controls. Either method is satisfactory for confirming the calibration.
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Chapter 6 Search Book TOC Go Back Calibration
Pre-Calibration Procedures
Introduction
It is advisable to perform calibration at a time when it can be completed without interruption. The Pre-Calibration Procedures in this section verify proper instrument performance to ensure a successful calibration.
These steps should be completed just prior to beginning the calibration procedure itself. If problems are detected during these checks, DO NOT
ATTEMPT TO CALIBRATE THE INSTRUMENT. If necessary, CALL
THE CUSTOMER SUPPORT CENTER FOR ASSISTANCE AT 1
(800) CELL DYN. After the problems have been resolved, repeat the
Pre-Calibration Procedures to verify proper performance.
The Pre-Calibration Procedures checklist included in this section may be
duplicated as needed.
Calibration Guidelines
1.
(as directed in Chapter 9, Maintenance , of this manual) is up-to-
date before calibrating the instrument. Instrument cleanliness is essential for accurate calibration. Therefore, each laboratory should perform any additional maintenance according to its requirements.
2.
Use only recommended CELL-DYN reagents.
3.
Verify the precision for the Open and Closed modes prior to
calibration as directed in the Pre-Calibration Procedures Checklist
later in this chapter.
4.
Select and process all whole blood samples according to the requirements given in the
Whole Blood Calibration Guidelines
section of this chapter.
5.
Be certain that any calibrator vials used are brought to room temperature and mixed according to the manufacturer’s instructions given in the package insert.
CELL-DYN
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6-27
Calibration
Search Book TOC Go Back
Chapter 6
Instrument Logbook
Create a logbook for the instrument. This logbook should contain all necessary calibration documentation and other information that is pertinent to your instrument. Suggested sections that you may wish to include in the logbook are:
• Installation documentation
• Laboratory’s operating procedure
• Quality control
• Calibration
• Maintenance
• Reagent lot number changes
• Troubleshooting
• Problem resolution
• Service calls
• Software upgrades
This logbook should be stored near the instrument and be accessible to all operators and Abbott Service Personnel.
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Chapter 6 Search Book TOC Go Back Calibration
CELL-DYN 3000
PRE-CALIBRATION PROCEDURES CHECK LIST
Instrument:__________________________________
Date:_____________________________________________
Operator:____________________________________
________________________________________________________________________________________
____
1._______ Perform all required maintenance.
2._______ Verify that all the reagent containers are at least 1/3 full and that the waste container is less than 1/2 full.
3._______ Verify that the reagents have not reached the expiration date.
Diluent:
HGB Lyse:
Lot #____________Exp. Date _______
Lot #____________ Exp. Date _______
Sheath Reagent: Lot #____________ Exp. Date _______
4._______ If applicable, verify that the calibrator has not reached the expiration date.
Lot #____________ Exp. Date _______
5._______ After the maintenance has been completed, verify that the Background Counts are within the acceptable limits. Record the background counts below or attach a printout to this document.
WBC
RBC
HGB
PLT
<
<
<
0.5
0.05
0.2
<1 0.0
________
________
________
________
6._______ Verify that the RBC Count Time is at the baseline value. Record the count time below.
RBC Count Time __________
7._______ From the DIAGNOSTICS MENU, obtain a printout of the VOLTAGE READINGS Screen.
8._______ Prime the instrument with five normal whole blood samples.
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6-29
Calibration
Search Book TOC Go Back
Chapter 6
9.______
Verify the Open mode precision by analyzing a fresh, normal whole blood sample 10 times in succession. Run the sample in an empty control file and record the CVs below or attach a file printout to this document.
PARAMETER
WBC
CV% LIMIT
<2.5%
CV
________
RBC
HGB
MCV
PLT
<1.7%
<1.2%
<1.5%
<6.0%
________
________
________
________
10.______ Verify the Closed mode precision of the Sample Loader by obtaining 15 mL of blood from the same donor. Aliquot the blood into five 5 mL tubes that contain no anticoagulant. Run each tube two times in succession. If you have a Closed Sampler, verify its precision by analyzing a fresh, normal whole blood sample 10 times in succession. Run the samples in an empty control file and record the CVs below or attach a file printout to this document:
PARAMETER CV% LIMIT CV
WBC
RBC
HGB
MCV
<2.5%
<1.7%
<1.2%
<1.5%
________
________
________
________
PLT <6.0% ________
11._____
If any problems are detected during the procedures outlined above, document the problem and the corrective action on the following page.
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Problems Detected
________________________________________________________________________________________
________________________________________________________________________________________
________________________________________________________________________________________
________________________________________________________________________________________
________________________________________________________________________________________
________________________________________________________________________________________
________________________________________________________________________________________
________________________________________________________________________________________
________________________________________________________________________________________
________________________________________________________________________________________
________________________________________________________________________________________
________________________________________________________________________________________
________________________________________________________________________________________
________________________________________________________________________________________
________________________________________________________________________________________
________________________________________________________________________________________
________________________________________________________________________________________
________________________________________________________________________________________
________________________________________________________________________________________
________________________________________________________________________________________
________________________________________________________________________________________
________________________________________________________________________________________
________________________________________________________________________________________
________________________________________________________________________________________
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NOTES
Chapter 6
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Open Mode Procedures
Auto-Cal Using The CELL-DYN Calibrator
Procedure
The calibration procedure has been divided into subsections that consist of a series of easy-to-follow steps. Always follow the entire procedure unless specifically directed to skip to another section.
NOTE: Be sure to perform Pre-Calibration procedures and read
the Auto-Cal Overview before beginning this procedure.
Starting Auto-Cal
1.
From the MAIN MENU Screen , press [CALIBRATION].
2.
If necessary, press [OPEN SAMPLER] to display the Open Mode
Calibration Factors.
3.
If desired, press [PRINT] to obtain a printout of the current whole blood factors displayed on the screen.
NOTE: These calibration factors are retained in the Auto-Cal
Calibration Log until 10 entries have been made. As each
subsequent entry is made, the oldest existing entry is deleted.
4.
Press [AUTO-CALIBRATE] to select the AUTO-
5.
If necessary, press [CHANGE SAMPLER] to select the Open mode.
6.
Press [CALIBRATR] to select Calibrator Auto-Cal.
NOTE: If necessary, press [CONFIRM SELECTION] to continue.
Entering the Reference Values
Enter the reference (assay) values for the calibrator as follows:
1.
Delete the existing values: press [CLEAR REF VALS] followed by [CONFIRM CLEAR].
2.
Type the lot number of the Calibrator in the <SPEC ID> field.
Press the Enter key on the keyboard to save the entry and advance the cursor.
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Chapter 6
3.
Type the desired number of runs (from 5 to 10) in the <# OF
RUNS> field. Press the Enter key on the keyboard to save the entry and advance the cursor.
4.
Type the assay value for each parameter in the appropriate parameter reference values field. Press the Enter key on the keyboard after each entry to save the entry and advance the cursor.
5.
If desired, press [PRINT SUMMARY] to obtain a printout of the reference values.
Performing the Calibration
1.
Press [START AUTO-CAL]. The instrument automatically performs three background counts. The screen displays the message:
PREPARING ANALYZER FOR CALIBRATION,
PLEASE WAIT...
on the bulletin line.
2.
If the data from the background counts is acceptable, the displayed message changes to:
READY TO CALIBRATE. PUSH CONTINUE AUTO-CAL
KEY. START SAMPLES
Proceed to step 7.
3.
If the data from the background counts is unacceptable, the displayed message alternates between:
BACKGROUND COUNTS EXCEED LIMITS. PERFORM
MAINTENANCE TO CLEAR BACKGROUND and
READY TO CALIBRATE. PUSH CONTINUE AUTO-CAL
KEY. START SAMPLES
4.
Press [QUIT AUTO-CAL] followed by [CONFIRM QUIT] to exit Auto-Cal.
5.
Check the background results and troubleshoot out-of-range parameters.
6.
When the problem has been resolved, return to the
CALIBRATION MENU and press [AUTO-CALIBRATE]
followed by [CALBRATR] and [START AUTO-CAL].
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7.
When the background results are acceptable, press [CONTINUE
AUTO-CAL].
8.
Prepare the calibrator for use according to the directions given in the package insert. Be certain to carefully read and follow directions given for warming and mixing.
9.
Run the calibrator one time. The reference value, <VALUE> and
the results of the analysis, <RUN1> appear on the CALIBRATOR
AUTO-CAL, RESULTS FOR SPECIMEN (N) screen display.
• The Auto-Cal program automatically compares the results of the first run of the Calibrator with the parameter reference values entered for that sample to verify that the difference is within acceptable limits.
• If the first run passes this internal Reference Check, proceed to step
10.
• If the first run fails the Reference Check for any parameter, the results are highlighted and the bulletin line displays the message:
THIS RESULT IS OUTSIDE THE ALLOWED LIMITS.
REPEAT THIS SPECIMEN
• The run may be repeated at this time by pressing [REPEAT
SPECIMEN] followed by [CONFIRM REPEAT]. When the repeat function is used, all results for the failed run are automatically deleted.
• If the repeated run also fails the Reference Check, the result(s) are highlighted and no calibration factor will be calculated for that parameter.
• If all parameters fail the Reference Check, results of that run are not displayed and the bulletin line displays the message:
ABANDON CAL FOR SPECIMEN 1 - RESULT NOT
INCLUDED IN MEAN
• Repeat the run as directed above.
• If all parameters on the repeated run also fail the Reference Check, confirm that the reference values were entered correctly. If the reference values are correct, discard the calibrator vial. Obtain a new vial (be sure that it is properly warmed and mixed) and repeat the procedure. If all parameters fail again, call the Customer
Support Center for assistance at 1 (800) CELL DYN.
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Chapter 6
10.
Consecutively run the Calibrator for the remaining number of runs.
Each subsequent run must pass the Reference Check and an additional internal Precision Check. If a run fails either check, the result for that parameter is highlighted and no calibration factor will be calculated for the parameter. Calibration must be repeated for the highlighted parameter. Calibration factors will be calculated for the remaining parameters.
NOTE: Five runs are displayed on the screen. The screen automatically scrolls when a sixth run is completed. Press the
Left Arrow key on the keyboard to view the previous runs if more than 5 runs were chosen in the reference screen. Press the
Right Arrow key on the keyboard to view the last five runs.
Calibration Factor Calculation
As each run of the Calibrator is completed, a Calibration Factor is calculated and updated. This factor is displayed in the column labeled
<SPEC (N) FACTOR>.
The column labeled <MEAN FACTOR (N)> contains the average of the calibration factors for each parameter for all of the calibrators used in the calibration. The number after mean factor indicates the number of
Calibrators used to compute that mean factor.
NOTE: If only one calibrator is used, the specimen factor and the mean factor are the same.
The <FACTOR % DIFF> column displays the difference between the calibration factor currently in the instrument and the mean factor computed by the Auto-Cal program.
When all runs of the calibrator have been completed, the message:
NEW CAL FACTOR COMPUTED. READY FOR ACCEPTANCE is displayed on the bulletin line.
1.
Press [PRINT] to obtain a printout of the <SPEC> and <MEAN
FACTORS> and the <FACTOR % DIFF>.
2.
Enter the factor % difference for each parameter in the Calibration
Criteria Worksheet provided at the end of this procedure. (This worksheet may be duplicated as needed.) The Calibration Criteria
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NOTE: Delete the sign of the Factor % Diff value before entering it on the chart.
3.
To determine which parameters require calibration, continue with the next section.
Table 6.3: Calibration Criteria Chart
WBC
RBC
HGB
MCV
PLT
Validation Range
Cal Not Required
<1 .5%
<1 .0%
<1 .0%
<1 .0%
< 3.0%
Calibration Range
Cal Required
>1.5% but <10%
>1.0% but <10%
>1.0% but <10%
>1.0% but <10%
>3.0% but <15%
Calibration Limit
Do Not Cal
>10%
>10%
>10%
>10%
>15%
Determining Which Parameters Need Calibration
1.
Validation Range
If the factor % difference is equal to or less than the following values, CALIBRATION IS NOT REQUIRED for that parameter as the value is within the Validation Range.
Results EQUAL TO OR LESS THAN VALIDATION RANGE:
WBC <1 .5%
RBC <1 .0%
HGB
MCV
PLT
<1 .0%
<1 .0%
< 3.0%
If the results for all parameters are less than the values given above: press [QUIT AUTO-CAL] followed by [CONFIRM QUIT].
The Auto-Cal Calibration Log is available for comments only when
a calibration factor is changed or reentered. Therefore, document the calibration in the <COMMENTS> line by accessing the log as follows:
From the CALIBRATION MENU Screen press [ENTER
FACTOR].
Retype any existing Cal Factor. Press the Enter key on the keyboard to save the entry and advance the cursor.
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Chapter 6
Press [RETURN].
When the CALIBRATION LOG Screen is displayed, indicate in
the <COMMENTS> line that instrument calibration was confirmed and no changes were required. Press the Enter key on the keyboard to save the entry and advance the cursor.
Be certain to retain all necessary documentation in the instrument logbook.
2.
Calibration Limit
If the factor % difference for a particular parameter is greater than the following value, there may be an instrument problem as the value has exceeded the Calibration Limit.
Results GREATER THAN CALIBRATION LIMIT:
WBC >10%
RBC >10%
HGB >10%
MCV >10%
PLT >15%
Check to see if any component that could affect the calibration was changed as this could cause the factor % difference to exceed the above limits. For example:
Shear valve
WBC flow cell
RBC/PLT transducer assembly
RBC/PLT aperture
Syringe(s) Hemoglobin flow cell
If a component was changed calibrate the instrument as needed according to the directions in this procedure. If no components have been changed and the factor % difference exceeds these limits, DO NOT CALIBRATE; CONFIRM THAT ALL PRE-
CALIBRATION PROCEDURES WERE COMPLETED AND
THEN CALL THE CUSTOMER SUPPORT CENTER FOR
ASSISTANCE AT 1 (800) CELL DYN.
Press [QUIT AUTO-CAL] followed by [CONFIRM QUIT] to exit Auto-Cal.
Troubleshoot accordingly. Be certain to retain all necessary documentation in the instrument logbook.
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3.
Calibration Range
If the factor % difference falls within the following Calibration
Range, calibration is required for that parameter. CALIBRATE
THE OPEN MODE as directed in this procedure, either for all parameters or specific parameters.
Results WITHIN THE FOLLOWING CALIBRATION RANGE:
WBC >1.5% but <1 0%
RBC >1.0% but <1 0%
HGB >1.0% but <1 0%
MCV >1.0% but <1 0%
PLT >3.0% but <1 5%
If all parameters require calibration, continue with the following section. If only specific parameters require calibration, skip to the
“ Calibration for Individual Parameters ” section.
Calibration for All Parameters
1.
If the factor % difference for all parameters falls within the acceptable Calibration Range limits, press [ACCEPT MEANS].
The message:
ALL DATA AND RESULTS WILL GO AWAY is displayed on the bulletin line.
2.
Be certain that all desired printouts have been made.
3.
Press [CONFIRM ACCEPT] to save the mean factors and
complete the Auto-Cal procedure .
4.
The CALIBRATION LOG Screen is automatically displayed.
The log holds 10 entries. (The screen displays five entries. Display the other five by pressing the Page Up key on the keyboard.) When the log is full, subsequent entries cause the oldest entry to be deleted and the remaining entries to move up one line so that the current factors are added to the bottom of the list. Therefore, the log should be printed periodically for purposes of documentation.
The log displays the <DATE>, <TIME>, <OPERATOR ID>,
<CALIBRATION FACTORS> and a line for <COMMENTS>.
NOTE: The letters in parentheses after each factor indicate the method of factor derivation: A = Autocal, F = Factory,
E = Enter Factor (manual factor entry).
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Chapter 6
Type any comments in the <COMMENTS> field. Press the Enter key on the keyboard to save the entry and advance the cursor.
NOTE: Comments may be added to the Calibration Log only after a calibration factor is changed or reentered.
If desired, press [PRINT LOG] to obtain a printout of the
Calibration Log for documentation.
Calibration for Individual Parameters
If only certain individual parameters require calibration, continue with this section:
1.
Press [QUIT AUTO-CAL] followed by [CONFIRM QUIT] to exit Auto-Cal.
2.
Press [RETURN] twice to return to the CALIBRATION MENU
3.
Press [ENTER FACTOR]. The ENTER WHOLE BLOOD
4.
Type any mean factors computed by Auto-Cal for those parameters that require calibration in the appropriate fields. (Refer to the
printout made in step 1 of the “ Calibration Factor Calculation ”
section.) Move the cursor to the desired position, type the factor and press the Enter key on the keyboard to save the entry and advance the cursor.
5.
Press [RETURN].
6.
When the CALIBRATION LOG Screen is displayed, indicate the
parameters that required calibration in the <COMMENTS> line.
Press the Enter key on the keyboard to save the entry and advance the cursor.
NOTE: Manually entered factors are followed by the letter E in parentheses to indicate “Enter Factor”.
7.
If desired, press [PRINT LOG] to obtain a printout of the
Calibration Log for documentation.
Completing Open Mode Calibration
1.
Press [RETURN] to return to the CALIBRATION MENU
2.
Press [MAIN] to exit the CALIBRATION MENU .
3.
Confirm the calibration of the Open mode by running commercial
controls as directed in the Post-Calibration Procedures section.
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CELL-DYN 3000
Auto-Cal Calibration Worksheet
Instrument:______________________________________
Date:________________________________________
Operator:________________________________________
________________________________________________________________________________________
_______
Auto-Cal Calibration Criteria
Factor
%Diff*
Validation Range
Cal Not Required
Cal Range
Cal Required
WBC
RBC
HGB
MCV
PLT
< 1.5%
< 1.0%
< 1.0%
< 1.0%
< 3.0%
>1.5% but
>3.0% but
< 10%
>1.0% but < 10%
>1.0% but < 10%
>1.0% but < 10%
< 15%
* Delete the sign of the Factor % Difference before entering it on the chart.
** Do not calibrate. Call the Customer Support Center for assistance at 1 (800) CELL DYN.
Cal Limit
Do Not Cal**
>10%
>10%
>10%
>10%
>15%
Cal?
Y/N
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Chapter 6
Auto-Cal Using Whole Blood Samples
Procedure
The calibration procedure has been divided into subsections that consist of a series of easy-to-follow steps. Always follow the entire procedure unless specifically directed to skip to another section.
NOTE: Be sure to complete the Pre-Calibration procedures and
read the Whole Blood Calibration and the
sections before beginning this procedure.
Starting Auto-Cal
1.
From the MAIN MENU Screen , press [CALIBRATION].
2.
If necessary, press [OPEN SAMPLER] to display the Open Mode
Calibration Factors.
3.
If desired, press [PRINT] to obtain a printout of the <CURRENT
WHOLE BLOOD FACTORS> displayed on the screen.
NOTE: These calibration factors are retained in the Auto-Cal
Calibration Log until 10 entries have been made. As each
subsequent entry is made, the oldest existing entry is deleted.
4.
Press [AUTO-CALIBRATE] to select the
5.
If necessary, press [CHANGE SAMPLER] to select the Open mode.
6.
Press [WHOLE BLOOD] to select Whole Blood Auto-Cal.
NOTE: If necessary, press [CONFIRM SELECTION] to continue.
Entering the Reference Values
Enter the reference values for the whole blood samples as follows:
1.
Delete any existing values: press [CLEAR REF VALS] followed by [CONFIRM CLEAR].
2.
Type the appropriate information in the <SPEC ID>, <# OF
RUNS> and parameter reference values fields for each whole blood sample to be used for the calibration. (A minimum of 5 whole blood samples is required. Each sample must be run in triplicate.) Press the Enter key on the keyboard after each entry to save it and advance the cursor.
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NOTE: The <# OF RUNS> entered indicates the number of times the sample will be consecutively cycled through the instrument. Each sample may be run a maximum of 10 times.
3.
If desired, press [PRINT SUMMARY] to obtain a printout of the reference values.
Performing the Calibration
1.
Press [START AUTO-CAL].
The instrument automatically performs three background counts.
The screen displays the message:
PREPARING ANALYZER FOR CALIBRATION, PLEASE
WAIT...
on the bulletin line.
2.
If the data from the background counts is acceptable, the displayed message changes to:
READY TO CALIBRATE. PUSH CONTINUE AUTO-CAL
KEY. START SAMPLES
Proceed to step 7.
3.
If the data from the background counts is unacceptable, the displayed message alternates between:
BACKGROUND COUNTS EXCEED LIMITS, PERFORM
MAINTENANCE TO CLEAR BACKGROUND and
READY TO CALIBRATE. PUSH CONTINUE AUTO-CAL
KEY. START SAMPLES
4.
Press [QUIT AUTO-CAL] followed by [CONFIRM QUIT] to exit Auto-Cal.
5.
Check the background results and troubleshoot out-of-range parameters.
6.
When the problem has been resolved, return to
the CALIBRATION MENU Screen and press
[AUTO-CALIBRATE] followed by [WHOLE BLOOD] and [START AUTO-CAL].
NOTE: The information entered in step 2 of the “ Entering the
Reference Values ” section is retained.
7.
When background results are acceptable, press
[CONTINUE AUTO-CAL].
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Chapter 6
8.
Run the first whole blood sample one time. The reference value,
<VALUE>, and the results of the analysis, <RUN1>, appear on the
WHOLE BLOOD AUTO-CAL, RESULTS FOR SPECIMEN
• The Auto-Cal program automatically compares the results of the first run of each whole blood sample with the Parameter Reference
Values entered for that sample to verify that the difference is within acceptable limits.
• If the first run passes this internal Reference Check, proceed to step
9.
• If the first run fails the Reference Check for any parameter, the results are highlighted and the bulletin line displays the message:
THIS RESULT IS OUTSIDE THE ALLOWED LIMITS.
RERUN THIS SPECIMEN
NOTE: Check to be sure the reference values were entered correctly and the correct sample was run before repeating it.
The specimen may be repeated at this time by pressing [REPEAT
SPECIMEN] followed by [CONFIRM REPEAT]. When the repeat function is used, all results for the failed run are automatically deleted.
• If the repeated run also fails the Reference Check, the result(s) are highlighted and no calibration factor will be calculated for that parameter.
• If all parameters fail the Reference Check, results of that run are not displayed and the bulletin line displays the message:
ABANDON CAL FOR SPECIMEN 1 - RESULT NOT
INCLUDED IN MEAN
Repeat the specimen as directed above.
• If all parameters on the repeated run also fail the Reference Check, discard that sample and continue with the next calibration sample.
If desired, a replacement sample may be added after the remaining samples have been run.
9.
Run each sample for the number of runs entered in step 2 of the
“ Entering the Reference Values ” section. Each subsequent run
must pass the Reference Check and an additional internal Precision
Check. If a run fails either check, that parameter is highlighted and no calibration factor will be calculated for the parameter.
Calibration factors will be calculated for the remaining parameters.
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10.
When all runs of a sample have been completed, the bulletin line displays the message:
NEW CAL FACTOR COMPUTED. READY FOR NEXT CAL
SPECIMEN
Press [NEXT SPECIMEN] to run the next sample.
Calibration Factor Calculation
As each run of a whole blood sample is completed, a Calibration Factor is calculated and updated. This factor is displayed in the column labeled
<SPEC (N) FACTOR>.
The column labeled <MEAN FACTOR> contains the average of the calibration factors for all whole blood samples used in the calibration.
The number in parentheses after mean factor indicates the number of samples used to compute that mean factor.
The <FACTOR % DIFF> column displays the difference between the calibration factor currently in the instrument and the mean factor computed by the Auto-Cal program.
When all runs of all whole blood samples have been completed, the message:
NEW CAL FACTOR COMPUTED – READY FOR ACCEPTANCE is displayed on the bulletin line.
1.
Press [PREVIOUS SPECIMEN] and/or [NEXT SPECIMEN] to review and/or print the results of all whole blood samples that were analyzed.
NOTE: These results are only available for review (and printout) before the [ACCEPT MEANS] key is pressed.
2.
Press [PRINT] to obtain a printout of the <SPEC> and <MEAN
FACTORS> and the <FACTOR % DIFF>.
3.
Enter the factor % difference for each parameter in the Calibration
Criteria Worksheet provided at the end of this procedure. (This worksheet may be duplicated as needed.) The Calibration Criteria
NOTE: Delete the sign of the factor % difference value before entering it on the chart.
4.
To determine which parameters require calibration, continue with
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Chapter 6
WBC
RBC
HGB
MCV
PLT
Table 6.4: Calibration Criteria Chart
Validation Range
Cal Not Required
<1.5%
<1.0%
<1.0%
<1.0%
<3.0%
Calibration Range
Cal Required
>1.5% but < 10%
>1.0% but < 10%
>1.0% but < 10%
>1.0% but < 10%
>3.0% but < 15%
Calibration Limit
Do Not Cal
>10%
>10%
>10%
>10%
>15%
Determining Which Parameters Need Calibration
1.
Validation Range
If the Factor % Difference is equal to or less than the following values, CALIBRATION IS NOT REQUIRED for that parameter as the value is within the Validation Range.
Results EQUAL TO OR LESS THAN VALIDATION RANGE:
WBC <1 .5%
RBC
HGB
<1
<1
.0%
.0%
MCV
PLT
<1 .0%
< 3.0%
If the results for all parameters are less than the values given above, press [QUIT AUTO-CAL] followed by [CONFIRM QUIT].
The Auto-Cal Calibration Log is available for comments only when
a calibration factor is changed or reentered. Therefore, document the calibration in the <COMMENTS> line by accessing the log as follows:
From the CALIBRATION MENU Screen press [ENTER
FACTOR].
Retype any existing Cal Factor. Press the Enter key on the keyboard to save the entry and advance the cursor.
Press [RETURN].
When the CALIBRATION LOG Screen is displayed, indicate in
the <COMMENTS> line that instrument calibration was confirmed and no changes were required. Press the Enter key on the keyboard to save the entry and advance the cursor.
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Be certain to retain all necessary documentation in the instrument logbook.
2.
Calibration Limit
If the factor % difference for a particular parameter is greater than the following value, there may be an instrument problem, as the value has exceeded the Calibration Limit.
Results GREATER THAN CALIBRATION LIMIT:
WBC >10%
RBC
HGB
MCV
PLT
>10%
>10%
>10%
>15%
Check to see if any component that could affect the calibration was changed as this could cause the factor % difference to exceed the above limits. For example:
Shear valve
WBC flow cell
RBC/PLT transducer assembly
RBC/PLT aperture
Syringe(s) Hemoglobin flow cell
If a component was changed, calibrate the instrument as needed according to the directions in this procedure. If no components have been changed and the factor % difference exceeds these limits, DO NOT CALIBRATE; CONFIRM THAT ALL PRE-
CALIBRATION PROCEDURES WERE COMPLETED AND
THEN CALL THE CUSTOMER SUPPORT CENTER FOR
ASSISTANCE AT 1 (800) CELL DYN.
Press [QUIT AUTO-CAL] followed by [CONFIRM QUIT] to exit Auto-Cal.
Troubleshoot accordingly. Be certain to retain all necessary documentation in the instrument logbook.
3.
Calibration Range
If the factor % difference falls within the following Calibration
Range, calibration is required for that parameter. CALIBRATE
THE OPEN MODE as directed in this procedure, either for all parameters or specific parameters.
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Chapter 6
Results WITHIN THE FOLLOWING CALIBRATION RANGE:
WBC >1.5% but <10%
RBC >1.0% but <10%
HGB >1.0% but <10%
MCV >1.0% but <10%
PLT >3.0% but <15%
If all parameters require calibration, continue with the following section. If only specific parameters require calibration, skip to the
“ Calibration for Individual Parameters ” section.
Calibration for All Parameters
1.
If the factor % difference for all parameters falls within the acceptable Calibration Range Limits, press [ACCEPT MEANS].
The message:
ALL DATA AND RESULTS WILL GO AWAY is displayed on the bulletin line.
2.
Be certain that all desired printouts have been made.
3.
Press [CONFIRM ACCEPT] to save the mean factors and
complete the Auto-Cal procedure .
4.
The CALIBRATION LOG Screen is automatically displayed.
The log holds 10 entries. (The screen displays five entries. Display the other five by pressing the Page Up key on the keyboard.) When the log is full, subsequent entries cause the oldest entry to be deleted and the remaining entries to move up one line so that the current factors are added to the bottom of the list. Therefore, the log should be printed periodically for purposes of documentation.
The log displays the <DATE>, <TIME>, <OPERATOR ID>,
<CALIBRATION FACTORS> and a line for <COMMENTS>.
NOTE: The letters in parentheses after each factor indicate the method of factor derivation: A = Autocal, F = Factory,
E = Enter Factor (manual factor entry).
5.
Type any comments in the <COMMENTS> field. Press the Enter key on the keyboard to save the entry and advance the cursor.
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NOTE: Comments may be added to the Calibration Log only after a calibration factor is changed or reentered.
6.
If desired, press [PRINT LOG] to obtain a printout of the
Calibration Log for documentation.
Calibration for Individual Parameters
If only certain individual parameters require calibration, continue with this section:
1.
Press [QUIT AUTO-CAL] followed by [CONFIRM QUIT] to exit Auto-Cal.
2.
Press [RETURN] twice to return to the CALIBRATION MENU
3.
Press [ENTER FACTOR].
The ENTER WHOLE BLOOD FACTOR Screen is displayed.
4.
Type any mean factors computed by Auto-Cal for those parameters that require calibration in the appropriate fields. (Refer to the
printout made in step 2 of the “ Calibration Factor Calculation ”
section.) Move the cursor to the desired position, type the factor and press the Enter key on the keyboard to save the entry and advance the cursor.
5.
Press [RETURN].
6.
When the CALIBRATION LOG Screen is displayed, indicate the
parameters that required calibration in the <COMMENTS> line.
Press the Enter key on the keyboard to save the entry and advance the cursor.
NOTE: Manually entered factors are followed by the letter E in parentheses to indicate “Enter Factor”.
7.
If desired, press [PRINT LOG] to obtain a printout of the
Calibration Log for documentation.
Completing Whole Blood Open Mode Calibration
1.
Press [RETURN] to return to the CALIBRATION MENU
2.
Press [MAIN] to exit the CALIBRATION MENU .
3.
Confirm the calibration of the Open mode by running commercial
controls as directed in the Post-Calibration Procedures section.
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Chapter 6
CELL-DYN 3000
Auto-Cal Calibration Worksheet
Instrument:______________________________________
Date:________________________________________
Operator:________________________________________
________________________________________________________________________________________
_______
Auto-Cal Calibration Criteria
Factor
%Diff*
Validation Range
Cal Not Required
Cal Range
Cal Required
WBC
RBC
HGB
MCV
PLT
< 1.5%
< 1.0%
< 1.0%
< 1.0%
< 3.0%
>1.5% but
>1.0% but
>1.0% but
>1.0% but
>3.0% but
< 10%
< 10%
< 10%
< 10%
< 15%
* Delete the sign of the Factor % Difference before entering it on the chart.
** Do not calibrate. Call the Customer Support Center for assistance at 1 (800) CELL DYN.
Cal Limit
Do Not Cal**
>10%
>10%
>10%
>10%
>15%
Cal?
Y/N
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Manual Calibration — Open Mode
Procedure
The calibration procedure has been divided into subsections that consist of a series of easy-to-follow steps. Always follow the entire procedure unless specifically directed to skip to another section.
NOTE: Be sure to complete the Pre-Calibration steps and read
the Whole Blood Calibration and
sections before beginning this procedure.
Preparing for Manual Calibration
1.
From the MAIN MENU Screen , press [CALIBRATION].
2.
If necessary, press [OPEN SAMPLER] to display the Open Mode
Calibration Factors.
3.
Press [PRINT] to obtain a printout of the <CURRENT WHOLE
BLOOD FACTORS> displayed on the screen.
4.
Press [RETURN] followed by [MAIN] to return to the MAIN
Determining the Open Mode Mean
1.
, press [RUN].
2.
If necessary, press [CHANGE SAMPLER] to select the Open mode.
3.
Press [SPECIMEN TYPE].
4.
Use the Arrow keys on the keyboard to move the cursor to an empty QC File and type “CD MEAN” in the <FILENAME> field.
5.
Press the Enter key on the keyboard to save the name. Use the Up
Arrow key on the keyboard to move the cursor back into the “CD
MEAN” file.
6.
Press [QC SPECIMEN] to return to the RUN Screen .
7.
Run each sample the appropriate number of times into the “CD
MEAN” QC file.
NOTE: A minimum of 5 whole blood samples is required.
Whole blood samples must be run at least in triplicate. A
Commercial Calibrator must be run 5—10 times.
8.
With the cursor at "CD MEAN," press [MAIN] followed by [QC
LOGS] and [VIEW QC LOG].
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Chapter 6
9.
Press [PRINT QC LOG] to obtain a printout of the data.
10.
Press [RETURN] followed by [MAIN] to return to the MAIN
Calibration Factor Calculations
1.
Use the mean value for each parameter from the CD MEAN file printout and the Current Open Mode Calibration Factor printout
from step 3 ( Preparing for Manual Calibration section) for the
calibration factor calculations.
2.
Enter the information from step 1 on the Manual Calibration worksheet provided at the end of this procedure to calculate the
New Open Mode Calibration Factor for each parameter as follows.
Calibrator Calibration:
Assay Value
---------------------------------------------
CELL-DYN Mean
× Current Open Mode
Calibration Factor
=
New Open Mode
Calibration Factor
Whole Blood Calibration:
Reference Mean
---------------------------------------------
CELL-DYN Mean
× Current Open Mode
Calibration Factor
=
New Open Mode
Calibration Factor
3.
Referring to the New Open Mode Cal Factor from the previous step and the Current Open Mode Cal Factor from the printout, use the appropriate chart on the worksheet to compute the Factor %
Difference as follows:
New Open Mode Factor - Current Open Mode Factor
New Open Mode Factor x 100
= Factor % Difference
4.
Enter the factor % difference for each parameter in the Manual
Calibration Criteria chart on the worksheet. The Calibration
Criteria are shown in Table 6.5
NOTE: Delete the sign of the factor % difference value before entering it on the chart.
5.
