Abbott CELL-DYN 3200 System Operator's Manual
Abbott CELL-DYN 3200 is a multiparameter hematology analyzer designed for in vitro diagnostic use in clinical laboratories. It features advanced technology, providing accurate and reliable results for a comprehensive range of hematology parameters. With its user-friendly design and comprehensive support, the CELL-DYN 3200 streamlines workflow and enhances efficiency in the laboratory.
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Foreword
Customer Support
United States: 1 (800) CELL DYN or 1 (800) 235-5396
Abbott Diagnostics Customer Support Center:
200 Abbott Park Road
Abbott Park, Il 60064
Canada: 1 (800) 387-8378
For customers outside the U.S., call your local Hematology Customer Support
Representative.
Intended Use
We welcome you to the role of Operator of the CELL-DYN 3200 System. Using state-of-the-art technology, we have designed your instrument to function consistently and dependably on a day-to-day basis.
The CELL-DYN 3200 System is backed by dedicated professionals who excel in engineering, training, and technical expertise. As you are a valued customer, we will teach you how to operate, maintain, and troubleshoot your system.
For continuing service, we also provide telephone technical assistance should you need additional information or assistance in diagnosing a problem. This service is available 7 days a week, 24 hours a day in the United States.
If a problem should arise that 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.
The CELL-DYN 3200 is a multiparameter hematology analyzer designed for in vitro diagnostic use in clinical laboratories.
Proprietary Statement
The entire contents copyrighted 1995, 1998, 1999, and 2001 by Abbott
Laboratories. Abbott Laboratories’ software programs are protected by copyright.
All rights are reserved. The software was developed solely for use with Abbott
Laboratories equipment and for in vitro diagnostic applications as specified in the operating instructions. No part of this document may be reproduced, stored, or transmitted in any form or by any means (electronic, mechanical, photocopied, recorded, or otherwise) without the prior written permission of Abbott
Laboratories.
CELL-DYN ® 3200 System Operator’s Manual
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ii
Patent Statement
The following U.S. Patents are relevant to the CELL-DYN 3200 Instrument:
5,017,497; 5,378,633; 5,510,267; and 5,733,784.
Instrument Disclaimer
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.
Pictorial Disclaimer
The sample printouts/screens/graphics contained in this manual are for information and illustration purposes only. Abbott Laboratories makes no representations or warranties about the accuracy and reliability of the information on the printouts/ screens/graphics, and this information is not to be used for clinical or maintenance evaluation.
Abbott Instrument Warranty
Abbott Laboratories warrants CELL-DYN Instruments 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 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 Hematology
Customer Support Center immediately and be prepared to furnish pertinent details concerning the defect, the Instrument model number, and the serial number.
Abbott’s Warranty coverage limits are as follows:
1. Abbott Hematology Customer Support Center: 24 hours per day, 7 days per week phone support in the United States.
2. Field Service Representative support: 8:30 A.M.
to 5:00 P.M.
Monday through
Friday (excluding all Abbott-observed holidays).
3. Any on-site service performed at other times and all service required to correct defects or malfunctions not covered by this Warranty (as noted in the paragraph below) will be billed at Abbott’s labor rates then in effect.
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.
CELL-DYN ® 3200 System Operator’s Manual
9140181K—July 2002
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 of 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.
The CELL-DYN 3200 Series Hematology Systems are manufactured by Abbott
Diagnostics, Abbott Laboratories, at 5440 Patrick Henry Drive, Santa Clara, CA
95054, 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
Hematology Customer Support Center. (U.S. customers only.)
Regulatory and Safety Agency Approvals
In Vitro Diagnostic Directive
Legal Manufacturer
Authorized Representative
98/79/EC
Abbott Laboratories
Abbott Park, Il 60064 US
ABBOTT
Max-Planck-Ring 2
65205 Wiebaden
Delkenheim, Germany
UL1262
CSA 22.2 # 151
IEC 1010-1
Approved
Approved
Approved
CELL-DYN ® 3200 System Operator’s Manual
9140181K—July 2002 iii
Trademark Statements
BJC-600e is a trademark of Canon Inc.
Canon is a registered trademark of Canon Inc.
CELL-DYN is a registered trademark of Abbott Laboratories.
CELL-DYN HemCal is a registered trademark of Abbott Laboratories.
Epson is a registered trademark of Seiko Epson Inc.
Hemogard is a registered trademark of Becton Dickinson and Company.
MAPSS is a trademark of Abbott Laboratories.
MICROLINE is a registered trademark of Oki America, Inc.
Millipore is a registered trademark of Millipore Corporation.
OKIDATA is a registered trademark of Oki America, Inc.
Retic-RITE is a registered trademark of Abbott Laboratories.
Sarstedt is a registered trademark of Walter Sarstedt Gerate, a German
Company.
Technicon H
•
3 is a registered trademark of Miles Inc.
TEFLON is a registered trademark of E.I. DuPont de Nemours Co., Inc.
TYGON is a registered trademark of Norton Performance Plastics.
VACUTAINER is a registered trademark of Becton Dickinson and
Company.
VenojectII is a registered trademark of Terumo Medical Company.
Westgard is a registered trademark of Westgard Quality Corporation.
iv CELL-DYN ® 3200 System Operator’s Manual
9140181K—July 2002
Symbols
The symbols listed below are used on CELL-DYN labeling, including the instrument, reagents, calibrators, controls, and this manual. Please note that
Warning and Caution symbols and statements are in this manual in
Instrument/Power related
$&,1387
Alternating Current
Input
Busy
%86<
&20 Communications Port 1
32:(5
35(66
35(66
Power
Pressure 1
Pressure 2
&20 Communications Port 2
Fault
35(66 Pressure 3
Ready
)$8/7
)5(48(1&<
Frequency
5($'<
5(9
Revision
Serial number
)86(
)86(6
Fuse
Fuses
61
6(59,&(',6.
Service disk
+66/ High Speed Serial Link 6(783',6.
Set-Up disk
,167$//$7,21',6.
.(<%2$5'
/,1()5(46(/(&7
Installation Disk
Keyboard
Line frequency select
6+($59$/9(
728&+
75$3
Shear Valve
Touch
Trap
Vacuum 1
/,1(92/7$*(
/,1(92/7$*(6(/(&7
/37
/37
Line Voltage
Line Voltage Select
First Parallel Printer
Port
Second Parallel Printer
Port
Maximum power
9$&
9*$
9(17
:$67(
Video Graphics Adapter
Vent
Waste
Waste sensor
0$;32:(5
02'(/
3(5,67$/7,&3803
Model number
Peristaltic Pump
:$67(6(1625
<9$/9( Y-Valve
CELL-DYN ® 3200 System Operator’s Manual
9140181K—July 2002 v
Reagent related
&1)5((+*%12&/<6(
',/8(17
',/8(176+($7+
(1=<0$7,&&/($1(5&21&(175$7(
Cyanide-Free Hemoglobin/Nucleated Optical Count Lyse
Diluent
Diluent/Sheath
Enzymatic Cleaner Concentrate
Expiration Date
+(02*/2%,1
+*%
+*%/<6(
/27
5%&
6+($7+
8 o C
2 o C
:%&
:%&/<6(
Calibrator/Control related
&21752/$66$<
:+2/(%/22'&$/,%5$725
:+2/(%/22'&21752/
:%&21752/+
:%&21752//
:%&21752/1
Hemoglobin
Hemoglobin
Hemoglobin Lyse
Lot Number
Red Blood Cell
Sheath
Storage temperature.
White Blood Cell
White Blood Cell Lyse
Control Assay
Whole Blood Calibrator
Whole Blood Control
Whole Blood Control, High
Whole Blood Control, Low
Whole Blood Control, Normal
(Example shows “Store at 2º–8ºC”) vi CELL-DYN ® 3200 System Operator’s Manual
9140181K—July 2002
Miscellaneous
(&5(3
,9'
5()
Authorized Representative
Consult instructions for use
Date of Manufacture
For In Vitro Diagnostic Use
Legal Manufacturer
List Number
CELL-DYN ® 3200 System Operator’s Manual
9140181K—July 2002 vii
Instrument Labeling
The following labels are affixed to the CELL-DYN 3200 System:
Current CELL-DYN customer’s instruments are CE Marked to the
European Electro-Magnetic Compliance (EMC) and Low-Voltage
Directives and have the following labels:
DANGER
GEFAHR DANGER
PELIGRO PERICOLO
LASER LIGHT WHEN OPEN.
BEI OFFENER ABDECKUNG TRITT
LASERSTRAHL AUS.
RAYON LASER SI OUVERT.
RADIACION LASER SI SE ABRE.
LUCE LASER SE APERTO.
AVOID DIRECT EXPOSURE TO BEAM.
NICHT DIREKT IN DEN LASERSTRAHL BLICKEN.
EVITER TOUTE EXPOSITION DIRECTE
AU FAISCEAU LASER.
NO SE EXPONGA DIRECTAMENTE AL RAYO LASER.
EVITARE OGNI ESPOSIZIONE DIRETTA AL RAGGIO.
PN 9230701D
Laser Label, Front Panel
Class l Laser Product per lEC 825-1[1993]
PN 9230702A
Laser Label, Rear Panel
ABBOTT DIAGNOSTICS
A wholly owned subsidiary of Abbott Laboratories
Abbott Park IL. 60064
THIS PRODUCT CONFORMS TO
THE APPLICABLE REQUIREMENTS
OF 21 CFR SUBCHAPTER J
AT THE DATE OF MANUFACTURE
MANUFACTURED DATE
MODEL NO.
SERIAL NO.
LIST NO.
REV
MADE IN U.S.A.
PN 9230308 REV E
Serial Number Label, Rear Panel viii CELL-DYN ® 3200 System Operator’s Manual
9140181K—July 2002
WARNING : SET FOR 120 VOLTS
When operation at other line voltage is required, refer to operation manual for detailed instructions.
WARNUNG : FUER 120 VOLT EINGESTELLT
Ist der Betrieb mit einer anderen Netzspannung erforderlich, entnehmen Sie die genauen
Anweisungen der Bedienungsanleitung.
MISE EN GARDE : PARAMETRE POUR UTILISATION SUR 120 VOLTS
Si une utilisation à une tension de réseau différente est requise, reportez-vous au Manuel
Technique pour de plus amples informations.
ADVERTENCIA : CONFIGURADO PARA 120 VOLTIOS
Si se necesita otra tensión diferente a la indicada, consulte el Manual de Operaciones para instrucciones más detalladas.
AVVERTENZA : CONFIGURATO PER 120 VOLT
Se la tensione è di voltaggio diverso, fare riferimento alle istruzioni dettagliate nel Manuale di
Impiego.
PN 9230003
Voltage Label, Rear Panel
CE Label
CAUTION: DO NOT HANDLE
SOLUTION CONTAINER
UNLESS PROPERLY
PROTECTED. REFER TO
OPERATOR’S MANUAL FOR
INSTALLATION PROCEDURE.
PN 9230334
Solution Container Label, Rear Panel
CELL-DYN ® 3200 System Operator’s Manual
9140181K—July 2002 ix
x
New CELL-DYN customer’s instruments are CE Marked to the European
In Vitro Diagnostic Directive, which encompasses the requirements of the
EMC and Safety Directives, and have the following labels:
CAUTION –
CLASS 3B LASER LIGHT WHEN OPEN.
AVOID EXPOSURE TO BEAM.
PN 9230701
Laser Label, Front Panel
CLASS 1 LASER PRODUCT
PN 9230702
Laser Label, Rear Panel
ABBOTT DIAGNOSTICS DIVISION
Abbott Laboratories
Abbott Park IL, 60064 USA
THIS PRODUCT CONFORMS TO
THE APPLICABLE REQUIREMENTS
OF 21 CFR SUBCHAPTER J AT THE DATE
OF MANUFACTURE
DATE OF MANUFACTURE
MADE IN U.S.A.
PN 9230308 REV G
Serial Number Label, Rear Panel
CELL-DYN ® 3200 System Operator’s Manual
9140181K—July 2002
ABBOTT LABORATORIES
Abbott Park, IL 60064 USA
ABBOTT
Max-Planck-Ring 2
65205 Wiesbaden
Germany
+49-6122-580
CE Mark Label, Rear Panel
PN 9230751A
WARNING : SET FOR 120 VOLTS
When operation at other line voltage is required, refer to Operator’s Manual for detailed instructions.
PN 9230003E
Voltage Label, Rear Panel
CAUTION: DO NOT HANDLE
SOLUTION CONTAINER
UNLESS PROPERLY
PROTECTED. REFER TO
OPERATOR’S MANUAL FOR
INSTALLATION PROCEDURE.
PN 9230334
Solution Container Label, Rear Panel
NOTE: The most current representation of these labels will be depicted in graphics contained in this manual.
CELL-DYN ® 3200 System Operator’s Manual
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NOTES xii CELL-DYN ® 3200 System Operator’s Manual
9140181K—July 2002
How to Use This Manual
Overview
This Operator’s Manual contains complete instructions for using and maintaining the CELL-DYN 3200 System.
This manual was designed to fill several needs, from providing step-by-step operating instructions to listing accessory part numbers. You will find it a valuable aid as you learn to use the system and an essential reference thereafter.
A basic principle of effective learning is to proceed from the general to the specific.
That is the way the material in this manual is presented. And that is how we wish to present the manual to you.
The first and most important step is to get acquainted with the Master Table of
Contents . For this reason, we start with a brief overview to show you how the information is organized in sections.
After that, we explain how the manual is physically designed to help you locate desired information quickly and easily.
Finally, we discuss different ways material is presented for different purposes and explain various icons that identify specialized types of information in the text.
Please take the time to read and understand this brief preparatory section.
Manual Organization
Front Matter
The pages in front of the Master Table of Contents contain two main sections: A
Foreword that includes customer support and intended use information, and How to Use This Manual that includes a description of the organization. These pages also contain proprietary, warranty, trademark statements, and Manual Revision and
Status Logs.
Section 1. Use or Function
This section provides an overall description of the system and its components. It names the major system components and tells what they are used for.
Section 2. Installation Procedures and Special Requirements
This section provides instructions for installing the CELL-DYN 3200 system. It explains proper location, installation, setup, and configuration to meet your laboratory’s specific needs.
Section 3. Principles of Operation
This section explains the principles behind the system’s operation. It describes what the system measures and how those measurements are made. It also explains the translation of those measurements into useful data and reports for the user.
CELL-DYN ® 3200 System Operator’s Manual
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xiv
Section 4. Performance Characteristics and Specifications
This section contains useful details on the dimensions of the instrument, proper operating environment, and performance specifications.
Section 5. Operating Instructions
This section contains detailed instructions to set up the instrument and explains the procedures for daily start-up and shutdown, sample collection and handling, routine operation of the instrument, sample analysis, and use of the data log.
Section 6. Calibration Procedures
This section takes you step by step through the calibration process. It discusses calibration materials, guidelines, and methods, including troubleshooting procedures and corrective action.
Section 7. Operational Precautions and Limitations
This section contains a summary of known factors that may adversely affect the proper operation of the instrument or the quality of the output.
Section 8. Hazards
This section covers possible hazards arising from the operation of the instrument, as well as decontamination and waste handling procedures.
Section 9. Service and Maintenance
This section discusses routine maintenance and cleaning on a daily, weekly, monthly, and “as needed” basis. Also included are detailed instructions for removing, cleaning, and replacing various components to ensure proper system performance.
Section 10. Troubleshooting and Diagnostics
This section discusses the diagnostics capability of the instrument. It contains a troubleshooting guide to help users identify probable causes of a system malfunction or of suspect data, and to suggest the proper corrective action.
Section 11. Quality Control
This section covers the proper mixing, handling, and running of control material, setting up QC files and using the QC capabilities of the instrument, and setting up and using the X-B Analysis Program. It also provides a review of the Westgard ®
Rules.
Section 12. Printers
This section reviews the setup and use of printers for graphics output and ticket printing.
Section 13 .
Sample Loader
This section includes material from all the previous sections which pertains specifically to the installation, operation, and maintenance of the Sample Loader.
CELL-DYN ® 3200 System Operator’s Manual
9140181K—July 2002
Section 14. Reticulocyte Package
This section contains detailed information on how to turn ON the reticulocyte package, set up retic QC and retic patient limits, and prepare and process retic samples.
Appendices
Appendix A describes how to use bar codes on the CELL-DYN 3200 and contains information on bar code types and bar code labels.
Appendix B lists the part numbers of components, accessories, controls, reagents, and consumables associated with the CELL-DYN 3200 System for user convenience when placing orders.
Index
This section contains an alphabetical listing of subject matter to help users quickly locate specific information about the system.
Manual Construction
The physical construction of the manual supports its sectional organization.
Master Table of Contents
The Master Table of Contents at the beginning of this manual lists each section and its subsections.
Section Separators
A large separator tab marks the start of each section.
CELL-DYN ® 3200 System Operator’s Manual
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Text Conventions Used in This Manual
The following list summarizes the text conventions that are used in this manual:
Information
Menu name
Soft keys (screen label keys)
Keyboard/keypad keys
Status
Courier
Presentation
Sans serif font, all capital letters
Sans serif font, all capital letters, enclosed in brackets
Regular font, initial capital letters only when appropriate
Regular font, all capital letters READY
STANDBY
INITIALIZED
Regular font, enclosed in angle brackets < Operator ID > field Data entry field
Screen message or other screen display
ON and OFF All caps, regular font
Examples
MAIN MENU
DATA LOG menu
[RUN] arrow keys
↑ arrow key
Enter key
ESC key
Page Up key the pound (#) key the asterisk (*) key
Waste Full
ON
OFF
Soft Keys (Screen Label Keys)
Screen labels are menu keys displayed at the bottom of the display screen. Directly below the display screen is a row of eight unlabeled pressure-sensitive keys which correspond to the menu labels. Pressing one of these keys (on the membrane keypad) initiates the action specified by the corresponding menu label.
This manual indicates that one of these “soft keys” is to be pressed by showing the label in all caps, bold, sans serif font, and enclosed in brackets. For example, when the manual calls for the operator to press the key under the RUN label and then the key under the SPECIMEN TYPE label, the text will read “Press [RUN] followed by
[SPECIMEN TYPE] .”
Keyboard/Keypad Keys
In some cases, the operator must press a key on the PC keyboard or on the pressuresensitive keypad on the front of the instrument. Such keys include the Enter key, the ESC key, the pound (#) key, and other special function keys. Special function keys, such as the arrow keys, are in regular type. The arrow symbol may be substituted for the word. For example, the text will read “Press the arrow keys” or
“Press the ↑ key” or “Press the ↑ arrow key.”
The Print Screen key on the keyboard can be used to print the screen as it is displayed on the monitor. This allows the operator an option to print the screen when the [PRINT] soft key is not available.
xvi CELL-DYN ® 3200 System Operator’s Manual
9140181K—July 2002
Safety
NOTE: Press the Print Screen Key only when the displayed screen is at a static state. Pressing the key during an instrument action, i.e., run cycle may not print the screen properly.
Operation, maintenance and servicing of hematology systems may expose individuals to potential safety and health hazards. All work must be performed as described in the CELL-DYN Operator’s manual or as directed by an Abbott Representative. For detailed safety information, refer to
Warnings are inserted throughout this manual to alert personnel to potential hazards. The standard warning conventions including signal words and symbols are described in
.
CELL-DYN ® 3200 System Operator’s Manual
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Revision Status
Document Control
Number(s)
9140181H
9340541B
9140181J
Revision
Date
10/01
N/A
3/02
Section(s)
Revised
All
All (new tabset)
Forward
How To Use This
Manual
Master Table of
Contents
List of Figures
1: Use or Function
2: Installation
Procedures and
Special
Requirements
All
N/A
All
All pp. 1 through 5; 12 through 14; 19 p. 3
Pages Revised and Added pp. 1-1 and 1-2; 1-8; 1-18 and 1-19 pp. 2-3; 2-7; 2-15
3: Principles of
Operation
4: Performance
Characteristics and
Specifications
5: Operating
Instructions
6: Calibration p. 3-7 pp. 4-4 and 4-5 pp. 5-8; 5-10; 5-99 pp. 6-21; 6-26; 6-30 through 6-32; 6-57
7: Operational
Precautions and
Limitations pp. 7-1 and 7-2
8: Hazards
9: Service and
Maintenance
All pp. 9-12; 9-55 and 9-56
13: Sample Loader p. 13-1
Appendix B
Index pp. B-1; B-3
All xviii CELL-DYN ® 3200 System Operator’s Manual
9140181K—July 2002
Document Control
Number(s)
Revision
Date
Section(s)
Revised
Pages Revised and Added
NOTE: For existing customers, pages of 9140181J will be changed to Revision K and sent with 9140181K
9140181K 7/02 Forward All
All How To Use This
Manual
Master Table of
Contents pp. 1 through 5; 10; 12 through 20
List of Figures
List of Tables pp. 3 and 4
All
1: Use or Function pp. 1-1 and 1-2; 1-8; 1-16; 1-18 and 1-19
2: Installation
Procedures and
Special
Requirements pp. 2-3; 2-5; 2-7; 2-15 pp. 3-7; 3-16; 3-28; 3-31 through 3-36 3: Principles of
Operation
4: Performance
Characteristics and
Specifications
5: Operating
Instructions
6: Calibration pp. 4-4 and 4-5 pp. 5-8; 5-10; 5-42 through 5-44; 5-86 and
5-87; 5-99; 5-128 pp. 6-21; 6-26; 6-30 through 6-32; 6-57 pp. 7-1 and 7-2 7: Operational
Precautions and
Limitations
8: Hazards
9: Service and
Maintenance
10:
Troubleshooting and Diagnostics
All pp. 9-12; 9-21; 9-25; 9-46; 9-55 and 9-56;
9-59; 9-61 pp. 10-24 and 10-25; 10-28 and
10-29; 10-65; 10-89
11: Quality Control p. 11-17
13: Sample Loader p. 13-1
14: Reticulocyte
Package
Appendix B pp. 14-20; 14-47; 14-61; 14-68 through
14-69 pp. B-1; B-3
Index All
CELL-DYN ® 3200 System Operator’s Manual
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Revision Log
Document
Control Number
Instructions: Use this log to provide a permanent record to verify that revised chapter(s) and/or page(s) have been added to this manual.
1. Record the document control number of the revised section in the first column. You will find the number in the footer. Make an entry for each chapter you receive and place in the manual.
2. Record the revision date, also found in the footer, in the second column.
3. Record the current CELL-DYN 3200 System software version in the third column.
4. Write your initials or signature in the fourth column to verify that you have placed the revised page(s) in the manual.
5. Record the date that you added the revised section to the manual in the fifth column.
Revision
Date
Software Version
Revision
Incorporated by
Date
Incorporated
Conclusion
xx
We hope you have found this preview of the manual useful. The information in this section should help you better understand the construction and organization of this manual and help you get started easily and quickly.
CELL-DYN ® 3200 System Operator’s Manual
9140181K—July 2002
Master Table of Contents
Master Table of Contents
Foreword
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i
Customer Support . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i
Proprietary Statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i
Instrument Disclaimer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ii
Abbott Instrument Warranty. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ii
Regulatory and Safety Agency Approvals . . . . . . . . . . . . . . . . . . . . . iii
Trademark Statements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iv
Instrument Labeling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . viii
How to Use This Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xiii
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xiii
Manual Organization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xiii
Manual Construction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xv
Text Conventions Used in This Manual . . . . . . . . . . . . . . . . . . . . . . xvi
Soft Keys (Screen Label Keys). . . . . . . . . . . . . . . . . . . . . . . . . . xvi
Keyboard/Keypad Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xvi
Use or Function
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
Analyzer Components. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6
Front Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6
Flow Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6
Left Side Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6
Right Side Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6
Rear Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7
Component Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8
Front Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8
Left Front Cover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8
Right Front Cover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8
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9140181K—July 2002
Master Table of Contents-1
Master Table of Contents
Master Table of Contents-2
Front Skirt Cover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9
Status Indicator Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9
(Open Sample) Aspiration Probe . . . . . . . . . . . . . . . . . . . . . . . . 1-9
Touch Plate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9
Sample Loader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9
(Closed Sample) Tower Cover . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9
Shear Valve Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-10
Syringe Assembly. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-11
Sample Transfer Peristaltic Pump . . . . . . . . . . . . . . . . . . . . . . 1-11
HGB Flow Cell and Mixing Chamber . . . . . . . . . . . . . . . . . . . 1-11
WBC Mixing Chamber. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-11
RBC/PLT Mixing Chamber . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-11
Wash Block. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-11
Normally Closed Valves. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-12
Diluent Reservoir . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-12
Sheath Reservoir. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-12
Waste Chambers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-12
Bubble Traps. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-12
Aerosol Filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-12
Pinch Valves . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-12
Closed Mode Aspiration Tower . . . . . . . . . . . . . . . . . . . . . . . . 1-12
Left Side Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-14
Fan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-14
Right Side Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-15
Floppy Disk Drive (Slot) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-15
Main Power Switch. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-16
Analyzer Serial Number Label . . . . . . . . . . . . . . . . . . . . . . . . . 1-16
Data Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-16
Disk Storage Container. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-16
Fan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-16
Waste Sensor Connector. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-17
Waste Outlet Tube Connector . . . . . . . . . . . . . . . . . . . . . . . . . 1-17
Reagent Inlet Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-17
Power Supply Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-17
Line Frequency and Line Voltage Select Switches . . . . . . . . . 1-18
Main Power Connector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-18
Fuse. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-18
Flow Cell Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-19
Laser Optics Bench Assembly . . . . . . . . . . . . . . . . . . . . . . . . . 1-19
Data Module Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-20
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9140181K—July 2002
Master Table of Contents
Computer (inside the Data Module) . . . . . . . . . . . . . . . . . . . . . 1-20
PC Keyboard Connector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-21
LIS (Laboratory Information System) Connector . . . . . . . . . . 1-21
Analyzer BDM Diagnostics (Unused) . . . . . . . . . . . . . . . . . . . 1-21
HSSL (High Speed Serial Link) Connectors . . . . . . . . . . . . . . 1-21
Membrane Keypad Interface Connector. . . . . . . . . . . . . . . . . . 1-21
Display Station Interface Connector. . . . . . . . . . . . . . . . . . . . . 1-21
Ticket Printer Connector. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-21
Graphics Printer Connector . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-21
Display Station Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-22
Display Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-22
Membrane Keypad . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-22
Screen Controls. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-22
Soft Keys. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-22
Video Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-23
Power Cord . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-23
Sample Loader Components. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-23
Racks. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-23
Tower Cover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-24
Bar Code Reader. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-24
Tube Sensor Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-24
Tube Mixer Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-24
Closed Sample Aspiration Tower Module . . . . . . . . . . . . . . . . 1-24
Reagent System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-25
Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-25
CELL-DYN Reagents. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-26
CELL-DYN 3200 Diluent/Sheath . . . . . . . . . . . . . . . . . . . . . . 1-26
CELL-DYN 3200 CN-Free HGB/NOC Lyse. . . . . . . . . . . . . . 1-26
CELL-DYN 3200 WBC Lyse. . . . . . . . . . . . . . . . . . . . . . . . . . 1-26
Reticulocyte Reagent System—CELL-DYN Reticulocyte Reagent1-27
Consumables. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-27
Installation Procedures and Special Requirements
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
Package Inspection and Inventory . . . . . . . . . . . . . . . . . . . . . . . 2-1
Space Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Waste Disposal Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Power Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4
Reagent and Waste Tubing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5
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Master Table of Contents-3
Master Table of Contents
Normally Closed Valves. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6
Open Left Front Cover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7
Open Right Front Cover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7
Remove Tower Cover. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7
Remove Front Skirt. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7
Remove Sample Loader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8
Tubing Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9
Flow Panel and Syringe Inspection . . . . . . . . . . . . . . . . . . . . . 2-10
Graphics Printer Installation Procedure . . . . . . . . . . . . . . . . . . . . . 2-12
Self-Test Printouts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-13
Ticket Printer Installation Procedure . . . . . . . . . . . . . . . . . . . . . . . 2-13
Loading Individual Tickets in the Ticket Printer . . . . . . . . . . . 2-14
Self-Test Printouts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-14
Sample Loader Inspection (SL Model). . . . . . . . . . . . . . . . . . . . . . 2-15
Principles of Operation
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
Sample Aspiration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
Sample Analysis Cycle Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
Sample Aspiration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
Sample Segments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
RBC/PLT Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
Hemoglobin Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4
WBC Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4
Results Displayed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6
Instrument Flushed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6
Instrument Rinsed. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6
Introduction to Flow Cytometry . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7
Detection with the Optical Bench. . . . . . . . . . . . . . . . . . . . . . . . 3-8
Optical Flow Cell . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9
WBC Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10
WBC Reagent . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-11
WBC Differential . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-11
Mononuclear-Polymorphonuclear Separation . . . . . . . . . . . . . 3-12
Neutrophil-Eosinophil Separation . . . . . . . . . . . . . . . . . . . . . . 3-13
Mononuclear Separation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-14
Other Scatterplots . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-15
Nuclear Optical Count . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-15
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Master Table of Contents
Resistant RBC. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-16
WBC Histograms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-17
NWBC-LYM-MONO Histogram. . . . . . . . . . . . . . . . . . . . . . . 3-17
MONO-POLY Histogram. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-17
NOC Histogram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-17
WBC Parameters. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-18
WBC Flagging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-19
RBC/PLT Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-19
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-19
RBC Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-20
RBC Count . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-20
MCV . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-20
HCT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-20
MCH . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-21
MCHC. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-21
RDW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-21
RBC Flagging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-21
Platelet Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-21
PLT Count. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-22
MPV . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-22
PCT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-22
PDW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-22
Platelet Flagging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-22
Hemoglobin Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-23
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-23
HGB Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-23
HGB Flagging. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-23
Laboratory Worksheet Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-24
Operational Messages and Data Flagging . . . . . . . . . . . . . . . . . . . . . . . . . 3-27
Instrument Fault and Status Conditions . . . . . . . . . . . . . . . . . . . . . 3-27
Cell Populations and Flagging . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-28
Fragile WBCs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-28
Lyse-Resistant RBCs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-28
Parameter Flagging Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-29
Dispersional Data Alerts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-30
Suspect Parameter Flags . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-30
WBC Descriptors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-30
Interpretive Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-36
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Master Table of Contents-5
Master Table of Contents
Performance Characteristics and Specifications
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
Physical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
Power Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
Consumption. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
Transport and Storage Specifications . . . . . . . . . . . . . . . . . . . . . 4-4
Operational Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5
Operating Environment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5
Startup/Shutdown Times. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5
Run Cycle Times . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5
Approximate Aspiration Volumes (Whole Blood). . . . . . . . . . . 4-5
Batch Size . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5
Throughput . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6
Collection Tube and Sample Volume. . . . . . . . . . . . . . . . . . . . . 4-6
Bar Code Specifications — CELL-DYN 3200SL . . . . . . . . . . . . . . 4-6
Bar Code Label Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6
Measurement Specifications — CELL-DYN 3200SL and CS. . . . . 4-7
Measurement Channels. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7
WBC (WOC) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7
WBC (NOC) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7
RBCs and PLTs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7
HGB . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7
Background Counts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-9
Hemogram Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11
WBC Differential Parameters. . . . . . . . . . . . . . . . . . . . . . . . . . 4-11
Hemogram Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-13
WBC Differential Parameters. . . . . . . . . . . . . . . . . . . . . . . . . . 4-14
Comprehensive Flagging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-14
Typical Precision . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-15
Within Sample . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-15
Typical Paired Difference Precision Normal . . . . . . . . . . . . . . 4-16
Sensitivity and Specificity of WBC Differential Flags . . . . . . . . . 4-16
Abnormalities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-17
Sample Loader Physical Specifications . . . . . . . . . . . . . . . . . . . . . 4-19
Sample Loader Operational Specifications. . . . . . . . . . . . . . . . . . . 4-20
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Operating Instructions
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
Data Module Program Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3
Main Menu Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3
Flowchart Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5
Menu Flowcharts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5
Main Menu Flowchart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5
Set Up Menu Flowchart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6
Run Menu Flowchart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-7
Data Log Menu Flowchart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-7
Quality Control Menu Flowchart . . . . . . . . . . . . . . . . . . . . . . . . 5-8
Calibration Menu Flowchart. . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-9
Diagnostics Menu Flowcharts . . . . . . . . . . . . . . . . . . . . . . . . . 5-10
Diagnostics Menu Flowchart (continued). . . . . . . . . . . . . . . . . 5-11
Special Protocols Flowchart . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-12
Set Up Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-13
Date/Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-14
Patient Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-16
Reagent Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-18
QC Set Up Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-21
Operation Set Up Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-37
Units Selection Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-45
Customize Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-47
General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-59
Power ON Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-59
Initializing the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-60
Operating the Instrument . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-61
Power OFF Procedure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-62
Daily Start-Up Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-63
RUN Screen Format . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-65
Upper Left Corner (Run Screen Demographics) . . . . . . . . . . . 5-65
Status Box . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-66
Upper Right Corner . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-66
Center Section. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-67
Bulletin Line . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-67
Run Menu Soft Keys. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-67
CS Model . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-67
SL Model . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-68
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Master Table of Contents
Soft Key Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-68
Clear Fault. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-69
Work List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-69
Specimen Type . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-71
Customize Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-78
Print Ticket . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-78
Print Report. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-78
Main . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-78
Additional Examples of Run Menu Screens. . . . . . . . . . . . . . . 5-79
Sample Collection and Handling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-83
Anticoagulant . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-83
Sample Stability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-83
Sample Collection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-83
Interfering Substances. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-84
Sample Identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-85
Sample Mixing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-86
Sample Analysis on the CELL-DYN 3200SL . . . . . . . . . . . . . . . . . . . . . . 5-87
Instrument Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-87
Sample Loader Operating Tips . . . . . . . . . . . . . . . . . . . . . . . . . 5-88
Daily Quality Control Checks. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-88
Open Mode QC Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-88
Closed Mode QC Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-89
Running Samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-89
Open Mode Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-90
Open Mode Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-90
Closed Mode Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-91
Closed Mode Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-91
Sample Analysis on the CELL-DYN 3200CS . . . . . . . . . . . . . . . . . . . . . . 5-93
Instrument Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-93
Daily Quality Control Checks. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-93
QC (Open or Closed Mode) Procedure. . . . . . . . . . . . . . . . . . . 5-94
Running Samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-94
Open Mode Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-94
Open Mode Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-94
Closed Mode Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-95
Closed Mode Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-96
Out of Range. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-97
Fault Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-97
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3 Consecutive Flow Errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-98
Sampling Errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-98
3 Consecutive Sampling Errors . . . . . . . . . . . . . . . . . . . . . . . . 5-98
Daily Shutdown . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-99
Peristaltic Pump Tubing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-100
Short Term Shutdown. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-100
Intermediate-term Shutdown . . . . . . . . . . . . . . . . . . . . . . . . . 5-100
Prolonged Shutdown. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-101
Quick Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-104
Work List Review. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-105
Work List Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-107
Work List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-107
Work List Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-109
Work List Soft Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-110
Work List Set Up Procedure. . . . . . . . . . . . . . . . . . . . . . . . . . 5-111
Sample Analysis — SL Model . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-115
Closed Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-115
Open Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-118
Sample Analysis — CS Model . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-120
Closed Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-120
Open Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-123
Scrolling Through the Data Log . . . . . . . . . . . . . . . . . . . . . . . 5-125
DATA LOG Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-125
Edit ID. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-127
Display Specimen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-127
Find Specimen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-129
Reject From X-B. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-130
Customize Data Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-132
Transmit Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-136
Print Data Log. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-136
Data Log Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-137
Data Log Set Up Procedures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-138
Customizing the Data Log Display. . . . . . . . . . . . . . . . . . . . . 5-138
Data Review from the Data Log . . . . . . . . . . . . . . . . . . . . . . . . . . 5-143
Displaying A Record . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-143
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Master Table of Contents
Calibration Procedures
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
When to Calibrate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4
Calibration Materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5
Instrument Logbook . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5
Calibration Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-7
Calibration Materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-8
Calibrator Requirements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-8
Fresh Whole Blood Requirements . . . . . . . . . . . . . . . . . . . . . . . 6-8
Pre-Calibration Check List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-9
PRE-CALIBRATION PROCEDURES CHECK LIST . . . . . . . . . 6-10
Problems Detected . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-12
Calibration Menu Soft Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-15
Enter Factor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-15
Calibration Log. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-16
Auto-Calibrate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-17
Methodology. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-19
Auto-Cal Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-21
Start Auto-Cal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-21
Delete a Run . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-24
Accept . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-24
Auto-Cal Procedure — Open Mode . . . . . . . . . . . . . . . . . . . . . . . . 6-26
Displaying the Auto-Cal Screen . . . . . . . . . . . . . . . . . . . . . . . . 6-26
Entering Reference Values . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-26
Processing Samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-26
Calibration Check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-27
Determining Which Parameters Need Calibration . . . . . . . . . . 6-27
Completing Calibration Log . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-28
Confirming Open Mode Calibration. . . . . . . . . . . . . . . . . . . . . 6-28
Auto-Cal Procedure — Closed Mode. . . . . . . . . . . . . . . . . . . . . . . 6-29
Entering Reference Values . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-30
Processing Samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-30
Calibration Check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-30
Determining Which Parameters Need Calibration . . . . . . . . . . 6-30
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Master Table of Contents
Enter Calibration Factor Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-33
General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-34
Calibrator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-34
Fresh Whole Blood . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-34
ICSH Recommendations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-34
Determining Reference Values — Fresh Whole Blood . . . . . . . . . 6-35
Whole Blood Calibration Reference Values Worksheet . . . . . . . . 6-37
Calibration Procedure — Open Mode . . . . . . . . . . . . . . . . . . . . . . 6-37
Determining New Calibration Factors . . . . . . . . . . . . . . . . . . . 6-37
Determining Which Parameters Need Calibration . . . . . . . . . . 6-39
Entering New Calibration Factors — Open Mode . . . . . . . . . . 6-41
Confirming Open Mode Calibration. . . . . . . . . . . . . . . . . . . . . . . . 6-42
Calibration Procedure — Mode to Mode . . . . . . . . . . . . . . . . . . . . 6-43
Determining the Closed Mode Mean . . . . . . . . . . . . . . . . . . . . 6-43
Determining Which Parameters Need Calibration . . . . . . . . . . 6-45
Calculating New Closed Mode Calibration Factors . . . . . . . . . 6-46
Entering New Calibration Factors — Closed Mode. . . . . . . . . 6-47
Confirming Closed Mode Calibration . . . . . . . . . . . . . . . . . . . . . . 6-48
Quality Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-49
Calibration Backup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-49
Manual Calibration Worksheets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-51
Operational Precautions and Limitations
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
Location Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
Reagent Storage and Handling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3
Printer Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3
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Master Table of Contents
Hazards
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
Warning Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
Signal Words . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
Hazard Information and Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3
Handling and Disposing of Biohazardous Materials . . . . . . . . . . . . 8-3
Chemical Hazards. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4
Electrical Hazards. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4
Physical and Mechanical Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5
Service and Maintenance
Special Protocols Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-3
Reagent Reservoir. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-4
Empty/Fill Flow Cell . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-5
Clean/Restore Shear Valve . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-5
Disable/Enable Analyzer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-5
More . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-6
Auto-Clean . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-6
Daily Shutdown . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-7
Prepare Shipping. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-7
Clean Needle. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-7
Extended Auto-Clean . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-7
More . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-7
Preventive Maintenance Schedule . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-9
Preventive Maintenance Schedule . . . . . . . . . . . . . . . . . . . . . . . . . 9-10
Daily . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-10
Weekly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-10
Monthly. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-10
Semi-Annual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-10
Nonscheduled Maintenance Procedures . . . . . . . . . . . . . . . . . . 9-10
Flow Panel Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-11
Decontamination Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-12
Materials Required . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-14
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Master Table of Contents
Procedure—CS and SL Models . . . . . . . . . . . . . . . . . . . . . . . . 9-14
Clean Aspiration Needle. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-15
Materials Required . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-15
Procedure — SL Model . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-15
Procedure — CS Model . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-16
Closed Sample Tower. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-16
Materials Required . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-16
Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-16
Sample Loader Tray and Tube Grippers. . . . . . . . . . . . . . . . . . . . . 9-17
Materials Required . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-17
Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-17
Weekly Maintenance Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-19
Sample Loader and Racks. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-19
Materials Required . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-19
Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-19
Sample Transfer Pump Tubing Check . . . . . . . . . . . . . . . . . . . . . . 9-19
Extended Auto-Clean . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-20
Monthly Maintenance Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-21
Fan Filter Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-21
Materials Required . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-22
Filter Cleaning Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-22
Extended Auto-Clean . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-23
Materials Required . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-24
Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-24
Diluent/Sheath Filter Replacement Procedure . . . . . . . . . . . . . . . . 9-25
Materials Required . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-25
Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-25
Semiannual Maintenance Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-27
Printer Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-27
Nonscheduled Maintenance Frequency . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-29
Nonscheduled Maintenance Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-31
Shear Valve Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-31
Materials Required . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-31
Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-32
Open Sample Probe Interior Cleaning . . . . . . . . . . . . . . . . . . . . . . 9-33
Materials Required . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-33
Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-34
Unclogging the Open Sample Aspiration Probe. . . . . . . . . . . . . . . 9-36
Closed Sample Needle Interior Cleaning . . . . . . . . . . . . . . . . . . . . 9-36
Materials Required . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-36
Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-36
Unclogging the Closed Sample Aspiration Needle . . . . . . . . . . . . 9-39
Syringe Cleaning. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-39
Materials Required . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-40
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Master Table of Contents-13
Master Table of Contents
Disabling the Analyzer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-40
Procedure—Sample Injection Syringe . . . . . . . . . . . . . . . . . . . . . . 9-42
Procedure—HGB Lyse Syringe . . . . . . . . . . . . . . . . . . . . . . . . 9-42
Procedure—WBC Lyse Syringe. . . . . . . . . . . . . . . . . . . . . . . . 9-42
Procedure—Diluent/Sheath Syringe. . . . . . . . . . . . . . . . . . . . . 9-43
Enabling the Analyzer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-45
HGB Flow Cell Manual Cleaning Procedure . . . . . . . . . . . . . . . . . 9-45
Materials Required . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-46
Bar Code Reader Window Cleaning. . . . . . . . . . . . . . . . . . . . . . . . 9-47
Materials Required . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-47
Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-47
Reagent Line Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-48
Open Sample Probe Replacement . . . . . . . . . . . . . . . . . . . . . . . . . 9-48
Materials Required . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-48
Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-48
Closed Sample Needle Replacement . . . . . . . . . . . . . . . . . . . . . . . 9-50
Materials Required . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-50
Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-50
Sample Transfer Pump Tubing Replacement . . . . . . . . . . . . . . . . . 9-52
Materials Required . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-52
Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-52
Normally Closed Valve Tubing Replacement . . . . . . . . . . . . . . . . 9-53
Materials Required . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-53
Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-53
Syringe Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-55
Materials Required . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-55
Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-55
Fuse Replacement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-55
Materials Required . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-55
Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-55
Preparation for Shipping or Extended Period of Non-Use . . . . . . . 9-56
Materials Required . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-57
Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-57
Y Valve Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-59
Materials Required . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-59
Procedure Open . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-59
Procedure Closed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-61
Maintenance Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-63
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Master Table of Contents
Troubleshooting and Diagnostics
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1
Diagnostics Menu Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-4
Fault Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-4
Execution Times . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-6
CNT Rate Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-6
Clear Faults . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-8
Raw Data Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-9
More . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-9
Main . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-10
Second Diagnostics Menu Screen. . . . . . . . . . . . . . . . . . . . . . . . . 10-10
Motor Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-10
Solenoid Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-11
Pump Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-11
Drain Accumulator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-15
Initialization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-15
Third Diagnostics Menu Screen . . . . . . . . . . . . . . . . . . . . . . . . . . 10-16
Voltage Readings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-17
Fourth Diagnostics Menu Screen . . . . . . . . . . . . . . . . . . . . . . . . . 10-18
Fifth Diagnostics Menu Screen — CS Model . . . . . . . . . . . . . . . 10-19
Serial Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-20
Fifth Diagnostics Menu Screen — SL Model . . . . . . . . . . . . . . . 10-22
Introduction to Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . 10-23
Obtaining Technical Assistance . . . . . . . . . . . . . . . . . . . . . . . . . . 10-24
Customer Support . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-24
Troubleshooting Tips and Techniques . . . . . . . . . . . . . . . . . . . . . 10-25
Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-25
Troubleshooting Background Count. . . . . . . . . . . . . . . . . . . . 10-25
Troubleshooting Reagent Problems . . . . . . . . . . . . . . . . . . . . 10-26
Troubleshooting the “Sampling error-incomplete aspiration”
Message . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-27
Troubleshooting a Flow Error Message . . . . . . . . . . . . . . . . . 10-27
Troubleshooting Imprecise or Inaccurate Data. . . . . . . . . . . . 10-27
Instrument Conditions and Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-31
Tables for Instrument Conditions and Messages . . . . . . . . . . . . . . . . . . . 10-33
Index of Table 10.1: Status Conditions . . . . . . . . . . . . . . . . . 10-33
Index of Table 10.2: General Fault Conditions . . . . . . . . . . . 10-38
Index of Table 10.3: Sample-Related Fault Conditions . . . . . 10-83
Index of Table 10.4: Non-Functional Fault Conditions . . . . . 10-89
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Master Table of Contents
Quality Control
QC Menu Softkeys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-3
X-B Set Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-4
X-B File . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-5
View QC Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-7
CELL-DYN Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-15
Use of Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-15
Mixing and Handling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-15
Assay Verification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-16
Running Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-17
® Rules. . . . . . . . . . . . . . . . . . . . . . . 11-18
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-18
® Rules. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-18
Rule Violations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-19
X-B Analysis. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-20
Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-20
X-B Program Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-21
X-B Analysis for RBC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-23
X-B Analysis for WBC. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-25
Printers
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-1
Maintenance and Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-3
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-3
Graphics Printer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-5
Printing Tickets. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-5
Loading Individual Tickets. . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-5
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Sample Loader
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-1
Physical and Performance Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . 13-3
Dimensions and Weight . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-3
Rack and Tube Capacity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-3
Minimum Sample Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-3
Maximum Sample Volume. . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-3
Sample Loader Components. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-5
Bar Code Label Placement . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-6
RUN Screens. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-9
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-10
Start Loader. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-11
Stop Loader. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-11
Restarting the Loader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-11
Fault Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-12
Processing Stations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-13
Rack Movement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-14
Load Side . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-14
Mixing and Aspiration Stations . . . . . . . . . . . . . . . . . . . . . . . 13-15
Unload Side. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-16
Sample Identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-17
Stopping the Sample Loader. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-18
Sample Loader Cycle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-19
Operating Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-21
Routine Operating Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-23
Running Samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-23
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-23
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-23
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Master Table of Contents-17
Master Table of Contents
Reticulocyte Package
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-1
Section Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-1
Flowchart Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-4
Flowcharts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-4
Turning the Reticulocyte Package ON and OFF . . . . . . . . . . . . . . 14-8
Turning ON the Reticulocyte Package . . . . . . . . . . . . . . . . . . . 14-8
Turning OFF the Reticulocyte Package . . . . . . . . . . . . . . . . . 14-10
Retic Main Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-12
Retic Set Up Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-14
Retic Patient Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-15
Retic QC Set Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-17
QC Files Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-20
Operation Set Up Soft Key . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-22
Units Selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-23
Retic Run Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-24
Retic Data Log Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-24
Edit ID. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-27
Display Specimen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-28
Find Specimen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-30
Transmit Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-30
Print Data Log. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-31
Data Review from the Retic Data Log . . . . . . . . . . . . . . . . . . . . . 14-32
Retic QC Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-33
View QC Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-35
Retic Diagnostics Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-39
Fault Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-41
Retic Count Rate. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-41
Clear Faults . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-42
Retic Raw Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-43
Print. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-43
Retic Main. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-43
Retic Special Protocols Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-44
Reagent Reservoir. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-45
Empty/Fill Flow Cell . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-45
Clean/Restore Shear Valve . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-45
Disable/Enable Analyzer . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-46
Retic Main. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-46
Retic Specimen Type Flowchart. . . . . . . . . . . . . . . . . . . . . . . . . . 14-48
Retic Specimen Type Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-49
Master Table of Contents-18 CELL-DYN ® 3200 System Operator’s Manual
9140181K—July 2002
Master Table of Contents
Clear Fault. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-49
Patient Specimen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-50
QC Specimen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-57
Background. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-58
Retic Main. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-58
Reticulocyte Specimens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-59
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-59
Specimen Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-59
Interfering Substances. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-60
Running. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-60
Specimen Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-63
Specimen Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-63
Control Material . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-65
Mixing and Handling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-65
Reagent . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-65
Quality Control Specimens. . . . . . . . . . . . . . . . . . . . . . . . . . . 14-66
General Guidelines for Reticulocyte Troubleshooting . . . . . . 14-67
Operational Messages and Data Flagging . . . . . . . . . . . . . . . . . . 14-68
Dispersional Data Alerts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-68
Instrument Alert Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-68
High Background Counts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-69
Appendix A - Bar Codes
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1
Bar Code Function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1
Understanding the Label’s Code. . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2
Bar Code Types and Characteristics. . . . . . . . . . . . . . . . . . . . . . . . . A-3
Code 39 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3
Code 128 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3
Interleaved 2 of 5 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3
Codabar. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3
Bar Code Label Formats . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-5
Bar Code Check Digit Formats. . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-5
Bar Code Label Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-6
CELL-DYN Bar Code Labels. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-6
Bar Code Label Placement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-6
CELL-DYN ® 3200 System Operator’s Manual
9140181K—July 2002
Master Table of Contents-19
Master Table of Contents
Appendix B - Parts List
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-1
CELL-DYN 3200 Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-1
CELL-DYN 3200 Optional Accessories . . . . . . . . . . . . . . . . . . . . . B-2
Index
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Index-1
Master Table of Contents-20 CELL-DYN ® 3200 System Operator’s Manual
9140181K—July 2002
List of Figures
List of Figures
Use or Function
CELL-DYN 3200SL. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
CELL-DYN 3200CS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
CELL-DYN 3200 System Components . . . . . . . . . . . . . . . . . . . . . . 1-5
CELL-DYN 3200SL Analyzer Front Panel . . . . . . . . . . . . . . . . . . . 1-8
Flow Panel Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-10
Left Side Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-14
Right Side Panel Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-15
Rear Panel Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-16
Power Supply Module. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-18
Optical Bench . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-19
Data Module Components - Rear Panel . . . . . . . . . . . . . . . . . . . . . 1-20
Display Station Components. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-22
Sample Loader Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-23
Installation Procedures and Special Requirements
Reagent Inlet Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6
Analyzer Front Covers — SL Model . . . . . . . . . . . . . . . . . . . . . . . . 2-7
Sample Loader Tower. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8
Sample Loader Mounting Screws. . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8
Normally Closed Valves . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9
Tubing in a Normally Closed Valve . . . . . . . . . . . . . . . . . . . . . . . . 2-10
CELL-DYN 3200 Printer Ports . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-12
Analyzer With Sample Loader . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-15
Tube Rack Showing Label Placement Locations . . . . . . . . . . . . . . 2-16
Principles of Operation
Optical Flow Cell . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9
WBC Light Scatter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10
Mononuclear-Polymorphonuclear Scatter . . . . . . . . . . . . . . . . . . . 3-12
Neutrophil-Eosinophil Scatter . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-13
Mononuclear Scatter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-14
WBC Histograms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-17
WBC Data and Scatterplots . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-18
RBC Data and Histogram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-20
PLT Data and Histogram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-22
Laboratory Worksheet Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-24
CELL-DYN ® 3200 System Operator’s Manual
9140181H—October 2001
List of Figures-1
List of Figures
Operating Instructions
Main Menu Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4
Set Up Menu Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-13
Date/Time Set Up Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-14
Patient Limits Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-15
Diluent/Sheath Log Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-18
QC Set Up Menu Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-20
X-B Set Up Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-21
QC Means/Limits Entry Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-24
QC Range Entry Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-25
Update From File Key . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-26
Lot Number Entry Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-29
Replicate ID Entry Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-30
Customize QC Display Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-32
Customize QC Display Screen Showing Standard Groups . . . . . . 5-32
Customize QC Printout Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-35
Operation Set Up Menu Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-36
Language Selection Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-37
Select Color Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-39
Bar Code Set Up Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-41
Computer Set Up Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-42
Units Selection Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-45
Customize Printed Report Screen for the Graphics Printer . . . . . . 5-48
Customize Printout Header Screen for the Graphics Report . . . . . 5-50
Customize Printed Report Screen for Blank Tickets . . . . . . . . . . . 5-52
Customize Printed Report Screen for Pre-Printed Tickets . . . . . . . 5-54
Customize Displayed Report Screen . . . . . . . . . . . . . . . . . . . . . . . 5-56
Run Screen for Patient Samples - CS Model . . . . . . . . . . . . . . . . . 5-67
Run Screen for Patient Samples - SL Model . . . . . . . . . . . . . . . . . 5-68
Work List Screen - Page 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-69
Work List Screen - Page 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-70
Specimen Type Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-71
Run Screen Showing Patient Results . . . . . . . . . . . . . . . . . . . . . . . 5-72
Run Screen for a QC File . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-73
Run Screen for Background Counts . . . . . . . . . . . . . . . . . . . . . . . . 5-74
Run Screen for Fragile WBC Counts . . . . . . . . . . . . . . . . . . . . . . . 5-75
Run Screen for Latex Counts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-76
Run Screen for Resistant RBC Counts . . . . . . . . . . . . . . . . . . . . . . 5-77
Display Specimen Screen Showing Flagging Messages and
RBC MORPH Message . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-79
Display Specimen Screen Showing Bulletin Line Message. . . . . . 5-80
Laboratory Worksheet Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-81
List of Figures-2 CELL-DYN ® 3200 System Operator’s Manual
9140181H—October 2001
List of Figures
Work List Screen - Page 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-108
Work List Screen - Page 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-108
Work List Set Up Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-111
Data Log Screen - Page 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-126
Display Specimen Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-127
Data Log Search Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-129
Data Log Screen Showing Reject From X-B Key . . . . . . . . . . . . 5-130
Data Log Screen Showing Accept Into X-B Key . . . . . . . . . . . . . 5-131
Customize Display for Data Log Screen Showing
Standard Groups . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-132
Customize Display for Data Log Screen Showing
Group 1 Customized . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-133
Customize Printout for Data Log Screen . . . . . . . . . . . . . . . . . . . 5-134
Print Data Log Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-137
Data Log Codes Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-138
Customize Display for Data Log Screen Showing
Standard Groups . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-139
Customize Printout for Data Log Screen Showing Customized
Display Specimen Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-143
Find Specimen Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-144
Edit Specimen Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-145
Calibration Procedures
Calibration Menu Screen Displaying Open Sampler
Calibration Factors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-13
Calibration Menu Screen Displaying Closed Sampler
Calibration Factors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-14
Enter Calibration Factor Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-15
Calibration Log Screen (CS Model) . . . . . . . . . . . . . . . . . . . . . . . . 6-17
Auto Calibration Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-18
Auto Calibration Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-21
START AUTO CAL Key Displayed . . . . . . . . . . . . . . . . . . . . . . . 6-22
Results Display Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-23
ACCEPT Key Displayed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-25
Confirm Acceptance of New Factors . . . . . . . . . . . . . . . . . . . . . . . 6-25
Enter Factor Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-34
Hazards
Laser Warning Label. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-6
Laser Warning Label Position - Protective Cover . . . . . . . . . . . . . . 8-7
Laser Warning Label Position - Flow Panel . . . . . . . . . . . . . . . . . . . 8-7
Class 1 Laser Product Label . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-8
Class 1 Laser Product Label Location . . . . . . . . . . . . . . . . . . . . . . . 8-8
CELL-DYN ® 3200 System Operator’s Manual
9140181K—July 2002
List of Figures-3
List of Figures
Service and Maintenance
First Special Protocols Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-3
Reagent Reservoir Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-4
Second Special Protocols Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-6
Analyzer Flow Panel Components . . . . . . . . . . . . . . . . . . . . . . . . . 9-11
Auto-Clean Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-13
Sample Transfer Peristaltic Pump. . . . . . . . . . . . . . . . . . . . . . . . . . 9-20
Analyzer Rear Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-21
Special Protocols: Extended Auto-Clean Screen . . . . . . . . . . . . . . 9-23
Replacing the Diluent/Sheath Filter . . . . . . . . . . . . . . . . . . . . . . . . 9-25
Shear Valve Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-31
Open Sample Probe Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-34
Closed Sample Needle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-37
Syringe Assemblies. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-39
Sample Loader Tower. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-40
Sample Loader Mounting Screws. . . . . . . . . . . . . . . . . . . . . . . . . . 9-41
Sample Injection Syringe Removal . . . . . . . . . . . . . . . . . . . . . . . . 9-41
Diluent/Sheath Syringe Replacement . . . . . . . . . . . . . . . . . . . . . . . 9-44
HGB Flow Cell Access Tubing . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-46
Open Sample Probe Replacement. . . . . . . . . . . . . . . . . . . . . . . . . . 9-49
Closed Sample Needle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-51
Tubing in Normally Closed Valve . . . . . . . . . . . . . . . . . . . . . . . . . 9-54
Fuse Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-56
Y Valve Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-60
Troubleshooting and Diagnostics
First Diagnostics Menu Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-3
Operator Correctable Fault Report Screen . . . . . . . . . . . . . . . . . . . 10-4
Fatal Fault Report Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-5
Fault Report — No Fault Pending Screen . . . . . . . . . . . . . . . . . . . 10-5
Count Rate Summary Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-6
WOC Count Rate Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-7
WOC Count Rate Graph . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-8
Raw Data Summary Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-9
Second Diagnostics Menu Screen. . . . . . . . . . . . . . . . . . . . . . . . . 10-10
Figure 10.11 Pump Operation Screen — Vacuum ON . . . . . . . . . . . . . . . . . . . 10-12
Figure 10.15 Third Diagnostics Menu Screen . . . . . . . . . . . . . . . . . . . . . . . . . . 10-16
List of Figures-4 CELL-DYN ® 3200 System Operator’s Manual
9140181K—July 2002
List of Figures
Figure 10.17 Fourth Diagnostics Menu Screen . . . . . . . . . . . . . . . . . . . . . . . . . 10-18
Figure 10.18 Fifth Diagnostics Menu Screen (CELL-DYN 3200CS) . . . . . . . . 10-19
Figure 10.20 Serial Test Transmit Message Screen . . . . . . . . . . . . . . . . . . . . . . 10-21
Figure 10.21 Fifth Diagnostics Menu Screen (CELL-DYN 3200SL) . . . . . . . . 10-22
Quality Control
Quality Control Menu Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-3
X-B Set Up Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-4
X-B RBC Graphs Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-5
X-B RBC Data Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-6
The View QC Log Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-7
The Levey-Jennings Menu Screen . . . . . . . . . . . . . . . . . . . . . . . . . 11-9
The Levey-Jennings Menu Screen Showing Next 10. . . . . . . . . . 11-10
QC Log Screen With Rejected Results. . . . . . . . . . . . . . . . . . . . . 11-11
Levey-Jennings Menu Screen Showing Westgard ®
Rule Violations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-19
Sample Loader
Analyzer With Sample Loader . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-1
CELL-DYN 3200 Sample Loader . . . . . . . . . . . . . . . . . . . . . . . . . 13-5
Tube Labeling Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-7
Rack with Bar Code Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-8
CELL-DYN 3200SL RUN Screen . . . . . . . . . . . . . . . . . . . . . . . . . 13-9
Sample Loader Restart Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-10
Sample Loader Stations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-14
Rack Movement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-15
Unload Side Full . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-16
Reticulocyte Package
Operation Set Up Menu Screen with Reticulocyte
Package Disabled . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-8
Operation Set Up Menu Screen with Reticulocyte
Package Enabled . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-10
Reticulocyte Main Menu Screen. . . . . . . . . . . . . . . . . . . . . . . . . . 14-12
Reticulocyte Set Up Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-14
Reticulocyte Patient Limits Screen. . . . . . . . . . . . . . . . . . . . . . . . 14-16
Reticulocyte QC Log Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-17
Retic QC Range Entry Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-18
Retic QC Means/Limits Screen . . . . . . . . . . . . . . . . . . . . . . . . . . 14-19
QC FILE SET UP Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-21
Figure 14.10 Operation Set Up Menu Screen with Reticulocyte
Package Enabled . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-22
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List of Figures-5
List of Figures
Figure 14.13 Reticulocyte Data Log Screen (Parameter Results) . . . . . . . . . . . 14-26
Figure 14.14 Reticulocyte Display Specimen Screen . . . . . . . . . . . . . . . . . . . . 14-28
Figure 14.15 Reticulocyte Data Log Search Screen . . . . . . . . . . . . . . . . . . . . . 14-30
Figure 14.16 Reticulocyte Data Log Screen Showing the Starting
Reticulocyte Sequence Number Field. . . . . . . . . . . . . . . . . . . . . . 14-31
Figure 14.17 Reticulocyte Display Specimen Screen . . . . . . . . . . . . . . . . . . . . 14-32
Figure 14.19 View Reticulocyte QC Log Screen. . . . . . . . . . . . . . . . . . . . . . . . 14-35
Figure 14.20 The Reticulocyte Levey-Jennings Screen. . . . . . . . . . . . . . . . . . . 14-37
Figure 14.21 View Reticulocyte QC Log Screen with Rejected Results. . . . . . 14-38
Figure 14.22 Reticulocyte Diagnostics Screen . . . . . . . . . . . . . . . . . . . . . . . . . 14-40
Figure 14.23 Reticulocyte Count Rate Screen (Tabular Format). . . . . . . . . . . . 14-41
Figure 14.24 Reticulocyte Count Rate Screen (Graphic Format) . . . . . . . . . . . 14-42
Figure 14.26 Reticulocyte Special Protocols Screen . . . . . . . . . . . . . . . . . . . . . 14-44
Figure 14.27 Reticulocyte Specimen Type Screen . . . . . . . . . . . . . . . . . . . . . . 14-49
Figure 14.28 The First Reticulocyte Patient Specimen Screen . . . . . . . . . . . . . 14-50
Figure 14.29 The Second Reticulocyte Patient Specimen Screen
(Displayed When the Specimen ID is Found) . . . . . . . . . . . . . . . 14-51
Figure 14.30 The Third Reticulocyte Patient Specimen Screen (Displayed
When the Specimen ID Found is More Than Eight Hours Old) . 14-52
Figure 14.31 The Fourth Reticulocyte Patient Specimen Screen
(Displayed When the Specimen ID Is Not Found) . . . . . . . . . . . . 14-53
Figure 14.32 The Reticulocyte Run Result Screen for a Patient Specimen. . . . 14-54
Figure 14.33 Reticulocyte Run Result Screen for a QC Specimen . . . . . . . . . . 14-57
Figure 14.34 Reticulocyte Run Result Screen for a Background Specimen . . . 14-58
Bar Codes
Bar Code Placement Guide. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-7
List of Figures-6 CELL-DYN ® 3200 System Operator’s Manual
9140181H—October 2001
List of Tables
List of Tables
Principles of Operation
5-Part Differential . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-25
5-Part Differential Plus Additional Parameters . . . . . . . . . . . . . . . 3-25
Parameter Flagging Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-29
Specimen Modes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-31
Performance Characteristics and Specifications
Instrument Dimensions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
Dimensions After Packaging for Shipment . . . . . . . . . . . . . . . . . . . 4-3
Power Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
Instrument Average Run Cycle Times . . . . . . . . . . . . . . . . . . . . . . . 4-5
Sample Throughput (Patient Mode) . . . . . . . . . . . . . . . . . . . . . . . . . 4-6
Carryover for WOC, NOC, RBC, HGB, and PLT . . . . . . . . . . . . . . 4-9
Carryover for Reticulocyte . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10
Precision of the Hemogram Parameters (N = 20). . . . . . . . . . . . . . 4-11
Precision of the WBC Differential Parameters (N=20) . . . . . . . . . 4-12
Linearity Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-12
Accuracy of Hemogram Parameters . . . . . . . . . . . . . . . . . . . . . . . . 4-13
Accuracy of WBC Differential Parameters . . . . . . . . . . . . . . . . . . 4-14
Typical Precision of Hemogram Parameters . . . . . . . . . . . . . . . . . 4-15
Typical Precision of Hemogram Parameters . . . . . . . . . . . . . . . . . 4-16
Abnormalities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-17
Flagging Analysis Truth Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-18
Analysis of False Negative Results . . . . . . . . . . . . . . . . . . . . . . . . 4-18
Sample Loader Physical Specifications . . . . . . . . . . . . . . . . . . . . . 4-19
Sample Loader Operational Specifications. . . . . . . . . . . . . . . . . . . 4-20
Operating Instructions
Service and Maintenance
Nonscheduled Maintenance Frequency . . . . . . . . . . . . . . . . . . . . . 9-29
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List of Tables-1
List of Tables
Troubleshooting and Diagnostics
Status Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-34
General Fault Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-40
Sample-Related Fault Conditions . . . . . . . . . . . . . . . . . . . . . . . . . 10-84
Non-Functional Fault Conditions . . . . . . . . . . . . . . . . . . . . . . . . . 10-90
Quality Control
Troubleshooting X-B RBC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-25
Reticulocyte Package
Known or Potential Interferents . . . . . . . . . . . . . . . . . . . . . . . . . . 14-60
Instrument Alert Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-68
Data Invalidating Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-69
Parts List
CELL-DYN 3200 Accessories Kit . . . . . . . . . . . . . . . . . . . . . . . . . . B-1
CELL-DYN 3200 Sample Loader Accessories Kit . . . . . . . . . . . . . B-2
CELL-DYN 3200 Optional Accessories . . . . . . . . . . . . . . . . . . . . . B-2
CELL-DYN 3200 Controls/Calibrator . . . . . . . . . . . . . . . . . . . . . . . B-3
CELL-DYN 3200 Reagents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-4
CELL-DYN 3200 Reagent Inlet/Outlet Tubing . . . . . . . . . . . . . . . . B-4
List of Tables-2 CELL-DYN ® 3200 System Operator’s Manual
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.