To determine which parameters require calibration, continue with
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WBC
RBC
HGB
MCV
PLT
Table 6.5: Calibration Criteria Chart
Validation Range
Cal Not Required
<1.5%
<1.0%
<1.0%
<1.0%
<3.0%
Calibration Range
Cal Required
>1.5% but < 10%
>1.0% but < 10%
>1.0% but < 10%
>1.0% but < 10%
>3.0% but < 15%
Calibration Limit
Do Not Cal
>10%
>10%
>10%
>10%
>15%
Determining Which Parameters Need Calibration
1.
Validation Range
If the Factor % Difference is equal to or less than the following values, CALIBRATION IS NOT REQUIRED for that parameter as the value is within the Validation Range.
Results EQUAL TO OR LESS THAN VALIDATION RANGE:
WBC <1 .5%
RBC <1 .0%
HGB <1 .0%
MCV <1 .0%
PLT < 3.0%
If desired, the manual calibration results may be documented in the
The Auto-Cal Calibration Log is available for comments only when
a calibration factor is changed or reentered. Therefore, document the calibration in the <COMMENTS> line by accessing the log as follows:
From the CALIBRATION MENU Screen press [ENTER
FACTOR].
Retype any existing Cal Factor. Press the Enter key on the keyboard to save the entry and advance the cursor.
Press [RETURN].
When the CALIBRATION LOG Screen is displayed, indicate in
the <COMMENTS> line that instrument calibration was confirmed and no changes were required. Press the Enter key on the keyboard to save the entry and advance the cursor.
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Chapter 6
Be certain to retain all necessary documentation in the instrument logbook.
2.
Calibration Limit
If the factor % difference for a particular parameter is greater than the following value, there may be an instrument problem, as the value has exceeded the Calibration Limit.
Results GREATER THAN CALIBRATION LIMIT:
WBC >10%
RBC >10%
HGB >10%
MCV >10%
PLT >15%
Check to see if any component that could affect the calibration was changed as this could cause the factor % difference to exceed the above limits. For example:
Shear valve RBC/PLT transducer assembly
WBC flow cell
Syringe(s)
RBC/PLT aperture
Hemoglobin flow cell
If a component was changed, calibrate the instrument as needed according to the directions in this procedure. If no components have been changed and the factor % difference exceeds these limits, DO NOT CALIBRATE; CONFIRM THAT ALL PRE-
CALIBRATION PROCEDURES WERE COMPLETED AND
THEN CALL THE CUSTOMER SUPPORT CENTER FOR
ASSISTANCE AT 1 (800) CELL DYN.
3.
Calibration Range
If the factor % difference falls within the following Calibration
Range, calibration is required for that parameter. CALIBRATE
THE OPEN MODE as directed in this procedure, either for all parameters or specific parameters.
Results WITHIN THE FOLLOWING CALIBRATION RANGE:
WBC
RBC
HGB
MCV
PLT
>1.5% but
>1.0% but
>1.0% but
>1.0% but
>3.0% but
<1 0%
<1 0%
<1 0%
<1 0%
<1 5%
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Calibrating the Open Mode
1.
From the MAIN MENU Screen , press [CALIBRATION].
2.
Press [ENTER FACTOR] to display the ENTER WHOLE
3.
Type the New Open Mode Calibration Factors for the parameters that require calibration into the appropriate fields in the <OPEN
SAMPLER> column. Move the cursor to the desired position, type the factor and press the Enter key on the keyboard to save the factor and advance the cursor.
4.
After the New Open Mode Calibration Factors have been entered, press [RETURN].
5.
The CALIBRATION LOG Screen is automatically displayed.
The log holds 10 entries. (The screen displays five entries. Display the other five by pressing the Page Up key on the keyboard.) When the log is full, subsequent entries cause the oldest entry to be deleted and the remaining entries to move up one line, so that the current factors are added to the bottom of the list. Therefore, the log should be printed periodically for purposes of documentation.
The log displays the <DATE>, <TIME>, <OPERATOR ID>,
<CALIBRATION FACTORS> and a line for <COMMENTS>.
NOTE: The letters in parentheses after each factor indicate the method of factor derivation: A = Autocal, F = Factory,
E = Enter Factor (manual factor entry).
6.
Type any comments in the <COMMENTS> field. Press the Enter key on the keyboard to save the entry and advance the cursor.
NOTE: Comments may be added to the Calibration Log only after a calibration factor is changed or reentered.
7.
If desired, press [PRINT LOG] to obtain a printout of the
Calibration Log for documentation.
Completing Manual Calibration
1.
Press [RETURN] to return to the CALIBRATION MENU
2.
Press [MAIN] to exit the CALIBRATION MENU .
3.
Retain all necessary documentation in the instrument logbook.
4.
Confirm the calibration of the Open mode by running commercial
controls as directed in the Post-Calibration Procedures section.
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Chapter 6
CELL-DYN 3000
Manual Calibration Worksheet
Instrument:____________________________________ Date:___________________________________
Operator:______________________________________
________________________________________________________________________________________
_
Calculate All Factors To Three Decimal Places
New Open Mode Calibration Factors
Assay or Ref Mean x Current Open Mode Cal Factor* = New Open Mode Cal Factor
Open Mode
WBC
RBC
HGB
MCV
PLT
Assay Value or
Ref Mean
/
/
/
/
/
/
Open
Mode
Mean x
x
x
x
x
x
Current
Open Mode
Cal Factor* =
=
=
=
=
=
New Open
Mode Cal
Factor Range**
0.700 - 1.300
0.800 - 1.200
0.700 - 1.300
0.700 - 1.300
0.700 - 1.300
* Current factor as printed in this manual calibration procedure.
** If factor exceeds limits, do not calibrate. Check all calculations and call the Customer Support Center for assistance at 1 (800)
CELL DYN.
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Factor % Difference
New Open Mode Factor - Current Open Mode Factor x 100 = % Diff
New Open Mode Factor
New Open
Mode
Factor -
Current Open
Mode Factor* /
New Open
Mode Factor
WBC
RBC
HGB
MCV
PLT
-
-
-
-
-
/
/
/
/
/
* Current Open Mode factor as printed at the start of this calibration procedure.
x 100 =
x 100 =
x 100 =
x 100 =
x 100 =
x 100 =
%Diff
Manual Calibration Criteria
WBC
RBC
HGB
MCV
PLT
%Diff*
Validation Range
Cal Not Required
<1.5%
<1.0%
<1.0%
<1.0%
<3.0%
Cal Range
Cal Required
>1.5% but < 10%
>1.0% but < 10%
>1.0% but < 10%
>1.0% but < 10%
>3.0% but < 15%
* Delete the sign of the % Diff before entering it on the chart.
** Do not calibrate. Call the Customer Support Center for assistance at 1 (800) CELL DYN.
Cal Limit
Do Not Cal**
>10%
>10%
>10%
>10%
>15%
Cal?
Y/N
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NOTES
Chapter 6
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Closed Mode Procedures
Mode To Mode Auto-Cal, Sampler Loader Procedure
Procedure
The calibration procedure has been divided into subsections that consist of a series of easy-to-follow steps. Always follow the entire procedure unless specifically directed to skip to another section.
Determining Reference Values
The samples used for the calibration should be run in the Open Mode as patient samples in order to properly identify them. (Single replications of each of 10 whole blood samples are required.) A printout of the Data Log for those sequence numbers can be used to enter the Reference Values and may be retained for documentation.
1.
From the MAIN MENU Screen , press [RUN].
2.
If necessary, press [CHANGE SAMPLER] to select the Open mode.
3.
Press [SPECIMEN TYPE] then press [PATIENT].
4.
Type the sample identification for the first sample in the <NEXT
ID> field. Press the Enter key on the keyboard to save the entry and advance the cursor. Run the sample, noting the sequence number.
5.
Repeat step 4 for each sample. Note the sequence number of the last sample.
6.
Access the Data Log. Press [PRINT DATA LOG].
7.
Type the range of sequence numbers for the calibration samples in the indicated fields to obtain the printout.
Starting Auto-Cal
Confirm the calibration of the Open mode before performing this procedure.
NOTE: Be sure to complete the Pre-Calibration procedures and
read the Whole Blood Calibration and the
Overview sections before beginning this procedure.
1.
From the MAIN MENU Screen , press [RUN] then press [WORK
LIST]. Ensure that WORK LIST and BAR CODE, as indicated in upper left corner, are both OFF.
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Chapter 6
2.
From the MAIN MENU Screen , press [CALIBRATION].
3.
If necessary, press [CLOSED SAMPLER] to display the Closed
Mode Calibration Factors.
4.
If desired, press [PRINT] to obtain a printout of the <CURRENT
WHOLE BLOOD FACTORS> displayed on the screen.
NOTE: These calibration factors are retained in the Auto-Cal
Calibration Log until 10 entries have been made. As each
subsequent entry is made, the oldest existing entry is deleted.
5.
Press [AUTO-CALIBRATE] to select the AUTO-
6.
If necessary, press [CHANGE SAMPLER] to select the Closed mode.
7.
Press [WHOLE BLOOD] to select Whole Blood Calibration.
NOTE: If necessary, press [CONFIRM SELECTION] to continue.
Entering the Reference Values
Enter the reference values for the whole blood samples as follows:
1.
Delete any existing values: press [CLEAR REF VALS] followed by [CONFIRM CLEAR].
2.
For each sample used, type the appropriate information in the
<SPEC ID> and <# OF RUNS> fields. Press the Enter key on the keyboard after each entry to save it and advance the cursor.
NOTE: The <# OF RUNS> entered indicates the number of times the sample will be consecutively cycled through the instrument. Each sample may be run a maximum of 5 times. For
Mode to Mode calibration, each sample should be run once but samples may be run more than one time if desired. However, samples should be run the same number of times in each mode.
3.
Type the Open mode value for each parameter in the appropriate parameter reference values field. Press the Enter key on the keyboard to save the entry and advance the cursor.
4.
If desired, press [PRINT SUMMARY] to obtain a printout of the reference values.
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Performing the Calibration
1.
Press [START AUTO-CAL].
The instrument automatically performs three background counts.
The screen displays the message:
PREPARING ANALYZER FOR CALIBRATION,
PLEASE WAIT...
on the bulletin line.
2.
If the data from the background counts is acceptable, the displayed message changes to:
READY TO CALIBRATE. PUSH CONTINUE AUTO-CAL
KEY. START SAMPLES
3.
If the data from the background counts is unacceptable, the displayed message will alternate between:
BACKGROUND COUNTS EXCEED LIMITS.
MAINTENANCE RECOMMENDED and
READY TO CALIBRATE. PUSH CONTINUE AUTO-CAL
KEY. START SAMPLES
4.
Press [QUIT AUTO-CAL] followed by [CONFIRM QUIT] to exit Auto-Cal.
5.
Check the background results and troubleshoot out-of-range parameters.
6.
When the problem has been resolved, return to the
CALIBRATION MENU Screen and press [AUTO-
CALIBRATE] followed by [WHOLE BLOOD] and [START
AUTO-CAL].
NOTE: The information entered in steps 2 and 3 of the
“ Entering the Reference Values ” section is retained.
7.
When background results are acceptable, press [CONTINUE
AUTO-CAL].
8.
Place the tubes in a Sample Loader End Rack (use an End Rack so the Sample Loader will stop when the run is completed) in the order in which the reference values were entered.
NOTE: If each sample is to be run more than once, leave one space between the samples in the rack. This prevents overmixing of the samples.
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Chapter 6
9.
Press the Start key on the Sample Loader. The Sample Loader will automatically run each sample for the indicated number of runs.
10.
When all runs of a sample have been completed, the bulletin line displays the message:
NEW CAL FACTOR COMPUTED. READY FOR NEXT CAL
SPECIMEN
The Sample Loader automatically advances to the next sample.
11.
As the samples are processed, the reference value <VALUE> and the results of the analysis (<RUN1>, <RUN2>, etc.) appear on the
WHOLE BLOOD AUTO-CAL, RESULTS FOR SPECIMEN
• The Auto-Cal program automatically compares the results of the first run of each whole blood sample with the parameter reference values entered for that sample to verify that the difference is within acceptable limits.
• If the first run fails this internal reference check for any parameter, the results are highlighted and will be excluded from the calculation of the calibration factor.
• If all parameters fail the reference check, results of that run are highlighted and excluded from the calculation of the calibration factor. The bulletin line displays the message:
ABANDON CAL FOR SPECIMEN 1 - RESULT NOT
INCLUDED IN MEAN
NOTE: In the event of a reference check failure, the Sample
Loader will continue to process samples. If desired, a replacement sample may be added after the remaining samples have been run.
12.
Subsequent runs of each sample must pass the reference check and an additional internal precision check. If a run fails either check, the parameter is highlighted and no calibration factor will be calculated for the parameter. Calibration factors will be calculated for the remaining parameters. Calibration must be repeated for the highlighted parameter.
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Calibration Factor Calculation
As each run of the whole blood samples is completed, a Calibration
Factor is calculated and updated. This factor is displayed in the column labeled <SPEC (N) FACTOR>.
The column labeled <MEAN FACTOR> contains the average of the calibration factors for all of the whole blood samples used in the calibration. The number in parentheses after mean factor indicates the number of samples used to compute that mean factor.
The <FACTOR % DIFF> column displays the difference between the calibration factor currently in the instrument and the mean factor computed by the Auto-Cal program.
When all runs of all whole blood samples have been completed, the message:
NEW CAL FACTOR COMPUTED. READY FOR ACCEPTANCE is displayed on the bulletin line.
1.
Press [PREVIOUS SPECIMEN] and/or [NEXT SPECIMEN] to review and/or print the results of all whole blood samples analyzed.
NOTE: These results are only available for review and/or printing before the [ACCEPT MEANS] key is pressed.
2.
Press [PRINT] to obtain a printout of the <SPEC> and <MEAN
FACTORS> and the <FACTOR % DIFF>.
3.
Enter the factor % difference for each parameter in the Mode to
Mode Calibration Criteria Worksheet provided at the end of this procedure. (This worksheet may be duplicated as needed.) The
Calibration Criteria are shown in Table 6.6
NOTE: Delete the sign of the factor % difference value before entering it in the chart.
4.
To determine which parameters require calibration, continue with
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Chapter 6
Table 6.6: Mode to Mode Calibration Criteria Chart
MODE TO MODE CALIBRATION CRITERIA
WBC
RBC
HGB
MCV
PLT
Validation Range
Cal Not Required
<1.75%
<1.25%
<1.25%
<1.25%
<3.50%
Calibration Range
Cal Required
>1.75% but < 10%
>1.25% but < 10%
>1.25% but < 10%
>1.25% but < 10%
>3.50% but < 20%
Calibration Limit
Do Not Cal
>10%
>10%
>10%
>10%
>20%
Determining Which Parameters Need Calibration
1.
Validation Range
If the factor % difference is equal to or less than the following values, CALIBRATION IS NOT REQUIRED for that parameter as the value is within the Validation Range.
Results EQUAL TO OR LESS THAN VALIDATION RANGE:
WBC <1 .75%
RBC <1 .25%
HGB <1 .25%
MCV <1 .25%
PLT < 3.50%
If the results for all parameters are less than the values given above:
Press [QUIT AUTO-CAL] followed by [CONFIRM QUIT].
Document the calibration as follows:
The Auto-Cal Calibration Log is available for comments only when
a calibration factor is changed or reentered. Therefore, document the calibration in the <COMMENTS> line by accessing the log as follows:
From the CALIBRATION MENU Screen , press [ENTER
FACTOR].
Retype an existing Cal Factor. Press the Enter key on the keyboard to save the entry and advance the cursor.
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Press [RETURN].
When the CALIBRATION LOG Screen is displayed, indicate in
the <COMMENTS> line that instrument calibration was confirmed and no changes were required. Press the Enter key on the keyboard to save the entry and advance the cursor.
Be certain to retain all necessary documentation in the instrument logbook.
2.
Calibration Limit
If the factor % difference for a particular parameter is greater than the following value, there may be an instrument problem as the value has exceeded the Calibration Limit.
Results GREATER THAN CALIBRATION LIMIT:
WBC
RBC
HGB
MCV
PLT
>10%
>10%
>10%
>10%
>20%
Check to see if any component that could affect the calibration was changed as this could cause the factor % difference to exceed the above limits. For example:
Shear valve
WBC flow cell
Syringe(s)
RBC/PLT transducer assembly
RBC/PLT aperture
Hemoglobin flow cell
If a component was changed, calibrate the instrument as needed according to the directions in this procedure. If no components have been changed and the factor % difference exceeds these limits, DO NOT CALIBRATE; CONFIRM THAT ALL PRE-
CALIBRATION PROCEDURES WERE COMPLETED AND
CALL THE CUSTOMER SUPPORT CENTER FOR
ASSISTANCE AT 1 (800) CELL DYN.
Press [QUIT AUTO-CAL] followed by [CONFIRM QUIT] to exit Auto-Cal.
Troubleshoot accordingly. Be certain to retain all necessary documentation in the instrument logbook.
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Chapter 6
3.
Calibration Range
If the factor % difference falls within the following Calibration
Range, calibration is required for that parameter. CALIBRATE
THE INSTRUMENT as directed in this procedure, either for all parameters or specific parameters.
Results WITHIN THE FOLLOWING CALIBRATION RANGE:
WBC >1.75% but
RBC >1.25% but
HGB >1.25% but
MCV >1.25% but
<1
<1
<1
<1
0%
0%
0%
0%
PLT >3.50% but < 20%
If all parameters require calibration, continue with the following section. If only specific parameters require calibration, skip to the
“ Calibration for Individual Parameters ” section.
Calibration for All Parameters
1.
If the factor % difference for all parameters falls within the acceptable Calibration Range limits, press [ACCEPT MEANS].
The message:
ALL DATA AND RESULTS WILL GO AWAY is displayed on the bulletin line.
2.
Be certain that all desired printouts have been made.
3.
Press [CONFIRM ACCEPT] to save the Mean Factors and complete the
4.
The CALIBRATION LOG Screen is automatically displayed.
The log holds 10 entries. (The screen displays five entries. Display the other five by pressing the Page Up key on the keyboard.) When the log is full, subsequent entries cause the oldest entry to be deleted and the remaining entries to move up one line so that the current factors are added to the bottom of the list. Therefore, the log should be printed periodically for purposes of documentation.
The log displays the <DATE>, <TIME>, <OPERATOR ID>,
<CALIBRATION FACTORS> and a line for <COMMENTS>.
NOTE: The letters in parentheses after each factor indicate the method of factor derivation: A = Autocal, F = Factory, E = Enter
Factor (manual factor entry).
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5.
Type any comments in the <COMMENTS> field. Press the Enter key on the keyboard to save the entry and advance the cursor.
NOTE: Comments may be added to the Calibration Log only after a calibration factor is changed or reentered.
6.
If desired, press [PRINT LOG] to obtain a printout of the
Calibration Log for documentation.
Calibration for Individual Parameters
If only certain individual parameters require calibration, continue with this section:
1.
Press [QUIT AUTO-CAL] followed by [CONFIRM QUIT] to exit Auto-Cal.
2.
Press [RETURN] twice to return to the CALIBRATION MENU
3.
Press [ENTER FACTOR]
The ENTER WHOLE BLOOD FACTOR Screen is displayed.
4.
Type any mean factors computed by Auto-Cal for those parameters that require calibration in the appropriate fields. (Refer to the printout
made in step 2 of the “ Calibration Factor Calculation ” section of
this procedure.) Move the cursor to the desired position, type the factor and press the Enter key on the keyboard to save the factor and advance the cursor.
5.
Press [RETURN].
6.
When the CALIBRATION LOG Screen is displayed, indicate the
parameters that required calibration in the <COMMENTS> line.
Press the Enter key on the keyboard to save the entry and advance the cursor.
NOTE: Manually entered factors are followed by the letter E in parentheses to indicate “Enter Factor”.
7.
If desired, press [PRINT LOG] to obtain a printout of the
Calibration Log for documentation.
Completing Mode to Mode Calibration
1.
Press [RETURN] to return to the CALIBRATION MENU
2.
Press [MAIN] to exit the CALIBRATION MENU .
3.
Retain all necessary documentation in the instrument logbook.
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Chapter 6
4.
Confirm the calibration of the Closed Mode by running
commercial controls as directed in the Post-Calibration Procedures
section.
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Chapter 6 Search Book TOC Go Back Calibration
CELL-DYN 3000
Mode to Mode Calibration Worksheet
Instrument:__________________________________ Date:______________________________________
Operator:______________________________________
________________________________________________________________________________________
Mode to Mode Calibration Criteria
Factor
%Diff*
Validation Range
Cal Not Required
Cal Range
Cal Required
WBC
RBC
HGB
MCV
PLT
<1.75%
<1.25%
<1.25%
<1.25%
<3.50%
>1.75% but < 10%
>1.25% but < 10%
>1.25% but < 10%
>1.25% but < 10%
>3.50% but < 20%
* Delete the sign of the Factor % Diff before entering it on the chart.
** Do not calibrate. Call the Customer Support Center for assistance at 1 (800) CELL DYN.
Cal Limit
Do Not Cal**
>10%
>10%
>10%
>10%
>20%
Cal?
Y/N
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Chapter 6
Mode To Mode Auto-Cal, Closed Sampler Procedure
Procedure
NOTE: Be sure to complete the Pre-Calibration procedures and
read the Whole Blood Calibration and the
sections before beginning this procedure.
Determining Reference Values
The samples used for the calibration should be run in the Open Mode as patient samples in order to properly identify them. (Single replications of each of 10 whole blood samples are required.) A printout of the Data Log for those sequence numbers can be used to enter the Reference Values and may be retained for documentation.
1.
From the MAIN MENU Screen , press [RUN].
2.
If necessary, press [CHANGE SAMPLER] to select the Open mode.
3.
Press [SPECIMEN TYPE] then press [PATIENT].
4.
Type the sample identification for the first sample in the <NEXT
ID> field. Press the Enter key on the keyboard to save the entry and advance the cursor. Run the sample, noting the sequence number.
5.
Repeat step 4 for each sample. Note the sequence number of the last sample.
6.
Access the Data Log. Press [PRINT DATA LOG].
7.
Type the range of sequence numbers for the calibration samples in the indicated fields to obtain the printout.
Starting Auto-Cal
The calibration procedure has been divided into subsections that consist of a series of easy-to-follow steps. Always follow the entire procedure unless specifically directed to skip to another section.
Confirm the calibration of the Open mode before performing this procedure.
1.
From the MAIN MENU Screen , press [RUN] then press [WORK
LIST]. Ensure that WORK LIST and BAR CODE, as indicated in upper left corner, are both OFF.
2.
From the MAIN MENU Screen , press [CALIBRATION].
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3.
If necessary, press [CLOSED SAMPLER] to display the Closed
Mode Calibration Factors.
4.
If desired, press [PRINT] to obtain a printout of the <CURRENT
WHOLE BLOOD FACTORS> displayed on the screen.
NOTE: These calibration factors are retained in the Auto-Cal
Calibration Log until 10 entries have been made. As each
subsequent entry is made, the oldest existing entry is deleted.
5.
Press [AUTO-CALIBRATE] to select the AUTO-
6.
If necessary, press [CHANGE SAMPLER] to select the Closed mode.
7.
Press [WHOLE BLOOD] to select Whole Blood Auto-Cal.
NOTE: If necessary, press [CONFIRM SELECTION] to continue.
Entering the Reference Values
Enter the reference values for the whole blood samples as follows:
1.
Delete any existing values: press [CLEAR REF VALS] followed by [CONFIRM CLEAR].
2.
For each sample used, type the appropriate information in the
<SPEC ID> and <# OF RUNS> fields. Press the Enter key on the keyboard after each entry to save it and advance the cursor.
NOTE: The <# OF RUNS> entered indicates the number of times the sample will be consecutively cycled through the instrument. Each sample may be run a maximum of 5 times. For
Mode to Mode calibration, each sample should be run once but samples may be run more than one time if desired. However, samples should be run the same number of times in each mode.
3.
Type the Open mode value for each parameter in the appropriate parameter reference values field. Press the Enter key on the keyboard after each entry to save it and advance the cursor.
4.
If desired, press [PRINT SUMMARY] to obtain a printout of the reference values.
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Chapter 6
Performing the Calibration
1.
Press [START AUTO-CAL].
The instrument automatically performs three background counts.
The screen displays the message:
PREPARING ANALYZER FOR CALIBRATION, PLEASE
WAIT...
on the bulletin line.
2.
If the data from the background counts is acceptable, the displayed message changes to:
READY TO CALIBRATE. PUSH CONTINUE AUTO-CAL
KEY. START SAMPLES
3.
If the data from the background counts is unacceptable, the displayed message will alternate between:
BACKGROUND COUNTS EXCEED LIMITS. PERFORM
MAINTENANCE TO CLEAR BACKGROUND and
READY TO CALIBRATE. PUSH CONTINUE AUTO-CAL
KEY. START SAMPLES
4.
Press [QUIT AUTO-CAL] followed by [CONFIRM QUIT] to exit Auto-Cal.
5.
Check the background results and troubleshoot out-of-range parameters.
6.
When the problem has been resolved, return to the CALIBRATION
MENU Screen and press [AUTO-CALIBRATE] followed by
[WHOLE BLOOD] and [START AUTO-CAL].
NOTE: The information entered in steps 2 and 3 of the
“ Entering the Reference Values ” section is retained.
7.
When background results are acceptable, press [CONTINUE
AUTO-CAL].
8.
Run the first whole blood sample. The reference value, <VALUE>,
and the results of the analysis, <RUN1>, appear on the WHOLE
BLOOD AUTO-CAL, RESULTS FOR SPECIMEN (N) screen
display.
• The Auto-Cal program automatically compares the results of the first run of each whole blood sample with the parameter reference values entered for that sample to verify that the difference is within acceptable limits.
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• If the first run passes this internal Reference Check, proceed to
• If the first run fails the Reference Check for any parameter, the results are highlighted and the bulletin line displays the message:
THIS RESULT IS OUTSIDE THE ALLOWED LIMITS.
REPEAT THIS SPECIMEN
NOTE: Check to be sure the reference values were entered correctly and the correct sample was run before repeating it.
The specimen may be repeated at this time by pressing [REPEAT
SPECIMEN] and [CONFIRM REPEAT]. When the repeat function is used, all results for the failed run are automatically deleted.
• If the repeated run also fails the Reference Check, the result(s) are highlighted and no calibration factor will be calculated for that parameter.
• If all parameters fail the Reference Check, results of that run are not displayed and the bulletin line displays the message:
ABANDON CAL FOR SPECIMEN 1 - RESULT NOT
INCLUDED IN MEAN
Repeat the specimen as directed above.
• If all parameters on the repeated run also fail the Reference
Check, discard that sample and continue with the next calibration sample. If desired, a replacement sample may be added after the remaining samples have been run.
9.
Run each sample for the number of runs entered in step 2 of the
“ Entering the Reference Values ” section. Each subsequent run
must pass the Reference Check and an additional internal Precision
Check. If a run fails either check, that parameter is highlighted and no calibration factor will be calculated for the parameter.
Calibration must be repeated for the highlighted parameter.
Calibration factors will be calculated for the remaining parameters.
10.
When all runs of a sample have been completed, the bulletin line displays the message:
NEW CAL FACTOR COMPUTED. READY FOR NEXT CAL
SPECIMEN
Press [NEXT SPECIMEN] to run the next sample.
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Calibration Factor Calculation
As each run of the whole blood samples is completed, a Calibration
Factor is calculated and updated. This factor is displayed in the column labeled <SPEC (N) FACTOR>.
The column labeled <MEAN FACTOR> contains the average of the calibration factors for all of the whole blood samples used in the calibration. The number in parentheses after mean factor indicates the number of samples used to compute that mean factor. The <FACTOR %
DIFF> column displays the difference between the calibration factor currently in the instrument and the mean factor computed by the Auto-
Cal program.
When all runs of all whole blood samples have been completed, the message:
NEW CAL FACTOR COMPUTED. READY FOR ACCEPTANCE is displayed on the bulletin line.
1.
Press [PREVIOUS SPECIMEN] and/or [NEXT SPECIMEN] to review and/or print the results of all whole blood samples analyzed.
NOTE: These results are only available for review and/or printing before the [ACCEPT MEANS] key is pressed.
2.
Press [PRINT] to obtain a printout of the <SPEC> and <MEAN
FACTORS> and the <FACTOR % DIFF>.
3.
Enter the factor % difference for each parameter in the Mode to
Mode Calibration Criteria Worksheet provided at the end of this procedure. (This worksheet may be duplicated as needed.) The
Calibration Criteria are shown in Table 6.7
NOTE: Delete the sign of the factor % difference value before entering it in the chart.
4.
To determine which parameters require calibration, continue with
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Table 6.7: Mode to Mode Calibration Criteria Chart
Mode to Mode Calibration Criteria
WBC
RBC
HGB
MCV
PLT
Validation Range
Cal Not Required
<1.75%
<1.25%
<1.25%
<1.25%
<3.50%
Calibration Range
Cal Required
>1.75% but < 10%
>1.25% but < 10%
>1.25% but < 10%
>1.25% but < 10%
>3.50% but < 20%
Calibration Limit
Do Not Cal
>10%
>10%
>10%
>10%
>20%
Determining Which Parameters Need Calibration
1.
Validation Range
If the factor % difference is equal to or less than the following values, CALIBRATION IS NOT REQUIRED for that parameter as the value is within the Validation Range.
Results EQUAL TO OR LESS THAN VALIDATION RANGE:
WBC <1 .75%
RBC
HGB
MCV
<1 .25%
<1 .25%
<1 .25%
PLT < 3.50%
If the results for all parameters are less than the values given above:
Press [QUIT AUTO-CAL] followed by [CONFIRM QUIT].
Document the calibration as follows:
The Auto-Cal Calibration Log is available for comments only when
a calibration factor is changed or reentered. Therefore, document the calibration in the <COMMENTS> line by accessing the log as follows:
From the CALIBRATION MENU Screen , press [ENTER
FACTOR].
Retype an existing Cal Factor. Press the Enter key on the keyboard to save the entry and advance the cursor.
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Press [RETURN].
When the CALIBRATION LOG Screen is displayed, indicate in
the <COMMENTS> line that instrument calibration was confirmed and no changes were required. Press the Enter key on the keyboard to save the entry and advance the cursor.
Be certain to retain all necessary documentation in the instrument logbook.
2.
Calibration Limit
If the factor % difference for a particular parameter is greater than the following value, there may be an instrument problem as the value has exceeded the Calibration Limit.
Results GREATER THAN CALIBRATION LIMIT:
WBC
RBC
HGB
MCV
>10%
>10%
>10%
>10%
PLT >20%
Check to see if any component that could affect the calibration was changed as this could cause the factor % difference to exceed the above limits. For example:
Shear valve RBC/PLT transducer assembly
WBC flow cell RBC/PLT aperture
Syringe(s) Hemoglobin flow cell
If a component was changed, calibrate the instrument as needed according to the directions in this procedure. If no components have been changed and the factor % difference exceeds these limits, DO NOT CALIBRATE; CONFIRM THAT ALL PRE-
CALIBRATION PROCEDURES WERE COMPLETED AND
CALL THE CUSTOMER SUPPORT CENTER FOR
ASSISTANCE AT 1 (800) CELL DYN.
Press [QUIT AUTO-CAL] followed by [CONFIRM QUIT] to exit Auto-Cal.
Troubleshoot accordingly. Be certain to retain all necessary documentation in the instrument logbook.
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3.
Calibration Range
If the factor % difference falls within the following Calibration
Range, calibration is required for that parameter. CALIBRATE
THE CLOSED MODE as directed in this procedure, either for all parameters or specific parameters.
Results WITHIN THE FOLLOWING CALIBRATION RANGE:
WBC >1.75% but <10%
RBC >1.25% but <10%
HGB >1.25% but
MCV >1.25% but
PLT >3.50% but
<10%
<1
<
0%
20%
If all parameters require calibration, continue with the following section. If only specific parameters require calibration, skip to the
“ Calibration for Individual Parameters ” section.
Calibration for All Parameters
1.
If the factor % difference for all parameters falls within the acceptable Calibration Range limits, press [ACCEPT MEANS].
The message:
ALL DATA AND RESULTS WILL GO AWAY is displayed on the bulletin line.
2.
Be certain that all desired printouts have been made.
3.
Press [CONFIRM ACCEPT] to save the Mean Factors and
complete the Auto-Cal procedure .
4.
The CALIBRATION LOG Screen is automatically displayed.
The log holds 10 entries. (The screen displays five entries. Display the other five by pressing the Page Up key on the keyboard.) When the log is full, subsequent entries cause the oldest entry to be deleted and the remaining entries to move up one line so that the current factors are added to the bottom of the list. Therefore, the log should be printed periodically for purposes of documentation.
The log displays the <DATE>, <TIME>, <OPERATOR ID>,
<CALIBRATION FACTORS> and a line for <COMMENTS>.
The letters in parentheses after each factor indicate the method of factor derivation: A = Autocal, F = Factory, E = Enter Factor
(manual factor entry).
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5.
Type any comments in the <COMMENTS> field. Press the Enter key on the keyboard to save the entry and advance the cursor.
Comments may be added to the Calibration Log only after a calibration factor is changed or reentered.
6.
If desired, press [PRINT LOG] to obtain a printout of the
Calibration Log for documentation.
Calibration for Individual Parameters
If only certain individual parameters require calibration, continue with this section:
1.
Press [QUIT AUTO-CAL] followed by [CONFIRM QUIT] to exit Auto-Cal.
2.
Press [RETURN] twice to return to the CALIBRATION MENU
3.
Press [ENTER FACTOR].
The ENTER WHOLE BLOOD FACTOR Screen is displayed.
4.
Type any mean factors computed by Auto-Cal for those parameters that require calibration in the appropriate fields. (Refer to the
printout made in step 2 of the “ Calibration Factor Calculation ”
section of this procedure.) Move the cursor to the desired position, type the factor and press the Enter key on the keyboard to save the factor and advance the cursor.
5.
Press [RETURN]
6.
When the CALIBRATION LOG Screen
is displayed, indicate the parameters that required calibration in the <COMMENTS> line.
Press the Enter key on the keyboard to save the entry and advance the cursor.
NOTE: Manually entered factors are followed by the letter E in parentheses to indicate “Enter Factor”.
7.
If desired, press [PRINT LOG] to obtain a printout of the
Calibration Log for documentation.
Completing Mode to Mode Calibration
1.
Press [RETURN] to return to the CALIBRATION MENU
2.
Press [MAIN] to exit the CALIBRATION MENU .
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3.
Retain all necessary documentation in the instrument logbook.