Section 1
Section 1 Use or Function
Use or Function
Overview
The CELL-DYN 3200 is a multiparameter, automated hematology analyzer designed for in vitro diagnostic use in clinical laboratories. The instrument has two versions, the automated sample loader (CELL-DYN 3200SL), and manual closed
sampler (CELL-DYN 3200CS). An example of each version is shown in Figure 1.1
The term CELL-DYN 3200 refers to both versions unless either the Closed
Sampler (CS) or Sample Loader (SL) model is specifically stated. The terms open sample and closed sample are used interchangeably with open sampler and closed sampler. Generally, when referring to the mode of operation, the terms Open
Sampler and Closed Sampler are used and when referring to components of the instrument, Open Sample and Closed Sample are used, e.g., Open Sample
Aspiration Probe.
Figure 1.1 CELL-DYN 3200SL
The CELL-DYN 3200SL is equipped with a Sample Loader Module. The Sample
Loader provides continuous automated closed sampling for up to 50 closed-tube samples at a time. The Sample Loader is also referred to as the Auto Sampler.
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1-1
Use or Function
Overview Section 1
Figure 1.2 CELL-DYN 3200CS
The CELL-DYN 3200CS is equipped with a built-in manual Closed Sample
Aspiration Module which aspirates blood from a closed collection tube that has been inserted in the Closed Sample Module.
Both models aspirate blood from open collection tubes. This method is referred to as the Open Sampler mode.
Intended Use
The CELL-DYN 3200 is a multiparameter, automated hematology analyzer designed for in vitro diagnostic use in clinical laboratories.
The CELL-DYN 3200 generates the following hematologic measurements on
EDTA-anticoagulated whole blood:
WBC — White Blood Cell or leukocyte count
NEU — Neutrophil absolute count %N — Neutrophil percent
LYM — Lymphocyte absolute count %L — Lymphocyte percent
MONO — Monocyte absolute count %M — Monocyte percent
EOS — Eosinophil absolute count %E — Eosinophil percent
BASO — Basophil absolute count %B — Basophil percent
RBC — Red Blood Cell or erythrocyte count
HGB — Hemoglobin concentration
HCT — Hematocrit
MCV — Mean Cell Volume
MCH — Mean Cell Hemoglobin
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Section 1 Use or Function
MCHC — Mean Cell Hemoglobin Concentration
RDW — Red Cell Distribution Width
PLT — Platelet or thrombocyte count
MPV — Mean Platelet Volume
PDW *— Platelet Distribution Width
PCT * — Plateletcrit
Retic % —Reticulocyte Percent
Retic Abs —Reticulocyte Absolute Count
* Clinical significance has not been established for these parameters. Therefore, they are not reportable.
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1-3
Use or Function
Overview
NOTES
Section 1
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Section 1 Use or Function
System Components
The CELL-DYN 3200 consists of three major modules, the Analyzer, Data
Module, and the Display Station. The Analyzer and Data Module are housed in
single chassis. The Display Station is a standalone module. Figure 1.3 lists the
major subassemblies in each of the modules.
The Analyzer contains the hardware to aspirate, dilute, and analyze each whole blood specimen.
The Data Module contains the components for analyzing, storing, and reporting specimen results.
The Display Station module consists of a 15" color monitor and pressure-sensitive keypad for selecting the displayed commands that operate the system.
The Sample Loader attaches to the front of the CELL-DYN 3200SL Analyzer and is an integral part of the SL model. The Sample Loader is discussed throughout this manual where appropriate. It is also discussed in detail in
.
CELL-DYN 3200 System
Analyzer
Flow Panel
Electrical Power Supply
Pneumatic Power Supply
Laser Optics Assembly
Syringe Drive Assemblies
Open Sample Probe Assembly
Reagent/Waste System
Closed Sample Tower Assembly
Sample Loader (SL model only)
Figure 1.3 CELL-DYN 3200 System Components
Data Module
486 Computer
Floppy Disk Drive
Hard Disk Drive
PC Keyboard
Serial/Parallel Interface Ports
Printed Circuit Boards
Display Station
15" Color Monitor
Membrane Keypad
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1-5
Use or Function
System Components Section 1
Analyzer Components
The major components of the Analyzer are listed below and shown in Figures 1.4
Front Panel
Right Front Cover
Left Front Cover
Front Skirt Cover (CS model)
Sample Loader (SL model)
Status Indicator Panel
Closed Sample Tower Cover
Open Sample Aspiration Probe with Touch Plate
Flow Panel
Closed Sample Aspiration Tower Module
Shear Valve Assembly
Syringes (4)
Sample Transfer Peristaltic Pump
Optical Flow Cell Assembly
Laser Optics Bench Assembly (behind Flow Panel)
HGB Flow Cell/Mixing Assembly
WBC Mixing Chamber
RBC/PLT Mixing Chamber
Open Sample Aspiration Probe and Wash Block
Normally Closed Valves (6)
Diluent Reservoirs (2)
Open/Closed Mode Switching Assembly (Y Valve Assembly)
Waste Chambers (4)
Venting Chamber
Bubble Traps
Aerosol Filter
Normally Open Pinch Valves
Ultrasonic Sensor
LED Sensor
Diluent/Sheath Filter
Left Side Panel
Fan
Right Side Panel
Floppy Disk Drive Slot
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Section 1
Rear Panel
Main Power Switch
Main Power Connector
Display Station Communications Connector
Line Frequency and Line Voltage Select Switches
Fuse
Fan with Air Intake Filter
Serial and Parallel Interface Ports (Data Module)
Keyboard Connector Port
Touch Pad Connector Port
Waste Sensor Connector
Waste Outlet Tube Connector
Diluent/Sheath Inlet Tube Connector
WBC Lyse Inlet Tube Connector
HGB Lyse Inlet Tube Connector
Analyzer Serial Number Label
Disk Storage Container
Use or Function
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1-7
Use or Function
System Components Section 1
Component Description
Front Panel
The major components of the Front Panel are depicted in Figure 1.4. A brief
description of each component’s function follows.
1
2
1 Left Front Cover
2 Right Front Cover
3 Status Indicator Panel
4 Aspiration Probe
5 Touch Plate
6 Sample Loader
7 Tower Cover
4
7
3
5
6
Figure 1.4 CELL-DYN 3200SL Analyzer Front Panel
Left Front Cover
The Left Front Cover protects the left portion of the flow panel. The cover is hinged on the left, opening from the center to expose the left half of the flow panel.
Access to the left half of the flow panel is necessary to view the operation of the left flow panel components, to access the solenoids, pinch valves, normally closed valves, and to perform certain maintenance procedures. The cover is held in place by hinges and magnetic fasteners (located on the top inside edge of the cover).
Right Front Cover
The Right Front Cover protects the right portion of the flow panel and supports the Touch Plate and Status Indicator Panel. The cover is hinged on the right, opening from the center to expose the right half of the flow panel. Access to the right half of the flow panel is necessary to view the action of the right flow panel components, to access the syringe assemblies, solenoids, pinch valves, normally closed valves, and to perform certain maintenance procedures.
The cover is held in place by hinges and magnetic fasteners (located on the top inside edge of the cover).
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Section 1 Use or Function
Front Skirt Cover (not pictured)
The Front Skirt Cover protects the lower front part of the flow panel. The skirt should be removed to access the two lower Normally Closed Valves on the left side of the Flow Panel. The Skirt is removed from the instrument by removing the four
Phillips-head screws holding the Skirt to the Analyzer. The Skirt on the SL model has two removable sections adjacent to the Flow Panel. The section on the right side should be removed to provide easy access to all four syringes and two syringe drives.
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 wash block moves down to the end of the probe and returns to a position that is covered by the Right Front Cover. When Closed
Sampler mode is selected, the Wash Block moves down to the end of the probe and remains down until the Open Sampler mode is again selected.
Touch Plate
The Touch Plate is used to start the run cycle for (1) both the Open Sampler and
Closed Sampler modes on the CS model and (2) Open Sampler mode only on the
SL model. It is located directly behind the Open Sample Aspiration Probe and is part of the Right Front Cover. Pressing the Touch Plate starts the selected run cycle.
Sample Loader
See Subsection: Sample Loader Components
later in this section.
(Closed Sample) Tower Cover
The Closed Sample Tower Cover protects the Tower Assembly and Shear Valve.
The Tower Cover for the SL model is larger than its counterpart on the CS model in order to cover the top central portion of the Sample Loader. Part of the cover is translucent to allow viewing of the Shear Valve’s operation. The cover is held in place by two pins at the bottom and magnetic fasteners at the top. Both covers have an Interlock Sensor Switch which prevents the instrument from operating in the
Closed Mode if the cover is not in place.
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Use or Function
System Components Section 1
Flow Panel
1 Vent Filter
2 Vent
3 Sample Transfer
Peristaltic Pump
4 Waste Chambers
5 WBC Mixing Chamber
6 RBC Mixing Chamber
7 HGB Flow Cell
8 Shear Valve
9 Y Valve
10 Open Sample Probe
(With Wash Block)
11 Normally Closed
Valves
12 Diluent Reservoir
13 Sheath Reservoir
14 Normally Closed
Valves
15 Diluent/Sheath Filter
16 Tube Spinner
17 Closed Sample
Needle (With Wash
Block)
18 Sample Injection
Syringe
19 HGB Lyse Syringe
20 WBC Lyse Syringe
21 Diluent/Sheath
Syringe
22 Waste Chambers
The major components of the Flow Panel
are depicted in Figure 1.5. A brief
description of Flow Panel components follows.
1
2 3
12 13
Figure 1.5 Flow Panel Components
4
14
5
15
6 7
16 17
8 9
18 19 20 21
11
10
22
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 of the valve rotate. The aspirated blood is isolated in three separate volume segments — one for the WBC dilution, one for the HGB dilution and one for the RBC/PLT dilution. Sensors located before and after the shear valve ensure the integrity of the aspirated specimen. In both Open and Closed modes an ultrasonic sensor checks the segment as it is aspirated. Additionally, in the Closed mode, an optical sensor checks the segment as it exits the shear valve.
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Section 1 Use or Function
Syringe Assembly
There are two syringe driver assemblies, each containing two syringes. Each syringe is operated by its own stepper motor. The function of each syringe is described below:
• Diluent/Sheath Syringe — (1) delivers a specific volume of diluent to transport the RBC segment from the Shear Valve to the RBC/PLT Mixing
Chamber and to dilute the segment prior to measurement, and (2) delivers a specific volume of diluent to transport the HGB segment from the Shear
Valve to the HGB Mixing Chamber and to dilute the segment prior to measurement.
• HGB Lyse Syringe — delivers a specific volume of HGB Lyse to the HGB
Mixing Chamber/Flow Cell to further dilute the HGB segment prior to measurement.
• WBC Lyse Syringe — delivers a specific volume of WBC Lyse to transport the WBC segment from the Shear Valve to the WBC Mixing Chamber and to dilute the segment prior to measurement.
• Sample Injection Syringe — injects a specific volume of the diluted sample into the Optical Flow Cell for RBC/PLT, WBC (WOC), and WBC (NOC) measurements.
Sample Transfer Peristaltic Pump
The Sample Transfer Peristaltic Pump is composed of a rotor and a pump tube holder. It is used to transfer the WBC dilution, RBC/PLT dilution, and HGB/NOC dilution to the Optical Flow Cell from their respective mixing chambers.
HGB Flow Cell and Mixing Chamber
The HGB Flow Cell Assembly is integrated with a mixing chamber and contains the following components:
• A fully enclosed (light-tight) mixing chamber with optical windows and electronics
• An LED Light Source
• A Photodetector for measuring the light transmitted.
WBC Mixing Chamber
The WBC Mixing Chamber is used to swirl mix the WBC dilution.
RBC/PLT Mixing Chamber
The RBC/PLT Mixing Chamber is used to swirl mix the RBC/PLT dilution.
Wash Block
There are two Wash Blocks on the instrument, one for the Open Sample Aspiration
Probe and one for the Closed Sample Needle. Both Wash Blocks work in a similar fashion: After aspiration, they move down the outside of the probe or needle, rinsing it with diluent. The diluent rinse is then transferred to the waste chamber.
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Use or Function
System Components Section 1
Normally Closed Valves
The Normally Closed Valves prevent the backflow of reagents in critical areas when the power is turned off.
Diluent Reservoir
The Diluent Reservoir maintains the diluent supply for cleaning and sample dilution.
Sheath Reservoir
The Sheath Reservoir maintains a constant sheath supply for hydrodynamic focusing in the Flow Cell.
Waste Chambers
The Waste Chambers collect the waste liquid from the Analyzer flow panel.
Bubble Traps
The Bubble Traps (not shown) are used to prevent bubbles and liquid from being pulled into the vacuum accumulators and the vacuum pump.
Aerosol Filter
The Aerosol Filter (not shown) is used to prevent aerosols escaping into the atmosphere.
Pinch Valves
The Pinch Valves (not shown) are used to control air and liquid throughout the
Analyzer.
Closed Mode Aspiration Tower
The Aspiration Tower contains the Aspiration/Vent Needle, Needle Wash Block,
Sample Tube Spinner Assembly, and tubing to aspirate blood samples from closed sample tubes.
Vent/Aspiration Needle
The Vent/Aspiration Needle combines both venting and aspiration of blood samples from closed sample tubes.
Wash Block
Discussed in the previous subsection.
Spinner Assembly
The Spinner Assembly consists of a tube holder, motor, and belt. These are attached to the Closed Mode Aspiration Needle drive mechanism, and they move up and down in tandem with the needle. As the Spinner Assembly and needle descend together, the spinning tube holder centers and rotates the sample tube, allowing the Bar Code Reader to read the bar code on the sample tube. After the bar code is read, the needle penetrates the rubber stopper and aspirates the sample.
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Section 1 Use or Function
Bar Code Reader
The Bar Code Reader is an LED type and can accommodate Code 39, Code 128,
CODABAR, and Interleaved 2 of 5 formats. On the CS model, the Bar Code
Reader is located to the right of the door opening on the Door Assembly. On the SL model, the Bar Code Reader is located to the left of the Mixing Assembly on the
Sample Loader.
Door Assembly (CS Model)
The Door Assembly consists of a tube holder/door, Bar Code Reader, Interlock
Switch, and electrical latch to open the door after aspiration has occurred. The
Interlock Switch will cause the instrument to halt if the door is opened between the time the Touch Plate is pressed and the system emits a beep to indicate that aspiration is completed. Opening the door during this period will cause a Fatal
Fault condition.
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Use or Function
System Components
Left Side Panel
Section 1
The only major component on the Left Side Panel is the Fan, shown in Figure 1.6.
Fan
A Fan cools the internal components of the Analyzer.
1 Fan
1
Figure 1.6 Left Side Panel
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Section 1
Right Side Panel
Use or Function
The only major component on the Right Side Panel is the Floppy Disk Drive shown
1 Floppy Disk Drive Slot
1
Figure 1.7 Right Side Panel Components
Floppy Disk Drive (Slot)
The Floppy Disk Drive allows information to be downloaded or uploaded using a
3.5" floppy disk.
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Use or Function
System Components Section 1
Rear Panel
1 Main Power Switch
2 Analyzer Serial
Number
3 Data Module
4 Disk Storage
Container
5 Fan
6 Ground Connector
7 Waste Sensor
Connector
8 Waste Outlet Tube
Connector
9 Reagent Inlet Panel
10 Power Supply Module
The major components on the Rear Panel
are depicted in Figure 1.8. A brief
functional description of the main components follows.
1 4 5
2
3
6
7
10
8
9
Figure 1.8 Rear Panel Components
Main Power Switch
The Main Power Switch turns on power for the Analyzer, Data Module, and
Sample Loader (SL model only).
Analyzer Serial Number Label
Although not an instrument component, the Analyzer Serial Number may be required when consulting with the Abbott Hematology Customer Support Center.
Data Module
See
Subsection: Data Module Components
later in this section.
Disk Storage Container
This container is used to store the Installation and Set Up disks.
Fan
A Fan cools the internal components of the Analyzer.
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Section 1 Use or Function
Waste Sensor Connector
The waste-full sensor plug connects to the Waste Sensor Connector port. The ground shield on the cable should be attached to the Ground Connector on the rear panel. When the electrical sensor is tripped, the
EXTERNAL 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, the dummy plug (supplied in the accessory kit) must be inserted in the connector.
Waste Outlet Tube Connector
This port is used to connect the waste outlet tube.
Reagent Inlet Panel
Diluent/Sheath Inlet Tube Connector
This color-coded (red) port is used to connect the diluent inlet tube with its associated cap, sinker and label.
WBC Lyse Inlet Tube Connector
This color-coded (purple) port is used to connect the WBC lyse inlet tube with its associated cap, sinker and label.
HGB Lyse Inlet Tube Connector
This color-coded (blue) port is used to connect the HGB lyse inlet tube with its associated cap, sinker and label.
Power Supply Module
The Power Supply Module supplies the power to operate the Analyzer and Data
Module.
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Use or Function
System Components Section 1
Line Frequency and Line Voltage Select Switches
These switches are used to select the Line Frequency and Voltage for the Analyzer
WARNING : SET FOR 120 VOLTS
When operation at other line voltage is required, refer to Operator’s Manual for detailed instructions.
1 Line Voltage Select
Switch
2 Line Frequency Select
Switch
3 Main Power
Connector
4 Fuse
PN 9230003E
WARNING: These switches are set at the factory for 120 volts. When operation at
other line voltage is required, refer to Figure 1.9.
2
1
4
3
Figure 1.9 Power Supply Module
Main Power Connector
This receptacle is used to connect the main power cord to the instrument.
Fuse
An 8-amp (110/120 V) T (Slo-Blo) or 4-amp (220/240 V) T (Slo-Blo) Fuse protects the Analyzer from electrical spikes.
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Section 1 Use or Function
Top Panel
Flow Cell Assembly
The Flow Cell Assembly contains the fluidics and hardware needed to hydrodynamically focus the RBC/PLT and WBC sample streams in the path of the laser beam for analysis. The primary components of this assembly are:
• Sample Feed Nozzle — a specially designed tube used to deliver the diluted sample into the sheath stream
• Sample Flow Cell — an optically clear quartz chamber with a central square opening of a specific size, which flares out into a cone at the bottom of the flow cell
Laser Optics Bench Assembly
The Laser Optics Bench Assembly (located behind the Flow Panel) contains the
Helium-Neon laser, the flow cell, and the optics and detectors required for enumeration and differentiation of white blood cells, red blood cells, and platelets
2
1 Orthogonal (90° and
90°D) Scatter Light
Detectors
2 Laser Tube
3 Forward Angle (0° and
10°) Scatter Light
Detectors
4 Optical Flow Cell
5 Laser
1
CAUTION –
CLASS 3B LASER LIGHT WHEN OPEN.
AVOID EXPOSURE TO BEAM.
PN 9230701
3
Figure 1.10 Optical Bench
5 4
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Use or Function
System Components
10
9
8
1
2
3
4
Section 1
Data Module Components
The major components of the Data Module are depicted in Figure 1.11. A
description of each component’s function follows.
1 PC Keyboard
Connector
2 COM1 (LIS
Connector)
3 COM2 (Unused)
4 Analyzer BDM
Diagnostics (Unused)
5 HSSL Connector
6 HSSL Connector
7 Membrane Keyboard
Interface Connector
8 Display Station
Interface Connector
9 Ticket Printer
Connector
10 Graphics Printer
Connector
7
5
6
Figure 1.11 Data Module Components - Rear Panel
Computer (inside the Data Module)
• Intel 486DX microprocessor
• 8 megabytes RAM (expandable to 16 megabytes)
• VGA graphics with 1 megabyte cache
• 2 enhanced parallel ports and 2 serial ports
• 2 FIFO UART Com1 and Com2 ports
• 3 PCI slots
Data Storage
Data storage consists of a 3.5-inch, 1.4 megabyte Floppy Disk Drive and a one gigabyte EIDE (enhanced IDE) Hard Disk Drive .
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Section 1 Use or Function
The floppy disk drive is used to update the software program and to download data.
The hard drive is used to store the User Interface Software and Patient Data Log.
It has sufficient capacity to store the most recent 10,000 cycles, including numeric and graphics data.
Printed Circuit Boards
A set of Printed Circuit Boards constitutes the measurement and control electronics for detection, amplification, and processing of signals.
PC Keyboard Connector
The PC Keyboard Connector port is used to connect the standard computer keyboard.
LIS (Laboratory Information System) Connector
Two serial ports are provided. COM1 is used to connect the Laboratory
Information System to the Data Module. COM2 is unused.
Analyzer BDM Diagnostics (Unused)
HSSL (High Speed Serial Link) Connectors
The High Speed Serial Link transfers data between the Analyzer and the Data
Module. The HSSL Connector on the Data Module connects to the HSSL
Connector on the back panel of the Analyzer.
Membrane Keypad Interface Connector
The Membrane Keypad Interface Connector allows data to be sent from the
Membrane Keypad on the Display Monitor to the Data Module.
Display Station Interface Connector
The Display Station Interface Connector allows data to be sent to the monitor and data to be received from the Membrane Keypad (Soft Keys) on the Display
Station.
Ticket Printer Connector
This port is used to connect the printer cable when the printer is used to print data in a ticket format.
Graphics Printer Connector
This port is used to connect the printer cable when the printer is used to print data in a graphics format.
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Use or Function
System Components
Display Station Components
The major components of the Display Station are shown in Figure 1.12.
A description of each component’s function follows.
1 Membrane Keypad
Screen Controls
2 Degauss
3 Side Pincushion
4 V Size
5 V Shift
6 H Size
7 H Shift
8 Reset to Default
9 Brightness
10 Contrast
11 ON/OFF Switch
12 Soft Keys
1
Section 1
2
3
4
12
5 6 7
8 9
10 11
Figure 1.12 Display Station Components
Display Monitor
A 15-inch diagonal, high-resolution Display Monitor with 16-color illumination displays all alphanumeric and graphical data.
Membrane Keypad
The Membrane Keypad allows commands to be transferred from the Display
Monitor to the Data Module.
Screen Controls
The Controls
available on the Display Monitor are shown in Figure 1.12. The
Brightness and Contrast controls are located under the control panel shown in the figure.
Soft Keys
A row of eight unlabeled pressure-sensitive Soft Keys (membrane keypad) is located directly below the screen. Each key initiates a function defined by the screen label currently displayed directly above it.
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Section 1 Use or Function
Video Cable (not shown)
The Video Cable allows data from the Data Module to be transferred to the Display
Monitor.
Power Cord (not shown)
A built-in power cord on the Display Station connects to an outside power supply and provides power to the monitor and keypad.
Sample Loader Components
The major components of the Sample Loader
A description of each component’s function follows.
1 Aspiration Needle
2 Wash Block
3 Spinner Motor
4 Tube Spinner
5 Tube Mixer Assembly
6 Bar Code Reader
2
1
3
4
5
6
Figure 1.13 Sample Loader Components
Racks
Each Sample Loader Rack is able to accommodate up to 10 tubes. Racks are labeled with rack number and tube position, and with a 2-digit Bar Code 39 format.
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Use or Function
System Components Section 1
Tower Cover
The Tower Cover on the SL model, although not part of the Sample Loader, has an Interlock Sensor Switch which prevents the loader from operating if the cover is not in place. If the cover is removed during operation, the Sample Loader comes to an immediate halt, causing a fatal fault. This feature provides further safety for the operator.
Bar Code Reader
The Bar Code Reader is an LED type and can accommodate Code 39, Code 128,
CODABAR, and Interleaved 2 of 5 formats. On the SL model, the Bar Code
Reader is located on the Sample Loader. It reads the bar code on the tube when the tube is at the aspiration station.
Tube Sensor Assembly
The Tube Sensor Assembly senses the presence of a sample tube at each Mixing
Station.
Tube Mixer Assembly
The Mixer Assembly consists of a double-tube holder directly attached to a stepper motor. As the rack advances, the tube holder descends and grabs the tube.
The tube holder rotates 15 times in an outward motion of approximately 135 degrees. The double-tube configuration of the tube holder allows each tube to be held and mixed twice in succession before it passes to the mixing station. An air cylinder governs the rotation movement of the tube holder.
Closed Sample Aspiration Tower Module
The Closed Sample Aspiration Tower is used to aspirate whole blood from a closed collection tube. It is used when the Closed Sampler mode is selected on either the SL or CS model. The configuration of the Tower Module differs depending on the model.
In the CS model, the Tower Module consists of the following components:
• Aspiration/Vent Needle
• Wash Block
• Tube Spinner (includes motor and belt)
• Door Assembly (includes Tube Holder, Bar Code Reader, Swivel Door,
Solenoid, and Interlock Switch).
In the SL model, the Tower Module consists of the following components:
• Aspiration/Vent Needle
• Wash Block
• Tube Spinner (includes motor and belt)
The Door Assembly is eliminated from the Tower, and the Bar Code Reader is moved to the Sample Loader which also contains the Mixer Assembly.
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Section 1 Use or Function
The major components of the Tower Module are briefly described below:
• A two-part Needle consisting of a venting needle and an aspiration needle that pierces the collection tube stopper, vents vacuum or pressure from inside the tube, aspirates the whole blood, and is retracted for rinsing at the end of each cycle
• A Tube Spinner to grasp and spin the tube for bar code reading
• The Driver Motor and Belt to operate the Tube Spinner
• A Closed Sample Door/Tube Retainer which holds a single closed collection tube in the proper position for (1) reading the bar code if applicable, and (2) stopper penetration and sample aspiration by the needle
Printer
The Printer is discussed in detail in
Reagent System
Introduction
The Reagent System is formulated specifically for the CELL-DYN 3200 Series 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 3200 system is checked at the factory using the specified reagents and all performance claims are generated using these reagents.
The reagents used with the CELL-DYN 3200 are:
• RBC/PLT Reagent - Diluent/Sheath
• WBC Reagent - WBC Lyse
• HGB Reagent - CN-Free HGB/NOC Lyse
• Reticulocyte Reagent
Reagents must be stored at room temperature to ensure optimal performance. All reagents should be protected from direct sunlight, extreme heat and freezing during shipment and storage. Temperatures below 32° F (0°C) may cause reagent layering that changes the tonicity and conductivity of the reagents.
CAUTION: If any reagent has been frozen, it must not be used.
The reagent inlet tubes have a cap attached that minimizes evaporation and contamination during use. However, reagent quality may deteriorate with time.
Therefore, use all reagents within the dating period indicated on the label.
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Use or Function
System Components Section 1
CELL-DYN Reagents
CELL-DYN 3200 Diluent/Sheath (List Number 03H79-01)
CELL-DYN Diluent/Sheath is formulated to meet the following requirements:
• Act as the diluent for 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
• Serve as a sheath fluid for the hydrodynamic focusing process
• Serve as a rinsing agent for the fluidics system
• Provide background counts equal to or less than:
WOC: 0.10 x K/µL
NOC: 0.10 x K/µL
RBC: 0.02 x M/µL
HGB: 0.10 x g/dL
PLT: 5.0 x K/µL
CELL-DYN 3200 CN-Free HGB/NOC Lyse (List Number 03H80-02)
CELL-DYN CN-Free HGB/NOC Lyse is formulated to meet the following requirements:
• Rapidly lyse the red blood cells and minimize the resultant stroma
• Strip the white cell cytoplasm leaving the nuclear membrane intact so the white cell nuclei can be enumerated
• Convert hemoglobin to a stable chromagen complex that is measurable at
555 nm.
CELL-DYN 3200 WBC Lyse (List Number 03H78-01)
CELL-DYN WBC Lyse is formulated to meet the following requirements:
• Act as the diluent for the WBCs
• Osmotically lyse the red cells
• Maintain the light scattering properties of the WBCs for the duration of the measurement period
• Provide sufficient wetting action to prevent accumulation of air bubbles in the WBC flow system
• Maintain a WOC background count equal to or less than 0.10 x K/µL
• Act as a diluent for Reticulocytes
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Section 1 Use or Function
Reticulocyte Reagent System—CELL-DYN Reticulocyte Reagent
(List Number 03H40-01)
CELL-DYN Reticulocyte Reagent is formulated specifically to provide optimal system performance for the CELL-DYN 3200 Reticulocyte procedure. Use of reagents other than those specified in this manual is not recommended because instrument performance can be affected. Each CELL-DYN 3200 System is checked at the factory using the specified reagents and all performance claims were generated using these reagents.
Reagent must be stored in the dark at room temperature. All reagents should be protected from direct sunlight, extreme heat, and freezing during storage.
CAUTION: If any reagent has been frozen, it must not be used.
Reagent tubes have been capped to minimize evaporation. However, reagent quality may deteriorate with time. Therefore, use all reagents within the dating period indicated on the label.
Consumables
The following consumables are used with the CELL-DYN 3200 System:
• Preprinted tickets
• Color Ink Cartridges
• DYN-A-WIPE Lint-free pads
• Enzymatic Cleaner Concentrate
For information on ordering parts and accessories, reagents, controls, calibrators, and consumables, please refer to Appendix B - Parts and Accessories .
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Use or Function
System Components
NOTES
Section 1
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Section 2
Section 2 Installation Procedures and Special Requirements
Installation Procedures and Special Requirements
Overview
Initial Preparation
Installation of the CELL-DYN 3200 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. Never attempt to install the system without an authorized Abbott representative present.
The remainder of this chapter gives general requirements for a successful installation. Procedures are also included for installing the Printer and Sample
Loader.
Package Inspection and Inventory
The instrument is shipped from the factory as follows:
CELL-DYN 3200SL
• 1 crate containing the instrument including Sample Loader
• 1 box containing the CELL-DYN Accessory kit and Sample Loader
Accessory kit
• 1 box containing the Color Graphics Printer
• 1 box containing the Ticket Printer (optional)
• CELL-DYN Reagents
• CELL-DYN Operator’s Manual
CELL-DYN 3200CS
• 1 crate containing the instrument
• 1 box containing the CELL-DYN Accessory Kit
• 1 box containing the Color Graphics Printer
• 1 box containing the Ticket Printer (optional)
• CELL-DYN Reagents
• CELL-DYN Operator’s Manual
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Installation Procedures and Special Requirements
Overview Section 2
CELL-DYN Accessory Kit
• Keyboard Cover
• Fuse, SB 8.0 amps 110/120V (2)
• Fuse, SB 4.0 amps 220/240V (2)
• Printer Paper 9.5" x 11"
• Power Cord (Analyzer)
• Reagent Line Kit
• Printer Cable
• 10 ' long Tygon ® tubing
• Diluent/Sheath filters
• Large Peristaltic Pump Tubing
• Waste Dummy Plug
• Wire Puller (Solenoids)
• RS232 Plug (Loop back)
Sample Loader Accessory Kit
• 5 Tube Racks (Pre-labeled)
The instrument will be uncrated and inspected for damage by the trucking company when the system is delivered. If desired, the trucking company will transport the instrument to the laboratory and place it in the designated space.
Inspect the remaining boxes for damage. If there is any damage, or if any crates or boxes are missing, contact the Abbott Hematology Customer Support Center for assistance.
The reagents needed for installation are shipped when the instrument is shipped.
This shipment includes: WBC Lyse Reagent, CN-Free HGB/NOC Lyse Reagent, and Diluent/Sheath Reagent.
The calibrator and controls needed for the installation are shipped when the instrument is shipped. This shipment includes: CELL-DYN Calibrator and
Tri-level Control.
If any reagents, calibrator or control materials are missing, contact the Abbott
Hematology Customer Support Center for assistance.
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Section 2 Installation Procedures and Special Requirements
Space Requirements
Approximately 6 linear feet of space is required on the counter top to accommodate the instrument, display station, and printer. Sufficient space is required beneath for the reagents and the waste container (if one is used).
Do not position the instrument so that it is difficult to operate the main power switch.
Allow six inches of space behind the instrument and 12 inches above and in front of the fan on the left side of the LQVWUXPHQW for air flow. In addition, allow adequate space around the instrument to perform necessary maintenance procedures, to provide service access, and to allow the instrument to be easily disconnected from its power source.
Locate the instrument:
• On a stable, level surface
• On a nonporous, nonabsorbent work surface and flooring that can be easily cleaned and disinfected using recommended procedures
• Away from direct sunlight
• Away from the path of a cooled or heated air outlet
• Away from any other instruments that may interfere with it, such as a centrifuge, any x-ray equipment, MRI equipment, a CRT, a video terminal, a computer, or a copier
Place the reagents below the instrument.
Waste Disposal Requirements
Observe the following requirements for waste routing and disposal:
• Allow room for a suitable, properly labeled, waste container or position the instrument to permit the waste to be routed directly to a drain suitable for disposal of waste. The drain must be suitable for waste that could present a biological or chemical hazard.
• If routing waste to a waste container, ensure the Waste Sensor is properly connected.
• If routing waste to a drain, make sure the Dummy Plug is inserted into the
SENSOR port.
• Users are responsible for disposing of waste in accordance with local, state, and federal regulations.
WARNING: Potential Biohazard. The waste is under pressure. Be sure that the Waste Outlet Tube is securely placed in the drain hole or waste box, flow of waste is unobstructed, and all System components are located away from possible waste overflow.
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Installation Procedures and Special Requirements
Overview Section 2
Power Requirements
Be sure that the system is located at the desired site before attempting any connections. A minimum of three power outlets are required for either model: one outlet for the Analyzer, one for the Printer, and one for the Display Station. If a
Ticket Printer will also be installed, a fourth power outlet will be needed. Grounded power outlets and a voltage regulator for the Analyzer are required for optimum performance.
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Section 2 Installation Procedures and Special Requirements
Tubing Installation
Reagent and Waste Tubing
1. Locate the reagent tubing in the Accessory Kit.
2. Inspect each length of tubing carefully for damage or cracks.
3. Attach the non-weighted end of the tubing with the Purple WBC Lyse label to the Purple
Connector on the right side of the Rear Panel. (Refer to Figure
2.1.) This reagent is for the WBC dilution. Wipe the outside of the tubing
with a damp lint-free pad (such as DYN-A-WIPE) and place the weighted end into the container of CELL-DYN WBC Lyse. Secure the cap. Place the container on the same level as or lower than the unit.
4. Attach the non-weighted end of the tubing with the Red Diluent/Sheath label to the Red Connector. This reagent is for the RBC dilution and for rinsing the flow system. Wipe the outside of the tubing with a damp lint-free pad (such as DYN-A-WIPE) and place the weighted end into the container of
CELL-DYN Diluent/Sheath. Secure the cap. Place the container on the same level as or lower than the unit.
5. Attach the non-weighted end of the tubing with the Blue HGB Lyse label to the Blue Connector. This reagent is for the HGB dilution. Wipe the outside of the tubing with a damp lint-free pad (such as DYN-A-WIPE) and place the weighted end into the container of CELL-DYN HGB Lyse. Secure the cap.
Place the container on the same level as or lower than the unit .
6. Attach the Waste Outlet Tubing to the :DVWH Outlet Connector. Place the end of the tubing with the cap and sensor into the waste collection container.
Ensure that the waste collection container is adequately labeled. Secure the cap, or remove the cap from the tubing and place the tubing into a drain suitable for collection of waste with possible biological and chemical hazard .
Be sure that the tubing is secured to the drain hole.
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2-5
Installation Procedures and Special Requirements
Tubing Installation
1 Waste Full Sensor
2 Waste Outlet
Connector
3 HGB Lyse Connector
4 Diluent/Sheath
Connector
5 WBC Lyse Connector
Section 2
1 2 3 4 5
Figure 2.1 Reagent Inlet Panel
7. Locate the Waste-Full Sensor Plug attached to the cap's electrode wires.
Insert the plug into the :DVWH6HQVRU connector located on the Reagent Inlet
Panel. Attach the ground shield on the cable to the connection on the rear panel.
If the waste tube is placed directly into a drain, insert the Dummy Plug
(provided in the Accessory kit) into the Waste Sensor Connector, as the
EXTERNAL WASTE FULL
alert will activate if no plug is inserted. For information on ordering a Waste Dummy Plug, refer to Appendix B ¥ Parts and Accessories .
Normally Closed Valves
To gain access to all six Normally Closed Valves on the Flow Panel, open both the
Left and Right Front Covers and remove the Tower Cover. Remove the Front Skirt
(CS model) or move the Sample Loader (SL model) away from the instrument.
(Refer to instructions later in this section for opening and removing these components.)
Before shipment, the tubing is removed from these valves. To ensure correct system operation, the tubing must be completely inserted in all the valves before the instrument power is turned ON. Follow the directions below to open the front covers and remove the Skirt or Sample Loader to allow access to all the Normally
Closed Valves. Refer to Figure 2.2.
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Section 2
1 Left Front Cover
2 Right Front Cover
3 Touch Plate
4 Phillips-head Screws
5 Sample Loader
6 Tower Cover
1
Installation Procedures and Special Requirements
2
6 3
5
4
Figure 2.2 Analyzer Front Covers — SL Model
Open Left Front Cover
To open the Left Front Cover on both the SL and CS models, gently pull on the hand hold to release it. Swing the cover all the way to the left to completely expose the left side of the Flow Panel.
Open Right Front Cover
To open the Right Front Cover on both the SL and CS models, gently pull on the hand hold to release it. Swing the cover all the way to the right to completely expose the right side of the Flow Panel. Because of the attached Touch Plate and
Status Panel, this cover should not be removed from the instrument.
Remove Tower Cover
To remove the Tower Cover on both the SL and CS (tower door on the CS model must be open) models, rotate tower away from front panel using hand hold. Lift bottom of cover off skirt locating pins and gently pull the top of the cover away from the analyzer.
Remove Front Skirt
To remove the Front Skirt Cover on the CS model, remove the four Phillips-head screws, two on either side of the instrument, which hold the skirt to the instrument frame. Pull the skirt away from the instrument.
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Installation Procedures and Special Requirements
Tubing Installation Section 2
Remove Sample Loader
To access the Flow Panel, the Sample Loader on the SL Model is pulled away from the analyzer as follows:
1. Remove Tower Cover.
2. Open Left and Right Front Covers as follows. Gently pull on cover using hand hold and swing door open about 30-45 degrees. Lift door fully upward from bottom area closest to door hinge bracket, then rotate door fully open so that the lift-and-hold feature on upper door hinge mechanism is engaged.
3. Remove the screw that holds the Sample Loader Tower in place on the Front
Panel. Refer to the following figure:
Figure 2.3 Sample Loader Tower
4. Loosen the flat-head screws, two on each side of the instrument. Refer to the following figure:
2-8
Figure 2.4 Sample Loader Mounting Screws
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Section 2 Installation Procedures and Special Requirements
5. Carefully lift and pull the Sample Loader away from the instrument approximately 2-3 inches.
6. Push the Sample Loader down to lock it into place.
Tubing Installation
1 Normally Closed
Valves
NOTE: The tubing must be installed before the power is turned ON for the instrument to operate correctly. Follow the directions below to install the diluent tubing.
1. Locate the six normally closed valves on the flow panel. Refer to Figure 2.5
for the location of these valves.
2. The procedure described below applies to all the Normally Closed Valves on
the Flow Panel. Refer to Figure 2.6.
3. Select any of the Normally Closed Valves. Carefully insert the diluent tubing into the slot at the top of the valve. Work the tubing firmly back and forth with a flossing motion until it is completely inserted into the valve and resting on the bottom of the slot. Unless this tubing is securely seated, the flow system will not function properly.
1
Figure 2.5 Normally Closed Valves
1
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Installation Procedures and Special Requirements
Tubing Installation
1 Tubing
2 Slot
3 Valve
4 Connectors
1
4 2
3
Section 2
4
Figure 2.6 Tubing in a Normally Closed Valve
4. When the tubing has been installed properly, it should move back and forth freely.
5. Confirm that both ends of the diluent tubing are firmly attached to the connectors.
6. Repeat steps 3 through 5 until the tubing has been inserted in all six of the
Normally Closed Valves.
Flow Panel and Syringe Inspection
1. Inspect the Flow Panel components for obvious damage and to ensure the tubing is properly positioned under all solenoid pinch valves.
2. If there is any damage, contact the Abbott Hematology Customer Support
Center.
3. When the inspection of the Flow Panel is completed, turn the Main Power
Switch to ON .
4. Before putting the front covers and skirt back on the instrument, run several background counts (by pressing the Touch Plate) to observe proper functioning of the instrument. Check for leaks, crimps in the tubing, and the opening of the Solenoid pinch valves. Observe the operation of the syringes.
The syringes should move freely up and down with no evidence of air bubbles.
5. If no problems are detected, close the Left and Right Front Covers and press into place. Reattach the Tower Cover and press into place (for the SL model, line up the two holes on the bottom of the cover with the two pins on the
Sample Loader molding). On the CS model, reattach the Front Skirt using the four Phillips-head screws. On the SL model, lift up and slide the Sample
Loader forward using the center guide to properly align the loader with the
Analyzer. Secure the loader by tightening the four Phillips-head screws.
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Section 2 Installation Procedures and Special Requirements
Printer Installation
Overview
Remove the printer(s) from its shipping container and visually inspect it for damage. Find a suitable location adjacent to the instrument. Be sure the printer power switch is in the OFF position. Retain the manuals shipped with the printer(s) and store them in a convenient location.
NOTE: If the printer is placed on top of the instrument, be sure that the paper does not restrict air flow to the rear panel fan.
Basic installation procedures follow for the Ticket and Graphics Printers. When used with the CELL-DYN 3200, the Graphics Printer prints color or black-andwhite graphic reports and the Ticket Printer prints tickets or black-and-white graphic reports. Depending on the output desired, one or both printers may be connected to the instrument.
Follow installation instructions carefully to be sure that the printer(s) is connected
to the correct port. (See Figure 2.7.) For 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.
IMPORTANT: The CELL-DYN 3200 System has been configured for and tested on the following printers: Canon ® BJC ™ -620, BJC4300/4400 and Epson ®
800/850/888 color ink jet printers for graphics output, and OKIDATA ®
MICROLINE ® 320 dot matrix printer for ticket printing. Abbott recommends using only these printers. If other printers are substituted, problems may occur with your printouts.
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Installation Procedures and Special Requirements
Printer Installation
1 Graphics Printer Port
2 Ticket Printer Port
Section 2
2
1
Figure 2.7 CELL-DYN 3200 Printer Ports
Graphics Printer Installation Procedure
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 printer. Do not plug the other end into an outlet until you are ready to load paper.
3. Make sure that the power to the instrument is turned OFF. Remove the printer cable (which looks like a power cord with two connectors) from the
Accessory kit and plug one end into the parallel port on the rear of the printer.
(There is a metal plate covering the printer’s serial port to avoid confusion.)
Fasten the wire clips to the connector for a secure connection.
4. Plug the other end of the printer cable into the Graphics Printer port on the
back of the Data Module. (See Figure 2.7) Tighten the screws on the
connector for a secure connection.
NOTE: This port is configured for use as a graphics printer only. To print tickets, you may connect a Ticket Printer to the Ticket Printer port.
5. Install the ink cartridge as directed in the printer manual.
6. Load the paper as directed in the printer manual.
7. If necessary, refer to
Section 5: Operating Instructions ;
for instructions on customizing the printout.
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Section 2 Installation Procedures and Special Requirements
Self-Test Printouts
IMPORTANT
Run any self-test printouts before using the printer for the first time. These selftests may be run any time to verify proper printer operation.
The CELL-DYN 3200 software automatically controls and adjusts most print conditions for the Graphics Printer, including page width. 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 Hematology
Customer Support Center for assistance.
Ticket Printer Installation Procedure
The Ticket Printer is an OKIDATA ® MICROLINE ® 320 dot matrix printer or compatible printer.
The Ticket Printer is normally used to print result data on blank or pre-printed tickets but can be used to print a complete graphics report on continuous tractorfeed paper. (Blank tickets are available in continuous tractor-feed sheets.
Pre-printed tickets must be loaded individually.)
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 instrument is turned OFF. Remove the printer 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. (The port is constructed so that the connector will only fit in the proper way.)
Fasten the wire clips to the connector for a secure connection.
4. Plug the other end of the printer cable into the Ticket Printer port on the back
of the Data Module. (See Figure 2.7.) Tighten the screws on the connector for
a secure connection.
NOTE: This port is configured for use as a ticket printer only. To print graphics reports, you may connect a Graphics Printer to the
Graphics Printer port.
5. Install the ribbon as directed in the printer manual.
6. Load the paper or blank, continuous-feed tickets as directed in the printer manual, OR, if you are using pre-printed individual tickets, continue with the following procedure.
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Installation Procedures and Special Requirements
Printer Installation Section 2
Loading Individual Tickets in the Ticket Printer
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 tractorfeed paper.
NOTE: To print on these tickets, the printer cable must be connected to the Ticket
Printer Connector.
1. Be sure that the printer is turned OFF and the printer cable is connected to the
Ticket Printer connector on the back of the instrument. If the connection is incorrect, turn the instrument 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). 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.
Self-Test Printouts
Run any self-test printouts indicated in the printer manual before using the Ticket
Printer for the first time. These self-tests may be run any time to verify proper printer operation.
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Section 2 Installation Procedures and Special Requirements
Sample Loader Inspection (SL Model)
The Sample Loader is attached directly to the Analyzer to form an integrated unit,
Four screws, two on either side, hold the Sample Loader to the Analyzer. A power cord provides power from the Analyzer to the loader, and an interface cable allows communication between the Analyzer and loader. The Analyzer and Sample
Loader are also connected by two quick-disconnect tube lines, one for pressure and one for vacuum.
The tube spinning and sample aspiration mechanism on the Tower Module is identical on both the SL and CS models. The Tower Cover on the SL model differs from its counterpart on the CS model in two ways:
1. It is larger in order to extend over the center portion of the Sample Loader which contains the Bar Code Reader and Mixing Assembly.
2. It serves as a safety cover, halting operation of the Sample Loader if it is removed.
Figure 2.8 Analyzer With Sample Loader
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Installation Procedures and Special Requirements
Printer Installation Section 2
To inspect the Sample Loader:
1. Unpack the instrument from its shipping container and place it on a flat surface.
2. Remove the protective plastic.
3. Inspect the Sample Loader for signs of obvious damage and verify the loader is securely attached to the Analyzer.
4. Remove the set of 5 tube racks from the Sample Loader Accessory Kit.
5. Inspect all the racks for signs of damage.
6. Verify that each rack has a bar code label in position 1 and that the label is on
the same side as the open slots. Refer to Figure 2.9 for proper label placement
and alignment.
NOTE: For the Sample Loader to operate properly, the racks must be placed to the right of the tower (the “load” area) with the labels and slots facing the operator, not the Analyzer, so that the Bar Code
Reader can read the rack label and the tube labels through the rack slots. Refer to
Section 13: Sample Loader for additional
information on the Sample Loader.
1 Rack Bar Code Label
2 Rack Tube Position
Labels
1
Figure 2.9 Tube Rack Showing Label Placement Locations
NOTE: Tube bar code labels must be
≥
3 digits.
2
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Section 2
Power On
Installation Procedures and Special Requirements
1. Turn the instrument’s Main Power Switch to ON. When the initialization process is complete, press the [RUN] key to prime the instrument. When the priming process is complete, the READY light on the Analyzer’s indicator panel is lit and the message
READY
is displayed in the Status Box on the monitor.
2. Prime the Sample Loader by running several blood samples in the Closed
Mode. If necessary, refer to the directions given in
Subsection: Sample Analysis on the CELL-DYN 3200SL ,
Running Samples, Closed Mode Procedure .
3. Confirm that the background count is acceptable before running patient samples.
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Installation Procedures and Special Requirements
Printer Installation
NOTES
Section 2
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Section 3 Principles of Operation
Section 3 Principles of Operation
Overview
The principles the CELL-DYN 3200 uses to measure, count and calculate the hematological parameters are discussed in Sample Analysis Cycle Overview and
Introduction to Flow Cytometry within this section. Subsequent sections discuss the measurement process for WBC, RBC, PLT, and HGB. The last subsection,
Operational Messages and Data Flagging, discusses the flags generated by the instrument due to measured parameters outside predefined limits, sample abnormality, interference in the measurement process, or detection of an abnormal subpopulation. Quality Control methodology is discussed in
Control . Reticulocytes and Reticulocyte flagging are discussed in
Section 14: Reticulocyte Package .
The two independent measurement channels used in the CELL-DYN 3200 are:
• The Optical channel for determining the WBC, NOC, and RBC/PLT data
• The Hemoglobin channel for determining the HGB
During each instrument cycle, the sample is aspirated, diluted, and mixed before each parameter is measured.
NOTE: An increase in flags will occur in RRBC and FWBC modes.
Sample Aspiration
There are two modes of whole blood sample aspiration on the CELL-DYN 3200.
The operator selects the mode of aspiration from the RUN screen.
• The Open Sampler Mod e is used to aspirate the sample from a collection tube that has been opened and is held under the open sample aspiration probe.
• The Closed Sampler Mode is used to aspirate the blood directly from a closed collection tube by piercing the tube stopper. On the CS model, sample tubes are processed manually. On the SL model, sample tubes are processed automatically using the Sample Loader.
The aspiration volumes are:
Open Mode 150 µL ± 10%
Closed Mode (CS) 240 µL ± 10%
Sample Loader (SL) 240 µL ± 10%
Once the mode of aspiration is selected, the whole blood sample is aspirated to the
Shear Valve by vacuum/pressure action. An ultrasonic sensor, located upstream of the Shear Valve, checks the integrity of the sample stream before it enters the Shear
Valve. An LED sensor, located downstream of the Shear Valve, checks the sample stream to ensure the proper amount of blood has been transferred through the Shear
Valve.
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3-1
Principles of Operation
Overview
NOTES
Section 3
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Section 3 Principles of Operation
Sample Analysis Cycle Overview
Sample Aspiration
A sample is aspirated either in Open Mode or Closed Mode and transferred to the
Shear Valve. The sample volume in Open Mode is 150 µL. The sample volume in
Closed Mode is 240 µL.
Sample Segments
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.
The Shear Valve rotates in order to separate three volumes of the aspirated whole blood sample. The three volumes are:
20 µL for the WBC dilution
1.67 µL for the RBC/PLT dilution
12 µL for the HGB dilution
RBC/PLT Analysis
1. The Diluent/Sheath Syringe dispenses 2.79 mL of diluent through the Shear
Valve where the 1.67 µL RBC/PLT volume is transferred to the RBC Mixing
Chamber.
2. The segment and diluent are then routed to the RBC/PLT Mixing Chamber where the dilution is swirl mixed. The final dilution is 1:1675.
3. The Sample Transfer Pump transfers the RBC/PLT dilution from the RBC/
PLT Mixing Chamber to the Optical Flow Cell Sample Feed Nozzle.
4. Diluent/Sheath reagent, under constant pressure in the Sheath Reservoir, is directed into the Optical Flow Cell.
5. Sequentially, the Sample Metering Syringe injects 24 µL of the RBC/PLT dilution into the flow cell at a pressure (and speed) lower than that of the diluent/sheath reagent.
6. The higher speed of the sheath, which surrounds the RBC/PLT dilution, and the special geometry of the flow cell combine to focus the RBC/PLT dilution stream so that individual cells can be counted.
7. A laser beam is focused on the flow cell. As the sample stream intersects the laser beam, the light scattered is measured at 0°, 10°, and 90° for red blood cells, and at 0°and 10° for platelets.
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Principles of Operation
Sample Analysis Cycle Overview Section 3
Hemoglobin Analysis
1. The Diluent/Sheath Syringe injects 1.7 mL of diluent through the Shear
Valve where the 12 µL HGB volume is transferred to the HGB Flow Cell.
2. The HGB Lyse Syringe dispenses 0.9 mL of HGB Lyse into the line after the diluent has transferred the HGB volume to the HGB Flow Cell. The entry point for the HGB Lyse is between the Shear Valve and the HGB Flow Cell.
3. The segment, lyse, and diluent are routed to the HGB Flow Cell where the dilution is swirl mixed. The final dilution is 1:218.
4. A low-energy LED attached to the HGB Flow Cell measures the absorbance of light at 555 nm. The absorbance is proportional to the HGB concentration of the sample.
WBC Analysis
WBCs are analyzed optically as follows:
1. The WBC Lyse Syringe dispenses 0.973 mL of WBC Lyse reagent through the shear valve where the 20 µL WBC volume is transferred to the WBC
Mixing Chamber.
2. The segment and reagent are then routed to the WBC Mixing Chamber where the dilution is swirl mixed. The final dilution is 1:50. The diluted sample remains in the mixing chamber for 14 seconds for the lysing of the red blood cells.
3. The Sample Transfer Pump transfers the WBC dilution from the WBC
Mixing Chamber to the Optical Flow Cell Sample Feed Nozzle.
4. Diluent/Sheath reagent, under constant pressure in the Sheath Reservoir, is directed into the Optical Flow Cell.
5. Sequentially, the Sample Metering Syringe injects 46.5 µL of the WBC dilution into the flow cell at a pressure (and speed) lower than that of the diluent/sheath reagent.
6. The higher speed of the sheath, which surrounds the WBC dilution, and the special geometry of the flow cell combine to focus the WBC dilution stream so that individual cells can be counted.
7. 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 detectors located in the forward (0° and 10°) and side (90° and 90°D) angles.
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Section 3 Principles of Operation
Fragile WBCs and Resistant RBCs
When running samples in the normal Patient mode, the operator may suspect the presence of fragile WBCs when the FWBC flag is displayed or may suspect the presence of resistant RBCs when the RRBC and NRBC flags are displayed.
In the case of samples containing fragile WBCs or resistant RBCs, an alternate method is used to measure white blood cells. The results of this method are referred to as the Nuclear Optical Count (NOC). The NOC measurement is derived from the
HGB dilution as described below. Refer to Nuclear Optical Count and Resistant
RBC later in this section for additional information.
There are two different key labels on the SPECIMEN TYPE screen, one for fragile
WBCs and one for resistant RBCs. Refer to
Run Menu Soft Keys, Subsection:
in
Section 5: Operating Instructions for a discussion of the
Specimen Types available.
When the Fragile WBC specimen type is selected, both NOC and WOC are reported in the Data Log. The NOC value is reported as WBC on the RUN screen and Laboratory Worksheet.
When the Resistant RBC specimen type is selected, both NOC and WOC are reported in the Data Log. Either NOC or WOC is reported as WBC (based on algorithmic decision-making) on the RUN screen and Laboratory Worksheet.
NOTE: When QC specimen type is selected, both NOC and WOC are reported in the Data Log. Either NOC or WOC is reported as WBC (based on algorithmic decision-making) on the RUN screen.
The analysis for Fragile WBC and Resistant RBC is performed as follows:
1. After the HGB sample is measured (refer to Hemoglobin Analysis earlier in this section), the Sample Transfer Pump transfers the diluted solution from the HGB Flow Cell to the Optical Flow Cell Sample Feed Nozzle.
2. Diluent/Sheath reagent, under constant pressure in the Sheath Reservoir, is directed into the Optical Flow Cell.
3. Sequentially, the Sample Metering Syringe injects 140 µL of the HGB dilution into the flow cell.
4. The higher speed of the sheath which surrounds the HGB dilution, and the special geometry of the flow cell, focus the HGB dilution stream so that individual cells can be counted.
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 by the 0 degree detector. The nuclei of the lysed cells are counted as the NOC result.
6. The WBC Analysis in Fragile WBC and QC specimen type occurs as described in WBC Analysis earlier in this section.
7. The WBC Analysis in Resistant RBC mode occurs as described in WBC
Analysis above except that the diluted WBC segment is lysed in the WBC
Mixing Chamber for an additional 15 seconds.
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Principles of Operation
Sample Analysis Cycle Overview
Results Displayed
Section 3
All data is transmitted to the Data Module for analysis. Results are computed for all parameters and are displayed on the RUN screen. Results are also stored in a log format called the Data Log.
Instrument Flushed
1. The remaining sample segment from the aspiration process is flushed to
Waste Chamber #2.
2. The remaining segments in the WBC and RBC Mixing Chambers are flushed to Waste Chamber #3.
3. The segments sent to the Optical Flow Cell are flushed to Waste Chamber #1.
Instrument Rinsed
1. The Open Sample Aspiration Probe is rinsed internally and externally with diluent/sheath.
2. In Closed Mode, the needle is rinsed internally and externally with diluent/ sheath.
3. The WBC and RBC/PLT Mixing Chambers are rinsed with diluent/sheath.
4. The Optical Flow Cell and Sample Line tubing are rinsed with diluent/sheath.
5. The HGB Flow Cell is rinsed with diluent/sheath.
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Section 3 Principles of Operation
Flow Cytometry
Introduction to Flow Cytometry
The CELL-DYN 3200 uses flow cytometric techniques to analyze the RBC/PLT,
WBC, and NOC populations. 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 in a single file produced by a fluid stream are passed through a beam of light. A sensor or sensors measure, by the loss or scattering of light, the physical or chemical characteristics of the cells or particles.
3
Flow cytometry enables the rapid screening of large numbers of cells 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 to focus the sample flow stream
A light source and focusing optics
Light collectors, signal detectors, and polarizers
Data collection and storage
Data display and analysis
2
1 Orthogonal (90° and
90°D) Scatter Light
Detectors
2 Laser Tube
3 Forward Angle (0° and
10°) Light Detectors
4 Optical Flow Cell
5 Laser
1
CAUTION –
CLASS 3B LASER LIGHT WHEN OPEN.
AVOID EXPOSURE TO BEAM.
PN 9230701
3
Figure 3.1 Optical Bench
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3-7
Principles of Operation
Flow Cytometry Section 3
Detection with the Optical Bench
The optical bench assembly contains the components that make up the flow
cytometer. It is depicted in Figure 3.1. The main purpose of the 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.
The light source is a vertically polarized 10 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 that allows the cell stream to wander slightly in the flow cell and still be exposed to the same light intensity. An imaging lens centers the focused laser beam onto the quartz flow cell.
The Sample Transfer Syringe injects different sample dilutions into the sheath stream in the Optical 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 light beam, which allows them to be detected one at a time in the sensing region of the detectors.