4.
Confirm the calibration of the Closed mode by running commercial
controls as directed in the Post-Calibration Procedures section.
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Chapter 6
CELL-DYN 3000
Mode to Mode Calibration Worksheet
Instrument:__________________________________ Date:______________________________________
Operator:______________________________________
________________________________________________________________________________________
Mode to Mode Calibration Criteria
Factor
%Diff*
Validation Range
Cal Not Required
Cal Range
Cal Required
WBC <1.75% >1.75% but < 10%
RBC
HGB
<1.25%
<1.25%
>1.25% but < 10%
>1.25% but < 10%
MCV <1.25% >1.25% but < 10%
PLT <3.50% >3.50% but < 20%
* Delete the sign of the Factor % Difference before entering it on the chart.
** Do not calibrate. Call the Customer Support Center for assistance at 1 (800) CELL DYN.
Cal Limit
Do Not Cal**
>10%
>10%
>10%
>10%
>20%
Cal?
Y/N
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Manual Mode To Mode Calibration
Procedure
The calibration procedure has been divided into subsections that consist of a series of easy-to-follow steps. Always follow the entire procedure unless specifically directed to skip to another section.
Confirm the calibration of the Open mode before performing this procedure.
NOTE: Be sure to complete the Pre-Calibration procedures and
read the Whole Blood Calibration and the
Overview sections before beginning this procedure.
Preparing for Manual Mode to Mode Calibration
1.
From the MAIN MENU Screen , press [CALIBRATION].
2.
If necessary, press [CLOSED SAMPLER] to display the Closed
Mode Calibration Factors.
3.
Press [PRINT] to obtain a printout of the <CURRENT WHOLE
BLOOD FACTORS> displayed on the screen.
4.
Press [RETURN] followed by [MAIN] to return to the MAIN
Determining the Open Mode Mean
1.
From the MAIN MENU Screen , press [RUN].
2.
If necessary, press [CHANGE SAMPLER] to select the Open mode.
3.
Press [SPECIMEN TYPE].
4.
Use the arrow keys on the keyboard to move the cursor to an empty
QC file and type “OPEN MEAN” in the <FILENAME> field.
5.
Press the Enter key on the keyboard to save the name. Use the Up
Arrow key on the keyboard to move the cursor back to the “OPEN
MEAN” file.
6.
Press [QC SPECIMEN] to return to the RUN Screen .
7.
Run each sample one time into the “OPEN MEAN” QC file.
8.
Press [MAIN] followed by [QC LOGS] and [VIEW QC LOG].
9.
With the cursor at "OPEN MEAN" file, press [PRINT QC LOG] to obtain a printout of the data.
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Chapter 6
Determining the Closed Mode Mean
1.
From the MAIN MENU Screen , press [RUN].
2.
Press [CHANGE SAMPLER] to select the Closed mode.
3.
Press [SPECIMEN TYPE].
4.
Use the arrow keys on the keyboard to move the cursor to an empty
QC file and type “CLOSED MEAN” in the <FILENAME> field.
5.
Press the Enter key on the keyboard to save the name. Use the Up
Arrow key on the keyboard to move the cursor back to the
“CLOSED MEAN” file.
6.
Press [QC SPECIMEN] to return to the RUN Screen .
7.
Run each sample one time into the “CLOSED MEAN” QC file.
8.
Press [MAIN] followed by [QC LOGS]. With the cursor at
"CLOSED MEAN" file, press [VIEW QC LOG].
9.
Press [PRINT QC LOG] to obtain a printout of the data.
10.
Press [RETURN] followed by [MAIN] to return to the MAIN
Difference Calculation
10.
Press [RETURN] followed by [MAIN] to return to the MAIN
1.
Use the mean value for each parameter from the “OPEN MEAN” and “CLOSED MEAN” file printouts for the calculations.
2.
Enter the information from step 1 on the Manual Mode to Mode
Calibration worksheet and calculate the Mode to Mode Calibration bias for each parameter as follows:
Closed Mode Mean - Open Mode Mean
Open Mode Mean x 100 = % Difference
3.
Enter the % difference for each parameter in the Mode to Mode
Calibration Criteria chart on the worksheet. (This worksheet may
be duplicated as needed.) The Calibration Criteria are shown in
NOTE: Delete the sign of the factor % difference before entering it on the chart.
4.
To determine which parameters require calibration, continue with
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Table 6.8: Mode to Mode Calibration Criteria Chart
Mode to Mode Calibration Criteria
WBC
RBC
HGB
MCV
PLT
Validation Range
Cal Not Required
<1.75%
<1.25%
<1.25%
<1.25%
<3.50%
Calibration Range
Cal Required
>1.75% but < 10%
>1.25% but < 10%
>1.25% but < 10%
>1.25% but < 10%
>3.50% but < 20%
Calibration Limit
Do Not Cal
>10%
>10%
>10%
>10%
>20%
Determining Which Parameters Need Calibration
1.
Validation Range
If the % difference is equal to or less than the following values,
CALIBRATION IS NOT REQUIRED for that parameter as the value is within the Validation Range.
Results EQUAL TO OR LESS THAN VALIDATION RANGE:
WBC <1 .75%
RBC
HGB
MCV
<1 .25%
<1 .25%
<1 .25%
PLT < 3.50%
If desired, the Manual Mode to Mode Calibration results may be
documented in the Auto-Cal Calibration Log as follows:
The
Auto-Cal Calibration Log is available for comments only when
a calibration factor is changed or reentered. Therefore, document the calibration in the <COMMENTS> line by accessing the log as follows:
From the CALIBRATION MENU Screen press [ENTER
FACTOR].
Retype any existing Cal Factor. Press the Enter key on the keyboard to save the entry and advance the cursor.
Press [RETURN].
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Chapter 6
When the CALIBRATION LOG Screen is displayed, indicate in
the <COMMENTS> line that instrument calibration was confirmed and no changes were required. Press the Enter key on the keyboard to save the entry and advance the cursor.
Be certain to retain all necessary documentation in the instrument logbook.
2.
Calibration Limit
If the % difference for a particular parameter is greater than the following values, there may be a computation error or instrument problem as the value has exceeded the Calibration Limit.
Results GREATER THAN CALIBRATION LIMIT:
WBC >10%
RBC
HGB
>10%
>10%
MCV
PLT
>10%
>20%
Recheck the numbers entered on the worksheets and then recheck all calculations.
Check to see if any component was changed which could affect the calibration as this could cause the % difference to exceed the above limits. For example:
Shear valve RBC/PLT transducer assembly
WBC flow cell RBC/PLT aperture
Syringe(s) Hemoglobin flow cell
If a component was changed, calibrate the instrument as needed according to the directions in the following sections. If no components have been changed, the calculations are correct and the
% difference exceeds these limits, DO NOT CALIBRATE.
CONFIRM THAT ALL PRE-CALIBRATION PROCEDURES
WERE COMPLETED AND THEN CALL THE CUSTOMER
SUPPORT CENTER FOR ASSISTANCE AT
1 (800) CELL DYN.
3.
Calibration Range
If the % difference falls within the following Calibration Range, calibration is required for that parameter. CALIBRATE THE
INSTRUMENT as directed in the following sections, either for all parameters or specific parameters.
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Results WITHIN THE FOLLOWING CALIBRATION RANGE:
WBC >1.75% but <1 0%
RBC
HGB
MCV
PLT
>1.25% but
>1.25% but
>1.25% but
>3.50% but
<1 0%
<1 0%
<1
<
0%
20%
Calibration Factor Calculation
1.
Use the appropriate worksheet to calculate the New Closed Mode
Calibration Factor for the parameters that require calibration as follows: (Use the Current Closed Mode Cal Factor printed at the start of this procedure.)
Closed Mode Mean
× Current Closed Mode
Calibration Factor
=
New Closed Mode
Calibration Factor
If the New Closed Mode Calibration Factor falls within the acceptable range given on the worksheet, calibrate the Closed
Mode as directed in the next section.
If the New Closed Mode Calibration Factor for a given parameter falls outside the acceptable range, there may be a computation error. DO NOT CALIBRATE THAT PARAMETER. Recheck all calculations and then call the Customer Support Center for assistance at 1 (800) CELL DYN.
Calibrating the Closed Mode
1.
From the MAIN MENU Screen , press [CALIBRATION].
2.
Press [ENTER FACTOR] to display the ENTER WHOLE
3.
Type the New Closed Mode Calibration Factors for the parameters that require calibration in the appropriate fields in the <CLOSED
SAMPLER> column. Move the cursor to the desired position, type the factor and press the Enter key on the keyboard to save the factor and advance the cursor.
4.
After the new Closed mode calibration factors have been entered, press [RETURN].
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5.
The CALIBRATION LOG Screen is automatically displayed.
The log holds 10 entries. (The screen displays five entries. Display the other five by pressing the Page Up key on the keyboard.) When the log is full, subsequent entries cause the oldest entry to be deleted and the remaining entries to move up one line so that the current factors are added to the bottom of the list. Therefore, the log should be printed periodically for purposes of documentation.
The log displays the <DATE>, <TIME>, <OPERATOR ID>,
<CALIBRATION FACTORS> and a line for <COMMENTS>.
NOTE: The letters in parentheses after each factor indicate the method of factor derivation: A = Autocal, F = Factory, E = Enter
Factor (manual factor entry).
6.
Type any comments in the <COMMENTS> field. Press the Enter key on the keyboard to save the entry and advance the cursor.
NOTE: Comments may be added to the Calibration Log only after a calibration factor is changed or reentered.
7.
If desired, press [PRINT LOG] to obtain a printout of the
Calibration Log for documentation.
Completing Mode to Mode Calibration
1.
Press [RETURN] to return to the CALIBRATION MENU
2.
Press [MAIN] to exit the CALIBRATION MENU .
3.
Retain all necessary documentation in the instrument logbook.
4.
Confirm the calibration of the Closed mode by running commercial
controls as directed in the Post-Calibration Procedures section.
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CELL-DYN 3000
Manual Calibration Worksheet
Instrument:____________________________________ Date:___________________________________
Operator:______________________________________
________________________________________________________________________________________
_
Calculate All Factors To Three Decimal Places
WBC
RBC
HGB
MCV
PLT
Mode to Mode Calibration Difference
Closed Mode Mean - Open Mode Mean x 100 = % Diff
Open Mode Mean
Closed Mode
Mean -
-
-
-
-
-
Open Mode
Mean /
/
/
/
/
/
Open Mode
Mean x 100 =
x 100 =
x 100 =
x 100 =
x 100 =
x 100 =
% Diff
Mode to Mode Calibration Criteria
%Diff*
Validation Range
Cal Not Required
Cal Range
Cal Required
WBC
RBC
HGB
MCV
PLT
<1.75%
<1.25%
<1.25%
<1.25%
<3.50%
>1.75% but < 10%
>1.25% but < 10%
>1.25% but < 10%
>1.25% but < 10%
>3.50% but < 20%
* Delete the sign of the % Diff before entering it on the chart.
** Do not calibrate. Call the Customer Support Center for assistance at 1 (800) CELL DYN.
Cal Limit
Do Not Cal**
>10%
>10%
>10%
>10%
>20%
Cal?
Y/N
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3000 System Operator’s Manual
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6-87
Calibration
Search Book TOC Go Back
Chapter 6
New Closed Mode Calibration Factors
Open Mode Mean x Current Closed Mode Cal Factor* = New Closed Mode Cal Factor
Closed Mode Mean
Open Mode
Mean /
Closed
Mode
Mean x
Current
Closed Mode
Cal Factor* =
New
Closed
Mode Cal
Factor Range**
WBC
RBC
HGB
MCV
/
/
/
/
x x x x
=
=
=
=
0.700 - 1.300
0.800 - 1.200
0.700 - 1.300
0.700 - 1.300
PLT / x = 0.700 - 1.300
* Current factor as printed in this manual calibration procedure.
** If factor exceeds limits, do not calibrate. Check all calculations and call the Customer Support Center for assistance at 1 (800)
CELL DYN.
Mode to Mode Post-Calibration Difference
Closed Mode Mean - Open Mode Mean x 100 = % Diff
Open Mode Mean
Closed
Mode
Mean* -
Open
Mode
Mean /
Open Mode
Mean x 100 =
WBC
RBC
HGB
MCV
-
-
-
-
/
/
/
/
x 100 =
x 100 =
x 100 =
x 100 =
PLT / x 100 =
* Mean after calibration.
** If % Diff exceeds limits, call the Customer Support Center for assistance at 1 (800) CELL DYN.
%Diff Range**
<1 .75%
<1 .25%
<1 .25%
<1 .25%
< 3.50%
6-88
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Chapter 6 Search Book TOC Go Back Calibration
Post-Calibration Procedures
If calibration was changed, complete the procedures in this section.
Quality Control
Confirm calibration changes by running all levels of commercial controls into the appropriate QC Files. If any parameters exceed the limits, proceed as follows:
1.
Obtain new vials of the controls.
2.
Warm and mix them per package insert and again run them into the appropriate QC files.
If parameters still exceed the limits, proceed as follows:
1.
Collect all the calibration documentation including the pre-calibration worksheets. (Be certain you have recorded lot numbers where indicated.)
2.
Call the Customer Support Center for assistance at
1 (800) CELL DYN.
NOTE: Inform the Customer Support Specialist if a reagent and/or lot number of reagent was changed just prior to the calibration procedure.
3.
Include documentation as to the resolution of the problem in the instrument logbook.
Calibration Back-Up
The current calibration factors should be saved on the CELL-DYN 3000
Set-Up Disk whenever calibration is changed. Data should also be saved whenever any Set-Up information is changed and after any service work is performed. The backup procedure copies the following Set-Up information from the Data Station to the
Set-Up Disk:
• Calibration Factors
• QC Limits
• Patient Limits
• Customize display and printout selections
• Units Selection
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6-89
Calibration
6-90
Search Book TOC Go Back
Chapter 6
• Analyzer Module Set Points (e.g., gains, dil factors [internal calibration factors], thresholds, pressure/vacuum settings)
• RBC Editing Ratio
To back up the calibration factors, proceed as follows:
1.
Turn the Data Station power switch OFF.
2.
Turn the Analyzer power switch OFF.
3.
Obtain the Set-Up Disk from the diskette box located behind the upper front cover of the Analyzer.
4.
Insert the Set-Up Disk in the Data Station disk drive.
5.
Turn the Data Station power switch ON.
6.
The DATA STATION Screen displays the following:
THIS DISK CAN BE USED TO COPY SET UP
INFORMATION TO OR FROM THE DATA STATION HARD
DISK. THE FOLLOWING COMMANDS ARE AVAILABLE:
GET [ENTER] - COPIES SET-UP INFORMATION FROM
THE DATA STATION HARD DISK ONTO THE SET-UP
DISK
PUT [ENTER] - COPIES SET-UP INFORMATION FROM
THE SET-UP DISK ONTO THE DATA STATION HARD
DISK
7.
Type GET.
8.
Press the Enter key on the keyboard. The Set-Up information is copied from the Data Station Hard Disk onto the Set-Up Disk.
Previous Set-Up information that was stored on the disk is overwritten.
9.
When the copy process is complete, the “a:>” prompt is displayed on the screen.
10.
Remove the Set-Up Disk from the disk drive and return it to the diskette box.
11.
Turn the Data Station power switch OFF.
12.
Wait five seconds and then turn the Analyzer power switch ON.
13.
Turn the Data Station power switch ON.
14.
When the Data Station Status Box indicates INITIALIZED, press the [RUN] soft key to Prime.
CELL-DYN
3000 System Operator’s Manual
9140240E — May 1995
Chapter 6 Search Book TOC Go Back Calibration
References
1.
ICSH, Protocol for Evaluation of Automated Blood Cell Counters,
Clinical and Laboratory Hematology 1988, 10:203, 212.
2.
NCCLS Standard H7-A, Procedure for Determining Packed Cell
Volume by the Microhematocrit Method; Approved Standard
(1985).
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3000 System Operator’s Manual
9140240E — May 1995
6-91
Calibration
Search Book TOC Go Back
NOTES
Chapter 6
6-92
CELL-DYN
3000 System Operator’s Manual
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Chapter 7 Search Book TOC Go Back
Quality Control
Chapter Table of Contents
Quality Control Menu
Quality Control Guide
General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-13
Running Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-13
Control Material . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-13
Mixing and Handling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-13
Assay Verification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-14
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-15
CELL-DYN 3000 Westgard Rules . . . . . . . . . . . . . . . . . . . . . . . 7-15
Rule Violations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-17
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-18
Lower/Upper Acceptance Limits . . . . . . . . . . . . . . . . . . . . . . . . 7-18
Target Value . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-19
Action Limit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-19
Establishing the Target Value . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-19
Interpreting X-B Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-19
CELL-DYN Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-19
CELL-DYN
3000 System Operator’s Manual
9140240E — May 1995
Table of Contents-1
Table of Contents Search Book TOC Go Back
NOTES
Chapter 7
Table of Contents-2
CELL-DYN
3000 System Operator’s Manual
9140240E — May 1995
Chapter 7
Introduction
Search Book TOC Go Back
Quality Control
The CELL-DYN® 3000 offers several quality control options to monitor and validate instrument performance. The options are:
X-B Analysis—Bull’s moving average program applied to the
RBC indices
20 QC Files—Statistical and graphical analysis of the data in each file to calculate the mean, standard deviation and coefficient of variation
Westgard Rules—A multi-rule system applied to the data in each of the QC files
The options may be used independently or in combination at the
operator’s request. Each option is discussed in detail in the Quality
Control Guide section of this chapter.
The first section of this chapter describes the functions of the keys in the
QC MENU . Interpretation of the data is discussed in the
CELL-DYN
3000 System Operator’s Manual
9140240E — May 1995
7-1
Quality Control
Search Book TOC Go Back
NOTES
Chapter 7
7-2
CELL-DYN
3000 System Operator’s Manual
9140240E — May 1995
Chapter 7
QC LOGS
Search Book TOC Go Back Quality Control
Quality Control Menu
This section discusses the options available when the [QC LOGS] key
is pressed. The options used to set up the QC files
are available from the QC MENU (see Figure 7.1
. Refer to the Set Up QC Files section of Chapter 5, Operating
Instructions , for an explanation of these keys as they will not be
discussed in this section.
The following soft key labels are displayed when the [QC LOGS] key
on the MAIN MENU Screen is pressed:
MAIN
*These keys are discussed in Chapter 5, Operating Instructions .
CELL-DYN
3000 System Operator’s Manual
9140240E — May 1995
7-3
Quality Control
X-B FILE
SHOW
DATA
Search Book TOC Go Back
Chapter 7
QC MENU
Ready
File Name
1.
L0058A
2.
N0058A
3.
H0058A
4.
FILE 4
5.
FILE 5
6.
FILE 6
7.
FILE 7
8.
FILE 8
9.
FILE 9
10. FILE 10
# Specimens
0
0
0
0
76
102
65
0
0
0
File Name
11.
PATIENT
12.
FILE 12
13.
FILE 13
14.
FILE 14
15.
FILE 15
16.
FILE 16
17.
FILE 17
18.
FILE 18
19.
FILE 19
20.
FILE 20
Select a QC file with the arrow keys or enter a new file name.
Mar 13 1993
Operator ID
Sequence #
# Specimens
0
0
0
0
0
0
0
0
30
0
15:51
734
0525
X-B
SET UP
X-B
FILE
VIEW
QC LOG
QC
LIMITS
SETUP
QC FILE
CUSTOMIZE CUSTOMIZE
DISPLAY PRINTOUT
MAIN
Figure 7.1: QC Menu Screen
The following soft key labels are displayed when the [X-B FILE] key is pressed:
SHOW DATA or
SHOW GRAPHS (Key label alternates between the two selections)
RETURN
displays the results for X-B batches 1–20 and the lower and upper limits.
The date and time that each batch was completed are also displayed.
7-4
CELL-DYN
3000 System Operator’s Manual
9140240E — May 1995
Chapter 7 Search Book TOC Go Back Quality Control
SHOW
GRAPHS
X-B DISPLAY
Uninitialized
Mar 12 1993
Operator ID
Sequence #
14:28
734
2368
Batch MCV MCH MCHC DATE
6
7
4
5
1
2
3
8
9
10
90.36
90.62
90.61
89.54
30.34
90.23
30.34
33.82
93.23
30.84
33.34
91.42
30.73
33.43
91.44
30.74
33.62
90.64
30.76
34.59
90.64
30.72
33.82
29.39
29.56
29.50
33.70
32.33
32.59
32.78
10/17/92
10/19/92
10/22/92
10/26/92
10/30/92
11/02/92
11/16/92
11/17/92
12/07/92
12/08/92
Upper 94.50
Lower 85.50
31.50
35.70
28.50
32.30
TIME Batch MCV MCH MCHC DATE
13:35
13:59
10:11
15:45
10:52
15:46
10:58
09:50
10:58
09:42
11 89.84
12 90.16
13 90.69
14 91.91
15 92.74
16 89.29
17 89.07
18
19
20
89.08
89.66
89.07
29.52
29.50
30.16
30.90
31.12
30.01
30.03
30.04
30.12
29.81
32.79
33.82
33.70
33.68
12/10/92
32.80
01/12/93
33.32
01/18/93
33.37
01/18/93
33.37
01/21/93
33.48
02/01/93
33.82
02/02/93
02/04/93
03/08/93
03/09/93
Upper 94.50
Lower 85.50
31.50
28.50
35.70
32.30
TIME
10:38
10:45
13:38
15:58
11:13
11:13
14:23
14:23
15:36
10:53
SHOW
GRAPHS
PRINT RETURN
Figure 7.2: The X-B Display Screen (Data)
CELL-DYN
3000 System Operator’s Manual
9140240E — May 1995
7-5
Quality Control
Search Book TOC Go Back
Chapter 7
X-B DISPLAY
Ready
PAGE UP/DN FOR MORE DATA
Dec 22 1992
Operator ID
Sequence #
14:40
734
0630
RETURN
VIEW
QC LOG
94.50
90.00
85.50
MCV
31.50
30.00
28.50
MCH
35.70
34.00
32.30
MCHC
SHOW
DATA
PRINT RETURN
Figure 7.3: The X-B Display Screen (Graph)
The [PRINT] key is used to print the X-B data or graphs. When this key is pressed, the data for all 20 batches and graphs is automatically printed.
The [RETURN] key is used to return to the QC MENU Screen .
The [VIEW QC LOG] key is used to display the QC log indicated by the position of the cursor. Each QC log display shows the following
7-6
CELL-DYN
3000 System Operator’s Manual
9140240E — May 1995
Chapter 7 Search Book TOC Go Back Quality Control
2613
2614
2615
2706
2707
2708
Upper Limits:
Lower Limits:
Seq
2475
2573
2574
2575
N:
Mean:
Std Dev:
CV (
.
/.):
Lot Number: 2345
Exp. Date: 04/01/93
N0058A: 90/120
Page 9 of 9
VIEW QC LOG
Ready
USE < OR > FOR MORE DATA
Mar 15 1993
Operator ID
Sequence #
09:56
734
2723
8.3
4.58
13.8
89.5
17.6
265.
10.3
7.1
4.22
13.0
83.5
13.2
215.
8.3
WBC RBC HGB MCV RDW PLT MPV
7.4
7.4
7.4
7.7
4.40
4.35
4.39
4.37
13.5
13.2
13.3
13.3
86.2
86.5
86.6
86.5
15.6
15.1
15.5
15.3
248.
240.
236.
233.
9.1
9.3
8.9
9.3
7.7
7.6
7.4
7.6
4.42
13.2
86.0
15.6
244.
4.37
13.4
85.7
15.4
238.
4.36
13.3
86.1
15.6
251.
4.35
13.2
86.8
16.2
243.
9.2
9.1
8.8
8.7
7.4
7.6
4.38
13.2
86.5
15.4
235.
4.35
13.3
86.3
15.5
227.
8.9
9.5
WBC RBC HGB MCV RDW PLT MPV
90 90 90 90 90 90 90
7.5
4.35
13.2
85.8
15.6
0.2
0.05
0.1
0.4
0.3
234.
9.0
9.
0.2
2.3
1.3
1.1
0.5
1.6
3.8
2.6
Date
O 03/10/93
O 03/11/93
O 03/11/93
O 03/11/93
O 03/12/93
O 03/12/93
O 03/12/93
O 03/15/93
O 03/15/93
O 03/15/93
Time Op
09:09 734
08:55 734
08:57 734
08:58 734
09:12 734
09:13 734
09:14 734
08:29 734
08:30 734
08:30 734
PURGE
QC LOG
LEVEY-
JENNINGS
REJECT
SPECIMEN
DELETE
SPECIMEN
WRITE QC
TO DISK
QC LOG
RETURN
Figure 7.4: The View QC Log Screen
1.
Upper Left Corner
Lot number and expiration date if the file was configured for this type of control. If the file was configured for a replicate ID, it is displayed here.
File name, the number of runs currently in the file and the file capacity (e.g., 90/120 indicates that the file contains 90 runs out of a possible 120).
The page number of the display and the total number of pages in the file.
2.
Status Box
USE < OR > FOR MORE DATA. This message indicates that the left and right arrow keys on the keyboard should be used to display the other groups of data.
3.
Upper Right Corner
The current date, time and operator ID are displayed along with the last sequence number that was used.
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3000 System Operator’s Manual
9140240E — May 1995
7-7
Quality Control
7-8
Search Book TOC Go Back
Chapter 7
4.
The remainder of the screen displays the file information and the data. The upper and lower limits entered are displayed immediately above the parameter names. The sequence number for each result is displayed to the left of the data. The date, time and operator ID when the sample was run are displayed to the right of the data.
5.
The following QC log codes are displayed in the column immediately preceding the date. These codes are the same as those used in the data log:
O — Sample was run in the open mode
C — Sample was run in the closed mode
N — Incomplete aspiration in the open mode
I — Incomplete aspiration in the closed mode
K — Metering fault (clog or flow error)
M — Mixing error on the Sample Loader
B — Blood detected in Sample Loader sample aspiration line
6.
The statistics are displayed below the data as follows:
N:
Mean: the number of runs used in the calculation the mean value for the number of runs used in the calculation
Std Dev: the standard deviation for the number of runs used in the calculation
CV (%): the coefficient of variation in percent for the number of runs used in the calculation
The following soft key labels are displayed on the VIEW QC LOG
(Key label alternates between
selections)
RETURN
The function of each of these keys is discussed in this section.
CELL-DYN
3000 System Operator’s Manual
9140240E — May 1995
Chapter 7
PURGE
QC LOG
LEVEY-
JENNINGS
Search Book TOC Go Back Quality Control
The [PURGE QC LOG] key is used to delete the contents of the QC log. When the [PURGE QC LOG] key is pressed, the following soft key labels are displayed:
CONFIRM PURGE
CANCEL PURGE
These keys are used to confirm or cancel the purge QC log command.
CAUTION: If the [CONFIRM PURGE] key is pressed, the results are permanently deleted from the QC log.
The Levey-Jennings results are displayed using graphs on which one point represents one sample. A maximum of 30 points are on one graph.
A maximum of 120 points are possible for this analysis. In order to see all the points, the user must "scroll" through the graph by pressing the
[NEXT 10] key. When this key is pressed, the last 20 points are shifted over by 10 and the next 10 points are included in the graph. This gives the effect of "scrolling" through the data. The graph title (for example,
WBC:++++++) indicates rule compliance or violation over the total set of samples, not just the visible samples.
labels are displayed when the [LEVEY-JENNINGS] key is pressed:
GROUP 1
GROUP 2
GROUP 3
GROUP 4
PREVIOUS 10
NEXT 10
(This key is displayed only when more than 30 entries are in the file.)
(This key is displayed only when more than 30 entries are in the file.)
RETURN
CELL-DYN
3000 System Operator’s Manual
9140240E — May 1995
7-9
Quality Control
GROUP
1 - 4
Search Book TOC Go Back
Chapter 7
Each of these keys is used to select the graphs for a group of data that correspond to the groups selected in the customize QC display option.
Subsequent groups may be selected by pressing the appropriate soft keys.
NOTE: The soft key for the group currently shown on the screen is not displayed.
QC file: PRECOP 03/01
Seq num: 291 to 2571
7.00
6.40
5.80
WBC : – – – – – –
.700
.500
.300
MONO : – – – – – –
LEVEY-JENNINGS MENU
Ready
4.50
3.20
1.90
NEU : – – – – – –
.400
.300
.200
EOS : – – – – – –
Apr 09 1993
Operator ID
Sequence #
16:26
734
2581
LYM : – – – – – –
3.20
2.30
1.40
.200
.100
0.00
BASO : – – – – – –
GROUP
2
GROUP
3
GROUP
4
PREVIOUS
10
NEXT
10
PRINT RETURN
Figure 7.5: The Levey-Jennings Menu Screen
The [PRINT] key is used to print the Levey-Jennings graphs. When the
[PRINT] key is pressed, all of the graphs are automatically printed.
The [RETURN] key is used to return to the VIEW QC LOG Screen .
RETURN
The [REJECT SPECIMEN] key is used to exclude the results for the specimen indicated by the cursor position.
7-10
REJECT
SPECIMEN
CELL-DYN
3000 System Operator’s Manual
9140240E — May 1995
Chapter 7
DELETE
SPECIMEN
Search Book TOC Go Back Quality Control
When the key is pressed, the key label changes to [ACCEPT
SPECIMEN], an “R” is displayed in the column immediately left of the results and the statistics are recomputed excluding those results. (See
Figure 7.6.) The data is still displayed and stored in the file but is excluded from the statistical calculation.
When the [ACCEPT SPECIMEN] key is pressed, the “R” is deleted and the statistics are recomputed including those results.
VIEW QC LOG
Ready
USE < OR > FOR MORE DATA
Mar 15 1993
Operator ID
Sequence #
09:59
734
2723 Norm 45 OPEN: 90/120
Page 7 of 9
Upper Limits:
Lower Limits:
Seq
1838
1839
1840
1937
1938
1939
2036
2037
2038
2184
R
N:
Mean:
Std. Dev:
CV (
.
/.):
7.5
7.7
7.3
7.4
8.3
7.1
4.58
13.8
89.5
17.6
265.
10.3
4.22
13.0
83.5
13.2
215.
8.3
WBC RBC HGB MCV RDW PLT MPV
7.6
4.37
13.1
85.9
15.6
221.
8.8
4.31
4.33
4.38
4.38
13.0
13.1
13.1
13.3
85.9
85.8
85.9
85.9
15.8
15.1
15.5
15.8
224.
232.
239.
258.
9.3
8.8
9.8
8.8
7.5
7.4
7.1
7.2
4.38
13.2
85.9
15.4
233.
4.39
13.1
86.1
15.2
225.
4.39
13.0
86.0
15.5
238.
4.33
13.0
86.1
15.4
235.
9.0
8.8
8.6
9.1
7.4
4.39
13.1
86.0
15.9
234.
8.9
WBC RBC HGB MCV RDW PLT MPV
89 89 89 89 89
7.5
4.35
13.2
85.8
15.6
0.2
0.05
0.1
0.4
0.3
89
234.
9.
89
9.0
0.2
2.3
1.3
1.1
0.5
1.6
3.9
2.6
Date
O 03/02/93
O 03/02/93
O 03/02/93
O 03/03/93
O 03/03/93
O 03/03/93
O 03/04/93
O 03/04/93
O 03/04/93
O 03/05/93
Time Op
09:50 734
09:52 734
09:52 734
09:06 734
09:07 734
09:08 734
08:36 734
08:37 734
08:38 734
09:15 734
PURGE
QC LOG
LEVEY-
JENNINGS
ACCEPT
SPECIMEN
DELETE
SPECIMEN
WRITE QC
TO DISK
QC LOG
RETURN
Figure 7.6: View QC Log Screen (With Rejected Results)
The [DELETE SPECIMEN] key is used to delete the results for the specimen indicated by the cursor position. When the [DELETE
SPECIMEN] key is pressed, the following key labels are displayed:
CONFIRM DELETION
CANCEL DELETION
NOTE: These keys are used to confirm or cancel the delete command. When the [CONFIRM DELETION] key is pressed, the results are deleted from the file (the data is not displayed or stored in the file) and the statistics are recomputed excluding those results.
CELL-DYN
3000 System Operator’s Manual
9140240E — May 1995
7-11
Quality Control
WRITE QC
TO DISK
QC LOG
RETURN
Search Book TOC Go Back
Chapter 7
The feature enabling the transfer of QC limits and data from a QC file onto a floppy disk is not currently available. Therefore the following keys mentioned in this manual should not be used at this time: [LAB ID
SETUP], [LOAD FROM DISK], and [WRITE QC TO DISK].
The [PRINT QC LOG] key is used to print the entire QC log.
The [RETURN] key is used to return to the QC MENU Screen .
7-12
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Chapter 7 Search Book TOC Go Back Quality Control
Quality Control Guide
General Information
The first section of this guide gives information about running controls
and guidelines for basic assay verification. The section on Westgard
Rules defines the rules used on the CELL-DYN 3000 and gives guidance
All QC data should be reviewed according to your laboratory’s protocol.
Refer to the section on Westgard Rules for suggestions on how to use them
in a review protocol. Refer to the section on X-B analysis for suggestions
and guidelines for interpreting X-B results.
Running Controls
Control Material
Use the CELL-DYN Tri-Level control materials for performing quality control checks on the CELL-DYN 3000. These controls should be run:
• After daily start up procedures are completed
• After a reagent lot number change
• After calibration (confirmatory step)
• After maintenance, a service call or component replacement
• In accordance with the laboratory’s quality control protocol
• According to regulatory requirements
The CELL-DYN controls may be run in any mode of operation: open mode, CS mode or SL mode.
NOTE: Controls for the Sample Loader and closed sampler are
packaged in Vacutainer® tubes. Refer to the list given at the end
of this chapter for the appropriate list number.
Mixing and Handling
Always mix and handle commercial control materials according to the directions given in the package insert. As the directions may vary from manufacturer to manufacturer, pay particular attention to the following:
• Check the condition of the control material when it is received in the laboratory. Be sure the vials are at the proper temperature and are not leaking. Check for hemolysis.
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Quality Control
Assay Verification
Search Book TOC Go Back
Chapter 7
• Store the controls at recommended temperatures. Storage in a central location in the refrigerator, away from the door if it is opened frequently, is advisable.
• Carefully warm and resuspend the product according to the directions given in the package insert. Proper mixing is essential for accurate results.