Since the average diameter of the cells are smaller than the focused laser beam, the cells do not scatter much laser light. If the remaining unscattered light were allowed to reach the 0° and 10° (forward) detectors, it would saturate the electronics. Therefore, an obscuration bar blocks 0° – 1° of the forward unscattered light beam. The forward angles of scatter are directed to a perforated mirror. The
0° (1° – 3°) light scatter passes through the mirror to the 0° silicon photodiode detector. The 10° (7° – 10° or narrow angle) light scatter is deflected off the mirror to the 10° silicon photodiode detector.
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° 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 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 in the 0° and 10° detectors, the cell counter counts the pulse and stores it for further evaluation. Pulses that fall below this threshold are not included in the count.
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 WOC differential and RBC, PLT, and NOC counts. Data stored on floppy disks in the list mode format may be reconstructed into scatterplots at any time or analyzed by different algorithms as revisions are made.
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Section 3
1 Sample Feed Nozzle
2 Sheath Stream
3 Sample Stream
4 Focused Laser Beam
5 Various Angles of
Scattered Light
Principles of Operation
5
4
3
2
1
Figure 3.2 Optical Flow Cell
Optical Flow Cell
In a flow cytometer, the cell suspension is transferred from the mixing chamber 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 fast-moving, cell-free liquid (sheath fluid) . Since the two liquids travel at different rates of speed, they do not intermingle. 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
. (Refer to Figure 3.2 for a drawing of the Optical Flow Cell.)
As the cells enter the view volume (specific viewing area), they intersect with the laser beam. The different types of cells 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 a measure of cell size. Side angle (orthogonal) light scatter is a measure of cell surface and internal structure but 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 measurement. (See Fig. 3.3 for an example of the light scatter measured by the
CELL-DYN 3200.)
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Principles of Operation
Flow Cytometry Section 3
WBC Measurement
Overview
The Optical Channel is used for the determination of WBC data. During sample aspiration, 20 µL of sample is segmented in the Shear Valve for WBC measurement. The WBC Syringe dispenses 0.973 mL of WBC lyse to the Shear
Valve. The sample and lyse are then transferred to the WBC Mixing Chamber where the dilution is swirl mixed, resulting in a 1:50 dilution ratio.
The Sample Transfer Pump transfers the WBC dilution from the mixing chamber to the sample feed nozzle in the Optical Flow Cell. At the same time, sheath reagent, under constant pressure in the Sheath Reservoir, is transferred to the sheath feed nozzle in the Optical Flow Cell and injected into the cell. At the same time, the Sample Metering Syringe injects 46.5 µL of the WBC dilution into a sheath stream. The sample stream is then hydrodynamically focused to align the cells in single file as they pass through the Optical Flow Cell, which is an optically clear quartz chamber. A vertically polarized Helium Neon Laser is the light source.
The instrument measures:
• Both types of forward angle light scatter (1° to 3°, referred to as 0°, and 7° to
11°, referred to as 10° or narrow angle)
• Both types of orthogonal (side) light scatter (70° to 110°, referred to as 90°, and 70° to 110° depolarized, referred to as 90°D).
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.
1 Focused Laser Beam
2 0° Scatter
3 10° Scatter
4 90° Scatter
5 90°D Scatter
2
1
4
3 5
Figure 3.3 WBC Light Scatter
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Section 3
WBC Reagent
WBC Differential
Principles of Operation
Figure 3.3 illustrates the measurement of light scattered during the WBC optical
measurement process.
The WBC count is determined by enumerating the number of occurrences above a hardware 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 a scatterplot. It may also be presented in two histograms at operator request.
The WBC reagent used with the CELL-DYN 3200 instrument is the CELL-DYN
WBC Lyse. It is an integral part of the WBC analysis. White blood cells diluted in the reagent maintain cellular integrity close to their native state. The structure of the basophils changes slightly due to the hygroscopic nature of the basophilic granules.
The RBCs are also altered by the reagent. The osmotic pressure of the RBC is higher than that of the reagent. Therefore, the hemoglobin in the RBC diffuses out of the cell and water from the reagent diffuses into the cell. The cell membrane remains intact but the RBC now has the same refractive index as the sheath, thereby rendering it invisible to the laser.
The light scatter information is graphically presented in the form of scatterplots.
(The data can also be presented in histograms, available on request.) Each cell analyzed is represented by a dot on the scatterplot. 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. The CELL-DYN 3200 uses the scatterplots to differentiate the WBCs into five subpopulations:
Neutrophils
Eosinophils
Lymphocytes
Basophils
Monocytes
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3-11
Principles of Operation
Flow Cytometry
Mononuclear – Polymorphonuclear
Separation
Section 3
Mononuclear – Polymorphonuclear
Identification
10° Complexity 10° Complexity
Figure 3.4 Mononuclear-Polymorphonuclear Scatter
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°/10° scatterplot is shown in Figure 3.4.) 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.
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Section 3
Neutrophil – Eosinophil
Separation
Principles of Operation
Neutrophil – Eosinophil
Identification
90° Lobularity
Figure 3.5 Neutrophil-Eosinophil Scatter
90° Lobularity
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°D/90° scatterplot is shown in Figure 3.5.) Only the
polymorphonuclear cells are plotted on this scatterplot. 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 .
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.
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3-13
Principles of Operation
Flow Cytometry
Mononuclear
Separation
Mononuclear
Identification
Section 3
10° Complexity
Figure 3.6 Mononuclear Scatter
10° Complexity
Mononuclear Separation
The scatter information is plotted with the 0° scatter on the Y axis and the 10°
scatter on the X axis. (The 0°/10° scatterplot is shown in Figure 3.6.) 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 WBC Lyse reagent. Consequently, the degranulated
Basophils becomes a less complex cell that falls into the mononuclear cluster.
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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Section 3 Principles of Operation
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.
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.
Nuclear Optical Count
Samples containing fragile WBCs are difficult to measure accurately because of the rapid breakdown of cells during the measurement process. To obtain an accurate WBC count, an alternate method using the HGB segment (instead of the
WBC segment) is used to measure samples containing fragile WBCs.
The HGB sample segment, after being measured in the HGB Flow Cell, is transferred to the Optical Flow Cell instead of being sent to a waste chamber as in normal Patient cycles. While in the HGB Flow Cell, the HGB reagent lyses the cytoplasmic membrane of the white blood cells but allows the nuclear membrane to remain intact. This results is a greater stability of the white cells in the sample.
The HGB segment is lysed for approximately 15 seconds before it is sent to the
Optical Flow Cell.
As the HGB segment passes through the Optical Flow Cell, the nuclei of the cells are counted. The results of this measurement are stored in the Data Log as NOC.
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3-15
Principles of Operation
Flow Cytometry
Resistant RBC
Section 3
When a specimen containing resistant RBCs is run in the routine patient mode, the lytic agent in the WBC lyse reagent may be insufficient to lyse the “resistant” cells in the time allotted for the WBC count. Consequently, unlysed RBCs can be erroneously included in the WBC count resulting in a falsely elevated value. When this occurs, a significant amount of stroma will be present in the N1 region below the WBC dynamic threshold on the 0º/10º scatterplot.
When these type of specimens are rerun in the Resistant RBC mode, the diluted
WBC sample is held in the mixing chamber 15 seconds longer than in the routine patient mode. This additional lysing time is used to break down (lyse) the resistant
RBC cells and prevent them from interfering with the WBC count and differential.
NOTE: A higher incidence of false positive band flags may be evident on specimens run under the Resistant RBC specimen type.
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Section 3
WBC Histograms
Principles of Operation
Figure 3.7 WBC Histograms
The CELL-DYN 3200 can present the WBC scatter information as two histograms:
NWBC-LYM-MONO (N-L-M) and Mono-Poly (M-P). The NOC (Nuclear Optical
Count) data can also be presented as a histogram. (Refer to Figure 3.7.) These
histograms may be displayed and printed at the operator’s request.
NWBC-LYM-MONO Histogram
The scatter information is plotted in a histogram format with the relative number of cells on the Y axis and the NWBC, Lymphocyte and Monocyte size distribution data on the X axis.
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.
NOC Histogram
The NOC data is plotted in a histogram format with the relative number of nuclei on the Y axis and the size distribution data on the X axis.
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3-17
Principles of Operation
Flow Cytometry
WBC Parameters
Section 3
Figure 3.8 WBC Data and Scatterplots
The WBC data is generally displayed as depicted in Figure 3.8. All numeric and
graphic data are automatically displayed on the 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 algorithms then determine the WBC and the percent of cells in each subpopulation.
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
NEU
LYM
# x K/µL
# x K/µL and %
# x K/µL and %
MONO # x K/µL and %
EOS # x K/µL and %
BASO # x K/µL and %
The decimal point moves to display up to three decimal places for the absolute number and percent.
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Section 3 Principles of Operation
The WBC subpopulations are further identified by the following colors:
Neutrophils — yellow
Lymphocytes — blue
Monocytes — purple
Eosinophils — green
Basophils — white
NOTE: The basophils are displayed as white dots but appear as black dots on color printouts.
The WBC scatter information is usually displayed in two scatterplots as shown in
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.
GRANLRTY/LOBULARITY
The granularity (90°D scatter) information is plotted on the Y axis and the lobularity (90° scatter) information is plotted on the X axis.
WBC Flagging
Refer to the “Operational Messages and Data Flagging” subsection of this section for WBC flagging information.
RBC/PLT Measurement
Overview
The Optical Channel is used for the determination of RBC and PLT data. During sample aspiration, 1.67 µL of sample is segmented in the Shear Valve for RBC/PLT measurement.
The Diluent/Sheath Syringe dispenses 2.79 mL of diluent to the Shear Valve. The sample and diluent are then transferred to the RBC/PLT Mixing Chamber where the dilution is swirl mixed, resulting in a 1:1,675 dilution ratio.
The Sample Transfer Pump transfers the RBC/PLT dilution from the mixing chamber to the sheath feed nozzle in the Optical Flow Cell. The Sample Metering
Syringe injects 24 µL of RBC/PLT dilution into the sheath stream. The sample stream is then hydrodynamically focused to align the cells in single file as they pass through the Optical Flow Cell, which is an optically clear quartz chamber. A vertically polarized Helium Neon Laser is the light source.
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 RBC parameters are calculated using 0°, 10°, and 90° sensor data, while the
PLT parameters are calculated using 0° and 10° sensor data.
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Principles of Operation
Flow Cytometry
RBC Parameters
Section 3
Figure 3.9 RBC Data and Histogram
All numeric and frequency size distribution data are automatically displayed on the
RUN screen in the format selected. The size distribution data for the red cells is displayed graphically as a histogram using 0° data. 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 3.9.
RBC Count
The Red Blood Cell Count is directly measured, and is expressed as follows:
RBC = # x M/µL
Counts below 1.0 x M µL are displayed to three decimal places. The RBC count is corrected for coincidence and WBC interference.
MCV
The Mean Cell Volume is the average volume of the individual red blood cells.
The MCV is derived from the RBC size distribution data on the 0°, 10°, and 90° histograms, and is expressed in femtoliters.
HCT
The Hematocrit 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
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Section 3 Principles of Operation
MCH
The Mean Corpuscular Hemoglobin is the average amount 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 is the ratio of the weight of hemoglobin to the volume of the average red blood cell expressed in grams per deciliter. MCHC is calculated from the HGB and the HCT as follows:
MCHC = (HGB/HCT) x 100
RDW
Red Cell Distribution Width is a measure of the heterogeneity of the RBC population. The CELL-DYN 3200 reports a relative RDW equivalent to a CV in grams per deciliter. The RDW is derived from the RBC histogram using the 20th and 80th percentiles.
RBC Flagging
Refer to the “Operational Messages and Data Flagging” subsection of this section for RBC Flagging information.
Platelet Parameters
Events counted in the RBC/PLT dilution between floating thresholds are included in the platelet (PLT) data, which is collected using the 0° and 10° sensors. The lower threshold floats between 1 and 3 fL and the upper threshold floats between
15 and 35 fL. If there is not enough data to determine the PLT count, the lower and upper thresholds are set at 2 and 35 fL respectively. Once the thresholds have been determined, the PLT count is derived from the 10° data.
Data can be displayed in two formats. It can be displayed as a scatterplot (0°/10°) including the RBCs. Data can also be displayed as one of the following three histograms:
PLT only using 10° data
PLT and RBC using 0° data
PLT and RBC using 10° data
PLT data are shown as a histogram of the 10° data in the following figure.
Events counted in the region below the lower threshold are usually either optical noise or small particulate matter. Events counted in the region above the upper threshold are counted as RBCs. If interference with either threshold region exceeds a predetermined limit, the PLT parameters are flagged accordingly. The flags are discussed in the last section of this chapter.
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Principles of Operation
Flow Cytometry
PLT Count
The PLT count is expressed as thousands per microliter (K/µL).
Section 3
Figure 3.10 PLT Data and Histogram
MPV
The Mean Platelet Volume is derived from the PLT histogram after the PLT count has been determined. The MPV is expressed in femtoliters.
PCT
The Plateletcrit 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
PDW
Platelet Distribution Width is a measure of the heterogeneity of the PLT population. It is expressed as the geometric standard deviation.
NOTE: Clinical significance has not been established for PCT and PDW.
Therefore, they are not reportable in the U.S.
Platelet Flagging
Refer to the “Operational Messages and Data Flagging” section of this chapter for
PLT flagging information.
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Section 3 Principles of Operation
Hemoglobin Measurement
Overview
The HGB channel is used for the colorimetric determination of hemoglobin.
During sample aspiration, 12 µL of sample is segmented in the Shear Valve for
HGB measurement.
Before the HGB is measured, a reference value is obtained using the
CELL-DYN 3200 Diluent/Sheath in the HGB Flow Cell. A zero or blank reading is obtained on the diluent to provide a reference to which the sample signal is compared. Five separate blank readings are made on the diluent. The lowest and highest are eliminated and the remaining three are averaged to give the final HGB reference reading.
The Diluent/Sheath Syringe dispenses 1.7 mL of diluent/sheath to the Shear Valve, transferring the HGB segment to the HGB Mixing Chamber. The HGB Lyse
Syringe then dispenses 0.9 mL of HGB Lyse into the mixing chamber. The mixture is swirl mixed, resulting in a 1:218 dilution ratio. The HGB lyse reagent lyses the red blood cells, converting the hemoglobin that is released by a cyanide-free chemical process. When the lysing action is completed, a low-energy LED in the
HGB Flow Cell, attached to the mixing chamber, measures the amount of absorbance which is proportional to the HGB concentration.
A LED with a wavelength of 555 nm is the light source. A photodetector measures the light that is transmitted.
Five separate HGB readings are made on each sample. The lowest and highest are eliminated and the remaining three are averaged to give the final HGB sample reading.
After the hemoglobin readings have been made, the HGB Flow Cell is rinsed with diluent/sheath (in the normal run mode).
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. Up to two decimal places may be displayed for hemoglobin results less than 10.0 g/dL.
HGB Parameters
The Hemoglobin is directly measured and is expressed in grams of hemoglobin per deciliter of whole blood.
HGB Flagging
Refer to the “Operational Messages and Data Flagging” subsection of this section for HGB flagging information.
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Principles of Operation
Flow Cytometry Section 3
Laboratory Worksheet Screen
The LABORATORY WORKSHEET screen is provided to assist the laboratory
staff in data review and validation (refer to Figure 3.11.) This screen is for
laboratory use only. This screen displays the 5-Part Differential plus additional parameters. The RUN and DATA LOG screens display only the 5-Part Differential.
The difference between the two formats is shown in Table 3.1 and 3.2.
NOTE: The parameters MON and LYM have an “e” after the label, indicating that the values are estimated. MONe represents monos minus blasts. LYMe represents reported lymphs minus variant lymphs.
3-24
Figure 3.11 Laboratory Worksheet Screen
To access the LABORATORY WORKSHEET screen, press the Page Down key on the keyboard while the RUN menu is displayed or while the DISPLAY SPECIMEN screen
(in the DATA LOG menu) is displayed. The format is fixed and cannot be changed.
The specimen displayed on the screen is identified by the Specimen ID number and
Sequence number in the upper left corner of the screen.
To print the LABORATORY WORKSHEET screen, press the [ PRINT ] soft key or the
Print Screen key on the keyboard. Press [ RETURN ] to return to the RUN menu or
DISPLAY SPECIMEN screen (in DATA LOG menu), depending on which menu was used to access the worksheet.
The 5-Part Differential separates WBC into 5 components: Neutrophils,
Lymphocytes, Monocytes, Eosinophils, and Basophils. The additional parameters further separate the Neutrophils, Lymphocytes, and Monocytes into their constituent components. Eosinophils and Basophils are the same in both tables.
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Section 3
Table 3.1
5-Part Differential
Parameter Results (K/µL)
1
2
3
4
5
WBC
NEU
LYM
MONO
EOS
BASO
11.15
5.91
3.16
2.06
0.02
0.00
8
9
6
7
Table 3.2
5-Part Differential Plus Additional Parameters
Parameter Results (K/µL)
WBC
NEU
11.15
5.91
1
2
3
SEG
BAND
IG
LYM
4.80
0.00
1.11
3.16
4
5
LYMe
VARL
MONO
BLST
MONe
EOS
BASO
2.01
1.15
2.06
1.69
0.37
0.02
0.00
Principles of Operation
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3-25
Principles of Operation
Flow Cytometry
NOTES
Section 3
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Section 3 Principles of Operation
Operational Messages and Data Flagging
Introduction
Operational messages and data flags appear on the RUN screen, on printed reports and can be transmitted to a laboratory computer system. The CELL-DYN 3200 monitors instrument 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, and numeric, scatter 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 Tables 10.1 through
Table 10.4 in Section 10: Troubleshooting and Diagnostics ;
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 are 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.
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Principles of Operation
Operational Messages and Data Flagging Section 3
Cell Populations and Flagging
Fragile WBCs
Typically, fragile WBCs are abnormal lymphocytes that are present in chronic lymphocytic leukemia (CLL) and are the “smudge cells” that appear when the blood smear is made.
When processing samples in the Patient mode (Patient is selected as the Specimen
Type in the RUN screen), if fragile WBCs are present the WBC (WOC) count may be abnormally low due to the gradual destruction of the cytoplasmic membrane of these fragile cells by the lysing agents during the Run cycle.
When the FWBC flag displays, repeat the specimen using Specimen Type Fragile
WBC. This selection uses the HGB sample dilution containing intact WBC nuclei.
This Nuclear Optical Count (NOC) provides a more accurate WBC count when fragile WBCs are present.
Lyse-Resistant RBCs
Resistant RBCs are red blood cells which contain abnormalities or whose membranes have been altered, making them more resistant to the lysing process.
When running samples in the Patient mode, the hypo-osmotic lysing ability of the
WBC Lyse reagent is usually insufficient to lyse any lyse-resistant RBC cells, if present, in the time allotted for the WBC count. Consequently, the unlysed RBCs may be erroneously included in the WBC count, resulting in a falsely elevated count.
In normal patient samples, lyse-resistant RBCs are either absent or their number is negligible. In patient samples with a significant number of lyse-resistant RBCs, usually there is also a significant amount of stroma interference present in the N1 region below the dynamic WOC threshold on the 0º / 10º scatterplot.
When stroma interference is suspected and other conditions are met, the RRBC
(Resistant RBC) flag is displayed, alerting the user to run the specimen in the
Resistant RBC mode (Resistant RBC is selected as the Specimen Type). The WBC lyse time is extended, allowing for a complete lysing of the lyse-resistant RBCs to obtain an accurate WBC count.
For samples suspected of containing NRBCs or resistant RBCs, or those whose smear review indicates the presence of NRBCs (e.g., sickle cells or target cells), run the sample(s) in Resistant RBC specimen type to verify the WBC count.
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Section 3 Principles of Operation
Parameter Flagging Messages
Table 3.3 summarizes all of the parameter flagging messages by parameter and
category.
Table 3.3
Parameter Flagging Messages
Parameter Dispersional Data Alerts
Suspect
Parameter Flags
Suspect
Population Flags
Interpretive
Messages
WBC
Differential
NEU
LYM
MONO
EOS
BASO
RBC
HGB
MCV
RDW
PLT
MPV
Result displays in yellow if below lower limit
Result displays in purple 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
WBC
Same as WBC
DFLT (NLMEB)
DFLT (NE)
DFLT (LM)
DFLT (B)
DFLT (LB)
Same as WBC
Same as WBC
LRI
URI
LURI
NWBC
FWBC
NRBC
RRBC
Leukopenia
Leukocytosis
BAND
IG
BLAST
VAR LYM
RBC MORPH
Neutropenia
Neutrophilia
Lymphopenia
Lymphocytosis
Monocytosis
Eosinophilia
Basophilia
Anemia
Polycythemia
Microcytic RBC
Macrocytic RBC
Hypochromic
Hyperchromic
Anisocytosis
The MPV value may be suppressed
(not displayed or printed).
Thrombocytopenia
Thrombocytosis
Microcytic PLT
Macrocytic PLT
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Principles of Operation
Operational Messages and Data Flagging Section 3
Dispersional Data Alerts
These alerts are triggered by the numeric limits entered into the six Patient Limit
Sets (see Section 5: Operating Instructions
; Subsection: Set Up Instructions
for an explanation) or taken from the instrument’s preset linearity limits. 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 purple
Linearity Exceeded: Result displayed as >>>
Graphic Report:
Blank Ticket:
Results outside limits are underlined
Results outside limits are underlined
Preprinted Ticket: Results outside limits are marked with an asterisk
Specimens with results that exceed the linearity should be diluted with diluent/ sheath 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 and do not require correction.
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.
Introduction to WBC Flagging
There are five WBC parameter flags: WBC, DFLT (NLMEB), DFLT (NE), DFLT
(LM), and DFLT (B). The following WBC population flags may be displayed:
NWBC, FWBC, NRBC, RRBC, BAND, IG, BLAST, VAR LYM. If any of the
WBC population or parameter flags is displayed, the message
SUSPECT
is displayed under and to the right of the Limits field on the RUN and LABORATORY
WORKSHEET screens. This message also appears on printouts.
WBC Descriptors
The WBC Descriptors (WOC and NOC) are included on the display screen and printout to provide additional information about the reported WBC value. If there is a clinically significant difference between the two results in the QC and Resistant
RBC specimen types, the instrument will select the appropriate result and display a descriptor in parentheses next to the WBC value.
NOTE: In the Fragile WBC specimen types, the NOC value is always selected.
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Section 3 Principles of Operation
Table 3.4
Specimen Modes
Data Flagging
Patient, QC, Resistant RBC Mode Flagging (when WOC and NOC are equivalent)
Descriptor/Flag Cause Suggested Action
NWBC 1) When stroma interference is >1.5% of analyzed events and there is no declining WOC kinetic rate.
2) In patients with leukopenia the NWBC is set when the stroma interference is
>2.5.%
Review smear for platelet clumps, giant platelets or low levels of NRBCs and follow your laboratory’s review criteria.
If no other suspect parameter flags are present, the WBC and differential may be reported.
NRBC
NRBC
WBC
DFLT (NLMEB)
RRBC
WBC
DFLT (NLMEB)
FWBC
VAR LYMPH
WBC
DFLT (NLMBEB)
When stroma interference is >3.0% of analyzed events and there is no declining WOC kinetic rate, or
When the patient is anemic and the stroma interference is >0.9% of analyzed events and there is no declining WOC kinetic rate.
Review smear for the presence of NRBCs and follow your laboratory’s review criteria.
In addition to the criteria above, if the number of analyzed events is high or indicates a likely interference in the WBC count, then the WBC alert and DFLT
NLMEB flags are also given.
Review smear for the presence of NRBCs and follow your laboratory’s review criteria.
Confirm WBC count by alternate method.
Stroma interference is high and a declining WOC kinetic rate is detected.
Repeat in Resistant RBC Mode.
If flag persists, review for presence of NRBCs and verify Lymph valve. Confirm WBC count by alternate method.
Stroma interference is low but a declining WOC kinetic rate is detected, or
Stroma interference is low and there is no declining WOC kinetic rate, but
WOC>8.0 K/uL and LYM%>80%.
Repeat in FWBC mode. NOC result will be reported as WBC result.
Review smear to confirm lymph count and presence of fragile WBCs.
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3-31
Principles of Operation
Operational Messages and Data Flagging Section 3
Table 3.4
Specimen Modes (Continued)
Patient, QC, Resistant RBC Mode Flagging (when WOC and NOC are equivalent)
Descriptor/Flag Cause Suggested Action
DFLT(NLMEB)
DFLT (NE) or DFLT (LM) or DFLT (B) or DFLT (LB)
One or more of the following conditions are true:
1) Fragile cells may be present. (When the FWBC flag is triggered, DFLT
(NLMEB) flag is always set.)
2) There are too few cells to calculate the differential.
3) The mono-poly population is not well separated.
NOTE: There are four different DFLT flags: (NLMEB), (NE), (LM), and
(B).
(N=Neutrophils, L=Lymphocytes,
M=Monocytes, E=Eosinophils,
B=Basophils)
If the DFLT (NLMEB) flag is accompanied by the FWBC flag, repeat in the FWBC mode.
If the DFLT (NLMEB) flag is accompanied by the RRBC flag, repeat in the RRBC mode.
Review scatterplot for clear separation of cell cluster.
Review a stained smear to verify the differential values.
The letters in parentheses indicate which
WBC subpopulation or group of subpopulations is suspect. The DFLT flag may be due to the presence of abnormal cell clusters that the instrument cannot reliably discriminate among WBC subpopulations. Thus, a default threshold is selected.
Review scatterplot for clear separation of cell cluster.
Review a stained smear to verify the differential values.
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Section 3 Principles of Operation
Table 3.4
Specimen Modes (Continued)
Patient, QC, Resistant RBC Mode Flagging (when WOC and NOC are equivalent)
Descriptor/Flag Cause Suggested Action
BAND 1) The BAND flag is triggered if any of the following conditions are met:
2) The CV% of the neutrophil cluster on the 0 ° axis exceeds expected criteria.
3) The instrument detects > 12.5% of the total WBC count as BAND cells
The ratio of suspected bands to mature neutrophils is >50%
Review a stained smear for the presence of bands and follow your laboratory’s review criteria.
NOTE: When bands are present, they are included in the total neutrophil count.
IG
BLAST
VAR LYM
RBC MORPH
The IG flag is triggered if the following condition is met:
The instrument detects > or = 3% of the total WBC count as IG cells
Review a stained smear for the presence of immature granulocytes and follow your laboratory’s review criteria.
NOTE: When IGs are present, they are included in the total neutrophil count.
The BLAST flag is triggered if the following condition is met:
The instrument detects > 1% of the total
WBC count as Blast cells
Review a stained smear for the presence of blasts and follow your laboratory’s review criteria.
NOTE: When blasts are present, they are included in the monocyte count.
When the FWBC flag is triggered, the
VAR LYM flag is always set.
In addition, the flag is set if any of the following attributes apply:
1) Position of the lymphocyte cluster on the scatter plot is abnormal.
2) The ratio between lymphocytes and other WBC subpopulations is increased.
3) Lymphocyte count (absolute or %) is elevated
Review a stained smear for the presence of variant lymphocytes and follow your laboratory’s review criteria.
NOTE: 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.
One or more of the following parameters exceeds expected limits:
MCV < 80fL or >100fL
MCH < 25pg or >34pg
MCHC < 29g/dL or >37g/dL
RDW >18.5%
Review a stained smear for abnormal RBC or
PLT morphology and follow your laboratory's review criteria.
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3-33
Principles of Operation
Operational Messages and Data Flagging Section 3
Table 3.4
Specimen Modes (Continued)
Patient, QC, Resistant RBC Mode Flagging (when WOC and NOC are equivalent)
Descriptor/Flag Cause Suggested Action
LRI 1) Interference in the lower threshold region (2fL–3fL) > 25% of PLT count.
2) Too much interference between noise and PLT population
3) Too much noise in the 0-low threshold region
NOTE: LRI may be caused by:
Debris
Contaminated reagent
Microbubbles
Dirty Diluent/Sheath filter
Repeat the specimen. If the flag persists, review a smear and verify the platelet count.
If the flag persists on subsequent samples, check the platelet background count. If the background count exceeds the specification, troubleshoot accordingly.
URI
LURI
NO MPV
1) Interference in the upper threshold region (15–35fL) > 25% of PLT peak
2) PLT aggregate count (PLT clumps)
> 15% of PLT count
URI may be cause by:
Microcytic RBCs
Schistocytes
Giant Platelets
Sickle Cells
Platelet Clumps
Review MCV, platelet histogram and scatterplot.
If the scatterplot shows overlap in the RBC or platelet populations or a population is present above the platelet scatters, review a smear to determine the cause and confirm the platelet count.
Interference is present in both the upper and lower regions of the PLT histogram.
Same actions as for LRI and URI
1) MPV < 3.5
2) PLT has an abnormal distribution
Repeat the specimen. If the MPV data is suppressed, review the smear for abnormal platelet morphology and platelet aggregates and follow your laboratory’s review criteria.
Verify the platelet count.
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Section 3 Principles of Operation
Table 3.4
Specimen Modes (Continued)
Descriptor/Flag
(NOC)
WBC
RRBC/NRBC
DFLT (NLMEB)
(WOC)
WBC
RRBC/NRBC
Resistant RBC and QC Modes
Cause Suggested Action
WOC > NOC in the Resistant RBC cycle
(NOC is selected as WBC count.)
NOTE: Higher WOC is due to unlysed
RRBCs. Lymphocyte count is corrected by adding the difference between WOC and
NOC to the lymphocyte count.
Review a stained smear to determine the cause of the interference (NRBC and/or unlysed RRBCs).
Verify the WBC value by an alternate method according to your laboratory’s protocol.
NOC > WOC and high stroma interference in the Resistant RBC cycle
(WOC is selected as WBC count.)
Review a stained smear to determine the cause of the interference (NRBC and/or unlysed RRBCs).
Verify the WBC value by an alternate method according to your laboratory’s protocol.
(WOC)
WBC
NRBC
(NOC)
WBC
FWBC
VAR LYM
DFLT (NLMEB)
NOC >WOC, low stroma interference, and %L<60% in the Resistant RBC cycle
(WOC is selected as WBC count.)
Review a stained smear for the presence of
NRBCs.
NOTE: If NRBCs are present, report WOC for
WBC count.
Confirm WBC by an alternate method.
NOC>WOC, low stroma interference, and %L>60% in the Resistant RBC cycle.
(NOC is selected as WBC count.)
NOTE: Lymphocyte count is corrected by adding the difference between WOC and NOC to the lymphocyte count.
Review smear to confirm Lymph count and presence of fragile WBCs.
Fragile WBC Mode
Descriptor/Flag
(NOC)
FWBC
VAR LYM
DFLT (NLMEB)
Cause Suggested Action
In the Fragile WBC cycle, the FWBC flag is always displayed along with the DFLT
(NLMEB) flag.
(NOC is selected as WBC count.)
Review smear to confirm Lymph count and presence of fragile WBCs.
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3-35
Principles of Operation
Operational Messages and Data Flagging Section 3
Interpretive Messages
Interpretive messages appear only on the graphics report and are generated when the
numeric limits entered in the Patient Limit Sets are exceeded. (see Section 5:
Operating Instructions ; Subsection:
Set Up Instructions for an explanation).
These messages are printed only when the Interpretive Report option is selected on the CUSTOMIZE REPORT SCREEN . The Interpretive messages are summarized below.
WBC Messages
Message
Leukopenia
Leukocytosis
Neutropenia
Neutrophilia
Lymphopenia
Lymphocytosis
Monocytosis
Eosinophilia
Basophilia
Cause 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
3-36
RBC Messages
Message
Anemia
Polycythemia
Microcytic RBC
Macrocytic RBC
Hypochromic
Hyperchromic
Anisocytosis
PLT Messages
Message
Thrombocytopenia
Thrombocytosis
Microcytic PLT
Macrocytic PLT
Cause 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
Cause 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
CELL-DYN ® 3200 System Operator’s Manual
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Section 3 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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3-37
Principles of Operation
References
NOTES
Section 3
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Section 4
Section 4 Performance Characteristics and Specifications
Performance Characteristics and Specifications
Overview
This section is a collection of detailed information about the CELL-DYN 3200
System.
Included in this section are:
• Physical Specifications
• Operational Specifications
• Bar Code Specifications
• Measurement Specifications
• Performance Specifications
• Performance Characteristics
• Sample Loader Specifications
Specifications for the Host Interface (List Number 06H71-01) are not included in this section but can be ordered by calling Abbott Customer Service at
1 (800) 323-9100.
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4-1
Performance Characteristics and Specifications
Overview
NOTES
Section 4
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Section 4 Performance Characteristics and Specifications
System Specifications
Physical Specifications
Table 4.1 and Table 4.2 contain physical specifications for both the
CELL-DYN 3200SL and CS models.
Table 4.1
Instrument Dimensions
Analyzer SL Analyzer CS
Display
Monitor
Ticket Printer
(Dot Matrix)
Graphics
Printer
(Color Bubble
Jet)
Height
Width
19" (48.2 cm)
32.8" (83.3 cm)
19" (48.2 cm)
32.8" (83.3 cm)
Depth 29.3" (74.4 cm) 23.3" (59.2 cm)
Weight 232 lb (105.5 kg) 214 lb (97.3 kg)
15" (38.1 cm)
14" (35.5 cm)
16" (40.6 cm)
30 lb (13.6kg)
6" (15.2 cm)
16.5" (41.9 cm)
14.5" (36.8 cm)
16.5 lb (7.5 kg)
7.2" (18.3 cm)
16.1" (40.9 cm)
9.9" (25.1 cm)
9.9 lb (4.5 kg)
Table 4.2
Dimensions After Packaging for Shipment
Height
Width
Depth
Weight
Analyzer SL
38" (96.5 cm)
34" (86.3 cm)
31" (78.7 cm)
273 lb (124 kg)
Analyzer CS
38" (96.5 cm)
34" (86.3 cm)
31" (78.7 cm)
255 lb (116 kg)
Display
Monitor
20" (50.8 cm)
18" (45.7 cm)
18" (45.7 cm)
37.5 lb (17 kg)
Ticket Printer
(Dot Matrix)
9.5" (24 cm)
21" (53 cm)
18.5" (46 cm)
21 lb (9.5 kg)
Graphics
Printer
(Color Bubble
Jet)
12" (30.5 cm)
19.5" (49.5 cm)
14.8" (37.6 cm)
16.4 lb (7.4 kg)
CELL-DYN ® 3200 System Operator’s Manual
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4-3
Performance Characteristics and Specifications
System Specifications Section 4
Power Specifications
Table 4.3 shows the power requirements for both the CELL-DYN 3200 SL and CS
models.
Table 4.3
Power Specifications
Analyzer Input Requirements
Module
Analyzer
Analyzer &
Sample Loader
Monitor
Printer
Voltage
110 VAC ± 10%
120 VAC ± 10%
220 VAC ± 10%
240 VAC ± 10%
110 VAC ± 10%
120 VAC ± 10%
220 VAC ± 10%
240 VAC ± 10%
100–240 VAC
120 VAC ± 10%
220 - 260 VAC
Frequency
50/60 ± 3Hz
50/60 ± 3Hz
50/60 ± 3Hz
50/60 ± 3Hz
50/60 ± 3Hz
50/60 ± 3Hz
50/60 ± 3Hz
50/60 ± 3Hz
50/60 Hz
50/60 Hz
Max Current
6 amps
6 amps
3 amps
3 amps
6 amps
6 amps
3 amps
3 amps
1.3 amps
0.5 amps
BTU/Hr
1945
1945
1945
1945
1945
1945
1945
1945
205
Consumption
Analyzer:
Monitor:
Graphics Printer:
900 watts
156 watts
60 watts
1116 watts maximum (3810 BTU per hour)
Transport and Storage Specifications
There are no specific environmental conditions for transport or storage.
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Section 4 Performance Characteristics and Specifications
Operational Specifications
Operating Environment
Indoor Use
Laboratory Temperature 15–30°C (59°–86°F)
Relative Humidity 20–80%, RHNC
Startup/Shutdown Times
Auto-Startup (from STANDBY) Approximately 5.0 minutes
Auto-Startup (from power OFF) Approximately 7.0 minutes*
Shutdown (to STANDBY) 10 minutes
* 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.
Run Cycle Times
Table 4.4 shows the average Run cycle times for different specimen types run in
the Open and Closed Modes on the CS and SL models.
Table 4.4
Instrument Average Run Cycle Times
CS and SL - Models
Cycle Times:
Ready to Ready
OPEN
CLOSED
Patient
QC, Fragile WBC
Resistant RBC
Patient
QC, Fragile WBC,
Resistant RBC
51 seconds
95 seconds
93 seconds
60 seconds
103 seconds
Approximate Aspiration Volumes (Whole Blood)
Open mode 150 µL
Closed mode 240 µL
Batch Size
Up to 50 tubes per batch
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4-5
Performance Characteristics and Specifications
System Specifications
Throughput
Section 4
Table 4.5 contains sample throughput information for the CELL-DYN 3200SL and
CS.
Table 4.5
Sample Throughput (Patient Mode)
CS Model Samples Per Hour
Open
Closed
71
62
SL Model
Open
Closed
Samples Per Hour
71
58
NOTE: Maximum throughput may be achieved with normal samples that do not generate any instrument operational messages.
Collection Tube and Sample Volume
13-mm diameter x 75-mm high collection tubes
• Minimum sample volume (SL Models) > 1.5 mL
• Minimum sample volume (CS Models) > 1.5 mL
• Maximum sample volume ~ 3 mL (Sample Loader)
NOTE: The sample volume in the tube must be within the specified limits for adequate mixing and sampling.
Bar Code Specifications — CELL-DYN 3200SL
Bar Code Format
The following formats with or without check digits are acceptable:
• Code 39
• Code 128 (check digit only)
• Interleaved 2 of 5
• Codabar
Bar Code Label Specifications
Refer to Appendix A and ANSI specifications for complete information on bar code label formats, check digits and specifications.
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Section 4 Performance Characteristics and Specifications
Measurement Specifications — CELL-DYN 3200SL and CS
Measurement Channels
Laser optics for WBC and RBC/PLT
Hemoglobin Absorbance
Reticulocyte %
WBC (WOC)
Method
Light source
Wave length
Dilution
Laser light scatter
Vertically polarized 5–10 mW helium-neon laser
632.8 nm
1:50 of blood in WBC lyse
Data Collection Four angles measured: 0°, 10°, 90°, and 90° depolarized. Data collected in 256 channels for each angle of light scatter
WBC (NOC)
Method
Light source
Wave length
Dilution
Laser light scatter
Vertically polarized 5–10 mW helium-neon laser
632.8 nm
1:218 of blood in diluent/sheath and HGB Lyse
Data Collection Four angles measured: 0°, 10°, 90°, and 90° depolarized. Data collected in 256 channels for each angle of light scatter
RBCs and PLTs
Method
Light source
Wave length
Dilution
Laser light scatter
Vertically polarized 5–10 mW helium-neon laser
632.8 nm
1:1,675 of blood in diluent/sheath
Data Collection Three angles measured: 0°, 10°, and 90°. Data collected in 256 channels for each angle of light scatter
HGB
Method
Light Source
Wavelength
Dilution
Modified methemoglobin
LED, wavelength: 555 nm
555 nm
1:218 of blood in diluent/sheath and HGB Lyse
Data Collection Five absorbance readings for the blank, lowest and highest readings eliminated. The three remaining absorbance readings are averaged for the HGB reference. Five absorbance readings for the sample, lowest and highest readings eliminated. The three remaining absorbance readings are averaged for the
HGB sample.
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4-7
Performance Characteristics and Specifications
System Specifications
Retic
Section 4
Method
Light source
Wave length
Dilution
Laser light scatter of cells stained with New Methylene Blue
Vertically polarized 5–10 mW helium-neon laser
632.8 nm
1:50 of stained blood in WBC Lyse
Data Collection Three angles measured: 0°, 10° and 90°. Data collected in 256 channels for each angle of light scatter.
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Section 4 Performance Characteristics and Specifications
Performance Specifications
Background Counts
Background counts for the following parameters are acceptable up to the limits listed:
WOC <0.10 K/µL
NOC <0.10 K/µL
RBC <0.02 M/µL
HGB <0.10 g/dL
PLT <5.0 K/µL
RETIC <100 counts/count cycle
Carryover
Carryover is the degree of influence the previous sample has on the next sample and is expressed as a percent. Fresh whole blood samples that are used to verify carryover specifications should have results that fall within each laboratory’s reference interval (normal range). Each sample is run in triplicate followed by three background cycles.
The percent carryover for CBC parameters, as shown in Table 4.6, is calculated
using the following formula:
% Carryover =
Background
Sample
3
-
1
Background
Background
3
Absolute Carryover = Background
1
- Background
3
3
Table 4.6
Carryover for WOC, NOC, RBC, HGB, and PLT
X 100
Parameter
WOC
Specimen Range
4.1–11.0 x K/ µL
Carryover
< 1% or 0.1 K/ µL
NOC
RBC
4.1–11.0 x K/ µL
4.0–6.0 x M/ µL
< 1% or 0.1 K/ µL
< 1% or 0.03 M/ µL
HGB
PLT
12.1–17.0 g/ dL
150.0–400.0 x K/ µL
< 1% or 0.1 g/ dL
< 1% or 6 K/ µL
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4-9
Performance Characteristics and Specifications
Performance Specifications Section 4
Reticulocyte % measurement carryover, as shown in Table 4.7, is calculated using
actual Listmode counts, rather than using the Reticulocyte percent. It is calculated using the following formula:
% Carryover =
Background
Retic Listmode
3
1
Background
3
- Background Count
3
X 100
Reticulocyte carryover is determined on fresh whole blood samples with RBC in the range 4.0–6.0 M/µL. Retic Background Count is reported on the Retic Run
Results Screen, while Retic Listmode can be found in DIAGNOSTICS
→
RETIC
RAW DATA.
Table 4.7
Carryover for Reticulocyte
Parameter Specimen Range Carryover
RETIC % 1.8%–20% with 30,000 Listmode events
< 0.5%
Precision
Precision is the measurement of how closely the instrument is able to reproduce the same results from repeated runs of the same sample.
Table 4.8 and Table 4.9 present the limits of acceptable precision for specimens run
in both the Open and Closed modes. The stated CV% in these tables represents the instrument’s precision at a 95% confidence level from N=20 replicate runs based on the same sample.
NOTE: 95% confidence limit means that at least 19 of the 20 determinations meet this limit.
NOTE: N=20 is based on one whole blood sample aliquotted into 4 tubes, with each tube run 5 times in Closed mode.
Fresh whole blood 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 precision values listed in this section are applicable to Patient, Fragile WBC,
Resistant RBC (Open mode only), and Reticulocyte RBC (Open Mode Only) specimen types.
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Section 4 Performance Characteristics and Specifications
Hemogram Parameters
Precision specifications for the hemogram parameters are presented using coefficient of variation (CV).
The stated CV% in the following Table represents the instrument precision at a
95% confidence level from N = 20 replicate runs based on the same sample.
Table 4.8
Precision of the Hemogram Parameters (N = 20)
Parameter Specimen Range CV
WBC (WOC) < 2.7%
WBC (NOC)
RBC
HGB
MCV
RDW
PLT
4.1–11.0 x K/ µL
4.1–11.0 x K/ µL
4.0–6.0 x M/ µL
12.1–17.0 g/d L
81.0–100.0 fL
12.0–16.0%
150.0–400.0 x K/ µL
< 2.7%
< 1.5%
< 1.0%
< 1.0%
< 5.0%
< 4.0%
MPV
RETIC %
5.0–10.0 fL
0.5–2.7%
< 5.0%
< 15.0%
WBC Differential Parameters
Precision specifications for the WBC Differential parameters are given as a 95% confidence limit for N=20 replicate runs based on the same sample.
This confidence limit represents the allowable difference (plus or minus) of the individual results from the mean of the 20 determinations (runs). Specimens selected for the precision study must have means that fall within the specimen range listed in both tables.
These samples should not display any of the following suspect Parameter Flags:
WBC or DFLT.
To determine the 95% confidence limit of a parameter:
1. Find the value listed in the Confidence Limit column for that parameter.
2. Add that value to the mean to determine the upper limit.
3. Subtract that value from the mean to determine the lower limit.
For example, if the mean of the Neutrophil parameter is 50, the 95% confidence limit is 47.8–52.2.
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4-11
Performance Characteristics and Specifications
Performance Specifications Section 4
Table 4.9
Precision of the WBC Differential Parameters (N=20)
Parameter Specimen Range % 95% Confidence Limit
Neutrophil %
Lymphocyte %
46–75
20–45
± 2.2
± 2.8
Monocyte %
Eosinophil %
Basophil %
3.5–11.5
0.5–8.0
0.5–2.0
± 2.7
± 1.0
± 1.0
Linearity
Linearity specifications are determined by analyzing dilutions of a linearity 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. This analysis is performed with the line going through the
origin (0,0) except for the RETIC % parameter. Table 4.10 contains the linearity
specifications for the hemogram parameters.
Table 4.10 Linearity Specifications
Parameter Linear Range
Absolute
Deviation
Relative
Deviation
WOC (WBC)
NOC (WBC)
0.0–250 K/ µL
0.0–250 K/ µL
± 0.4
± 0.4
< 4.0%
< 4.0%
RBC 0.00–8.00 M/ µL ± 0.1
< 2.5%
HGB
MCV
PLT
MPV
RETIC %
0.0–25.0 g/dL
34.0–172 fL
0.0–1750 K/ µL
2.0–18.0 fL
0.50–23.00%
± 0.3
± 2.0
± 10.0
± 1.0
± 1.1
< 2.0%
< 2.0%
< 7.0%
< 9.0%
< 7.0%
4-12 CELL-DYN ® 3200 System Operator’s Manual
9140181H—October 2001
Section 4 Performance Characteristics and Specifications
For MCV and MPV, three bead sizes were analyzed and the method of leastsquares regression (not forcing the intercept through zero) was used for analysis of the data. It should be noted that the reference diameters of the latex particles were calculated by the manufacturer using electronic impedance volume analysis. The optical analysis on the CELL-DYN 3200 is sensitive to the refractive index of the latex particles and although the relationship is linear, a regression through zero is not possible.
Correlation
The CELL-DYN 3200 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.
Table 4.11 and Table 4.12 demonstrate the accuracy of the hemogram parameters
and WBC Differential parameters respectively.
Hemogram Parameters
Table 4.11
Accuracy of Hemogram Parameters
Parameter Correlation Coefficient
WBC (WOC)
WBC (NOC)
RBC
HGB
MCV
RDW
PLT
MPV
RETIC %
> 0.99
> 0.99
> 0.98
> 0.98
> 0.98
> 0.91
> 0.98
> 0.72
> 0.90
All parameters were correlated against the CELL-DYN 3700, except for MCV,
MPV, RDW, and RETIC % which were correlated against the CELL-DYN 4000.
CELL-DYN ® 3200 System Operator’s Manual
9140181H—October 2001
4-13
Performance Characteristics and Specifications
Performance Specifications
WBC Differential Parameters
Table 4.12 Accuracy of WBC Differential Parameters
Parameter Correlation Coefficient
Neutrophil # and %
Lymphocyte # and %
Monocyte # and %
Eosinophil # and %
Basophil # and %
> 0.95
> 0.94
> 0.86
> 0.84
> 0.73
Section 4
Comprehensive Flagging
Table 4.13 Flagging Analysis Using both the Distributional and Morphological Flags
Agreement True Negative and True Positive
False Positives
False Negatives
>
<
<
80%
20%
1%
4-14 CELL-DYN ® 3200 System Operator’s Manual
9140181H—October 2001
Section 4 Performance Characteristics and Specifications
Performance Characteristics
Typical Precision
Within Sample
The pooled precision values (CVs) for the Hemogram parameters, shown in
Table 4.14, are based on the analysis of data from N = 20 replicate runs based on
the same sample.
NOTE: N=20 is based on one whole blood sample aliquotted into 4 tubes, with each tube run 5 times.
The data was obtained from several CELL-DYN 3200 systems over a period of weeks. These precision values represent the typical performance from instruments that are maintained properly, are operating in acceptable environmental conditions and are using only recommended reagents and supplies.
Table 4.14 Typical Precision of Hemogram Parameters
Parameter CV
WBC (WOC)
WBC (NOC)
RBC
HGB
MCV
RDW
PLT
MPV
0.5%
2.3%
2.3%
1.8%
1.9%
1.9%
0.6%
0.4%
CELL-DYN ® 3200 System Operator’s Manual
9140181H—October 2001
4-15
Performance Characteristics and Specifications
Performance Characteristics Section 4
Typical Paired Difference Precision Normal
The typical paired difference precision of the measured parameters is presented as the total CV calculated from samples run in duplicate on the same system. (Refer
Table 4.15 Typical Precision of Hemogram Parameters
Parameter Number of Pairs Total CV
WBC (WOC)
RBC
HGB
MCV
RDW
PLT
MPV
%N
%L
%M
%E
%B
10
10
10
10
10
10
10
10
10
10
10
10
2.01%
0.81%
0.72%
0.38%
1.76%
3.11%
3.68%
1.23%
2.07%
7.72%
8.06%
16.82%
Sensitivity and Specificity of WBC Differential Flags
The sensitivity and specificity of the WBC flags were evaluated using the general principles for morphological classifications outlined in the NCCLS H20-A
Standard: “Reference Leukocyte Differential Count (Proportional) and Evaluation of Instrumental Methods” as a guideline. The statistics were determined by comparing the CELL-DYN 3200 System results with results obtained from a reference CELL-DYN 3500 System. Discrepant results were arbitrated with a manual, microscopic, 400-cell differential count.
4-16 CELL-DYN ® 3200 System Operator’s Manual
9140181H—October 2001
Section 4 Performance Characteristics and Specifications
Abnormalities
Table 4.16 Abnormalities
1. RBC count <4.00 M/mL
2. RBC count >6.20 M/mL
3. WBC count <4.0 K/mL
4. WBC count >11.0 K/mL
5. WBC count >100.0 K/mL
6. PLT count <150 K/mL
7. PLT count >450 K/mL
The following tables present a list of abnormalities targeted during this evaluation and the resultant data.
Table 4.16 lists the various types of specimens that the sites attempted to collect
during this evaluation:
19. Lipemic
20. Basophils >3%
21. Icteric
22. Hemoglobinopathies S and C
23. Containing macrocytic PLTs
24. Uremic
25. Paraproteinemia
26. Patients on immunosuppressant therapy 8. MCV <60 fL
9. MCV >110 fL
10. Containing RBCs resistant to lysis
11. Containing agranular neutrophils
27. Containing cryoglobulins
28. Containing micro clots
29. Containing cell fragments
30. Platelet satellitosis condition 12. Containing variant lymphocytes
13. Containing lymphoblasts
14. Containing bands >5%
15. Immature granulocytes (myelos, metas, pros)
31. Containing cold agglutinins
32. Containing dual RBC populations
33. Containing Heinz and Howell-Jolly Bodies
34. Containing Malarial Parasites 16. Containing myeloblasts/monoblasts
17. Containing > 1 NRBC per 100 WBCs
18. Hypogranular eosinophils
35. Containing >5.0% Reticulocytes
36. Chronic Lymphocytic Leukemia (CLL)
CELL-DYN ® 3200 System Operator’s Manual
9140181H—October 2001
4-17
Performance Characteristics and Specifications
Performance Characteristics Section 4
Truth Table
The Truth Table, showing sensitivity and specificity and the analysis of the false negative results, is presented in this section. For the distributional analysis, absolute limits were used. The data is based on the evaluation of a total of 848 cases.
TP = True Positive
TN = True Negative
FP = False Positive
FN = False Negative
Table 4.17 Flagging Analysis Truth Table
CELL-DYN 3200
Normal
CELL-DYN 3200
Morphological
Positive
CELL-DYN 3200
Distributional
Positive
Total
Reference Normal
Reference Morphological
Positive
Reference Distributional
Positive
455 TN
1 FN
1 FN
15 FP
167 TP
49 TP
0 FP
13 TP
147 TP
470
181
197
Agreement = 98.0%
False Positives = 3.19%
False Negatives = 0.53%
Specificity
Sensitivity
= 96.81%
= 99.47%
Table 4.18 shows the manual differential and CELL-DYN 3200 differential for
false negative results.
Table 4.18 Analysis of False Negative Results
Manual Differential CELL-DYN 3200
Morphological False
Negative
2.5% Immature grans and 3.5 NRBCs
No flag generated
4-18
Distributional False
Negative
CELL-DYN 3500
WBC = 4.596
CELL-DYN 3200
WBC = 4.71
CELL-DYN ® 3200 System Operator’s Manual
9140181K—July 2002
Section 4 Performance Characteristics and Specifications
Sample Loader Specifications
Sample Loader Physical Specifications
The Sample Loader attaches to the front of the CELL-DYN 3200SL Analyzer and
is an integral part of the SL model. Table 4.19 contains the physical specifications
for the Sample Loader.
Table 4.19 Sample Loader Physical Specifications
Sample Loader (with skirt)
Height
Width
Depth
Weight
6" (15.2 cm)
32.5" (82.5 cm)
6.4" (16.2 cm)
18 lb (8.1 kg)
CELL-DYN ® 3200 System Operator’s Manual
9140181H—October 2001
4-19
Performance Characteristics and Specifications
Sample Loader Specifications Section 4
Sample Loader Operational Specifications
Operational specifications for the Sample Loader are given in Table 4.20.
Table 4.20 Sample Loader Operational Specifications
Feature Specification
Rack Capacity 5 racks on the load side;
5 racks on the unload side
50 (10 tubes per rack) Tube Capacity
Sample Throughput
(1) Patient
(2) FWBC, RRBC, QC
Run Cycle Time
(1) Patient
(2) FWBC, RRBC, QC
Number of Mixing Stations
Degree of Mixing Rotation
Number of Mixing Rotations
Maximum Tube Size
Bar Code Reader
Bar Code Labels
(1) 58 samples/hour
(2) 34 samples/hour
(1) 62 seconds
(2) 105 seconds
2: Mixing Stations #1 and #2
0 – 135 degrees
15 times at Mixing Station #1
15 times at Mixing Station #2
16mm (DIA) X 80mm (High)
LED type
Code 39, I2of5, Codabar, Code 128
For information on tube types and size, refer to Tube Types in
;
Subsection: Physical and Performance Specifications
.
For information on bar codes types and operation, refer to
.
For general information on Sample Loader operation, refer to Section 13: Sample
; Subsection: Sample Loader Description .
4-20 CELL-DYN ® 3200 System Operator’s Manual
9140181H—October 2001
Section 5
Section 5 Operating Instructions
Operating Instructions
Overview
This section, which discusses the operation of the CELL-DYN 3200, is divided into eight major subsections:
Data Module Program Overview
Software Flowcharts
Set Up Instructions
Specimen Collection and Handling
Routine Operation
Sample Analysis
Work List
Using the Data Log
The three major menus in the program that are used for routine operation —
SET UP , RUN , and DATA LOG — are discussed in this section. The remaining parts of the program are discussed in the following sections:
Calibration Section 6: Calibration Procedures
Special Protocols Section 9: Service and Maintenance
Troubleshooting Section 10: Troubleshooting and Diagnostics
Quality Control Section 11: Quality Control
CELL-DYN ® 3200 System Operator’s Manual
9140181H—October 2001
5-1
Operating Instructions
Overview
NOTES
Section 5
5-2 CELL-DYN ® 3200 System Operator’s Manual
9140181H—October 2001
Section 5 Operating Instructions
Data Module Program Overview
The Data Module 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 system 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:
SET UP
RUN
DATA LOG
RETIC DATA LOG
QUALITY CONTROL
CALIBRATION
DIAGNOSTICS
SPECIAL PROTOCOLS
NOTE:
Reticulocyte menu operating instructions are detailed in Section 14:
.
Main Menu Screen
The MAIN MENU screen is divided into four sections. The upper left-hand corner shows the current version of the Data Module 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.
CELL-DYN ® 3200 System Operator’s Manual
9140181H—October 2001
5-3
Operating Instructions
Data Module Program Overview
Feb 23, 2001
Section 5
5-4
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
CALIBRATION screen.) This operator ID will be displayed on all 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 file identity, Sample ID number, and any existing fault conditions
The MAIN MENU key labels are displayed across the bottom of the screen.
CELL-DYN ® 3200 System Operator’s Manual
9140181H—October 2001
Section 5 Operating Instructions
Software Flowcharts
Flowchart Conventions
Menus are shown as square-cornered rectangles in the flowcharts, and soft keys are shown as round-cornered rectangles:
MAIN MENU
SET UP RUN DATA LOG RETIC
DATA LOG
QUALITY
CONTROL
CALIBRA-
TION
Soft keys are also depicted as follows in flowcharts:
DIAG-
NOSTICS
SPECIAL
PROTOCOLS
MAIN MENU
KEYS
SUBMENU
KEYS
TOGGLE
KEYS
TOGGLE
KEYS
Menu Flowcharts
After pressing one of the MAIN MENU soft keys, the appropriate submenu is displayed. From the submenus, more options are available. The MAIN MENU options flowchart is shown on this page. On the following pages, flowcharts show the submenus under each MAIN MENU option.
Main Menu Flowchart
MAIN MENU
SET UP RUN DATA LOG RETIC
DATA LOG
QUALITY
CONTROL
CALIBRA-
TION
DIAG-
NOSTICS
SPECIAL
PROTOCOLS
CELL-DYN ® 3200 System Operator’s Manual
9140181H—October 2001
5-5
Operating Instructions
Software Flowcharts
Set Up Menu Flowchart
Section 5
SET UP MENU
LIMIT
SET 1
DATE/
TIME
PATIENT
LIMITS
REAGENT
LOG
QC SET UP
MENU
OPERATION
SET UP
UNITS
SELECTION
CUSTOMIZE
REPORT
MAIN
LIMIT
SET 2
LIMIT
SET 3
DELETE
ENTRY
LIMIT
SET 4
X-B
SET UP
SHEATH
LOG
LIMIT
SET 5
LAB ID
SET UP
HGB LYSE
LOG
LIMIT
SET 6
QC
WBC LYSE
LIMITS
LOG
PRINT RETURN
LOG
RETURN
SET UP
QC FILE
CUSTOMIZE
DISPLAY
CUSTOMIZE
PRINTOUT
TURN ON
RETIC PKG
TURN OFF
RETIC PKG
LANGUAGE
1
SELECT
COLOR
2
BAR CODE
SET UP
COMPUTER
SET UP
RETURN
MAIN
REINIT
INTERFACE
STOP
TRANSMISS
TOGGLE
ON/OFF
SET UP
CONFIRM
STOP
CANCEL
STOP
TURN X-B
RBC ON
TURN X-B
RBC OFF
TURN X-B
WBC ON
TURN X-B
WBC OFF
PRINT RETURN
USA
UNITS
SI
UNITS
SI MOD
UNITS
SET 1
UNITS
SET 2
UNITS
SELECT
UNITS
RETURN
ENGLISH English
2
1
RANGE
ENTRY
MEANS/
LIMITS
UPDATE
FROM FILE
LOAD
FROM DISK
LOAD
LOW
LOAD
NORMAL
RETURN
LOAD
HIGH
RETURN
SELECT
PARAMETER
PLACE
PARAMETER
CANCEL STANDARD
SELECTION SELECTION
RETURN
NEXT
LANGUAGE
RETURN
LOT
NUMBER
REPLICATE
ID
TOGGLE
ON/OFF
PRINT RETURN
WBC
GROUP
SELECT
PARAMETER
PLACE
PARAMETER
CANCEL
SELECTION
STANDARD
GROUPS
RBC
GROUP
PLT
GROUP
DIFF
GROUP
RETURN
LATEX
SET
CUSTOM
PLACEMENT
RETURN
RESTORE
PREVIOUS
RESTORE
DEFAULT
RETURN
CUSTOMIZE DISPLAYED REPORT
PARAM
SET 1
PARAM
SET 2
PARAM
SET 3
PARAM
SET 4
CUSTOMIZE
PRINTOUT
CUSTOMIZE
HEADER
SELECT
GRAPH
SET UP
TOGGLE
PARAMETER
PARAM
SET 1
CUSTOMIZE PRINTED REPORT
Ready
PARAM
SET 2
PARAM
SET 3
PARAM
SET 4
CUSTOMIZE
PRINTOUT
CANCEL
GRAPH
PLACE
GRAPH
SET UP
CUSTOMIZE PRINTOUT HEADER
Ready
RESTORE
HEADER
BLANK
HEADER
CUSTOMIZE
DISPLAY
CUSTOMIZE
PRINTOUT
SET UP
RESTORE
HEADER
TICKET
PRINTER
PRE-PRNTD GRAPHICS
TICKET PRINTER
CUSTOMIZE
DISPLAY
BLANK
TICKET
STOP
PRINTING
CONFIRM
STOP
CUSTOMIZE
HEADER
CANCEL
STOP
TOGGLE
ON/OFF
SET UP
5-6 CELL-DYN ® 3200 System Operator’s Manual
9140181H—October 2001
Section 5
Run Menu Flowchart
Operating Instructions
RUN
START
LOADER
CLEAR
FAULT
PRIME
STOP
LOADER
RESUME RESET
WORK
LIST
SPECIMEN
TYPE
CUSTOMIZE
REPORT
CHANGE
SAMPLER
PATIENT see CUSTOMIZE REPORT on SET UP MENU
QC
SPECIMEN
BACK-
GROUND
TICKET
FRAGILE
WBC
REPORT
COLOR
MAIN
LATEX RESISTANT
RBC
RETURN
INSERT/
DELETE
DELETE
ALL
WORK LIST
SET UP
WORK LIST
RETURN
CONFIRM CANCEL
DELETION SELECTION
TOGGLE
ON/OFF
RETURN
INSERT DELETE RETURN
Data Log Menu Flowchart
DATA LOG
EDIT
ID
DISPLAY
SPECIMEN
FIND
SPECIMEN
REJECT
FROM X-B
ACCEPT
INTO X-B
CUSTOMIZE
DATA LOG
TRANSMIT
DATA
DATA LOG
MAIN
SELECT
PARAMETER
STANDARD
GROUPS
CUSTOMIZE
PRINTOUT
RETURN
PLACE
PARAMETER
CANCEL
SELECTION
RETURN SELECT
PARAMETER
STANDARD
SELECTION
RETURN
PLACE
PARAMETER
CANCEL
SELECTION
RETURN
WBC
GROUP
RBC
GROUP
PLT
GROUP
DIFF
GROUP
CUSTOM
PLACEMENT
CUSTOMIZE
PRINTOUT
RETURN
PREVIOUS
SPECIMEN
NEXT
SPECIMEN
EDIT
SPECIMEN
CUSTOMIZE
REPORT
TRANSMIT
SPECIMEN
TICKET
REPORT
RETURN
CONFIRM CANCEL see CUSTOMIZE REPORT on SET UP MENU
CELL-DYN ® 3200 System Operator’s Manual
9140181H—October 2001
5-7
Operating Instructions
Software Flowcharts
Quality Control Menu Flowchart
Section 5
QC MENU
Ready
GROUP
1
GROUP
2
GROUP
3
X-B
SET UP
GROUP
4
X-B
FILE
PREVIOUS
10
VIEW
QC LOG
NEXT
10
QC
LIMITS
SET UP
QC FILE
CUSTOMIZE
DISPLAY
CUSTOMIZE
PRINTOUT
MAIN
TURN X-B
RBC ON
TURN X-B
RBC OFF
TURN X-B
WBC ON
TURN X-B
WBC OFF
X-B RBC
GRAPHS
X-B RBC
DATA
X-B WBC
GRAPHS
X-B WBC
DATA
RETURN
PRINT RETURN
SELECT
PARAMETER
PLACE
PARAMETER
CANCEL
SELECTION
STANDARD
SELECTION
RETURN
SELECT
PARAMETER
PLACE
PARAMETER
CANCEL
SELECTION
STANDARD
GROUPS
RETURN
WBC
GROUP
RBC
GROUP
PLT
GROUP
DIFF
GROUP
LATEX
SET
CUSTOM
PLACEMENT
RETURN
REPLICATE
ID
LOT
NUMBER
TOGGLE
ON/OFF
PRINT RETURN
PURGE
QC LOG
LEVEY-
JENNINGS
REJECT
SPECIMEN
ACCEPT
SPECIMEN
DELETE
SPECIMEN
MOVE
SPECIMEN
CONFIRM
PURGE
CANCEL
PURGE
WRITE QC
TO DISK
CONFIRM
DELETION
CANCEL
DELETION
MOVE TO
FILE
CANCEL
MOVE
WRITE
LOW
QC LOG
RANGE
ENTRY
MEANS/
LIMITS
UPDATE
FROM FILE
LOAD
FROM DISK
RETURN
LOAD
LOW
LOAD
NORMAL
LOAD
HIGH
RETURN
RETURN
CONFIRM
UPDATE
WRITE
NORMAL
RETURN
WRITE
HIGH
RETURN
PRINT RETURN
5-8 CELL-DYN ® 3200 System Operator’s Manual
9140181K—July 2002
Section 5
Calibration Menu Flowchart
Operating Instructions
CALIBRATION
Ready
RESTORE
FACTORS
RESET ALL
TO 1.000
ENTER
FACTOR
CALIBRATION
LOG
AUTO
CALIBRATE
CLOSED
SAMPLER
OPEN
SAMPLER
RETURN
*WHOLE
BLOOD
*CALIBRATOR
CLOSED
SAMPLER
OPEN
SAMPLER
LOG
RETURN
MAIN
RETURN
START
AUTO-CAL
QUIT RETURN
CONFIRM
QUIT
CANCEL
QUIT
ACCEPT DELETE
A RUN
QUIT
CONFIRM
QUIT
CANCEL
QUIT
PRINT RETURN
*NOTE: Instrument will reflect last mode of calibration, either whole blood or calibrator.