• Check the open-vial stability dating and do not use products longer than is recommended as results may be compromised.
• Wipe the threads on the vial and the inside of the cap.
• Never subject a vial to excessive heat or agitation.
New lots of control material should be analyzed in parallel with current lots prior to their expiration dates. This may be accomplished by running the new controls twice a day for five days. The mean of the ten runs is used to confirm the assay value. A control file is set up for the new lot number to easily establish the mean. If desired, this same control file can then be used to run the control for the remainder of the dating period.
Creating another file is not required.
The expected ranges published by manufacturers are generally too broad
for effective quality control.
1 Therefore, each laboratory should establish
acceptable ranges. These ranges may be determined by evaluating three to six months of data (data from the Interlaboratory Quality Control
Program may be used) for a particular level of control. The individual SD values may be averaged as follows:
Average SD =
(N1 x SD1
2
)+(N2 x SD2
2
)+...(Ni x SDi
2
)
(N1 + N2 + ...Ni) - 1 where:
N = number of values in a group
SD = Standard Deviation of the values i = the last group of values
The resultant long-term instrument SD and the laboratory-established mean for each lot number should be used to monitor instrument performance.
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Westgard Rules
Introduction
A control rule tests the control result against control limits to determine whether the CELL-DYN 3000 shows acceptable accuracy and precision.
The limits are derived from the mean and standard deviation of control measurements obtained when instrument performance is stable and acceptable. The most common rule used in hematology quality control is the mean ± 2SD limits. Ninety-five percent of the control results should fall within the ±2SD limits.
Quality control rules detect random or systematic error. Random error may be defined as an increase in the SD. Systematic error may be defined as a shift in the mean value. A multi-rule quality control procedure combines several control rules to improve the detection of both types of error.
Westgard recommended a multi-rule approach to evaluating quality control results .
Westgard rules may be used to monitor quality control results on the
CELL-DYN 3000.
CELL-DYN 3000 Westgard Rules
The modified Westgard Rules (Westgard’s nomenclature is given in parentheses) available on the CELL-DYN 3000 are:
Rule 1 (1
3s
):
Rule 2 (2
2s
):
Rule 3 (R
4s
):
Rule 4
(2 of 3
2s
):
Value outside 3SD
A control result exceeded the mean ± 3SD
Two consecutive values outside the same 2SD
Two consecutive results fell outside 2SD on the same side of the mean
Two consecutive values outside opposite 2SD
One result was greater than 2SD above the mean and the next result was greater than 2SD below the mean.
Consequently, the range between the results is greater than 4SD.
Two of three consecutive values outside same 2SD
Two of the last three results fell outside 2SD on the same side of the mean
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Chapter 7
Rule 5 (4
1s
): Four consecutive values outside same 1SD
Four consecutive results fell outside 1SD on the same side of the mean
Rule 6 (10x): Ten consecutive values on the same side of mean
Ten consecutive results fell on the same side of the mean
The rules may be used singly or in combination depending on operator
preference. Selections are made on the QC FILE SET UP Screen .
When a rule is selected, a plus sign is displayed to the right of the parameter name on the LEVEY-JENNINGS MENU Screens. (See
Figure 7.7.) Six plus signs indicate that all six rules are selected in order from left to right. A minus sign is displayed if a rule is not selected.
8.3
7.7
7.1
QC file: NORM 45 OPEN
Seq num: 9558 to 684
WBC:1+–++6
MCV:1+–+++
89.5
86.5
83.5
MPV:1+–+++
10.3
9.3
8.3
4.58
4.40
4.22
LEVEY-JENNINGS MENU
Ready
RBC:1+–++6
RDW:1+–++6
17.6
15.4
13.2
Mar 15 1993
Operator ID
Sequence #
10:00
734
2723
HGB:++–+++
13.8
13.4
13.0
PLT:1+–+++
265.
240.
215.
GROUP
2
GROUP
3
GROUP
4
NEXT
10
PRINT RETURN
Figure 7.7: Levey-Jennings Menu Screen Showing Westgard Rule
Violations
The number of the rule that was violated is displayed in place of the plus sign. Figure 7.7 shows examples of the plus and minus signs and rule-violation indications.
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Chapter 7
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Whenever a rule is violated, the bulletin line on the VIEW QC LOGS
WESTGARD WARNINGS: SEE LEVEY-JENNINGS
Rule Violations
Only the directly measured parameters need to be monitored with multiple rules.
4
In reference 4 (pp. 190–192) , Cembrowski suggests a
protocol for using the Westgard rules in hematology. The following is a synopsis of that protocol.
Since three levels of control are typically used to monitor a hematology analyzer, it is reasonable to consider all three runs at the same time. In other words, check for rule violations across the three levels, not just within a particular level. If the same rule is violated for more than one level, determine whether the violation indicates a loss of precision or a loss of accuracy and troubleshoot accordingly.
Cembrowski suggests that the results for all three levels first be checked to see if they are within their 2SD limits. If all three levels meet this criterion, the instrument is in control.
If any control result exceeds the 2SD limits, check to see if it exceeds the
3SD limits. If a result exceeds 3SD, there are two possibilities. There is either an instrument problem or a problem with the particular level of control. Therefore, if a result exceeds 3SD, run another bottle of that control. If the problem persists, then additional investigation is required.
Check to see if either the 2 of 3
2s
or R
4s
rules have been violated for any level or across levels. If the problem is confined to one level of control, check for a 2
2s
rule violation for that level. Again, if the violations are confined to one level of control, use another bottle and possibly another lot. Check expiration dates and data entry. Check to be sure that the control is run into the correct file.
If a combination of rules has been violated across the three levels, determine whether the violations indicate a loss of precision or a loss of accuracy and troubleshoot accordingly. If necessary, call the Abbott
Customer Support Center for assistance at
1 (800) CELL DYN.
When the problem has been resolved, Cembrowski suggests that all levels be run again in duplicate to confirm that it has in fact been corrected.
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Chapter 7
X-B Analysis
Introduction
X-B analysis is an automated means of monitoring instrument performance by using the known stability of the red cell indices.
X-B is used to indicate X
B
, which is the symbol for a moving average of hematology values calculated using an algorithm developed by Dr. Brian
Bull of Loma Linda University. X-B analysis uses the Bull algorithm to monitor instrument performance by tracking the average red cell indices in the patient population analyzed on the instrument.
The red cell indices, MCV, MCH and MCHC, are known to be stable because the red cell apparently functions best in a very narrow range of size and Hemoglobin content. Therefore, the body exerts tight physiologic control and will vary the number of red cells before altering the average volume or Hemoglobin concentration of those red cells.
a means of utilizing this information for quality control on the
CELL-DYN 3000.
The X-B algorithm analyzes the indices on the patient samples run through the instrument in batches of 20. The mean of each batch is compared to a target value, and a percent deviation is computed and compared to the acceptable limits. This is similar to comparing the results of a commercial control run to the appropriate assay value to determine whether the result falls within the 2SD range.
Lower/Upper Acceptance Limits
The lower and upper limits determine which patient results will be used in the X-B moving average calculation. They should be set wide enough to exclude grossly abnormal samples (such as background counts) but should include at least 95% of the patient results. Only results that fall within the set limits are used in the calculation.
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Target Value
The target value for X-B is similar to the assay value for a commercial control. It is derived from the patient population analyzed on the instrument.
Action Limit
The action limit is the acceptable limit of variation around the target value.
Establishing the Target Value
A recent study 6 by Dr. Bull collected data from 1767 hospitals and
yielded the following mean values:
MCV
MCH
MCHC
89.9 fL
30.5 pg
33.9 g/dL
values to initiate the X-B analysis program.
Laboratories seeing specialized patient populations, e.g., pediatric hospitals or tumor centers, may need to verify these values due to
“abnormal” patient populations. Target values may be verified by evaluating approximately 500 samples and comparing the X-B means for those samples to the entered target values.
The CV on 500 samples for each index should be
≤
1.5%. (Dr. Bull’s study {mentioned in the previous paragraph} found CVs from 0.5% to
1.2%. The 1.5% is one-half the allowable ± 3% action limit, which is acceptable for this confirmatory step.) If the CVs are >1.5%, an additional 500 samples should be evaluated.
Interpreting X-B Results
A suggested protocol and guidelines for interpreting X-B data can be found in Chapter 1 of Laboratory Hematology, An Account of
Laboratory Techniques, edited by I. Chanarin.
8
CELL-DYN Controls
Tri-Level, 1 box, 2.5-mL vials x 12, list number 93111-01
Tri-Level, 1 box, 3.0-mL tubes x 12, list number 99129-01
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NOTES
Chapter 7
7-20
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References
1.
Cembrowski GS, Carey RN. Laboratory quality management, p.
189.
2.
Westgard JO et al. A multi-rule Shewhart chart for quality control in clinical chemistry. Clin Chem 1981; 27:3:493–501.
3.
Cembrowski GS, et al. Use of a multi-rule control chart for the quality control of PT and APTT analyses. Lab Med June 1989;
418–421.
4.
Cembrowski GS, Carey RN. Laboratory quality management. P.
190.
5.
Bull BS, Korpman RA. Intralaboratory quality control using patients’ data. In: Cavill I, ed. Quality Control. Edinburgh:
Churchill Livingstone 1982, 121–150.
6.
Bull BS, Jones AR, Gibson M, Twedt D. A method for the independent assessment of the accuracy of hematology whole blood calibrators. AJCP (accepted for publication), 1992.
7.
Bull BS, Hay KL. Are red blood cell indexes international? Arch
Pathol Lab Med 1985; 109:604–606.
8.
Chanarin I, ed. Laboratory hematology, an account of laboratory techniques. Edinburgh: Churchill Livingstone, 1989:3–7.
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NOTES
Chapter 7
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Precautions, Limitations and Hazards
Chapter Table of Contents
Location Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
Electrical Safety Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2
Mechanical Safety Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3
Chemical Safety Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3
Decontamination Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4
Blood Samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4
Reagent Storage and Handling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5
Sample Loader Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-6
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Table of Contents-1
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NOTES
Chapter 8
Table of Contents-2
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Precautions, Limitations and Hazards
Limitations
• The CELL-DYN 3000® is designed for in vitro diagnostic use.
• Abbott has designed the CELL-DYN 3000 system components for optimal performance. Substitution of reagents, calibrators, controls and components manufactured by other companies may adversely affect the performance of the Analyzer.
• Follow the recommended maintenance schedules and procedures as
outlined in Chapter 9, Maintenance , of this manual.
• All service and repair must be performed by authorized Abbott representatives.
Location Requirements
• An authorized Abbott representative must install the instrument.
• Place the CELL-DYN 3000 Analyzer and Data Station on a hard, level surface. The location should have nonporous, non-absorbing work surfaces and flooring which can be easily cleaned and disinfected using recommended procedures. Locate the system:
• Away from direct sunlight
• Away from the path of a cooled or heated air outlet
• Away from centrifuges, x-ray equipment, CRTs, video terminals, computers and copiers
• Do not place reagent containers above the instrument.
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8-1
• The following space should be available to ensure proper ventilation:
• Behind the Analyzer and Data Station: 6" (15 cm)
• Left of the Analyzer: 6" (15 cm)
• Above the Analyzer and Data Station: 6" (15 cm)
• Right of the Data Station: 6" (15 cm)
(As long as the Data Station is located to the right of the Analyzer, no space is required between the two units.)
• Care should be taken to prevent blocking of the air vents on the left side of the Analyzer, on the back of the Analyzer, and on the back of the Data Station.
• Pay special attention to the path of the printer paper in the event that the printer is placed on top of the Data Station. (Do not place
the printer on top of the Analyzer.) Refer to Chapter 11, Printer , for
more details.
Electrical Safety Precautions
• Do not disconnect any electrical connection while the power is ON.
• For continued protection from electric shock, use only approved power cords such as those supplied and connect power cords only to properly grounded outlets.
WARNING: Electrical Shock Hazard. Do not remove any instrument panel cover that is securely fastened in place by screws. The potential for electrical shock is increased whenever these panels are removed.
•
Replace only the externally accessible, labeled fuse located near
the power cord connector. Use a replacement fuse only of the
specified type and electrical rating. Refer to Chapter 10,
Troubleshooting , for detailed instructions.
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Chapter 8 Search Book TOC Go Back Precautions, Limitations and Hazards
Mechanical Safety Precautions
• Avoid contact with needle tips at all times.
• Wear rubber gloves and use extreme caution when performing maintenance procedures on the following components, as they can pinch or puncture:
• Shear valve assembly
• Closed sampler needle
• Sample Loader needles
• Sample Loader
• Wash block
Chemical Safety Precautions
Exposure to potential hazards of chemicals used in the operation and maintenance of the CELL-DYN 3000 should be prevented by the use of information on material safety data sheets (MSDS) and proper personal protective equipment, work procedures, and equipment as specified on the OSHA Hazard Communication Standard (29 CFR Part 1910.1200).
Infection Control
• Consider all blood specimens potentially infectious. Wear disposable gloves while handling test samples. Do not smoke, eat or drink in areas where test samples are handled. Do not pipette by mouth.
• Consider all clinical specimens and controls, calibrators, etc. that contain human blood or serum as potentially infectious. Use established, good laboratory working practices when handling these samples. Wear gloves, lab coats and suitable eye protection and follow other biosafety practices as specified in the OSHA
Bloodborne Pathogen Rule or other equivalent biosafety procedures.
WARNING: Potential Biohazard. Follow established biosafety practices when performing maintenance, service or troubleshooting procedures. Wear gloves, lab coat, and suitable
eye protection. Refer to Chapter 8, Precautions, Limitations and
Hazards , for additional information.
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Chapter 8
Decontamination Procedures
• Perform the Auto-Clean procedure. This procedure flushes all of the fluid pathways with reagents to purge any waste from the fluid pathways. (The open sample aspiration probe and the SL or CS needles are automatically rinsed after every cycle.) The surfaces of the instrument should be wiped with a nonabrasive detergent solution to remove any soiling. This should be followed with a wipe with a 10% chlorine bleach solution.
• If the instrument is to be shipped, it must be decontaminated prior
to shipment. Refer to the instructions given in the Preparation for
Inactivity or Shipping procedure in the Special Procedures section of Chapter 9, Maintenance .
Blood Samples
• Decontaminate and dispose of all specimens and potentially contaminated materials in accordance with local, state and federal regulations.
• Waste liquid is a possible source of biological and chemical hazard.
Handle with extreme care during the disposal process.
•
Refer to the Sample Collection and Handling section in Chapter 5,
Operating Instructions , for precautions and limitations pertaining
to sample collection and handling. This section also includes information on interfering substances.
Spills
Clean up spills of potentially infectious materials in accordance with established biosafety practices. A generally accepted procedure for clean up of such spills is to absorb the spill with toweling or other absorbent material, wipe the area with a detergent solution and then wipe the area with an appropriate tuberculocidal agent such as 10% chlorine bleach.
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Chapter 8 Search Book TOC Go Back Precautions, Limitations and Hazards
Reagent Storage and Handling
• Store reagents, calibrators and controls according to the directions in the package inserts that accompany them.
• Protect reagents from extreme heat and freezing during storage.
Temperatures below 32°F (0°C) may cause layering that changes the tonicity and conductivity of the reagent. If freezing occurs, do not use the reagent.
• Protect reagents from direct sunlight, evaporation and contamination. Use of the reagent container cap attached to each inlet tube minimizes the latter two occurrences.
• Never add remaining reagent from a container being replaced to a freshly opened container. This may contaminate the new reagent.
• Before operating the instrument for the first time, make sure each reagent line is connected to the appropriate inlet and reagent container.
• Make sure the waste line is connected to the appropriate outlet and routed to a suitable waste container or drain. If the waste is routed to a waste container, make sure the waste sensor is properly connected. If the waste is routed to a drain, make sure a dummy plug is inserted in the waste sensor connector.
Laser Precautions
• After the Analyzer is powered ON, allow a minimum of 15 minutes for the laser to warm and stabilize before running samples.
DANGER: Do not remove any cover on the Analyzer that is fastened in place by screws. These covers protect the operator from exposure to the laser inside the Analyzer.
• The Sample Loader bar code reader also uses a laser. The bar code laser is ON only when bar code labels are being read.
Printer Precautions
The printhead can get very hot during extended periods of printing.
Allow it to cool before touching.
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Chapter 8
Sample Loader Precautions
• Samples that will be run on the Sample Loader should be collected in 13 x 75 mm tubes. The recommended tube is a 13 x 75 mm tube with a hemoguard closure that draws 3 mL of blood.
• The safety cover has an interlock switch that prevents Sample
Loader operation when the cover is not in place. Lifting the cover while the Sample Loader is operating causes an immediate
Emergency Stop condition. Do not bypass the interlock switch to operate the Sample Loader without the safety cover.
• Do not allow the tube racks to soak in water. Do not use an automated washing system that operates at elevated temperatures as this may damage the racks.
• Clean the Sample Loader needles prior to touching them by sampling with a tube containing enzymatic cleaner followed by an
Auto-Clean procedure. Wear gloves, lab coat and suitable eye protection and follow other biosafety practices as specified in the
OSHA Bloodborne Pathogen Rule or other equivalent biosafety procedures.
• Liquid spills in the rack drive mechanism are a potential reason for failure of the rack to advance. Liquid spills that flow in the Sample
Loader Control Panel could cause operational failure. If a spill occurs, turn the Sample Loader off immediately and notify the
Customer Support Center for further assistance at 1 (800) CELL
DYN.
WARNING: Potential Biohazard. The needle is sharp and potentially contaminated with infectious materials. Handle with care.
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Maintenance
Chapter Table of Contents
Preventive Maintenance Schedule . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-3
Weekly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-3
(for troubleshooting or corrective action) . . . . . . . . . . . . . . . . . . . 9-3
Special Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-4
Analyzer Flow Panel Components Diagram . . . . . . . . . . . . . . . . . . . . 9-4
Special Protocols Menu
Daily
Daily Maintenance Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-13
Auto-Clean . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-13
Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-14
Sample Loader Aspiration Needle . . . . . . . . . . . . . . . . . . . . . . . 9-15
Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-15
Closed Sampler Aspiration Needle . . . . . . . . . . . . . . . . . . . . . . . 9-16
Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-16
Weekly
Weekly Maintenance Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-17
Shear Valve . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-17
Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-18
Aspiration Peristaltic Pump Tubing . . . . . . . . . . . . . . . . . . . . . . 9-20
Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-22
Sample Loader Tray, Racks and Safety Cover . . . . . . . . . . . . . . 9-22
Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-23
Monthly
Monthly Maintenance Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-25
Reagent Syringes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-25
Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-26
WBC Transfer Peristaltic Pump Tubing . . . . . . . . . . . . . . . . . . . 9-28
Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-29
Air Filters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-29
Analyzer Filter Procedure . . . . . . . . . . . . . . . . . . . . . . . . 9-30
Data Station Filter Procedure . . . . . . . . . . . . . . . . . . . . . 9-31
Extended Auto-Clean . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-32
Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-33
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Chapter 9
As Required
As Required Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-35
RBC/PLT Aperture Plate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-35
Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-36
Hemoglobin Flow Cell Manual Cleaning Procedure . . . . . . . . .9-39
Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-40
Vacuum Accumulator Cleaning Procedure . . . . . . . . . . . . . . . . .9-41
Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-41
Special Procedures
Closed Sampler Tube Retainer Adjustment . . . . . . . . . . . . . . . . . . . .9-43
Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-43
Preparation for Inactivity or Shipping . . . . . . . . . . . . . . . . . . . . . . . .9-44
Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-44
Repackaging for Shipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-46
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Chapter 9
Introduction
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Maintenance
The CELL-DYN® 3000 is designed to require minimal routine maintenance.
• The fluidics are automatically rinsed between samples.
• A thorough system rinse is performed automatically when the unit has been idle for five minutes after the last cycle is completed.
• The wash block rinses both the outside and inside of the aspiration probe during each cycle of the open sampler mode.
• The outside and inside of the closed mode needles are rinsed during each closed mode cycle.
• The instrument is automatically placed in STANDBY if it has been idle for four hours after the last cycle is completed.
The operator is encouraged to routinely perform the required maintenance in order to ensure optimum performance. This chapter describes the recommended preventive maintenance procedures for the
Many required preventive maintenance procedures have been automated on the CELL-DYN 3000. These programs can be accessed by pressing
the [SPECIAL PROTOCOLS] key on the Data Station. The SPECIAL
PROTOCOLS MENU is discussed in the next section .
All maintenance procedures should be recorded on a maintenance log.
This log provides a historical maintenance record to aid in tracking maintenance schedules and in troubleshooting.
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Maintenance
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Chapter 9
The maintenance schedule outlined on the following page will minimize operational problems with the CELL-DYN 3000. The recommended intervals are based on instruments operating in laboratories that process samples from a general patient population. The intervals are affected by the volume of samples processed, the workload schedule, the operating environment and the patient population that is analyzed. Each laboratory must assess its own situation and modify these recommended intervals as necessary. Overdue maintenance is usually indicated by an increase in imprecision of one or more of the directly measured parameters. This increase is due to carryover or dilution/sampling inconsistencies. If this occurs, the appropriate maintenance should be performed more
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Preventive Maintenance Schedule
The following procedures should be performed at the scheduled time intervals or as determined by each individual lab:
Daily
Perform the Auto Clean procedure
Weekly
Clean and lubricate the shear valve
Replace the aspiration peristaltic pump tubing
Clean the Sample Loader tray, racks and safety cover
Monthly
• RBC Diluent syringe
• HGB Diluent syringe
• HGB Lyse syringe
• WBC Sheath syringe
• WBC Metering syringe
Replace the WBC transfer peristaltic pump tubing
Clean the Analyzer and Data Station air filters
Perform the Extended Auto Clean procedure
As Required Maintenance (for troubleshooting or corrective action)
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Maintenance
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Chapter 9
Special Procedures
Closed sampler tube retainer adjustment
WARNING: Potential Biohazard. Follow established biosafety practices when performing maintenance, service or troubleshooting procedures. Wear gloves, lab coat, and suitable
eye protection. Refer to Chapter 8, Precautions, Limitations and
Hazards for additional information.
CAUTION: Use powder-free gloves when performing the maintenance procedure to avoid contaminating the instrument.
Analyzer Flow Panel Components Diagram
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WBC Flow
Cell Cover
Vent
Accumulator
HGB
Mixing
Chamber
WBC
Mixing
Chamber
WBC Transfer
Peristaltic Pump
HGB
Flow Cell
Waste
Chamber 1
RBC/PLT
Transducer
Assembly
Hydrophobic
Filters
Waste
Chamber 2
Sample Aspiration
Peristaltic Pump
Shear Valve
Assembly
Status
Indicator
Panel
READY
BUSY
FAULT
Vacuum
Accumulator
Drain Lines
RBC/PLT
Metering
Assembly
Closed
Sampler
Module
WBC Metering Syringe
(contains Sheath reagent)
HGB Lyse Syringe
(contains HGB Lyse)
WBC Sheath Syringe
(contains Sheath reagent)
RBC Diluent Syringe
(contains Diluent)
HGB Diluent Syringe
(contains Diluent)
Optical
Bench
Assembly
Wash
Block
Open
Sample
Aspiration
Probe
Touch
Plate
Maintenance
Search Book TOC Go Back
NOTES
Chapter 9
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Chapter 9
SPECIAL
PROTOCOLS
Search Book TOC Go Back Maintenance
Special Protocols Menu
The SPECIAL PROTOCOLS Screen ( Figure 9.2
) is accessed from the
MAIN MENU Screen by pressing the [SPECIAL PROTOCOLS] key.
The following soft key labels are displayed:
or
(Key label alternates between these two selections.)
(Key label alternates between these two selections.)
(Key label alternates between these two selections.)
(Key label alternates between these two selections.)
(Key label alternates between these two selections.)
MAIN
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Maintenance
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Chapter 9
SPECIAL PROTOCOLS
Ready
May 15 1993
Operator ID
Sequence #
10:01
734
2723
EMPTY
RBC
EMPTY
REAG RESV
9-8
EMPTY
RBC
EMPTY
REAG RESV
EMPTY
WBC
CLEAN
SHEAR VAL
DISABLE
ANALYZER
MORE MAIN
Figure 9.2: Special Protocols Screen
A brief description of the function of each soft key follows. Detailed instructions for the use of each key are given in the appropriate maintenance procedure.
The [EMPTY RBC] key is used to empty both chambers in the RBC/
PLT transducer assembly prior to removing the aperture plate. When the transducer assembly is empty, the key label changes to [FILL RBC].
The display in the Status Box reads:
Not Ready: See SPECIAL
When the [FILL RBC] key is pressed, the transducer assembly is refilled with reagent.
The [EMPTY REAG RESV] key is used to drain the reagent reservoirs located on the left side panel of the Analyzer.
After the reagent reservoirs are drained, the [FILL REAG RESV] key is displayed and the status box reads:
Not Ready: See SPECIAL
When the [FILL REAG RESV] key is pressed, the reagent reservoirs are filled.
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Chapter 9 Search Book TOC Go Back Maintenance
EMPTY
WBC
CLEAN
SHEAR VAL
DISABLE
ANALYZER
MORE
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3000 System Operator’s Manual
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The [EMPTY WBC] key is used to drain the Sheath from the WBC flow cell. When the flow cell is empty, the key label changes to [FLUSH
SHEATH]. The display in the Status Box reads:
Not Ready: See SPECIAL
When the [FLUSH SHEATH] key is pressed, the flow cell is refilled with Sheath.
The [CLEAN SHEAR VAL] key is used to prepare the shear valve for cleaning. When the key is pressed, the shear valve rotates into the position necessary for its removal. When the rotation is complete, the key label changes to [RESTORE SHEAR VAL]. The display in the Status
Box reads:
Not Ready: See SPECIAL
When the [RESTORE SHEAR VAL] key is pressed, the shear valve rotates to distribute the shear valve lubricant and then rotates back to its operational position.
The [DISABLE ANALYZER] key is used to prevent the Analyzer from cycling while certain maintenance procedures are performed. When the
Analyzer is disabled, the key label changes to [ENABLE ANALYZER].
The display in the Status Box reads:
Not Ready: See SPECIAL
When the [ENABLE ANALYZER] key is pressed, the Analyzer is returned to the operational state.
When the [MORE] key is pressed, the second SPECIAL
) and the following soft key labels are
displayed:
MAIN
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Maintenance
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Chapter 9
SPECIAL PROTOCOLS
Ready
Mar 11 1993
Operator ID
Sequence #
12:10
734
4249
FLUSH
SHEATH
AUTO
CLEAN
FLUSH
SHEATH
AUTO
CLEAN
DAILY
SHUTDOWN
PREPARE
SHIPPING
CLEAN
NEEDLE
EXTEND
AUTOCLEAN
MORE MAIN
Figure 9.3: Special Protocols Screen 2
The [FLUSH SHEATH] key is used to flush the WBC flow cell with
Sheath reagent.
The [AUTO CLEAN] key is used to initiate the Auto-Clean procedure.
The shear valve, the WBC mixing chamber, the WBC flow cell, the HGB mixing chamber, the HGB flow cell, the RBC/PLT transducer assembly and all of the associated fluidics are automatically cleaned and rinsed during the procedure.
When the [AUTO CLEAN] key is pressed, the screen displays the
message shown in Figure 9.5, Special Protocols: Auto-Clean Screen .
The following soft key labels are displayed:
START
CANCEL
These keys are used to start or cancel the Auto-Clean procedure.
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DAILY
SHUTDOWN
PREPARE
SHIPPING
CLEAN
NEEDLE
EXTEND
AUTOCLEAN
WARNING: Potential Biohazard. Follow established biosafety practices when performing maintenance, service or troubleshooting procedures. Wear gloves, lab coat, and suitable
eye protection. Refer to Chapter 8, Precautions, Limitations and
Hazards, for additional information.
NOTE: Once Auto-Clean is initiated, it cannot be stopped by the operator. The cycle is complete after 11 minutes.
The [DAILY SHUTDOWN] key is used to initiate the daily shutdown procedure. During the procedure, the fluidics are automatically rinsed and drained. At the end of the procedure, the Analyzer is placed in
STANDBY. The valves are exercised periodically while the Analyzer is in STANDBY to preserve the integrity of the tubing.
The [PREPARE SHIPPING] key is used to prepare the Analyzer for shipment or a period of inactivity.
The [CLEAN NEEDLE] key is used to clean the needle(s) in either of the closed modes (CS or SL) of operation. When the key is pressed, the needle is forcefully rinsed with Diluent.
The [EXTEND AUTOCLEAN] key is used to initiate the Extended
Auto-Clean procedure.
When the [EXTEND AUTOCLEAN] key is pressed, the screen
displays the message shown in Figure 9.12, Special Protocols:
Extended Auto-Clean Screen . The following soft key labels are
displayed:
START
CANCEL
These keys are used to start or cancel the Extended Auto-Clean procedure.
NOTE: Once Extended Auto-Clean is initiated, the cycle can be stopped after 38 minutes; otherwise it will continue for a total of
2.5 hours.
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MORE
The [MORE] key is used to return to the first
After certain Special Protocols, the following screen is displayed.
SPECIAL PROTOCOLS
Initialized
Sep 14 1994
Operator ID
Sequence #
16:20
JC
3288
Special Protocol Cycle has completed.
Run 5 Background Counts.
Confirm that background results are acceptable before running samples.
EMPTY
RBC
EMPTY
REAG RESV
EMPTY
WBC
CLEAN
SHEAR VAL
DISABLE
ANALYZER
MORE
Figure 9.4: Special Protocols: Process Complete Screen
MAIN
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Chapter 9 Search Book TOC Go Back Maintenance
Daily
Daily Maintenance Procedures
NOTE: After performing maintenance procedures, the
Auto-Clean procedure should be performed.
Auto-Clean
The Auto-Clean procedure is a fully automated procedure designed to clean the shear valve, the WBC mixing chamber, the WBC flow cell, the
HGB mixing chamber, the HGB flow cell, the RBC/PLT transducer assembly, the needle in the CS or SL version and all the associated fluidics.
The forward and reverse action of the peristaltic pumps is used during this procedure to gently scrub and remove any fibrin or debris within the system. The Auto-Clean procedure (see Figure 9.5) takes approximately
11 minutes.
SPECIAL PROTOCOLS
Ready
Mar 15 1993
Operator ID
Sequence #
10:09
734
2723
Hold a bottle of Cell-Dyn Enzymatic Cleaner under the probe, and press the START key.
When the auto-clean cycle is completed, run three or more background counts.
This cleaning process takes about 11 minutes.
START CANCEL
Figure 9.5: Special Protocols: Auto-Clean Screen
WARNING: Potential Biohazard. Follow established biosafety practices when performing maintenance, service or troubleshooting procedures. Wear gloves, lab coat, and suitable
eye protection. Refer to Chapter 8, Precautions, Limitations and
Hazards , for additional information.
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Maintenance
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Chapter 9
CAUTION: Use powder-free gloves when performing the maintenance procedure to avoid contaminating the instrument.
Materials Required
1.
CELL-DYN Enzymatic Cleaner (brought to room temperature)
2.
Clean test tube or container
3.
Lint-free wipes or gauze
4.
Warm water
5.
Gloves, lab coat, and suitable eye protection
Procedure
1.
Select the open sampler mode.
2.
Carefully wipe the outside of the open sampler probe and the bottom of the wash block with a piece of gauze dampened with warm water and a few drops of CELL-DYN Enzymatic Cleaner.
3.
From the MAIN MENU Screen , Press [SPECIAL
PROTOCOLS] followed by [MORE] to access the Auto-Clean function.
4.
Press [AUTO CLEAN].
Instructions for performing the procedure are given on the screen
5.
Dispense approximately 1.5 mL of enzymatic cleaner (undiluted) into a clean container and hold the container under the open sampler probe.
NOTE: Do not press the touch plate. The Auto Clean procedure is only initiated by the [START] key.
6.
Press [START].
7.
Continue to hold the container under the probe until a beep tone is heard. Remove the container and discard the remaining enzymatic cleaner.
8.
When the Auto-Clean procedure is completed, press [MAIN] to return to the
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Chapter 9 Search Book TOC Go Back Maintenance
9.
Verify that the background counts are acceptable by running 5
Sample Loader Aspiration Needle
The aspiration needle on the Sample Loader version of the CELL-DYN
3000 should be cleaned regularly to remove protein buildup or debris and reduce the possibility of a blockage.
Materials Required
1.
CELL-DYN Enzymatic Cleaner (brought to room temperature)
2.
Diluent
3.
Three empty Vacutainer® tubes
4.
Gloves, lab coat, and suitable eye protection
Procedure
1.
Aliquot approximately 2 mL of enzymatic cleaner (undiluted) into one of the Vacutainer tubes.
2.
Aliquot approximately 2 mL of diluent into each of the other two
Vacutainer tubes.
3.
If necessary, from the Data Station RUN Screen, press [CLOSED
SAMPLER] to select the closed mode.
4.
Press [SPECIMEN TYPE] followed by [BACKGROUND].
5.
Place the enzymatic cleaner tube followed by the two diluent tubes in a Sample Loader end rack.
6.
Position the rack in the Sample Loader tray and install the Sample
Loader safety cover.
CAUTION: The Sample Loader will not operate unless the safety cover is in place.
7.
Press the START key on the Sample Loader control panel to initiate processing.
8.
Three audible beep tones indicate that processing is completed.
9.
Check to see that the background counts are acceptable by running
10.
Discard all tubes used.
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Maintenance
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Chapter 9
Closed Sampler Aspiration Needle
The aspiration needle on the closed sampler version of the CELL-DYN
3000 should be cleaned regularly to remove protein buildup or debris and reduce the possibility of a blockage.
Materials Required
1.
CELL-DYN Enzymatic Cleaner (brought to room temperature)
2.
Diluent
3.
Three empty Vacutainer® tubes
4.
Gloves, lab coat, and suitable eye protection
Procedure
1.
Aliquot approximately 2 mL of enzymatic cleaner (undiluted) into one of the Vacutainer tubes.
2.
Aliquot approximately 2 mL of diluent into each of the other two
Vacutainer tubes.
3.
If necessary, from the Data Station RUN Screen , press [CLOSED
SAMPLER] to select the closed mode.
4.
Press [SPECIMEN TYPE] followed by [BACKGROUND].
5.
Aspirate the enzymatic cleaner.
6.
Aspirate the Diluent.
7.
Check to see that the background counts are acceptable by running
8.