CELL-DYN ® 3200 System Operator’s Manual
9140181H—October 2001
5-9
Operating Instructions
Software Flowcharts
Diagnostics Menu Flowcharts
DIAGNOSTICS MENU
Ready
FAULT
REPORT
EXECUTION
TIMES
CNT RATE
SUMMARY
CLEAR
FAULTS
RAW DATA
SUMMARY
MORE
WOC
CNT RATE
WOC
CNT GRAPH
WOC
CNT DATA
RBC/PLT
CNT RATE
RBC/PLT
CNT GRAPH
RBC/PLT
CNT DATA
NOC
CNT RATE
NOC
CNT GRAPH
NOC
CNT DATA
PRINT RETURN
MOTOR
OPERATION
SOLENOID
OPERATION
PUMP
OPERATION
DRAIN
ACCUMULATOR
INITIAL-
IZATION
MORE
MAIN
MAIN
Section 5
CYCLE
BANK
STEP
SOLENOID
DIAG-
NOSTICS SOFTWARE
VERSIONS
DIGITAL
READINGS
VOLTAGE
READINGS
GAIN
ADJUSTMNT
MORE
VACUUM
ON
VACUUM
OFF
PRESSURE
ON
PRESSURE
OFF
VACUUM PRESSURE
TEST TEST
DIAGNOSTICS
PRINT MAIN
MOTOR PWR
CHECKING
HOME
MOTORS
EXERCISE
MOTORS
SHEAR VAL
TIME
SHEAR VAL
DISPENSE
SHEAR VAL
ASPIRATE
Y-VALVE
TO CLOSE
Y-VALVE
TO OPEN
PRINT DIAGNOSTICS
FINISH
SELECT
SELECT DIGITAL
READINGS
VOLTAGE
READINGS
GAIN
ADJUSTMNT
MORE PRINT MAIN
**
RBC LIN
DATA
RBC LIN
HISTOGRAM
WBC
DATA
VERIFY
GAINS
**
AUTO GAIN
ADJUSTMNT
CURRENT
SETTINGS
DIAGNOSTICS
RBC
DATA
RBC
HISTOGRAM
PLT
DATA
PLT
HISTOGRAM
NOC
DATA
NOC
HISTOGRAM
MORE MAIN
* SL only
** This information appears on the next page.
WBC 1
DATA
WBC 1
HISTOGRAM
WBC 2
DATA
WBC 2
HISTOGRAM
CALC
CV
SCATTER
GRAPHS
SMOOTHING
ON/OFF
EXTENDED
WBC COUNT
PRINT DIAGNOSTICS
SERIAL
TEST
BAR CODE
ALIGNMENT
FPU
TEST
TOWER
TEST
*LOADER
TEST
MORE
STOP
TRANSMISS
TRANSMIT
MESSAGE
RETURN
NEEDLE
DOWN
RETRACT
SOLENOID
SPIN
MOTOR
SENSOR
TEST
DIAGNOSTICS
MAIN
TUBE
BARCODE
RACK
BARCODE
READ
RATE
RETURN
5-10
MIXER
DOWN
ROTATE
MIXUP
CYCLE
BLADDERS
START
RACE ADV
EXTEND
ARMS
TUBE
SENSOR
DIAGNOSTICS
CELL-DYN ® 3200 System Operator’s Manual
9140181K—July 2002
Section 5
Diagnostics Menu Flowchart (continued)
DIAGNOSTICS
MORE
MORE
MORE
RBC LIN
DATA
WBC
DATA
RBC
DATA
Operating Instructions
PLT
DATA
RBC 0
DATA
RBC 10
DATA
RBC 0
HISTOGRAM
RBC 10
HISTOGRAM
RBC 90
DATA
RBC 90
HISTOGRAM
SMOOTHING
ON/OFF
PRINT DIAGNOSTICS
PLT 0
DATA
PLT 0
HISTOGRAM
PLT 10
DATA
PLT 10
HISTOGRAM
SMOOTHING
ON/OFF
PRINT DIAGNOSTICS
NOC
DATA
NOC 0
DATA
NOC 10
DATA
NOC 0
HISTOGRAM
NOC 10
HISTOGRAM
NOC 00
NOC 10
NOC 90
NOC10
NOC 90
NOC00
PRINT DIAGNOSTICS
RBC LIN 0
DATA
RBC LIN 10
DATA
RBC LIN 0
HISTOGRAM
RBC LIN 10
HISTOGRAM
RBC LIN 90
DATA
RBC LIN 90
HISTOGRAM
RBC VOLUME
DATA
SMOOTHING
ON/OFF
CALC
CV
PRINT DIAGNOSTICS
CELL-DYN ® 3200 System Operator’s Manual
9140181H—October 2001
5-11
Operating Instructions
Software Flowcharts
Special Protocols Flowchart
SPECIAL PROTOCOLS
CLEAR
FAULT
REAGENT
RESERVOIR
EMPTY/FILL
FLOW CELL
CLEAN/RES
SHEAR VALVE
DISABLE/ENAB
ANALYZER
MORE MAIN
Section 5
EMPTY
DIL/SHEATH
FILL
DIL/SHEATH
EMPTY
HGB LYSE
FILL
HGB LYSE
EMPTY
WBC LYSE
FILL
WBC LYSE
RETURN
EMPTY
FLOW CELL
RETURN
FILL
FLOW CELL
CLEAN
SHEAR
VALVE
RESTORE
SHEAR
VALVE
DISABLE
ANALYZER
ENABLE
ANALYZER
RETURN
RETURN
AUTO
CLEAN
DAILY
SHUTDOWN
PREPARE
SHIPPING
CLEAN
NEEDLE
EXTEND
AUTOCLEAN
MORE MAIN
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Section 5 Operating Instructions
Set Up Instructions
This section discusses the options available when the [SET UP] 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.
Set Up Menu
Figure 5.2 Set Up Menu Screen
When the [SET UP] key is pressed, the following soft key labels are displayed:
DATE/TIME
PATIENT LIMITS
REAGENT LOG
QC SET UP MENU
OPERATION SET UP
UNITS SELECTION
CUSTOMIZE REPORT
MAIN
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Operating Instructions
Set Up Instructions Section 5
Date/Time
Figure 5.3 Date/Time Set Up 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 SET UP
screen shown in Figure 5.3 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
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, below the format selection box) and the cursor moves to the entry position. After the date has been entered, the cursor moves to the TIME entry field (3).
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Section 5 Operating Instructions
To Set Date/Time
1. From the SET UP MENU screen, press [DATE/TIME] to display the DATE/TIME
SET UP screen.
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 (year must be 4 digits) 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.
(For example, 00 for 12 midnight, 06 for 6 am, and 13 for 1 pm.) 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 SET UP MENU screen.
Figure 5.4 Patient Limits Screen
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Operating Instructions
Set Up Instructions
Patient Limits
Section 5
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.) The following soft key labels are displayed (See
[PATIENT LIMITS] key is pressed:
LIMIT SET 1
LIMIT SET 2
LIMIT SET 3
LIMIT SET 4
LIMIT SET 5
LIMIT SET 6
RETURN
NOTE: The key label for the limit set displayed on the screen is not shown.
Six 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 purple 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.
LIMIT SET 1 contains upper and lower limits pre-set at the factory. The operator shall be able to change these limits. Once these limits are changed, the operator can return to the factory-set limits by either manually inputting the factory-set limits or by re-installing the Set Up Disk.
LIMIT SETS 2 through 6 contain zeros for the lower limits and 9s for the upper limits when the instrument is first installed.
In addition to entering limit set data, the operator can also pre-assign limit sets to patients based on patient sex and age.
Automatic Patient Limit Set Assignment
Sex and Age fields for each Patient Limit Set are shown in the upper left corner of the LIMIT SET screen.
Limit Set 1 is the default Limit Set. It is assigned to any Patient without both an age and a sex designation or whose age and sex (if input) cannot be assigned by the system to a specific Limit Set. The operator cannot change the displayed data in the
Sex and Age fields of Limit Set 1.
For Limit Sets 2 through 6, the operator can pre-assign a Limit Set based on age and sex. The options for Sex are:
M for Male
F for Female
U for Undefined (either the patient’s sex is unknown or the Limit Set is intended to cover both male and female)
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Section 5 Operating Instructions
Patient age is entered in Weeks and/or Years. The range for Weeks is zero to 51.
The range for Years is 1 to 199. Any number input shall be interpreted by the system as “equal to or less than.” Age ranges are automatically established by using successively higher numbers. For example, if the number 1 is entered in the Years field for Limit Set 2 and the number 5 is entered in the Years field for Limit Set 3, then any patient whose age is 1 year or less will automatically be assigned Limit
Set 2 and any patient whose age is greater than 1 year but equal to or less than 5 years will automatically be assigned Limit Set 3.
The appropriate Limit Set is automatically assigned when a patient’s sex and date of birth are entered on the RUN screen or Work List.
To Set Patient Limits
1. Press [PATIENT LIMITS] to display the PATIENT LIMITS screen.
A Patient Limit Set is displayed on the screen. When a Limit Set is displayed on the screen, the set number (Limit Set 1, Limit Set 2, etc.) is displayed in the status box and the soft key corresponding to that number is blanked out. The other limit sets may be selected by pressing the appropriate soft key.
2. Select a Limit Set by pressing the appropriate [LIMIT SET] soft key.
3. To pre-assign a Limit Set based on a patient’s sex and age, enter one of the three Sex codes and press the Enter key. The cursor moves to the Years field.
Enter a number for years and press Enter or use the arrow keys to move the cursor to the Weeks field. Enter a number for Weeks and press Enter or use the arrow keys to move the cursor to the desired limit entry field.
NOTE: Limit Set 1 is the default Limit Set and cannot be altered.
4. With the cursor in the first entry field to be changed, type the desired number.
5. Press the Enter key on the keyboard to save the entry and automatically advance the cursor to the next entry position.
6. Repeat steps 4 and 5 until all desired entries have been made.
7. 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.
8. Press the appropriate soft key to select another Limit Set and repeat steps
3–7 to pre-assign a Limit Set and to enter the desired limits.
9. Press [RETURN] to return to the SET UP MENU screen.
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Operating Instructions
Set Up Instructions Section 5
Reagent Log
Figure 5.5 Diluent/Sheath 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
DIL/SHEATH LOG
HGB LYSE LOG
WBC LYSE LOG
PRINT LOG
RETURN
NOTE: The key label for the reagent log displayed in the Status Box is not displayed with the other keys.
When the [REAGENT LOG] key is pressed, one of the logs is displayed as shown in
Figure 5.5. (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
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Section 5 Operating Instructions
To Complete Reagent Log Entry
1. Press [REAGENT LOG] to display a REAGENT LOG screen.
2. If the desired reagent log is not already displayed, use the soft key to select the appropriate log.
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 and print data.
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Operating Instructions
Set Up Instructions Section 5
To Delete Entries
When the log is full (the log holds 10 entries), the oldest entry must be deleted to create space for a new entry. Abbott suggests that, for documentation purposes, the log be printed when it is full.
1. Press [REAGENT LOG] to display a REAGENT LOG screen. If necessary, press a soft key to display the appropriate log.
2. Move the cursor to the oldest entry in the log.
3. Press [DELETE ENTRY] . The [COMPLETE DELETION] and [RESTORE ENTRY] keys are displayed.
4. Press [COMPLETE DELETION] to delete the selected entry.
5. If desired, a new entry may then be made as described above.
NOTE: New entries may also be made by typing over old entries without deleting them.
6. Press [RETURN] to return to the main SET UP MENU screen.
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Figure 5.6 QC Set Up Menu Screen
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Section 5
QC Set Up Menu
Operating Instructions
The [QC SET UP MENU]
key is used to display a list of the QC files (see Figure 5.6)
and the following soft key labels:
X-B SET UP
LAB ID SET UP
QC LIMITS
SET UP QC FILE
CUSTOMIZE DISPLAY
CUSTOMIZE PRINTOUT
MAIN
This section discusses the procedures that are used to set up the QC files. Typically, a QC file(s) is set up, then QC Limits are established. Therefore, the keys in the QC
SET UP menu will be discussed in this order.
Figure 5.7 X-B Set Up Screen
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Operating Instructions
Set Up Instructions Section 5
X-B Setup Menu
The [X-B SET UP] key is used to select the X-B SET UP
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 for both the WBC and RBC parameters. The following soft key labels are displayed when the [X-B SET UP] key is pressed:
TURN X-B RBC ON/
TURN X-B RBC OFF
TURN X-B WBC ON/
TURN X-B WBC OFF
RETURN
(The key alternates between the selections.)
(The key alternates between the selections.)
The following options are available on the X-B SET UP
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 (such as background counts) 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.
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 Section 11: Quality Control .
To Set Up X-B
1. Press [X-B SET UP] to display the X-B SET UP screen.
2. Use the Arrow keys on the keyboard to move the cursor to the desired entry field.
3. Type the numbers 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. If the soft key [TURN X-B RBC ON] or [TURN X-B WBC ON] is displayed, press the appropriate key to enable the X-B program.
NOTE: For example, when the X-B RBC program is enabled the screen displays the message
THE X-B RBC PROGRAM IS ON
and the
[TURN X-B RBC OFF] key is displayed.
7. Press [RETURN] to return to the QC SET UP MENU screen.
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Section 5 Operating Instructions
Lab ID Set Up
The [LAB ID SET UP] key on the QC Set Up Menu is used to enter Laboratory
Identification information for the QC files. This information is necessary for participants in the CELL-DYN Interlaboratory QC Program who wish to submit their results on a floppy disk. Laboratory Identification must be entered before QC data can be transferred to the floppy disk.
Procedure: LAB ID SET UP
1. From the MAIN MENU screen, press [SET UP] , followed by
[QC SET UP] .
2. From the QC Set Up screen, press [LAB ID SET UP] to display the
LAB ID SET UP screen.
3. Type the appropriate information and press the Enter key on the keyboard after each entry to save it and advance the cursor to the next entry field.
4. If desired, press the Print Screen key on the keyboard to obtain a printout of the entered information.
5. Press [RETURN] to return to the QC SET UP screen.
QC Limits Menu
The [QC LIMITS] key is used to display the QC MEANS/LIMITS ENTRY screen and the following soft key labels:
RANGE ENTRY and
MEANS/LIMITS
UPDATE FROM FILE
LOAD FROM DISK
RETURN
(The key alternates between the selections.)
QC Limits Entry
QC Limits are entered by pressing the [QC LIMITS] key. This key is available on the
QC SET UP MENU screen and the QC MENU screen. Two types of QC limits are available:
Means and Limits — used to enter the mean value and a ± range value that defines
the upper and lower flagging limits (see Figure 5.8)
Range Entry — used to enter the upper and lower flagging limits as absolute
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.
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Operating Instructions
Set Up Instructions Section 5
5-24
Figure 5.8 QC Means/Limits Entry Screen
Means/Limits Entry
1. Select a file from the QC SET UP 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 [MEANS/LIMITS] and [RANGE ENTRY] .
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.
7. Press [RETURN] to save the entries and return to the QC SET UP screen.
NOTE: When the entries are saved by pressing the [RETURN] soft key, 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.
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Section 5 Operating Instructions
Figure 5.9 QC Range Entry Screen
Range Entry
1. Select a file from the QC SET UP 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.
7. Press [RETURN] to save the entries and return to the QC SET UP screen.
NOTE: When the entries are saved by pressing the [RETURN] soft key, 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
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Operating Instructions
Set Up Instructions Section 5
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Figure 5.10
Update From File Key
Update From File
The [UPDATE FROM FILE] key is displayed on the QC MEANS/LIMITS ENTRY and QC
RANGE ENTRY
screens when there are two or more results in the file. (See Figure
[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
Load From Disk
The [LOAD FROM DISK] key is used to enter the lot number, expiration date, and assay values into a QC file directly from a floppy disk. When this option is used, the lot number, expiration date, mean value and limits (either for QC Range entry or QC Means/Limits entry) are automatically entered in the selected file. The values may be edited after they are displayed on the screen.
NOTE: The information is entered for each level, one level at a time.
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Section 5 Operating Instructions
Procedure: Load From Disk
1. Press [QUALITY CONTROL] to display a list of QC files.
2. Use the arrow keys on the keyboard to move the cursor to the desired file.
Type the file name (e.g., Low L0036) and press the Enter key on the keyboard to save the name and advance the cursor to the next file.
NOTE: The file must be empty in order to load the information from the disk.
3. When the desired files have been named, use the Arrow keys on the keyboard to move the cursor back to the first file desired for data entry.
4. Press [QC LIMITS] followed by [MEANS/LIMITS] or
[RANGE ENTRY] to display the QC MEANS/LIMITS ENTRY or RANGE ENTRY screen for the selected file.
5. Press [LOAD FROM DISK] to display the LOAD FROM DISK screen.
6. Insert the disk containing the assay information for the relevant lot number into the Data Station disk drive.
NOTE: Be certain to carefully check lot numbers. Be sure the lot number on the disk matches the lot number that is being put into use. If the lot number is included in the filename, be sure the disk contains assay information for that lot number.
7. Check the status box to be sure the correct file is selected and press the appropriate soft key:
[LOAD LOW] to load the low control assay data.
[LOAD NORMAL] to load the normal control assay data.
[LOAD HIGH] to load the high control assay data.
8. The limits are displayed for the selected file. If desired, the limits may be edited.
9. Press [RETURN] to return to the QC MENU screen.
10. Select the next file and repeat steps 7 and 8 to load the assay data for the appropriate level of control.
11. Repeat steps 8-11 until the assay data for each level has been loaded.
12. When all the assay data has been loaded, remove the disk from the disk drive.
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Operating Instructions
Set Up Instructions Section 5
Set Up QC File
The [SET UP 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.
NOTE: The system defaults to the LOT NUMBER screen upon initial set up.
Otherwise, the screen last selected will be displayed.
The QC SET UP 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 [SET UP QC FILE] key is pressed:
REPLICATE ID/LOT NUMBER (The key alternates between the selections.)
TOGGLE ON/OFF (This key is only present when the cursor is in one of the Westgard ® Rule Selection fields.)
RETURN
The LOT NUMBER ENTRY and REPLICATE ID ENTRY
5.11 and 5.12. The options available are as follows:
1. <Lot Number> and <Expiration Date> entry fields
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.
2. <Replicate ID> entry field
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.
3.
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NOTE: Westgard ®
rules are discussed in detail in Section 11: Quality Control .
The Westgard ® Rule selections are available on either of the QC FILE SET UP screens.
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Section 5 Operating Instructions
QC File Set Up
1. Press [QC SET UP MENU] to display the QC SET UP 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 [SET UP QC FILE] to display the QC FILE SET UP screen.
Figure 5.11 Lot Number Entry Screen
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Operating Instructions
Set Up Instructions Section 5
To Enter Lot Number Data
1. If necessary, from the QC FILE SET UP screen, press [LOT NUMBER] to display the <Lot Number> and <Expiration Date> entry fields.
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. Type the expiration date in the format indicated using one or two digits. This is the same format selected on the DATE/TIME SET UP 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 QC FILE SET UP screen.
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Figure 5.12 Replicate ID Entry Screen
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Section 5 Operating Instructions
To Enter Replicate ID Data
1. If necessary, from the QC FILE SET UP screen, press [REPLICATE ID] to display the < Replicate Id !
entry field.
2. The cursor is in the <Replicate ID> entry field. Type the sample 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 To Enter Lot Number Data procedure.
Customize Display
The [CUSTOMIZE DISPLAY] key in the QC SET UP menu is used to customize the
display of information in the QC logs. Figure 5.13 shows the
CUSTOMIZE QC
DISPLAY
screen with the standard groups displayed. Figure 5.14 shows the
CUSTOMIZE QC DISPLAY screen where the WBC and RBC groups have been customized.
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 of 4 rows of parameters that are currently selected in
Groups 1 through 4. A list of all available parameters is displayed under the matrix.
The standard groups, which include predetermined parameter sets, are identified as follows:
Group 1
Group 2
Group 3
Group 4
WBC parameters
RBC parameters
PLT parameters
WBC Diff parameters
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.
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Operating Instructions
Set Up Instructions Section 5
Figure 5.13 Customize QC Display Screen
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Figure 5.14 Customize QC Display Screen Showing Standard Groups
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Section 5 Operating Instructions
To Customize QC Log Display
1. Select a file from the QC SET UP 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 SET UP menu screen.
10. Repeat this procedure to customize the display for other QC logs.
Standard Groups
Predetermined groups of parameters, called Standard Groups, may be selected by pressing the [STANDARD GROUPS]
key (refer to Figure 5.14). 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 operatorselected placement.
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Operating Instructions
Set Up Instructions Section 5
Customize QC Log Display (Standard Groups)
1. Select a file from the QC SET UP 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 CUSTOMIZE QC 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 SET UP menu screen.
9. Repeat this procedure to select standard groups for other QC logs.
Latex Set
This key is intended to be used by Abbott Service personnel only. If the [LATEX
SET] key is pressed, parameters in all groups will be affected. 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.
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Section 5 Operating Instructions
Figure 5.15 Customize QC Printout Screen
Customize Printout
The [CUSTOMIZE PRINTOUT] key in the QC SET UP menu is used to customize the
printout format for the QC logs. (See Figure 5.15.) The following soft key labels
are displayed when the [CUSTOMIZE PRINTOUT] key is pressed:
(Toggles to PLACE PARAMETER when 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.
Standard Selection
The [STANDARD SELECTION] key is used to automatically arrange the parameters
in predetermined print groups (see Figure 5.14).
Select Parameter
The [SELECT PARAMETER/PLACE PARAMETER] key is used to customize the QC
Log printout.
1. Select a file from the QC SET UP 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.
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Operating Instructions
Set Up Instructions Section 5
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.
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, the cursor advances to the next parameter in the list under the printout group, and the key label changes back to [SELECT PARAMETER] .
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 SET UP menu screen.
9. Repeat this procedure to customize the printout for other QC logs.
Feb 23, 2001
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Figure 5.16 Operation Set Up Menu Screen
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Section 5 Operating Instructions
Operation Set Up Menu
The OPERATION SET UP MENU
screen (see Figure 5.16) allows the operator to
select screen colors, the type of bar code used, and to configure the transmission to an on-line (host) computer. The following soft key labels are displayed when the
[OPERATION SET UP] key is pressed:
TURN ON RETIC PKG
LANGUAGE
SELECT COLOR
BAR CODE SET UP
COMPUTER SET UP
RETURN
Figure 5.17 Language Selection Screen
Language Selection < (QJOLVKGHIDXOWODQJXDJH >
The LANGUAGE SELECTION
screen, shown in Figure 5.17, will allow the user to
select one of the following non-English languages for display and printout:
French
German
Italian
Japanese
Portuguese
Spanish
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Operating Instructions
Set Up Instructions Section 5
The following soft keys are displayed when the [LANGUAGE] key is pressed:
ENGLISH
English
NEXT LANGUAGE
RETURN
XVHGWRUHWXUQWRWKHGHIDXOWODQJXDJH
(name of currently displayed language)
Pressing the capitalized [ENGLISH] soft key allows the operator to return to English which is the default language.
The name of the currently displayed language is displayed next to [ENGLISH] . For example, if English is the displayed language, then [English] will be displayed in the second key position. The name of each language is displayed using the spelling convention of the host language: French is displayed as [français] , German as
[deutsch] , and Spanish as [español] .
Pressing the language key affects the display and printout of soft keys, bulletin and screen messages, and demographic data; it does not effect the measurement process or other functional aspects of the program.
Pressing the [NEXT LANGUAGE] soft key will allow the user to scroll through the available languages.
To Change the Language
1. In the OPERATION SET UP MENU , press [LANGUAGE] .
2. Press [NEXT LANGUAGE] to scroll through the list of languages available on the instrument.
3. When the desired language is displayed in the second soft key label position, press [RETURN] to save the selection and return to the OPERATION SET UP
MENU .
4. If desired, attach a keyboard appropriate to the language selected.
CAUTION: If a different keyboard will be attached to the instrument because of the change in language, the instrument (Analyzer only) should first be turned OFF before the old keyboard is unplugged and the new keyboard is attached. This will prevent accidental injury to the operator or damage to the instrument.
NOTE: Permanent language selection must be made during installation. If the instrument is re-booted, it will revert to the installed language selection.
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Section 5 Operating Instructions
Figure 5.18 Select Color Screen
Select Color
The SELECT COLOR
screen, shown in Figure 5.18, allows the user to select various
colors for displaying parameter data and other information on the screen. The following soft keys are displayed when the [SELECT COLOR] key is pressed:
RESTORE PREVIOUS
RESTORE DEFAULT
RETURN
Color Reference
Main Body 1
Main Body 2
Main Body 3
Main Body 4
Main Body 5
Main Body 6
Main Body 7
Main Body 8
Title Block
Inverse Title
Bulletin
Function Keys
Cursor
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Main screen
Flags
Run mode description
Values below limits
Values above limits
Sequence numbers in Data Log
RBC Histogram/New entry before Enter key is pressed
PLT Histogram/New entry after Enter key is pressed
Top center of screen
Title not currently used
Alert messages above function keys
Soft key descriptions
Screen cursor
5-39
Operating Instructions
Set Up Instructions Section 5
To Change Color Settings
1. Press [SELECT COLOR] in the OPERATION SET UP MENU .
2. Use the Arrow keys on the keyboard to move the cursor to the desired location in either the Foreground or Background columns.
3. Enter the number corresponding to the desired color from the list on the left side of the screen. Press the Enter key to save the entry and move the cursor to the next position.
NOTE: The one field which cannot be changed is Background for Main body 1. This background must always remain black.
4. When all desired changes have been made, press [RETURN] to return to the
OPERATION SET UP MENU.
5. If the operator changes a color selection, then wishes to cancel the change and keep the original setting, pressing [RESTORE PREVIOUS] while this screen is still displayed will cancel all changes and restore the original color selection.
Pressing [RESTORE DEFAULT] will cause the screen colors to revert to the configuration set at the factory prior to shipment.
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Section 5 Operating Instructions
Figure 5.19 Bar Code Set Up Screen
Bar Code Set Up
The [BAR CODE SET UP] key is used to select the type of bar code to be read and to
enable or disable the check digit option for the selected bar code. (See Figure 5.19.)
NOTE: For more information about check digits and bar codes, refer to Appendix
A, Bar Codes.
To Set Up Bar Code
1. From the OPERATION SET UP MENU screen, press [BAR CODE SET UP] to display the BAR CODE SET UP screen.
2. Type the number for the type of bar code that will be used:
1 — Code 39
2 — Interleaved 2 of 5
3 — CODABAR
4 — Code 128
Press the Enter key on the keyboard to save the entry and advance the cursor to the Bar Code Check Digit field.
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 [SET UP] to return to the OPERATION SET UP MENU .
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Operating Instructions
Set Up Instructions
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Section 5
OFF
OFF
OFF
OFF
OFF
8
1
OFF
OFF
0
0.3
9600
Auto-transmission of ALTERED parameter data
Auto-transmission of NON-ALTERED parameter data
Auto-transmission of ALTERED graph data
Auto-transmission of NON-ALTERED graph data
Transmission CTS enabled
Auto-transmission of extended histogram records
Auto-transmission of scatter data
Transmission of 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 BaudRate (300,600,1200,2400,4800,9600,19200,38400,56000)
Figure 5.20 Computer Set Up Screen
Computer Set Up Menu
The [COMPUTER SET UP] key is used to display the COMPUTER SET UP screen (see
Figure 5.20) and the following soft key labels:
REINIT INTERFACE
STOP TRANSMISS
TOGGLE ON/OFF
SET UP
The CELL-DYN 3200 can transmit data to an on-line computer (Laboratory
Information System) using a direct serial link. Data may be transmitted automatically as each sample is run or at the operator’s request. The
CELL-DYN 3200 also can receive patient information transmitted to it by the on-line computer.
The COMPUTER SET UP 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.
Reinit Interface
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.
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Section 5 Operating Instructions
Stop Transmiss
The [STOP TRANSMISS] key is used to terminate the current data transmission to an on-line computer. When the [STOP TRANSMISS] key is pressed, the following soft key labels are displayed:
CONFIRM STOP
CANCEL STOP
Pressing [CONFIRM STOP] causes the transmission to terminate. Pressing [CANCEL
STOP] allows the transmission to continue.
Toggle ON/OFF
The [TOGGLE ON/OFF] key enables or disables the first seven options in the list displayed on the COMPUTER SET UP screen.
A description of the options available on the COMPUTER SET UP screen is given below:
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 graph data
When this option is enabled, histograms are automatically transmitted to the
LIS for any sample with flagged results.
4.
Auto-transmission of NON-ALERTED graph data
When this option is enabled, histograms are automatically transmitted to the
LIS for any sample without flagged results.
5.
Transmission CTS enabled
6.
Auto-transmission of extended histogram records
When this option is enabled, extended histograms are automatically transmitted to the LIS.
7.
Auto-transmission of scatter data
When this option is enabled, scatter data is automatically transmitted to the
LIS.
8. The remaining options are configured according to the requirements of the
LIS:
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, 19200, 38400, 56000)
The numbers in parentheses after the options indicate the selections available.
NOTE: Refer to the Interface Specification for complete information on interfacing.
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Operating Instructions
Set Up Instructions Section 5
NOTE: Auto-transmitting extended data uses CPU time during the acquisition cycle. In order to reduce the time taken by this transmission, autotransmission of extended data is only allowed at the baud rates of 38400 and
56000. If there is a need to re-transmit data, this can be done one specimen at a time from the DISPLAY SPECIMEN menu if the correct baud rate has been selected and transmission of either extended histograms or extended scatter plots has been selected.
Computer Set Up Procedure
1. From the OPERATION SET UP MENU , press [COMPUTER SET UP] to display the COMPUTER SET UP screen.
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 [SET UP] to return to the OPERATION SET UP MENU screen.
7. Press [RETURN] to return to the SET UP MENU .
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Section 5 Operating Instructions
Figure 5.21 Units Selection Screen
Units Selection Menu
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 5.21.) The following soft
key labels are displayed when the [UNITS SELECTION] key is pressed:
USA UNITS
SI UNITS
SI MOD UNITS
SET1 UNITS
SET2 UNITS
SELECT UNITS
RETURN
The units selected by each of the soft keys are shown on the screen display in
Figure 5.21. The following table demonstrates how values are reported for the
same sample under each “units” category.
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Operating Instructions
Set Up Instructions Section 5
RDW
PLT
MPV
PCT
PDW**
RETIC
ABS
WBC*
RBC
HGB
HCT
MCV
MCH
MCHC
Table 5.1
Report Units
USA
Parameter
Value Units
5.32
5.15
16.2
47.6
92.3
31.5
34.1
12.5
323
8.26
0.267
17.5
51.5
K/µL
M/µL g/dL
% fL pg g/dL
%
K/µL fL
%
10GSD
K/µL
SI pg g/L
%CV g/L fL mL/L
10GSD
Units g/L
T/L g/L
L/L fL
31.5
341
12.5
323
8.26
2.67
17.5
Value
5.32
5.15
162
0.476
92.3
1.96
21.2
12.5
323
8.26
2.67
17.5
SI MOD
Value Units
5.32
10e9/L
5.15
10.1
0.476
92.3
10e12/L mmol/L
L/L fL fmol mmol/L
%CV
10e9/L fL mL/L
10GSD
31.5
341
12.5
323
8.26
0.267
17.5
Value
SET1
Units
5.32
10e3/µL
5.15
162
47.6
92.3
10e6/µL g/L
% fL pg g/L
%CV
10e3/µL fL
%
10GSD
31.5
34.1
12.5
32.3
8.26
0.267
17.5
Value
SET2
Units
53.2
10e2/µL
515.
16.2
47.6
92.3
10e4/µL g/dL
% fL pg g/dL
%
10e4/µL fL
%
10GSD
51.5
g/L 51.5
10e9/L 51.5
10e3/µL 5.15
10e4/µL
* NEU, LYM, MONO, EOS and BASO are reported in the same units as the WBC
** Report Unit is Geometric Standard Deviation
To Change Units Selection
1. From the SET UP 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 4 and 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 SET UP MENU screen.
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Section 5 Operating Instructions
Customize Report
The [CUSTOMIZE REPORT] key is used to customize displayed and/or printed reports. When the [CUSTOMIZE REPORT] key is pressed, the screen that was displayed last will appear (Graphics Printer is the default screen).
Customize Printout
The [CUSTOMIZE PRINTOUT] key is used to customize the printout for the Graphics
Printer and the Ticket Printer. For ease of explanation, the two printer types are discussed individually. Specific instructions are given for customizing a report for the graphics printer, for a blank ticket, and for a pre-printed ticket. 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/
TICKET PRINTER
CUSTOMIZE DISPLAY
STOP PRINTING
CUSTOMIZE HEADER
TOGGLE ON/OFF
SET UP
(The key alternates between the selections.)
When the [CUSTOMIZE PRINTOUT] key is pressed, the screen that was used for the last entry (graphics printer or ticket printer) 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.
When the [TICKET PRINTER] key is pressed, the following soft key label is also displayed:
BLANK TICKET/
PRE-PRNTD TICKET (The key label alternates between the selections.)
The [CUSTOMIZE DISPLAY] key is used to customize the display as discussed in the next 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
The [CANCEL STOP] key cancels 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
Two additional keys are displayed when the [CUSTOMIZE HEADER] key is pressed:
RESTORE HEADER
BLANK HEADER
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.
The [SET UP] key is used to return to the SET UP MENU screen.
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Operating Instructions
Set Up Instructions Section 5
5-48
Figure 5.22 Customize Printed Report Screen for the Graphics Printer
Graphics Printer
When the [GRAPHICS PRINTER] key is pressed, the CUSTOMIZE PRINTED REPORT
screen for the Graphics Printer is displayed. (See Figure 5.22.) A description of the
options available on the CUSTOMIZE PRINTED REPORT screen is given below:
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
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 RBC PROGRAM STATUS
When this option is enabled, the status of the X-B RBC program is printed on the report. The X-B status (for example, X-B RBC: 13/OUT2) is printed below the Status Box.
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Section 5 Operating Instructions
6.
PRINT X-B WBC PROGRAM STATUS
When this option is enabled, the status of the X-B WBC program is printed on the report. The X-B status (for example, X-B WBC: 13/OUT2) is printed below the Status Box.
7.
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 present. Refer to
Principles of Operation ; Subsection:
Flagging for an explanation of the Interpretive Report messages. (Also see
the [PATIENT LIMITS] key discussion earlier in this section.)
8.
PRINT LIMITS REPORT
When this option is enabled, the Patient Limits set that was applied to the results is printed on the report.
9.
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.
10. 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.
11. LINE-FEEDS PER PAGE FOR GRAPHICS PRINTER (1 to 99)
This option is used to select the size of the printed report.
12. COLOR PRINTING
When this option is enabled, a color printout can be obtained on the
CELL-DYN 3200 by pressing the [COLOR PRINT] key.
To Customize the Graphics Report
1. Go to the Graphics Printer set up section of the CUSTOMIZE PRINTED
REPORT
screen (refer to Figure 5.22).
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 any of the ON/OFF selections.
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 8.5" 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 [SET UP] to return to the SET UP MENU screen, or continue with the following procedure for customizing the header.
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Operating Instructions
Set Up Instructions Section 5
5-50
Figure 5.23 Customize Printout Header Screen for the Graphics Report
Customize Header
The [CUSTOMIZE HEADER] key is used to customize the header for the graphics
report. (See Figure 5.23.) 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
SET UP
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.
Blank Header
The [BLANK HEADER] key is used to erase the current header.
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Section 5 Operating Instructions
To Customize the Graphics Header
1. From any CUSTOMIZE PRINTED REPORT screen, press [CUSTOMIZE HEADER] to display the CUSTOMIZE PRINTOUT HEADER screen. Use the Arrow keys to skip a field.
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.
5. In the header box field, type the information to be displayed on the first line of the header. Each line holds 77 characters. Press the Enter key to move to the next header line.
NOTE: The number of lines of data in the header box cannot exceed the number of lines indicated in the first field. For example, if 3 were input in the first field, then a maximum of 3 lines will be accepted in the header box. The operator may type in 4 lines of data, but only the first three lines will be saved when the operator exists this screen. (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. Each line can be positioned independently of the other lines in the header box. Use the Space Bar on the keyboard to position the cursor for typing.
6. Press [SET UP] to return to the SET UP MENU screen.
Ticket Printer
Two options are available when the [TICKET PRINTER] key is pressed:
BLANK TICKET/
PRE-PRNTD TICKET (The key alternates between the selections.)
The [PRE-PRNTD TICKET] key is used to customize the printed report for a pre-printed ticket. The [BLANK TICKET] key is used to customize the printed report for a blank ticket.
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Operating Instructions
Set Up Instructions Section 5
5-52
Figure 5.24 Customize Printed Report Screen for Blank Tickets
Blank Ticket
When the [BLANK TICKET] key is pressed, the CUSTOMIZE PRINTED REPORT screen for blank tickets is displayed. The following options are available:
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 SPECIMENS
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.
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.
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Section 5 Operating Instructions
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 (BANDS, 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.
To Customize a Blank Ticket
1. If the Blank Ticket section of the CUSTOMIZE PRINTED REPORT screen is not displayed, press [BLANK TICKET] .
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 step 3 until all ON/OFF 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 (a maximum of 2 lines) and press the Enter key on the keyboard to save the entry and advance the cursor to the header box field.
8. With the cursor in the header box, 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.
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Operating Instructions
Set Up Instructions Section 5
NOTE: The number of lines of data in the header box cannot exceed the number of lines entered in step 8 above. For example, if 1 were input, then a maximum of 1 line will be accepted in the header box.
The operator may type in 2 lines of data, but only the first line will be saved when the operator exists this screen.
NOTE: The numbers displayed above the header box on the screen indicate the position of the header on the printed page. Each line can be positioned independently. Use the Space Bar on the keyboard to position the cursor for typing.
9. If desired, press the Print Screen key on the keyboard to obtain a printout of the selections.
10. Press [SET UP] to return to the SET UP MENU screen .
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Figure 5.25 Customize Printed Report Screen for Pre-Printed Tickets
Pre-Printed Tickets
When the [PRE-PRNTD TICKET] key is pressed, the CUSTOMIZE PRINTED REPORT
screen is displayed. The numbers on the screen shown in Figure 5.25 correspond
to the following numbered options:
1.
TICKET PRINTER — PRE-PRINTED TICKET
When this option is enabled, the ticket printer is configured for a pre-printed ticket. (The blank ticket option is automatically turned OFF.)
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Section 5 Operating Instructions
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.
To Customize the Pre-Printed Ticket
1. Go to the Ticket Printer - Pre-printed Ticket section of the CUSTOMIZE
PRINTED REPORT screen
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 [SET UP] to return to the SET UP MENU screen.
Customize Displayed Report
Customized displays can be established for each of the four parameter sets. The
CUSTOMIZE DISPLAYED REPORT
screen (see Figure 5.26) for the indicated
parameter set (in this case PARAM SET 1) and the following soft key labels are displayed when the [CUSTOMIZE DISPLAY] key in the CUSTOMIZE PRINTED
REPORT screen is pressed:
PARAM SET 1*
PARAM SET 2*
PARAM SET 3*
PARAM SET 4*
CUSTOMIZE PRINTOUT
CUSTOMIZE HEADER/
CANCEL GRAPH
SELECT GRAPH/
PLACE GRAPH
SET UP
(The key label alternates between the selections.)
(The key label alternates between the selections.)
*The soft key for the displayed parameter set is blanked out.
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Operating Instructions
Set Up Instructions Section 5
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Figure 5.26 Customize Displayed Report Screen
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.
Parameter Sets
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.
The “Empty” selection at the bottom of the Histogram list may be used to “blank” the scatterplot or histogram display at the selected position. Move the cursor to
Empty and press [SELECT GRAPH] . Move the cursor to the desired scatterplot or histogram and press [PLACE GRAPH] .
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Section 5 Operating Instructions
To Customize the Display Screen
1. From the SET UP 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.
NOTE: The [TOGGLE PARAMETER] key is displayed only when the cursor is positioned in the list of individual parameters displayed on the left side of the screen.
5. Repeat steps 3 and 4 until all parameter selections have been made. Use the
Right Arrow key to move the cursor to the next section.
6. Use the Arrow keys to move the cursor to the desired scatterplot or histogram.
7. Press [SELECT GRAPH] to select it. The scatterplot or histogram name is highlighted and the cursor moves to a display position. The key label changes to [PLACE GRAPH] and the [CANCEL GRAPH] key is displayed.
8. If necessary, use the Arrow keys on the keyboard to move the cursor to the desired display position.
9. Press [PLACE GRAPH] to display the selection at the indicated position. The cursor moves to the next scatterplot or histogram in the list.
10. Repeat steps 6 through 9 until all selections have been made for the current
Parameter Set.
11. If desired, press the Print Screen key on the keyboard to obtain a printout of the selected Parameter Set.
12. Press [PARAM SET “X”] to select another Parameter set and repeat steps 3 through 11 to customize the display for it.
13. Press [SET UP] to return to the SET UP MENU screen.
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Operating Instructions
Set Up Instructions Section 5
Interpretive Report Messages
If the
PRINT INTERPRETIVE REPORT
option on the CUSTOMIZE PRINTED
REPORT screen for the Graphics Printer is enabled, Interpretive Report messages are printed on the report. Some of these messages are generated from the information entered for the Patient Limits. The following messages are generated by specimen results which exceed the Patient Limits:
WBC Messages
Leukopenia — result exceeds the lower limit for WBC
Leukocytosis — result exceeds the upper limit for WBC
Neutropenia — result exceeds the lower limit for Neutrophil absolute number
Neutrophilia — result exceeds the upper limit for Neutrophil absolute number
Lymphopenia — result exceeds the lower limit for Lymphocyte absolute number
Lymphocytosis — result exceeds the upper limit for Lymphocyte absolute number
Monocytosis — result exceeds the upper limit for Monocyte absolute number
Eosinophilia — result exceeds the upper limit for Eosinophil absolute number
Basophilia — result exceeds the upper limit for Basophil absolute number
RBC Messages
Anemia — result exceeds the lower limit for RBCs
Polycythemia — result exceeds the upper limit for RBCs
Microcytic RBC — result exceeds the lower limit for MCV
Macrocytic RBC — result exceeds the upper limit for MCV
Hypochromic — result exceeds the lower limit for MCHC
Hyperchromic — result exceeds the upper limit for MCHC
Anisocytosis — result exceeds the upper limit for RDW
PLT Messages
Thrombocytopenia —result exceeds the lower limit for PLTs
Thrombocytosis —result exceeds the upper limit for PLTs
Microcytic PLT —result exceeds the lower limit for MPV
Macrocytic PLT —result exceeds the upper limit for MPV
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Section 5 Operating Instructions
Routine Operation
General Information
This subsection contains information and procedures that are recommended for the routine operation of the CELL-DYN 3200.
The following topics are included in this subsection:
Instrument Start-up
RUN menu
Sample Collection and Handling
Sample Analysis on the CELL-DYN 3200 SL
Sample Analysis on the CELL-DYN 3200 CS
Daily Shutdown Procedure
Unless stated otherwise, all subsections apply to both the Sample Loader and
Closed Sampler versions of the CELL-DYN 3200. For convenience, instructions for running samples in the Open Mode are repeated in each of the two Running Samples subsections. Refer to
for additional information on
Sample Loader operation and to Appendix A for information on the use of bar code labels.
Power ON Procedure
The System power switch on the back of the Analyzer 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 four hours, an automatic Shutdown cycle is initiated.
The instrument is placed in the
STANDBY
state at the end of the automatic Shutdown cycle.
Power switches for the Display Monitor and printer should be left ON as long as power to the System is ON. Power to the monitor and printer should be turned OFF when the System is turned OFF, when a malfunction is suspected, or when maintenance is required.
Power to the Printer may be left on or off at the operator’s discretion. Refer to
Section 12: Printers for complete instructions on printer operation.
IMPORTANT: If the power has been OFF more than five minutes, the laser must be allowed to warm up for 15 minutes once the power is turned back
ON. Do not process samples during this warm-up period.
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Operating Instructions
Routine Operation Section 5
To power-up the instrument:
1. Verify that all components are properly installed (syringes, tubing in the normally closed valves, 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, including the Tower
Cover.
5. If a condition caused power to the instrument to be turned OFF, verify that the condition has been corrected.
6. Turn the power switches ON in the following order: a. System (includes Analyzer, Data Module, and Sample Loader) b. Display Monitor c. Printer
7. When the
INITIALIZED
message appears in the Status Box on the MAIN
MENU , press [RUN] to prime the system.
Initializing the System
The term initialization refers to the automatic process that occurs when the instrument is first turned ON, or after certain problems have been corrected and the instrument must again be brought to the READY state. Initialization is a two-step process:
1. Initializing the hardware and software
2. Priming the system with reagents
The system is initialized when the Analyzer is turned ON or when the
[INITIALIZATION] key, located in the second DIAGNOSTICS MENU , is pressed. During the initialization process, the software located in the Data Module is accessed and downloaded to the Analyzer. When this has been accomplished, all Analyzer pumps and motors are moved to their “home” positions. (Increase motor noise is common during this period.) When the system has been initialized, the message
INITIALIZED
is displayed in the Status Box.
The next step is to prime the system with reagents. When the initialized message appears in the Status Box on the MAIN MENU , press [RUN] to prime the system.
When the priming cycle is finished, the message
READY
is displayed in the Status
Box.
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Section 5 Operating Instructions
Operating the Instrument
Activating The RUN Cycle
On the CS model, start the RUN cycle for either the Open or Closed Mode by pressing the Touch Plate.
NOTE: The door Assembly must be closed for the Closed Mode RUN cycle to be activated.
On the SL model, Start the RUN cycle for Open Mode by pressing the Touch Plate.
Start the RUN cycle for Closed Mode by pressing the [START LOADER] key in the
RUN menu. For additional information, refer to Sample Loader Description, Soft
Keys in
.
Orderly Stops
The CS model, whether in Open or Closed Mode, automatically halts after each sample has been processed unless the Touch Plate is pressed again to start a new
RUN cycle.
The SL model in Open Mode automatically halts after each sample has been processed unless the Touch Plate is pressed again to start a new RUN cycle.
The SL model in Closed Mode automatically halts when no more racks are detected on the load side and the last track has passed under the Tower to the Unload side.
Emergency Stops
To immediately halt all operation of the instrument, do one of the following:
1. Turn OFF the main power switch, located in the upper left corner of the back panel.
2. Push the window section of the Tower Cover toward the instrument to release the latches and break the safety interlock sensor connection. As soon as the connection is broken, the instrument halts. It is not necessary to remove the
Tower Cover to stop operations. This method applies to both CS and SL models. In addition, the CS model has a safety interlock sensor attached to the swivel door mechanism which holds the sample tube.
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Operating Instructions
Routine Operation Section 5
Power OFF Procedure
It is not necessary to turn the system OFF under normal operating conditions. The system should be turned OFF when certain maintenance procedures will be performed, when the system will be moved, or when the system will be inactive for an extended period of time (longer than 2 weeks).
For Maintenance
When certain tests or maintenance procedures require power to be OFF, use the following procedure:
1. With the system still ON, perform any maintenance that is due.
2. Perform the Auto-Clean procedure in the SPECIAL PROTOCOLS menu. (If necessary, refer to
Section 9: Service and Maintenance
;
3. When the Auto-Clean cycle is finished, press [DAILY SHUTDOWN] . When the
Daily Shutdown cycle is finished, the message
STANDBY
will be displayed in the Status Box.
4. Turn the power switches OFF in the following order: a. System (includes Analyzer, Data Module, and Sample Loader) b. Display Monitor c. Printer
NOTE: In an emergency situation, turn power OFF in any order as quickly as possible.
For Extended Period
Additional procedures are required if the instrument will be inactive for an extended period of time (more than 2 weeks), moved to a different location in the lab, or shipped to a distant location. For detailed instructions, refer to
Intermediate-term Shutdown and Prolonged Shutdown later in this section.
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Section 5 Operating Instructions
Start-Up Procedure
To startup the instrument, do the following:
1. If the instrument is OFF, first turn the power ON. When
INITIALIZED
is displayed in the MAIN MENU Status Box, press [RUN] to prime the instrument and bring it to the READY state.
2. If the instrument is already ON and
STANDBY
or
INITIALIZED
is displayed in the MAIN MENU Status Box, press [RUN] to prime the instrument and bring it to the READY state.
3. Perform the daily Quality Control checks as directed within this section.
Daily Start-Up Procedure
The daily start-up routine consists of the following procedures:
1. Check the reagent levels and replace reagent containers as necessary.
2. Check printer paper; add more paper as necessary.
3. Check tubing in the Normally Closed Valves and Sample Transfer Peristaltic
Pump for breaks, crimps, or other obstructions.
4. Run background counts until acceptable results are obtained for all background parameters (WBC, RBC, HGB, and PLT). Acceptable results are specified in
Section 4: Performance Characteristics and Specifications ;
.
5. Quality control procedures (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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Operating Instructions
Start-Up Procedure
NOTES
Section 5
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Section 5 Operating Instructions
Run Menu
The RUN menu and its sub-menus are described below, including soft keys, demographics area, Work List, and bulletin line.
To display the RUN menu, press [RUN] in the MAIN MENU . If the instrument has not been primed, the priming cycle occurs before the RUN menu is displayed.
RUN Screen Format
Upper Left Corner (Run Screen Demographics)
The Demographics Section of the RUN screen differs depending on the specimen type selected. These differences are discussed below.
Patient
The Upper Left Corner of the RUN screen for patient samples displays the following data entry fields:
NEXT ID— used to enter the ID number for the next sample to be run. (Up to 12 characters may be entered.)
NAME— used to enter the patient’s name. (Up to 28 characters may be entered.)
PAT ID— used to enter patient identification information, such as a Social Security number. (Up to 16 characters may be entered.)
SEX— used to enter the sex of the patient.
DOB— used to enter the date of birth of the patient. (4 digits must be entered for the
Year.)
COL— used to enter the collection date and time of the specimen.(4 digits must be entered for the Year.)
DR— used to enter the name of the patient’s physician. (Up to 22 characters may be entered.)
CMT— used to enter operator comments. (Up to 16 characters may be entered.)
PARAM SET/LIMITS SET— displays the number of the Parameter Set (1–4) and
Limit Set (1-6) that will be applied to the sample results
X-B Status—
If the XB-RBC and/or the XB-WBC functions are enabled, the XB file status for each is displayed under the Status Box.
NOTE: The Parameter and Limits 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 later in this section.
An example of the RUN
screen for patient specimens is shown in Figure 5.27.
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Operating Instructions
Run Menu Section 5
Fragile WBC and Resistant RBC
If the specimen type selected is FRAGILE WBC, then the label “FrgWBC” appears instead of “Name” in the Demographics Section. If the specimen type selected is
RESISTANT RBC, then the label “ResRBC” appears instead of “Name” in the
Demographics Section.
QC Specimen, Background, Latex
If the specimen type selected is 4&63(&,0(1 , %$&.*5281' or /$7(; the following information is displayed in the Demographics Section:
Type— displays the name of the QC file or displays Background or Latex. For a QC file, the number of runs in the QC file and total file space is displayed to the right of the type as in the following example:
XX/120current number of specimens in a batch of 120 (applies only to QC
Specimens).
Param Set:— indicates the Parameter Set applied to the results run in the QC file.
For BACKGROUND and LATEX, the default Param Set is 1.
Status Box
The Status Box is displayed in the Top Center of the 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 Status Box also displays status and instructive messages during the run cycle.
These messages are:
Aspirating
Remove specimen
Dispensing
Counting
Rinsing
Ready
Upper Right Corner
The Upper Right Corner of the RUN screen displays the following information:
• Current date and time
• Operator ID — Identification of the current operator
• Sequence # — Automatically increments as cycles are run
• Selected Sampler mode — Open Sampler or Closed Sampler
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Section 5 Operating Instructions
Center Section
The Center Section of the 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.
Bulletin Line
The Bulletin Line is displayed immediately above the key labels. Messages appear in this line to identify status or fault conditions.
Run Menu Soft Keys
CS Model
Figure 5.27 Run Screen for Patient Samples - CS Model
The soft keys displayed at the bottom of the RUN menu are used to access the menu options that are available. The soft keys displayed on the SL model are slightly different from the keys displayed on the CS model. The keys shown on the CS
model are listed below. (See Figure 5.27.)
(This key label is blank unless a Fault occurs.) CLEAR FAULT
WORK LIST
SPECIMEN TYPE
CUSTOMIZE REPORT
CHANGE SAMPLER
PRINT TICKET
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Operating Instructions
Run Menu
PRINT REPORT/
COLOR PRINT
MAIN
SL Model
Section 5
(This key label changes to &2/2535,17 when the color printing option is selected in the
&86720,=('35,17('5(3257 screen for the Graphics Printer)
Figure 5.28 Run Screen for Patient Samples - SL Model
The soft keys shown on the SL model are similar to the CS model except for the first key (leftmost key label on the screen) in Closed Mode, shown below, which is
used to operate the Sample Loader. (See Figure 5.28.)
START LOADER/
STOP LOADER (This key label alternates between the selections)
If a fault occurs, this key label changes to [CLEAR FAULT] similar to the CS model.
Soft Key Description
A brief description of the function of each key is given below. Instructions for running samples are given in Sample Analysis on the CELL-DYN 3200CS and
Sample Analysis on the CELL-DYN 3200SL in this section.
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Section 5
Clear Fault
Work List
Operating Instructions
The blank key label in the CS model or the [START/STOP LOADER] key label in the
SL model 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 state 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
Section 10: Troubleshooting and Diagnostics
.
This key is used to display the WORK LIST screen, shown in Figures 5.29 and 5.30.
Use the left and right arrow keys to scroll between the pages. When the [WORK
LIST] key is pressed, the WORK LIST screen appears and the following soft key labels are displayed:
INSERT/DELETE
DELETE ALL
WORK LIST SET UP
PRINT WORK LIST
RETURN
Figure 5.29 Work List Screen - Page 1
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Operating Instructions
Run Menu Section 5
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Figure 5.30 Work List Screen - Page 2
The Work List is used to pre-assign 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. However, if bar codes are used on the tubes, they must contain more than two digits to avoid a possible mis-reading of the 2-digit bar code assigned to each rack.
For a detailed discussion of the Work List, refer to Using the Work List later in this section.
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Section 5
Specimen Type
Operating Instructions
Figure 5.31 Specimen Type Screen
The [SPECIMEN TYPE] key is used to select the type of specimen that will be run.
[SPECIMEN TYPE] key is pressed, the screen displays a list of the QC files and the following soft key labels:
PATIENT
QC SPECIMEN
BACKGROUND
FRAGILE WBC
LATEX
RESISTANT RBC
RETURN
The function of each key is discussed below.
Selecting a Specimen Type
Most samples will be run in the Patient mode. If a FWBC or RRBC flag is displayed on the 581 screen, the presence of fragile WBCs or resistant RBCs is suspected. Depending on the flag, select either Fragile WBC or Resistant RBC as the Specimen Type and re-run the sample.
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Operating Instructions
Run Menu
Patient
Section 5
Figure 5.32 Run Screen Showing Patient Results
The [PATIENT] key is used to display the RUN screen for patient samples. (See
Figure 5.32.) 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.
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Section 5
QC Specimen
Operating Instructions
Figure 5.33 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. (Refer to Figure 5.31 for a display of QC files). After the cursor is moved to
the desired file, the [QC SPECIMEN] key is pressed to display the 581 screen for the
selected file. (Refer to Figure 5.33.) Results from this run option are stored in the
selected file and in the Data Log.
NOTE: The selected QC file is identified in the upper left section of the screen and is also identified in the Status Box after the sample has been run.
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Operating Instructions
Run Menu
Background
Section 5
Figure 5.34 Run Screen for Background Counts
The [BACKGROUND] key is used to select the run mode and display the RUN screen
for background counts. (Refer to Figure 5.34.) Results from this run option are
identified by the designation %$&.*5281' in the Data Log and are automatically excluded from the X-B analysis.
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Section 5
Fragile WBC
Operating Instructions
Figure 5.35 Run Screen for Fragile WBC Counts
The [FRAGILE WBC] key is used to select the Fragile WBC specimen type. This cycle is used to obtain an accurate WBC count for samples containing fragile
WBCs. After HGB has been measured, the diluted HGB sample is sent to the
Optical Flow Cell (instead of the Waste System) where the nuclei of the lysed white cells are counted. This count is referred to as the Nuclear Optical Count (NOC).
The Fragile WBC screen (refer to Figure 5.35) is similar to the Patient screen
except that “FrgWBC” replaces “Name” in the Demographics Section.
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Operating Instructions
Run Menu
Latex
Section 5
5-76
Figure 5.36 Run Screen for Latex Counts
The [LATEX] key is used to select the run mode for latex particles and display the
RUN screen for them. The LATEX screen is similar to the QC FILE screen, except that
“Latex” replaces the QC File name in the Demographics Section.
This key is for use by Abbott service personnel only.
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Section 5
Resistant RBC
Operating Instructions
Figure 5.37 Run Screen for Resistant RBC Counts
The [RESISTANT RBC] key is used to select the Resistant RBC specimen type. This cycle is used to process samples containing RBCs that are resistant to lysis. 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 WBC lyse and reduces interference from the lyse-resistant RBCs. (The interference caused by these RBCs frequently generates WBC and Differential flags. The Resistant RBC mode reduces the number of flags generated.)
The RESISTANT RBC
screen (refer to Figure 5.37) is similar to the Patient screen
except that “ResRBC” replaces “Name” in the Demographics Section.
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Operating Instructions
Run Menu
Customize Report
Section 5
The [CUSTOMIZE REPORT] key is discussed in the Set Up Instructions earlier in this section.
Change Sampler
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 one of the two following messages:
SELECTING OPEN MODE
SELECTING CLOSED MODE
Prior to running a sample, if the [CHANGE SAMPLER] key is pressed, it will automatically clear any patient information entered in the demographics section of the RUN screen.