Discard all tubes used.
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Chapter 9 Search Book TOC Go Back Maintenance
Weekly
Weekly Maintenance Procedures
WARNING: Potential Biohazard. Follow established biosafety practices when performing maintenance, service or troubleshooting procedures. Wear gloves, lab coat, and suitable
eye protection. Refer to Chapter 8, Precautions, Limitations and
Hazards , for additional information.
CAUTION: Use powder-free gloves when performing the maintenance procedure to avoid contaminating the instrument.
Shear Valve
Regular cleaning and lubrication of the shear valve is required for optimal performance. Any reagent or blood residue may cause the valve
to leak or function improperly. The shear valve assembly is depicted in
The shear valve is made of a ceramic material and consists of three separate sections — front, center and rear. The rear and front sections are connected to the CELL-DYN 3000 by tubing that should not be removed.
NOTE: The center section is not connected by tubing and must be handled carefully, as it will break if it is dropped. Care should be taken to avoid chipping, scratching or otherwise damaging any of the sections.
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Chapter 9
Retaining Screw
Front Section
Center Section
Rear Section
Lock Notch
Rim Notch
Shear Valve
Mounting Guide
Figure 9.6: Shear Valve Assembly
Materials Required
1.
Shear valve lubricant
2.
Nonabrasive, lint-free wipes
3.
A container of warm water
4.
Gloves, lab coat, and suitable eye protection
Procedure
1.
Remove the upper front cover to gain access to the shear valve.
2.
From the Data Station MAIN MENU , press [SPECIAL
PROTOCOLS] followed by [CLEAN SHEAR VAL]. This prepares the shear valve for removal and puts the Analyzer into a
NOT READY mode.
3.
Turn the shear valve retaining screw counterclockwise until it can be removed.
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4.
Grasp the entire valve assembly firmly and pull it away from the
Analyzer with a slight rocking motion until it is free of the mounting guide.
NOTE: If the O-ring, and/or plastic bushing are accidentally removed with the shear valve, replace them at this time. Place the bushing on the mounting guide with the curved inner surface facing the rear of the instrument and slide it back as far as it will go. Slide the O-ring back on the mounting guide until it is against the flat inner surface of the bushing.
5.
Rotate the center and front sections in the opposite direction from the rear section to release any suction and free the rear section.
CAUTION: Be careful to keep a firm grip on the center section, as it is not attached to the front or back sections and it may break or crack if dropped.
6.
Place the rear section with its attached tubes on a clean wipe in the shear valve compartment.
7.
Rotate the center and front sections in opposite directions to separate them.
8.
Place the center section in a container of warm water and allow it to soak for the remainder of the cleaning procedure.
CAUTION: Do not soak the center section in bleach as it may damage the ceramic.
9.
Place the front section with its attached tubes on a clean wipe in the shear valve compartment.
10.
Clean the mounting guide with lint-free wipes dampened with warm water to remove any blood or residue. Dry the guide.
11.
Wipe the inner surfaces of the front and rear sections with a clean nonabrasive wipe dampened with warm water. Use care to avoid scratching any of the inner surfaces. Wipe the surfaces dry with a lint-free wipe.
NOTE: Hold the sections by the edges to avoid getting fingerprints on the inner surfaces.
12.
Remove the center section from the warm water, wipe the surfaces with a nonabrasive wipe dampened in warm water and dry it with a lint-free wipe.
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Chapter 9
13.
View each surface of the center section under reflective light to confirm that it is clean, dry, free of lint and fingerprints.
14.
Place the center section aside on a clean nonabrasive wipe. Use care to avoid scratching the surfaces.
15.
Align the lock notch of the rear section with the mounting guide.
Carefully slide the section back as far as it will go. Avoid crimping any of the attached tubing.
16.
Place three drops of shear valve lubricant on both clean, dry surfaces of the center section.
17.
Spread a thin, uniform layer of lubricant over each surface with a clean, dry, gloved finger.
18.
Align the center section so that the rim notch in the outer edge
faces to the right. (Refer to Figure 9.6
CAUTION: Damage to the instrument can occur if the center section is installed backwards. Be certain the rim notch faces to the right.
19.
Carefully slide the section onto the mounting guide and push it back until it touches the rear section.
20.
Align the lock notch of the front section with the mounting guide.
Carefully slide it back until it touches the center section.
21.
Firmly hold the three valve sections in place and replace the shear valve retaining screw. Turn the screw clockwise until it stops.
22.
Press [RESTORE SHEAR VAL]. The valve automatically rotates several times to distribute the lubricant. The instrument is returned to the READY mode when the rotation is finished.
23.
Replace the upper front cover.
24.
Press [MAIN] to return to the MAIN MENU Screen .
25.
Verify that the background counts are acceptable by running 5
Aspiration Peristaltic Pump Tubing
The tubing in the aspiration peristaltic pump needs to be replaced on a regular basis to ensure proper fluid movement through the instrument. The frequency of replacement depends on instrument use in each laboratory.
Abbott recommends changing the aspiration pump tubing weekly. A
peristaltic pump is depicted in Figure 9.7
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Chapter 9 Search Book TOC Go Back Maintenance
Metal
Bracket
Rollers
Metal
Bracket
Collar
Collar
Pump
Tubing
Figure 9.7:
Release Lever
Aspiration Peristaltic Pump
Materials Required
1.
Sample aspiration peristaltic pump tubing
2.
Gloves, lab coat, and suitable eye protection
WARNING: Potential Biohazard. Follow established biosafety practices when performing maintenance, service or troubleshooting procedures. Wear gloves, lab coat, and suitable
eye protection. Refer to Chapter 8, Precautions, Limitations and
Hazards , for additional information.
CAUTION: Use powder-free gloves when performing the maintenance procedure to avoid contaminating the instrument.
NOTE: The sample aspiration pump tubing has a smaller diameter than the WBC transfer pump tubing and is identified by the orange collar on each end.
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Chapter 9
Procedure
1.
From the SPECIAL PROTOCOLS Screen , press [DISABLE
ANALYZER].
2.
Remove the upper front cover to gain access to the peristaltic pumps.
3.
Locate the sample aspiration pump to the left of the shear valve.
4.
Pull the release lever away from the rollers and remove the tubing from the metal brackets that hold it on each side of the rollers. (See
5.
Disconnect the tubing at the plastic fittings.
6.
Connect the new tubing to the plastic fittings.
7.
Place the collars on the ends of the tubing into the metal guides.
Hold the release lever open and push the tubing underneath the pump rollers. Position the tubing in the center of the rollers.
8.
Replace the upper front cover.
9.
Press [ENABLE ANALYZER].
10.
Press [MAIN] to return to the MAIN MENU Screen .
11.
Verify that the background counts are acceptable by running 5
Sample Loader Tray, Racks and Safety Cover
The Sample Loader tray, racks and safety cover should be cleaned on a regular basis. Blood spills in the tray or racks should be cleaned up immediately to allow proper movement of the racks. Weekly cleaning is recommended but more frequent cleaning may be indicated by the laboratory workload.
Materials Required
1.
Container (large enough to hold a rack) filled with a mild detergent solution made with warm (not hot) water
2.
Clean, warm water for rinse
3.
Lint-free wipes or towels
4.
Gloves, lab coat, and suitable eye protection
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WARNING: Potential Biohazard. Follow established biosafety practices when performing maintenance, service or troubleshooting procedures. Wear gloves, lab coat, and suitable
eye protection. Refer to Chapter 8, Precautions, Limitations and
Hazards , for additional information.
CAUTION: Use powder-free gloves when performing the maintenance procedure to avoid contaminating the instrument.
Procedure
1.
Remove the racks from the Sample Loader tray.
2.
Wash the racks in the detergent solution. Do not allow them to soak in the solution, as the labels will come off. Use cotton swabs to dislodge any debris.
3.
Verify rack labels are intact and undamaged.
NOTE: Do not wash the racks in an automated dishwasher that operates at high temperatures because the heat may damage the racks.
4.
Rinse the racks with warm water and dry thoroughly with lint-free wipes or towels.
5.
Wipe the stainless steel tray area with a lint-free wipe moistened with water. Dry the tray with a lint-free wipe or towel.
6.
Wipe the stainless steel plate and glass bar code reader window beneath the tower with a lint-free wipe moistened with water. Dry with a lint-free wipe.
7.
Clean the mixing head with a lint-free wipe moistened with water.
Dry the head with a lint-free wipe.
8.
Wash the safety cover with the detergent solution, rinse and dry it.
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Maintenance
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NOTES
Chapter 9
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Monthly
Monthly Maintenance Procedures
Reagent Syringes
The reagent syringes need to be cleaned on a regular basis to prevent reagent residue buildup, which may cause leakage or improper functioning. Syringes should be cleaned one at a time to ensure that each syringe is replaced in the correct position. Replace each syringe after it is cleaned and then remove the next one to be cleaned. The WBC syringe assembly is depicted in Figure 9.8.
WBC Metering Syringe
WBC Sheath
Syringe
Syringe
Holder Plate
V-Block
Holder
Pedestal
Assembly
Thumbscrew
Flange
Figure 9.8: WBC Syringe Assembly
Materials Required
1.
A large container filled with approximately 500 mL of warm water
2.
Lint-free wipes and gauze
3.
Distilled water
4.
Small container of each reagent to refill the clean syringes
5.
Gloves, lab coat, and suitable eye protection
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Chapter 9
WARNING: Potential Biohazard. Follow established biosafety practices when performing maintenance, service or troubleshooting procedures. Wear gloves, lab coat, and suitable
eye protection. Refer to Chapter 8, Precautions, Limitations and
Hazards , for additional information.
CAUTION: Use powder-free gloves when performing the maintenance procedure to avoid contaminating the instrument.
Procedure
1.
From the Data Station MAIN MENU Screen , press [SPECIAL
PROTOCOLS] followed by [DISABLE ANALYZER].
2.
Remove the front covers to gain access to the syringe assembly.
CAUTION: When performing the following steps 3, 4, & 5, avoid applying pressure to the syringe plunger which may cause a system fatal fault or leakage of reagent.
3.
Loosen the syringe holder plate thumbscrew and rotate the syringe holder plate into a vertical position.
4.
Lift the syringe out of the holder. Note the liquid level in the
syringe so that it can be refilled after cleaning to approximately this same level.
5.
Grasp the plastic luer lock fitting at the tip of the syringe which attaches it to the tubing. Carefully turn the syringe counterclockwise to release it from the fitting. Use gauze to absorb excess reagent.
6.
Dispense the reagent into a sink or an appropriate waste container.
7.
Aspirate warm water into the syringe until it is full. Continue to pull on the plunger until it is removed from the barrel.
CAUTION: Do not push or pull on the plunger when the syringe is dry, as it may damage the plunger. Avoid touching the plunger because oil from the fingers may cause it to move erratically.
8.
Rinse the plunger and barrel thoroughly with distilled water.
Carefully reinsert the plunger into the wet barrel.
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9.
Refill the syringe with the appropriate reagent (refer to Figure 9.1
the level noted in
step 4 above. Hold the syringe upright and tap the
side gently to dislodge any bubbles that may adhere to the tip of the plunger and dispense the bubbles.
NOTE: Be sure to fill the syringe with the correct reagent or results could be compromised.
CAUTION: When positioning the RBC diluent syringe plunger in the slot, DO NOT push on the plunger because the excess force applied to the diluent will cause a system fatal fault. Fatal faults lock the system up; the analyzer is inoperable until the problem is corrected.
10.
Carefully adjust the position of the plunger as necessary to insert it into the pedestal assembly which moves it up and down during the cycle.
11.
Insert the syringe tip into the luer lock fitting and turn the syringe clockwise until the fitting is finger tight. Be careful to not overtighten the fitting or crimp the associated tubing.
12.
Insert the syringe into the V-block holder and the end of the plunger into its slot in the pedestal assembly. Carefully check the position of the flange at the base of the barrel. The flange must be inserted into the narrow space at the base of the V-block in order to hold the syringe securely in place during the cycle. (Refer to
13.
Return the syringe holder plate to the horizontal position over the syringe. Tighten the thumbscrew until the plate is secure. (Refer to
CAUTION: Check to be sure that the plate holding the WBC syringes is installed so that the indentation in the plate holds the
smaller WBC metering syringe. (See Figure 9.8
14.
Repeat this procedure to clean each of the remaining syringes.
15.
When all syringes have been reinstalled, press [ENABLE
ANALYZER].
16.
Press [MAIN] to return to the MAIN MENU Screen .
17.
Run several background counts to observe the action of each syringe during the cycle. The plunger should move smoothly up and down and should not leak.
18.
Replace the front covers after the operation of the syringes has been verified.
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Maintenance
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Chapter 9
19.
Verify that the background counts are acceptable by running 5
WBC Transfer Peristaltic Pump Tubing
The tubing in the WBC transfer peristaltic pump needs to be replaced on a regular basis to ensure proper movement of fluid through the WBC flow cell. The frequency of replacement depends on instrument use in each laboratory. Abbott recommends changing the WBC pump tubing monthly. A peristaltic pump is depicted in the following figure.
Collar
Pump
Tubing
Collar
Metal
Bracket
Release Lever
9-28
Rollers
Metal
Bracket
Figure 9.9: WBC Transfer Peristaltic Pump
Materials Required
1.
WBC transfer pump tubing
2.
Gloves, lab coat, and suitable eye protection
WARNING: Potential Biohazard. Follow established biosafety practices when performing maintenance, service or troubleshooting procedures. Wear gloves, lab coat, and suitable
eye protection. Refer to Chapter 8, Precautions, Limitations and
Hazards , for additional information.
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Air Filters
CAUTION: Use powder-free gloves when performing the maintenance procedure to avoid contaminating the instrument.
NOTE: The sample aspiration pump tubing has a smaller diameter than the WBC transfer pump tubing and is identified by the orange collar on each end.
Procedure
1.
From the
SPECIAL PROTOCOLS Screen , press [DISABLE
ANALYZER].
2.
Remove the upper front cover to gain access to the peristaltic pumps.
3.
Locate the WBC Transfer pump on the upper left side of the flow
panel. (See Figure 9.1, Analyzer Flow Panel Components .)
4.
Pull the release lever away from the rollers and remove the tubing from the metal brackets that hold it on each side of the rollers. (See
5.
Disconnect the tubing at the plastic fittings.
6.
Connect the new tubing to the plastic fittings.
7.
Place the collars on the ends of the tubing into the metal guides.
Hold the release lever open and push the tubing underneath the pump rollers. Position the tubing in the center of the rollers.
8.
Replace the upper front cover.
9.
Press [ENABLE ANALYZER].
10.
Press [MAIN] to return to the MAIN MENU Screen .
11.
Verify that the background counts are acceptable by running 5
The left side panel of the Analyzer contains a set of air inlet filters that clean the air entering the Analyzer. The Data Station has an air filter (fan filter) located on the rear panel. Each filter requires monthly removal and cleaning to maintain a constant, unrestricted air flow. More frequent cleaning may be required whenever the instrument is located in a particularly dusty or warm area.
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Maintenance
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Chapter 9
Air
Inlet
Filters
9-30
Figure 9.10: Analyzer Left Side Panel
Materials Required
1.
Running water
2.
Lint-free wipes or towels
3.
Small vacuum cleaner (optional)
4.
Gloves, lab coat, and suitable eye protection
Analyzer Filter Procedure
1.
Remove the front covers to gain access to the filter holders on the left
side panel. (See Figure 9.10, Analyzer Left Side Panel .)
2.
Grasp the upper filter handle and slide the holder forward to remove it. The lower filter is removed the same way.
3.
Rinse the filters with warm water from the inside to the outside to remove the dust. Blot each filter with lint-free tissues or towels to dry the filters completely before replacing them.
or
Clean the filters by vacuuming them.
4.
Insert the upper filter holder into its slot. Slide it back into place until the holder is flush with the front panel. Repeat this process to install the lower filter holder. The metal side of the filter should be facing toward the instrument.
5.
Replace the front covers.
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Chapter 9 Search Book TOC Go Back Maintenance
Data Station Filter Procedure
1.
Locate the fan filter on the rear of the Data Station, if present. (See
Figure 9.11.)
2.
The plastic frame that holds the filter in place snaps onto the bracket that holds the fan. Pull on the top corners to remove the frame.
Fan
Filter
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3000 System Operator’s Manual
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Figure 9.11: Data Station Rear Panel
3.
Rinse the filter with warm water from the inside to the outside to remove the dust. Blot the filter with lint-free tissues or towels to completely dry it before replacement.
or
Clean the filter by vacuuming it.
4.
Place the filter over the fan.
5.
Place the frame over the filter and press to snap it back into place.
9-31
Maintenance
Extended Auto-Clean
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Chapter 9
The Extended Auto-Clean procedure is a fully automated procedure designed to clean the shear valve, the WBC mixing chamber, the WBC flow cell, the HGB mixing chamber, the HGB flow cell, the RBC/PLT transducer assembly, the needle in the CS or SL version and all the associated fluidics. The forward and reverse action of the peristaltic pumps is used during this procedure to gently scrub and remove any fibrin or debris within the system.
The Extended Auto-Clean procedure takes approximately 2.5 hours.
(When the 2.5 hours are completed, the instrument is in the STANDBY mode.) The procedure may be canceled by pressing the [CANCEL] key, which is displayed after 38 minutes.
Materials Required
1.
CELL-DYN Enzymatic Cleaner (brought to room temperature)
2.
Clean test tube or container
3.
Lint-free wipes or gauze
4.
Warm water
5.
Gloves, lab coat, and suitable eye protection
WARNING: Potential Biohazard. Follow established biosafety practices when performing maintenance, service or troubleshooting procedures. Wear gloves, lab coat, and suitable
eye protection. Refer to Chapter 8, Precautions, Limitations and
Hazards , for additional information.
CAUTION: Use powder-free gloves when performing the maintenance procedure to avoid contaminating the instrument.
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Chapter 9 Search Book TOC Go Back Maintenance
SPECIAL PROTOCOLS
Ready
Nov 091992
Operator ID
Sequence #
12:25
734
0630
Hold a bottle of Cell-Dyn Enzymatic Cleaner under the probe, and press the START key
When the Extended Auto-Clean process is completed, the instrument will automatically go to STANDBY.
This process takes 2.5 hours.
NOTE:
After 38 minutes, the cleaning process may be interrupted to process specimens.
START CANCEL
Figure 9.12: Special Protocols: Extended Auto-Clean Screen
Procedure
1.
Ensure that waste container is less than 1/2 full.
2.
Select the open sampler mode.
3.
Carefully wipe the outside of the open sample aspiration probe and the bottom of the wash block with a piece of gauze dampened with warm water and a few drops of CELL-DYN Enzymatic Cleaner.
Wipe any dried reagent or blood off the bottom of the wash block.
4.
Press [SPECIAL PROTOCOLS] followed by [MORE] to access the Extended Auto-Clean function.
5.
Press [EXTEND AUTOCLEAN].
Instructions for performing the procedure are given on the screen
6.
Dispense approximately 1.5 mL of enzymatic cleaner undiluted into a clean container and hold the container under the open sample aspiration probe.
NOTE: Do not press the touch plate. The Extended Auto Clean procedure is initiated only by the [START] key.
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Maintenance
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Chapter 9
7.
Press [START].
8.
Continue to hold the container under the probe until a beep tone is heard. Remove the container and discard the remaining enzymatic cleaner.
NOTE: The complete procedure takes 2.5 hours but may be terminated after 38 minutes by pressing the [CANCEL] key. If the [CANCEL] key is pressed, a rinse cycle is initiated which prepares the instrument for sample processing. When the rinse
cycle finishes, press [MAIN] to return to the MAIN MENU
9.
At the end of the 2.5 hours, the instrument automatically goes into the STANDBY mode. Press [RUN] to bring the Analyzer out of
STANDBY and prepare it for sample processing.
10.
Verify that the background counts are acceptable by running 5
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Chapter 9 Search Book TOC Go Back Maintenance
As Required
As Required Maintenance
RBC/PLT Aperture Plate
The RBC/PLT aperture plate is automatically cleaned during the
Auto-Clean procedure. However, occasionally it may be necessary to remove the aperture plate for cleaning. Refer to the instrument logbook to find the latest baseline count time. Use the baseline count time to determine the frequency of cleaning needed.
NOTE: The count time is displayed on the RUN Screen to the
right of the MPV result. The count time is also displayed on the
RAW DATA SUMMARY Screen accessible from the
The RBC/PLT aperture should be cleaned if the count time differs from the baseline value by more than 0.4 seconds or if there are frequent RBC
CLOG messages. The RBC/PLT aperture plate is located in the RBC/
PLT transducer assembly.
The transducer assembly is depicted in Figure 9.13.
von Behrens
RBC Transducer
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Figure 9.13: Transducer Assembly — Levers Closed
Lever Closed
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Maintenance
9-36
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Chapter 9
Materials Required
1.
Cleaning solutions:
Either of the following solutions may be used to clean the aperture plate. Each solution should be prepared fresh just before use, as it will deteriorate over time. a.
Mix 20 drops of enzymatic cleaner and 20 mL of warm water in a container that is large enough to hold the aperture plate.
b.
Make a 25% bleach solution by adding 5 mL of bleach to 15 mL of distilled water in a container that is large enough to hold the aperture plate.
2.
Aperture brush from the accessory kit
3.
Wash bottle containing distilled water
4.
Lint-free wipes and gauze
5.
Sonic cleaner (optional)
6.
Gloves, lab coat, and suitable eye protection
WARNING: Potential Biohazard. Follow established biosafety practices when performing maintenance, service or troubleshooting procedures. Wear gloves, lab coat, and suitable
eye protection. Refer to Chapter 8, Precautions, Limitations and
Hazards , for additional information.
CAUTION: Use powder-free gloves when performing the maintenance procedure to avoid contaminating the instrument.
Procedure
1.
Remove the front covers to gain access to the RBC/PLT transducer assembly.
2.
Confirm that the Analyzer is in the READY state.
3.
From the MAIN MENU Screen , press [SPECIAL
PROTOCOLS] followed by [EMPTY RBC].
This will drain the liquid from the transducer assembly.
CAUTION: DO NOT attempt to remove the aperture plate without first emptying the transducer assembly.
4.
When the empty RBC cycle stops, place a lint-free wipe or gauze under the transducer to prevent liquid from dripping onto the solenoids located directly below it.
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Chapter 9 Search Book TOC Go Back Maintenance
5.
Pull the red release lever located in front of the transducer out and to the right to release the aperture plate. (See Figure 9.14.)
Counting
Chamber
Mixing
Chamber
Aperture
Plate
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3000 System Operator’s Manual
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Release
Lever
Figure 9.14: Transducer Assembly and Aperture Plate
6.
Pull the aperture plate straight out from between the transducer chambers to remove it from the assembly. Note the orientation of the plate, as it must be replaced correctly. (See Figure 9.14.)
7.
Place the plate into the container of freshly prepared cleaning solution. Submerge the aperture completely in the solution. (The opening is located inside the red jewel embedded in center of the plate.) Rotate the aperture brush in the opening to ensure the cleaning solution penetrates it completely. Allow the plate to soak for five minutes. DO NOT soak the plate longer than five minutes as prolonged soaking may damage the aperture plate.
CAUTION: DO NOT use anything but the aperture brush provided in the accessory kit to clean the aperture. Using other implements may damage the aperture.
NOTE: If desired, the container (with the aperture plate and cleaning solution) may be placed in a sonic cleaner for two to three minutes instead of cleaning the aperture with a brush.
CAUTION: DO NOT sonicate the aperture longer than three minutes as prolonged sonication may loosen the aperture jewel.
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Maintenance
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Chapter 9
8.
When the plate is clean, remove it from the cleaning solution and thoroughly rinse it with a stream of deionized water. Do not dry the aperture plate.
9.
Insert the plate between the transducer chambers with the orientation notch on the bottom leading edge. Carefully push the plate into place. Be sure that it is completely seated between the chambers.
10.
Move the release lever back to the left to securely hold the plate in
11.
Press [FILL RBC] to refill the transducer assembly and the associated tubing.
12.
Replace the upper and lower front covers.
13.
Press [MAIN] followed by [RUN] to return to the RUN Screen .
14.
Verify that the background counts are acceptable by running 5 background counts.
15.
When an acceptable background count has been obtained, record the count time in the instrument logbook. This is the baseline count time for the instrument.
NOTE: The baseline value may only be obtained immediately after the RBC/PLT aperture has been cleaned.
16.
Verify that controls are acceptable. If unacceptable, refer to
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Chapter 9 Search Book TOC Go Back Maintenance
Hemoglobin Flow Cell Manual Cleaning Procedure
NOTE: This is not a routine cleaning/maintenance procedure. It should be performed only if routine methods fail or at the request of the Abbott Customer Support Center.
Under normal circumstances, the Auto-Clean procedure is sufficient to ensure the cleanliness of the HGB flow cell. If the Auto-Clean procedure fails to adequately clean the flow cell, this procedure may be used. The
HGB flow cell, the HGB mixing chamber and Solenoid 14 are depicted in Figure 9.15.
Solenoid 14
Hemoglobin
Mixing
Chamber
CELL-DYN
3000 System Operator’s Manual
9140240E — May 1995
Hemoglobin
Flow Cell
WBC
Mixing
Chamber
Figure 9.15: The HGB Mixing Chamber, HGB Flow Cell and Solenoid
14
Materials Required
1.
Cleaning solution: Make a 25% bleach solution by adding
5 mL of bleach to 15 mL of deionized water
2.
10-20 mL syringe with a piece of tubing attached
3.
Gloves, lab coat, and suitable eye protection
WARNING: Potential Biohazard. Follow established biosafety practices when performing maintenance, service or troubleshooting procedures. Wear gloves, lab coat, and suitable
eye protection. Refer to Chapter 8, Precautions, Limitations and
Hazards , for additional information.
9-39
Maintenance
9-40
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Chapter 9
CAUTION: Use powder-free gloves when performing the maintenance procedure to avoid contaminating the instrument.
Procedure
1.
Press [SPECIAL PROTOCOLS] followed by [DISABLE
ANALYZER] to disable the Analyzer.
2.
Remove the front covers to gain access to the HGB mixing chamber and HGB flow cell assembly.
3.
Manually open Solenoid 14 to completely drain all the liquid from the HGB mixing chamber and HGB flow cell. (If necessary, refer
4.
Close Solenoid 14 as soon as the HGB Mixing Chamber is completely drained.
5.
Locate the fitting and the attached tubing on the side of the HGB mixing chamber. Follow the tubing to the T fitting and disconnect the tubing from the fitting.
6.
Fill the syringe with the cleaning solution and connect it to the tubing. Dispense 10 mL of the cleaning solution into the mixing chamber.
7.
Remove the syringe and reconnect the tubing.
8.
Manually open Solenoid 14 and allow two-thirds of the bleach solution to drain into the HGB flow cell.
9.
Close Solenoid 14 to hold the bleach solution in the flow cell.
10.
Allow the bleach solution to remain in the mixing chamber and flow cell for 5-10 minutes.
11.
When the time has elapsed, manually open Solenoid 14 to drain the bleach solution from the mixing chamber and flow cell.
12.
Press [ENABLE ANALYZER] followed by [MAIN] to return to
13.
Rinse the bleach solution out of the system by running a minimum of five background counts.
14.
Replace the front covers.
15.
Verify that the background counts are acceptable by running 5
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Chapter 9 Search Book TOC Go Back Maintenance
Vacuum Accumulator Cleaning Procedure
Materials Needed
1.
Large syringe (50/60 mL)
2.
400 mL of distilled water
3.
Empty receptacle
4.
Hemostat or clamp
5.
Gloves, lab coat, and suitable eye protection
WARNING: Potential Biohazard. Follow established biosafety practices when performing maintenance, service or troubleshooting procedures. Wear gloves, lab coat, and suitable
eye protection. Refer to Chapter 8, Precautions, Limitations and
Hazards , for additional information.
CAUTION: Use powder-free gloves when performing the maintenance procedure to avoid contaminating the instrument.
Procedure
1.
Turn the Analyzer and Data Station power OFF.
2.
Remove the upper and lower front covers from the Analyzer to gain access to the flow panel.
3.
Locate the two vacuum accumulator drain lines on the bottom left-
hand corner of the flow panel. (Refer to Figure 9.1
4.
Place the empty receptacle under one of the lines while removing the white cap. If the fluid does not drain freely, attach the syringe to the line.
5.
Pull back on the plunger to aspirate any liquid from the accumulator. Discard the liquid.
NOTE: It may be necessary to aspirate several times to ensure all the liquid has been drained from each accumulator.
6.
Rinse the accumulator with 200 mL of distilled water. Inject the water into the accumulator in four 50 mL aliquots. Clamp the line after each injection to prevent the water from draining out of the accumulator.
7.
Place the empty receptacle under the line to aspirate the liquid from the accumulator and discard it. Clamp the line after each aspiration to prevent the fluid from draining out of the accumulator.
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Maintenance
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Chapter 9
8.
Replace the white caps on the line.
9.
Repeat Steps 4 through 8 with the other drain line.
10.
Replace the upper and lower front covers on the Analyzer.
11.
Power ON the Analyzer and then power ON the Data Station.
12.
Verify that the background counts are acceptable by running 5
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Chapter 9 Search Book TOC Go Back Maintenance
Special Procedures
Closed Sampler Tube Retainer Adjustment
It is necessary to adjust the tube retainer on the CELL-DYN 3000CS to accommodate different sized Vacutainer® tubes. The closed sampler module is depicted in Figure 9.16.
Tube
Retainer
Release Levers
(One on each side)
Cap Piercer
Well
Touch Plate
CELL-DYN
3000 System Operator’s Manual
9140240E — May 1995
Figure 9.16: Closed Sampler Module
Procedure
1.
Squeeze the release levers on the sides of the tube retainer between the thumb and forefinger to loosen it and slide the clamp up.
2.
Insert the Vacutainer tube cap-down into the cap piercer well.
3.
Slide the clamp down to hold the tube snugly in place.
4.
Release the levers when the tube retainer has been properly positioned.
5.
Check the height adjustment with several Vacutainer tubes to be certain that it is correct. The tube should fit snugly into the tube retainer.
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Maintenance
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Chapter 9
Preparation for Inactivity or Shipping
The Prepare For Shipping Procedure must be performed if the instrument will not be used for two weeks or more. This procedure must also be performed prior to shipping the instrument or relocating it. Salt deposits and reagent residue may clog the flow system if they are not removed prior to a period of inactivity or shipment. In addition, the tubing should be removed from the normally closed valves located under the reagent reservoirs. Leaving this tubing in the valves while the instrument is inactive may cause it to crimp permanently.
Materials Required
1.
Container with approximately 500 mL of deionized water.
2.
If the instrument will be shipped, the following are also needed:
Shear valve dummy center section (this is stored in the disk storage container located on the Analyzer flow panel to the right of the
WBC flow cell access cover)
Four plastic bags to hold the reagent inlet and waste outlet tubes
3.
Gloves, lab coat, and suitable eye protection
WARNING: Potential Biohazard. Follow established biosafety practices when performing maintenance, service or troubleshooting procedures. Wear gloves, lab coat, and suitable
eye protection. Refer to Chapter 8, Precautions, Limitations and
Hazards , for additional information.
CAUTION: Use powder-free gloves when performing the maintenance procedure to avoid contaminating the instrument.
Procedure
1.
From the Data Station MAIN MENU Screen , press [SPECIAL
PROTOCOLS] followed by [MORE] followed by [PREPARE
SHIPPING].
2.
Ensure that the waste container is less than 1/2 full.
3.
Place the reagent lines in the container of deionized water and then press the [START] key. The flow system will be automatically rinsed.
NOTE: No additional operator action is required during the rinse cycle.
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Chapter 9 Search Book TOC Go Back Maintenance
4.
When the process is complete turn OFF the power to Analyzer,
Data Station, and Sample Loader (if CELL-DYN 3000SL).
5.
Carefully remove the reagent inlet tubes from the normally closed valves under the reagent reservoirs located on the left side panel of
the Analyzer. (If necessary, refer to Figure 1.6
these normally closed valves.)
6.
Move the peristaltic pump tubing from under the sample aspiration pump and the WBC transfer pump.
To return to operational status after the period of inactivity, do the following:
1.
Replace reagent inlet tubing into the normally closed valves under the reagent reservoirs located on the left side panel of the Analyzer.
(If necessary, refer to Figure 1.6
for the location of these normally
closed valves.)
2.
Replace peristaltic pump tubing into the sample aspiration pump and the WBC transfer pump.
3.
Replace reagent lines into the appropriate reagent cubitainers.
4.
Power ON the Analyzer and then the Data Station.
5.
When Initialized, press [RUN] to prime.
6.
Verify that the background counts are acceptable by running 5 background counts before running controls. If the controls are
unacceptable, refer to Chapter 10, Troubleshooting .
If the instrument is to be shipped, perform the following steps:
1.
Obtain the shear valve dummy center piece from the disk storage container.
2.
Reassemble it using the dummy center piece.
3.
Wrap the ceramic center piece carefully for protection and place it in the accessory kit.
4.
Disconnect the power cords and put them in the accessory kit.
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Maintenance
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Chapter 9
5.
Remove the reagent inlet and waste outlet tubes. Place each tube in a protective plastic bag and put the bags in the accessory kit.
WARNING: Potential Biohazard. Follow established biosafety practices when performing maintenance, service or troubleshooting procedures. Wear gloves, lab coat, and suitable
eye protection. Refer to Chapter 8, Precautions, Limitations and
Hazards , for additional information.
6.
Replace the front covers.
7.
Wipe the surface of the instrument with disinfectant. Refer to
Chapter 8, Precautions, Limitations and Hazards , for additional
information.
Repackaging for Shipment
When the CELL-DYN 3000 is to be shipped and the original packaging is available, repackage the instrument as it was originally shipped.
When the instrument is to be shipped and the original packaging is unavailable, call the Customer Support Center for assistance with repackaging the unit for shipment at 1 (800) CELL DYN.