Print Ticket
The [PRINT TICKET] key is used to print a report on a ticket when a printer is connected to the Ticket Printer Port on the Data Module. The report is printed on the type of ticket that is selected from the CUSTOMIZE PRINTED REPORT screen.
Print Report
The [PRINT REPORT] key is used to print a graphics report when printer is connected to the Graphics Printer Port on the Data Module. When the color printing option on the CUSTOMIZE PRINTED REPORT screen is ON, the key label changes to [COLOR PRINT] . A color graphics report is printed when the [COLOR
PRINT] key is pressed and the printer connected to the Graphics Printer Port is a color printer.
Main
The [MAIN] key is used to return to the MAIN MENU screen.
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Section 5 Operating Instructions
Additional Examples of Run Menu Screens
Flagging Messages
An example of some flagging messages is shown in Figure 5.38.
A detailed explanation of all flagging messages is given in
Section 3: Principles of Operation
.
Figure 5.38 Display Specimen Screen Showing Flagging Messages and RBC
MORPH Message
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Operating Instructions
Run Menu Section 5
Bulletin Line Messages
Bulletin Line messages alert the operator to problems with the instrument or provide instructions. An example of a Bulletin Line message reading “Ticket
printer unavailable” is shown in Figure 5.39.
Figure 5.39 Display Specimen Screen Showing Bulletin Line Message
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Section 5 Operating Instructions
Laboratory Worksheet
To display the LABORATORY WORKSHEET screen, press the Page Down key on the keyboard while the RUN menu is displayed or while the DISPLAY SPECIMEN screen in the DATA LOG menu is displayed.
The LABORATORY WORKSHEET screen displays additional parameters as shown in
Figure 5.40. This screen is for laboratory use only.
Figure 5.40 Laboratory Worksheet Screen
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Run Menu
NOTES
Section 5
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Section 5 Operating Instructions
Sample Collection and Handling
Anticoagulant
All performance claims given in this manual were generated from samples collected in K
3
EDTA.
Sample Stability
Any refrigerator-stored specimens should be brought to room temperature before processing. If specimens are to be run within eight hours after collection, storage at room temperature is recommended. If specimens are to be run more than eight hours after collection, storage at temperatures between 2° and 8° C is recommended.
Stability studies show that, when specimens are refrigerated at temperatures between 2° and 8° C, and brought to room temperature before mixing and processing, results for the RBC, HGB, MCV, PLT are stable (±5%) for up to 36 hours after collection. The total WBC and MPV is stable (±5%) for up to 24 hours after collection. The stability of the total WBC decreases to ±10% at 36 hours after collection. An increase in false-positive Suspect Population Flags may be seen on samples processed less than 30 minutes or more than 4 hours after collection time.
The stability of capillary samples collected in microtainers may vary depending on the microtainer manufacturer. Refer to the manufacturer’s package insert for stability claims.
Sample Collection
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 .
WARNING: Potential Biohazard. Consider all specimens, reagents, controls, calibrators, etc., that contain human blood or serum as potentially infectious. Wear gloves, lab coats, and safety glasses, and follow other biosafety practices as specified in the OSHA Bloodborne Pathogen Rule
(29 CFR Part 1910.1030) or other equivalent biosafety procedures.
Samples that will be run on the Sample Loader must have a minimum volume of
1.5 mL to ensure proper mixing by the Sample Loader.
Samples that will be run on the Closed Sampler model must have a minimum volume of 1.5 mL to ensure proper sampling.
A minimum of 180 µL should be collected for capillary samples. This ensures an adequate amount of blood for the Open Mode (150 µL) aspiration.
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Sample Collection and Handling Section 5
Interfering Substances
The CELL-DYN 3200 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), lytic-resistant 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
Section 3: Principles of Operation ;
Subsection: Operational Messages and Data Flagging
.
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Section 5 Operating Instructions
Preparing to Run Samples
Before running specimens, the operator should enter data in the demographics section of the RUN screen to properly identify patient samples.
Operator ID
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 MENU or the CALIBRATION menu.
When either menu 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
Sample identification information is entered in the upper left corner of the RUN screen. These entry fields are made available when the Patient, Fragile WBC, or
Resistant RBC specimen types are selected. To select one of these three specimen types, do the following:
1. Go to the RUN menu and press [SPECIMEN TYPE]
2. Press one of the following keys to select the desired specimen type —
[PATIENT] , [FRAGILE WBC] , [RESISTANT RBC] .
Enter the sample identification information as follows:
1. A Sample ID number (Next ID field) of up to 12 characters may be entered in the NEXT ID entry field.
2. The remaining patient demographic information may be entered at the operator’s discretion. Refer to Run Screen for Patient Samples earlier in this section for a discussion of these fields.
3. Parameter Set 1 and Patient Limits Set 1 are the default settings when the instrument is shipped from the factory. The results are displayed and printed using these settings unless the operator changes these entry fields. New parameter and/or limits sets can be entered anytime before a sample is run or after the results of a sample run are 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. For complete instructions, refer to Using the Data Log later in this section.
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Preparing to Run Samples
Sample Mixing
Section 5
Proper mixing of specimens prior to sample aspiration is essential for obtaining accurate results on the CELL-DYN 3200 System. For control or calibrator mixing instructions, refer to the manufacturer’s product insert.
Specimens stored at refrigerator temperatures must be brought to room temperature prior to mixing.
Specimens to be run in the Closed mode (CS Model) or Open mode must be well mixed on a mechanical mixer or hand mixed by inversion per your laboratory’s protocol. Immediately prior to sample aspiration, mix again by inverting the tube a minimum of 5 times.
For specimens collected in micro-collection devices, refer to the manufacturer’s insert for proper mixing and handling.
WARNING: Potential Biohazard. Consider all specimens, reagents, controls, calibrators, etc., that contain human blood or serum as potentially infectious. Wear gloves, lab coats, and safety glasses, and follow other biosafety practices as specified in the OSHA Bloodborne Pathogen Rule
(29 CFR Part 1910.1030) or other equivalent biosafety procedures.
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Section 5 Operating Instructions
Sample Analysis on the CELL-DYN 3200SL
Introduction
This section explains how samples are run on the CELL-DYN 3200SL model in both Open and Closed Modes. Samples should not be run until daily QC checks have been performed and the instrument is in the READY state. 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
RUN screen.
For Open Mode only, when specimens have not been run for one hour or more, a background should be run immediately prior to running a patient specimen.
Samples should be well mixed (a mechanical mixer is preferred 3 ) before they are run in the Open Mode on the instrument. For specimens collected in microcollection devices, refer to the manufacturer’s instructions for proper mixing and handling instructions.
The Sample Loader automatically mixes the samples immediately before aspiration.
Instrument Preparation
1. Be sure that the green READY light on the Analyzer Status Indicator Panel is illuminated and the
READY
message is displayed in the Status Box on the
581 screen.
2. If the Status Box on the Data Station RUN screen displays
STANDBY
or
INITIALIZED
press [RUN] to initiate the automatic Start Up cycle.
3. When the automatic Start Up cycle is completed, 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.
NOTE: Backgrounds may be repeated by pressing the Touch Plate.
5. If the Sample Loader is to be used, be sure that at least one rack (maximum of five) is in the load area to the right of the Tower Cover and that the Tower
Cover is in place.
6. To switch from Open Mode to Closed Mode, press the [CHANGE SAMPLER] key. Wait until the message
READY
is displayed in the Status Box.
7. Perform the daily Quality Control checks as directed in
Analysis on the CELL-DYN 3200SL .
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Sample Analysis on the CELL-DYN 3200SL Section 5
Sample Loader Operating Tips
1. All Sample Loader tubing must be connected before turning ON the System.
2. All samples must be properly mixed before they are placed in the Sample
Loader racks.
3. Place the labeled tubes in the Sample Loader rack and load the rack on the
Sample Loader.
4. 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
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.
WARNING: Potential Biohazard. Consider all specimens and reagents, controls, calibrators, etc., that contain human blood or serum as potentially infectious. Wear gloves, lab coats, and safety glasses, and follow other biosafety practices as specified in the OSHA Bloodborne Pathogen Rule
(29 CFR Part 1910.1030) or other equivalent biosafety procedures.
Open Mode QC Procedure
1. In 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 subsection following this procedure for complete instructions on running samples.
5. Verify that the results are acceptable.
NOTE: Out-of-range 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 as directed in
Section 10: Troubleshooting and
; Subsection: Troubleshooting Guide .
7. When the control results are acceptable, patient samples may be analyzed.
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Section 5 Operating Instructions
Closed Mode QC Procedure
The operator must manually stop the Sample Loader as directed in this procedure when different levels of controls are run.
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 Closed Mode.
4. Place the controls in the Sample Loader rack in the order in which they are to be run.
5. Be sure the Tower Cover is in place and press the [START LOADER] key.
6. After the first control is aspirated, press the [STOP LOADER] key.
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 LOADER] key.
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 [QUALITY
CONTROL] .
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 screen.
14. Verify that the results are acceptable.
NOTE: Out-of-range results are displayed in color.
15. Press [RETURN] to return to the main QUALITY CONTROL screen.
16. Repeat steps 12–15 for all levels of controls that were run.
17. 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 as directed in
Section 10: Troubleshooting and
; Subsection: Troubleshooting Guide .
18. When the control results are acceptable, patient samples may be analyzed.
Running Samples
WARNING: Potential Biohazard. Consider all specimens and reagents, controls, calibrators, etc., that contain human blood or serum as potentially infectious. Wear gloves, lab coats, and safety glasses, and follow other biosafety practices as specified in the OSHA Bloodborne Pathogen Rule
(29 CFR Part 1910.1030) or other equivalent biosafety procedures.
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Sample Analysis on the CELL-DYN 3200SL Section 5
Open Mode Analysis
The Open Sampler mode aspirates the sample from an open collection tube.
OPEN
SAMPLER
is displayed in the upper right corner of the RUN screen when this mode is selected. The open sample aspiration probe is available (Wash Block raised) 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 green READY light on the Analyzer Status Indicator Panel is illuminated and
READY
is displayed in the Status Box on the 581 screen.
3. With the stopper still in the tube, mix the sample well (invert the tube a minimum of 5 times to thoroughly mix the sample).
4. Open the sample tube and place it under the Open Sample Aspiration Probe.
Raise the tube until the end of the probe is deeply immersed in the sample.
CAUTION: Do not let the probe touch the bottom of the sample tube. It may affect aspiration and produce erroneous results.
5. Press the Touch Plate located behind the probe to start the cycle. The yellow
BUSY light on the Analyzer Status Indicator Panel is illuminated. The Status
Box on the 581 screen displays messages to indicate the various stages of the cycle.
6. Remove the tube when the beep sounds. The message
REMOVE SPECIMEN is displayed in the Status Box. The wash block moves down the probe and cleans it.
7. When the cycle is finished, the wash block moves up the probe, the green
READY light on the Analyzer Status Indicator Panel is illuminated, and the results are displayed on the 581 screen.
NOTE: Another sample may be aspirated at this point even though
READY is not displayed in the Status Box on the screen. Generally, the
READY light on the Analyzer Status Indicator Panel will be illuminated before the Status Box on the screen displays
READY
.
8. If automatic report printing has been specified, a report is printed according to the options selected during Set Up. If the Color Printing option was selected in the CUSTOMIZED PRINTED REPORT screen for the Graphics
Printer, the printouts will be in color. Otherwise, the reports will be printed in black and white.
9. If automatic printing has not been specified, a report may be printed by pressing either [PRINT REPORT] RU [COLOR PRINT] . The [COLOR PRINT] key will be displayed if the Color Printing option was selected.
10. Repeat this procedure for subsequent samples.
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Section 5 Operating Instructions
Closed Mode Analysis
The Closed Sampler mode on CELL-DYN 3200SL models 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 RUN screen when this mode is selected. The wash block moves down to the end of the open sample aspiration probe when this mode is selected.
Closed Mode Procedure
1. If necessary, in the RUN screen press [CHANGE SAMPLER] to select the Closed
Mode.
2. Be sure that the green READY light on the Analyzer Status Indicator Panel is illuminated and
READY
is displayed in the Status Box on the RUN screen.
3. Place the well mixed samples in the Sample Loader racks.
NOTE: The racks and tube positions are identified by the bar code label on the rack and indicated as RxTx. 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 Using the
Work List later in this section for more information.)
4. Place the racks in the Sample Loader to the right of the Tower Cover with the slotted side (with bar code labels) facing the operator.
5. Verify the Tower Cover is in place.
NOTE: The Sample Loader will not operate without the Tower Cover in place.
6. Press the [START LOADER] key on the RUN screen.
7. The Sample Loader automatically processes all the samples. Processing stops when the last rack is finished or the [STOP LOADER] key is pressed. The last rack is finished when it has moved completely to the unload side of the
Sample Loader.
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Sample Analysis on the CELL-DYN 3200SL
NOTES
Section 5
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Section 5 Operating Instructions
Sample Analysis on the CELL-DYN 3200CS
Introduction
This section explains how samples are run on the CELL-DYN 3200CS models, both Open and Closed Modes. Samples should not be run until daily QC checks have been performed and the instrument is in the READY state. 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 RUN screen. Samples should be well mixed (a mechanical mixer is preferred 3 ) before they are run in the Open or Closed Mode on the instrument.
Instrument Preparation
1. Be sure that the green READY light on the Analyzer Status Indicator Panel is illuminated.
2. If the Status Box on the RUN screen displays
STANDBY
or
INITIALIZED
, press [RUN] to initiate the automatic Start Up cycle.
3. When the cycle is finished, 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.
NOTE: Backgrounds may be repeated by pressing the touch plate.
5. If controls will be processed in Closed Mode, press [CHANGE SAMPLER] .
6. 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.
WARNING: Potential Biohazard. Consider all specimens and reagents, controls, calibrators, etc., that contain human blood or serum as potentially infectious. Wear gloves, lab coats, and safety glasses, and follow other biosafety practices as specified in the OSHA Bloodborne Pathogen Rule
(29 CFR Part 1910.1030) or other equivalent biosafety procedures.
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QC (Open or Closed Mode) Procedure
1. In 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 desired mode.
4. Run the control.
NOTE: Refer to the Running Samples subsection following this procedure for complete instructions on running samples.
5. Verify that the results are acceptable.
NOTE: Out-of-range 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 as directed in
Section 10: Troubleshooting and
; Subsection: Troubleshooting Guide .
7. When the control results are acceptable, patient samples may be analyzed.
Running Samples
WARNING: Potential Biohazard. Consider all specimens and reagents, controls, calibrators, etc., that contain human blood or serum as potentially infectious. Wear gloves, lab coats, and safety glasses, and follow other biosafety practices as specified in the OSHA Bloodborne Pathogen Rule
(29 CFR Part 1910.1030) or other equivalent biosafety procedures.
Open Mode Analysis
The Open Sampler mode aspirates the sample from an open collection tube.
OPEN
SAMPLER
is displayed in the upper right corner of the 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, in the RUN screen press [CHANGE SAMPLER] to select the Open
Mode.
2. Be sure that the green READY light on the Analyzer Status Indicator Panel is illuminated and
READY
is displayed in the Status Box on the RUN screen.
3. With the stopper still in the tube, mix the sample well (invert the tube a minimum of 5 times to thoroughly mix the sample).
4. Open the sample tube and place it under the Open Sample Aspiration Probe.
Raise the tube until the end of the probe is deeply immersed in the sample.
NOTE: Do not let the probe touch the bottom of the sample tube. It may affect aspiration and produce erroneous results.
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Section 5 Operating Instructions
5. Press the Touch Plate located behind the probe to start the cycle. The yellow
BUSY light on the Analyzer Status Indicator Panel is illuminated. The Status
Box on the RUN screen displays messages to indicate the various stages of the cycle.
6. Remove the tube when the beep sounds. The message
REMOVE SPECIMEN is displayed in the Status Box. The wash block moves down the probe and cleans it.
7. When the cycle is finished, the wash block moves up the probe, the green
READY light on the Analyzer Status Indicator Panel is illuminated, and the results are displayed on the RUN screen.
NOTE: Another sample may be aspirated at this point even though
READY is not displayed in the Status Box on the screen. Generally, the
READY light on the Analyzer Status Indicator Panel will be illuminated before the Status Box on the screen displays
READY
.
8. If automatic report printing has been specified, a report is printed according to the options selected during Set Up. The reports are printed in black and white. If automatic printing has not been specified, a report may be printed by pressing [PRINT REPORT] .
NOTE: To obtain a color printout, press [COLOR PRINT] . (The color printing option on the CUSTOMIZE PRINTED REPORT screen must be ON.)
9. 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 Sample
Tower Module.
CLOSED SAMPLER
is displayed in the upper right corner of the
581 screen when this mode is selected. The wash block moves down to the end of the Open Sample Aspiration Probe when this mode is selected.
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Sample Analysis on the CELL-DYN 3200CS Section 5
Closed Mode Procedure
1. Be sure that the green READY light on the Analyzer Status Indicator Panel is illuminated and
READY
is displayed in the Status Box on the RUN screen.
2. If necessary, in the 581 screen press [CHANGE SAMPLER] to select the
Closed Mode.
3. With the stopper still in the tube, mix the sample well (invert the tube a minimum of 5 times to thoroughly mix the sample).
4. Place the well-mixed sample, with the stopper facing up, into the Tube
Holder and push the door closed.
NOTE: The Touch Plate will not operate if the door has not been closed.
5. Press the Touch Plate located behind the probe to start the cycle. The yellow
BUSY light on the Analyzer Status Indicator Panel is illuminated.
6. Remove the tube when the door opens. A beep sounds when the door opens.
NOTE: The door automatically opens whenever a sample has been aspirated in the Closed Mode or a background count has been run in Open Mode. There is also a tab under the Door Assembly that mechanically releases the door. This tab can be used if the door is closed and no tube is in the holder. The door will not open if the needle is in the tube. In case of an emergency stop, the operator will have to remove the Tower Cover and manually raise the needle out of the sample.
7. When the cycle is finished, the green READY light on the Analyzer Status
Indicator Panel is illuminated and the results are displayed on the RUN screen.
NOTE: Another sample may be aspirated at this point even though
READY is not displayed in the Status Box on the screen. Generally, the
READY light on the Analyzer Status Indicator Panel will be illuminated before the Status Box on the screen displays
READY
.
8. Repeat this procedure for subsequent samples.
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Section 5 Operating Instructions
Alerts and Indicators
This subsection describes information displayed on the screen as the samples are analyzed and/or when reports are printed. This subsection does not discuss how to interpret parameter flags, which are displayed after the sample is run. Refer to
Section 3: Principles of Operation
; Subsection: Operational Messages and Data
.
Out of Range
Fault Conditions
The [CLEAR FAULT] key is displayed and a message (e.g.,
DILUENT EMPTY
) appears in the Status Box 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.
After the problem has been corrected, press [CLEAR FAULT] to resume operation.
Flow Errors
• 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 purple 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 pre-printed ticket.
• Results that exceed a parameter’s linear range are indicated by >>>> in place of the result.
If a RBC Flow Error occurs, results are suppressed for the RBC/PLT parameters and the
RBC FLOW ERROR
message is displayed on the Bulletin line. The RBC/
PLT scatterplots are suppressed.
If a WOC Flow Error occurs, results are suppressed for the WBC and Differential and the
WOC FLOW ERROR
message is displayed on the Bulletin line. The WBC scatterplots are suppressed.
If a NOC Flow Error occurs, results are suppressed for the WBC and Differential and the
NOC FLOW ERROR
message is displayed on the Bulletin line. The NOC scatterplots are suppressed.
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3 Consecutive Flow Errors
If the Sample Loader is being used and the instrument detects one of the following:
1. Three consecutive RBC flow errors.
2. Three consecutive WOC flow errors.
3. Three consecutive NOC flow errors.
The Sample Loader halts at the end of the cycle and the Bulletin line displays the appropriate message:
1.
3 CONSECUTIVE RBC FLOW ERRORS.
2.
3 CONSECUTIVE WOC FLOW ERRORS.
3.
3 CONSECUTIVE NOC FLOW ERRORS.
Sampling Errors
The message
SAMPLING ERROR-INCOMPLETE ASPIRATION
is displayed on the Bulletin line if insufficient sample was detected during aspiration.
SAMPLING
ERR
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 pre-printed ticket and printed above the list of parameters on the blank ticket.
3 Consecutive Sampling Errors
If the Sample Loader is being used and the Instrument detects three consecutive incomplete aspirations, the Sample Loader halts at the end of the cycle and the
Bulletin line displays the message
3 CONSECUTIVE INCOMPLETE ASPIRATIONS.
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Section 5 Operating Instructions
Daily Shutdown Procedure
Daily Shutdown
The Daily Shutdown Procedure consists of rinsing the Flow System. Whether or not this procedure is followed on a daily basis depends on instrument usage and the laboratory’s procedures. It may not be necessary to perform this procedure every day, since the instrument automatically goes into a STANDBY state (Automatic
Shutdown) if it has been idle for four hours. Before the instrument enters the
STANDBY state, the Flow Panel is automatically rinsed.
If desired, the operator may place the instrument in the STANDBY state by pressing the [DAILY SHUTDOWN] soft key in the second level SPECIAL PROTOCOLS menu. When this key is pressed or when Automatic Shutdown is initiated, the following occurs:
• The Flow System is rinsed.
• The timer control, which periodically opens all of the solenoid valves to prevent pinched tubing, is set.
The Daily Shutdown cycle takes approximately 10 minutes.
For a more thorough cleaning of the instrument prior to Daily Shutdown, perform the following procedures:
1. In the SPECIAL PROTOCOLS menu, press [AUTO CLEAN] .
2. Clean Sample Loader including racks and Tower Cover.
3. Press [DAILY SHUTDOWN] .
4. Leave Power ON.
5. Empty Waste (as needed)
NOTE: The Auto-Clean cycle may be run as part of the Daily Start-Up
Procedure, depending on operator preference. The Clean Needle process should be used if there is a problem with Closed Mode aspiration and an obstruction in the needle is a suspected cause.
The Auto-Clean and Clean Needle procedures are described in detail in
Subsection: Daily Maintenance Procedures
.
Procedures for cleaning the Sample Loader are described in detail in Section 13:
.
In addition to the daily procedures listed above, if the instrument will remain idle for a period of time, then supplemental shutdown procedures are required depending on the expected duration of the idle time — Short-term, Intermediate, or Prolonged Shutdown. These categories are discussed below.
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Daily Shutdown Procedure Section 5
Peristaltic Pump Tubing
IMPORTANT: By removing the tubing under the Sample Transfer Peristaltic
Pump, the life of the tubing is significantly prolonged. The tubing should be removed if the instrument will be idle for more than 24 hours and reinserted prior to operating the instrument.
Short Term Shutdown
If the shutdown time is expected to be 72 hours or less, follow the procedure below:
1. In the MAIN MENU , press [SPECIAL PROTOCOLS] .
2. If the instrument is to be cleaned first, press [AUTO CLEAN] , otherwise go to step 3.
3. Press [DAILY SHUTDOWN] .
4. Leave power ON.
5. Tubing should be removed from under the Peristaltic Pump.
Intermediate-term Shutdown
If the shutdown time is expected to exceed 72 hours (but less than 2 weeks), follow the procedure below:
1. With the system still ON, perform any maintenance that is due.
2. In the MAIN MENU , press [SPECIAL PROTOCOLS] .
3. Press [AUTO CLEAN] to clean the instrument.
4. Press [DAILY SHUTDOWN] .
5. When the '$,/<6+87'2:1 cycle is finished, turn power OFF in the following order: a. System (includes Analyzer, Data Module, and Sample Loader) b. Display Monitor c. Printer
NOTE: In an emergency situation, turn OFF power in any order as quickly as possible.
6. Remove the tubing from under the Sample Transfer Peristaltic Pump.
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Prolonged Shutdown
If the shutdown time is expected to exceed two weeks, follow the procedure below:
1. In the MAIN MENU , press [SPECIAL PROTOCOLS]
2. Press [AUTO CLEAN] to clean the instrument.
3. Press [PREPARE FOR SHIPPING] . Follow the instructions on the screen.
4. When the procedure is completed, turn the power OFF.
5. Remove the following tubing:
• Tubing in the Normally Closed Valves on the Flow Panel (refer to Figure
• Tubing under the Peristaltic Pump.
6. Record this maintenance in your maintenance log.
CAUTION: Do not forget to reinsert the tubing securely in the Normally
Closed Valves and under the peristaltic pump before turning the instrument
back ON. Refer to Section 2: Installation Procedures and Special
; Subsection: Tubing Installation
.
For the SL model, also refer to the Prolonged Shutdown Procedure in
.
If the instrument will be shipped, refer to the instructions in
Subsection: Preparation for Shipping or Extended Period of Non-
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NOTES
Section 5
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Section 5 Operating Instructions
Using The Work List
Introduction
The Work List is used to pre-assign sample identification and display and print criteria for samples that will be run. It is essentially a list of samples (including the pre-assigned information) that the operator intends to run on the instrument. Work List entries may be downloaded from a host computer to the CELL-DYN 3200 System, or the entries can be made by an operator at the instrument.
This section will provide an overall review of the Work List, discuss the WORK LIST menu and WORK LIST SET UP menu, and discuss the procedures for running samples under the following conditions:
1. Work List records with Bar Codes in the <Specimen ID> field are downloaded from the LIS.
2. Work List records with other sample identification (non Bar Code) in the
<Specimen ID> field are downloaded from the LIS.
3. Work List records with Bar Codes in the <Specimen ID> field are entered at the instrument by the operator.
4. Work List records with other sample identification (non Bar Code) in the
<Specimen ID> field are entered at the instrument by the operator.
As samples are processed, the Work List is accessed. If the identifying information on the sample, such as a bar code number, matches the identifying information of an entry in the Work List, then a “match” has occurred and that entry is removed from the Work List. The demographic data and the results of the sample run are displayed on the 581 screen and stored in the Data Log. The demographic data is also included on the printed report.
The Work List can accept a specimen identifier other than a bar code in the
Specimen ID field. However, since both models come equipped with a bar code reader for the Closed Mode, it is expected that bar code numbers will be the preferred method for identifying samples.
The following bar code symbologies may be used in the <Specimen ID> field:
• Code 39, Code 128, Interleaved 2 of 5, and Codabar
NOTE: Refer to Appendix A for complete information on the use of bar code labels.
NOTE: The number on bar code labels must be greater than 2 digits to avoid possible confusion by the bar code reader with the 2 digit bar code label on the racks.
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Quick Guide
Section 5
The Work List has been designed with three objectives in mind:
1. Relieve the operator from the task of entering demographic data by downloading that data from a host.
2. Process samples quickly, efficiently, and accurately.
3. Upload sample results with corresponding demographic data to the LIS for distribution to authorized personnel.
SL Model
If the instrument is the SL model and bar codes are used with Work List entries, the operator should do the following:
1. Wait for Work List entries to be downloaded from the host.
2. Place the samples in the racks and load the racks onto the Sample Loader.
3. In the RUN screen, press [CHANGE SAMPLER] to select the Closed Mode if necessary.
4. Press [SPECIMEN TYPE] followed by the appropriate specimen type (Patient,
Fragile WBC, or Resistant RBC).
5. Press [START LOADER] to begin processing.
6. When processing is finished, verify that all entries have been deleted from the
Work List, indicating that all samples were successfully matched to their corresponding entries.
CS Model
If the instrument is the CS model and bar codes are used with Work List entries, the operator should do the following:
1. Wait for Work List entries to be downloaded from the host.
2. Place a sample tube in the Door Assembly and close the door.
3. In the RUN screen, press [CHANGE SAMPLER] to select the Closed Mode if necessary.
4. Press [SPECIMEN TYPE] followed by the appropriate specimen type (Patient,
Fragile WBC, or Resistant RBC).
5. Press the Touch Plate to begin processing.
6. When processing is finished, verify that all entries have been deleted from the
Work List, indicating that all samples were successfully matched to their corresponding entries.
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Work List Review
Operating Instructions
General
1. The Work List is always ON.
2. A host can download Work List records at any time. The instrument will accept any record with data in the <Specimen ID> field. This field may contain a bar code number or other Specimen ID.
3. If a record is sent with a blank <Specimen ID> field, the instrument will reject that record and respond by sending a message back to the host identifying the record that was rejected and stating the reason for the rejection.
4. The Work List can contain “mixed” records: Some records may have bar code numbers in the <Specimen ID> field and some may have other
Specimen ID numbers.
5. The Work List can hold a maximum of 600 records. If a batch of records is sent by the host but there is insufficient space in the Work List to accept all the records, the instrument will not accept any of the records and responds by sending a message back to the host stating the Work List is full.
6. When fields have been turned ON in the WORK LIST SET UP menu, those fields are highlighted on the Work List. The cursor automatically skips to the next highlighted field when the Enter key is pressed.
7. If the operator types in a bar code number or non-bar code Specimen ID into the Specimen ID field on the RUN screen and presses the Return key, the system immediately searches the Work List for a matching entry. If a match is found, the demographic information is displayed on the RUN screen.
NOTE: This feature is not possible on the SL model Closed Mode because the operator cannot input data to the RUN screen.
Download from Host
1. In most cases, it is expected that Work List data will be downloaded from a host. As an alternative, the operator may enter all demographic data — including either a Bar Code, other Specimen ID, or Rack and Tube # — at the instrument.
2. If Work List records with Bar Codes are downloaded from the host, the samples given to the operator for processing must also have Bar Codes, otherwise no matches can occur.
3. If Work List records with Specimen IDs (non Bar Code) are downloaded from the host and the operator is given samples with Specimen IDs, the operator may do the following: a. For SL models Closed Mode: Enter the Rack and Tube # of each sample into the <Rack and Tube> field for the appropriate Work List entry.
b. For SL models Open Mode: Enter the Specimen ID of each sample into the <Next ID> field on the RUN screen before processing the sample.
c. For CS models Open and Closed Modes: Enter the Specimen ID of each sample into the <Next ID> field on the RUN screen before processing the sample.
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Format
1. The Work List will be searched only when the following Specimen Types are selected in the RUN screen: Patient, Fragile WBC, or Resistant RBC. Work
List cannot be used when Background or QC Specimen are selected.
2. There are 3 formats for matching samples with Work List entries: Bar Code, other Specimen ID, and Rack and Tube #.
3. The <Specimen ID> field in the Work List must have either a bar code number or other Specimen ID.
4. The <Rack and Tube #> is a separate field in the Work List record.
Matching Entries
As stated earlier, the Work List is always ON. If the Work List contains records when samples are processed in either Closed or Open Mode, the system will:
1. Attempt to match the bar code number (if any) on the sample tube with a bar code number in the Work List. The match must be exact, including upper/ lower case.
2. Attempt to match the Specimen ID (non Bar Code) entered on the RUN screen with a Specimen ID (non Bar Code) in the Work List entry.
3. Attempt to match the rack and tube position of a sample with a Rack and
Tube # in the Work List (the instrument reads the bar code on the rack and keeps track of each tube position).
If a match occurs, that entry is removed from the Work List. The results of that sample along with its demographic data are displayed on the RUN screen and stored in the Data Log.
If a sample cannot be matched with any of the entries in the Work List, no entries are deleted from the Work List. The results of that sample are displayed on the RUN screen without demographic data (except for the Bar Code, Specimen ID, or system-assigned Rack and Tube number) and stored in the Data Log in the same manner. To add demographic data to that sample, the operator must go the Data
Log and, using the [EDIT SPECIMEN] soft key, enter the appropriate demographic information.
If the instrument is unable to read a Bar Code on the tube and is unable to read the bar code on the rack, a malfunction has occurred. Sample Loader processing is terminated to avoid possible sample mis-identification and a fault message is displayed.
SL Model — Closed Mode
In the SL Closed Mode, the Work List is searched after each tube bar code is read
(the RUN cycle has begun).Work List entries are matched using one of the following two methods:
1. Bar Codes on the sample tubes (for Bar Code Reader).
2. Rack and Tube # entered into the Work List by the operator.
NOTE: Demographic data cannot be entered into the RUN screen in the
Closed Mode on the SL model.
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CS Model — Closed Mode
In the CS Closed Mode, the Work List is searched after each tube bar code is read
(the RUN cycle has begun). Work List entries are matched using one of the following three methods:
1. Bar Codes on the sample tubes (for Bar Code Reader).
2. Bar Codes entered into the <Next ID> field of the RUN screen by the operator.
3. Non-Bar Code Specimen IDs entered into the <Next ID> field on the RUN screen by the operator.
SL Model — Open Mode
In the SL Open Mode, the Work List is searched as soon as the operator enters a bar code number or non-bar code Specimen ID in the <Next ID> field and presses the Enter key. If a match is found, the demographic information is immediately displayed on the RUN screen. This will occur even if the Touch Plate is not pressed.
Work List entries are matched using one of the following two methods:
1. Bar Codes entered into the <Next ID> field of the RUN screen by the operator.
2. Non-Bar Code Specimen IDs entered into the <Next ID> field on the RUN screen by the operator.
CS Model — Open Mode
In the CS Open Mode, the Work List is searched as soon as the operator enters a bar code number or non-bar code Specimen ID in the <Next ID> field and presses the Enter key. If a match is found, the demographic information is immediately displayed on the RUN screen. This will occur even if the Touch Plate is not pressed.
Work List entries are matched using one of the following two methods:
1. Bar Codes entered into the <Next ID> field of the RUN screen by the operator.
2. Non-Bar Code Specimen IDs entered into the <Next ID> field on the RUN screen by the operator.
Work List Menu
Work List
The [WORK LIST] key is displayed on the RUN screen. The WORK LIST screen and the following soft key labels are displayed when the [WORK LIST] key is pressed:
INSERT/DELETE
DELETE ALL
WORK LIST SET UP
PRINT WORK LIST
RETURN
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Figure 5.41 Work List Screen - Page 1
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Figure 5.42 Work List Screen - Page 2
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Section 5
Work List Screen
Operating Instructions
The two pages of the WORK LIST screen are depicted in Figures 5.41 and 5.42. Use the left and right arrow keys to scroll between the pages.
1.
Sequence #
The sequential number of the Work List entries is displayed in this field. The
Work List holds 600 entries. When the Work List is full, existing entries must be deleted before additional entries can be made. Work List entries are automatically deleted as samples are run and “matches” made.
2.
RACK AND TUBE #
The rack and tube number is displayed as xxyy where xx, the rack number, is any two digit number between 01 and 99 inclusively and yy, the tube number, is any two digit number between 01 and 10 inclusively.
NOTE: Rack and tube number can only be entered by the operator at the instrument, not downloaded from a host.
In the Work List, the cursor skips the <Rack and Tube> field when moving from entry to entry. The cursor always starts in the <Specimen ID> field. To place the cursor in the <Rack and Tube> field, the operator must use the left arrow key to move the cursor from the <Specimen ID> field to the <Rack and
Tube> field.
3.
SPECIMEN ID
The specimen identification must consist of either a Bar Code number or other Specimen ID. Up to 12 characters may be entered. The sample is identified on the 581 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 record.
Also, an entry must be made in this field before a Work List record can be downloaded from a host.
4.
PATIENT NAME
The name entered in this field should be associated with the bar code number or rack and tube number entered in the <Specimen ID> field. Up to 28 characters can be entered in this field.
5.
PATIENT ID
The Patient ID can be a social security number or other identifier. Up to 16 characters can be entered in this field.
6.
PATIENT SEX
Either “M” or “F” may be entered for the sex of the patient.
7.
PATIENT DOB
The patient’s date of birth may be entered in this field using the format selected in the Date/Time Set Up menu, such as mm/dd/yyyy . Note that 4 digits are used for the year.
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8.
COLLECTION DATE AND TIME
The date and time the specimen was collected may be entered in this field.
Date is entered as mm/dd for month and day only with no year. Time is entered as hh/mm where hh represents the hour (from 00 to 23) and mm represents the minute (from 00 to 59).
9.
DR NAME
The name of the patient’s doctor may be entered in this field. Up to 22 characters may be entered.
10. LIMIT SET
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 (pre-selected) Patient
Limit Set is used.
11. PARAMETER SET
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 (pre-selected) Parameter Set is used.
Work List Soft Keys
The function of each of the soft keys displayed on the WORK LIST screen is discussed below.
Insert/Delete
When the [INSERT/DELETE] key is pressed, the following soft key labels are displayed:
INSERT
DELETE
RETURN
Insert
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 line.
Delete
The [DELETE] key is used to delete a line of information from the Work List. 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 line is deleted at the cursor position and the remainder of the Work List is moved up one line.
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Delete All
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.
Work List Set Up
Refer to Work List Set Up Procedure below for a discussion of the WORK LIST SET
UP screen and options.
Print Work List
The [PRINT WORK LIST] key is used to print the Work List.
Return
The [RETURN] key is used to return to the RUN screen.
Work List Set Up Procedure
The [WORK LIST SET UP] key is used to display the WORK LIST SET UP screen shown in Figure 5.43.
Figure 5.43 Work List Set Up Screen
The WORK LIST SET UP screen consists of nine ON/OFF toggle fields and two
“number” fields.
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Use the arrow keys to move the cursor to the desired field. Use the [TOGGLE ON/
OFF] key to change an option and advance the cursor to the next field.
ON/OFF Fields
Turning fields ON or OFF in this screen affects the movement of the cursor in the
WORK LIST screen when the operator makes entries to the Work List.
1. When the operator enters data into a <Work List> field and presses the Enter key, the cursor will move to the next field that was turned ON in the WORK
LIST SET UP screen, skipping any intervening fields that were left OFF.
2. For example: a. Only the <Dr Name> field in the WORK LIST SET UP screen was turned
ON, and b. The operator is making new patient entries into the Work List.
In this case, when the operator enters data in the <Specimen ID> field and presses the Enter key, the cursor goes to the next ON field, which in this example is Dr Name . All intervening fields are skipped.
NOTE: OFF fields will still accept data. The operator can use the arrow keys to move the cursor to an OFF field and input data. Pressing the
Enter key saves the data and moves the cursor to the next ON field.
Number Fields
The system will accept any number in the range 1 to 6 for Patient Limits and 1 to
4 for Parameter Set. The number selected for either field serves as the default for that field for subsequent entries and is independent of whether that field is ON or
OFF.
For example:
1. If the <Patient Limits> field is OFF but the default setting is changed to 6, then 6 will be displayed as the default setting on the Work List.
2. Because the <Patient Limits> field is OFF, the cursor will bypass this field in the Work List.
3. If the <Patient Limits> field were ON, the cursor in the Work List would stop in this field, allowing the operator to select a different setting, such as 2, for that entry. The next entry would continue to display the default setting, which in this example is 6.
NOTE: Regardless of the default value for either the <Limit Set> or
<Parameter Set> fields, the operator can use the arrow keys to move the cursor to the field and enter another value. This new value will affect only that entry. All previous entries will retain their original settings, and all subsequent entries will use the default setting selected in the WORK LIST SET UP menu.
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Work List Set Up Menu Fields
1.
SPECIMEN NAME ENTRY SELECTED
This field is used to specify whether or not a specimen (patient) name will be entered into the Work List. If this option is turned OFF, the cursor will skip to the next ON field. However, the operator can use the arrow keys to place the cursor in this field and enter data, if desired.
2.
PATIENT ID ENTRY SELECTED
This field is used to specify whether or not a patient ID will be entered into the Work List. If this option is turned OFF, the cursor will skip to the next ON field. However, the operator can use the arrow keys to place the cursor in this field and enter data, if desired.
3.
PATIENT SEX ENTRY SELECTED
This field is used to specify whether or not the sex of the patient will be entered into the Work List. If this option is turned OFF, the cursor will skip to the next ON field. However, the operator can use the arrow keys to place the cursor in this field and enter data, if desired.
4.
PATIENT DOB ENTRY SELECTED
This field is used to specify whether or not the patient’s date of birth will be entered into the Work List. If this option is turned OFF, the cursor will skip to the next ON field. However, the operator can use the arrow keys to place the cursor in this field and enter data, if desired.
5.
COLLECTION DATE AND TIME ENTRY SELECTED
This field is used to specify whether or not the collection date and time of the specimen will be entered into the Work List. If this option is turned OFF, the cursor will skip to the next ON field. However, the operator can use the arrow keys to place the cursor in this field and enter data, if desired.
6.
DR NAME ENTRY SELECTED
This field is used to specify whether or not the name of the patient’s doctor will be entered into the Work List. If this option is turned OFF, the cursor will skip to the next ON field. However, the operator can use the arrow keys to place the cursor in this field and enter data, if desired.
7.
PATIENT LIMITS ENTRY SELECTED
If this option is turned OFF, the prior setting will be entered automatically for each entry. The operator can, however, input a different setting for individual entries by using the arrow keys to place the cursor in this field and type in a new setting. The new setting applies only to the entry(ies) that was changed.
If this option is turned ON, the operator may then select another default setting by typing in a number from 1 to 6. This new setting will be automatically assigned to each new entry by the operator. The operator also has the ability to enter a different setting for individual entries. When the cursor moves to the <Patient Limits Set> field of a particular entry, the operator may override the default setting and type in a new setting for that entry.
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8.
DEFAULT PATIENT LIMIT SET (1 to 6)
This field is used to specify the default (pre-assigned) Patient Limit Set that is automatically assigned to each sample unless otherwise indicated in the
Work List. Any number between 1 and 6 inclusively may be entered.
9.
PARAMETER SET ENTRY SELECTED
If this option is turned OFF, the prior setting will be entered automatically for each entry. The operator can, however, input a different setting for individual entries by using the arrow keys to place the cursor in this field and type in a new setting. The new setting applies only to the entry(ies) that was changed.
If this option is turned ON, the operator may then select another default setting by typing in a number from 2 to 4. This new setting will be automatically assigned to each new entry. The operator also has the ability to enter a different setting for individual entries. When the cursor moves to the
<Parameter Set> field of a particular entry, the operator may override the default setting and type in a new setting for that entry.
10. DEFAULT PARAMETER SET (1 to 4)
This field is used to specify the default (pre-assigned) Parameter Set that is automatically assigned to each sample unless otherwise indicated in the Work
List. Any number between 1 and 4 inclusively may be entered.
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Sample Analysis — SL Model
The procedures described below discuss the operation of the Work List in both
Open and Closed Modes using either Bar Codes or other Specimen ID for sample identification.
Closed Mode
On the SL model, although the RUN screen is displayed in the Closed Mode it is not possible to enter data on this screen. If Closed Mode is selected, demographic data can only be entered on the WORK LIST or DATA LOG screens.
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 bar code labels are used in Work List entries, samples may be run in any order after the Work List has been created. If Work List records are not downloaded from a host, they may be entered by the operator at the instrument.
As samples are processed, the instrument does the following:
• Reads the bar code label on the tube and searches the Work List for that bar code number.
• If a match is found, the demographic data from the Work List is displayed on the RUN screen along with the results, and the entire record is stored in the
Data Log. The Work List entry is deleted.
• If no match occurs, the Bar Code number is displayed on the RUN screen without demographic data and stored in the Data Log along with the results.
No Work List entry is deleted.
Running Samples with Bar Codes
1. In the RUN screen, press [SPECIMEN TYPE] followed by the appropriate specimen type (Patient, Fragile WBC, or Resistant RBC).
2. If necessary, press [CHANGE SAMPLER] to select the Closed Mode.
3. Be sure that each sample to be run has a bar code label on the tube.
4. If Work List records containing bar codes were downloaded from a host, go to step 6. If entries are to be made by the operator at the instrument, go to step 5.
5. If Work List records are entered by the operator at the instrument, do the following: a. Enter all the Work List records, including bar code and demographic data, associated with the samples to be run into the Work List. DOUBLE
CHECK to ensure that each Bar Code was entered correctly into the
<Specimen ID> field.
6. Place all the samples to be run into the Sample Loader racks and load the racks onto the Sample Loader (if not already done).
NOTE: The samples in the racks do not have to be in the same order as the
Work List entries.
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7. Press [START LOADER] to begin sample processing.
8. The samples are processed in the order in which they were placed in the racks. The Sample Loader automatically stops when all samples in the last rack have been processed.
NOTE: Additional entries may be made to the Work List while processing takes place. To input additional entries to the Work List, press
[WORK LIST] to display the WORK LIST screen. Type in the new entries.
9. When all samples have been processed, check to see if all entries have been deleted from the Work List. Entries are automatically deleted from the Work
List when a match occurs. Entries remaining in the Work List indicate a successful match did not occur. The operator should follow laboratory procedures to determine the cause of this discrepancy.
Using the Work List with Specimen IDs
When Work List entries contain Specimen IDs (non bar code), the operator must enter the rack and tube position of each sample into the <Rack and Tube #> field of the appropriate Work List entry, otherwise no match can occur. It is not necessary for the samples in the racks to be in the same order as the entries in the
Work List, but the position of each sample in the racks must match its Rack and
Tube # in the Work List.
Sample identification is made from the information entered in the
<Rack and Tube #> 6 th field on the Work List.
If a match occurs (based on the Rack and Tube #), the sample results along with the demographic data (including the Specimen ID) are displayed on the RUN screen and sent to the Data Log.
NOTE: The Rack and Tube # is not displayed on the RUN screen or sent to the Data Log. The Rack and Tube # is used only for the purpose of matching Work List entries with samples.
If a match does not occur, it indicates the operator typed an incorrect Rack and
Tube # into the Work List. The operator may either:
1. Correct the Rack and Tube # in the Work List and re-run the sample (this avoids having to enter all the demographic data manually), OR
2. Go to the Data Log, find the entry by the Rack and Tube # assigned by the instrument, and enter the remaining demographic information.
NOTE: If the instrument cannot match a sample with a Work List entry using Bar Code, Specimen ID, or Rack and Tube #, it identifies the sample by its actual rack and tube position and assigns that number to the <Specimen ID> field of that sample. The results along with the assigned rack and tube number are sent to the Data Log without deleting any records in the Work List, since no match was made.
The sample is identified in the Data Log by the Rack and Tube # assigned by the instrument.
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NOTE: If the instrument is unable to read a Bar Code on the tube and is unable to read the Bar Code on the rack, a malfunction has occurred. Sample Loader processing is halted. Determine which rack position is the source of the problem before removing the rack.
Check the bar code label for that position to determine the cause of the malfunction. If unable to fix or replace the label, use a new rack.
Whichever rack is used, remove any samples that were aspirated and identified properly. Place the rack at the starting position on the load side of the Sample Loader. Press the [CLEAR FAULT] key followed by [RESET LOADER] to resume processing.
Running Samples with Specimen IDs
1. If Work List records were downloaded from a host, perform steps a through e below. If Work List records are to be entered by the operator at the instrument, go to step 2.
a. In the RUN screen, press [WORK LIST] .
b. For each sample to be run, find the matching entry in the Work List.
c. Type the rack and tube number for that sample into the
<Rack and Tube #> field for that entry in the Work List and place the sample into the appropriate rack and tube position. DOUBLE CHECK to ensure the sample was actually placed in the rack and tube position indicated in the Work List entry.
NOTE: The samples in the racks do not have to be in the same order as the Work List entries, but the actual rack and tube number of each sample must be correctly assigned to the Work List entry for that sample.
a. Repeat this process for all samples. When finished, place the racks on the
Sample Loader.
b. Go to step 3.
2. To enter Work List records at the instrument, do the following: a. In the RUN screen, press [WORK LIST] .
b. Enter all the Work List records associated with the samples to be run, including the Rack and Tube #. DOUBLE CHECK to ensure that each
Specimen ID was entered correctly in the <Specimen ID> field.
DOUBLE CHECK to ensure that the actual rack and tube position for each sample was correctly entered in the <Rack and Tube #> field in the
Work List.
NOTE: The samples in the racks do not have to be in the same order as the Work List entries.
a. When all entries have been completed, place the tubes in racks and load the racks onto the Sample Loader (if not already done).
3. Press [RETURN] to return to the RUN screen.
4. In the RUN screen, press [SPECIMEN TYPE] followed by the appropriate specimen type (Patient, Fragile WBC, or Resistant RBC).
5. If necessary, press [CHANGE SAMPLER] to select the Closed Mode.
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6. Press [START LOADER] to begin sample processing.
7. The samples are automatically processed in the order in which they were placed in the racks. The Sample Loader automatically stops when all samples in the last rack have been processed.
NOTE: Additional entries may be made to the Work List while processing takes place. To input additional entries to the Work List, press
[WORK LIST] to display the WORK LIST screen. Type in the new entries.
8. When all samples have been processed, check to see if all entries have been deleted from the Work List. Entries are automatically deleted from the Work
List when a match occurs. Entries remaining in the Work List indicate a successful match did not occur. The operator should follow laboratory procedures to determine the cause of this discrepancy.
Running STAT Samples
1. STAT samples may be run in either the Closed or Open Modes on the SL model.
2. STAT samples with either Bar Codes or Specimen IDs may be run using the
Work List.
3. STAT records may be downloaded from a host or entered into the Work List by the operator.
4. STAT samples are processed in the same manner as other Work List samples.
Refer to Running Samples with Bar Codes and Running Samples with
Specimen IDs discussed earlier in this section.
Open Mode
Using the Work List with Bar Codes
If Work List entries with Bar Codes have been downloaded from a host, the operator must type the bar code number into the <Next ID> field on the RUN screen.
When the bar code number is entered in the <Next ID> field on the RUN screen the system will automatically try to match the bar code number with a Work List entry.
If a successful match occurs and the sample is processed, the results along with the demographic data in the Work List will be displayed on the RUN screen and sent to the Data Log. That entry will be deleted from the Work List.
If a successful match does not occur and the sample is processed, the results of the run are sent to the Data Log with only the bar code number entered by the operator.
The operator must then go to the Data Log and enter the remaining demographic data for that sample. No entry is deleted from the Work List.
Running Samples
1. In the RUN screen, press [SPECIMEN TYPE] followed by the appropriate specimen type (Patient, Fragile WBC, or Resistant RBC).
2. If necessary, press [CHANGE SAMPLER] to select Open Mode.
3. Enter the bar code number into the <Next ID> field on the RUN screen.
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4. Place the well-mixed sample under the Open Sample Aspiration Probe, make sure the end of the probe is deeply immersed in the sample, and press the
Touch Plate to start the cycle.
NOTE: Additional entries may be made to the Work List while processing takes place. To input additional entries to the Work List, press
[WORK LIST] to display the WORK LIST screen. Type in the new entries.
5. When all samples have been processed, check to see if all entries have been deleted from the Work List. Entries are automatically deleted from the Work
List when a match occurs. Entries remaining in the Work List indicate a successful match did not occur. The operator should follow laboratory procedures to determine the cause of this discrepancy.
Running STAT Samples with Bar Codes
STAT samples with bar codes are processed in the same manner as described in the sections Using the Work List with Bar Codes and Running Samples immediately above.
Using the Work List with Specimen IDs
If Work List records with Specimen IDs (non bar code) were downloaded from a host, the operator can use the Work List by entering the Specimen ID on the sample tube into the <Next ID> field on the RUN screen. The instrument will attempt to match the number in the <Next ID> field on the RUN screen with the same number in the <Specimen ID> field in the Work List.
If a match occurs and the sample is processed, the results along with the demographic data from the Work List will be displayed on the RUN screen and sent to the Data Log. That entry will be deleted from the Work List.
If a match does not occur and the sample is processed, only the sample results and
Specimen ID entered on the RUN screen will be displayed on the RUN screen and stored in the Data Log. No entry will be deleted from the Work List. The operator must go to the Data Log to enter the remaining demographic information.
Running Samples
1. In the RUN screen, press [SPECIMEN TYPE] followed by the appropriate specimen type (Patient, Fragile WBC, or Resistant RBC).
2. If necessary, press [CHANGE SAMPLER] to select Open Mode.
3. Enter the Specimen ID into the <Next ID> field on the RUN screen.
4. Place the well-mixed sample under the Open Sample Aspiration Probe, make sure the end of the probe is deeply immersed in the sample, and press the
Touch Plate to start the cycle.
NOTE: Additional entries may be made to the Work List while processing takes place. To input additional entries to the Work List, press
[WORK LIST] to display the WORK LIST screen. Type in the new entries.
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Running STAT Samples with Specimen IDs
STAT samples with Specimen IDs are processed in the same manner as described in Using the Work List with Specimen IDs and Running Samples immediately above.
Sample Analysis — CS Model
For the CELL-DYN 3200CS model, only a Bar Code or other Specimen ID may be used with the Work List to match entries. Because this model has no Sample
Loader, rack and tube position cannot be used to identify specimens.
Samples are run individually in both Open and Closed Modes.
WARNING: Potential Biohazard. Consider all specimens and reagents, controls, calibrators, etc., that contain human blood or serum as potentially infectious. Wear gloves, lab coats, and safety glasses, and follow other biosafety practices as specified in the OSHA Bloodborne Pathogen Rule
(29 CFR Part 1910.1030) or other equivalent biosafety procedures.
Closed Mode
5. When all samples have been processed, check to see if all entries have been deleted from the Work List. Entries are automatically deleted from the Work
List when a match occurs. Entries remaining in the Work List indicate a successful match did not occur. The operator should follow laboratory procedures to determine the cause of this discrepancy.
Using the Work List with Bar Codes
The Closed Sample Aspiration Tower 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 bar code numbers are used in Work List entries, samples may be run in any order after the Work List has been created. If Work List records are not downloaded from a host, they may be entered by the operator at the instrument.
As samples are processed, the instrument does the following:
• reads the bar code label on the tube and searches the Work List for that bar code number
• If a match is found, the demographic data from the Work List is displayed on the RUN screen along with the results, and the entire record is stored in the
Data Log. The Work List entry is deleted.
• If no match is found, the Bar Code number is displayed on the RUN screen without demographic data and stored in the Data Log along with the results.
No Work List entry is deleted.
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Running Samples with Bar Codes
1. If Work List records containing bar codes were downloaded from a host, perform steps a through h below. If entries are to be made by the operator at the instrument, go to step 2. a. In the RUN screen, press [SPECIMEN TYPE] followed by the appropriate specimen type (Patient, Fragile WBC, or Resistant RBC).
b. If necessary, press [CHANGE SAMPLER] to select the Closed Mode.
c. Be sure that each sample to be run has a bar code label on the tube.
d. Place a well-mixed sample in the Tube Retainer and close the door.
e. Press the Touch Plate to run the sample.
f. When the sample has been aspirated, the door will open. Remove the tube.
g. Repeat steps d through f until all Work List samples have been processed.
NOTE: Additional entries may be made to the Work List while processing takes place. To input additional entries to the Work
List, press [WORK LIST] to display the WORK LIST screen. Type in the new entries.
h. Go to step 3.
2. If Work List records are entered by the operator at the instrument, perform steps a through h below: a. In the RUN screen, press [SPECIMEN TYPE] followed by the appropriate specimen type (Patient, Fragile WBC, or Resistant RBC).
b. If necessary, press [CHANGE SAMPLER] to select the Closed Mode.
c. Be sure that each sample to be run has a bar code label on the tube.
d. Enter all the Work List records associated with the samples to be run into the Work List. DOUBLE CHECK to ensure that each Bar Code was entered correctly into the <Specimen ID> field.
e. Place a well-mixed sample in the Tube Retainer and close the door.
f. Press the Touch Plate to run the sample.
g. When the sample has been aspirated, the door will open. Remove the tube.
h. Repeat steps e through g until all Work List samples have been processed.
NOTE: Additional entries may be made to the Work List while processing takes place. To input additional entries to the Work
List, press [WORK LIST] to display the WORK LIST screen. Type in the new entries.
3. When all samples have been processed, check to see if all entries have been deleted from the Work List. Entries are automatically deleted from the Work
List when a match occurs. Entries remaining in the Work List indicate a successful match did not occur. The operator should follow laboratory procedures to determine the cause of this discrepancy.
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Using the Work List with Specimen IDs
To match Work List entries using Specimen ID, the operator must first enter a sample’s Specimen ID into the <Next ID> field on the RUN screen before running the sample. As the sample is processed, the instrument searches the Work List for a matching Specimen ID.
If a match occurs, the sample results along with the demographic data from the
Work List is displayed on the RUN screen and sent to the Data Log. That entry is deleted from the Work List.
If a match does not occur, only the sample results with the Specimen ID entered on the
RUN screen is displayed and sent to the Data Log. No entry is deleted from the Work List.
Running Samples with Specimen IDs
1. In the RUN screen, press [SPECIMEN TYPE] followed by the appropriate specimen type (Patient, Fragile WBC, or Resistant RBC).
2. If necessary, press [CHANGE SAMPLER] to select the Closed Mode.
3. If Work List records were downloaded from a host, go to step 5.
4. To enter Work List records at the instrument, do the following: a. In the RUN screen, press [WORK LIST] .
b. Enter all the Work List records, including demographic data and
Specimen ID, associated with the samples to be run. DOUBLE CHECK to ensure that each Specimen ID was entered correctly in the
<Specimen ID> field.
5. Select a sample tube and type the Specimen ID shown on the tube into the
Next ID field on the RUN screen.
6. Place a well-mixed sample in the Tube Retainer and close the door.
7. Press the Touch Plate to run the sample.
8. When the sample has been aspirated, the door will open. Remove the tube.
9. Repeat steps 5 through 8 until all samples have been processed.
NOTE: Additional entries may be made to the Work List while processing takes place. To input additional entries to the Work List, press
[WORK LIST] to display the WORK LIST screen. Type in the new entries.
10. When all samples have been processed, check to see if all entries have been deleted from the Work List. Entries are automatically deleted from the Work
List when a match occurs. Entries remaining in the Work List indicate a successful match did not occur. The operator should follow laboratory procedures to determine the cause of this discrepancy.
Running STAT Samples
The procedure for running STAT samples is similar to the procedure for running
Work List samples described above. For STAT samples with bar codes, refer to
Running Samples with Bar Codes above. For STAT samples with Specimen IDs, refer to Running Samples with Specimen IDs above.
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Open Mode
Operating Instructions
Work List Samples
Work List samples are processed in the Open Mode on the CS model in the same manner as on the SL model. For a description of this procedure, refer to Sample
Analysis — SL Model ,
Subsection: Open Mode Analysis .
STAT Samples
STAT samples are processed in the Open Mode on the CS model in the same manner as on the SL model. For a description of this procedure, refer to Sample
Analysis — SL Model ,
Subsection: Open Mode Analysis .
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NOTES
Section 5
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Section 5 Operating Instructions
Using The Data Log
Introduction
The Data Log stores all data and demographic information in a log format for the last 10,000 cycles run on the CELL-DYN 3200. The record information is stored chronologically by sequence number. Scattergrams and histograms are stored for all 10,000 records.
NOTE: 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 records are added to the bottom of the list.
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 customizing the display and printout of the Data Log. The final section gives instructions for data review from the Data Log.
Scrolling Through the Data Log
Each screen display (page) may contain up to 18 specimens.
Use the Left and Right Arrow keys to scroll through the complete list of parameters for all specimens displayed on a page. Use the Up and Down Arrow keys to move the cursor between specimens on a page.
Use the Page Up key to scroll through preceding pages. Use the Page Down key to scroll through succeeding pages.
DATA LOG Menu
The function of each of the soft keys in the DATA LOG menu, shown in Figure 5.44, is discussed in this section.
The Data Log consists of 5 pages (screens). The first page contains limited demographic data on the patient, and subsequent pages display parameter results.
The following data is common to all 5 screens:
1. Sequence #
2. Specimen ID
3. Collection Date and Time
4. Operator ID
The second page displays the results for the WBC Parameters. The third page displays the results for the RBC parameters. The fourth page displays the results for the PLT parameters. The fifth page displays the results for the WBC parameters expressed as a percent.
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Figure 5.44 Data Log Screen - Page 1
When the [DATA LOG] key is pressed in the MAIN MENU , the DATA LOG menu and 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 one of the following patient record types: Patient, Fragile WBC, and Resistant RBC.
** This key is displayed if the sequence number of the patient record is preceded by a “b”, “r”, or “w”.
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Section 5
Edit ID
Operating Instructions
The [EDIT ID] key is used to edit the Specimen ID from the DATA LOG screen. 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.
Figure 5.45 Display Specimen Screen
Display Specimen
The [DISPLAY SPECIMEN] key is used to display the results for the record indicated by the cursor position. (See Figure 5.45.) 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/COLOR PRINT (The key label alternates between the selections.)
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.
*** This key is displayed only if the cursor is positioned next to one of the following patient record types: Patient, Fragile WBC, or Resistant RBC.
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Previous Specimen
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.
Next Specimen
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.
Edit Specimen
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.
Customize Report
The [CUSTOMIZE REPORT] key is used to customize the RUN screen display, header and printout as described in the Set Up Instructions section of this chapter.
Transmit Specimen
The [TRANSMIT SPECIMEN] key is used to transmit the displayed report to a
Laboratory Information System or on-line computer. If auto-transmit extended histograms or scatter plots is selected, the transmit specimen key will transmit the extended data.
Print Ticket
The [PRINT TICKET] key is used to print a ticket (in the currently selected format) for the displayed record.
Print Report
The [PRINT REPORT] key is used to print a graphics report (in the currently selected format) for the displayed record.
NOTE: If color printing has been selected (refer to the Set Up Instructions), the key label changes to [COLOR PRINT] .
Return
The [RETURN] key is used to return to the main DATA LOG screen.
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Find Specimen
Figure 5.46 Data Log Search Screen
The [FIND SPECIMEN] key is used to locate a particular record by entering the
Sequence number, Specimen ID number or Patient Name for the desired record.
When this key is pressed, the DATA LOG SEARCH screen is displayed. (See Figure
5.46.) If the record is not found in the Data Log, the Bulletin line displays the message:
NO ENTRY FOUND
.
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Using The Data Log
Reject From X-B
Section 5
If the cursor is positioned at a sample identified with a “r”, “w”, or “b” preceding the sequence number (indicating that the results are included in the XB analysis), the [REJECT FROM X-B] key label is displayed. (See Figure 5.47.)
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Figure 5.47 Data Log Screen Showing Reject From X-B Key
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
“R”, “w”, or “b” is deleted), and the key label changes to [ACCEPT INTO X-B] . (See
Figure 5.48.)
If the [ACCEPT INTO X-B] key is pressed, the “R” is deleted, the “r”, “w”, or “b” is displayed and results are now included in the X-B analysis.
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Figure 5.48 Data Log Screen Showing Accept Into X-B Key
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Customize Data Log
The [CUSTOMIZE DATA LOG] key is used to customize the Data Log display. The
CUSTOMIZE DISPLAY FOR DATA LOG screen (see Figure 5.49) and the following soft key labels are displayed when the [CUSTOMIZE DATA LOG] key is pressed:
SELECT PARAMETER/
PLACE PARAMETER
STANDARD GROUPS/
CUSTOM PLACEMENT
CUSTOMIZE PRINTOUT
RETURN
(The key alternates between the selections.)
(The key alternates between the selections.)
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Figure 5.49 Customize Display for Data Log Screen Showing Standard Groups
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 second 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. Figure 5.50 shows a customized Data
Log display screen.
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Section 5 Operating Instructions
Figure 5.50 Customize Display for Data Log Screen Showing Group 1 Customized
Select Parameter
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.
Place Parameter
The [PLACE PARAMETER] key is used to display the parameter in the location indicated by the position of the cursor.
Cancel Selection
The [CANCEL SELECTION] key is used to cancel the selection and display the
[SELECT PARAMETER] key.
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Standard Groups
Pre-determined groups of parameters, called Standard Groups, may be selected by pressing the [STANDARD GROUPS] key. Refer to Figure 5.49 which 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.
Figure 5.49 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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Figure 5.51 Customize Printout for Data Log Screen
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Section 5 Operating Instructions
Customize Printout
The [CUSTOMIZE PRINTOUT] key is used to customize the printout format of the
Data Log. (See Figure 5.51.) The following soft key labels are displayed when the
[CUSTOMIZE PRINTOUT] key is pressed:
SELECT PARAMETER/
PLACE PARAMETER
STANDARD SELECTION
RETURN
(The key alternates between the selections.)
The CUSTOMIZE PRINTOUT FOR DATA LOG screen shows the order (from left to right) in which the indicated parameters will be printed.
Select Parameter
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.
Place Parameter
The [PLACE PARAMETER] key is used to display the parameter in the location indicated by the position of the cursor.
Cancel Selection
The [CANCEL SELECTION] key is used to cancel the selection and display the
[SELECT PARAMETER] key.
Standard Selection
The [STANDARD SELECTION] key is used to configure the printout in the predetermined print group shown in Figure 5.49. When the key is pressed, the print group is changed to the Standard Selection.
Return
The [RETURN] key is used to return to the main DATA LOG screen.
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Using The Data Log
Transmit Data
Section 5
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).
When the [TRANSMIT DATA] key is pressed, the <Starting Sequence #> field appears in the upper left corner of the screen and the cursor is positioned in this field. The operator should enter the sequence number of the first specimen to be transmitted and press the Enter key. If the number is valid, the system accepts the entry and the
<Ending Sequence #> field appears in the upper left corner of the screen. The operator should type in the ending sequence number and press Enter. The system begins transmitting automatically. If only one record is to be transmitted, the starting and ending sequence number will be the same.
NOTE: Use the ESC key to cancel this function and return to the DATA LOG menu.
Use the Backspace key or left arrow key to cancel an entry and retype the sequence number.
Because specimen records are shown in summary form on the DATA LOG menu, only the summary data of these records will be transmitted. No histogram data accompanies the summary data.
Print Data Log
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 5.52.)
When the [PRINT DATA LOG] key is pressed, the <Starting Sequence #> field appears in the upper left corner of the screen and the cursor is positioned in this field. The operator should enter the sequence number of the first specimen to be printed and press the Enter key. If the number is valid, the system accepts the entry and the <Ending Sequence #> field appears in the upper left corner of the screen.
The operator should type in the ending sequence number and press Enter. The system begins printing automatically. If only one record is to be printed, the starting and ending sequence number will be the same.
NOTE: Use the ESC key to cancel this function and return to the DATA LOG menu.
Use the Backspace key or left arrow key to cancel an entry and retype the sequence number.
Because specimen records are shown in summary form on the DATA LOG menu, only the summary data of these records will be printed. No histogram data accompanies the summary data.
NOTE: To print histogram data, the operator must press the [DISPLAY SPECIMEN] key in the DATA LOG menu to select and display an individual specimen.
Then, the [PRINT REPORT] key will print the results of the specimen displayed on the screen, including histograms.
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Figure 5.52 Print Data Log Screen
Data Log Codes
The Data Log Codes are displayed in the Data Log in the column immediately preceding the date (see Figure 5.52). These codes are displayed in the following order:
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
— Flow Error
R
— Resistant RBC key was used to run this sample
F
— Fragile WBC key was used to run this sample
NOTE: For Background and Latex specimens, only the O and C codes are used.
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Using The Data Log
An example of codes displayed in the Data Log is shown in Figure 5.53.
Section 5
Figure 5.53 Data Log Codes 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 5.54 shows the Standard 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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Figure 5.54 Customize Display for Data Log Screen Showing Standard Groups
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:
NOC
EMPTY
Nuclear Optical Count
Inserts an empty column in the display
To Customize the Data Log Display
1. In the main DATA LOG screen, press [CUSTOMIZE DATA LOG] to display the
CUSTOMIZE DISPLAY FOR DATA LOG screen.
2. If necessary, press [CUSTOM PLACEMENT] to display the CUSTOMIZE
DISPLAY FOR DATA LOG screen and key labels for custom placement.
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.
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Operating Instructions
Using The Data Log Section 5
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.
Standard Groups
The Data Log display may also be customized with pre-determined groups
(Standard Groups) of parameters using the [STANDARD GROUPS] key. Figure 5.54 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
.
To Customize the Data Log Display for Standard Groups
1. From the main DATA LOG screen, press [CUSTOMIZE DATA LOG] to display the
CUSTOMIZE DISPLAY FOR DATA LOG screen.
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.
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.
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Section 5 Operating Instructions
Figure 5.55 Customize Printout for Data Log Screen Showing Customized Print
Group
Customizing the Printout
The CUSTOMIZE PRINTOUT FOR DATA LOG screen (see Figure 5.55) 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 parameter may also be printed in the Data Log:
NOC — Nuclear Optical Count
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Operating Instructions
Using The Data Log Section 5
To Customize the 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.
Standard Selection
The [STANDARD SELECTION] key is used to automatically arrange the parameters in a predetermined print group.
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Section 5 Operating Instructions
Data Review from the Data Log
Use the Page Up/Down keys and arrow keys to view Data Log records and parameters within a record as described earlier in Scrolling Through the Data
Log .
Displaying A Record
A copy of the RUN screen may be displayed for all 10,000 records in the
CELL-DYN 3200 Data Log. A record is displayed by positioning the cursor at the record in the Data Log listing and pressing [DISPLAY SPECIMEN] . The record is displayed on the DISPLAY SPECIMEN screen. (See Figure 5.56.)
Figure 5.56 Display Specimen Screen
To Display a Record
1. From the MAIN MENU screen, press [DATA LOG] .
2. Use the Arrow keys on the keyboard to move the cursor to the desired record
(use the Page Up and Page Down keys to scroll between pages).
3. Press [DISPLAY SPECIMEN] to display the RUN screen for the selected record.
4. If desired, press [PRINT REPORT] to obtain a printout.
NOTE: If a color printing has been selected, the key label changes to
[COLOR PRINT] and a color printout is generated when the key is pressed.
5. 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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Operating Instructions
Using The Data Log
To Find a Record
Section 5
5-144
Figure 5.57 Find Specimen Screen
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. Refer to
Figure 5.57.
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.)
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Section 5 Operating Instructions
To Edit a Record
The Patient Demographics and the Parameter and Patient Limits Sets may be edited for each record. (See Figure 5.58.)
Figure 5.58 Edit Specimen Screen
To Edit a 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] or [COLOR PRINT] to obtain a printout.
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Operating Instructions
References Section 5
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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Section 6
Section 6 Calibration Procedures
Calibration Procedures
Overview
The CELL-DYN 3200 System is calibrated at the factory just prior to shipment. An
Abbott Field Service Representative will assist the operator in confirming the calibration during instrument installation. Calibration may be performed using commercial calibrator or fresh whole blood samples. Only the directly measured parameters — WOC, NOC, RBC, HGB, MCV, PLT, and MPV — may be calibrated.
Calibration should be confirmed on a regular basis according to the laboratory’s schedule for maintaining good laboratory practice.
On-board quality control programs are designed to provide continual monitoring and verification of instrument calibration. The laboratory should make the decision to recalibrate based on the performance of the CELL-DYN 3200 in these quality control programs.
Instrument calibration is discussed in the following order:
• General Information
• Pre-Calibration Procedures
• Calibration Menu and Soft Keys
• Auto-Cal Method
• Enter Factor Method
• Calibration Worksheets
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Calibration Procedures
Overview
NOTES
Section 6
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Section 6 Calibration Procedures
General Information
The CELL-DYN 3200 System has two modes of operation:
• Open Mode
• Closed Mode
Both the Open and Closed Modes are calibrated individually. It is recommended that the primary mode (open mode) be calibrated first.
NOTE: The procedure for calibrating Closed Mode differs slightly between the
SL and CS models.
Three methods of calibration are available on the CELL-DYN 3200 System:
Auto-Calibration, Enter Factor, and Latex.
1. The Auto-Calibration method is designed to quickly and easily calibrate the system, using commercial control material or fresh whole blood.
a. On the CS model, Auto-Calibration can be used in both the Open and
Closed Modes.
b. On the SL model, Auto-Calibration can be used only in the Open Mode.
The Enter Factor Method must be used to calibrate the Closed Mode.
2. The Enter Factor method is a manual procedure for calibrating the instrument. With this method, Fresh Whole Blood is normally used but
Calibrator may also be used.
3. Latex material may also be used to calibrate the instrument but this procedure should only be performed by Abbott service personnel.
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Calibration Procedures
General Information Section 6
When to Calibrate
Scheduled calibration of the CELL-DYN 3200 should conform to the guidelines established by regulatory agencies.
Calibration 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.
Unscheduled calibration is indicated following service adjustments performed by
Abbott Field Service Representatives, such as major component changes.
Unscheduled calibration is also necessary when indicated by the results of the
Quality Control program. Quality Control includes (1) statistical computations and
Westgard ® Rules for commercial or patient controls, and (2) monitoring of patient samples for WBC parameters with moving averages and RBC parameters using
Bull’s Moving Average Program (X-B).
The laboratory should make the decision to recalibrate based on the results of the instrument’s performance, as indicated by these quality control programs.
However, calibration should be considered as the very last step in a troubleshooting sequence. Performing unnecessary calibrations may mask an underlying problem with the instrument’s performance.
Calibration is also recommended following the replacement of any major instrument component, such as the Shear Valve, that could affect the accuracy of the instrument. Calibration should also be confirmed by running the same samples used to calibrate the instrument to test the accuracy of the reported results. The procedures for confirming calibration are described in subsections Auto-Cal
Method and Enter Factor Method .
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Section 6 Calibration Procedures
Calibration Materials
WARNING: Potential Biohazard. Consider all specimens and reagents, controls, calibrators, etc., that contain human blood or serum as potentially infectious. Wear gloves, lab coats, and safety glasses, and follow other biosafety practices as specified in the OSHA Bloodborne Pathogen Rule
(29 CFR Part 1910.1030) or other equivalent biosafety procedures.
Three types of calibration materials can be used to calibrate the CELL-DYN 3200:
• CELL-DYN 22 Calibrator (List Number: 99120-01) or
CELL-DYN HemCal ™ Calibrator (List Number: 01H61-01)
CELL-DYN Calibrator may be used to calibrate the Open and Closed
Modes. The same Calibrator used to calibrate should also be used to confirm calibration.
• Fresh Whole Blood
F resh whole blood may be used to calibrate the Open and Closed Modes.
The Auto-Cal method uses one sample to calibrate compared to the Enter
Factor method which uses five samples. Reference values are obtained by running the sample(s) on a reference instrument, using acceptable reference methodology, and calculating the mean reference value for each parameter.
The same sample(s) used to calibrate should also be used to confirm calibration.
• Latex
Latex is used to calibrate the Optical Bench. This calibration is verified by an Abbott representative during installation of the instrument.
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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Calibration Procedures
General Information
NOTES
Section 6
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Section 6 Calibration Procedures
Pre-Calibration Procedures
Overview
The Pre-Calibration Procedures in this subsection 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 ABBOTT HEMATOLOGY CUSTOMER SUPPORT
CENTER FOR ASSISTANCE. After the problems have been resolved, repeat the
Pre-Calibration Procedures to verify proper performance.
NOTE: Instrument calibration, including the pre-calibration procedures, should be completed without interruption.
Calibration Guidelines
1. Always perform the Daily, Weekly and Monthly scheduled maintenance as
directed in Section 9: Service and Maintenance
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.
NOTE: If necessary, refer to the directions for customizing the display and printout of a QC file given in
Section 5: Operating Instructions
;
Subsection: Set Up Instructions .
4. Select and process all whole blood samples according to the requirements given in Fresh Whole Blood Requirements later in this section.
5. Try to obtain a sufficient amount of sample (calibrator or fresh whole blood) so that the same sample can be used for precision check, calibration in Open and Closed Modes, and confirmation in Open and Closed Modes. If sufficient sample is not available, use a different sample for precision check.
6. Be certain that all samples used are brought to room temperature and mixed well before aspiration.
7. Be certain that the technologist performing the calibration has read and understands the information contained in the package insert for the calibrator.
8. Be certain that the technologist performing the calibration has read and understands the calibration procedure(s) and the appropriate overviews described in this manual.
9. Confirm that reagent containers are at least one third full. Replace them as necessary.
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Calibration Procedures
Pre-Calibration Procedures Section 6
10. Confirm that the waste container is no more than half full. If necessary, empty it as described in
;
Subsection: Handling and Disposing of Biohazardous Materials
.
11. Confirm that background counts are within limits. If the system has been idle for fifteen minutes or more, a Background count should be run immediately prior to running any calibration specimens.
12. Confirm that the Operator ID number is entered.
Calibration Materials
Calibrator Requirements
• For commercial calibrators, follow the directions given in the package insert.
Be certain to carefully read and follow directions given for warming and mixing.
• Auto-Cal Method: The calibrator should be cycled for a minimum of 6 and a maximum of 10 consecutive runs when calibrating in either Open or Closed
Mode.
• Enter Factor Method: The calibrator should be cycled for a minimum of 6 consecutive runs. Additional samples and/or repetitions of the specimens may be used to achieve calibration accuracy beyond NCCLS recommendations.
• The Calibrator sample should contain a minimum of 5.0 mL. If necessary, aliquot a sufficient amount of sample into a single tube for Closed Mode processing.
Fresh Whole Blood Requirements
The International Committee for Standardization in Hematology (ICSH) defines a fresh blood sample as one available for processing less than four hours following venous sampling.
Normal Sample
• Blood samples should be from the general patient population, with values for all parameters which are within the laboratory’s normal range.
• All cellular morphology must be normal.
• No known interfering substances should be present (for example, lipemia, icterus, medications).
• All samples must be properly collected in the EDTA anticoagulant used by the laboratory.
• Each tube should contain at least 90% of the nominal collection volume of blood.
• Samples should be at room temperature and mixed properly.
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Section 6 Calibration Procedures
Sample Age
• All blood samples should be less than four hours old when calibration begins.
1 These samples must be less than eight hours old by the time calibration is completed.
• No more than two hours should elapse between the CELL-DYN 3200 run and the assay by reference methodology or reference instrument. If samples are run on the CELL-DYN 3200 first, assay by reference methodology should be completed within one hour. (Certain reference methodologies are sensitive to
RBC swelling caused by in vitro deoxygenation.)
Sample Amount
The whole blood sample volume should be at least 12 mL to accomplish the following:
• Obtain reference values on a reference instrument prior to calibration.
• Calibrate both the Open and Closed Modes.
• Confirm calibration of both modes.
NOTE: Because only one fresh whole blood sample is used in Auto-Cal, it is important that a representative sample be selected to calibrate the instrument. A sample containing abnormalities may adversely affect calibration.
Number of Cycles
• Samples should be assayed first on a reference instrument or by reference methodology and then on the CELL-DYN 3200.
• Auto-Cal Method: A single fresh whole blood sample should be cycled for
10 consecutive runs when calibrating in either Open or Closed Mode.
• Enter Factor Method: Five fresh whole blood samples should be cycled twice each for a total of at least ten runs when calibrating in either Open or Closed
Mode. Additional samples and/or repetitions of the specimens may be used to achieve calibration accuracy beyond NCCLS recommendations.
Pre-Calibration Check List
Follow the procedures outlined in the Pre-Calibration Check List to ensure the instrument is ready for calibration. Use the Problem List to note any problems encountered. Make copies of both lists as needed.
NOTE: Always complete the Pre-Calibration procedures before beginning any calibration.
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Calibration Procedures
Pre-Calibration Procedures
CELL-DYN 3200
PRE-CALIBRATION PROCEDURES CHECK LIST
Section 6
Instrument:
Operator:
Date:
1._______ Perform all required maintenance.
2._______ Verify that all reagent containers are at least 1/3 full and the waste container is less than 1/2 full.
3._______ Verify that the reagents have not reached the expiration date.
Diluent/Sheath: Lot #____________ Exp. date _______
HGB Lyse:
WBC Lyse:
Lot #____________
Lot #____________
Exp. date _______
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.
WOC < 0.10 ________
NOC < 0.10 ________
RBC < 0.02 ________
HGB < 0.10 ________
PLT < 5.0
________
6._______ Verify the Open Mode precision by analyzing a fresh, normal whole blood sample 10 times in succession. Select an empty QC file in the SPECIMEN TYPE menu. Make sure Open Mode is selected. Run the sample 10 times. When the runs have been completed, write the CVs displayed on the screen in the appropriate spaces below or attach a file printout to this document.
PARAMETER
WOC
NOC
CV% LIMIT
< 2.7%
< 2.7%
CV%
________
________
RBC
HGB
MCV
PLT
<
<
<
<
1.5%
1.0%
1.0%
4.0%
________
________
________
________
7.______
If the CV for all parameters fall within the limits, go to step 8 to verify Closed Mode precision. If a parameter’s CV exceeds the limit, run the sample again. If the over-limit condition persists, call the
Abbott Hematology Customer Support Center for assistance.
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Section 6
8.______
Verify the Closed Mode precision as follows:
Calibration Procedures a. For the CS model: Use the same sample as in the Open Mode. Select an empty QC file in the SPECIMEN TYPE menu. Make sure Closed Mode is selected. Run the sample 10 times. b. For the SL model: Use the same sample as in the Open Mode. Aliquot the blood in equal volumes into 10 5-mL tubes (each tube should contain a minimum of 1 mL of sample) containing no anticoagulant. Select an empty QC file in the SPECIMEN TYPE menu. Make sure Closed Mode is selected. Place the tubes in a rack, place the rack in the “loading” position, and press the [START LOADER] key. c. When all the samples have been processed on either the CS or SL model, record the CVs below or attach a file printout to this document.
PARAMETER CV% LIMIT CV%
WOC < 2.7% ________
NOC
RBC
HGB
MCV
<
<
<
<
2.7%
1.5%
1.0%
1.0%
________
________
________
________
PLT < 4.0% ________
9.______
If any problems are detected during the procedures outlined above, document them on the form on the following page. Make copies of this form as necessary.
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Calibration Procedures
Pre-Calibration Procedures Section 6
Problems Detected
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Section 6 Calibration Procedures
Calibration Menu
Overview
The CALIBRATION menu is accessed from the MAIN MENU by pressing the
[CALIBRATION] key. The CALIBRATION menu displays the current calibration factors for the mode indicated, the date and time the factors were entered, and the operator
ID. Figure 6.1 displays the calibration factors for the Open Mode, and Figure 6.2
displays the calibration factors for the Closed Mode. Note that Open Sampler is displayed in both figures, indicating Open Mode. The mode is independent of the calibration factors being displayed.
The following soft key labels are displayed:
ENTER FACTOR
CALIBRATION LOG
AUTO-CALIBRATE
OPEN SAMPLER/
CLOSED SAMPLER
MAIN
(Key label alternates between selections)
The function of each key is discussed briefly in this section.
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Figure 6.1 Calibration Menu Screen Displaying Open Sampler Calibration Factors
6-13
Calibration Procedures
Calibration Menu Section 6
Figure 6.2 Calibration Menu Screen Displaying Closed Sampler Calibration
Factors
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Section 6 Calibration Procedures
Calibration Menu Soft Keys
Enter Factor
The [ENTER FACTOR] key is used to display the ENTER CALIBRATION FACTOR screen which displays the current whole blood factors for the displayed mode (refer
to Figure 6.3). The soft keys available in this screen are:
RESTORE FACTORS
RESET ALL TO 1.000
RETURN
Restore Factors
The [RESTORE FACTORS] key is used to restore the previous calibration factors.
This key is active only immediately after factors have been changed.
Reset all to 1.000
The [RESET ALL TO 1.000] key is used to reset all of the calibration factors to 1.000.
Return
The [RETURN] key is used to return to the main CALIBRATION menu.
Figure 6.3 Enter Calibration Factor Screen
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Calibration Procedures
Calibration Menu
Calibration Log
Section 6
The [CALIBRATION LOG] key is used to display the CALIBRATION LOG screen for the
Open or Closed Mode (refer to Figure 6.4). The soft keys available in this screen
are:
OPEN SAMPLER/CLOSED SAMPLER
PRINT LOG
RETURN
The CALIBRATION LOG holds 10 entries. The last 5 entries are displayed on the screen. To display any previous entries, press the Page Up key on the keyboard.
NOTE: 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: F = Factory, A = Auto-Cal, E = Enter Factor
(manual factor entry).
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.
Open Sampler/Closed Sampler
The [OPEN SAMPLER/CLOSED SAMPLER] key is used to display the calibration factors for the displayed mode. This key toggles between the Open and Closed
Sampler Calibration Factors.
Print Log
The [PRINT LOG] key is used to print the Calibration Log for the displayed mode.
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Section 6 Calibration Procedures
Auto-Calibrate
Figure 6.4 Calibration Log Screen (CS Model)
Return
The [RETURN] key is used to return to the main CALIBRATION menu.
The [AUTO-CALIBRATE] key is used to display the AUTO CALIBRATION screen (refer
AUTO CALIBRATION screen changes during the calibration process as reference values are entered and as runs are completed. These changes are discussed in Auto-Cal Method later in this section.
When the [AUTO-CALIBRATE] key is pressed, the following soft key labels are displayed:
WHOLE BLOOD/
CALIBRATOR
RETURN
(This key alternates between the selections)
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Calibration Procedures
Calibration Menu Section 6
6-18
Figure 6.5 Auto Calibration Screen
The [WHOLE BLOOD] and [CALIBRATOR] keys alternate to display which type of calibration material is being used. This information is displayed in the upper left corner of the screen and stored with the updated calibration factors on the
Calibration Log.
The [PRINT] key is used to print the data displayed on the screen.
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Section 6 Calibration Procedures
Auto-Cal Method
Overview
Methodology
The Auto-Cal program provides an automated calibration method that prepares the
CELL-DYN 3200 System for calibration, calculates new calibration factors, and calibrates the instrument.
NOTE: Always complete the Pre-Calibration procedures before beginning any calibration.
The instrument should be calibrated in both Open and Closed Modes using either the CELL-DYN Calibrator or normal, fresh whole blood.
NOTE: Auto-Calibration is not available in the Closed Mode on the SL model. To calibrate Closed Mode, see Calibration Procedure — Mode to Mode in subsection Enter Factor Method .
The same reference values and the same samples should be used when calibrating both modes. Either mode may be calibrated first, but it is recommended to calibrate the primary mode first.
NOTE: Calibrator is the preferred material for calibrating the CELL-DYN 3200
System.
When samples are run, Auto-Cal does the following:
1. Accepts up to ten consecutive sample runs for either calibrator or fresh whole blood samples.
2. Compares sample results against internal precision and reference checks, highlighting results that fail these checks.
3. Calculates the new calibration factors (Mean Factors) and Factor % Diff values.
4. Compares the Factor % Diff values to ranges in an internal table to determine which parameters require calibration.
NOTE: These ranges are shown in the Calibration Range Criteria worksheets (Worksheet 3 for Open Mode and Worksheet 6 for
Closed Mode) in Manual Calibration Worksheets at the end of this section.
5. Highlights Factor % Diff values which require calibration or which are overlimit.
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Calibration Procedures
Auto-Cal Method
6-20
Section 6
Determining Reference Values
The minimum and maximum values for each parameter, displayed above the reference value fields, apply to both calibrator material and fresh whole blood.
Calibrator
Obtain the reference values from the assay sheet that is packaged with the calibrator material.
Fresh Whole Blood
Follow the procedure below to determine the calibration reference values using fresh whole blood.
NOTE: No more than two hours should elapse between determining the
Reference Mean Values and performing the calibration.
WARNING: Potential Biohazard. Consider all specimens and reagents, controls, calibrators, etc., that contain human blood or serum as potentially infectious. Wear gloves, lab coats, and safety glasses and follow other biosafety procedures as specified in the OSHA Bloodborne Pathogen Rule
(29 CFR 1910.1030) or other equivalent biosafety procedures.
1. Go to a reference hematology instrument or use appropriate hematology methods with one sample of normal, fresh whole blood.
NOTE: The Auto-Cal method is designed for 1 sample. If you want to use more than one fresh whole blood, you must use the Enter Factor method.
2. Run a minimum of 10 replicates from this sample on the reference instrument.
NOTE: Because the same sample will be used to first obtain reference values on a reference instrument then to calibrate in the Open and
Closed Modes, it is important to begin with a sufficient amount of sample.
3. If a mean value for each parameter based on at least 10 runs is not automatically calculated by the reference hematology instrument or hematology methods, use a calculator to determine the Reference Mean for each parameter. For example:
The cumulative Reference WBC Mean is 6.53 when the WBC results from each run are as follows:
• RUN 1 = 6.6, RUN 2 = 6.4, RUN 3 = 6.7
• RUN 4 = 6.5, RUN 5 = 6.6, RUN 6 = 6.4
• RUN 7 = 6.7, RUN 8 = 6.3, RUN 9 = 6.5
• RUN 10 = 6.6
The cumulative mean of 6.53 equals the sum of the values (65.3) divided by the 10 runs.
4. Save these values; they will be used to calibrate the CELL-DYN 3200
System.
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Section 6
Auto-Cal Menu
Calibration Procedures
When the [AUTO-CALIBRATE] key is pressed in the main CALIBRATION menu, the
AUTO-CALIBRATION
menu is displayed (refer to Figure 6.6). Reference values are
entered on this screen.
The Spec ID field in the upper left corner of the screen defaults to “CAL#01” to identify the sample as a “Calibration sample.” This field is user-definable and accepts up to 6 alphanumeric characters. As each calibration sample is run, the calibration program adds a “-” and the run number from “01” to “10.”
Start Auto-Cal
Figure 6.6 Auto Calibration Screen
AUTO CALIBRATION screen before any reference values are entered. When the first reference value has been entered and the Enter key pressed, the [START AUTO CAL] and [QUIT]
keys are displayed (refer to Figure 6.7).
After the [START AUTO CAL] key is pressed, the operator will not be able to toggle between Calibrator and Whole Blood nor make changes to the reference values, the
Spec ID, or the Operator ID. The instrument is ready to begin processing samples.
NOTE: Pressing the [WHOLE BLOOD] or [CALIBRATOR] key does not clear or change the reference values.
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Calibration Procedures
Auto-Cal Method Section 6
6-22
Figure 6.7 START AUTO CAL Key Displayed
A message is displayed on the bulletin line alerting the operator to start running samples.
As samples are processed, the results of each run are displayed as shown in
Figure 6.8. The following soft keys are displayed:
ACCEPT
DELETE A RUN
QUIT
RETURN
(Label appears after the 5th run)
(Label appears after the 1st run)
(Label appears after the 1st run)
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Section 6 Calibration Procedures
Figure 6.8 Results Display Screen
As the first sample is processed, the [START AUTO-CAL] key disappears and the
[DELETE A RUN] key appears. The [ACCEPT] key appears after the results of the fifth run are displayed.
The following information is displayed in the lower portion of the screen:
• Current Factor
• Mean Factor (new Calibration Factor)
• Factor % Diff
• CV %
The Current Factor is calculated for each run. The Mean Factor is an average based on all runs. The Factor % Diff shows the difference between the Mean Factor and the existing Calibration Factor for that parameter. The CV (Coefficient of Variation expressed as a percent) measures the degree of variation between runs.
NOTE: The Mean Factor is the new Calibration Factor.
If a result is highlighted in Green on the Run line, it indicates that parameter has failed a reference or precision check. That result will not be included in the Mean
Factor and Factor % Diff calculations for that parameter.
Consequently, the Mean Factor for some parameters may be based on fewer runs than other parameters and may even be based on fewer than 5 runs.
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Calibration Procedures
Auto-Cal Method Section 6
For example: a. Five samples have been run and the [ACCEPT] is displayed after the 5th run b. The Factor % Diff for WOC is green, indicating it needs to be calibrated c. The WOC result for Run #4 is highlighted, indicating it failed a reference or precision check d. The Mean Factor and Factor % Diff for WOC are based on only 4 runs because Run #4 failed its internal check e. If the operator presses the [ACCEPT] and [CONFIRM ACCEPT] keys, a new calibrator factor will be entered for WOC but the new factor will be based on 4, not 5, runs.
Delete a Run
If a result for a parameter is outside a predetermined limit, that result is highlighted and not included in the Mean Factor and Factor % Diff calculations. The operator has the option of keeping or deleting the entire run. To delete a run, do the following:
1. Press [DELETE A RUN] .
2. A prompt will appear at the bottom of the screen. Type in the number of the run to be deleted and press the Enter key.
NOTE: Only one run can be deleted in each calibration session. The system does not allow a deleted run to be replaced with a new run. For example, if there are 10 runs and the operator deletes Run #5, then calibration will be based on 9 runs (remember, a highlighted result on a run will not be included in the Mean Factor or Factor % Diff for that parameter).
Quit
When [QUIT] is pressed, the [CONFIRM QUIT] and [CANCEL QUIT] keys are displayed.
Pressing [CONFIRM QUIT] deletes all runs and reference values and returns the operator to the AUTO CALIBRATION
screen shown in Figure 6.6. The screen is ready
to receive new reference values. Pressing [CANCEL QUIT] returns the operator to the current screen.
Accept
This label appears after the results of the fifth run are displayed on the screen, allowing the operator to accept all the calibration factors shown in the lower
portion of the screen (refer to Figure 6.9). When
[ACCEPT] is pressed, two key labels [CONFIRM ACCEPT] and [CANCEL ACCEPT] are displayed (refer to
[CONFIRM ACCEPT] saves the new calibration factors and displays the CALIBRATION LOG screen. Pressing [CANCEL ACCEPT] returns the operator to the Calibration results screen.
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Section 6 Calibration Procedures
Figure 6.9 ACCEPT Key Displayed
Figure 6.10 Confirm Acceptance of New Factors
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Calibration Procedures
Auto-Cal Method Section 6
Auto-Cal Procedure
¥
Open Mode
Displaying the Auto-Cal Screen
1. If necessary, go to the RUN screen and press [CHANGE SAMPLER] to select the
Open Mode.
2. In the MAIN MENU , press [CALIBRATION] to display the main CALIBRATION menu.
3. If necessary, press [OPEN SAMPLER] to display the Open Sampler Calibration
Factors.
NOTE: This key is used to display either the current Open Sampler Factors or Closed Sampler Factors. It does not change the mode.
4. Press [PRINT] to obtain a printout of the current Open Sampler Calibration Factors.
5. Press [AUTO-CALIBRATE] to display the AUTO-CALIBRATION screen.
Entering Reference Values
1. To enter reference values for each parameter to be calibrated: a. If calibrator is used, if necessary press [CALIBRATION] , enter the corresponding reference (assay) value from the sheet enclosed with the calibrator material.
b. If fresh whole blood is used, if necessary press [WHOLE BLOOD] , enter the mean value obtained from the procedure in subsection Fresh Whole
Blood under Determining Reference Values above.
NOTE: Enter the WBC mean as the reference value for both WOC and
NOC.
2. Press the Enter key after each entry to save the value and advance the cursor to the next parameter.
NOTE: To change a value after it was entered, place the cursor on the appropriate field and enter the correct value. To clear a value, press
[QUIT] followed by [CONFIRM QUIT] .
3. When all reference values have been entered, press [START AUTO-CAL] to ready the instrument for calibration. The message
Ready to aspirate
Cal sample
is displayed.
Processing Samples
1. Specimen preparation: a. If using calibrator material, 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.
b. If using fresh whole blood, mix the sample well by inverting the tube at least ten times. Do not shake the specimen.
2. Place the well-mixed specimen under the Open Mode Sample Probe and press the Touch Plate. The sample is analyzed and the results are displayed.
3. Repeat steps 1 and 2 above until the desired number of runs for either
Calibrator or Fresh Whole Blood has been completed. Mix the sample well between each run.
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Section 6 Calibration Procedures
Calibration Check
During the RUN cycle, if a parameter fails the internal reference/precision checks for calibration, the value for that parameter is backlit in green on the run line, dashes are displayed in the Current Factor field, and the Mean Factor is not updated.
Determining Which Parameters Need Calibration
1. After the [ACCEPT] key is displayed, you may continue processing samples until the desired number of runs has been completed.
2. Observe the Factor % Diff value for each parameter being calibrated: a. If the value is not highlighted (remains uncolored), that parameter does not need calibration and the new calibration factor (Mean Factor) displayed on the screen will not replace the existing calibration factor when the [ACCEPT] key is pressed. An uncolored value indicates the
Factor % Diff is less than the value shown in column 2 of Worksheet 3,
Open Mode Calibration Range Criteria, provided in Manual Calibration
Worksheets at the end of this section. b. If the value is highlighted in green, that parameter needs to be calibrated and the new calibration factor displayed on the screen will replace the existing calibration factor when the [ACCEPT] key is pressed. Green indicates the Factor % Diff is within the range specified in column 3 of
Worksheet 3, Open Mode Calibration Range Criteria, provided in
Manual Calibration Worksheets at the end of this section. c. If the value is highlighted in purple, it indicates the Factor % Diff is greater than the value shown in column 4 of Worksheet 3, Open Mode
Calibration Range Criteria, provided in Manual Calibration Worksheets at the end of this section. d. If all Factor % Diff values are uncolored, go to Calibration Not Required below. If at least one Factor % Diff is green, go to Some Parameters
Need Calibration below. If at least one Factor % Diff is purple, go to subsection Over-Limit Parameters below.
Calibration Not Required
1. If all the Factor % Diff values are uncolored, then calibration is not required in Open Mode. No update to the Calibration Log is required and no calibration confirmation is required.
2. If Closed Mode has not been calibrated, go to subsection Auto-Cal — Closed
Mode , otherwise return to the MAIN MENU by pressing [RETURN] followed by
[MAIN] .
Some Parameters Need Calibration
1. If at least one Factor % Diff value is green and if no Factor % Diff values are highlighted in purple, press [ACCEPT] followed by [CONFIRM ACCEPT] to calibrate the Open Mode. Go to subsection Completing Calibration Log below.
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Calibration Procedures
Auto-Cal Method Section 6
Over-Limit Parameters
1. If the Factor % Diff for a parameter is highlighted in purple, it indicates there may be an instrument problem. In this case, do the following: a. Determine if any component on the instrument was changed. This could affect calibration. Such components include the Shear Valve, Optical
Flow Cell, Hemoglobin Flow Cell, or one of the syringes.
b. If a component was changed, then treat the result as if it fell within the
“calibration range” (even though it is greater than the upper limit).
CALIBRATION IS REQUIRED for that parameter. Use the arrow keys to move the cursor to the Factor % Diff value. Press the Enter key to change the purple to green, indicating calibration is now required.
Pressing [ACCEPT] followed by [CONFIRM ACCEPT] will calibrate this
“over limit” parameter along with any other “calibration required” parameters. Go to subsection Completing Calibration Log below.
NOTE: Because Factor % Diff values highlighted in purple can be changed to green using the Enter key, it is also possible for the operator to overwrite these values. However, the change only appears on the screen; the actual values calculated by the calibration program remain intact and the Mean Factors are not affected.
c. If no component was changed and your calculations are correct, DO
NOT CALIBRATE. CONFIRM THAT ALL PRE-CALIBRATION
PROCEDURES WERE COMPLETED AND THEN CALL THE
ABBOTT HEMOTOLOGY CUSTOMER SUPPORT CENTER FOR
ASSISTANCE (at 1-800-CELL-DYN in the U.S.). For Customers outside the U.S. contact your local Hematology Customer Support
Representative.
Completing Calibration Log
1. Complete the Calibration Log (adding comments) as required. If a printout of the log is desired, press [PRINT LOG] .
2. Press [RETURN] to return to the main CALIBRATION screen.
3. Press [PRINT] to obtain a copy of the new Open Sampler Calibration Factors.
Confirming Open Mode Calibration
To confirm calibration in the Open Mode, follow the instructions below. Use the same Calibrator or Fresh Whole Blood Sample that was used to calibrate the instrument.
1. In the CALIBRATION menu, press [MAIN] to return to the MAIN MENU .
2. In the MAIN MENU , press [RUN] followed by [SPECIMEN TYPE] and [QC
SPECIMEN] . Select an empty QC file.
3. Refer to Worksheet 7, Calibration Confirmation, in Manual Calibration
Worksheets at the end of this section. Make copies of this worksheet as necessary.
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Section 6 Calibration Procedures
4. Run the same Calibrator or Fresh Whole Blood sample 5 times. After each run, observe the values displayed on the RUN screen for those parameters that were calibrated and that now need confirmation. When the runs are complete, print the appropriate QC file and transfer the mean value onto Worksheet #7.
5. Follow the instructions on this worksheet for comparing the mean value against the reference value.
6. If the difference between the mean and reference (assay) value is within the stated tolerance limits, then calibration has been confirmed for that parameter. Go to step 8 below.
NOTE: Calibration of the open mode may also be confirmed by running commercial controls.
7. If a parameter mean is outside the tolerance limits, perform steps 4 and 5 again. If the mean is still outside the tolerance limits, call the Abbott
Hematology Customer Support Center for assistance (at 1-800-CELL-DYN in the U.S.).
8. When Open Mode calibration has been confirmed, do one of the following: a. If Closed Mode has not yet been calibrated, go to subsection Auto-Cal
Procedure — Closed Mode .
b. If Closed Mode calibration has been completed, press [MAIN] to return to the MAIN MENU .
Auto-Cal Procedure — Closed Mode
NOTE: Auto-Calibration is not available in the Closed Mode on the SL model. To calibrate Closed Mode, see Calibration Procedure — Mode to Mode in subsection Enter Factor Method .
Displaying the Auto-Cal Screen
1. If necessary, go to the RUN screen and press [CHANGE SAMPLER] to select the
Closed Mode.
2. In the MAIN MENU , press [CALIBRATION] to display the main CALIBRATION menu.
3. If necessary, press [CLOSED SAMPLER] to display the Closed Sampler
Calibration Factors.
4. Press [PRINT] to obtain a printout of the current Closed Sampler Calibration
Factors.
5. Press [AUTO-CALIBRATE] to display the AUTO-CALIBRATION screen.
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Calibration Procedures
Auto-Cal Method Section 6
Entering Reference Values
1. To enter reference values for each parameter to be calibrated: a. If calibrator is used, if necessary, press [CALIBRATOR] , then enter the corresponding reference (assay) value from the sheet enclosed with the calibrator material.
b. If fresh whole blood is used, if necessary, press [WHOLE BLOOD] , then enter the mean value obtained from the procedure in subsection Fresh
Whole Blood under Determining Reference Values above.
NOTE: Enter the WBC mean as the reference value for both WOC and
NOC.
2. Press the Enter key after each entry to save the value and advance the cursor to the next parameter.
NOTE: To change a value after it was entered, place the cursor on the appropriate field and enter the correct value. To clear a value, press
[QUIT] followed by [CONFIRM QUIT] .
3. When all reference values have been entered, press [START AUTO-CAL] to ready the instrument for calibration.
Processing Samples
1. Mix the sample well. If Calibrator, follow the directions on the package insert. If Fresh Whole Blood, invert the sample ten times. Do not shake the specimen. Place the well-mixed specimen in the Tube Retainer, close the door, and press the Touch Plate. The instrument performs RUN 1 and displays the values in the RUN 1 row.
2. Repeat step 1 above until the desired number of runs for either Calibrator or
Fresh Whole Blood has been completed.
Calibration Check
During the RUN cycle, if a parameter fails the internal reference/precision checks for calibration, the value for that parameter is backlit in green on the run line, dashes are displayed in the Current Factor field, and the Mean Factor is not updated.
Determining Which Parameters Need Calibration
1. After the [ACCEPT] key is displayed, you may continue processing samples until the desired number of runs has been completed.
2. Observe the Factor % Diff value for each parameter being calibrated: a. If the value is not highlighted (remains uncolored), that parameter does not need calibration and the new calibration factor (Mean Factor) displayed on the screen will not replace the existing calibration factor when the [ACCEPT] key is pressed. An uncolored value indicates the
Factor % Diff is less than the value shown in column 2 of Worksheet 5,
Mode to Mode Calibration Range Criteria, provided in Manual
Calibration Worksheets at the end of this section.
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Section 6 Calibration Procedures b. If the value is highlighted in green, that parameter needs to be calibrated and the new calibration factor displayed on the screen will replace the existing calibration factor when the [ACCEPT] key is pressed. Green indicates the Factor % Diff is within the range specified in column 3 of
Worksheet 6, Closed Mode Calibration Range Criteria, provided in
Manual Calibration Worksheets at the end of this section.
c. If the value is highlighted in purple, it indicates the Factor % Diff is greater than the value shown in column 4 of Worksheet 6, Closed Mode
Calibration Range Criteria, provided in Manual Calibration Worksheets at the end of this section. d. If all Factor % Diff values are uncolored, go to Calibration Not Required below. If at least one Factor % Diff is green, go to Some Parameters
Need Calibration below. If at least one Factor % Diff is purple, go to subsection Over-Limit Parameters below.
Calibration Not Required
1. If all the Factor % Diff values are uncolored, then calibration is not required in Closed Mode. No update to the Calibration Log is required and no calibration confirmation is required.
2. If Open Mode has not been calibrated, go to subsection Auto-Cal — Open
Mode , otherwise return to the MAIN MENU by pressing [RETURN] followed by
[MAIN] .
Some Parameters Need Calibration
1. If at least one Factor % Diff value is highlighted in green and if no Factor %
Diff values are highlighted in purple, press [ACCEPT] followed by [CONFIRM
ACCEPT] to calibrate the Closed Mode. Go to subsection Completing
Calibration Log below.
Over-Limit Parameters
1. If the Factor % Diff for a parameter is highlighted in purple, it indicates there may be an instrument problem. In this case, do the following: a. Determine if any component on the instrument was changed. This could affect calibration. Such components include the Shear Valve, Optical
Flow Cell, Hemoglobin Flow Cell, or one of the syringes.
b. If a component was changed, then treat the result as if it fell within the
“calibration range” (even though it is greater than the upper limit).
CALIBRATION IS REQUIRED for that parameter. Use the arrow keys to move the cursor to the Factor % Diff value. Press the Enter key to change the purple to green, indicating calibration is now required. Press
[ACCEPT] followed by [CONFIRM ACCEPT] to calibrate this “over limit” parameter along with any other “calibration required” parameters. Go to subsection Completing Calibration Log below.
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Calibration Procedures
Auto-Cal Method Section 6
NOTE: Because Factor % Diff values highlighted in purple can be changed to green using the Enter key, it is also possible for the operator to overwrite these values. However, the change only appears on the screen; the actual values calculated by the calibration program remain intact and the Mean Factors are not affected.
c. If no component was changed and your calculations are correct, DO
NOT CALIBRATE. CONFIRM THAT ALL PRE-CALIBRATION
PROCEDURES WERE COMPLETED AND THEN CALL THE
ABBOTT HEMATOLOGY CUSTOMER SUPPORT CENTER FOR
ASSISTANCE (at 1-800-CELL-DYN in the U.S.).
Completing Calibration Log
1. Complete the Calibration Log (adding comments) as required. If a printout of the log is desired, press [PRINT LOG] .
2. Press [RETURN] to return to the main CALIBRATION screen.
3. Press [PRINT] to obtain a copy of the new Closed Sampler Calibration Factors.
Confirming Closed Mode Calibration
To confirm calibration in the Closed Mode, follow the instructions below. Use the same Calibrator or Fresh Whole Blood Sample that was used to calibrate the instrument.
1. In the CALIBRATION menu, press [MAIN] to return to the MAIN MENU .
2. In the MAIN MENU , press [RUN] followed by [SPECIMEN TYPE].
Select an empty QC file and press [QC SPECIMEN] .
3. Refer to Worksheet 7, Calibration Confirmation, in Manual Calibration
Worksheets at the end of this section. Make copies of this worksheet as necessary.
4. Run the same Calibrator or Fresh Whole Blood samples in duplicate.
NOTE: You may also elect to Run Commercial Control as a means of confirming calibration.
5. After each run, observe the values displayed on the RUN screen for those parameters that were calibrated and that now need confirmation. Write these values in the appropriate space on Worksheet 7.
6. Follow the instructions on this worksheet for calculating a mean and comparing the mean value against the reference value.
7. If the difference between the mean and reference (assay) value is within the stated tolerance limits, then calibration has been confirmed for that parameter. Go to step 9 below.
8. If a parameter mean is outside the tolerance limits, perform steps 4 and 5 again. If the mean is still outside the tolerance limits, call the Abbott
Hematology Customer Support Center for assistance (at 1-800-CELL-DYN in the U.S.).
9. When Closed Mode calibration has been confirmed, press [MAIN] to return to the MAIN MENU .
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Section 6 Calibration Procedures
Enter Factor Method
Overview
The Enter Factor Calibration Method is used to enter a predetermined factor to adjust calibration when a consistent bias exists between the CELL-DYN 3200
System and a comparison analyzer. This method can also be used when calibrating the secondary mode of the system to the primary mode.
Either Calibrator or Fresh Whole Blood can be used for calibration.
Fresh Whole Blood: Because the same samples will be used to first obtain reference values on a reference instrument then to calibrate in the Open and Closed
Modes, it is important to begin with a sufficient amount of sample (12 mL each is recommended).
A set of worksheets is provided in Manual Calibration Worksheets at the end of this section to assist in the calibration process.
NOTE: Always complete the Pre-Calibration procedures before beginning any calibration.
Enter Calibration Factor Screen
When the Enter Factor key is pressed in the main CALIBRATION menu, the ENTER
CALIBRATION FACTO
R menu is displayed (refer to Figure 6.11). New calibration
factors are manually entered on this screen.
The following soft key labels are displayed:
RESTORE FACTORS
RESET ALL TO 1.000
RETURN
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Calibration Procedures
Enter Factor Method Section 6
Figure 6.11 Enter Factor Screen
General Information
Calibrator
The requirements for using Calibrator in the Enter Factor method are similar to the
Auto-Cal method. Refer to Calibrator Requirements under Calibration Materials earlier in this section.
Fresh Whole Blood
In addition to the requirements listed in Fresh Whole Blood Requirements under
Calibration Materials earlier in this section, the following procedures apply when using the Enter Factor method:
1. A minimum of five samples are required for adequate calibration.
2. Mean values should be calculated for each parameter based on 10 runs (five samples, each run twice into one QC file). These mean parameter values can then be entered as reference values on the CELL-DYN 3200 System.
ICSH Recommendations
When using fresh whole blood samples, reference values should be determined according to the following ICSH recommendations.
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Section 6 Calibration Procedures
WOC, NOC, RBC, and PLT
Reference values for white blood cells, red blood cells, and platelets may be determined using multiple counts from a certified hemocytometer, from a counter that meters a fixed, calibrated sample volume, or from a reliably calibrated hematology analyzer.
HGB
Reference values for hemoglobin 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 3200 System with a hemoglobin standard designed for the calibration of specific reference cyanmethemoglobin methods. The instrument uses a modified hemoglobinhydroxyalamine method which is not designed to analyze these standards directly.
MCV
Reference values for the mean cell volume may be determined by calculation from the reference microhematocrit and RBC measurements or from multiple analyses on a reliably calibrated hematology analyzer.
NOTE: Reference microhematocrit values may be determined by multiple analyses using the NCCLS method for Packed Cell Volume (PCV).
2 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.
Determining Reference Values — Fresh Whole Blood
Follow the procedures below to determine the reference values that will be used to calibrate the instrument using fresh whole blood.
NOTE: No more than two hours should elapse between determining the
Reference Mean Values and performing the calibration.
WARNING: Potential Biohazard. Consider all specimens potentially infectious. Wear gloves, lab coats, and safety glasses and follow other biosafety procedures as specified in the OSHA Bloodborne Pathogen Rule
(29 CFR 1910.1030) or other equivalent biosafety procedures.
1. Go to a reference hematology instrument (or use appropriate hematology methods) with 5 samples of normal, fresh whole blood. Run each sample at least twice for a minimum of 10 replicates on the reference instrument.
NOTE: Because the same samples will be used to first obtain reference values on a reference instrument then to calibrate in the Open and
Closed Modes, it is important to begin with a sufficient amount of each sample.
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Calibration Procedures
Enter Factor Method Section 6
2. If a mean value for each parameter based on at least 10 runs is not automatically calculated by the reference hematology instrument or hematology methods, use a calculator to determine the cumulative Reference
Mean for each parameter. For example:
The cumulative Reference WOC Mean is 7.15 when the WOC results from each run are as follows:
• Sample 1 = 9.2, 9.1
• Sample 2 = 4.5, 4.6
• Sample 3 = 6.1, 5.9
• Sample 4 = 7.0, 7.3
• Sample 5 = 8.9, 8.9
The cumulative mean of 7.15 equals the sum of the values (71.5) divided by the 10 runs.
You may use the worksheet on the following page to record the values obtained from running samples on a reference instrument. Make copies of the blank worksheet as necessary.
NOTE: Enter the WBC mean as the reference value for both the WOC and NOC.
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Section 6 Calibration Procedures
Whole Blood Calibration Reference Values Worksheet
Date: Technologist:
Sample ID Run #
WBC
(WOC)
WBC
(NOC)
RBC HGB MCV PLT
1
2
1
2
1
2
1
2
1
2
Cumulative Mean
NOTE: The WBC value obtained on the Reference Instrument should be used for calibrating both the WOC and NOC parameters on the CELL-DYN 3200
Instrument.
Calibration Procedure — Open Mode
Follow the procedure below for calibrating the instrument in the Open Mode.
NOTE: Use the same Calibrator or Fresh Whole Blood samples for calibrating
Open and Closed Modes.
Determining New Calibration Factors
1. If necessary, go to the RUN menu and press [CHANGE SAMPLER] to select the
Open Mode.
2. In the MAIN MENU , press [CALIBRATION] to display the main CALIBRATION menu.
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Calibration Procedures
Enter Factor Method Section 6
3. Obtain a printout of the current Open Sampler Calibration Factors as follows: a. If necessary, press [OPEN SAMPLER] to display the Open Sampler
Calibration Factors.
b. Press [PRINT] to obtain a printout of these factors. Save this printout. It will be used when completing Worksheet 1 at the end of this section.
4. Open an empty QC file as follows: a. In the MAIN MENU , press [RUN] to display the RUN menu.
b. If necessary, press [CHANGE SAMPLER] to select Open Mode.
c. Press [SPECIMEN TYPE] to display the SPECIMEN TYPE menu.
d. Use the arrow keys on the keyboard to move the cursor to an empty QC file and type the desired file name in the <File Name> field.
e. Press Enter to save the name. Use the Up Arrow key to move the cursor back to the file name.
f. Press [QC SPECIMEN] to return to the RUN screen.
5. If calibrator material is used, follow the mixing instructions found in the package insert. If fresh whole blood is used, mix it well by inverting the tube at least ten times. Do not shake the specimen.
WARNING: Potential Biohazard. Consider all specimens, calibrators, and controls that contain human blood as potentially infectious. Wear gloves, lab coats, and safety glasses and follow other biosafety procedures as specified in the OSHA Bloodborne Pathogen Rule (29 CFR 1910.1030) or other equivalent biosafety procedures.
6a. If calibrator material is used, when
READY
appears in the Status Box, place the calibrator under the Open Mode Sample Probe and press the Touch Plate to run the specimen. The results of the run are placed in the QC file selected in step 1. Repeat this step until the minimum number of recommended runs
(6) is completed. Go to step 7.
6b. If fresh whole blood is used, when
READY
appears in the Status Box place the sample under the Open Mode Sample Probe and press the Touch Plate to run the specimen. The results of the run are placed in the QC file selected in step 1. Repeat this process until 10 runs (2 from each sample) are completed.
7. When sample processing is completed, press [MAIN] followed by [ QUALITY
CONTROL] . Use the arrow keys to place the cursor on the appropriate QC file and press [ VIEW QC LOG] .
8. Press [PRINT QC LOG] to print the Summary Report for the selected QC file.
6-38 CELL-DYN ® 3200 System Operator’s Manual
9140181H—October 2001
Section 6 Calibration Procedures
9. To determine the New Calibration Factor for each parameter: a. For Calibrator, use the values on the assay sheet and the CELL-DYN mean values determined in steps 2 through 8 above. Enter this information in columns 1 and 2 respectively of Worksheet 1, Open Mode
Calibration — New Factors, provided in Manual Calibration
Worksheets at the end of this section. b. For Fresh Whole Blood, use the Reference Mean Values determined in
Determining Reference Values — Fresh Whole Blood described earlier
(refer to the Whole Blood Calibration Reference Values Worksheet) and the CELL-DYN Mean values determined in steps 2 through 8 above.
Enter this information in columns 1 and 2 respectively of Worksheet 1,
Open Mode Calibration — New Factors, provided in Manual
Calibration Worksheets at the end of this section. c. Enter the current Open Sampler Calibration Factors, obtained in step 3 above, in column 3 of Worksheet 1.
NOTE: Be sure to make copies of this worksheet as needed.
10. Follow the instructions on Worksheet 1 to calculate the new Open Mode
Calibration Factor for each parameter and enter this information in column 4 of the worksheet. The method for determining the new factors is: a. Calibrator Calibration:
&(//'<10HDQ
×
&XUUHQW2SHQ0RGH
&DOLEUDWLRQ)DFWRU b. Whole Blood Calibration:
1HZ2SHQ0RGH
&DOLEUDWLRQ)DFWRU
×
&XUUHQW2SHQ0RGH
&DOLEUDWLRQ)DFWRU
1HZ2SHQ0RGH
&DOLEUDWLRQ)DFWRU
For example, if the Reference Mean Value for WOC is 6.6, the CELL-DYN
Mean for WOC is 7.1, and the current Open Mode Calibration Factor for
WOC is 0.98, then:
(6.6 / 7.1) × 0.98 = 0.91
and 0.91 is your New Open Mode Calibration Factor for WOC.
Determining Which Parameters Need Calibration
To determine which parameters require calibration in the Open Mode, follow the procedure below:
1a. Transfer the values from column 4 of Worksheet 1 to the new Open Mode
Factor columns 1 and 3 of Worksheet 2, Open Mode Factor % Difference, provided in Manual Calibration Worksheets at the end of this section.
NOTE: Make copies of this worksheet as needed.
1b. Transfer the values for the Current Open Mode Cal factor from column 3 of
Worksheet 1 and enter these values in column 2 of Worksheet 2.
2. Follow the instructions on this worksheet to determine the Factor % Diff for each parameter.
CELL-DYN ® 3200 System Operator’s Manual
9140181H—October 2001
6-39
Calibration Procedures
Enter Factor Method Section 6
3. Transfer the Factor % Diff values from column 5 (calculated in Worksheet 2 ) to column 1 of Worksheet 3, Open Mode Calibration Range Criteria, provided in Manual Calibration Worksheets at the end of this section.
NOTE: Make copies of this worksheet as needed.
4. For each parameter, if the Factor % Diff is equal to or less than the value in the Lower Limit column, then CALIBRATION IS NOT REQUIRED for that parameter because the value is within range.
5. For each parameter, if the Factor % Diff falls between the upper and lower calibration range, shown in the Calibration Range column, then
CALIBRATION IS REQUIRED.
6. For each parameter, if the Factor % Diff is greater than the value in the
Upper Limit column, there may be a computation error or an instrument problem. In this case, do the following: a. Recheck all numbers and calculations on Worksheets 1 and 2.
b. Determine if any component on the instrument was changed. This could affect calibration. Such components include the Shear Valve, Optical
Flow Cell, Hemoglobin Flow Cell, or one of the syringes.
c. If a component was changed, then treat the result as if it fell within the
“calibration range” (even though it is greater than the upper limit).
CALIBRATION IS REQUIRED for that parameter. d. If no component was changed and your calculations are correct, DO
NOT CALIBRATE. Confirm that all Pre-Calibration procedures were completed and call the Abbott Hematology Customer Support Center for assistance (at 1-800-CELL-DYN in the U.S.).
7. Based on the results from steps 1 through 6 above, do one of the following: a. If any parameter needs to be calibrated in the Open Mode, go to Entering
New Calibration Factors — Open Mode . b. If none of the parameters requires Open Mode calibration and Closed
Mode has not been calibrated, go to Calibration Procedure — Mode to
Mode to determine if Closed Mode needs calibrating.
c. If none of the parameters requires Open Mode calibration and Closed
Mode calibration has already been completed, press [MAIN] to return to the MAIN MENU .
6-40 CELL-DYN ® 3200 System Operator’s Manual
9140181H—October 2001
Section 6 Calibration Procedures
Entering New Calibration Factors — Open Mode
1. In the main CALIBRATION menu, press [ENTER FACTOR] .
2. Use the arrow keys to select the first factor in the Open Sampler column to be changed. Type in the New Calibration Factor calculated in step 10 in
Determining New Calibration Factors above. Press the Enter key to save the factor and advance the cursor. If necessary, use the arrow keys to select the next factor to be changed.
NOTE: Prior to exiting the screen, the operator may press the [RESTORE
FACTORS] soft key to recall factors, stored on the Hard Disk, corresponding to the current mode — Open or Closed. [RESET ALL
TO 1.000] is used to reset all factors displayed on the screen to
1.000.
3. When all new factors have been entered, press [RETURN] to display the
CALIBRATION LOG screen with the new calibration factors.
NOTE: If no changes are made in the ENTER CALIBRATION FACTOR screen, pressing [RETURN] will bypass the CALIBRATION LOG screen and display the main CALIBRATION menu.
4. Complete the Calibration Log (adding comments) as required. If a printout of the log is desired, press [PRINT LOG] .
5. Press [RETURN] twice to return to the main CALIBRATION menu.
6. Press [PRINT] to obtain a copy of the new Open Sampler Calibration Factors.
7. Press [MAIN] to return to the MAIN MENU .
CELL-DYN ® 3200 System Operator’s Manual
9140181H—October 2001
6-41
Calibration Procedures
Enter Factor Method Section 6
Confirming Open Mode Calibration
1. Press [RUN] followed by [SPECIMEN TYPE] . Select an empty QC file and press
[QC SPECIMEN] .
2. Refer to Worksheet 7, Calibration Confirmation, in Manual Calibration
Worksheets provided at the end of this section.
NOTE: Make copies of this worksheet as necessary.
3a. Obtain the calibrator used in the calibration process and run it three times into the empty QC file. When the runs are completed, print the appropriate QC file and transfer the mean values to the appropriate spaces on Worksheet 7.
3b. Obtain each of the five samples used in the calibration process and run each sample once. When the five runs are complete, print the appropriate QC file and transfer the mean values to the appropriate spaces on Worksheet 7.
4. Follow the instructions on the worksheet for comparing the mean value against the assay values (calibrator), or reference mean (fresh whole blood).
5. If the difference between the mean of 3/5 runs and the assay value/reference mean is within the tolerance limits, then calibration is confirmed for that parameter. Proceed to calibrate the Closed Mode if not already calibrated.
NOTE: Calibration of the Open Mode may also be confirmed by running commercial controls.
6. If a parameter’s mean is outside the stated tolerance limits, repeat steps 3 and
4 above for that parameter. If the mean is still outside the stated tolerance limits, call the Abbott Hematology Customer Support Center for assistance
(at 1-800-CELL-DYN in the U.S.).
6-42 CELL-DYN ® 3200 System Operator’s Manual
9140181H—October 2001
Section 6 Calibration Procedures
Calibration Procedure — Mode to Mode
Follow the procedure below for calibrating the instrument in the Closed Mode.
NOTE: Use the same Calibrator or Fresh Whole Blood samples for calibrating
Open and Closed Modes.
Determining the Closed Mode Mean
1. If necessary, go to the RUN menu and press [CHANGE SAMPLER] to select the
Closed Mode.
2. In the MAIN MENU , press [CALIBRATION] to display the main CALIBRATION menu.
3. Obtain a printout of the current Closed Sampler Calibration Factors as follows: a. If necessary, press [CLOSED SAMPLER] to display the Closed Sampler
Calibration Factors.
b. Press [PRINT] to obtain a printout of these factors. Save this printout. It will be used when completing Worksheet 6 at the end of this section.
4. Open an empty QC file as follows: a. In the MAIN MENU , press [RUN] to display the RUN menu.
b. If necessary, press [CHANGE SAMPLER] to select Closed Mode.
c. Press [SPECIMEN TYPE] to display the SPECIMEN TYPE menu.
d. Use the arrow keys on the keyboard to move the cursor to an empty QC file and type the desired name in the <File Name> field.
e. Press Enter to save the name. Use the Up Arrow key to move the cursor back to the file name.
f. Press [QC SPECIMEN] to return to the RUN screen.