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Chapter 10 Search Book TOC Go Back
Troubleshooting
Chapter Table of Contents
Diagnostics Menu
Troubleshooting Guide
Introduction to Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-25
Obtaining Technical Assistance . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-26
Troubleshooting Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-27
Power ON Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-27
Power OFF Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-28
Initializing the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-28
Unclogging the Open Sample Aspiration Probe . . . . . . . . . . . . 10-30
Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-30
Operator-Replaceable Components . . . . . . . . . . . . . . . . . . . . . . . . . 10-32
Operator-Replaceable Fuse . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-32
Checking or Changing the Analyzer Fuse . . . . . . . . . . . . . . . . 10-32
Sample Loader Aspiration Needle or Vent Needle . . . . . . . . . 10-33
Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-34
Aperture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-36
Syringes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-37
Troubleshooting Tips and Techniques . . . . . . . . . . . . . . . . . . . . . . 10-38
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-38
Troubleshooting the Background Count . . . . . . . . . . . . . . . . . . 10-38
Troubleshooting Reagent Problems . . . . . . . . . . . . . . . . . . . . . 10-39
“Incomplete Aspiration-Sampling Error” Message . . . . . . . . . 10-39
Troubleshooting RBC Clog and Flow Error Messages . . . . . . 10-40
Troubleshooting the WBC Flow Error Message . . . . . . . . . . . 10-40
Troubleshooting Imprecise or Inaccurate Data . . . . . . . . . . . . . 10-41
Messages and Fault Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-43
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-43
Instrument Status Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . 10-45
General Fault Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-53
Sample-Related Fault Conditions . . . . . . . . . . . . . . . . . . . . . . . 10-67
Non-Functional Fault Conditions . . . . . . . . . . . . . . . . . . . . . . . 10-73
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3000 System Operator’s Manual
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Table of Contents-1
Table of Contents Search Book TOC Go Back
NOTES
Chapter 10
Table of Contents-2
CELL-DYN
3000 System Operator’s Manual
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Chapter 10
Introduction
Search Book TOC Go Back
Troubleshooting
This chapter gives instructions for identifying, troubleshooting and correcting instrument problems. The CELL-DYN
®
3000 continuously monitors the status of the system and displays pertinent information in the status box or on the Bulletin Line. If a problem is detected, the status box displays FAULT: SEE DIAG or SEE SPECIAL, the Bulletin Line displays a message and the word “Fault” on the Analyzer status indicator panel is illuminated in red. A description of the fault can be obtained by
pressing the [FAULT REPORT] key on the DIAGNOSTICS MENU
The first section of this chapter discusses the DIAGNOSTICS MENU
keys. The remainder of the chapter is devoted to the Troubleshooting
The
Troubleshooting Guide is designed to assist the operator in
identifying and resolving instrument problems. Instructions are also
given for obtaining technical assistance from the Abbott Customer
Support Center . The guide includes troubleshooting procedures,
instructions for component replacement and troubleshooting tips and
techniques. The last section describes the instrument messages and fault conditions . The tables
in this section include instructions for corrective action.
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Troubleshooting
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NOTES
Chapter 10
10-2
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Chapter 10 Search Book TOC Go Back Troubleshooting
Diagnostics Menu
This section describes the soft keys available from the DIAGNOSTICS
MENU Screens. These keys enable the operator or service representative to obtain information and execute programs that assist in troubleshooting and identify corrective action.
Several keys listed are described “For Service Use Only.” The data these keys provide is meaningful only to trained field service representatives and is not useful to the operator. If certain keys are pressed inadvertently, the system may have to be initialized.
There are five primary screens in the DIAGNOSTICS MENU . For ease
of explanation, the keys are discussed screen by screen.
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10-3
Diagnostics
The first DIAGNOSTICS MENU Screen (see Figure 10.1
following soft key labels are displayed when the [DIAGNOSTICS] key is pressed:
MAIN
DIAGNOSTICS MENU
Ready
Jan 18 1993
Operator ID
Sequence #
10:20
734
0630
FAULT
REPORT
EXECUTION
TIMES
CNT RATE
SUMMARY
CLEAR
FAULTS
RAW DATA
SUMMARY
MORE
Figure 10.1: First Diagnostics Menu Screen
PRINT MAIN
10-4
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Chapter 10
FAULT
REPORT
Search Book TOC Go Back Troubleshooting
When the [FAULT REPORT] key is pressed, information regarding the pending fault is displayed on the screen. The screen displays the words
OPERATOR CORRECTABLE FAULT REPORT: (see Figure 10.2)
or FATAL FAULT REPORT : (see Figure 10.3
information available. If there is no fault, the screen displays the words
NO FAULT PENDING . (See Figure 10.4
DIAGNOSTICS MENU
Diluent empty
Jan 20 1993
Operator ID
Sequence #
12:28
734
2715
Operator correctable fault report :
Diluent empty
FAULT
REPORT
EXECUTION
TIMES
CNT RATE
SUMMARY
CLEAR
FAULTS
RAW DATA
SUMMARY
MORE PRINT
Figure 10.2: Operator Correctable Fault Report Screen
MAIN
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10-5
Troubleshooting
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Chapter 10
Fatal fault report :
RBC diluent syringe overpressure
DIAGNOSTICS MENU
Fault: See DIAG
Jan 20 1993
Operator ID
Sequence #
12:20
734
2713
FAULT
REPORT
RBC diluent syringe overpressure
EXECUTION
TIMES
CNT RATE
SUMMARY
CLEAR
FAULTS
RAW DATA
SUMMARY
MORE PRINT MAIN
Figure 10.3: Fatal Fault Report Screen
Operator-correctable faults (for example, waste full, diluent empty) can be cleared by pressing the [CLEAR FAULTS] key after taking corrective action. After corrective action for a fatal fault, the system must be initialized.
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DIAGNOSTICS MENU
Ready
Jan 20 1993
Operator ID
Sequence #
15:58
734
1917
No fault pending
EXECUTION
TIMES
CNT RATE
SUMMARY
FAULT
REPORT
EXECUTION
TIMES
CNT RATE
SUMMARY
CLEAR
FAULTS
RAW DATA
SUMMARY
MORE PRINT
Figure 10.4: Fault Report – No Fault Pending Screen
This key is for service use only.
MAIN
When the [CNT RATE SUMMARY] key is pressed, the following soft
WBC CNT RATE or
WBC RATE GRAPH (The label alternates between these two when the soft key is pressed)
RBC CNT RATE or
RBC RATE GRAPH (The label alternates between these two when the soft key is pressed)
PLT CNT RATE or
PLT RATE GRAPH (The label alternates between these two when the soft key is pressed)
RETURN
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Troubleshooting
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Chapter 10
DIAGNOSTICS MENU
Ready
Jan 20 1993
Operator ID
Sequence #
12:29
734
2715
Max % diff WBC: 311 RBC: 295 PLT: 767
WBC
CNT RATE
RBC
CNT RATE
PLT
CNT RATE
PRINT RETURN
Figure 10.5: Count Rate Summary Screen
Each key displays kinetic data for the selected parameter from the last
cycle run. When each key is pressed, the count rate data is displayed (see
) and the key label changes to [RATE GRAPH] for that
parameter.
10-8
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Chapter 10 Search Book TOC Go Back Troubleshooting
DIAGNOSTICS MENU
Ready
Jan 20 1993
Operator ID
Sequence #
12:30
734
2716
WBC : TOTAL COUNT:
TIME: 0.50
COUNT: 361
RATE:
TIME:
714.85
4.63
COUNT: 3666
RATE: 864.71
5934
1.05
808
827.78
5.14
4074
800.00
1.55
1183
742.57
5.67
4500
811.43
2.07
1576
755.77
6.21
4924
777.98
2.57
1989
3.08
2359
826.00
725.49
6.73
7.24
5342 5743
803.85
794.06
3.62
2799
822.43
7.50
5934
720.75
4.12
3225
843.56
Max % diff WBC: 18 RBC: 7 PLT: 45
WBC
RATE GRAPH
RBC
CNT RATE
PLT
CNT RATE
PRINT RETURN
Figure 10.6: WBC Count Rate Data
Count rate data from the last cycle is displayed in a tabular format. The total count, time segments and rate per second are displayed for multiple data points from that cycle. (See Figure 10.6.) When the [RATE
graph are useful when troubleshooting problems related to these parameters.
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Troubleshooting
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Chapter 10
CLEAR
FAULTS
RAW DATA
SUMMARY
DIAGNOSTICS MENU
Ready
Jan 20 1993
Operator ID
Sequence #
12:29
734
2716
864.7
756.6
648.5
540.4
432.4
324.3
216.2
108.1
0.5
1.0
1.5
2.0
2.5
3.0
3.5
4.0
4.5
5.0
5.5
6.0
6.5
7.0
7.5
WBC RATE GRAPH
WBC
CNT RATE
RBC
CNT RATE
PLT
CNT RATE
PRINT RETURN
Figure 10.7: WBC Count Rate Graph
When the [CLEAR FAULTS] key is pressed, the Analyzer returns to the
READY state if the corrective action taken resolved the problem. If the corrective action did not correct the problem, the fault status does not change.
NOTE: Only operator-correctable faults can be cleared with the
[CLEAR FAULTS] key.
When the [RAW DATA SUMMARY] key is pressed, detailed information pertaining to the last cycle run is displayed. An example of
the RAW DATA SUMMARY Screen is shown in Figure 10.8
useful information for the operator, the
metering times and the HGB reference and sample readings , is highlighted in Figure 10.8
The information on metering times may be used to assist in troubleshooting chronic clog or flow error messages. The HGB reference and sample readings may be used to assist in troubleshooting erratic or imprecise HGB results.
10-10
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Chapter 10
MORE
MAIN
Search Book TOC Go Back Troubleshooting
DIAGNOSTICS MENU
Ready
Jan 28 1993
Operator ID
Sequence #
12:33
734
3143
List Mode WBC: 4350 RBC: 23598 PLT: 2682
Raw Count
4206
31166 2741
Count Time Upper: 3.53
HGB Sample
HGB Ref
WBC Alg
RBC Alg
PLT Alg
1: 1218
2255
% Tot: 98.6%
RER: 33.9%
Adj cnt: 2728
Count: 6.23
2: 1218
2254
3: 1219
Avg: 6.22
2255
4: 1219
2255
Timeout: 6.51
5: 1219
2258
Lo thr: 40
Lo thr: 8
CTRUE: 342.4
Hi thr: 219
FAULT
REPORT
EXECUTION
TIMES
CNT RATE
SUMMARY
CLEAR
FAULTS
RAW DATA
SUMMARY
MORE PRINT MAIN
Figure 10.8: Raw Data Summary Screen
When the [MORE] key is pressed, the second DIAGNOSTICS MENU
Screen is displayed. The [MORE] keys on the remaining screens always
display the next screen. Consequently, they are discussed last in each section.
When the [PRINT] key is pressed, a diagnostic report is printed. This report contains information pertinent to the data displayed on the screen at the time the key is pressed. If no data is displayed on the screen, the report prints the current fault status.
The [PRINT] key functions in this way on each screen. Therefore, it will not be discussed again in this section.
The [MAIN] key is used to return to the MAIN MENU Screen . The
[MAIN] key appears on each primary DIAGNOSTICS MENU Screen
and works the same way on each screen. Consequently, it will not be discussed again in this section.
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Chapter 10
When the [MORE] key on the first DIAGNOSTICS MENU Screen is
pressed, the second DIAGNOSTICS MENU Screen (see Figure 10.9) and the following soft key labels are displayed:
MAIN
DIAGNOSTICS MENU
Ready
Jan 18 1993
Operator ID
Sequence #
10:20
734
0630
MOTOR
OPERATION
SOLENOID
OPERATION
10-12
MOTOR SOLENOID PUMP
OPERATION OPERATION OPERATION
INITIAL-
IZATION
MORE MAIN
Figure 10.9: Second Diagnostics Menu Screen
This key is for service use only. The system must be initialized after this key is pressed.
This key is for service use only. The system must be initialized after this key is pressed.
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Chapter 10
PUMP
OPERATION
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When the [PUMP OPERATION] key is pressed, the following soft key labels (see Figure 10.10) are displayed:
(The key label alternates between these two selections.)
(The key label alternates between these two selections.)
(This key is displayed after either key listed above it is pressed.)
DIAGNOSTICS MENU
Not Ready: See DIAG
Jan 28 1993
Operator ID
Sequence #
12:34
734
3143
VACUUM
ON
PRESSURE
ON
VACUUM
TEST
PRESSURE
TEST
Figure 10.10: Pump Operation Screen
DIAG-
NOSTICS
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10-13
Troubleshooting
VACUUM
ON
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Chapter 10
When the [VACUUM ON] key is pressed, the key label changes to
[VACUUM OFF], the vacuum pump is turned ON and the screen displays the message VACUUM IS ON. (See Figure 10.11.) Press the
[VACUUM OFF] key to turn the pump OFF.
NOTE: The pump is automatically turned OFF and control of the pump is returned to the instrument when the screen is exited.
This key is useful for troubleshooting vacuum problems. If the pump does not turn ON when the key is pressed, the pump may be the cause of the vacuum problem.
DIAGNOSTICS MENU
Not Ready: See DIAG
Jan 18 1993
Operator ID
Sequence #
12:36
734
2716
Vacuum is on
PRESSURE
ON
VACUUM
OFF
PRESSURE
ON
INHIBIT
PUMPS
VACUUM
TEST
PRESSURE
TEST
DIAG-
NOSTICS
Figure 10.11: Pump Operation Screen — Vacuum ON
When the [PRESSURE ON] key is pressed, the key label changes to
[PRESSURE OFF], the pressure pump is turned ON and the screen displays the message PRESSURE IS ON. Press the [PRESSURE OFF] key to turn the pump OFF.
NOTE: The pump is automatically turned OFF and control of the pump is returned to the instrument when the screen is exited.
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Chapter 10
INHIBIT
PUMPS
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This key is useful for troubleshooting pressure problems. If the pump does not turn ON when the key is pressed, the pump may be the cause of the pressure problem.
When the [INHIBIT PUMPS] key is pressed, the key label changes to
[ENABLE PUMPS], operation of the pumps is inhibited (no vacuum or pressure is produced) and the screen displays the appropriate message.
(See Figure 10.12.) Press the [ENABLE PUMPS] key to enable pump operation.
NOTE: The pumps are automatically enabled and control of them is returned to the instrument when the screen is exited.
This key is useful when performing maintenance or troubleshooting procedures that require a vacuum or pressure line to be removed.
DIAGNOSTICS MENU
Not Ready: See DIAG
Jan 18 1993
Operator ID
Sequence #
12:36
734
3143
Vacuum is inhibited
VACUUM
TEST
VACUUM
OFF
PRESSURE
OFF
ENABLE
PUMPS
VACUUM
TEST
PRESSURE
TEST
DIAG-
NOSTICS
Figure 10.12: Inhibit Pumps Screen
When the [VACUUM TEST] key is pressed, the system releases the vacuum to atmosphere and then determines the amount of time required for it to return to the correct level. The key labels disappear and the
incrementing time is displayed on the screen . (See Figure 10.13
the test is complete, the time stops incrementing and the key labels are displayed.
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Troubleshooting
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Chapter 10
DIAGNOSTICS MENU
Vacuum Recovery Time Test
Jan 20 1993
Operator ID
Sequence #
12:39
734
2716
Time elapsed : 3.3
PRESSURE
TEST
DIAGNOSTICS
INITIAL-
IZATION
10-16
Figure 10.13: Vacuum Test Screen
When the [PRESSURE TEST] key is pressed, the system releases the pressure to atmosphere and then monitors the amount of time required for it to return to the correct level. The key labels disappear and the incrementing time is displayed on the screen. When the test is complete, the time stops incrementing and the key labels are displayed.
The [DIAGNOSTICS] key is used to return to the DIAGNOSTICS
When the [INITIALIZATION] key is pressed, the Analyzer is initialized. This is necessary when a fatal fault has occurred.
When the Analyzer is initialized, a prime cycle must be run.
NOTE: A prime cycle is automatically run whenever the [RUN] key is pressed after the system is initialized.
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3000 System Operator’s Manual
9140240E — May 1995
Chapter 10
MORE
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When the [MORE] key is pressed, the third DIAGNOSTICS MENU
Screen (see Figure 10.14) and the following soft key labels are displayed:
MAIN
DIAGNOSTICS MENU
Ready
Jan 18 1993
Operator ID
Sequence #
10:21
734
0630
DIGITAL
READINGS
CELL-DYN
3000 System Operator’s Manual
9140240E — May 1995
DIGITAL
READINGS
VOLTAGE
READINGS
MORE
Figure 10.14: Third Diagnostics Menu Screen
PRINT MAIN
This key is for service use only.
10-17
Troubleshooting
VOLTAGE
READINGS
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Chapter 10
When the [VOLTAGE READINGS] key is pressed, the voltage and vacuum/pressure values from a test point, measured at the moment when the key was pressed, is displayed. (See Figure 10.15.) The following additional soft key labels are displayed:
FINISH SELECT
SELECT
These two keys are for service use only.
The data provided by the VOLTAGE READINGS Screen can be useful in determining if a problem is caused by a hardware malfunction.
DIAGNOSTICS MENU
Ready
Jan 28 1993
Operator ID
Sequence #
Arrow keys to move around, SELECT key to select, FINISH SELECT key to go
12:40
734
3143
DCM: slf-tst f/ DAC slf-test ramp
SPM:
WBC threshold
RBC threshold
PLT L thrshld
PLT H thrshld
MAM: ch 1 offset ch 2 offset ch 3 offset ch 4 offset
VPM: press 1 psi press 2 psi
FCM:
HGB output
:0.00
:9.99
:0.86
:0.57
:0.53
:9.97
99mv refrence
9.901v refrnce
5v supply
10v refrence
-10v refrence
:0.08
:9.86
SPM tst f/ DAC :0.00
:5.12
:9.97
:-10.0
15v/2 pwr sp
-15v/2 pwr sp
WBC ch 1 peak
WBC ch 2 peak
WBC ch 3 peak
WBC ch 4 peak
:7.49
:-7.55
5v pwr sp
:0.00
:0.00
:0.00
:0.00
:5.14
RBC peak :0.00
RBC intgral :0.00
PLT peak :0.04
:0.20
:0.97
:0.64
:0.27
:12.0
:9.01
:5.53
ch 5 offset ch 6 offset ch 3-Vdyn/100 ch 4-Vdyn/100 press 3 psi
:-2.06
electrode v/2
:-3.00
apt crrnt set
:6.14
:5.65
:4.88 tst puls H set tst puls L set vac 1 in. Hg vac 2 in. Hg
:0.41
:-0.05
:-0.05
:-0.00
:11.8
:11.7 laser ref pos ref pres
:0.00
:5.00
neg ref pres :-5.07
MAIN FINISH
SELECT
SELECT DIGITAL
READINGS
VOLTAGE
READINGS
Figure 10.15: Voltage Readings Screen
MORE PRINT
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MORE
When the [MORE] key is pressed, the fourth DIAGNOSTICS MENU
Screen (see Figure 10.16) and the following soft key labels are displayed:
GAIN ADJUSTMNT
WBC DATA
RBC DATA
PLT DATA
MORE
MAIN
These keys are for service use only.
DIAGNOSTICS MENU
Ready
Jan 18 1993
Operator ID
Sequence #
10:20
734
0630
GAIN
ADJUSTMNT
WBC
DATA
RBC
DATA
PLT
DATA
MORE
Figure 10.16: Fourth Diagnostics Menu Screen
PRINT MAIN
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Troubleshooting
MORE
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Chapter 10
When the [MORE] key is pressed, the fifth and last DIAGNOSTICS
MENU Screen (see Figure 10.17) and the following soft key labels are displayed:
MAIN
*These keys are displayed on the CELL-DYN 3000SL only.
DIAGNOSTICS MENU
Ready
Jan 18 1993
Operator ID
Sequence #
12:49
734
3122
10-20
AUTO-SAMP
VERSION
BAR CODE
ALIGNMENT
BAR CODE
VERIFY
SERIAL
TEST
MORE PRINT MAIN
Figure 10.17: Fifth Diagnostics Menu Screen (CELL-DYN 3000SL)
CELL-DYN
3000 System Operator’s Manual
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Chapter 10
AUTO-SAMP
VERSION
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This key is used to display the software version installed in the Sample
Loader. The Sample Loader must be ON before the key is pressed. When the [AUTO-SAMP VERSION] key is pressed, the screen displays the following message (see Figure 10.18):
AUTO-SAMPLER SOFTWARE: followed by the version information
NOTE: This key is displayed on the CELL-DYN 3000SL only.
DIAGNOSTICS MENU
Ready
Jan 18 1993
Operator ID
Sequence #
12:50
734
3122
Auto-Sampler Software : F:VER 1.19 04-10-92
BAR CODE
ALIGNMENT
BAR CODE
VERIFY
AUTO-SAMP
VERSION
BAR CODE
ALIGNMENT
BAR CODE
VERIFY
SERIAL
TEST
MORE PRINT MAIN
Figure 10.18: Auto-Sampler Version Screen
This key is for service use only and is displayed on the CELL-DYN
3000SL only.
This key is for service use only and is displayed on the CELL-DYN
3000SL only.
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Troubleshooting
SERIAL
TEST
Search Book TOC Go Back
Chapter 10
The [SERIAL TEST] key is used to test the functionality of the external computer port (RS-232 standard), referred to as the “serial interface connector” on the Serial Test Screen, at the rear of the Data Station. This test is designed to assist in troubleshooting problems with interfacing to a
Laboratory Information System (LIS). The loop-back connector (supplied in the accessory kit) must be connected to the Data Station external computer port before performing the test.
NOTE: If the laboratory does not have an LIS, the loop-back connector may remain connected to the external computer port for convenience, as it does not interfere with routine operation. If an LIS is usually connected, the loop-back connector should be stored near the instrument when the connector is not in use.
When the key is pressed, the following soft key labels (see Figure 10.19) are displayed:
DIAGNOSTICS MENU
Ready
Serial Interface Test
1. See Interface Specification.
2. If transmission in progress, press “STOP TRANSMISS” key first
3. Attach Loop-back connector to the serial interface connector on back of the Data Station.
4. Press the “TRANSMIT MESSAGE” key to start the test.
Jan 20 1993
Operator ID
Sequence #
12:51
734
3122
10-22
STOP
TRANSMISS
TRANSMIT
MESSAGE
Figure 10.19: Serial Test Screen
DIAG-
NOSTICS
CELL-DYN
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9140240E — May 1995
Chapter 10
STOP
TRANSMISS
TRANSMIT
MESSAGE
Search Book TOC Go Back Troubleshooting
The [STOP TRANSMISS] key is used to stop any transmission that is in progress to an LIS. When the key is pressed, any transmission in progress is aborted.
When the [TRANSMIT MESSAGE] key is pressed, the message “CD-
3000 serial interface test” is transmitted from the Data Station to the external computer port, through the loop-back connector and back to the
Data Station. The screen (see Figure 10.20) displays the message:
MESSAGE SENT: CD-3000 serial interface test.
If the test is successful, the screen displays the message:
MESSAGE RECEIVED: CD-3000 serial interface test.
This message indicates that the Data Station is communicating properly.
If the test is not successful, no message appears.
DIAGNOSTICS MENU
Ready
Jan 20 1993
Operator ID
Sequence #
12:52
734
3122
Message sent : CD-3000 serial interface test.
Message received : CD-3000 serial interface test.
CELL-DYN
3000 System Operator’s Manual
9140240E — May 1995
STOP
TRANSMISS
TRANSMIT
MESSAGE
Figure 10.20: Serial Test Transmit Message Screen
DIAG-
NOSTICS
10-23
Troubleshooting
DIAGNOSTICS
MORE
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The [DIAGNOSTICS] key is used to return to the previous
Chapter 10
The [MORE] key is used to return to the first DIAGNOSTICS MENU
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Chapter 10 Search Book TOC Go Back Troubleshooting
Troubleshooting Guide
Introduction to Troubleshooting
Good troubleshooting skills are learned by using a logical, step-by-step approach to problem solving. The first step in the process is understanding normal instrument operation and preventive maintenance.
A good, working knowledge of the instrument is essential for identifying and resolving operational problems.
Logical troubleshooting may be divided into three steps:
1.
Problem Identification
2.
Problem Isolation
3.
Corrective Action
Step 1, the problem identification step, is not only identifying what is wrong but also noting what is right. The investigation should identify the problem area and eliminate areas that are working correctly. Once this is done, the troubleshooting process moves quickly to the next step.
Step 2, Problem Isolation, further classifies the problem. Instrument problems are generally divided into three categories:
• Hardware — component related
• Software — computer program related
• Measurement — related to sample analysis
Typically, hardware and software problems are corrected by an authorized Abbott service representative. Measurement problems are generally operator correctable. This category is further subdivided into problems related to sample handling, maintenance or calibration.
Step 3, Corrective Action, involves taking appropriate action to correct the problem. If the operator can correct the problem, with or without technical assistance, normal operation can quickly resume.
This Troubleshooting Guide is designed to enhance the troubleshooting process by providing information to assist in problem identification, isolation and corrective action.
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10-25
Troubleshooting
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Chapter 10
Obtaining Technical Assistance
Technical assistance is obtained by calling the Abbott Customer Support
Center at 1 (800) CELL DYN. It is important to provide the Customer
Support Specialist with a clear and detailed description of the problem.
When assistance is needed, please be prepared to provide the following information for the Customer Support Specialist:
1.
Instrument Model Name
2.
Serial number of the Analyzer and software version in use
3.
Description of the problem (whenever possible, print the fault
status report obtainable from the DIAGNOSTICS MENU Screen )
4.
The lot numbers and expiration dates of the CELL-DYN reagents and controls currently in use
5.
Examples of sufficient data to facilitate the discussion
6.
Quality control information
7.
Maintenance information
8.
Calibration changes
9.
Component changes
10-26
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Chapter 10 Search Book TOC Go Back Troubleshooting
Troubleshooting Procedures
The procedures in this section are for troubleshooting purposes only. A specific procedure should be performed when indicated in this chapter or at the request of an Abbott Customer Support Specialist.
WARNING: Potential Biohazard. Follow established biosafety practices when performing maintenance, service or troubleshooting procedures. Wear gloves, lab coat, and suitable
eye protection. Refer to Chapter 8, Precautions, Limitations and
Hazards , for additional information.
CAUTION: Use powder-free gloves when performing these procedures to avoid contaminating the instrument.
Power ON Procedure
IMPORTANT: The laser must be allowed to warm up for 15 minutes after the power is turned ON, if the power has been OFF more than five minutes. Do not process samples during this warm-up period.
1.
Verify that all components are properly installed (for example, syringes, shear valve, etc.).
2.
Verify that all reagents are properly installed.
3.
Verify that all necessary cables and power cords are properly connected.
4.
Verify that the Analyzer covers are properly installed. If the instrument is a CELL-DYN 3000SL, verify that the Sample Loader safety cover is in place.
5.
Verify that the cause of the power OFF situation has been corrected.
6.
Turn the power switches ON in the following order: a.
Analyzer b.
Data Station c.
Sample Loader, if present d.
Printer
7.
When the INITIALIZED message appears in the status box on the
Data Station screen , prime the system by pressing [PRIME] or
[RUN], whichever is displayed.
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Chapter 10
Power OFF Procedure
Initializing the System
It is not necessary to power OFF the system under routine operating conditions. The system should be powered OFF if certain service is performed, if the system is moved or if the system will be inactive for an extended period of time (longer than seven days).
When controlled conditions require the power to be turned OFF, use the following procedure.
1.
Perform any required maintenance that is due.
2.
3.
When the Auto-Clean procedure is complete, press [DAILY
SHUTDOWN]. When the daily shutdown is complete, the status box displays the STANDBY message.
NOTE: If the instrument will be inactive for more than two
Maintenance , for performing this cycle.
4.
Turn the power switches OFF in the following order: a.
Data Station b.
Analyzer c.
Sample Loader, if present d.
Printer
NOTE: In an emergency situation, turn OFF the power switches in any order as quickly as possible. Follow the Power ON procedure when the emergency is over.
The term initializing refers to the initialization process that is necessary after certain problems have been corrected. Initialization is a two-step process:
1.
Initializing the hardware and software
2.
Priming the system with reagents
The system is initialized by pressing the [INITIALIZATION] key on the
second DIAGNOSTICS MENU Screen . The system is automatically
initialized whenever the power is turned OFF and ON.
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During the initialization process, the Data Station software is accessed and downloaded to the Analyzer. Once this is accomplished, all Analyzer motors and pumps are moved to their “home” positions. (Increased motor noises are normal during this process.) When the initialization has been successfully completed, the message INITIALIZED is displayed in the status box.
The reagent priming step is necessary after any initialization. This is accomplished by pressing [RUN] or [PRIME], whichever is displayed.
All reagents are primed automatically, a background cycle is performed
and the results are displayed on the RUN Screen . When the reagents are
primed, the message READY is displayed in the status box.
On the CELL-DYN 3000SL, the Sample Loader may be initialized by pressing the INIT key on the Sample Loader operation keyboard. It may also be initialized by turning the Sample Loader power switch OFF and
ON. (The Sample Loader is initialized every time the power switch is turned ON.)
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Chapter 10
Unclogging the Open Sample Aspiration Probe
The open sample aspiration probe is thoroughly cleaned whenever the
Auto-Clean procedure is performed. If a blockage is suspected, it may be cleared as directed in the following procedure.
Materials Required
1.
Monofilament line
2.
Empty Vacutainer® tube
3.
Enzymatic Cleaner
4.
Gloves, lab coat, and suitable eye protection
WARNING: Potential Biohazard. Follow established biosafety practices when performing maintenance, service or troubleshooting procedures. Wear gloves, lab coat, and suitable eye protection. The probe is potentially contaminated with
CAUTION: Use powder-free gloves when performing this procedure to avoid contaminating the instrument.
Procedure
1.
Remove the tubing from the top of the open sample aspiration probe as indicated in
NOTE: The tubing is connected with a silicon tubing sleeve.
Disconnect the sleeve from the probe.
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Silicon Tubing
Sleeve
Disconnect At
This Point
Locking Bracket
Open
Sample
Aspiration
Probe
Wash Block
Figure 10.21: Open Sample Aspiration Probe
2.
Carefully insert the monofilament line into the probe and push it down through the probe until it extends from the end. If a clot has been pushed out of the probe, remove it from the monofilament line.
3.
Remove the monofilament line from the probe.
4.
Reconnect the tubing to the top of the probe.
5.
6.
When the Auto-Clean procedure is complete, run a blood sample and check for complete aspiration. (There should be a minimum of one inch of blood on either side of the shear valve tubing.)
7.
If aspiration is not complete, call for technical assistance.
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Chapter 10
Operator-Replaceable Components
Procedures are given in this section for those components that may be replaced by the operator. All other components must be replaced by an authorized representative.
CAUTION: Perform the Auto-Clean procedure as directed in
Chapter 9, Maintenance , before removing any component.
Always wear appropriate personal protective equipment when changing any component.
Operator-Replaceable Fuse
The CELL-DYN 3000 has a fuse located above the power cord connector on the rear panel. It should only be replaced with the following types of fuses:
For 220-volt operation, a 4-amp slow-blow fuse
For 110-volt operation, an 8-amp slow-blow fuse
Replacement fuses are provided in the accessory kit.
Checking or Changing the Analyzer Fuse
CAUTION: Always turn the Analyzer power switch OFF and disconnect the power cord from the receptacle before checking or changing the fuse.
1.
Turn the Analyzer power switch OFF and disconnect the power cord from the receptacle.
2.
Insert a screwdriver in the fuse holder slot on the rear panel of the
Analyzer.
3.
Push in and turn the fuse holder counterclockwise to remove it.
4.
Pull on the fuse to remove it from the holder.
5.
Check the fuse. If it is obviously blown, replace it. If it is not blown, verify that it is the correct type of fuse.
NOTE: If you are not sure if the fuse is blown, replace it and see if the problem is corrected.
6.
Check that the fuse is fully inserted into the fuse holder and replace the holder.
7.
Insert a screwdriver in the fuse holder slot and push in and turn clockwise to lock it in place.
8.
Reconnect the power cord to the receptacle and turn the Analyzer power switch ON.
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Sample Loader Aspiration Needle or Vent Needle
The Sample Loader aspiration needle or vent needle should be replaced
are depicted in
WARNING: Potential Biohazard. Follow established biosafety practices when performing maintenance, service or troubleshooting procedures. Wear gloves, lab coat, and suitable
eye protection. Refer to Chapter 8, Precautions, Limitations and
Hazards , for additional information.
CAUTION: The needles are sharp and are potentially contaminated with infectious material. Handle with extreme caution.
CAUTION: Use powder-free gloves when performing this procedure to avoid contaminating the instrument.
Materials Required:
1.
Sample Loader vent and aspiration needles are provided in the accessory kit.
2.
Enzymatic cleaner.
3.
Gauze.
4.
2.5-mm Allen wrench.
5.
Two Vacutainer® tubes approximately half full of diluent.
6.
Gloves, lab coat, and suitable eye protection.
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Aspiration
Tubing
Locking
Screw
Mounting
Bracket
Aspiration
Needle
Aspiration
Needle
Wash Block
Waste
Tubing
Port
Chapter 10
Vent
Tubing
Locking
Screw
Mounting
Bracket
Vent
Needle
Vent
Needle
Wash
Block
Mixing
Head
Figure 10.22: Sample Loader Vent/Aspiration Needle Assembly
Procedure
1.
Perform the Auto-Clean procedure as directed in Chapter 9 . When
the procedure is complete, turn the Sample Loader power switch
OFF.
2.
Remove all racks from the tray.
3.
Place some gauze under the aspiration needle and/or vent needle to catch any liquid.
4.
Disconnect the sample aspiration tubing from the Analyzer.
NOTE: The tubing is connected on the left side of the open sample aspiration probe.
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5.
Remove the four thumbscrews from the sides of the Sample Loader tower and remove the cover.
6.
Remove the two thumbscrews from the Sample Loader manual
keyboard cover and remove it. (Refer to Figure 12.5, Operation
7.
Press and hold the MAN and START keys on the manual keyboard at the same time and turn the power ON. The green light on the manual keyboard indicates that the manual mode is ON.
8.
Repeatedly press the N-down key until the needles are moved approximately half the way down. Turn the Sample Loader power switch OFF.
9.
Use the Allen wrench to loosen the locking screw on the
appropriate mounting bracket. (See Figure 10.22
remove the screw.
10.
Disconnect the tubing from the appropriate needle.
NOTE: Slide the silicon tubing sleeve onto the aspirate tubing before disconnecting it.
11.
Remove the aspiration needle by pulling it up through the wash block and the mounting bracket.
CAUTION: Use care when removing the needle to avoid puncture.
12.