WARNING: Potential Biohazard. Consider all specimens, calibrators, and controls that contain human blood as potentially infectious. Wear gloves, lab coats, and safety glasses and follow other biosafety procedures as specified in the OSHA Bloodborne Pathogen Rule (29 CFR 1910.1030) or other equivalent biosafety procedures.
5. Calibrating the CS model (Calibrator or Fresh Whole Blood): a. Mix the specimen well. If calibrator material is used, follow the mixing instructions found in the package insert. If fresh whole blood is used, mix it well by inverting the tube at least ten times. Do not shake the specimen.
b. Place the well-mixed specimen in the Tube Retainer, close the door, and press the Touch Plate. c. If calibrator material is used, repeat this process until a minimum of 6 runs has been completed.
d. If fresh whole blood is used, repeat this process until a minimum of 10 runs has been completed.
e. Go to step 7.
CELL-DYN ® 3200 System Operator’s Manual
9140181H—October 2001
6-43
Calibration Procedures
Enter Factor Method Section 6
6. Calibrating the SL model with Calibrator or Fresh Whole Blood: a. Determine the number of runs you expect to make (6 runs should be the minimum for calibrator, 10 runs for fresh whole blood) and obtain the same number of empty 5-mL tubes containing no anticoagulant. b. Mix the specimen well. If Calibrator, follow the directions on the package insert. If Fresh Whole Blood, invert the sample ten times. Do not shake the specimen.
c. Aliquot the sample as follows:
1. For Calibrator, aliquot the sample in equal volumes into the tubes
(each tube should contain a minimum of 1.5 mL of sample).
2. For Fresh Whole Blood, there should be a minimum of 5 samples
(refer to Number of Cycles under Calibration Materials earlier in this section). Aliquot the first sample in equal volumes into two tubes. Aliquot the second sample in equal volumes into another two tubes. Repeat this procedure until all 5 samples have been aliquoted
(for a total of 10 tubes).
d. Place the closed tubes on a rack and set the rack on the “load” side.
e. Press [START LOADER] . Allow the instrument to process all the samples.
7. When sample processing is completed, press [MAIN] followed by [QUALITY
CONTROL] . Use the arrow keys to place the cursor on the appropriate QC file and press [VIEW QC LOG] .
8. Press [PRINT QC LOG] to print the Summary Report for the selected QC file.
9. To determine the Mode to Mode Calibration Difference for each parameter: a. Transfer the information from Step 8 above to the Manual Mode to Mode
Calibration Worksheet and enter it in the first column. (Worksheet 4) b. Determine the Open Mode Mean for the Calibrator or Fresh Whole
Blood samples as described in the Calibration Procedure - Open Mode,
Determining New Calibration Factors, steps 2–8. Transfer the information to the Manual Mode to Mode Calibration worksheet and enter it in columns 2 and 3.
c. Calculate the Mode to Mode Calibration Difference for each parameter as follows:
Closed Mode Mean - Open Mode Mean
Open Mode Mean x 100 = % Difference
NOTE: Make copies of this worksheet as needed.
10. Enter the Mode to Mode Calibrator Difference for each parameter in column
4 of the worksheet.
6-44 CELL-DYN ® 3200 System Operator’s Manual
9140181H—October 2001
Section 6 Calibration Procedures
Determining Which Parameters Need Calibration
To determine which parameters require calibration in the Closed Mode, follow the procedure below:
1. Obtain the values derived in column 4 of Worksheet 4 and enter these values in column 1 of Worksheet 5, Mode to Mode Calibration Criteria, provided in subsection Manual Calibration Worksheets at the end of this section.
NOTE: Make copies of this worksheet as needed.
2. Follow the instructions on Worksheet 5 to determine which parameters require calibration.
NOTE: Make copies of this worksheet as needed.
3. For each parameter, if the % Diff is equal to or less than the value in the
Lower Limit column, then CALIBRATION IS NOT REQUIRED for that parameter because the value is within range.
a. If none of the parameters requires Closed Mode calibration and Open
Mode has not been calibrated, go to Calibration Procedure — Open
Mode to determine if Open Mode needs calibrating.
NOTE: It is recommended that the primary mode (Open Mode) be calibrated first.
b. If none of the parameters requires Closed Mode calibration and Open
Mode calibration has already been completed, press [MAIN] to return to the MAIN MENU .
4. For each parameter, if the % Diff falls between the upper and lower calibration range, shown in the Calibration Range column, then
CALIBRATION IS REQUIRED.
5. For each parameter, if the % Diff is greater than the value in the Upper Limit column, there may be a computation error or an instrument problem. In this case, do the following: a. Recheck all numbers and calculations on Worksheets 4 and 5.
b. Determine if any component on the instrument was changed. This could affect calibration. Such components include the Shear Valve, Optical
Flow Cell, Hemoglobin Flow Cell, or one of the syringes.
c. If a component was changed, then treat the result as if it fell within the
“calibration range” (even though it is greater than the upper limit).
CALIBRATION IS REQUIRED for that parameter. d. If no component was changed and your calculations are correct, DO
NOT CALIBRATE. Confirm that all Pre-Calibration procedures were completed and call the Abbott Hematology Customer Support Center for assistance (at 1-800-CELL-DYN in the U.S.).
CELL-DYN ® 3200 System Operator’s Manual
9140181H—October 2001
6-45
Calibration Procedures
Enter Factor Method Section 6
Calculating New Closed Mode Calibration Factors
Based on the results from steps 1 through 5 above, perform the following:
1. If Closed Mode calibration is required, use Worksheet 6 to calculate the New
Closed Mode Calibration Factor for the parameters that require calibration.
(Use the Current Closed Mode Cal Factor that was printed in 'HWHUPLQLQJ
WKH&ORVHG0RGH0HDQ step 3, at the start of this procedure.)
Calibrator Calibration:
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&XUUHQW&ORVHG0RGH
&DOLEUDWLRQ)DFWRU
Whole Blood Calibration:
1HZ&ORVHG0RGH
&DOLEUDWLRQ)DFWRU
×
&XUUHQW&ORVHG0RGH
&DOLEUDWLRQ)DFWRU
1HZ&ORVHG0RGH
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For example, if the Reference Mean Value for WOC is 6.6, the CELL-DYN
Mean for WOC is 7.4, and the current Closed Mode Calibration Factor for
WOC is 1.04, then:
(6.6 / 7.4) × 1.04 = 0.93
and 0.93 is the New Closed Mode Calibration Factor for WOC.
2a. If the new Closed Mode Calibration Factors falls within the acceptable range given on the worksheet, follow the procedure for entering new calibration factors below.
2b. If the New Closed Mode Calibration Factor for a given parameter falls outside the acceptable range, there may be a computation error. 'RQRW
FDOLEUDWHWKDWSDUDPHWHU Recheck all calculations. If the factor(s) is still outside the acceptable range, call the Abbott Hematology Customer Support
Center for assistance (at 1-800-CELL-DYN in the U.S.).
6-46 CELL-DYN ® 3200 System Operator’s Manual
9140181H—October 2001
Section 6 Calibration Procedures
Entering New Calibration Factors — Closed Mode
1. In the CALIBRATION menu, press [ENTER FACTOR] .
2. Use the arrow keys to select the first factor in the Closed Sampler column to be changed. Type in the New Calibration Factor calculated in Calculating
New Closed Mode Calibration Factors above. Press the Enter key to save the factor and advance the cursor. If necessary, use the arrow keys to select the next factor to be changed.
NOTE: Prior to exiting the screen, the operator may press the [RESTORE
FACTORS] soft key to recall factors, stored on the Hard Disk, corresponding to the current mode — Open or Closed. [RESET ALL
TO 1.000] is used to reset all factors displayed on the screen to
1.000.
3. When all new factors have been entered, press [RETURN] to display the
CALIBRATION LOG screen with the new calibration factors.
NOTE: If no changes are made in the ENTER CALIBRATION FACTOR screen, pressing [RETURN] will bypass the CALIBRATION LOG screen and display the main C ALIBRATION menu.
4. Complete the Calibration Log (adding comments) as required. If a printout of the log is desired, press [PRINT LOG] .
5. Press [RETURN] twice to return to the main CALIBRATION menu.
6. Press [PRINT] to obtain a copy of the new Closed Sampler Calibration Factors.
7. Press [MAIN] to return to the MAIN MENU .
CELL-DYN ® 3200 System Operator’s Manual
9140181H—October 2001
6-47
Calibration Procedures
Enter Factor Method Section 6
Confirming Closed Mode Calibration
1. Press [RUN] followed by [SPECIMEN TYPE] . Select an empty QC file and press
[QC SPECIMEN] .
2. Refer to Worksheet 7, Calibration Confirmation, in subsection Manual
Calibration Worksheets . Make copies of this worksheet as necessary.
3a. Obtain the calibrator used in the calibration process and run it three times into the empty QC file. When the runs are completed, print the appropriate QC file and transfer the mean values to the appropriate spaces on Worksheet 7.
3b. Take each of the five samples used in the calibration process and run each sample once. When done, print the appropriate QC file and transfer the values in the appropriate space on the Worksheet 7.
NOTE: Closed Mode Calibration may also be confirmed by running commercial controls.
4. Follow the instructions on the worksheet for comparing the mean value against the assay value (calibrator) or reference mean (fresh whole blood).
5. If the difference between the mean and assay value/reference mean is within the stated tolerance limits, then calibration has been confirmed for that parameter. Proceed to calibrate the Open Mode if not already calibrated.
6. If a parameter’s mean is outside the stated tolerance limits, repeat steps 3 and
4 above for that parameter. If the mean is still outside the stated tolerance limits, call the Abbott Hematology Customer Support center for assistance
(at 1-800-CELL-DYN in the U.S.).
6-48 CELL-DYN ® 3200 System Operator’s Manual
9140181H—October 2001
Section 6 Calibration Procedures
Post Calibration Procedure
Quality Control
Confirm calibration changes by running all levels of controls into the appropriate
QC files. If any parameters fall outside the limits, proceed as follows:
1. Obtain new vials of the controls.
2. Warm and mix them properly 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 in the U.S.).
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 Backup
The current calibration factors should be saved on the CELL-DYN 3200 Set-Up
Disk #1whenever 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 Module to
Set-Up Disk #1:
• Calibration Factors
• Retic QC
• Patient Limits
• Analyzer Module Set Points (e.g., gains, dilution factors [internal calibration factors], thresholds, pressure/vacuum settings)
• Units Selection
To back-up the calibration factors, proceed as follows:
1. With the MAIN MENU screen displayed, press the F12 key, then the F8 key.
The following message displays:
CD3200 program terminated (0)
CD3200 program terminated (0)
C:\CD3200>
CELL-DYN ® 3200 System Operator’s Manual
9140181H—October 2001
6-49
Calibration Procedures
Post Calibration Procedure Section 6
2. Obtain SET-UP Disk#1 from the Disk Storage Container located on the back of the instrument, and insert the disk into the instrument’s floppy disk drive
(located on the right-side panel of the instrument). Press and hold the [CTRL] and [ALT] keys, then press the [DELETE] key on the keyboard, this causes the data station to boot the floppy disk.
3. When the DOS prompt displays:
Select (A) Abort; (S) Save; (R) Restore: [A, S, R]?
type “ s ” (Save). The following files are saved:
Nonvol (NONVOL)
Calibration Log (CALLOG)
Worklist Log (WKLOG)
Error Log
Retic QC
(ERRORLOG)
(RQCLOG)
NOTE: The (R) Restore option copies existing setup information from the
SET-UP Disk to the Data Station hard disk. Selecting “ r ” will overwrite the current calibration and instrument setting files in the
CELL-DYN 3200 directory with previously-saved versions from the archive on the floppy disk. In this case, the instrument may need to be recalibrated and instrument settings may need to be re-established by a field service representative.
This option is used when a hardware or software failure occurs and should only be used at the direction of the Abbott Hematology
Customer Support Center.
NOTE: In the message “Write Protect Error Writing Drive A” displays, eject the SET-UP Disk. Unlock the disk by sliding the writeprotected tab on the disk’s corner. Reinsert the disk and press the
“ R ” (Retry) key on the keyboard.
4. When the following prompt displays, the backup is complete:
A:/
5. Remove SET-UP Disk #1 from the diskette drive and return it to the Disk
Storage Container located on the back of the instrument.
6. Turn the instrument power OFF then ON.
7. When the instrument is initialized, press the [RUN] key to prime the system.
6-50 CELL-DYN ® 3200 System Operator’s Manual
9140181H—October 2001
Section 6 Calibration Procedures
Manual Calibration Worksheets
Seven worksheets are provided to assist in the calculation and determination of new calibration factors for the CELL-DYN 3200 System. Three worksheets are designed for the Open Mode procedure, three worksheets for the Closed Mode procedure, and one worksheet for confirmation.
• Worksheet 1 Open Mode Calibration — New Factors
• Worksheet 2 Open Mode Factor % Difference
• Worksheet 3 Open Mode Calibration Range Criteria
• Worksheet 4 Mode to Mode Calibration Difference
• Worksheet 5 Mode to Mode Calibration Criteria
• Worksheet 6 New Closed Mode Calibration Factors
• Worksheet 7 Calibration Confirmation — QC Specimen Type
Make copies of these worksheets as necessary.
CELL-DYN ® 3200 System Operator’s Manual
9140181H—October 2001
6-51
Calibration Procedures
Manual Calibration Worksheets
Instrument:
WOC
NOC
RBC
HGB
MCV
PLT
(1)
Assay Value or
Ref Mean
/
/
/
/
/
/
/
Worksheet 1
Date:
Open Mode Calibration — New Factors
Operator:
(Calculate All Factors To Three Decimal Places)
(2)
Open Mode
Mean x
(3)
Current
Open Mode
Cal Factor
=
(4)
New
Open Mode
Cal Factor x x x x x x
=
=
=
=
=
=
Section 6
(5)
Range
0.700–1.300
0.700–1.300
0.800–1.200
0.700–1.300
0.700–1.300
0.700–1.300
1. In column 1, enter the calibrator assay values or the fresh whole blood reference means that were used in the calibration process (refer to step 9 on page 6-45). Use the same WBC Reference Value for WOC and
NOC.
2. In column 2, enter the mean values calculated in the QC file.
3. In column 3, enter the calibration factors that existed prior to running the current calibration procedure.
4. For each parameter, divide the value in column 1 by the value in column 2 and multiply the result by the value in column 3.
5. The value calculated in step 4 is the new calibration factor. Write this value in column 4.
6. Compare the new calibration factor in column 4 with the range shown in column 5. If the new factor falls within the range, go to Worksheet 2. If the new factor falls outside the range, check all calculations. If necessary, run the samples again into a new QC file and perform new calculations.
6-52 CELL-DYN ® 3200 System Operator’s Manual
9140181H—October 2001
Section 6 Calibration Procedures
Worksheet 2
Open Mode Factor % Difference
(Calculate All Factors To Three Decimal Places)
WOC
NOC
RBC
HGB
MCV
(1)
New Open
Mode Factor
–
–
–
–
–
–
(2)
Current Open
Mode Factor
/
/
/
/
/
/
(3)
New Open
Mode Factor
(4) x 100 = x 100 = x 100 = x 100 = x 100 = x 100 =
(5)
Factor
% Diff
PLT – / x 100 =
1. In column 1, enter the new factor calculated in column 4 of the previous worksheet.
2. In column 2, enter the calibration factor that existed prior to running the current calibration procedure.
3. Subtract the current factor in column 2 from the new factor in column 1 and divide the result by the current factor. Enter this result in column 3.
4. Multiply the result in column 3 by 100 and enter the result in column 5.
(1)
Factor%
Diff
Worksheet 3
Open Mode Calibration Range Criteria
(2)
Lower Limit
Cal Not Required
(3)
Calibration Range
Cal Required
(4)
Upper Limit
Do Not Cal
(5)
Cal? Y/N
WOC
NOC
RBC
HGB
MCV
<1.5%
<1.5%
<1.0%
<1.0%
<1.0%
>1.5% but <10%
>1.5% but <10%
>1.0% but <10%
>1.0% but <10%
>1.0% but <10%
>10%
>10%
>10%
>10%
>10%
PLT <3.0% >3.0% but <15% >15%
1. In column 1, enter the new Factor % Diff from column 5 of the previous worksheet (disregard the sign).
2. If the new Factor % Diff exceeds the limit in column 4, DO NOT CALIBRATE. Call the Abbott
Hematology Customer Support Center for assistance.
CELL-DYN ® 3200 System Operator’s Manual
9140181H—October 2001
6-53
Calibration Procedures
Manual Calibration Worksheets
Instrument:
Worksheet 4
Date:
Mode to Mode Calibration Difference
Operator:
Mode to Mode Calibration Difference
(Calculate All Factors To Three Decimal Places)
------------------------------------------------------------------------------------------------× 'LII
WOC
NOC
RBC
HGB
MCV
PLT
(1)
Closed
Mode Mean
–
–
–
–
–
–
–
(2)
Open Mode
Mean
/
/
/
/
/
/
/
(3)
Open Mode
Mean x 100 = x 100 = x 100 = x 100 = x 100 = x 100 = x 100 =
Section 6
(4)
% Diff
WOC
NOC
RBC
HGB
MCV
(1)
% Diff
<2.0%
<2.0%
<2.0%
<2.0%
<2.0%
Worksheet 5
Mode to Mode Calibration Criteria
(2)
Lower Limit
Cal Not Required
(3)
Calibration Range
Cal Required
>2.0% but <10%
>2.0% but <10%
>2.0% but <10%
>2.0% but <10%
>2.0% but <10%
(4)
Upper Limit
Do Not Cal
>10%
>10%
>10%
>10%
>10%
(5)
Cal? Y/N
PLT <3.0% >3.0% but <15% >15%
1. In column 1, enter the % Diff from column 5 of Worksheet 4 (disregard the sign).
2. If the % Diff exceeds the limit in column 4, DO NOT CALIBRATE. Call the Abbott Hematology
Customer Support Center for assistance.
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Section 6 Calibration Procedures
Worksheet 6
New Closed Mode Calibration Factors
(Calculate All Factors To Three Decimal Places)
Open Mode Mean
Closed Mode Mean
X Current Closed Mode Cal Factor * = New Closed Mode Cal Factor
WOC
NOC
RBC
HGB
MCV
PLT
Open Mode
Mean
/
/
/
/
/
/
/
Closed Mode
Mean x x x x x x x
Current
Closed Mode
Cal Factor*
=
=
=
=
=
=
=
New Closed
Mode
Cal Factor
Range**
0.700–1.300
0.700–1.300
0.800–1.200
0.700–1.300
0.700–1.300
0.700–1.300
* Current factor as printed by the operator in the Preparing for Manual Mode to Mode Calibration section within this procedure (Manual Mode to Mode Calibration).
** If factor exceeds limits, do not calibrate. Check all calculations and call the Abbott Hematology Customer
Support Center for assistance (at 1-800-CELL-DYN in the U.S.).
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6-55
Calibration Procedures
Manual Calibration Worksheets Section 6
Worksheet 7
Calibration Confirmation
QC Specimen Type
NOC RBC HGB Sample #
Mean Value of
3/5 Runs
Reference or
Assay Value
Difference
(absolute value)
WOC MCV PLT
Tolerance
Limits *
1. Select QC as the specimen type and run the calibrator or fresh whole blood sample 5 times.
2. Enter the mean from the QC file statistics for each parameter that was calibrated.
3. Enter the reference or assay values used to calibrate those parameters.
4. Calculate the difference between the mean and the reference or assay value.
5. Compare the difference with the Tolerance Limit. If it is within the limit, calibration is confirmed. QC specimen type allows confirmation of both WOC and NOC values.
* For Calibrator, use the pre-established tolerance limits found on the Calibrator Assay Sheet.
For Fresh Whole Blood, each laboratory should establish tolerance limits according to its protocol.
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Section 6 Calibration Procedures
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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Calibration Procedures
References
NOTES
Section 6
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Section 7 Operational Precautions and Limitations
Section 7 Operational Precautions and Limitations
Overview
This section deals with the precautions that need to be taken to ensure the performance and validity of the CELL-DYN 3200 System and its test results.
The following system precautions and limitations are reviewed in this section:
• General Limitations
• Location Requirements
• Reagent Storage and Handling
• Printer Precautions
Limitations
The CELL-DYN 3200 System is designed for in vitro diagnostic use.
• Abbott has designed the CELL-DYN 3200 System components for optimal performance. Substituting reagents, calibrators, controls, and components manufactured by other companies may adversely affect the performance of the instrument.
• Follow the recommended maintenance schedules and procedures as outlined
in Section 9: Service and Maintenance .
• During the warranty period, all service and repair must be performed by
Abbott-authorized representatives.
Location Requirements
The location of the CELL-DYN 3200 System is an important consideration that affects proper instrument functioning, operating safety, and ease of use.
• An Abbott-authorized representative must install the instrument.
• The location should have nonporous, nonabsorbing work surfaces and flooring that can be cleaned easily and disinfected using recommended procedures.
• Place the CELL-DYN 3200 System on a hard, level surface. Locate the system:
– away from direct sunlight.
– away from the path of a cooled air or heated air outlet.
– away from other instruments that may interfere with the
CELL-DYN 3200 System, such as drying ovens, centrifuges, x-ray equipment, MRI (magnetic resonance imaging) equipment, CRTs or computers, video terminals, copiers, ultrasonic cleaners, and patient areas. Please note that the CELL-DYN 3200 System has been evaluated to EN55011 and EN61000 for electromagnetic emissions and immunity, respectively.
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7-1
Operational Precautions and Limitations
Overview Section 7
• Do not place reagent containers above the Analyzer.
• The following space should be available to ensure proper ventilation:
– Bench top space: approximately 6 linear feet to accommodate the instrument, display station, and printer
– Below the instrument: sufficient space for reagents and waste container
(if one is used)
– Behind the instrument: 6 inches of space for proper ventilation
– Above the instrument: 6 inches of space for proper ventilation
– Left side of instrument: 12 inches of space in front of the fan for proper ventilation
• Allow adequate space around the instrument to perform necessary maintenance procedures, to provide service access, and to allow the instrument to be easily disconnected from its power source.
• Care should be taken to prevent blocking of the air vents or fans on the sides and the back of the instrument.
• Before operating the instrument for the first time, verify that each reagent line is connected to the appropriate inlet and reagent container. Refer to
Section 2: Installation Procedures and Special Requirements.
• 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.
• The printer and Display Station can be placed on top of the instrument.
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Section 7 Operational Precautions and Limitations
Precautions
Reagent Storage and Handling
• Store reagents, calibrators, and controls according to the directions contained in the package labels and/or inserts.
• Protect reagents from extreme heat and freezing during storage.
Temperatures below 0 ° C (32 ° F) 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 the Reagent Container Cap attached to each length of inlet tubing to minimize evaporation and contamination.
• Never add remaining reagent from a container being replaced to a freshly opened container. This may contaminate the new reagent.
• Never use a hemoglobin standard other than the one specified for the
CELL-DYN 3200 System. The CELL-DYN 3200 System uses a cyanide-free reagent.
Printer Precautions
The printhead on dot matrix printers can get very hot during extended periods of printing. Allow it to cool before touching it. Heat is not a problem with ink jet or bubble jet printers.
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Operational Precautions and Limitations
Precautions
NOTES
Section 7
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Section 8 Hazards
Section 8 Hazards
Overview
Operation, maintenance and servicing of automated hematology systems may expose individuals to potential safety and health hazards. All work must be performed as described in the CELL-DYN Operator’s Manual or as directed by an
Abbott Representative.
This section provides precautionary warnings and information necessary for the safe use of the CELL-DYN 3200 System. Supplementary warnings are inserted throughout this manual and on the instrument to alert personnel to potential hazards. Whenever hazard symbols are encountered on the instrument, users must consult the Operator’s Manual to determine the nature of the potential hazard and actions that must be taken.
The standard warning conventions including signal words (e.g., caution) and symbols are described below. Safety symbols appear next to signal words that identify hazards.
Warning Conventions
Signal Words
DANGER: Denotes an immediate hazard which, if not avoided, could result in serious injury or death.
WARNING: Denotes a hazard which, if not avoided, could result in moderate to serious injury.
CAUTION: Denotes a potential hazard that could result in injury. Also, used for conditions or activities which could interfere with proper functioning of the instrument.
NOTE: Denotes special operator/service information or standard practices.
Symbols
The general hazard symbol identifies an activity or area that may present a hazard to personnel or equipment.
The electrical hazard symbol alerts personnel to the possibility of electrical shock if procedural or engineering controls are not observed.
The biohazard symbol identifies an activity or area where personnel may be exposed to infectious substances if procedural or engineering controls are not observed.
The laser hazard symbol identifies an activity or area where personnel will be exposed to an eye hazard if procedural or engineering controls are not observed.
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Hazards
Overview
NOTES
Section 8
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Section 8 Hazards
Hazard Information and Precautions
General
Automated hematology instruments require the handling of whole blood and blood components by laboratory personnel. In addition, personnel must conduct maintenance to ensure proper performance of the instrument. These activities result in potential contact with infectious substances and other hazards. The following are warnings, precautions, and standard practices to help prevent injury.
CAUTION: If the instrument is used or modified in a manner not specified by the manufacturer, the protection provided by the instrument may be impaired.
Biohazards
WARNING: Potential Biohazard. Consider all clinical specimens, reagents, controls, surfaces or components that contain or have contacted blood, serum, or other bodily fluid as potentially infectious. Wear gloves, lab coats, and safety glasses, and follow other biosafety practices as specified in the OSHA Bloodborne Pathogen Rule (29CFR Part 1910.1030) or other equivalent biosafety procedures.
WARNING: Potential Biohazard. The aspiration needle and probe are sharp and potentially contaminated with infectious material. Avoid contact with the tips of the probe and needle.
Spills of potentially infectious materials should be cleaned up in accordance with established biosafety practices. A generally accepted procedure for cleaning such spills is to absorb the spill with toweling or other absorbent material, wipe the area with an appropriate tuberculocidal disinfectant such as 0.5% sodium hypochlorite solution (refer to formula in
Section 9: Service and Maintenance
,
Prior to maintenance, service, or shipping, the instrument should be
decontaminated in accordance with the procedures specified in Section 9: Service and Maintenance ,
Subsection: Decontamination Procedures and/or
Preparation for Shipping or Extended Period of Non-Use as appropriate. Remove and dispose
of contaminated disposables in accordance with local, state, and federal regulations.
Handling and Disposing of Biohazardous Materials
Dispose of liquid and solid waste in accordance with local, state, and federal regulations. Probes, needles, broken glass, and other sharps that are contaminated with potentially infectious substances should be collected in a “sharps” container for disposal as regulated medical waste. Contaminated gloves, wipes, swabs, and other disposables should be placed in a standard medical waste container.
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Hazards
Hazard Information and Precautions Section 8
Chemical Hazards
Prevent exposure to chemicals used in the operation and maintenance of the
CELL-DYN 3200 System (including reagents) by using appropriate personal protective equipment, work procedures, and information on Material Safety Data
Sheets (MSDS). Refer to
Section 2: Installation Procedures and Special
Requirements for an installation procedure for chemical containers.
Electrical Hazards
Basic electrical hazard awareness is essential to the safe operation of any hematology analyzer. To ensure safe operation of the CELL-DYN 3200 System:
• Periodically inspect electrical cabling into and on the instrument for signs of wear or damage.
• When moving equipment, lift all power cables clear of all system components.
CAUTION: Electrical Hazard. Do not disconnect any electrical connection while the power is on. Follow instructions for correctly powering down the instrument and all connected equipment before performing maintenance on parts which require protective covers to be removed for access. Use only approved power cords and electrical accessories, supplied with the instrument, or provided by Abbott, to protect against electrical shock.
CAUTION: Electrical Hazard. Turn off the power to the instrument and disconnect the power cord before removing any instrument panel that is securely fastened in place by screws or prior to replacing fuses. Replace only the externally accessible fuse located immediately above the power cord connector on the rear panel of the instrument. Use replacement fuses only of the specified type and electrical rating.
• Keep liquids away from all electrical connectors (such as electrical outlets) or communication connectors (such as the LIS connector).
• Keep the floor dry.
• The electrical circuit spacing of the CELL-DYN 3200 System is based on pollution degree (1) and altitude [up to 2000 M (6500 ft)] as per IEC
61010-1. Pollution degree 1 is defined as an environment where there is no pollution or only dry, non-conductive pollution.
CAUTION: If the instrument is used or modified in a manner not specified by the manufacturer, the protection provided by the instrument may be impaired.
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Section 8 Hazards
Physical and Mechanical Hazards
Observe these basic rules for mechanical safety:
• Carefully follow all procedures and instructions.
• Keep all protective covers in place when processing specimens.
• Never allow any part of your body to enter the region of movement of any mechanical component when the instrument is operating.
• Do not wear articles of clothing or accessories that could catch on the
System; keep pockets free of items that could fall into the System; keep long hair from catching on the System.
• Wear powder-free gloves and safety glasses when maintaining or repairing the instrument.
• Avoid contact with needle tips at all times.
• Use professional assistance only when moving or lifting the instrument to prevent injury.
• Use proper lifting techniques when moving reagent cubitainers to prevent injury.
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Hazards
Hazard Information and Precautions
Laser Hazards
Section 8
The CELL-DYN 3200 Instrument is a Class 1 (Class I) Laser Product per IEC
60825-1 . However, it contains a Class 3 B laser.
CAUTION: Class 3 B Laser Light when open. Avoid Exposure to
Beam . When the access door or inner protective cover are removed,
Helium-Neon laser power up to 10 mW continuous wave at 632.8 nm in a beam with 1 mR divergence could be accessible in the interior of the optics bench. Do not look directly into the laser beam or any reflections of the beam from a mirror-like surface. This amount of energy, with insignificant attenuation with distance, is sufficient to cause eye damage.
CAUTION: Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous laser light exposure.
During normal operation, the inner protective cover is to remain in place to prevent laser light exposure from the optics bench. The inner protective cover is to be removed only during servicing by qualified personnel.
The inner protective cover laser warning labels must not be removed and are to remain legible. The Protective Housing Label (Abbott P/N 9230701), shown in
Figure 8.1, consists of black lettering against a yellow background.
8-6
CAUTION –
CLASS 3B LASER LIGHT WHEN OPEN.
AVOID EXPOSURE TO BEAM.
PN 9230701
Figure 8.1 Laser Warning Label
This label is located in two places: on the Protective Cover (under the Top Cover)
that covers the laser mirrors (refer to Figure 8.2), and on the upper left side of the
Flow Panel (refer to Figure 8.3).
CELL-DYN ® 3200 System Operator’s Manual
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Section 8
1 Protective Cover
2 Laser Warning Label
1
CAUTION …
CLASS 3B LASER LIGHT WHEN OPEN.
AVOID EXPOSURE TO BEAM.
PN 9230701E
2
Hazards
Figure 8.2 Laser Warning Label Position - Protective Cover
1 Laser Warning Label
1
CAUTION –
CLASS 3B LASER LIGHT WHEN OPEN.
AVOID EXPOSURE TO BEAM.
PN 9230701
Figure 8.3 Laser Warning Label Position - Flow Panel
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8-7
Hazards
Hazard Information and Precautions Section 8
The Class 1 Laser Product Label (Abbott P/N 9230702), shown in Figure 8.4,
consists of black lettering against a yellow background.
CLASS 1 LASER PRODUCT
PN 9230702
Figure 8.4 Class 1 Laser Product Label
1 Main Power Switch
2 Class 1 Laser Product
Warning Label
The label is located on the upper left section of the instrument’s Rear Panel and is
positioned in a clearly visible location (refer to Figure 8.5).
1
CLASS 1 LASER PRODUCT
PN 9230702
2
Figure 8.5 Class 1 Laser Product Label Location
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Section 8 Hazards
References
1. Occupational Safety and Health Administration, 29 CFR Part 1910.1030.
Department of Labor. Occupational Exposure to Bloodborne Pathogens;
Final Rule.
235:64175-64182, 1991.
2. IEC 60825-1, International Electrotechnical Commission World Standards for electrical and electronic engineering, 60825: Safety of laser products,
60825-1 Part 1: Equipment classification, requirements, and users guide.
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8-9
Hazards
References
NOTES
Section 8
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Section 9
Section 9 Service and Maintenance
Service and Maintenance
Overview
The CELL-DYN 3200 is designed to require minimal routine maintenance. For example:
• The fluidics are automatically rinsed between samples.
• The instrument is automatically placed in the Standby state 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 section describes the recommended preventive maintenance procedures for the Analyzer. Instructions are also given for preparing the instrument for a prolonged period of inactivity.
Many required preventative maintenance procedures have been automated on the
CELL-DYN 3200. These programs can be accessed by pressing the
[SPECIAL PROTOCOLS] key. The SPECIAL PROTOCOLS menu is discussed in the next section followed by a discussion of Preventive Maintenance Schedule
Procedures.
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9-1
Service and Maintenance
Overview
NOTES
Section 9
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Section 9 Service and Maintenance
Special Protocols
The SPECIAL PROTOCOLS menu is used to access various preventative maintenance procedures. There are two major screen levels in this menu. The first level is displayed when the [SPECIAL PROTOCOLS] soft key in the MAIN MENU is pressed. The second major screen level is accessed by pressing the [MORE] key in
the first level. Within each major level are submenus. Figure 9.1 displays the key
labels in the first SPECIAL PROTOCOLS menu.
NOTE: Prior the entering the SPECIAL PROTOCOL menu to perform a procedure, ensure the instrument is at the READY state.
Figure 9.1 First Special Protocols Screen
Special Protocols Menu
When the [SPECIAL PROTOCOLS] key is pressed in the MAIN MENU , the following soft key labels are displayed:
REAGENT RESERVOIR
EMPTY/FILL FLOW CELL/
EMPTY FLOW CELL/
FILL FLOW CELL ( .H\ODEHODOWHUQDWHVEHWZHHQVHOHFWLRQV
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9-3
Service and Maintenance
Special Protocols Section 9
CLEAN/RES SHEAR VAL/
CLEAN SHEAR VAL/
RESTORE SHEAR VAL .H\ODEHODOWHUQDWHVEHWZHHQVHOHFWLRQV
DIS/ ENAB ANALYZER/
DISABLE ANALYZER/
ENABLE ANALYZER
MORE
( .H\ODEHODOWHUQDWHVEHWZHHQVHOHFWLRQV
MAIN
A brief description of the function of each soft key follows. Instructions for the detailed use of each key are given in the appropriate maintenance procedure.
Figure 9.2 Reagent Reservoir Keys
Reagent Reservoir
9-4
NOTE: This procedure is performed only in the Open Mode. If necessary, press
[CHANGE SAMPLER] in the RUN screen to select Open Mode.
The [REAGENT RESERVOIR] key is used to drain the reagent reservoirs located on the Flow Panel of the Analyzer. When the [REAGENT RESERVOIR] key is pressed,
the following soft key labels are displayed as shown in Figure 9.2:
EMPTY DIL/SHEATH
FILL DIL/SHEATH
EMPTY HGB LYSE
FILL HGB LYSE
EMPTY WBC LYSE
FILL WBC LYSE
RETURN
(The key alternates between the selections.)
(The key alternates between the selections.)
(The key alternates between the selections.)
CELL-DYN ® 3200 System Operator’s Manual
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Section 9 Service and Maintenance
The screen displays instructions for draining and filling the reagent reservoirs, as
Empty Dil/Sheath
When the [EMPTY DIL/SHEATH] key is pressed, the diluent and sheath reservoirs are drained and the key toggles to [FILL DIL/ SHEATH] . When the [FILL DIL/SHEATH] key is pressed, the diluent and sheath reservoirs are refilled.
Empty HGB Lyse
When the [EMPTY HGB LYSE] key is pressed, the HGB lyse supply tubing is drained and the key toggles to [FILL HGB LYSE] . When the [FILL HGB LYSE] key is pressed, the HGB lyse supply tubing is refilled.
Empty WBC Lyse
When the [EMPTY WBC LYSE] key is pressed, the WBC lyse supply tubing is drained and the key toggles to [FILL WBC LYSE] . When the [FILL WBC LYSE] key is pressed, the WBC lyse supply tubing is refilled.
Empty/Fill Flow Cell
NOTE: This procedure is performed only in the Open Mode. If necessary, press
[CHANGE SAMPLER] in the RUN screen to select Open Mode.
Pressing the [EMPTY/FILL FLOW CELL] key displays a submenu showing the [EMPTY
FLOW CELL] and [RETURN] keys.
When the [EMPTY FLOW CELL] key is pressed, diluent/sheath in the Optical Flow
Cell is drained and the key toggles to [FILL FLOW CELL] upon completion.
When the [FILL FLOW CELL] key is pressed, the flow cell is refilled with diluent/ sheath.
Clean/Restore Shear Valve
NOTE: This procedure is performed only in the Open Mode. If necessary, press
[CHANGE SAMPLER] in the RUN screen to select Open Mode.
The [CLEAN/RES SHEAR VAL] key is used to prepare the shear valve for cleaning.
Pressing the [CLEAN/RES SHEAR VAL] key displays a submenu showing the [CLEAN
SHEAR VAL] and [RETURN] keys.
When the [CLEAN SHEAR VAL] key is pressed, the System partially empties the syringes, flushing the reagents out of the shear valve and associated tubing. The shear valve then rotates into the position necessary for its removal. After the shear valve has rotated, the key toggles to [RESTORE SHEAR VAL] .
When the [RESTORE SHEAR VAL] key is pressed, the syringes refill the shear valve and the associated tubing, and the shear valve rotates back to its operational position.
Disable/Enable Analyzer
When the [DIS/ENAB ANALYZER] key is pressed, a submenu is displayed showing the [DISABLE ANALYZER] and [RETURN] keys.
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9-5
Service and Maintenance
Special Protocols Section 9
Pressing the [DISABLE ANALYZER] key prevents the Analyzer from cycling while certain maintenance procedures are performed. After the Analyzer has been disabled, the key toggles to [ENABLE ANALYZER] .
When the [ENABLE ANALYZER] key is pressed, the Analyzer is returned to the state prior to disabling.
More
Auto-Clean
9-6
Figure 9.3 Second Special Protocols Screen
When the [MORE] key is pressed, the second SPECIAL PROTOCOLS screen and the
following soft key labels are displayed, as shown in Figure 9.3:
AUTO CLEAN
DAILY SHUTDOWN
PREPARE SHIPPING
CLEAN NEEDLE
EXTENDED AUTOCLEAN
MORE
MAIN
NOTE: This procedure is performed only in the Open Mode. If necessary, press
[CHANGE SAMPLER] in the RUN screen to select Open Mode.
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Section 9 Service and Maintenance
The [AUTO CLEAN] key is used to initiate the Auto-Clean cycle. The Shear Valve, the RBC/PLT Mixing Chamber, the WBC Mixing Chamber, the Optical Flow Cell, the HGB Flow Cell, and all of the associated fluidics are automatically cleaned and rinsed during this cycle.
When the [AUTO CLEAN] key is pressed, the screen displays a set of instructions and the two following soft key labels:
AUTO CLEAN
RETURN
Press [ AUTO CLEAN] again to activate the Auto-Clean cycle. Press [ RETURN] to return to the second SPECIAL PROTOCOLS screen.
Daily Shutdown
The > DAILY SHUTDOWN] key is used to initiate the Daily Shutdown cycle. During the cycle, the fluidics are automatically drained and rinsed. At the end of the cycle, the Analyzer is placed in
STANDBY
. The electronic solenoid valves are automatically opened periodically while the Analyzer is in Standby to prevent the tubing from becoming pinched.
Prepare Shipping
NOTE: This procedure is performed only in the Open Mode. If necessary, press
[CHANGE SAMPLER] in the RUN screen to select Open Mode.
The [PREPARE SHIPPING] key is used to prepare the Analyzer for shipment or an extended period of inactivity. The cycle drains all of the reagents from the system and then rinses the fluidics with deionized water supplied by the operator.
Clean Needle
Extended Auto-Clean
NOTE: This procedure is performed only in the Open Mode. If necessary, press
[CHANGE SAMPLER] in the RUN screen to select Open Mode.
The [EXTENDED AUTOCLEAN] key is used to initiate the Extended Auto-Clean cycle, which is a longer version of the Auto-Clean cycle.
When the [EXTENDED AUTO CLEAN] key is pressed, the screen displays the
message shown in Figure 9.8 in the
Extended Auto-Clean subsection. The following soft key labels are displayed:
EXTENDED AUTO CLEAN
RETURN
Press [EXTENDED AUTO CLEAN] again to activate the Extended Auto-Clean cycle.
Press [RETURN] to return to the second Special Protocols screen.
More
The [CLEAN NEEDLE] key is used to clean the needle in the Tower module. When the key is pressed, the needle is forcefully rinsed with diluent.
The [MORE] key is used to return to the first SPECIAL PROTOCOLS menu.
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9-7
Service and Maintenance
Special Protocols
NOTES
Section 9
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Section 9 Service and Maintenance
Preventive Maintenance Schedule
Overview
The maintenance schedule outlined on the following page will minimize operational problems with the CELL-DYN 3200. The recommended intervals are based on instruments operating in laboratories that process samples from a general patient population. The intervals are affected by the following variables:
• Volume of samples processed
• Workload schedule
• Operating environment
• Patient population being analyzed
Each laboratory must assess its own situation and modify these recommended intervals as necessary.
CAUTION: Gloves should be worn during the maintenance procedures.
They should be powder-free or rinsed before performing the maintenance as powder may cause instrument problems. (For example, powder may clog ports in the shear valve and cause it to leak.)
IMPORTANT: 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 on more than a random basis, the appropriate maintenance should be performed more frequently.
A diagram of the analyzer flow panel is included to assist in component identification and location.
If you encounter trouble performing any of these maintenance procedures, contact the Abbott Hematology Customer Support Center at: 1 (800) CELL DYN
(1-800-235-5396).
To order any parts, accessories, or consumables, refer to
Appendix B — Parts and Accessories.
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9-9
Service and Maintenance
Preventive Maintenance Schedule Section 9
Preventive Maintenance Schedule
The following procedures should be performed at the scheduled time intervals or more often, depending on usage, as determined by each individual laboratory.
Keep a record of routine maintenance and parts replacement to ensure proper equipment care and to assist Abbott Customer Support Specialists and Abbott Field
Service Representatives in diagnosing instrument problems.
Daily
Run Auto-Clean Cycle
Clean Closed Sample Aspiration Needle
Clean Closed Sample Tower
Weekly
Clean Sample Loader and Racks
Check Sample Transfer Pump Tubing
Run the Extended Auto-Clean Cycle if routinely running reticulocyte counts.
Monthly
Clean Fan Filter
Run Extended Auto-Clean
Replace Diluent/Sheath Filter
Semi-Annual
Clean Printer
Nonscheduled Maintenance Procedures
Clean Shear Valve
Clean Interior of Open Sample Aspiration Probe
Unclog Open Sample Aspiration Probe
Clean Interior of Closed Sample Aspiration Needle
Unclog Closed Sample Aspiration Needle
Clean Syringes
Clean HGB Flow Cell
Clean Bar Code Reader Window
Clean Reagent Lines
Replace Open Sample Aspiration Probe
Replace Closed Sample Aspiration Needle
Replace Tubing in Sample Transfer Pump
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Section 9 Service and Maintenance
Replace Tubing in Normally Closed Valves
Replace Syringes
Replace Fuse
Prepare for Shipping or Extended Period of Non-Use
Clean Y Valve
Flow Panel Components
Figure 9.4 illustrates the Flow Panel components that may be inspected, cleaned,
or replaced during normal maintenance procedures.
4 5 6 7 8
10
9
1 Vent
2 Sample Transfer
Peristaltic Pump
3 Waste Chambers
4 WBC Mixing Chamber
5 RBC Mixing Chamber
6 HGB Flow Cell
7 Shear Valve
8 Y Valve
9 Open Sample Probe
(With Wash Block)
10 Normally Closed
Valves
11 Diluent Reservoir
12 Sheath Reservoir
13 Normally Closed
Valves
14 Diluent/Sheath Filter
15 Tube Spinner
16 Closed Sample
Needle (With Wash
Block)
17 Sample Injection
Syringe
18 HGB Lyse Syringe
19 WBC Lyse Syringe
20 Diluent/Sheath
Syringe
21 Waste Chambers
1 2
11 12
Figure 9.4 Analyzer Flow Panel Components
3
13 14 15 16 17 18 19 20 21
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Service and Maintenance
Preventive Maintenance Schedule Section 9
Decontamination Procedures
The OSHA Bloodborne Pathogen Rule (29 CFR Part 1910.1030) requires the decontamination of laboratory equipment prior to servicing or shipment:
• Decontaminate the instrument by performing the Auto-Clean cycle. This cycle flushes all of the fluid pathways with reagents to purge any waste from the fluid pathways. The Open Mode Sample Probe and the Closed Sample
Needle (CS Model) or Sample Loader Needle (SL Model) are automatically rinsed after every cycle. The surfaces of the instrument should be wiped with a nonabrasive detergent solution to remove any soiling, then wiped with a tuberculocidal disinfectant, such as a 0.5% sodium hypochlorite solution.
To calculate the percent (%) sodium hypochlorite concentration desired see the following formula:
A = Percent (%) of sodium hypochlorite solution desired
B = Percent (%) of sodium hypochlorite stock solution (as purchased)
X = Parts of water to be mixed with one part of the sodium hypochlorite stock solution
X =
B - A
A
Example:
If you need a 0.5% solution of sodium hypochlorite for a cleaning procedure, and the label on the bottle of bleach states that it is 5.25% sodium hypochlorite, then:
X =
5.25 - .5
.5
X = 9.5
Add 9.5 parts deionized water to 1 part bleach to obtain a 0.5% sodium hypochlorite solution, or 9.5 mL of deionized water to 1.0 mL of bleach (5.25% sodium hypochlorite) to obtain 10.5 mL of a 0.5% solution of sodium hypochlorite.
If the instrument is to be shipped, it must be decontaminated prior to shipment. This is accomplished by pressing the [PREPARE FOR SHIPPING] key in the SPECIAL
PROTOCOLS menu. Instructions for this procedure are given in section
Preparation for Shipping or Extended Period of Non-Use.
9-12 CELL-DYN ® 3200 System Operator’s Manual
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Section 9 Service and Maintenance
Daily Maintenance Procedures
Auto-Clean
WARNING: Potential Biohazard. Wear gloves, lab coats, and safety glasses and follow other biosafety practices as specified in the OSHA
Bloodborne Pathogen Rule (29 CFR Part 1910.1030) or other equivalent biosafety procedures.
The Auto-Clean Cycle is a fully automated cycle designed to clean the Shear
Valve, RBC/PLT Mixing Chamber, the WBC Mixing Chamber, the Optical Flow
Cell, the HGB Flow Cell, Open Sample Probe, the needle in the Tower Module, and all the associated fluidics. The forward and reverse action of the peristaltic pump is used during this cycle to gently scrub and remove any fibrin or debris within the system. The Auto-Clean cycle takes approximately 12 minutes. When the [AUTO CLEAN] key is pressed, instructions are displayed on the screen, as shown
NOTE: The Auto-Clean cycle should be run prior to performing any maintenance procedure. This ensures that all waste is purged from the fluid pathways.
Figure 9.5 Auto-Clean Screen
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Service and Maintenance
Daily Maintenance Procedures Section 9
Materials Required
1. CELL-DYN Enzymatic Cleaner. Enzymatic cleaner should be used at room temperature but stored at a temperature between 2°C and 8°C
(36°F and 46°F).
2. Clean VACUTAINER ® tube or other clean container
3. DYN-A-WIPE Lint-free pads (or other lint-free pads)
4. Deionized water
Procedure—CS and SL Models
1. The instrument should be in the Open Mode. If necessary, press the [CHANGE
SAMPLER] key in the RUN screen to select the Open Mode.
2. With the Wash Block raised, carefully wipe the outside of the Open Sample
Aspiration Probe and the bottom of the Wash Block with a DYN-A-WIPE (or other lint-free pad) that has been dampened with diluted enzymatic cleaner
(one part distilled water to one part enzymatic cleaner).
3. In the MAIN MENU , press [SPECIAL PROTOCOLS] I ollowed by [MORE] to access the Auto-Clean function.
4. Press [AUTO CLEAN] Instructions for performing the procedure are displayed on the screen.
5. Dispense approximately 1.5 mL of Enzymatic Cleaner into the
VACUTAINER ® or other clean container and hold the container under the probe.
6. Press [AUTO CLEAN] to activate the cleaning cycle.
NOTE: Do not press the Touch Plate. The Auto-Clean cycle is only initiated by the [AUTO CLEAN] key.
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 cycle is completed, three background counts are run to rinse the system. Check that the background counts are acceptable before running controls or patient samples. If the counts are unacceptable, troubleshoot accordingly (refer to
Section 10: Troubleshooting and
;
Subsection: Troubleshooting Guide ).
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Section 9 Service and Maintenance
Clean Aspiration Needle
The Aspiration Needle in the Tower Module should be cleaned regularly to remove protein buildup or debris and reduce the possibility of a blockage. The procedure for cleaning the needle differs slightly on the CS and SL models. Both procedures are described below.
WARNING: Potential Biohazard. The needle in the Tower Module is sharp and potentially contaminated with infectious materials. Avoid any contact with the needle.
Materials Required
1. CELL-DYN Enzymatic Cleaner
2. Diluent
3. Three empty VACUTAINER ® tubes
4. Gloves, lab coat, and safety glasses
Procedure — SL Model
1. Aliquot approximately 2 mL of Enzymatic Cleaner into one of the
VACUTAINER ® tubes.
2. Aliquot approximately 2 mL of diluent each into the other two
VACUTAINER ® tubes.
3. If necessary, press the [CHANGE SAMPLER] soft key in the RUN screen to select the Closed Mode.
4. In the RUN screen, press [SPECIMEN TYPE] followed by [BACKGROUND]
5. Place the enzymatic cleaner tube followed by the two diluent tubes in a
Sample Loader rack.
NOTE: A convenient way to perform this procedure is to add the tubes to the end of the last run of the day.
6. Position the rack on the load side of the Sample Loader (refer to Figure 13.7
if necessary). Make sure the Tower Cover is closed.
CAUTION: The Sample Loader will not operate unless the Tower Cover is in place.
7. Press the [START LOADER] key to initiate processing.
8. Audible beep tones indicate that processing is completed.
9. Run at least three background counts to rinse the system. Check that the background counts are acceptable before running controls or patient samples.
If the counts are unacceptable, troubleshoot accordingly (refer to
Troubleshooting and Diagnostics ;
Subsection: Troubleshooting Guide ).
10. When cleaning is completed, remain in the RUN screen to process patient samples or press [MAIN] to return to the MAIN MENU .
CELL-DYN ® 3200 System Operator’s Manual
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Service and Maintenance
Daily Maintenance Procedures Section 9
Procedure — CS Model
1. Aliquot approximately 2 mL of Enzymatic Cleaner into one of the
VACUTAINER ® tubes.
2. Aliquot approximately 2 mL of diluent each into the other two
VACUTAINER ® tubes.
3. If necessary, press the [CHANGE SAMPLER] soft key in the RUN screen to select the Closed Mode.
4. In the RUN screen, press [SPECIMEN TYPE] followed by [BACKGROUND]
5. Open the Tower Door, place the tube containing the Enzymatic Cleaner in the
Door Assembly, and close the door.
6. Press the Touch Plate to run the Enzymatic Cleaner. When aspiration is finished, remove the tube.
7. Repeat steps 5 and 6 using the two diluent tubes.
8. Run at least three background counts to rinse the system. Check that the background counts are acceptable before running controls or patient samples.
If the counts are unacceptable, troubleshoot accordingly (refer to
Troubleshooting and Diagnostics ;
Subsection: Troubleshooting Guide ).
Closed Sample Tower
Daily cleaning of the Tower Module is recommended when the Closed Mode is used.
Materials Required
1. Cleaning solution (0.5% sodium hypochlorite solution). See the formula for mixing this solution under Decontamination Procedures earlier in this section.
2. Clean, warm water for rinse
3. DYN-A-WIPE Lint-free pads (or other lint-free pads)
4. Gloves, lab coat, and safety glasses
Procedure
1. Lift the Tower Cover up and off the instrument.
2. Clean the following components with a lint-free wipe moistened with the cleaning solution prepared above.
a. Spin mechanism, including belt if necessary b. Under the Wash Block if there is evidence of residue build-up c. Any other area that appears to have been contaminated by specimen or reagents.
3. Rinse the components using a lint-free wipe moistened with warm water.
4. Dry the components with a DYN-A-WIPE (or other lint-free pad).
5. When finished, replace the Tower Cover.
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Section 9 Service and Maintenance
Sample Loader Tray and Tube Grippers
Daily cleaning of the Sample Loader tray and tube grippers is recommended when the Sample Loader is used.
Materials Required
1. Cleaning solution (0.5% sodium hypochlorite solution). See the formula for mixing this solution under Decontamination Procedures earlier in this section.
2. Clean, warm water for rinse
3. DYN-A-WIPE Lint-free pads (or other lint-free pads)
4. Gloves, lab coat, and safety glasses
Procedure
1. Lift the Tower Cover up and off the instrument.
2. Remove any racks from the loader.
3. Clean the following components with a lint-free wipe moistened with the cleaning solution prepared above.
a. Sample Loader tray (be sure to remove any dirt or debris that may impede the movement of the racks) b. Tube grippers inside the Mixing Block on the SL model (rotate the
Mixing Block to gain access to the grippers) c. Any other area that appears to have been contaminated by specimen or reagents d. Periodically check the bottom of the racks to insure there is no residue of dirt build-up. Clean as necessary.
4. Rinse the components using a lint-free wipe moistened with warm water.
5. Dry the components with a DYN-A-WIPE (or other lint-free pad).
6. When finished, replace the Tower Cover.
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Service and Maintenance
Daily Maintenance Procedures
NOTES
Section 9
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Section 9 Service and Maintenance
Weekly Maintenance Procedures
WARNING: Potential Biohazard. Wear gloves, lab coats, and safety glasses and follow other biosafety practices as specified in the OSHA
Bloodborne Pathogen Rule (29 CFR Part 1910.1030) or other equivalent biosafety procedures.
Sample Loader and Racks
The Sample Loader surface areas and racks should be cleaned on a regular basis.
Blood spills in the Sample Loader track or racks should be cleaned up immediately to allow proper movement of the racks. Weekly cleaning is recommended when the
Sample Loader is used, 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. DYN-A-WIPE Lint-free pads (or other lint-free pads)
4. Gloves, lab coat, and safety glasses.
Procedure
1. Remove the racks from the Sample Loader.
2. Wash the racks in the detergent solution. Do not allow them to soak in the solution because the labels will come off.
NOTE: Do not wash the racks in an automated dishwasher that operates at high temperatures because the heat may damage the racks.
3. Rinse the racks with warm water and dry thoroughly with a DYN-A-WIPE
(or other lint-free pad).
4. Wipe the Sample Loader with a lint-free wipe moistened with water. Dry it with a DYN-A-WIPE (or other lint-free pad).
5. Wipe the sides of the Sample Loader with a lint-free wipe moistened with detergent solution. Wipe off the detergent solution with a lint-free wipe moistened with water. Dry the sides with a DYN-A-WIPE (or other lint-free pad).
Sample Transfer Pump Tubing Check
Constant pressure on the tubing under the Peristaltic Pump Wheel tends to flatten the tubing, thereby inhibiting the flow of liquid past the pump. This tubing should be checked at least weekly to ensure it is maintaining its original shape. Replace the tubing after 2000 cycles or as necessary (refer to the Peristaltic Pump Tubing
Replacement procedure in Subsection: Nonscheduled Maintenance Procedures ).
CELL-DYN ® 3200 System Operator’s Manual
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Service and Maintenance
Weekly Maintenance Procedures
1 Tubing
2 Pump Shoe
3 Pump Wheel
Section 9
1
3
2
Figure 9.6 Sample Transfer Peristaltic Pump
To check the peristaltic pump tubing, follow the procedure below:
1. In the MAIN MENU , press [SPECIAL PROTOCOLS] followed by > DIS/ENAB
ANALYZER] and [DISABLE ANALYZER] to disable the Analyzer.
2. Gently pull on the hand hold of the Left Front Cover to swing the cover open.
3. Locate the Sample Transfer Pump on the left side of the Flow Panel. (Refer to Figure 9.6.)
4. Push the Pump Shoe away from the pump wheel and slip the tubing out.
5. Visually inspect the tubing for damage. If the tubing is damaged or flattened, change the tubing. (Refer to Peristaltic Pump Tubing Replacement later in this section.)
6. Using your fingers, massage the tubing to test its strength and resiliency and to remove any indentation caused by the wheel.
7. Push the Pump Shoe away from the pump wheel and slip the tubing back under the wheel. Make sure the tubing is securely positioned under the wheel.
8. Close the Left Front Cover and press into place.
9. Press [ENABLE ANALYZER] to return the instrument to the READY state.
10. Press [MAIN] to return to the MAIN MENU .
Extended Auto-Clean
The Extended Auto-Clean cycle (refer to the Monthly Procedures later in this section) should be run weekly when routinely running reticulocytes.
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Section 9 Service and Maintenance
Monthly Maintenance Procedures
WARNING: Potential Biohazard. Wear gloves, lab coats, and safety glasses and follow other biosafety practices as specified in the OSHA
Bloodborne Pathogen Rule (29 CFR Part 1910.1030) or other equivalent biosafety procedures.
Fan Filter Cleaning
There is an air filter on the rear panel of the Analyzer. The filter requires monthly removal and cleaning to maintain a constant, unrestricted air flow.
NOTE: More frequent cleaning is required whenever the instrument is located in a particularly dusty or warm area.
Figure 9.7 shows the location of the fan.
1 Disk Storage
Container
2 Fan
Figure 9.7 Analyzer Rear Panel
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Service and Maintenance
Monthly Maintenance Procedures Section 9
Materials Required
1. Running water
2. DYN-A-WIPE lint-free pads (or other lint-free pads)
3. Small vacuum cleaner (optional)
Filter Cleaning Procedure
1. Perform the Daily Shutdown procedure to place the instrument in STANDBY .
(Refer to Daily Shutdown Procedure in
Section 5: Operating Instructions .)
2. Turn the power switch to OFF.
3. Locate the Fan Filter on the rear panel. (Refer to Figure 9.7.)
4. Snap off the plastic frame which holds the filter in the mounting bracket.
5. Remove the filter and run a medium-pressure stream of warm water over them, or clean the filter by vacuuming them.
6. Blot dry the filter with a lint-free pad.
7. Reinsert the cleaned filter into its frame and snap the frame back onto the mounting bracket.
8. Turn the power switch to ON. After the instrument is initialized, press [RUN] to prime the system and place it in the READY state.
9. Record this maintenance in your maintenance log.
10. If the filter appears unusually dirty when cleaned once a month, adjust the cleaning cycle accordingly.
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Section 9 Service and Maintenance
Extended Auto-Clean
NOTE: Run Extended Auto-Clean weekly when routinely running reticulocytes.
The Extended Auto-Clean cycle is a fully automated cycle designed to clean the
Shear Valve, the RBC/PLT and WBC Mixing Chambers, the Optical Flow Cell, the
HGB Flow Cell, the needle in the CS or SL model, and all the associated fluidics.
The forward and reverse action of the peristaltic pump is used during this cycle to gently scrub and remove any fibrin or debris within the system.
The Extended Auto-Clean cycle takes approximately 2.5 hours to complete.
During this time, the instrument is not available to process samples or manipulate data. (When the process is complete, the instrument is automatically put in the
STANDBY
state.)
NOTE: Once the Extended Auto-Clean cycle has been started, it cannot be cancelled.
Information on performing the Extended Auto-Clean procedure is displayed on the
screen. (Refer to Figure 9.8.)
Figure 9.8 Special Protocols: Extended Auto-Clean Screen
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Service and Maintenance
Monthly Maintenance Procedures
Materials Required
1. CELL-DYN Enzymatic Cleaner (List Number 99644-01)
2. Clean test tube or container
3. DYN-A-WIPE lint-free pads (or other lint-free pads)
4. Warm water
Procedure
Section 9
1. Make sure the Open Sampler mode is selected.
2. Carefully wipe the outside of the Open Sample Aspiration Probe and the bottom of the Wash Block with an DYN-A-WIPE (or other lint-free pad) 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.
3. In the MAIN MENU , press [SPECIAL PROTOCOLS] followed by [MORE] and
[EXTENDED AUTOCLEAN] .
4. Follow the instructions shown on the screen. (Refer to Figure 9.8.)
5. Dispense approximately 1.5 mL of Enzymatic Cleaner into a clean container and hold the container under the probe. Raise the container until the end of the probe is completely immersed in the solution.
6.
3UHVV [EXTENDED AUTOCLEAN] DJDLQWRDFWLYDWHWKHFOHDQLQJF\FOH
NOTE: Do not press the Touch Plate. The Extended Auto-Clean cycle is initiated only by the [EXTENDED AUTOCLEAN] key.
7. 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 approximately 2.5 hours and may not be terminated.
8. At the end of the 2.5 hours, the instrument automatically goes into the
STANDBY
state. Press [RUN] to bring the Analyzer from
STANDBY
to
READY and to prepare it for running samples.
9. Run at least three background counts to rinse the system. Check that the background counts are acceptable before running controls or patient samples.
If the counts are unacceptable, troubleshoot accordingly (refer to
Troubleshooting and Diagnostics ;
Subsection: Troubleshooting Guide ).
10. Record this maintenance in your maintenance log.
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Section 9 Service and Maintenance
Diluent/Sheath Filter Replacement Procedure
The Diluent/Sheath Filter is located on the front panel to the left of waste chamber
#3. Replace the filter once a month, or whenever contamination is suspected. A sign of contamination is usually manifested by high platelet background, poorly defined PLT-RBC (0°/10°) scatterplot, excessive WBC flagging, or erroneous
5-part differential results. Refer to the Troubleshooting Guide for more details.