Insert the new aspiration or vent needle through the mounting bracket and down through the wash block until the wide collar at the top of the needle is flush with the top of the mounting bracket.
13.
Turn the aspiration needle until the hole in the needle faces the
waste tubing port. (See Figure 10.22
.) The orientation of the hole in
the vent needle is not important.
14.
Tighten the locking screw in the appropriate mounting bracket.
15.
Reconnect the tubing to the top of the needle.
NOTE: When connected, the aspirate tubing must be placed at least 1/4 inch over the top of the needle to cover it. The silicon tubing sleeve must slide over this connection for a proper seal.
16.
Reconnect the sample aspiration tubing to the Analyzer.
17.
Turn the Sample Loader power switch ON.
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Aperture
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Chapter 10
18.
Run the two diluent tubes and verify proper needle movement.
Check to be sure the background count is acceptable on the last cycle.
NOTE: If either needle does not move up and down smoothly, carefully check to be sure the locking screw is tight and that the tubing attached to the needle moves freely. If any problems are encountered, call for technical assistance. If the background
count is unacceptable, clean the needle as directed in Chapter 9,
Maintenance , and repeat the background count.
19.
Disconnect the sample aspiration tubing from the Analyzer.
20.
Replace the tower cover and check the tubing to ensure it is not pinched or crimped. Replace the manual keyboard cover.
21.
Reconnect the sample aspiration tubing to the Analyzer.
CAUTION: Be careful not to crimp or bend the tubing when reconnecting it. Do not use excessive force.
It may be necessary to replace the RBC/PLT aperture if no other solution to a related problem is found.
If you are replacing the aperture, verify that the correct aperture has been received. RBC/PLT apertures are identified by R/P etched on the plate.
Use the following procedure to replace the aperture.
1.
Perform the Auto-Clean procedure as directed in Chapter 9,
2.
3.
Clean the new aperture and install it as directed in the aperture cleaning procedure, and follow the remaining steps in that procedure.
CAUTION: Changing the aperture may alter instrument calibration. Therefore, confirm the calibration by running commercial controls before processing samples. If necessary,
recalibrate the instrument as directed in Chapter 6, Calibration .
4.
Repeat the samples that were run when the problem was detected to determine if it has been resolved. If the problem is not resolved, call for technical assistance at 1 (800) CELL DYN.
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Syringes
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If a syringe is cracked or broken, it should be replaced. It may also be necessary to replace a syringe if no other solution to a problem is found.
If this action is indicated by the Customer Support Center, obtain the appropriate replacement syringe. Then, use the following procedure:
1.
2.
Install the new syringe as directed in the syringe cleaning procedure and follow the remaining steps in that procedure.
3.
Repeat samples that were run when the problem was detected to determine if it has been resolved. If the problem is not resolved, call for technical assistance.
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Chapter 10
Troubleshooting Tips and Techniques
Introduction
Effective troubleshooting is possible only when the problem is clearly recognized and the probable cause is isolated. This is always facilitated by obtaining sufficient information and data pertaining to the specific problem. Carefully observe the situation. Document the steps that have been taken and record all results.
The following section is designed to guide the operator through a logical series of steps to obtain information regarding the nature of the problem.
If it is necessary to call for technical assistance, this information should be made available to the Customer Support Center.
Troubleshooting the Background Count
1.
Determine which parameter(s) exceed the background count
specifications: WBC, RBC, PLT, HGB. Refer to Chapter 4, System
2.
Check the data log to determine when the problem first occurred.
3.
Check the reagent log, maintenance log and if applicable, service reports to see if the problem occurred immediately after a specific action. For example, did the problem occur immediately after the reagent was changed?
4.
Check the background count in the open and closed modes to see if the problem is common to both modes.
5.
Run an electrical background count using the Electrical
Background specimen type several times and print the results. The
Electrical Background specimen type is found by pressing the
[SPECIMEN TYPE] soft key on the RUN Screen . The electrical
background for the RBC, MCV and PLT should be zero. The other background counts shown on the display and printout have the
same acceptable limits as shown in Chapter 4, System
Specifications in the Operator's Manual for Background Counts .
NOTE: The electrical background cycle turns off the current to the aperture. This cycle is used to assist in determining if electrical interference is causing the problem.
6.
Note the lot number of the reagents. Is it a new lot?
7.
For a list of probable causes and corrective actions, refer to
Table 10.4, Non-Functional Fault Conditions .
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Troubleshooting Reagent Problems
If a reagent (or reagents) is suspected as the cause of a particular problem, replace the container. However, the Analyzer has reservoirs which contain a small amount of reagent to maintain the supply within the system. This supply must be depleted before installing the new reagent.
To ensure that the new reagent is actually in the system, proceed as follows:
1.
From the first SPECIAL PROTOCOLS Screen , press [EMPTY
REAG RESERVOIR].
When the reservoirs are empty, the [FILL REAG RESERVOIR] key is displayed.
2.
Remove the appropriate reagent line from the container and wipe it with a lint-free wipe before placing it in the new container. Place the line in the new container and secure the cap.
3.
Press the [FILL REAG RESERVOIR] key to refill the reservoirs.
4.
Run five background counts before assessing the results.
Troubleshooting the “Incomplete Aspiration-Sampling Error” Message
1.
Check to see if the problem occurs in both the Open and Closed modes of operation. If the problem is confined to one mode only, the other may be eliminated as the cause of the problem.
2.
Determine whether the problem is a true incomplete aspiration.
Run a sample and verify that blood is visible to the left of the Status
Indicator panel.
3.
Verify that blood is pulled through the shear valve. Blood should be visible in the lines (approximately one inch) on both sides of the shear valve before it rotates. If blood is visible, there may be a sensor failure.
4.
For a list of probable causes and corrective actions, refer to
Table 10.3, Sample-Related Fault Conditions .
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Chapter 10
Troubleshooting RBC Clog and Flow Error Messages
1.
Remove the front covers and observe the metering tube while a cycle is in progress. Approximately 10–15 seconds after the start of the cycle, the metering tube should be flushed of all liquid. Verify that the liquid is completely flushed from the tube.
After the flush, a liquid column with a meniscus at the leading edge should travel down the tube. Verify that the meniscus is visible at the leading edge. A complete flush of the tube and a uniform meniscus are important to correct metering.
2.
Print the RUN Screen to record the metering times. The upper
metering time and the count time are both important in troubleshooting clogs or flow errors.
3.
Additional information pertaining to the last cycle can be found on
NOTE: The information is only available immediately after the cycle is completed. Therefore, the screen should be printed immediately after the clog or flow error occurs.
From the first DIAGNOSTICS MENU Screen , press [RAW
DATA SUMMARY] followed by [PRINT] to obtain a printout.
4.
Information pertaining to the vacuum level in the Analyzer can be
found on the VOLTAGE READINGS Screen .
From the third DIAGNOSTICS MENU Screen , press
[VOLTAGE READINGS] followed by [PRINT] to obtain a printout.
5.
The metering times are automatically stored in the data log.
Configure the data log to display and print the upper metering time and count time. (If necessary, refer to the directions given in
Chapter 5, Operating Instructions .)
6.
For a list of probable causes and corrective actions, refer to
Table 10.3, Sample-Related Fault Conditions .
Troubleshooting the WBC Flow Error Message
1.
The WBC FLOW ERROR message indicates a problem with the kinetic rate of the WBC measurement. The kinetic information is only available immediately after the cycle is complete. Therefore, the screen should be printed immediately after the WBC flow error occurs.
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2.
From the first DIAGNOSTICS MENU Screen , press [CNT
RATE SUMMARY].
3.
Press [WBC CNT RATE] to display the data for the kinetic rate followed by [PRINT] to obtain a printout.
4.
Press [WBC RATE GRAPH] to display the graph of the kinetic data followed by [PRINT] to obtain a printout.
5.
For a list of probable causes and corrective actions, refer to
Table 10.3, Sample-Related Fault Conditions .
Troubleshooting Imprecise or Inaccurate Data
1.
Obtain a normal fresh whole blood sample. Select an empty QC file and run a minimum of 10 Open mode runs into the file. Obtain a printout of the file.
2.
Run a minimum of nine Closed mode runs into the same file. (For the CELL-DYN 3000SL, aliquot a sample into three tubes and run each tube three times.) Use the [REJECT SPECIMEN] key to reject the Open mode runs and obtain a printout. This information can be used to determine if the problem is mode or measurement related.
3.
Compare the CVs of the precision data from a normal fresh whole
blood sample to the CVs of precision data from Table 4.7,
Precision of the Hemogram Parameters (N = 20) .
4.
Obtain printouts of related data as indicated in the following steps.
5.
WBC and Differential:
•
Configure the RUN Screen to display the following and obtain
printouts by pressing the Print Screen key on the keyboard.
(This requires two printouts per sample.)
Printout 1:
Printout 2:
Size/Complexity scatterplot
Depol/Orthogonal scatterplot
0
°
/90
°
scatterplot
90
°
/10
°
scatterplot
MP histogram
LBM histogram
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Chapter 10
If necessary, refer to the directions given in Chapter 5, Operating
Instructions , for customizing the display .
• Obtain printouts of the WBC kinetic data for several samples.
From the first DIAGNOSTICS MENU Screen , press [CNT
RATE SUMMARY].
Press [WBC CNT RATE] to display the data for the kinetic rate followed by [PRINT] to obtain a printout.
Press [WBC RATE GRAPH] to display the graph of the kinetic data followed by [PRINT] to obtain a printout.
• If there is a flagging problem or a problem with an abnormal sample, obtain a printout of a normal sample for comparison.
•
Obtain a printout of the RAW DATA SUMMARY Screen
immediately after the problem sample is run. From the first
DIAGNOSTICS MENU Screen , press [RAW DATA
SUMMARY] followed by [PRINT] to obtain a printout.
6.
RBC, HGB, MCV and PLT:
•
Configure the RUN Screen to display the RBC and PLT
histograms. Obtain printouts of problem samples.
•
Obtain a printout of the RAW DATA SUMMARY Screen
immediately after the problem sample is run. From the first
DIAGNOSTICS MENU Screen , press [RAW DATA
SUMMARY] followed by [PRINT] to obtain a printout.
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Messages and Fault Conditions
Overview
Messages displayed on the RUN Screen in the status box or on the
bulletin line are divided into two categories, instrument messages and
Instrument messages fall into two categories:
1.
Status Conditions — inform the operator of the instrument’s status or prompt the operator to take action relative to the last operator entry
2.
Fault Conditions — indicate fault or error detection
The status conditions
message and indicates its display location.
General fault conditions are listed in Table 10.2
sample-related fault conditions are listed in Table 10.3
Nonfunctional fault conditions are listed in Table 10.4
. Each table lists the probable cause and corrective
action.
The following tables are designed with the message or problem and display location (if applicable) centered on the first line. The corresponding explanation/action or probable cause/corrective action is indicated immediately below each message or problem.
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NOTES
Chapter 10
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Summary of Table 10.1, Instrument Status Conditions
Condition Page
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Chapter 10
Table 10.1: Instrument Status Conditions
The following abbreviations are used in this table:
BL — Bulletin Line
SB — Status Box
__________________________________________________________
Ready/SB
– – – – – – – – – – – – – – Explanation/Action– – – – – – – – – – – – – -
The Analyzer is ready to process samples.
__________________________________________________________
Selecting open/closed mode/SB
– – – – – – – – – – – – – – Explanation/Action– – – – – – – – – – – – – –
The [CHANGE SAMPLER] key was pressed and the Analyzer is changing to the selected mode of operation.
Resume processing when the READY message is displayed in the status box.
__________________________________________________________
Entering standby/SB
– – – – – – – – – – – – – – Explanation/Action– – – – – – – – – – – – – –
The instrument has been idle for four hours and therefore is automatically performing a cleaning cycle before entering the
STANDBY state. (Pressing the [DAILY SHUTDOWN] key also initiates this message.)
When the cycle is complete, press [PRIME] or [RUN] to initiate the priming cycle and return the instrument to the READY state. Resume operation when the cycle is complete.
__________________________________________________________
Standby/SB
– – – – – – – – –– – – – – Explanation/Action– – – – – – – – – – – – – – -
The instrument has entered the STANDBY state. Press [PRIME] or
[RUN] to initiate the priming cycle and return the instrument to the
READY state. Resume operation when the cycle is complete.
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Table 10.1
Instrument Status Conditions (Continued)
Initialized/SB
– – – – – – – – – – – – – Explanation/Action– – – – – – – – – – – – – – –
The Analyzer hardware initialization is complete.
Press [PRIME] or [RUN] to initiate the priming cycle and return the instrument to the READY state. Resume operation when the cycle is complete.
__________________________________________________________
Unpinching valves/SB
– – – – – – –– – – – – – – Explanation/Action– – – – – – – – – – – – – – –
The Analyzer was idle for a predetermined time period and therefore the valves are being exercised to be sure that tubing is not pinched shut.
Resume processing when the READY message is displayed in the status box.
__________________________________________________________
Extended Count/SB
– – – – – – –– – – – – – – Explanation/Action– – – – – – – – – – – – – – –
A low value has been detected for the WBC and/or PLT count. The
Analyzer is automatically extending the cycle to count more cells.
Press [PRIME] to resume processing.
__________________________________________________________
Clearing RBC Orifice/SB
– – – – – – –– – – – – – – Explanation/Action– – – – – – – – – – – – – – –
The [CLEAR ORIFICE] key was pressed or the instrument automatically performed the Clear Orifice function in response to a clog or flow problem.
Wait until the READY message is displayed in the status box and repeat the sample.
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Chapter 10
Table 10.1
Instrument Status Conditions (Continued)
Clearing fault/SB
– – – – – – – – – – – – – Explanation/Action– – – – – – – – – – – – – – –
The [CLEAR FAULT] key was pressed after an operator-correctable fault was detected.
Resume operation when READY is displayed in the status box and the word Ready on the status indicator panel is illuminated in green.
__________________________________________________________
Limits were changed to correct out of range values/BL
– – – – –– – – – – – – – – Explanation/Action– – – – – – – – – – – – – – –
A mathematically incorrect limit was manually entered (using [MEANS/
LIMITS]) during setup of a QC file. The numbers entered generated a range containing a number greater than the largest number allowed or less than zero. Therefore, the limits were automatically changed.
Check to be sure the entered values are correct. If appropriate, recalculate the mean and limits and enter correct values.
__________________________________________________________
Entries making upper limit = lower limit were rejected/BL
– – – – –– – – – – – – – – – Explanation/Action– – – – – – – – – – – – – –
A mathematically incorrect limit was entered (using [RANGE
ENTRY]) during setup of a QC file. The currently entered numbers are not accepted and the previously entered numbers for the parameter(s) remain.
Check to be sure the entered values are correct.
__________________________________________________________
Limits were exchanged to make upper > lower/BL
– – – – –– – – – – – – – – – Explanation/Action– – – – – – – – – – – – – –
A mathematically incorrect limit was entered (using [RANGE
ENTRY]) during setup of a QC file. The numbers entered caused the upper limit to be less than the lower limit. Therefore, the numbers were automatically exchanged.
Check to be sure the entered values are correct. If appropriate, enter correct values.
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Table 10.1
Instrument Status Conditions (Continued)
Westgard Warning — See Levey Jennings/BL.
The message is displayed on the VIEW QC LOG Screen only.
– – – – – – – – – – – – – – Explanation/Action– – – – – – – – – – – – – –
The Westgard Rules were selected during set up of the QC file and the data in the file has violated one or more of the selected rules.
Review the data in the QC file and take appropriate action.
__________________________________________________________
No Entry Found/BL
– – – – – – – – – – – – – – Explanation/Action– – – – – – – – – – – – – –
The number (sequence number or specimen ID number) entered on the
DATA LOG SEARCH Screen is not present in the data log.
Check that the entry was correct. If appropriate, enter the correct number.
__________________________________________________________
Duplicated Specimen ID/BL
– – – – – – – – – – – – – – Explanation/Action– – – – – – – – – – – – – –
The work list already contains the specimen ID number that has been entered.
It is not possible to enter the same specimen ID number twice in the work list. If appropriate, delete the previous entry and re-enter the number.
__________________________________________________________
Duplicated 4-digit Bar Code ID/BL
– – – – – – – – – – – – – – Explanation/Action– – – – – – – – – – – – – –
The work list already contains the 4-digit bar code number that has been entered.
It is not possible to enter the same 4-digit bar code number twice in the work list. If appropriate, delete the previous entry and re-enter the number.
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Chapter 10
Table 10.1
Instrument Status Conditions (Continued)
Bar Code flag not allowed to change
unless Work List is purged/BL
– – – – – – –– – – – – – – Explanation/Action– – – – – – – – – – – – – – –
The [BAR CODE ON] or [BAR CODE OFF] key was pressed and there is an existing work list.
Delete all samples from the work list before turning the bar code ON or
OFF.
__________________________________________________________
Auto Sampler Off/BL
– – – – – – –– – – – – – – Explanation/Action– – – – – – – – – – – – – – –
Power to the Sample Loader is turned OFF.
Turn ON the power switch and wait for the initialization cycle to be completed.
__________________________________________________________
Auto-Sampler Initializing/BL
– – – – – – –– – – – – – – Explanation/Action– – – – – – – – – – – – – – –
The Sample Loader hardware initialization cycle is in progress.
Wait for the cycle to be completed.
__________________________________________________________
Auto Sampler Ready/BL
– – – – – – –– – – – – – – Explanation/Action– – – – – – – – – – – – – – –
The Sample Loader initialization cycle is complete and samples may be processed. Press the Sample Loader START key to initiate processing.
__________________________________________________________
Auto Sampler Pause/BL
– – – – – – –– – – – – – – Explanation/Action– – – – – – – – – – – – – – –
The Sample Loader PAUSE key was pressed during operation and therefore, operation is suspended.
Press the Sample Loader START key to resume operation.
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Table 10.1
Instrument Status Conditions (Continued)
Auto Sampler Busy/BL
– – – – – – – – – – – – – Explanation/Action– – – – – – – – – – – – – – –
An action was requested during Sample Loader operation and the
Sample Loader cannot perform it.
Press the Sample Loader PAUSE key before requesting the desired action.
__________________________________________________________
Samples Completed/BL
– – – – – – – – – – – – – Explanation/Action– – – – – – – – – – – – – – –
The Sample Loader has completed processing samples in the end rack and has stopped automatically.
__________________________________________________________
Change Sampler in Ready State Only/BL
– – – – – – – – – – – – – Explanation/Action– – – – – – – – – – – – – – –
The [CHANGE SAMPLER] key was pressed while the Analyzer was busy.
The [CHANGE SAMPLER] key can only be pressed when the
Analyzer is in the READY state.
__________________________________________________________
Change sampler when Auto Sampler is not busy/BL
– – – – – – – – – – – – – Explanation/Action– – – – – – – – – – – – – – –
The [CHANGE SAMPLER] key was pressed while the Sampler Loader was busy.
Press the Sample Loader PAUSE key before pressing [CHANGE
SAMPLER].
__________________________________________________________
Change Specimen Type when Auto-Sampler is not busy/BL
– – – – – – – – – – – – – Explanation/Action– – – – – – – – – – – – – – –
The [SPECIMEN TYPE] key was pressed while the Sample Loader was busy. Press the Sample Loader PAUSE key before pressing
[SPECIMEN TYPE].
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Chapter 10
Table 10.1
Instrument Status Conditions (Continued)
Auto Sampler cannot be started if the safety cover is off/BL
– – – – – – – – – – – – – – Explanation/Action– – – – – – – – – – – – – –
The Sample Loader START key was pressed and the safety interlock switch did not sense that the safety cover was in place.
Replace the safety cover and then press the START key.
__________________________________________________________
Auto Sampler Emergency stop/BL
– – – – – – – – – – – – – Explanation/Action– – – – – – – – – – – – – – –
The Sample Loader E-STOP key was pressed during operation and the
Sample Loader is stopped.
Press the INIT key (if the light on the key is blinking) to initialize the
Sample Loader. If the INIT key light is not blinking, turn the Sample
Loader power switch OFF and ON to initialize.
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Summary of Table 10.2, General Fault Conditions
Condition Page
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Table 10.2: General Fault Conditions
The following abbreviations are used in this table:
BL — Bulletin Line
SB — Status Box
Information for each message is listed in order from the most likely cause of the message to the least likely cause of the message. Therefore, always troubleshoot a problem in this order. If a problem cannot be resolved by the corrective action indicated in this table, call for technical assistance.
__________________________________________________________
Not Ready: See DIAG or Not Ready: See Special/SB
If a fault condition has occurred, the word FAULT on the Analyzer status indicator panel is illuminated in red.
– – – – Probable Cause – – – – – – – – Corrective Action – – – –
1. A situation that prevents 1.
the READY state has been
detected. See the [FAULT REPORT] followed
DIAGNOSTICS MENU by [PRINT] to obtain a
SPECIAL printout describing the
problem. Refer to the whichever is indicated, for for appropriate table for more information. corrective action.
2. A diagnostic test was run 2.
The instrument must be using one of the initialized when the
DIAGNOSTICS MENU diagnostic test in progress
Screen keys. is complete. Initialize the
Analyzer by pressing the
[INITIALIZATION] key on
3. A special protocols 3.
Check the SPECIAL procedure is in progress. PROTOCOLS MENU Screen
and perform the action necessary to complete the
procedure.
4. System malfunction. 4.
Call for technical assistance.
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Table 10.2
General Fault Conditions (Continued)
Uninitialized/SB
– – – – Probable Cause – – – – – – – – Corrective Action – – – –
1.
2.
Data Station has power the Analyzer is not responding.
Communication malbetween the
Analyzer and Data Station.
1.
Ensure that the Analyzer but power cord is connected to the Analyzer and that the cord is connected to the power outlet. Initialize the
Analyzer by pressing the
[INITIALIZATION] key on
2.
Check the cable that function connects the Analyzer to the Data Station. If necessary, secure the connections. Initialize the
Analyzer by pressing the
[INITIALIZATION] key on
__________________________________________________________
Initialization Failed
Bottom of screen ( MAIN MENU is not displayed)
– – – – – Probable Cause – – – – – – – – – Corrective Action – – – –
1.
The Data Station was unable to initialize. The
CELL-DYN software does not display the
1.
Initialize the Analyzer by following the instructions
Power ON procedures given in the Troubleshooting
chapter. If the Data Station does not initialize, press the Print Screen key on the computer keyboard to document any screen messages, then call for technical assistance.
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Chapter 10
Table 10.2
General Fault Conditions (Continued)
Printer (Graphics or Ticket) Unavailable/SB
– – – - Probable Cause – – – – – – – - Corrective Action – – – –
1.
The print buffer (the memory area where the material is stored while awaiting printing) is full.
2.
The printer is turned OFF.
1.
Press the [STOP PRINTING] key followed by the
[CONFIRM STOP] key on
for the appropriate printer.
2.
Turn the printer power switch ON.
3.
The printer is not on-line.
4.
The printer is disconnected or the connection is loose.
3.
Check that the printer
“on-line” indicator is illuminated. If necessary, refer to the printer manual for assistance.
4.
Check the printer cable connection on the back of the Data Station and on the back of the printer. If necessary, secure the connections. Press [PRINT
REPORT]. If the message is still displayed, turn the printer power switch OFF and ON to reset the printer.
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Table 10.2
General Fault Conditions (Continued)
Diluent, Lyse, or Sheath empty/SB and BL
– – – – – Probable Cause – – – – – – – – Corrective Action – – – –
1.
Container is empty.
1.
Install a new container of reagent and then press
[CLEAR FAULT].
NOTE: Do not pour any remaining reagent into the new container.
2.
Reagent inlet tubing is crimped or obstructed.
2.
Inspect the inlet tubing to ensure it is not crimped and/or remove any obstruction.
3.
Reagent line is not on the bottom of the container.
4.
5.
An incorrect reagent or a nonconductive liquid is connected to the inlet tube.
Circuitry malfunction.
3.
Ensure that the line is properly inserted in the container and the sinker is on the bottom of the container.
4.
Check the label on the reagent container to be sure the correct reagent is installed. Trace the line to the inlet connector and ensure that it is connected to the correct one. Check the connection to be sure it is secure and then press
[CLEAR FAULT].
5.
Call for technical assistance.
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Chapter 10
Table 10.2
General Fault Conditions (Continued)
External waste full/SB
WARNING: Potential Biohazard. Follow established biosafety practices when performing maintenance, service or troubleshooting procedures. Wear gloves, lab coat, and suitable
eye protection. Refer to Chapter 8, Precautions, Limitations and
Hazards , for additional information.
– – – – – Probable Cause – – – – – – – – – Corrective Action – – – –
1.
Waste container full.
1.
Empty the waste container and/or replace it. Press
[CLEAR FAULT] to resume operation.
2.
Waste sensor connector is loose or disconnected.
2.
Reconnect the waste sensor connector and then press
[CLEAR FAULT].
3.
Shorted wire(s) or electrode(s) on the waste cap.
3.
Inspect wires and electrodes and call for technical assistance.
4.
Circuitry malfunction.
4.
Call for technical assistance.
__________________________________________________________
Blood in Line/BL
– – – – – Probable Cause – – – – – – – – Corrective Action – – – –
1.
At the beginning of the count cycle, the instrument detects blood in the sample line that runs from the top of the Sample Loader tower to the shear valve.
2.
After four Blood in Line faults, the Sample Loader halts.
1.
Check the sample line to see if it contains blood. If it does, clean or replace the
Sample Loader needle.
2.
Check for a crimp in the sample aspiration tubing between the Sample Loader and the Analyzer.
NOTE: If necessary, samples can be processed in the open mode, as it is not affected by this problem. To run samples in the open
this chapter. When initialization is complete, the open mode is automatically selected and samples can then be processed.
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Chapter 10 Search Book TOC Go Back Troubleshooting
Table 10.2
General Fault Conditions (Continued)
Shear Valve position fault/BL
– – – – Probable Cause – – – – – – – – Corrective Action – – – –
1.
The shear valve did not rotate properly or in the allotted time.
1.
Clean the shear valve.
__________________________________________________________
RBC diluent syringe overpressure/SB
– – – – – Probable Cause – – – – – – – – Corrective Action – – – –
1.
Clean the RBC diluent syringe.
1.
Excessive pressure was detected during the up-stroke of the RBC diluent syringe.
2.
The shear valve did not rotate completely or in the time allotted.
2.
Clean the shear valve.
3.
The center section of the shear valve is installed backwards.
3.
Verify that the center section of the shear valve is installed correctly.
4.
If the problem persists, call for technical assistance.
__________________________________________________________
Vacuum accumulator (1 or 2) wet/BL
– – – – – Probable Cause – – – – – – – – Corrective Action – – – –
1.
The internal vacuum accumulator has filled with liquid beyond allowable limits.
1.
Clean as directed in
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Chapter 10
Table 10.2
General Fault Conditions (Continued)
Flow sequence time out <x,x>/BL
NOTE: Characters in the brackets identify the problem flow sequence number and flow sequence name.
– – – – – Probable Cause – – – – – – – – Corrective Action – – – –
1.
An internal Analyzer flow sequence was not completed in the allotted time.
1.
Record the characters in the brackets. Call the Customer
Support Center to report the problem at
1 (800) CELL DYN.
Initialize the Analyzer by pressing the
[INITIALIZATION] key on
processing if the fault does not recur.
__________________________________________________________
Command sent at incorrect time/BL
– – – – – Probable Cause – – – – – – – – Corrective Action – – – –
1.
The Analyzer received a command from the Data
Station at the incorrect time and could not process it.
1.
Initialize the Analyzer by pressing the
[INITIALIZATION] key on
call for technical assistance.
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Table 10.2
General Fault Conditions (Continued)
Data acquisition overlap/BL
– – – – – Probable Cause – – – – – – – – Corrective Action – – – –
1.
The timing of communication between the
Analyzer and the Data
Station is incorrect.
1.
Document what was happening when the message was displayed and report the problem to the
Customer Support Center.
Initialize the Analyzer by pressing the
[INITIALIZATION] key on
processing if the fault does not recur.
NOTE: The error may occur when several tasks are requested in rapid sequence. For example, print data log, transmit result, sample processing, print ticket, print report, etc.
__________________________________________________________
List mode data phase error/BL
– – – – – Probable Cause – – – – – – – – Corrective Action – – – –
1.
The order of the data received by the Data
Station during a measurement was incorrect.
1.
Call for technical assistance.
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Chapter 10
Table 10.2
General Fault Conditions (Continued)
Message acknowledgment time out/BL
– – – – – Probable Cause – – – – – – – – – Corrective Action – – – –
1.
Communication between the Analyzer and the Data
Station did not occur when expected.
1.
Initialize the Analyzer by pressing the
[INITIALIZATION] key on
recurs, call for technical assistance.
__________________________________________________________
Message reception time out/BL
– – – – – Probable Cause – – – – – – – – Corrective Action – – – –
1.
Communication between the Analyzer and the Data
Station did not occur when expected.
1.
Initialize the Analyzer by pressing the
[INITIALIZATION] key on
recurs, call for technical assistance.
__________________________________________________________
Run time error/BL
– – – – – Probable Cause – – – – – – – – Corrective Action – – – –
1.
An illegal software operation was requested by the Analyzer.
1.
Document what was happening when the message was displayed and call for technical assistance.
2.
Initialize the Analyzer by pressing the
[INITIALIZATION] key on
processing if the fault does not recur.
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Table 10.2
General Fault Conditions (Continued)
Bad checksum in non-volatile RAM/BL
– – – – – Probable Cause – – – – – – – – Corrective Action – – – –
1.
When the system was powered ON, the Analyzer did not transmit the correct message to the Data Station.
1.
Call for technical assistance.
__________________________________________________________
Bad monitor command/BL
NOTE: This message does not pertain to the Data Station screen (CRT).
– – – – – Probable Cause – – – –
1.
During the initialization process, the Data Station and Analyzer did not communicate properly.
– – – – Corrective Action – – – –
1.
Initialize the Analyzer by pressing the
[INITIALIZATION] key on the second
call for technical assistance .
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Chapter 10
Table 10.2
General Fault Conditions (Continued)
Auto-Sampler alarm condition <u>; see DIAG/BL
– – – – – Probable Cause – – – – – – – Corrective Action – – – – –
1.
Sample Loader rack movement is impeded.
1.
Clear the rack movement obstruction and/or clean the Sample Loader racks and trays.
Press the [CLEAR FAULT]
to reinitialize the Sample
Loader and bring the Data
Station to the READY state.
OR
2.
The rack and/or position
ID label is unreadable.
3.
The specimen bar code label is the same as an
ID label used on the rack or slots.
From the DIAGNOSTICS menu , press the [FAULT
REPORT] soft key. Then press the [CLEAR FAULTS] soft key to reinitialize the
Sample Loader and bring the
Data Station to the READY state. (It is not necessary to press the Sample Loader
RESET key.)
2.
Check and/or replace the rack ID/position ID label.
3.
Ensure that your bar code labels are not replicates of the rack and position ID labels.
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Table 10.2
General Fault Conditions (Continued)
Auto-Sampler alarm condition <x,x> see DIAG/BL
NOTE: The characters in the brackets identify the condition.
– – – – – Probable Cause – – – – – – – – Corrective Action – – – –
1.
The Sample Loader detected a hardware fault and ceased operation.
1.
From the first
REPORT] followed by
[PRINT] to obtain a printout describing the problem. Initialize the
Sample Loader by pressing the INIT key on the Sample
Loader operation keyboard.
Samples may be processed if the fault does not recur.
2.
Circuitry malfunction.
2.
Call for technical assistance.
__________________________________________________________
Auto-Sampler command negatively acknowledged/BL
– – – – – Probable Cause – – – –
1.
The Sample Loader did not respond to an Analyzer command.
– – – – Corrective Action – – – –
1.
Ensure that the Sample
Loader power cord is connected to the Sample
Loader and that the cord is connected to the power outlet. Initialize the Sample
Loader by pressing the INIT key on the Sample Loader operation keyboard.
Check the connections of the cable that connects the
Sample Loader to the
Analyzer. If necessary, secure the connections.
Initialize the Sample Loader by pressing the INIT key on the Sample Loader operation keyboard.
2.
Circuitry malfunction.
2.
Call for technical assistance.
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NOTES
Chapter 10
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Summary of Table 10.3, Sample-Related Fault Conditions
Condition Page
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Chapter 10
Table 10.3: Sample-Related Fault Conditions
The following abbreviations are used in this table:
BL — Bulletin Line
SB — Status Box
Information for each message is listed in order from the most likely cause of the message to the least likely cause of the message. Therefore, always troubleshoot a problem in this order.
__________________________________________________________
Sampling Error — Incomplete Aspiration/BL
SAMPLING ERR is displayed on the RUN Screen to the right of the
MCHC result.
SAMPLING ERR is printed on the graphics and pre-printed ticket report.
SAMPLING ERROR is printed on the blank ticket.
– – – – – Probable Cause – – – – – – – Corrective Action – – – – –
1.
The blood sensors did not detect a sufficient amount of sample aspiration.
1.
Check the sample tube to be sure it contains a sufficient quantity of during blood.
2.
Clean the open sample aspiration probe as directed in the Troubleshooting Procedures
section of this chapter or
the closed mode needle (CS or SL ) as directed in
remove any obstructions.
3.
Change the aspiration peristaltic pump tubing as directed in Chapter 9,
4.
Clean the shear valve as directed in Chapter 9,
5.
Call for technical assistance.
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Table 10.3 Sample-Related Fault Conditions (Continued)
Mixing Error/BL
MIXING ERR is displayed on the RUN Screen to the right of the MCH
result.
SAMPLING ERR is displayed to the right of the MCHC result.
MIXING ERR is printed on the graphics report. A mixing error is always accompanied by a sampling error; therefore, SAMPLING ERR is printed on all reports.
– – – – – Probable Cause – – – – – – – – Corrective Action – – – –
1.
The blood sensors did not detect a sufficient amount of sample aspiration.
1.
Check the sample tube to be sure it contains a sufficient quantity of during blood.
2.
Clean the open sample aspiration probe as directed in the Troubleshooting Procedures
section of this chapter or
the closed mode needle (CS or SL ) as directed in
remove any obstructions.
3.
Change the aspiration peristaltic pump tubing as directed in Chapter 9,
4.
Clean the shear valve as directed in Chapter 9,
5.
Call for technical assistance.
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Chapter 10
Table 10.3 Sample-Related Fault Conditions (Continued)
Auto-Sampler consecutive data faults/BL
– – – – – Probable Cause – – – – – – – – Corrective Action – – – –
1.
During sample processing, four consecutive incomplete aspiration or metering faults were detected and the
Sample Loader halted.
1.
Correct the situation on the
Analyzer as follows:
•
•
•
Check the appropriate tubing for a plug or pinch.
Press [CLEAR ORIFICE] to clear the aperture.
Clean the Sample Loader needle . (If necessary,
refer to the instructions
2.
Press the [CLEAR FAULT]
automatically resumes processing.
3.
If the problem persists, follow the instructions
given in the Troubleshooting Tips and
chapter for trouble-
shooting clog, flow or incomplete aspiration messages.
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Table 10.3 Sample-Related Fault Conditions (Continued)
WBC Metering Fault — Flow Error/BL
WBC FLOW ERROR is displayed on the RUN Screen to the right of
the NEU results.
WBC FLOW is printed on the graphics report.
Results for WBC and Differential are suppressed.
– – – – – Probable Cause – – – –
1.
An increasing WBC count rate was detected in the
WBC flow cell during the
WBC measurement.
– – – – Corrective Action – – – –
1.
Repeat the sample.
2.
Change the WBC transfer peristaltic pump tubing as directed in Chapter 9,
3.
Clean the WBC metering syringe as directed in
4.
Refer to the Troubleshooting Tips and
chapter for help with collecting further information.
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Chapter 10
Table 10.3 Sample-Related Fault Conditions (Continued)
RBC Metering Fault — Clog or Flow Error/BL
CLOG or FLOW ERROR is displayed on the RUN Screen to the right
of the RDW result.
RBC CLOG or RBC FLOW is printed on the graphics report.
Results for RBC, PLT and related parameters are suppressed.
– – – – – Probable Cause – – – – – – – – Corrective Action – – – –
1.
The timing for the RBC/PLT 1.
Repeat the sample. If the metering was outside acceptable limits.
problem was caused by debris in the aperture, the automatic cleaning cycle may have corrected it.
2.
Clean the RBC/PLT aperture as directed in
NOTE: The Analyzer automatically cleans the RBC/PLT aperture after a metering fault is detected. CLEANING RBC
ORIFICE is displayed in the status box.
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Summary of Table 10.4, Non-Functional Fault Conditions
Condition Page
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Chapter 10
Table 10.4: Non-Functional Fault Conditions
Analyzer or Data Station will not power ON
– – – – – Probable Cause – – – – – – – – Corrective Action – – – –
1.
Power source is defective.
2.
Power cord is not securely connected to the Analyzer or is not connected to the power outlet.
1.
Verify that the power switch is OFF and connect the system to a known-good power source.
2.
Ensure that the power cord
is securely connected to the Analyzer or Data
Station and verify that it is connected to the power outlet.
3.
Analyzer fuse is blown or incorrect.
3.
The Analyzer fuse is located above the power cord connector on the rear panel.
Check the fuse as directed in the Troubleshooting
chapter.
CAUTION: Always turn the Analyzer power switch OFF and disconnect the power cord from the receptacle before checking or replacing any fuse.
4.
Defective power switch or other system malfunction.
4.
Call for technical assistance.
__________________________________________________________
No screen display
– – – – – Probable Cause – – – – – – – – Corrective Action – – – –
1.
Turn the power switch ON.
1.
Data Station power switch is turned OFF.
2.
Data Station brightness control is turned down.
Station until the image is
2.
Adjust the brightness control on the right side of the Data
3.
Defective Data Station or other component.
visible.
3.
Call for technical assistance.
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Chapter 10 Search Book TOC Go Back Troubleshooting
Table 10.4 Non-Functional Fault Conditions (Continued)
The MAIN MENU Screen is not displayed after initialization
– – – – – Probable Cause – – – –
1.
There is a floppy disk in the Data Station disk drive.
– – – – Corrective Action – – – –
1.
If a disk is present, remove it and initialize the Data
Station by turning the power switch OFF and ON.
2.
The external keyboard is defective.
2.
Disconnect the external keyboard from the Data
Station and then initialize the Data Station by turning the power switch OFF and
initialization is complete, call the Customer Support
Center and report the problem. Resume operation using the Data Station membrane keyboard.
3.
Call for technical assistance.
3.
A file is missing or is incorrect on the Data
Station’s hard drive.
4.
There is a hardware or software malfunction.
4.
Call for technical assistance.
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Chapter 10
Table 10.4 Non-Functional Fault Conditions (Continued)
The word FAULT on the Analyzer status indicator panel is illuminated in red
NOTE: This type of fault is usually accompanied by a message in the status box and/or on the bulletin line.
– – – – – Probable Cause – – – –
1.
The Analyzer has detected a fault situation and has
inhibited operation.
– – – – Corrective Action – – – –
1.
From the first
REPORT]. Print a copy of the report and perform the indicated corrective action. When the action is completed, initialize the Analyzer by pressing the
[INITIALIZATION] key on
2.
If the fault report does not indicate a message or action, document the situation and initialize the Analyzer by pressing the
[INITIALIZATION] key on
__________________________________________________________
Instrument will not stop cycling
– – – – – Probable Cause – – – – – – – – Corrective Action – – – –
1.
The touch plate is stuck or being held down in some way.
pressing it several times.
2.
Circuitry malfunction.
1.
Check the touch plate and remove any obstructions.
Verify that it is not sticking by
2.
Call for technical assistance.
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CELL-DYN
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Table 10.4 Non-Functional Fault Conditions (Continued)
Background count is outside acceptable limits
– – – – – Probable Cause – – – – – – – Corrective Action – – – –
1.
The Analyzer front covers are removed.
2.
3.
4.
Debris is present in the system or on the aperture plate.
The reagents are cold.
The reagents may be contaminated.
1.
Verify that the ground wires are securely connected and replace the front covers.
Repeat the background count.
2.
CLEAN] to clean the system. When the cycle is complete, repeat the background count.
Remove and clean the RBC/PLT aperture plate. Repeat the background count.
3.
Allow the reagents to warm to room temperature and then repeat the background count.
4.
Replace the appropriate reagent according to the directions given in the
Background Count procedure and the
Troubleshooting Reagent Problems procedure in the
chapter.
5.
There is liquid in the vacuum accumulator.
6.
There are bubbles in the diluent syringe.
7.
The shear valve is dirty.
5.
Clean the vacuum accumulators.
6.
Clean the diluent syringe.
7.
Clean the shear valve.
Repeat the background count.
10-77
Troubleshooting
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Chapter 10
Table 10.4 Non-Functional Fault Conditions (Continued)
The Data Station keyboards are not operational
– – – – – Probable Cause – – – – – – – Corrective Action – – – – –
1.
The computer is performing a function that inhibits the keys.
2.
There is an incomplete operator entry.
3.
A data transmission to the printer or laboratory computer is in progress.
4.
Keyboard entry is not possible on the displayed screen.
5.
Data Station computer, keyboard and/or circuitry malfunction.
1.
No action required.
Refer to the screen for the current Status Box message.
2.
Complete the operator entry or press the Esc key on the keyboard.
3.
No action required. Refer to the screen for the
Status Box message.
4.
No action required. Refer to the screen for the current Status Box message.
5.
Call for technical assistance.
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Chapter 10
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Table 10.4 Non-Functional Fault Conditions (Continued)
The Sample Loader does not power ON
– – – – – Probable Cause – – – – – – – – Corrective Action – – – –
1.
The power cord is loose or disconnected.
1.
Ensure that the power cord is securely connected to the Sample Loader and verify that it is connected to the power outlet.
2.
Circuitry malfunction.
2.
Call for technical assistance.
__________________________________________________________
The Sample Loader beeps and the START key is not illuminated
– – – – – Probable Cause – – – – – – – – Corrective Action – – – –
1.
The cable that connects the Sample Loader to the
Analyzer is loose or disconnected.
1.
Check that each end of the cable is securely connected.
If necessary, remove the cable and reconnect it.
Press the INIT key on the
Sample Loader operation keyboard to initialize the
Sample Loader.
2.
Circuitry malfunction.
2.
Call for technical assistance.
__________________________________________________________
The System does not communicate with LIS
– – – – – Probable Cause – – – – – – – – Corrective Action – – – –
1.
Interface malfunction.
2.
System not transmitting.
or receiving.
1.
Perform the [SERIAL TEST] procedure described on page 10-21 .
2.
Call for technical assistance.
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Troubleshooting
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NOTES
Chapter 10
10-80
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Printer
Chapter Table of Contents
Printing Graphics Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-1
Loading Individual Tickets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-2
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Table of Contents-1
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NOTES
Chapter 11
Table of Contents-2
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Chapter 11 Search Book TOC Go Back
Printer
Introduction
The CELL-DYN® 3000 has the capability of printing graphics reports and ticket printouts. The printer can be configured as either a graphics printer for graphics reports or a ticket printer for blank or preprinted tickets. The same printer can be used for either configuration, but if both tickets and graphics reports are required, two printers must be installed.
Graphics or ticket reports can be automatically printed at the completion of each run cycle or on command by the operator.
Instructions for the installation of either printer are given in the Printer
Installation section of Chapter 2, Installation . Complete directions for
customizing the printout type and format are given in the Set Up
Instructions section of Chapter 5, Operating Instructions .
Printing Graphics Reports
To print graphics, the printer cable must be connected to the graphics
printer port on the back of the Data Station . (See Figure 2.1
location of this port.) Refer to the Customize Printout section in the Set
Up section of Chapter 5, Operating Instructions , for instructions for
customizing the printout.
Printing Tickets
For a detailed description of the printer components and instructions for changing the ribbon and loading paper, refer to the manuals that accompany the printer. In particular, note the important safety instructions.
The printer can be used to print result data on blank or pre-printed tickets. Blank tickets are available in continuous tractor-feed sheets.
(These tickets are loaded like continuous-feed paper.) Preprinted tickets are loaded individually.
This section gives information about printing tickets and instructions for loading individual pre-printed tickets in the printer when it is configured to print tickets.
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Printer
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Chapter 11
To print tickets, the printer cable must be connected to the ticket printer
port on the back of the Data Station . (See Figure 2.1
this port.) Refer to the Customize Printout section in the Set Up section
of
Chapter 5, Operating Instructions , for instructions for customizing the
printout.
Loading Individual Tickets
Instructions are given for loading individual tickets. If fanfold, continuous-feed tickets are used, they should be loaded as directed in the printer manual for tractor-feed paper.
1.
Be sure that the printer is turned ON and the printer cable is connected to the ticket printer port on the back of the Data Station.
If the connection is incorrect, turn the Data Station power OFF, change the position of the cable and turn the power back ON.
2.
Set the ribbon cartridge headgap lever to adjust for the thickness of
the tickets. Refer to the following figure for the location of the
headgap lever and the printer manual for detailed instructions.
11-2
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Chapter 11
Printhead
(Detail View)
(Lower) Red Line on Paper Shield
Bail Lever
Search Book TOC Go Back
Headgap Lever
Paper Lever
(Detail View)
Paper Guide
Printer
Paper
Selection
Lever in
Single-Sheet
Position
Paper
Selection
Lever in
Tractor-Feed
Position
Paper
Separator
Access Cover
(Shown Open)
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Printer Power
On/Off Switch
Guide Wire
(in Locked Position)
Figure 11.1: OKIDATA ® MICROLINE ® Printer
3.
Move the paper selection lever to the rear position to select single-feed paper.
4.
Open the access cover and be sure the guide wire on the paper separator is pushed back into the locked position.
5.
Raise the separator to its upright position.
6.
Place a ticket on the paper separator and adjust the guides so that they barely touch the edges of the ticket.
11-3
Printer
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Chapter 11
7.
Pull the bail lever forward. The ticket will automatically feed into place. Release the paper bail lever.
8.
Be sure the printer is deselected (SEL indicator is not illuminated) and set the top of form by pressing and holding the TOF/QUIET key and pressing the FORM FEED key to move the ticket up or pressing the LINE FEED key to move the ticket down. (The ticket moves in very fine increments so it can be precisely positioned.)
NOTE: The ticket will only move down to a certain point to prevent potential ticket jams. Do not move the top of the ticket below the paper bail.
9.
Position the ticket so that the lower red line on the paper shield
(located between the print head and the paper) is positioned where the first line of printing should occur.
NOTE: When the top of form is set, the position is retained in the printer memory until it is reset.
10.
Press the SEL key to select the printer. The printer is now ready to print.
11-4
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Chapter 11
Maintenance
Search Book TOC Go Back Printer
Every six months (or after 300 hours of operation), use a clean, dry cloth to dust the area around the carriage shaft and platen. Be sure to remove any loose particles of paper. Do not use solvents or strong detergents on the cabinet.
WARNING: Be sure to turn the printer OFF and disconnect the power cord before cleaning.
Platen
Carriage Shaft
Figure 11.2: Printer Carriage Shaft and Platen
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Printer
Troubleshooting
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Chapter 11
Refer to the printer manuals for a list of the most common printer problems and how to solve them. If the problem is not resolved, contact the Abbott Customer Support Center for assistance at
1 (800) CELL DYN.
NOTE: If, during routine system operation, the message
PRINTER UNAVAILABLE is displayed on the bulletin line, check to see that the printer cable is securely connected to the
Data Station, the printer power switch is turned ON, and that the
SEL indicator is illuminated. Press the [PRINT] key on the Data
Station screen. If the message is still displayed, turn the printer power OFF, wait about five seconds, turn the power ON again and press the [PRINT] key on the Data Station screen. If the message is still displayed, there may be an internal printer error.
Contact the Abbott Customer Support Center for assistance at
1 (800) CELL DYN.
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Sample Loader
Chapter Table of Contents
CELL-DYN Bar Code Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-2
CELL-DYN Q Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-2
Bar Code Label Placement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-3
Sample Loader Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-4
Sample Loader Operation Keyboard Keys . . . . . . . . . . . . . . . . . . . . 12-5
Operating Principles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-7
Functional Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-7
Function Sequence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-12
Routine Operating Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-15
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NOTES
Chapter 12
Table of Contents-2
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Chapter 12
Overview
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Sample Loader
The Sample Loader for the CELL-DYN® 3000SL is an automated microprocessor-based sample-handling system designed to fit directly in front of the Analyzer. (See Figure 12.1.) The Analyzer communicates electronically with the Sample Loader and vice versa. The Sample
Loader delivers blood samples (and their identification information) to the CELL-DYN 3000SL for analysis. The sample tubes are transported in racks that maintain the tubes in an upright position. The Sample
Loader accommodates up to 100 samples with or without bar code labels.
Data Station
Analyzer
Analyzer
Pedestal
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Sample
Loader
Sample Loader
Platform
Figure 12.1: Analyzer with Sample Loader
Once initialized, when the START key on the Sample Loader is pressed, racks move to advance each tube through three processing stations located on the tower unit.
Station 1, Venting:
Station 2, Mixing:
Station 3, Aspirating: tube sensed, tube positioned by the plunger, and tube stopper punctured by vent needle to relieve vacuum bar code label read (if present), sample mixed plunger positions tube, tube stopper punctured, and sample aspirated
12-1
Sample Loader
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Station 3
Aspirating
Tower
Chapter 12
Station 2
Mixing
Station 1
Venting
Figure 12.2: Rack Movement
The tube racks move from the right side of the tray, through the three tower stations, to the left side of the tray. (See Figure 12.2.) The rack on the right side at the back of the tray is the first to be processed.
Fluids travel between the Analyzer and the Sample Loader through five tubes. These tubes carry blood and waste to the Analyzer and Diluent to the Sample Loader for cleaning. A cable is connected to the Analyzer to provide bidirectional communication.
Refer to Chapter 4, System Specifications , for complete specifications for the Sample Loader .
Labels
CELL-DYN Bar Code Labels
CELL-DYN 4-digit bar code labels are available for the Sample Loader
(L/N 99650-01 for one roll, or L/N 99651-01 for a box of ten). These labels may be used for positive specimen identification when laboratory-generated bar code labels are unavailable.
CELL-DYN Q Labels
Special bar code labels are available to identify QC specimens. These
“Q” labels (numbers Q1 – Q20, L/N 99652-01) automatically select QC files 1 to 20 and therefore should be used to process only QC specimens.
12-2
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Bar Code Label Placement
All labels should be placed on the tubes securely and without flaps or edges sticking out. Labels should not cover the cap (high collar) or the bottom (tail) of the tube. (See Figure 12.3.) Excessive numbers of labels may prevent tubes from mixing properly.
Top Surface
Should Be Dry
Clear
Tape
Properly Labeled Tubes
Barcode
Label
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3000 System Operator’s Manual
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Exposed
Bottom
16.5 mm
Diameter
Width Limit For
Multiple Labels
Improperly Labeled Tubes
Flap
High
Collar
Edges
Peeled
Loose
Tail
Figure 12.3: Tube Labeling Requirements
The bar code label should be placed on the tube just below the stopper with the bars perpendicular to the length of the tube. See Figure 12.3 for proper placement.
NOTE: Refer to Appendix A, Bar Codes , for complete
information on bar codes and specifications.
12-3
Sample Loader
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Chapter 12
Sample Loader Components
The Sample Loader consists of a main module and a tower unit as depicted in Figure 12.4. The functions of the keys on the Sample Loader
are discussed briefly in this section. The Sample Loader operation keyboard is shown in Figure 12.5
Safety Cover
Tower Unit
12-4
Operation
Keyboard
Tube Racks
Main Module
Figure 12.4: Sample Loader
The main module contains:
Power On/Off switch
Power and communication connectors
Operation keyboard
Safety cover
Tray to hold the tube racks
The tower unit contains:
Vent needle and vent needle wash block
One mixing head
Aspiration needle and aspiration needle wash block
Tube sensor
Vial positioning mechanism (referred to as the plunger)
Bar code reader
NOTE: A detailed functional description of all components is
given in the Functional Description section of this chapter.
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Thumbscrews Manual
Operation
Keys
Primary
Keys
Figure 12.5: Operation Keyboard
Sample Loader Operation Keyboard Keys
The operator controls the Sample Loader using the operation keyboard.
See Figure 12.5.
Primary Keys
The primary Sample Loader keys are:
INIT—Initiates the initialization cycle. This key appears after the
[RESET] key is pressed.
START—Initiates processing whenever the CELL-DYN 3000SL is in the closed mode READY state.
PAUSE—Pauses processing after the current cycle is completed. This key is used any time the processing needs to be interrupted.
REPEAT—Moves the sample back to the mixing station and remixes it prior to re-aspiration.
RESET—Resets the Sample Loader and activates the INIT key, usually in conjunction with an activated alarm situation.
E/STOP (emergency stop)—Terminates processing immediately. Any sample being processed when this key is pressed must be repeated.
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Sample Loader
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Chapter 12
Manual Operation Keys
The manual keys are located under a removable cover that is held in place by a set of thumbscrews. These keys are used to check specific
Sample Loader functions during troubleshooting or service. These keys
should only be used at the direction of the Customer Support Center or
an authorized Abbott representative.
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Chapter 12 Search Book TOC Go Back Sample Loader
Operating Principles
Functional Description
The Sample Loader is designed to fit directly in front of the Analyzer. A
Five tubes (one aspiration, two rinse and two waste) are connected from the Sample Loader tower to the Analyzer flow panel. A communication cable is connected from the Sample Loader’s right side panel to the
Analyzer’s left side panel. The Sample Loader operation keyboard is
located on the right side of the main module. (See Figure 12.4
Three stations located on the
Sample Loader tower unit are used to vent, mix, and aspirate each sample tube. (See Figure 12.6
sensor checks for the presence of a tube at Station 1. If a tube is detected, the vent needle punctures the stopper to vent the tube to atmospheric pressure. At Station 2, the mixing head extends to mix the sample and the bar code reader simultaneously reads any bar code label present. Mixing is done by rotating the tube in both directions. If the mixing head contacts a tube that was not sensed at Station 1, a fault occurs. At
Station 3, the aspiration needle extends to puncture the tube stopper and aspirate the mixed sample.
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Chapter 12
12-8
Station 3
Aspirating
Station 1
Venting
Station 2
Mixing
Figure 12.6: Tower Stations
When the tube is at Station 1 or Station 3, a plunger (vial positioning mechanism) positions the tube vertically in the rack and holds it while the tube is vented or the sample is aspirated. This enables the tube stopper to be pierced in the center and the rack to accommodate tubes with varying numbers of labels.
Ten tube racks must be in place for Sample Loader operation. The end
rack is marked with black labels on top and a black label on the left end
.) This rack is used to indicate the last rack
of a specific run. The Sample Loader automatically stops when the end rack reaches the left rear corner of the tray.
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Chapter 12 Search Book TOC Go Back Sample Loader
A clear plexiglass safety cover fits on top of the main Sample Loader module. This covers the tray and the processing stations to prevent aerosol contamination, exposure to the bar code reader laser and the needles while the Sample Loader is processing specimens.
NOTE: The Sample Loader has an interlock switch that prevents operation when the safety cover is not in place. The operator must press the PAUSE key and wait for the Sample
Loader to stop processing before lifting or removing the cover.
Lifting the cover while the Sample Loader is operating causes an immediate emergency stop condition, and the current sample must be rerun.
CAUTION: If a Sample Loader fault occurs that necessitates initialization of the Sample Loader, remove all samples that have been processed before restarting the Sample Loader. If these samples are not removed, misidentification of the remaining samples will occur.
When the Sample Loader detects the end rack, the Sample Loader stops and emits audible beeps for three seconds to alert the operator. The message SAMPLES COMPLETED appears in the Data Station bulletin line. Continuous processing can be accomplished by substituting a rack other than the end rack.
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Sample Loader
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Chapter 12
Bar Coded
Position
ID Label
Black End Rack Visual Indicator Label
(END RACK ONLY)
Rack ID
Number
Label
Tube
Rack
Bar Coded Rack
ID Label
Orient Numbered End
DOWNWARD
Figure 12.7: Tube Racks
Black End Rack Sensor Label
(END RACK ONLY)
NOTE: The bar coded rack ID label is read when the tube in the first position is moved to the aspirate station. If there is no bar code label on the rack or the label is unreadable, the Sample
Loader stops and the message Auto-Sampler alarm condition
<u>; see DIAG is displayed on the bulletin line. Refer to
Chapter 10, Troubleshooting . Bar coded rack ID labels on tube
racks are mandatory for proper Sample Loader operation. They must be placed on racks between tube positions 1 and 2, even if bar code labels on samples are not used. For more information,
refer to Chapter 2, Installation .
The bar coded rack ID label identifies each rack by number and is read by the bar code reader. The system tracks the rack number and tube position for each sample placed in the rack.
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Chapter 12 Search Book TOC Go Back Sample Loader
The Sample Loader bar coded rack ID label serves as the identification of tube position number 1. Bar coded position ID labels, numbers 2 through
10, used for identification of the remaining tube positions, are encoded as letters of the alphabet. The position ID label is read by the bar code reader during each rack movement. Failure to read the appropriate position ID label will result in an immediate fault and the Sample Loader
NOTE: Use of specimen ID bar code labels containing only a single letter or double letters (A to ZZ) will generate an Auto-
Sampler Alarm Condition <u>; See DIAG fault.
The Sample Loader provides positive specimen identification with a laser bar code reader at Station 2. As each tube reaches Station 2, the tube rotates and the bar code reader turns on to read the bar code label on the tube. If no bar code label is present or the label is unreadable, the sample is identified by the rack number and tube position, in the format
R(n)T(n), on the Data Station RUN Screen and in the Data Log.
The use of bar code labels is recommended for positive sample identification. Operation of the Sample Loader with non-bar-coded samples is allowed but careful attention to rack number and tube position of each sample is required for correct identification.
CAUTION: Liquid spills in the rack drive mechanism are a potential reason for failure of the rack to advance. Liquid spills that flow in the Sample Loader Control Panel could cause operational failure. If a spill occurs, turn the Sample Loader off immediately and notify the Customer Support Center for further assistance.
CAUTION: Do NOT remove any non-bar-coded samples from the racks until the specimen ID numbers are matched to the rack number and tube position and entered on the record.
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Sample Loader
Function Sequence
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Chapter 12
CAUTION: If a fault occurs which requires or causes the
Sample Loader to be reinitialized, the operator must remove the samples that have been processed to avoid accidentally repeating a sample. Whenever the Sample Loader reinitializes, the tube rack which was under the tower when the Sample Loader stopped moves back to the starting position. Processing, therefore, starts again with the tube in position number one of that rack.
The operator must pay careful attention to the rack number and tube position of each sample being processed, particularly when not using bar code labels and when using the work list. For a complete explanation of
the work list , see Chapter 5, Operating Instructions .
The following sequence is a basic description of the events which occur from the time that the Sample Loader power is turned ON through the complete processing cycle. During the cycle, the position of the tube racks is monitored by a sensor in each corner of the Sample Loader tray.
A fifth sensor detects the non-reflective black label on the end rack.
1.
Each time the Sample Loader is switched ON it completes an initialization cycle.
2.
When the Sample Loader is initialized and ready, the START key on the Sample Loader Keyboard flashes and the message AUTO
SAMPLER READY appears in the Data Station bulletin line.
3.
When the START key is pressed, the Sample Loader begins moving the right rear rack under the tower. As the rack advances, the sensor at Station 1 searches for a tube. When the sensor detects a tube, the plunger moves forward to position the tube so the stopper is pierced near the center. The vent needle punctures the tube to equilibrate the tube to atmospheric pressure. The rack advances to Station 2. The second tube in the rack is positioned at
Station 1.
4.
The mixing head moves down until the height sensor senses the tube at Station 2. Mixing begins and the bar code label is read simultaneously. If no bar code label is present, the sample is identified by rack number and tube position or by a work list entry.
(Refer to Chapter 5, Operating Instructions , for instructions for using the work list .)
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Chapter 12
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5.
The first sample is then mixed by counter-rotation.
NOTE: Tubes must be able to spin freely while in the tube racks. Tubes with excessive numbers of labels or with label flaps
) will not spin properly and will trigger
a mixing error. The bulletin line will display the message
SAMPLING ERROR — INCOMPLETE ASPIRATION.
The RUN Screen will display the MIXING ERROR and
SAMPLING ERROR messages.
The Sample Loader does not attempt to aspirate an improperly mixed sample. Therefore, the SAMPLING ERROR —
INCOMPLETE ASPIRATION message is displayed along with the MIXING ERROR message and results look like background counts.
If the tube cannot spin, the Sample Loader emits three beeps, the mixing head motor stops (to prevent damage to the motor) and the sample is not aspirated. The message MIXING ERROR is displayed and printed to the right of the MCH result, and the message SAMPLING ERROR is displayed and printed to the right of the MCHC result. An “M” appears in the column preceding the date in the data log and the QC log.
6.
Rack movement resumes and the first sample is moved to Station 3.
When the aspiration needle begins to move down, the plunger moves forward to position the tube so the stopper is pierced near the center. The needle moves down and the Sample Loader signals the Analyzer to aspirate the sample. The sample is pulled into the shear valve by action of the sample aspiration pump. The Analyzer then begins a normal count cycle.
7.
After the sample is aspirated, the aspiration needle is retracted and washed. The plunger retracts when the needle has been fully withdrawn from the tube.
8.
Steps 4 -7 are repeated until all tubes in the rack have been
processed.
9.
When the rack being processed reaches the left rear corner of the tray, the racks are rearranged. The Sample Loader moves the left front rack over to the right front side. The Sample Loader then pushes the racks on the right towards the rear and brings the racks on the left forward. Then the second rack is moved into position on the right side of the tower and the first tube is positioned at
Station 1.
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Sample Loader
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Chapter 12
10.
These sequences are repeated until the end rack sensor detects the end rack. When all tubes in this rack are processed, the Sample
Loader automatically stops and audible beeps alert the operator that processing is completed. The message SAMPLES COMPLETED is displayed in the bulletin line.
NOTE: An end rack is required to stop sampling automatically unless the Sample Loader is manually stopped or a fault occurs.
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Chapter 12 Search Book TOC Go Back Sample Loader
Routine Operating Procedures
Maintenance
Maintenance procedures on the Sample Loader should be performed as
directed in Chapter 9, Maintenance . These procedures consist of the
daily cleaning of the vent and aspiration needles and the
weekly cleaning of the tray and the tube racks . If the
vent or aspiration needle requires replacement , refer to Chapter 10, Troubleshooting .
Installation
For detailed instructions on how to install the Sample Loader , refer to
Troubleshooting
If a Sample Loader fault, error, or other problem is detected, an alert message is displayed on the bulletin line of the screen. For a description
of the fault, go to the DIAGNOSTICS MENU . For a list of messages,
descriptions of possible problems and recommended actions, refer to
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Sample Loader
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NOTES
Chapter 12
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Appendix A Search Book TOC Go Back
Bar Codes
Introduction To Bar Codes
This section gives a brief overview of what bar coding is, how bar code labels are used for data entry and the different types of bar codes that
may be used on the CELL-DYN® 3000 .
Bar coding is an automated method of gathering alphanumeric information and transmitting it to a computer. Because it eliminates typing and associated errors, bar coding offers speed, increased accuracy and efficiency. The major elements in a bar coding system are:
• The computer and its software, which interpret and store bar code data (for the CELL-DYN 3000, this is accomplished by the Data
Station and its software)
• The scanning device which “decodes” the information can be an integrated reader such as the one in the Sample Loader of
CELL-DYN 3000SL Analyzers
• The printer (typically a high-resolution laser printer) for generating bar code labels
• The bar code labels themselves
Bar Coding Function
The bar code label contains the actual identifying data in the form of a series of black bars and contrasting white spaces, which represent numbers and letters. The arrangement of the code follows one of several sets of rules for bar code languages, called symbologies. To decode the data in the label, a scanning device is used to pass a small spot of light over the bars and spaces.
Since dark bars reflect little light back into the scanning device, while white space reflects a lot of light, a light detector inside the scanner can translate the differences in reflection into electrical signals. The signals are then converted into sets of ones and zeros (the binary system used by computers) which stand for numbers and letters.
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Appendix A
Understanding the Label “Code”
In all bar code symbologies, the code consists of elements (single bars or white spaces) and characters (groups of elements which stand for numbers or letters). For example, in Code 39, a widely used symbology, each code character contains nine elements, at least three of which must be wide. Wide elements (whether they are bars or spaces) in this symbology have a binary value of 1. Narrow elements have a binary value of 0.
Most contemporary bar code systems have several features in common.
These include:
• The quiet zone, an area immediately before and after the bar code symbol, which enables the scanner to read the code properly.
• Start and stop characters which indicate the beginning and end of the bar code symbol. They allow the label to be scanned from either right to left or left to right, ensuring that code information is transmitted correctly.
• Intercharacter gaps that act as “spaces” between each character in the bar code symbol. Code 39 contains these gaps, but other codes, including Interleaved 2 of 5, do not use them.
• The interpretation line, an area at the bottom of the bar code label where human-readable information can be placed. This may or may not be the same data as in the label code.
• The optional check digit, an extra character in the bar code which permits the scanning device to mathematically determine whether it read the code correctly. This keeps the error rate as low as one in every billion characters read.
Bar Code Types and Characteristics
The Sample Loader reads three symbologies of bar codes, the descriptions of which follow:
Code 39
Also referred to as code 3 of 9, Code 39 encodes 43 data characters: 0-9,
A-Z, six symbols and spaces. Each character is represented by nine elements, three of which are wide and six of which are narrow.
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Interleaved 2 of 5
Interleaved 2 of 5 encodes the 10 numeric digits 0–9. The name is derived from the method used to encode two characters which are paired together. Bars represent the first character and the interleaved spaces represent the second character. Each character has two wide elements and three narrow elements, for a total of five elements.
Codabar
Codabar uses four bars and three spaces to represent the ten numeric digits 0-9 and certain special characters. The code is characterized by four unique start/stop codes and variable intercharacter spacing.
CELL-DYN 3000 Bar Code Specifications
The CELL-DYN 3000 Sample Loader Bar Code Reader can read Code
39, Interleaved 2 of 5 and Codabar formats. The Sample Loader can read these formats interchangeably if the check digit is disabled by using the
[BAR CODE SETUP] soft key from the
Code size and collection tube length limit the number of characters per label as follows:
• Code 39 — maximum of 9 characters. Do NOT use those that
more details.)
• Interleaved 2 of 5 — 10 or 12 characters only.
• Codabar — maximum of 12 characters.
Bar Code Label Specifications
Bar code labels (shown in Figure A.1
specifications:
• Printed on good quality label stock
• 0.25 inch quiet zone on each end
• 0.01 inch minimum narrow bar width
• 2:1 wide to narrow bar ratio
• 0.5 inch minimum bar length
• 2 inch maximum label length
• 1.25 inch maximum label width
• Maximum possible contrast between bars and background label
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Maximum Label Width
1.25 inches
Appendix A
Minimum
Quiet Zone
0.25 inches
Maximum
Label Length
2.0 inches
Figure A.1:
Minimum Bar Length
0.5 inches
Bar Code Label Specifications
CELL-DYN Bar Code Labels
CELL-DYN 4-digit bar code labels (Code 39 Format) are available for the Sample Loader (L/N 99650-01 for one roll, or L/N 99651-01 for a box of ten). These labels may be used for positive specimen identification when laboratory-generated bar code labels are unavailable.
CELL-DYN Q Labels
Special bar code labels are available to identify QC specimens. These
“Q” labels (numbers Q1– Q20, L/N 99652-01) automatically select QC files 1 to 20, and therefore should be used to process only QC specimens.
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Appendix A Search Go Back Bar Codes
Bar Code Label Placement
• All labels should be placed on the tubes securely and without flaps sticking out. (See Figure A.2.) Excessive numbers of labels may prevent tubes from mixing properly.
• The Bar Code Label should be placed on the tube just below the stopper with the bars perpendicular to the length of the tube. See
Figure A.2 for proper placement.
Top Surface
Should Be Dry
Properly Labeled Tubes
Bar Code
Label
Clear
Tape
Exposed
Bottom
16.5 mm
Diameter
Width Limit For
Multiple Labels
Improperly Labeled Tubes
Flap
Edges
Peeled
Loose
Tail
Figure A.2: Tube Labeling Requirements
High
Collar
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Appendix A
Acknowledgment
The authors wish to acknowledge Computype, Inc. of St. Paul, MN for providing their booklet "Bar Coding and Productivity" to assist in the writing of this appendix.
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