Materials Required
1. Diluent/Sheath Filter List Number 06H92-01
2. Paper Towel
3. Hemostat
4. Gloves, Safety Glasses, Lab Coat
Procedure
1. If the instrument is not in the STANDBY mode, then press [SPECIAL
PROTOCOLS] , followed by [DAILY SHUTDOWN] . If the instrument is already in STANDBY mode, then proceed to Step 2.
2. Turn the power switch OFF.
3. Locate the Diluent/Sheath Filter on the front panel. Refer to Figure 9.9.
Figure 9.9 Replacing the Diluent/Sheath Filter
4. Remove lower left section cover for easier access.
5. Remove the Diluent/Sheath Filter from its spring clip.
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Service and Maintenance
Monthly Maintenance Procedures Section 9
6. Pinch off the tubing above the luer slip inlet with hemostats. Clamp the tubing above the Diluent/Sheath Filter.
NOTE: Be sure not to damage the luer slip inlet port.
7. Disconnect the luer slip inlet from the used Diluent/Sheath Filter.
NOTE: Use a paper towel to absorb any liquid discharged from the filter or tubing.
8. Connect the luer slip inlet to the top of a new Diluent/Sheath Filter.
9. Disconnect the used Diluent/Sheath Filter from the silicon tubing at the lower end and discard it.
10. Attach the silicon tubing to the lower part of the new Diluent/Sheath Filter.
11. Remove the hemostats.
12. Install the new Diluent/Sheath Filter into the spring clip.
13. Turn the Power Switch ON.
14. Wait until the instrument is initialized, then press [RUN] to prime the system and place it in the READY state.
15. Run background cycles until the background reading is within specification, usually five to ten cycles. Refer to Section 4 for the background specification.
16. Record the completion of this procedure in the maintenance log.
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Section 9 Service and Maintenance
Semiannual Maintenance Procedures
Printer Cleaning
Every six months (or after about 300 hours of operation) turn the printer OFF, disconnect the power cord and use a clean, dry cloth to dust the area around the carriage shaft and platen or ink cartridge (depending on type of printer). Be sure to remove any loose particles of paper. Do not use solvents or strong detergents on the cabinet.
Refer to the printer manual that accompanied your printer for detailed cleaning and maintenance instructions.
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Service and Maintenance
Semiannual Maintenance Procedures
NOTES
Section 9
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Section 9 Service and Maintenance
Nonscheduled Maintenance Frequency
Table 9.1
Nonscheduled Maintenance Frequency
Procedure
Clean Shear Valve
Clean Interior of Open Sample
Aspiration Probe
Unclog Open Sample Aspiration
Probe
Clean Interior of Closed Sample
Aspiration Needle
Unclog Closed Sample Aspiration
Needle
Clean Sample Injection Syringe,
WBC and HGB Lyse Syringes
Clean Diluent/Sheath Syringe
Frequency
When it is suspected of being the source of imprecision.
When it is suspected of being the source of imprecision
When a blockage is suspected
When it is suspected of being the source of imprecision
When a blockage is suspected
Clean HGB Flow Cell
Clean Bar Code Reader Window
Clean Reagent Lines
Replace Open Sample Aspiration
Probe
When they are suspected of being the source of imprecision
When it is suspected of being the source of imprecision
When Auto-Clean has not cleared away a restriction, or an organic buildup is suspected of causing any of the following:
1. Elevated HGB results
2. HGB imprecision
When particle buildup on the window interferes with bar code reading
When contamination is suspected
1. When the probe is bent
2. When there is a nonremovable obstruction in the probe
CELL-DYN ® 3200 System Operator’s Manual
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Service and Maintenance
Nonscheduled Maintenance Frequency Section 9
Procedure
Replace Closed Sample Aspiration
Needle
Replace Tubing in Sample Transfer
Pump
Replace Tubing in Normally Closed
Valves
Replace Syringes
Replace Fuse
Prepare for Shipping or Extended
Period of Non-Use
Frequency
1. When the needle is bent
2. When there is a nonremovable obstruction in the needle
When it shows signs of indentation or flattening
When it shows signs of indentation or flattening
1. When it develops a leak
2. When it is suspected of being a source of imprecision
1. When the fuse fails
2. When changing the power setting from 110/120 VAC to 220/240 VAC or vice versa
1. When shipping the instrument
2. When storing the instrument
3. Before an extended period of non-use
4. When the entire flow system is suspected of being the source of bacterial or fungal contamination
Y Valve Cleaning
When an obstruction in the Y Valve is suspected
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Section 9 Service and Maintenance
Nonscheduled Maintenance Procedures
WARNING: Potential Biohazard. Wear gloves, lab coats, and safety glasses and follow other biosafety practices as specified in the OSHA
Bloodborne Pathogen Rule (29 CFR Part 1910.1030) or other equivalent biosafety procedures.
Shear Valve Cleaning
Cleaning of the Shear Valve ensures accurate and precise performance. Any reagent or blood residue may cause the valve to leak or function improperly. The
shear valve assembly is depicted in Figure 9.10.
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 3200 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.
1 Back Section
2 Center Section
3 Front Section
4 Retaining Screw
5 Rim Notch
6 Lock Notch
7 Mounting Arm
1
2
3
7
5
6
Figure 9.10 Shear Valve Assembly
Materials Required
1. DYN-A-WIPE Lint-free pads (or other lint-free pads)
2. A container of warm, deionized water
3. Gloves, lab coat, and safety glasses
4
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Service and Maintenance
Nonscheduled Maintenance Procedures
Procedure
Section 9
1. Pull the Tower Cover up and off the instrument (Tower Door on the CS model must be open).
2. In the MAIN MENU , press [SPECIAL PROTOCOLS] followed by [CLEAN/RES
SHEAR VAL @DQG [CLEAN SHEAR VAL] This prepares the Shear Valve for removal and puts the Analyzer into the NOT READY mode.
3. Place a clean gauze pad on the shelf in front of the Shear Valve.
4. Turn the Shear Valve Retaining Screw counterclockwise until it can be
removed. (Refer to Figure 9.10.)
5. Pull the front section forward until it is free of the mounting arm. Place the front section with its attached tubes on the clean gauze pad.
6. Pull the center section forward until it is free of the mounting arm. Keep the rear section in place.
NOTE: 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.
7. Place the center section in a container of warm water and allow it to soak for the remainder of the cleaning procedure.
NOTE: Do not soak the center section in bleach because the bleach may damage the ceramic.
8. Clean the mounting arm with a DYN-A-WIPE (or other lint-free pad) dampened with warm water to remove any blood or residue. Wipe the guide dry.
9. Pull out the rear section of the Shear Valve and wipe the inner surface with a
DYN-A-WIPE (or other lint-free pad) dampened with warm water. Use care to avoid scratching the inner surface. Do Not Dry.
NOTE: Hold the section by the edges to avoid getting fingerprints on the inner surface.
10. Align the lock notch of the rear section with the mounting guide. Carefully slide this section back onto the mounting arm as far as it will go. Avoid crimping any of the attached tubing.
11. Remove the center section from the warm water. Do Not Dry.
12. Place the center section aside on a clean gauze. Use care to avoid scratching the surfaces.
13. View each surface under reflective light to confirm that it is clean, and free of lint and fingerprints.
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Section 9 Service and Maintenance
14. Align the lock notch of the center section with the mounting guide. (Lock notch faces the mounting guide, smaller rim notch faces down.) Carefully slide this section back onto the mounting arm until it is flush with the rear
section. (Refer to Figure 9.10.)
CAUTION: Results may be affected if the center section is installed backwards. Be certain the rim notch faces down.
15. Wipe the inner surface of the front section with a DYN-A-WIPE (or other lint-free pad) dampened with warm water. Use care to avoid scratching the inner surface. Do not dry.
NOTE: Hold the section by the edges to avoid getting fingerprints on the inner surfaces.
16. Align the lock notch of the front section with the mounting guide. A pin on the inner rim should align with the groove on the mounting arm. Carefully slide this section back until it touches the center section.
17. Firmly hold the three valve sections together and replace the Shear Valve
Retaining Screw. Turn the screw clockwise until it stops.
18. Remove any cleaning materials (such as gauze pads) that may have been left on the instrument.
19. Press [RESTORE SHEAR VAL] WRUHWXUQWKH6KHDU9DOYHWRLWVRSHUDWLQJ
SRVLWLRQDQGWRUHWXUQWKHLQVWUXPHQW to the READY state.
20. Replace the Tower Cover (Tower Door on the CS model must be open).
21. Press [RETURN] followed by [MAIN] DQG [RUN] to display the RUN screen.
22. Run at least five background counts to rinse the system. Check that the background counts are acceptable before running controls or patient samples.
If the counts are unacceptable, troubleshoot accordingly (refer to
Troubleshooting and Diagnostics ;
Subsection: Troubleshooting Guide ).
23. Record this maintenance in your maintenance log.
Open Sample Probe Interior Cleaning
The Open Sample Aspiration Probe is thoroughly cleaned whenever the Auto-
Clean cycle is performed. However, additional cleaning may be required from time to time. The probe may be cleaned manually, as described below.
Materials Required
1. Gloves, lab coat, and safety glasses
2. Syringe (10 cc or larger) with at least 3" of 1/32" silicone tubing attached to the tip
3. Small needle-nose pliers or similar tool
4. Small beaker or container
5. Deionized water
6. Cleaning solution (0.5% sodium hypochlorite solution). See the formula for mixing this solution under Decontamination Procedures earlier in this section.
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Service and Maintenance
Nonscheduled Maintenance Procedures
Procedure
Section 9
WARNING: Potential Biohazard. The probe is sharp and potentially contaminated with infectious material. Avoid contact with tip of probe.
1. In the MAIN MENU , press [SPECIAL PROTOCOLS] IROORZHGE\ > DIS/ENAB
ANALYZER @DQG [DISABLE ANALYZER] .
2. Locate the tubing attached to the top of the Open Sample Probe. (Refer to
Figure 9.11.) Place a small beaker or container under the probe to catch the
rinse solution. (Hint: Attach one end of a length of 1/32” tubing to the aspiration end of the probe and place the other end of the tubing in the beaker to prevent splashing.)
1 Probe Tubing
2 Probe Top
3 Wash Block
1
2
3
Figure 9.11 Open Sample Probe Assembly
3. Hold the probe firmly with one hand and with the other hand use the pliers to carefully work the tubing up and off the top of the probe.
4. Use a syringe with 1/32" (internal diameter) tubing attached. Fill the syringe with the cleaning solution prepared earlier. Attach the tubing connected to the syringe onto the top of the probe and inject the solution to flush the probe.
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Section 9 Service and Maintenance
5. Fill the same syringe with deionized water and inject the water into the probe from the top to rinse the probe. Repeat the procedure three times to thoroughly rinse the probe.
NOTE: Empty the container or tube between rinses as necessary.
6. Hold the probe steady and reattach the tubing over the top. Use the pliers to carefully work the tubing down the probe. Be sure the tubing is firmly seated on the probe. (Remove any tubing that may have been placed on the aspiration end of the probe.)
NOTE: Wetting the top portion of the probe will allow the tubing to slide more easily.
7. Be sure to remove the beaker containing the rinse solution from the instrument.
8. Press [ENABLE ANALYZER] followed by [RETURN] and [MAIN] to return to the
MAIN MENU .
9. Press [RUN] followed by [SPECIMEN TYPE] and [BACKGROUND] .
10. Run at least three background counts to rinse the system. Check that the background counts are acceptable before running controls or patient samples.
If the counts are unacceptable, troubleshoot accordingly (refer to
Troubleshooting and Diagnostics ;
Subsection: Troubleshooting Guide ).
11. Record this maintenance in your maintenance log.
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Service and Maintenance
Nonscheduled Maintenance Procedures Section 9
Unclogging the Open Sample Aspiration Probe
If a blockage is suspected, it may be cleared using the procedure described above in Open Sample Probe Interior Cleaning .
Closed Sample Needle Interior Cleaning
The Aspiration Needle in the Tower Module should be cleaned regularly to remove protein buildup or debris and reduce the possibility of a blockage. In addition to the
Aspiration Needle Cleaning in Daily Maintenance Procedures, use the steps described below for cleaning the needle in the Tower Module.
Materials Required
1. Gloves, lab coat, and safety glasses
2. Syringe (10 cc or larger) with at least 3" of 1/32" (internal diameter) silicone tubing attached to the tip
3. Small needle-nose pliers or similar tool
4. Beaker or container
5. Deionized water
6. Cleaning solution (0.5% sodium hypochlorite solution). See the formula for mixing this solution under Decontamination Procedures earlier in this section.
Procedure
WARNING: Potential Biohazard. The sample needle is sharp and potentially contaminated with infectious material. Avoid contact with the tip of the needle.
1. In the MAIN MENU , press [SPECIAL PROTOCOLS] IROORZHGE\ > DIS/ENAB
ANALYZER @DQG [DISABLE ANALYZER] .
2. Pull the tower cover up and off the instrument. (Tower Door on the CS model must be open).
3. Locate the Aspiration Tubing and Vent Tubing attached to the top of the
Closed Sample Aspiration Needle. (Refer to Figure 9.12.)
NOTE: The Aspiration Needle consists of two separate needles joined together, one for venting and one for aspiration. The vent needle is the shorter of the two and faces the instrument. Note that the tubing attached to the opening at the top of the vent needle leads to a vent chamber on the left side of the Tower Module, while the tubing attached to the opening at the top of the aspiration needle leads to
Y valve located between the Shear Valve and the Open Sample
Probe.
4. Hold the needle firmly with one hand and with the other hand use the pliers to carefully work the Aspiration Tubing and Vent Tubing up and off the top of the needle.
5. Loosen the Thumb Screw at the top of the Needle Mounting Assembly and remove the clip holding the needle to the assembly.
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Section 9
1 Holding Clip
2 Aspiration Tubing
3 Vent Tubing
4 Needle Top
5 Vent Needle (shorter)
6 Aspiration Needle
(longer)
7 Wash Block
8 Needle Mounting
Assembly
9 Thumb Screw (with spring)
Service and Maintenance
6. Carefully pull the top of the needle forward until the flange clears the slot in the bracket. Lift the needle up and out of the Wash Block and place it in the beaker or container.
9
2
1
3
8
4
6
5
7
Figure 9.12 Closed Sample Needle
7. Use a syringe with 1/32" (internal diameter) tubing attached. Fill the syringe with the cleaning solution prepared earlier. Attach the tubing connected to the syringe onto the top of the Aspiration Needle and inject the solution to flush the needle.
8. Fill the same syringe with deionized water and inject the water into the needle from the top to rinse it. Repeat the procedure three times to thoroughly rinse the needle.
NOTE: Empty the container between rinses as necessary.
9. Repeat steps 7 and 8 to flush Vent Needle the same way.
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Service and Maintenance
Nonscheduled Maintenance Procedures Section 9
10. Place the needle back into the Wash Block, making sure the shorter part (vent needle) faces the instrument, and place the flange into its slot in the top bracket.
11. Reinstall the clip over the top of the needle and tighten the thumb screw.
12. Attach the vent tubing to the vent section of the needle and the aspiration tubing to the aspiration section.
NOTE: It is important that the tubing be attached correctly. (Refer to
NOTE: Wetting the top portion of the needle will allow the tubing to slide more easily.
13. Reattach the Tower Cover (Tower Door on the CS model must be open) and press into place.
14. Press [ENABLE ANALYZER] followed by [RETURN] and [MAIN] to return to the
MAIN MENU .
15. Run at least three background counts to rinse the system. Check that the background counts are acceptable before running controls or patient samples.
If the counts are unacceptable, troubleshoot accordingly (refer to
Troubleshooting and Diagnostics ;
Subsection: Troubleshooting Guide ).
16. Record this maintenance in your maintenance log.
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Section 9 Service and Maintenance
Unclogging the Closed Sample Aspiration Needle
If a blockage is suspected, it may be cleared using the procedure described above in Closed Sample Needle Interior Cleaning .
Syringe Cleaning
There are two syringe assemblies, each containing two syringes, on the Flow Panel
of the CELL-DYN 3200 system. The syringe assemblies are depicted in Figure
Syringes on the CELL-DYN 3200 System should be cleaned only as necessary 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.
1 Sample Injection
Syringe
2 HGB Lyse Syringe
3 WBC Lyse Syringe
4 Diluent/Sheath
Syringe
5 Holding Blocks
5
1
2
3
4
Figure 9.13 Syringe Assemblies
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Service and Maintenance
Nonscheduled Maintenance Procedures Section 9
Materials Required
1. A large container filled with approximately 500 mL of warm, deionized water
2. DYN-A-WIPE lint-free pads (or other lint-free pads)
3. Distilled water
4. Small container of each reagent to refill the clean syringes
5. Phillips-head screwdriver (#2)
6. Flat-head screwdriver
Disabling the Analyzer
1. In the MAIN MENU , press [SPECIAL PROTOCOLS] followed by > DIS/ENAB
ANALYZER @ and [DISABLE ANALYZER]
2. To gain access to the syringe assemblies, open Left and Right Front Covers as follows. Gently pull on cover using hand hold and swing door open about
30-45 degrees. Lift door fully upward from bottom area closest to door hinge bracket, then rotate door fully open so lift and hold feature on upper door hinge mechanism can be engaged. Lower door gently. Gently pull the Tower
Cover and lift the cover up and off the instrument. (Tower Door on the CS model must be open.) a. On the CS model, remove the four Phillips-head screws holding the Front
Skirt to the instrument and remove the skirt.
b. The skirt on the SL model has two removable sections adjacent to the
Flow Panel. Remove the section on the right side of the Flow Panel by lifting it up and off its holding pins.
For easy access to the Flow Panel, the Sample Loader on the SL Model can be pulled away from the analyzer by performing the following optional steps:
NOTE: Instruments with serial number 59965AF and below do not have the hardware configuration to support this option.
1. Remove the Phillips-head screw that holds the Sample Loader Tower
in place on the Front Panel. Refer to the following Figure 9.14.
9-40
Figure 9.14 Sample Loader Tower
2. Loosen the flat-head screws, two on each side of the instrument.
Refer to the following Figure 9.15.
CELL-DYN ® 3200 System Operator’s Manual
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Section 9 Service and Maintenance
1 Tube Fitting
2 Sample Injection
Syringe
3 Double Collar
4 Base
5 Luer Lock
Figure 9.15 Sample Loader Mounting Screws
3. Carefully lift and pull the Sample Loader away from the instrument approximately 2-3 inches.
4. Push the Sample Loader down to lock it in to place.
5
1
2
Figure 9.16 Sample Injection Syringe Removal
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4
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Service and Maintenance
Nonscheduled Maintenance Procedures Section 9
Procedure
—
Sample Injection Syringe
1. The syringe snaps into the holding block. To remove the syringe, place on finger behind the upper portion of the barrel and one finger behind the lower portion of the plunger. Gently pull forward until the syringe barrel snaps free of the holding block and the double collar attached to the bottom of the plunger clears the slot at the base of the mounting bracket. Note that the glass flange at the bottom of the barrel (which fits into the bottom part of the holding block) has the narrow side facing the instrument.
2. Use one hand to grasp the tube fitting at the top of the syringe that attaches the tubing to the syringe. Use the other hand to carefully turn the syringe counterclockwise to release it from the fitting.
3. Note the level of reagent in the syringe, since the same amount of reagent will have to be added after the syringe is cleaned. Dispense the reagent into a sink or an appropriate waste container.
4. Aspirate warm water into the syringe until it is full. Continue to pull on the plunger until it is removed from the barrel.
NOTE: 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.
5. Rinse the plunger and barrel thoroughly with distilled water. Carefully reinsert the plunger into the wet barrel.
6. Refill the syringe with fresh Diluent/Sheath reagent to the same level as noted in step 3.
NOTE: Verify there is no air bubble sitting on the tip of the plunger.
7. Insert the tube fitting into the top of the syringe and turn the syringe clockwise until the fitting is finger tight. Be careful not to overtighten the fitting or crimp the associated tubing.
8. Carefully adjust the position of the plunger as necessary to insert the double collar into the slot on the mounting bracket.
9. Snap the syringe into the holding block, making sure the narrow side of the glass flange on the barrel fits into the slot at the bottom of the block. Make sure the syringe is firmly in place.
Procedure
—
HGB Lyse Syringe
1. The procedure for removing, cleaning, and replacing the HGB Lyse Syringe is similar to the Sample Injection Syringe. Refer to the instructions in
Procedure—Sample Injection Syringe .
2. After cleaning, refill the syringe to the original level with fresh HGB Lyse reagent.
Procedure
—
WBC Lyse Syringe
1. The procedure for removing, cleaning, and replacing the WBC Lyse Syringe is similar to the Sample Injection Syringe. Refer to the instructions in
Procedure—Sample Injection Syringe .
2. After cleaning, refill the syringe to the original level with fresh WBC Lyse reagent.
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Section 9 Service and Maintenance
Procedure
—
Diluent/Sheath Syringe
1. Locate the Diluent/Sheath Syringe (refer to Figure 9.17). Note that the plastic
barrel of this syringe has four vertical edges, two of which fit into grooves on the holding block, and a circular plastic flange which also fits into a groove on the holding block.
2. Grasp the plastic tube fitting at the top of the syringe that attaches to the Luer
Lock. Carefully turn the Luer Lock on the syringe clockwise to release it from the fitting. Use the lint-free pads to absorb excess reagent.
3. Grasp the syringe barrel below the Luer Lock with one hand. With the other hand, grasp the syringe plunger below the metal band. Pull and twist one side of the syringe to remove it from the snap-in holding block.
4. Note the liquid level in the syringe so that it can be refilled after cleaning to approximately the same level.
5. Dispense the reagent into a sink or other appropriate waste container.
NOTE: Do not pull the plunger out of the barrel. Also, 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.
6. Immerse the tip of the syringe in the container of deionized water.
7. Aspirate deionized water into the syringe until it is full, and dispense the water into a sink or other appropriate waste container. Repeat this step several times to thoroughly rinse the syringe.
8. Refill the syringe with Diluent/Sheath reagent to the level noted in Step 4.
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Service and Maintenance
Nonscheduled Maintenance Procedures
1 Tube Fitting
2 Luer Lock
3 Holding Block
4 Diluent/Sheath
Syringe
5 Double Collar
1
2
3
4
Section 9
5
Figure 9.17 Diluent/Sheath Syringe Replacement
9. Insert the double collar on the plunger into the slot on the mounting bracket and line up the circular flange on the barrel with the slot on the holding block.
10. Insert one of the vertical edges on the barrel into a side groove on the holding block and carefully twist the barrel until the other side snaps into place. Make sure the syringe is firmly in place.
11. Place the tube fitting into the Luer Lock and turn the lock counterclockwise until the fitting is finger tight. Be careful not to overtighten the fitting or crimp the associated tubing.
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Section 9 Service and Maintenance
Enabling the Analyzer
When all syringes have been re-installed, do the following:
1. Press [ENABLE ANALYZER] followed by [RETURN] , [MAIN] and [RUN] to return to the RUN screen.
2. Run several background counts in the Open Mode and observe the action of the syringes during the cycle. The plungers should move smoothly up and down and should not leak.
3. After the operation of all the syringes has been verified, do the following: a. On the CS model, reattach the Front Skirt using the four Phillips-head screws. Do not pinch the tubing at the bottom.
b. On the SL model, align the removable right side skirt panel over its holding pins and slide down. If the Sample Loader has been pulled away as described in
Subsection: Disabling the Analyzer (optional steps),
perform the following steps:
1. Carefully lift and push the Sample Loader toward the instrument.
2. Push the Sample loader down to lock it in place.
3. Reinstall the Phillips-head screw that holds the Sample loader Tower in place on the Front Panel. Do not pinch any tubing between the
Tower and the Flow Panel. Refer to Figure 9.14.
4. Tighten the flat head screws: two on each side of the instrument.
c. Reattach the Tower Cover (Tower Door on the CS model must be open) and press into place.
d. Close the Left and Right Front Covers.
4. Run at least three background counts. Check that the background counts are acceptable before running controls or patient samples. If the counts are unacceptable, troubleshoot accordingly (refer to
Troubleshooting and Diagnostics ;
Subsection: Troubleshooting Guide ).
5. Record this maintenance in your maintenance log.
HGB Flow Cell Manual Cleaning Procedure
NOTE: This is not a routine cleaning/maintenance procedure. It should only be performed if routine methods fail or at the request of the Abbott
Hematology Customer Support Center.
Under normal circumstances, the Auto-Clean cycle is sufficient to ensure the cleanliness of the HGB Flow Cell. If the Auto-Clean cycle fails to adequately clean the flow cell, the procedure described below may be used.
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Service and Maintenance
Nonscheduled Maintenance Procedures
1 Solenoid 24
2 Tube Fitting
3 Shear Valve
2
3
1
Section 9
Figure 9.18 HGB Flow Cell Access Tubing
Materials Required
1. Cleaning solution (1.25% sodium hypochlorite solution). See the formula for mixing this solution under Decontamination Procedures earlier in this section.
2. 10 mL syringe
3. Gloves, lab coat, and safety glasses
4. Deionized water
Procedure
1. In the MAIN MENU , press [SPECIAL PROTOCOLS] followed b \> DIS/ENABLE
ANALYZER] and [DISABLE ANALYZER] to disable the Analyzer.
2. Gently pull on the hand hold of the right Front Cover to swing the cover open.
Pull the Tower Cover up and off the instrument (Tower Door on the CS model
must be open). Locate the HGB Flow Cell. (Refer to Figure 9.4.)
3. Remove the plastic drip pan under the Shear Valve by sliding it up and off the support stand.
4. Fill the syringe with the bleach solution.
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Section 9 Service and Maintenance
5. Locate the tubing just above solenoid #24 that attaches to the HGB Flow Cell.
(Refer to the previous figure.) Attach a hemostat to the tubing between the fitting and the HGB Flow Cell.
6. Disconnect the tubing from the fitting and insert the syringe. Remove the hemostat. Dispense the cleaning solution into the flow cell.
7. Allow the bleach solution to remain in the flow cell for 5 minutes.
8. When the time has elapsed, aspirate the solution back into the syringe and reattach the hemostat.
9. Reconnect the tubing and remove the hemostat.
10. Reinsert the plastic drip pan by aligning the grooves on the pan with the upright support arms and sliding the pan down until it rests on the support.
11. Reattach the Tower Cover (Tower Door on the CS model must be open) and press into place. Close Right Front Cover.
12. Press [ENABLE ANALYZER] followed by [RETURN] and [MAIN] and [RUN] .
13. Run at least three background counts to rinse the system. Check that the background counts are acceptable before running controls or patient samples.
If the counts are unacceptable, troubleshoot accordingly (refer to
Troubleshooting and Diagnostics ;
Subsection: Troubleshooting Guide ).
14. Record this maintenance in your maintenance log.
Bar Code Reader Window Cleaning
The cleaning procedure is similar for the SL and CS models even though the location of the Bar Code Reader is different.
Materials Required
1. Gloves, lab coat, and safety glasses
2. Applicator swabs (non-sterile)
3. Microscope lens tissues
4. Isopropyl alcohol, lens cleaner, or deionized water
Procedure
1. In the MAIN MENU , press [SPECIAL PROTOCOLS] followed by > DIS/ENAB
ANALYZER] and [DISABLE ANALYZER] .
2. Take three applicator swabs and wrap a lens tissue around each swab.
3. Moisten one of the wrapped swabs in isopropyl alcohol, lens cleaner, or deionized water.
4. Locate the Bar Code Reader Window.
5. Wipe the window with the moistened swab. Using one of the dry wrapped swabs, wipe the window dry. Use the second dry swab if necessary.
6. Visually inspect the window to ensure that blood, debris, and smudges have been removed.
7. Press the [ENABLE ANALYZER] key to bring the system to the READY state.
Press [RETURN] followed by [MAIN] and [RUN] to return to the RUN screen.
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Service and Maintenance
Nonscheduled Maintenance Procedures Section 9
Reagent Line Cleaning
The reagent lines should be cleaned if contamination is suspected. To clean the lines, refer to steps 1–4 in Preparation for Shipping or Extended Period of
Non-Use later in this section.
Open Sample Probe Replacement
Materials Required
1. Gloves, lab coat, and safety glasses
2. Replacement probe
3. 7/64" Allen wrench
4. Small needle-nose pliers or similar tool
Procedure
1. In the MAIN MENU , press [SPECIAL PROTOCOLS] IROORZHGE\ [DIS/ENAB
ANALYZER] and [DISABLE ANALYZER] .
2. Gently pull on the hand hold of the Right Front Cover and swing the cover open to access the right side of the Flow Panel. Remove Tower Cover.
3. Locate the tubing attached to the top of the Open Sample Probe. (Refer to
Figure 9.19.) Hold the probe firmly with one hand and with the other hand
use the pliers to carefully work the tubing up and off the top of the probe.
4. Using the Allen wrench, remove the two hex nuts holding the Probe Bracket
Arm to the Bracket Support Arm on the Probe Assembly Frame.
5. Pull the probe up and out of the Wash Block.
6. Insert the new probe into the Wash Block.
7. Place the Probe Bracket Arm on top of the Bracket Support Arm. Align the holes in the bracket arm to the holes in the Probe Assembly Frame. Insert and tighten the two hex nuts using the Allen wrench.
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Section 9 Service and Maintenance
Figure 9.19 Open Sample Probe Replacement
8. Hold the probe steady and reinsert the tubing over the top. Use the pliers to carefully work the tubing down the probe. Be sure the tubing is firmly seated on the probe.
NOTE: Wetting the top portion of the probe will allow the tubing to slide more easily.
9. Press [ENABLE ANALYZER] followed by [RETURN], [MAIN], and [RUN].
10. Press the Touch Plate to run a background count. Observe the action of the probe assembly to ensure there are no leaks and that it is operating smoothly.
11. Close the Right Front Cover. Reattach the Tower Cover and press into place
(Tower Door on the CS model must be open).
12. Run at least three background counts to rinse the system. Check that the background counts are acceptable before running controls or patient samples.
If the counts are unacceptable, troubleshoot accordingly (refer to
Troubleshooting and Diagnostics ;
Subsection: Troubleshooting Guide ).
13. Record this maintenance in your maintenance log.
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Service and Maintenance
Nonscheduled Maintenance Procedures Section 9
Closed Sample Needle Replacement
If the Closed Sample Aspiration Needle becomes bent or becomes clogged (and cleaning does not remove the blockage), the needle should be replaced.
Materials Required
1. Gloves, lab coat, and safety glasses
2. Replacement needle
3. Phillips-head screwdriver (#2)
4. Small needle-nose pliers or similar tool
Procedure
WARNING: Potential Biohazard. The sample needle is sharp and potentially contaminated with infectious material. Avoid contact with tip of needle.
1. In the MAIN MENU , press [SPECIAL PROTOCOLS] IROORZHGE\ > DIS/ENAB
ANALYZER] and [DISABLE ANALYZER] .
2. Pull the Tower cover up and off the instrument (Tower Door on the CS model must be open).
3. Locate the Aspiration Needle.
NOTE: The Aspiration Needle consists of two separate needles joined
together, one for venting and one for aspiration. (Refer to Figure
9.20.) The vent needle is the shorter of the two and faces the
instrument. Note that the tubing attached to the opening at the top of the vent needle leads to a vent chamber on the left side of the
Tower Module, while the tubing attached to the opening at the top of the aspiration needle leads to Y valve located between the Shear
Valve and the Open Sample Probe.
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Section 9
1 Holding Clip
2 Aspiration Tubing
3 Vent Tubing
4 Needle Top
5 Vent Needle (shorter)
6 Aspiration Needle
(longer)
7 Wash Block
8 Needle Mounting
Assembly
9 Thumb Screw (with spring)
9
8
Service and Maintenance
2
1
4
3
6
5
7
Figure 9.20 Closed Sample Needle
4. Hold the needle firmly with one hand and with the other hand use the pliers to carefully work the tubing up and off the top of both ends of the needle.
5. Loosen the Thumb Screw at the top of the Needle Mounting Assembly and remove the clip holding the needle to the assembly.
6. Carefully pull the top of the needle forward until the flange clears the slot in the bracket. Lift the needle up and out of the Wash Block.
7. Place the new needle into the Wash Block, making sure the shorter part
(venting needle) faces the instrument, and place the flange into its slot in the top bracket.
8. Reinstall the clip over the top of the needle and tighten the Thumb Screw.
9. Attach the vent tubing to the vent section of the needle and the aspiration tubing to the aspiration section.
NOTE: It is important that the tubing be attached correctly.
NOTE: Wetting the top portion of the needle will allow the tubing to slide more easily.
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Service and Maintenance
Nonscheduled Maintenance Procedures Section 9
10. Reattach the Tower Cover (Tower Door on the CS model must be open) and press into place.
11. Press [ENABLE ANALYZER] followed by [RETURN] and [MAIN] to return to the
MAIN MENU .
12. Run at least three background counts to rinse the system. Check that the background counts are acceptable before running controls or patient samples.
If the counts are unacceptable, troubleshoot accordingly (refer to
Troubleshooting and Diagnostics ;
Subsection: Troubleshooting Guide ).
13. Record this maintenance in your maintenance log.
Sample Transfer Pump Tubing Replacement
The tubing under the Sample Transfer Peristaltic Pump needs to be replaced on a regular basis to ensure proper fluid movement through the instrument. This tubing should be replaced at least every 2000 cycles. However, the frequency of replacement depends on instrument use in each laboratory. The Sample Transfer
Materials Required
1. Sample Transfer Peristaltic Pump Tubing
2. Gloves, lab coat, and safety glasses
Procedure
1. In the MAIN MENU, press [SPECIAL PROTOCOLS] followed by [DIS/ENAB
ANALYZER] and [DISABLE ANALYZER]
2. Gently pull on the hand hold of the Left Front Cover and swing the cover open.
3. Locate the Sample Transfer Peristaltic Pump on the left side of the panel.
4. Push the Pump Shoe away from the pump wheel and slip the tubing out.
5. Remove the tubing from the metal brackets that hold it on each side of the
rollers. (Refer to Figure 9.6.)
6. Disconnect the tubing at the plastic connector.
7. Connect the new tubing to the plastic connector.
8. Place the collars on the ends of the tubing into the metal guides. Hold the
Pump Shoe open and push the tubing underneath the pump rollers.
NOTE: Position the tubing in the center of the rollers.
9. Close the Left Front Cover.
10. Press [ENABLE ANALYZER] to bring the instrument to the READY state.
11. Press [RETURN] followed by [MAIN] and [RUN] to display the RUN screen.
12. Run at least three background counts to rinse the system. Check that the background counts are acceptable before running controls or patient samples.
If the counts are unacceptable, troubleshoot accordingly (refer to
Troubleshooting and Diagnostics ;
Subsection: Troubleshooting Guide ).
13. Record this maintenance in your maintenance log.
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Section 9 Service and Maintenance
Normally Closed Valve Tubing Replacement
Tubing in the Normally Closed Valves should be replaced when it shows signs of indentation or flattening and is impeding the flow of fluid through the tubing.
Materials Required
1. Valve Tubing (12 inches)
2. Gloves, lab coat, and safety glasses
3. Phillips-head screwdriver (#2)
4. Hemostats (2)
Procedure
1. In the MAIN MENU , press [SPECIAL PROTOCOLS] followed by > DAILY
SHUTDOWN] . Wait until the instrument is in STANDBY, then turn the power switch OFF.
2. Gently pull on the hand hold of the Right Front Cover and swing the cover open.
3. Gently pull on the hand hold of the Left Front Cover and swing the cover open.
4. Pull the Tower cover up and off the instrument (Tower Door on the CS model must be open).
5. To gain access to the lower portion of the Flow Panel: a. On the CS model, remove the four Phillips-head screws holding the Front
Skirt to the instrument and remove the skirt.
b. On the SL model, remove the section on the left side of the Flow Panel by lifting it up and off the holding pins on the rear rail of the Sample
Loader.
6. Locate all six Normally Closed Valves on the Flow Panel. (Refer to Figure
7. Use hemostats to clamp the tubing above and below the normally closed valve tubing connectors to prevent leakage when the normally closed valve tubing is replaced. Remove the tubing from each valve.
NOTE: On the SL model, space is limited between the inner edge of the
Sample Loader and the two normally closed values on the lower left side of the Flow Panel. Use caution when accessing the tubing in these two valves.
8. Pull the tubing from the connectors on either side as shown in Figure 9.21.
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1 Connectors
2 Tubing
3 Slot
4 Normally Closed Valve
1 2
3
4
Section 9
Figure 9.21 Tubing in Normally Closed Valve
9. Insert the new tubing section into both connectors. Make sure the tubing is pushed all the way into the connectors.
10. Reinsert the tubing into the slot on the valves. Work the tubing firmly back and forth until it is completely inserted into the valve and resting on the bottom of the slot. Unless the tubing is securely seated, the flow system will not function properly. Remove the hemostats.
11. Replace covers: a. On the CS model, reattach the Front Skirt using the four Phillips-head screws. Do not pinch the tubing at the bottom.
b. On the SL model, align the removable left side skirt panel over its holding pins and slide down.
c. Close the Left and Right Front Covers. Reattach the Tower Cover and press into place (Tower Door on the CS model must be open).
12. Turn the Power switch ON. Wait until the instrument is initialized, then press
[RUN] to prime the system and place it in READY state.
13. Run at least three background counts to rinse the system. Check that the background counts are acceptable before running controls or patient samples.
If the counts are unacceptable, troubleshoot accordingly (refer to
Troubleshooting and Diagnostics ;
Subsection: Troubleshooting Guide ).
14. Record this maintenance in your maintenance log.
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Section 9 Service and Maintenance
Syringe Replacement
A syringe should be replaced under the following conditions:
1. There is evidence of leaking
2. It is suspected of being a source of imprecision.
Materials Required
1. Replacement syringe
2. Gloves, lab coat, and safety glasses
Procedure
1. The procedures for removing and installing the Sample Injection Syringe,
WBC Lyse Syringe, HGB Lyse Syringe, and Diluent/Sheath Syringe are described earlier in this subsection.
2. After the old syringe has been removed, follow the instructions in Syringe
Cleaning to reinstall the new syringe and bring the Analyzer back to the
READY state.
Fuse Replacement
There are two conditions under which a fuse should be replaced:
1. If the fuse has failed, or
2. If the power setting is changed from 110/120 VAC to 220/240 VAC or vice versa.
Materials Required
1. Replacement fuse (8-amp T (Slo-Blo) for instruments operating at
110/120 VAC or 4-amp T (Slo-Blo) for instruments operating at
220/240 VAC)
2. Flathead screwdriver
Procedure
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CAUTION: Electrical Hazard. Turn off the power to the instrument and disconnect the power cord before removing any instrument panel that is securely fastened in place by screws or prior to replacing fuses. Replace only the externally accessible fuse located immediately above the power cord connector on the rear of the instrument. Use replacement fuses only of the specified type and electrical rating.
1. Turn the system OFF and disconnect the power cord. Locate the plastic fuse
holder on the Rear Panel. (Refer to Figure 9.22.)
2. With the system OFF, insert a flathead screwdriver into the notch on the fuse holder.
3. Push in and turn the fuse holder counter clockwise to release the holder. Pull the holder with the fuse completely out of its slot.
4. Pull the fuse to remove it from the holder. Check the fuse.
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1 Power Supply
2 Fuse Holder
3 Fuse Holder Notch
1
2
3
Section 9
Figure 9.22 Fuse Replacement
5. If it has obviously failed, replace it. Note the amp reading on the fuse and be sure you replace it with the correct fuse (8-amp or 4-amp).
NOTE: If the power setting is 110/120 VAC, use the 8-amp fuse. If the power setting is 220/240 VAC, use the 4-amp fuse.
6. If you are not sure if the fuse has failed, replace it and see if the problem is corrected.
7. To replace a fuse, insert the new fuse (either end) into the holder. Insert the holder (fuse first) all the way into the fuse slot.
8. Insert a flathead screwdriver into the notch on the fuse holder, push in, and turn clockwise to tighten the fuse holder.
9. Reconnect the power cord and turn the system ON.
10. Record the maintenance in your maintenance log.
Preparation for Shipping or Extended Period of Non-Use
The Prepare For Shipping cycle must be run if the instrument will not be used for two weeks or more. This cycle must also be run if: a. The instrument will be shipped b. The instrument will be moved (for example, to a different location within a laboratory) and movement will require detaching the reagent inlet tubing.
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Salt deposits and reagent residue may clog the flow system if they are not removed prior to a prolonged period of inactivity or shipment. In addition, the tubing should be removed from behind the Peristaltic Pump and from all of the Normally Closed
Valves. Leaving this tubing in the pump and in the valves while the instrument is inactive may cause it to crimp permanently. The Peristaltic Pump and Normally
Closed Valves on the Analyzer flow panel are shown in Figure 9.4.
NOTE: When starting the system after 2 weeks or more of inactivity, it is necessary to replace the Diluent/Sheath filter before priming the system.
Materials Required
1. Gloves, lab coat, and safety glasses
2. Phillips-head screwdriver (#2)
3. Disinfectant (cleaning solution); a solution containing 0.5% sodium hypochlorite. See the formula for mixing this solution under
Decontamination Procedures earlier in this section.
4. Container with approximately 500 mL of deionized water.
5. Four plastic bags
If the instrument will be shipped, the following are also needed:
6. Cardboard Disk Drive Protector
7. Shear valve dummy center section
Procedure
1. In the MAIN MENU , press [SPECIAL PROTOCOLS] followed by [MORE] and
[PREPARE SHIPPING]
2. Follow the instructions displayed on the screen.
3. Press the [PREPARE SHIPPING] key again to begin the rinse cycle.
NOTE: The message
SPECIAL PROTOCOL CYCLE IN PROGRESS
is displayed during the process.
4. When the process has finished, the message
SPECIAL PROTOCOL CYCLE
HAS COMPLETED
is displayed.
NOTE: If the reagent lines were cleaned because contamination was suspected and the operator intends to continue processing patient samples, do not perform any of the remaining steps. Instead, reconnect the reagent lines, go to the RUN screen, and run background counts until the counts are acceptable.
5. Turn the main power switch OFF. Also turn OFF power to the Display
Monitor, printers, and any other devices attached to the instrument.
6. Open Left and Right Front Covers as follows. Gently pull on the cover using hand hold and swing door open about 30-45 degrees. Lift door fully upward from bottom area closest to door hinge bracket, then rotate door fully open so lift and hold feature on upper door hinge mechanism can be engaged. Lower door gently. Pull the Tower cover up and off the instrument (Tower Door on the CS model must be open).
a. On the CS model, remove the four Phillips-head screws holding the Front
Skirt to the instrument and remove the skirt.
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Section 9 b. The skirt on the SL model has two removable sections adjacent to the
Flow Panel. Remove the section on the left side of the Flow Panel by lifting it up and off its holding pins.
7. Carefully remove the tubing from all the Normally Closed Valves on the
Flow Panel. Do not detach the tubing. If necessary, refer to Figure 9.4 for the
location of these valves.
8. Carefully remove the tubing from behind the Sample Transfer Peristaltic
Pump. Do not detach the tubing. If necessary, refer to Figure 9.6.
9. Remove all three Reagent Tubing lines, Waste Tubing line, and the Waste
Sensor line from their fittings on the rear of the Analyzer. The waste line should be emptied and rinsed with disinfectant.
10. Place each length of tubing in a separate protective plastic bag and close the bag. (Keep the Waste line and Waste Sensor line together.)
NOTE: Keep all tubing lines clean to prevent contamination.
11. Place the plastic bags containing the reagent and waste tubing in the
Accessory Kit.
12. Wipe the instrument with the disinfectant prepared earlier.
NOTE: If the instrument will be shipped, the following steps should also be done.
13. Remove and clean the Shear Valve as directed in Shear Valve Cleaning under
Nonscheduled Maintenance Procedures .
14. After the Shear Valve has been cleaned and dried, wrap the ceramic center section carefully for protection and place it in the Accessory Kit.
15. Obtain the Shear Valve Dummy Center section from the Accessory Kit.
Reassemble the Shear Valve on the instrument using the dummy center section.
16. Remove the Analyzer power cord from its connector on the rear of the
Analyzer and from the outlet receptacle. Place the cord in the Accessory Kit.
17. Remove the Display Monitor power cord from its outlet receptacle and secure it to the monitor.
18. Detach the Display Monitor Video Cable and the Membrane Keypad
Interface Cable from their respective connectors on the Data Module and secure the cables to the monitor.
19. Detach the Data Module Interface Cable from the back of the Analyzer.
20. Replace covers: a. On the CS model, reattach the Front Skirt using the four Phillips-head screws.
b. On the SL model, align the removable left side skirt panel over its holding pins and slide down.
c. Close Left and Right Front Covers as follows. Lift door fully upward from bottom area near door hinge bracket. While still holding door up, close door far enough to allow door to drop down into its normal position. Gently lower door and press into place so magnetic latch is engaged.
d. Reattach the Tower Cover and press into place (Tower Door on the CS model must be open).
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Section 9 Service and Maintenance
Y Valve Cleaning
The Y Valve should be cleaned whenever an obstruction in the valve is suspected.
If an obstruction in suspected in the Open Mode, follow the instructions in
Procedure - Open Mode below. If the Obstruction is suspected in the Closed Mode, follow the instructions in Procedure - Closed Mode which follows
Procedure - Open Mode .
Materials Required
1. Gloves, lab coat, and safety glasses.
2. Two Syringes (10 cc) with at least 3" of l/16" ID X 3/16" OD silicone tubing attached to the tip of each syringe. Attached to each tube should be a l/16" to l/16" connector.
3. Medium sized beaker or comparable container.
4. Deionized water
5. Cleaning solution (1.25% sodium hypochlorite solution). See the formula for mixing this solution under Decontamination Procedures earlier in this section.
Procedure - Open Mode
1. If the system is not already in Open Mode, press the [CHANGE SAMPLER] soft key in the RUN menu to select Open Mode.
2. In the MAIN MENU , press [SPECIAL PROTOCOLS] followed by [ DIS/ENAB
ANALYZER ] and [DISABLE ANALYZER] .
3. Gently pull on hand hold of the Right Front Cover and swing the cover open.
4. Lift the Tower Cover up and off of the Instrument.
5. Disconnect the tubing attached to the top of the Open Sample Probe.
6. Fill one of the syringes with the prepared cleaning solution. Fill the other syringe with deionized water.
7. Attach the syringe with the cleaning solution to the tubing that had been connected to the Open Sample Probe.
8. Locate the Tygon ® tubing between the Y Valve and Shear Valve. Refer to
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Figure 9.23 Y Valve Cleaning
9. Disconnect this tubing at the Shear Valve and place the end in the beaker to catch liquid.
10. Slowly inject the cleaning solution into the Y Valve. The liquid should pass through the Y Valve carrying any obstructing particles with it.
11. Repeat the flushing process if necessary. When the solution flows freely through the valve, the flushing process is completed.
12. Replace the syringe containing cleaning solution with the syringe containing the deionized water.
NOTE: Use paper towels to absorb any liquid that is discharged by the tubing.
13. Slowly inject deionized water into the Y Valve to remove any bleach residue.
14. When finished, remove the syringe containing deionized water.
15. Reconnect the tubing from the Y Valve to the top of the Open Sample Probe.
16. Reconnect the tubing between the Y Valve and the Shear Valve.
17. Remove the beaker.
18. Close the Right Front Cover and press into place. Reinstall Tower Cover.
19. In [SPECIAL PROTOCOLS] press [ENABLE ANALYZER] followed by [RETURN] and [MAIN] to return to the MAIN MENU .
20. Press [RUN] followed by [SPECIMEN TYPE] and [BACKGROUND] .
21. Run at least three background counts. Check that the background counts are acceptable before running controls or patient samples.
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Section 9 Service and Maintenance
22. If the counts are unacceptable, troubleshoot accordingly (refer to
Troubleshooting and Diagnostics ;
Subsection: Troubleshooting Guide ).
Rerun samples and confirm that problem is resolved.
23. Record the completion of this procedure in the maintenance log.
Procedure - Closed Mode
Gently pull on hand hold of the Right Front Cover and swing the cover open. Lift the Tower Cover up and off the instrument (Tower Door on the CS model must be open).
NOTE: The Right Front Cover should be open Prior to entering into Closed
Mode. (Wash block is lowered when in the Closed Mode and will prevent the door from opening.)
1. If the system is not already in the Closed Mode, press the [CHANGE
SAMPLER] soft key in the RUN menu to select Closed Mode.
2. In the MAIN MENU , press [SPECIAL PROTOCOLS] followed by [ DIS/ENAB
ANALYZER ] and [DISABLE ANALYZER]
3. Disconnect the tubing attached to the top of the Closed Sample probe.
(Tubing attached to vertical port on top of needle).
4. Fill one of the syringes with the prepared cleaning solution. Fill the other syringe with deionized water.
5. Attach the syringe with the cleaning solution to the tubing that had been connected to the Closed Sample Probe.
6. Locate the tubing between the Y Valve and Shear Valve. Refer to Figure 9.23.
7. Disconnect this tubing at the Shear Valve and place the end in the beaker to catch liquid.
8. Slowly inject cleaning solution into the Y Valve. The liquid should pass through the Y Valve carrying any obstructing particles with it.
9. Repeat the flushing process if necessary. When the solution flows freely through the valve, the flushing process is completed.
10. Remove the syringe with the cleaning solution and attach the syringe containing the deionized water.
NOTE: Use paper towels to absorb any liquid that is discharged by the tubing.
11. Slowly inject the deionized water into the Y Valve to remove any bleach residue.
12. When finished, remove the syringe containing deionized water.
13. Reconnect the tubing from the Y Valve to the top of the Closed Sample
Probe.
14. Reconnect the tubing between the Y Valve and the Shear Valve.
15. Remove the beaker.
16. Close the Right Front Cover and press into place. Reinstall the Tower Cover.
17. In [SPECIAL PROTOCOLS] press [ENABLE ANALYZER] followed by [RETURN] and [MAIN] to return to the MAIN MENU .
18. Press [RUN] followed by [SPECIMEN TYPE] and [BACKGROUND] .
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19. Run at least three background counts. Check that the background counts are acceptable before running controls or patient samples.
20. If the counts are unacceptable, troubleshoot accordingly (refer to
Troubleshooting and Diagnostics ;
Subsection: Troubleshooting Guide ).
Rerun samples and confirm that problem is resolved.
21. Record the completion of this procedure in the maintenance log.
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Section 10
Section 10 Troubleshooting and Diagnostics
Troubleshooting and Diagnostics
Overview
This section gives instructions for identifying, troubleshooting and correcting instrument problems. It is intended as a referral guide for customer troubleshooting and optimal instrument operation. The CELL-DYN 3200 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 FAULT indicator light on the Analyzer status indicator panel is illuminated in red. A description of the fault can be obtained by pressing the [FAULT REPORT] key in the
DIAGNOSTICS MENU screen.
The first part of this section discusses the DIAGNOSTICS MENU keys. The remainder of the section is devoted to the Troubleshooting Guide.
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 Hematology Customer Support Center. The Guide includes Troubleshooting Procedures, Instructions for Component Replacement and
Troubleshooting Tips and Techniques. The last part of this section describes the
Instrument Messages and Fault Conditions. The tables in this section include instructions for corrective action.
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Troubleshooting and Diagnostics
Overview
NOTES
Section 10
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Section 10 Troubleshooting and Diagnostics
Diagnostics Menu
Overview
This subsection 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 engineers and is not useful to the operator. If certain keys are pressed inadvertently, the system may have to be reinitialized.
There are five primary screens in the DIAGNOSTICS MENU . For ease of explanation, a diagram depicting the keys and functions available in each primary screen is shown below.
Figure 10.1 First Diagnostics Menu Screen
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Diagnostics Menu Section 10
Diagnostics Menu Screen
The first DIAGNOSTICS MENU
screen (see Figure 10.1) and the following soft key
labels are displayed when the [DIAGNOSTICS] key is pressed:
FAULT REPORT
EXECUTION TIMES
CNT RATE SUMMARY
CLEAR FAULTS
RAW DATA SUMMARY
MORE
MAIN
Fault Report
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:
Fatal Fault
Report:
(see Figure 10.3) and any additional information available. If there is no
fault, the screen displays the words
No Fault Pending
10-4
Figure 10.2 Operator Correctable Fault Report Screen
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Section 10 Troubleshooting and Diagnostics
Figure 10.3 Fatal Fault Report Screen
Figure 10.4 Fault Report — No Fault Pending Screen
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Diagnostics Menu Section 10
Operator correctable faults (for example, waste full, diluent empty) can be cleared by pressing the [CLEAR FAULT] key after taking corrective action. After corrective action for a fatal fault, the system must be reinitialized by pressing the
[INITIALIZATION] soft key in the second DIAGNOSTICS MENU screen (refer to
Execution Times
This key is for service use only.
Figure 10.5 Count Rate Summary Screen
CNT Rate Summary
When the [CNT RATE SUMMARY] key is pressed, the following soft key labels (see
WOC CNT RATE/WOC CNT GRAPH/WOC CNT DATA *
RBC/PLT CNT RATE/RBC/PLT CNT GRAPH/RBC/PLT CNT DATA *
NOC CNT RATE/NOC CNT GRAPH/NOC CNT DATA *
RETURN
* Key labels alternate between the selections.
NOTE: Once a [CNT RATE] key is pressed, that key toggles between [CNT DATA] and [CNT GRAPH] until the operator exits the screen. The keys then revert to [CNT RATE] .
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Section 10 Troubleshooting and Diagnostics
Figure 10.6 WOC Count Rate Data
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 Figure 10.6) and the
key label changes to [CNT GRAPH] for that parameter.
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
[CNT GRAPH] key for a particular parameter is
pressed, the rate-per-second data is displayed as a graph. (See Figure 10.7.) The
kinetic data and graph are useful when troubleshooting problems related to these parameters.
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Troubleshooting and Diagnostics
Diagnostics Menu Section 10
Clear Faults
Figure 10.7 WOC 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.
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Section 10 Troubleshooting and Diagnostics
Figure 10.8 Raw Data Summary Screen
Raw Data Summary
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
The HGB Reference and Sample readings may be used to assist in troubleshooting erratic or imprecise HGB results.
More
When the [MORE] key is pressed, the second DIAGNOSTICS MENU screen is displayed. The [MORE] keys on the remaining screens always display the next
DIAGNOSTICS MENU screen.
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.
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Troubleshooting and Diagnostics
Diagnostics Menu
Main
Section 10
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.
Figure 10.9 Second Diagnostics Menu Screen
Second Diagnostics Menu Screen
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:
MOTOR OPERATION
SOLENOID OPERATION
PUMP OPERATION
DRAIN ACCUMULATOR
INITIALIZATION
MORE
MAIN
Motor Operation
This key should be used only by an authorized Abbott representative. The system must be initialized after this key is pressed.
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Section 10
Solenoid Operation
Troubleshooting and Diagnostics
This key should be used only by an authorized Abbott representative. The system must be initialized after this key is pressed.
Pump Operation
Figure 10.10 Pump Operation Screen
When the [PUMP OPERATION] key is pressed, the following soft key labels (see
VACUUM ON/
VACUUM OFF
PRESSURE ON/
PRESSURE OFF
INHIBIT PUMPS/
ENABLE PUMPS
(The key label alternates between the selections.)
(The key label alternates between the selections.)
(Displayed when are pressed.)
VACUUM or PRESSURE keys
VACUUM TEST
PRESSURE TEST
DIAGNOSTICS
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Troubleshooting and Diagnostics
Diagnostics Menu Section 10
10-12
Figure 10.11 Pump Operation Screen — Vacuum ON
Vacuum On
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
.
[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.
Pressure 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.
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.
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Section 10 Troubleshooting and Diagnostics
Figure 10.12 Inhibit Pumps Screen
Inhibit Pumps
When the [VACUUM] or [PRESSURE] key is pressed, the [INHIBIT PUMPS] key
appears. (See Figure 10.12.) When the
[INHIBIT PUMPS] key is pressed, the operation of the pumps is inhibited (no vacuum and pressure are produced), the screen displays the message
Vacuum Is Inhibited
, and the key label changes to [ENABLE PUMPS] . 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, even if the pumps were disabled while in the screen.
This key is useful when performing maintenance or troubleshooting procedures that require a vacuum or pressure line to be removed.
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Troubleshooting and Diagnostics
Diagnostics Menu Section 10
10-14
Figure 10.13 Vacuum Test Screen
Vacuum Test
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.) When the test is finished, the time stops
incrementing and the key labels are displayed.
Pressure Test
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 finished, the time stops incrementing and the key labels are displayed.
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Section 10 Troubleshooting and Diagnostics
Figure 10.14 Drain Accumulators Screen
Drain Accumulator
When the [DRAIN ACCUMULATOR] key is pressed, the internal vacuum accumulators are drained of accumulated fluid. This key is used to correct the
“Vacuum Accumulator Wet” fault. The screen displays (see Figure 10.14) the
following message:
After draining the accumulators, press INITIALIZATION key to return to normal operation.
When the process is completed, the system must be initialized and primed. See
Initialization below.
Initialization
When the [INITIALIZATION] key is pressed, the Analyzer is initialized. This is necessary when a fatal fault has occurred.
After the Analyzer is initialized, it must be primed. To prime the Analyzer, go to the MAIN MENU and press the [RUN] soft key.
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Diagnostics Menu Section 10
Figure 10.15 Third Diagnostics Menu Screen
Third Diagnostics Menu Screen
When the [MORE] key in the second DIAGNOSTICS MENU is pressed, the third
DIAGNOSTICS MENU
screen (see Figure 10.15) and the following soft key labels
are displayed:
SOFTWARE VERSION *
DIGITAL READINGS *
VOLTAGE READINGS
GAIN ADJUSTMENT *
MORE
MAIN
* These keys are for service use only.
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Section 10 Troubleshooting and Diagnostics
Voltage Readings
Figure 10.16 Voltage Readings Screen
When the [VOLTAGE READINGS] key is pressed, the voltage and vacuum/pressure value from a test point, measured at the moment when the key was pressed, is
displayed. (See Figure 10.16.) 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.
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Troubleshooting and Diagnostics
Diagnostics Menu Section 10
Fourth Diagnostics Menu Screen
When the [MORE] key in the third DIAGNOSTICS MENU is pressed, the fourth
DIAGNOSTICS MENU
screen (see Figure 10.17) and the following soft key labels
are displayed:
RBC LIN DATA *
WBC DATA *
RBC DATA *
PLT DATA *
NOC DATA *
MORE
MAIN
* These keys are for service use only.
10-18
Figure 10.17 Fourth Diagnostics Menu Screen
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Section 10 Troubleshooting and Diagnostics
Fifth Diagnostics Menu Screen — CS Model
For CS models, when the [MORE] key in the fourth DIAGNOSTICS MENU is pressed, the fifth and last DIAGNOSTICS MENU
screen (see Figure 10.18) and the following
soft key labels are displayed:
SERIAL TEST
BAR CODE ALIGNMENT *
FPU TEST*
TOWER TEST *
DOOR TEST *
MORE
MAIN
* These keys are for service use only.
Figure 10.18 Fifth Diagnostics Menu Screen (CELL-DYN 3200CS)
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Troubleshooting and Diagnostics
Diagnostics Menu
Serial Test
Section 10
The [SERIAL TEST] key is used to test the functionality of the COM1 port (referred to as the “serial interface connector”) at the rear of the instrument. This test is designed to assist in troubleshooting problems with interfacing to a Laboratory
Information System (LIS). The loop-back connector must be connected to the
COM1 port before performing the test.
NOTE: If the laboratory does not have a LIS, the loop-back connector may remain connected to the COM1 port for convenience, as it does not interfere with routine operation. If a LIS is usually connected, the loop-back connector should be stored near the instrument when the connector is not in use.
10-20
Figure 10.19 Serial Test Screen
When the [SERIAL TEST] key is pressed, the following soft key labels (see
STOP TRANSMISS
TRANSMIT MESSAGE
RETURN
The screen displays the following:
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.
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Section 10 Troubleshooting and Diagnostics
Stop Transmiss
The [STOP TRANSMISS] key is used to stop any transmission that is in progress to a LIS. When the key is pressed, any transmission in progress is aborted.
Figure 10.20 Serial Test Transmit Message Screen
Transmit Message
When the [TRANSMIT MESSAGE] key is pressed, the message
“CELL-DYN serial interface test”
is transmitted from the Analyzer to the COM1 port, through the loop-back connector and back to the Analyzer. The
screen (see Figure 10.20) displays the message:
MESSAGE SENT: CELL-DYN serial interface test.
If the test is successful, the screen displays the message:
MESSAGE RECEIVED: CELL-DYN serial interface test.
This message indicates that the Data Station is communicating properly. If the test is not successful, no message appears.
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Troubleshooting and Diagnostics
Diagnostics Menu Section 10
Fifth Diagnostics Menu Screen — SL Model
For SL models, when the [MORE] key in the fourth DIAGNOSTICS MENU is pressed, the fifth and last DIAGNOSTICS MENU
screen (see Figure 10.21) and the following
soft key labels are displayed:
SERIAL TEST
BAR CODE ALIGNMENT *
FPU TEST *
TOWER TEST *
LOADER TEST *
MORE
MAIN
* These keys are for service use only.
10-22
Figure 10.21 Fifth Diagnostics Menu Screen (CELL-DYN 3200SL)
The [SERIAL TEST] and [MORE] keys function in a similar manner to that described in section Fifth Diagnostics Menu Screen — CS Model .
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Section 10 Troubleshooting and Diagnostics
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 preventative 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 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.
NOTE: Generally, conditions that are instrument- or reagent-related will occur on all samples, including controls. Therefore, it is important to confirm instrument performance by rerunning controls and/or additional patient specimens.
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Troubleshooting and Diagnostics
Troubleshooting Guide Section 10
Obtaining Technical Assistance
Technical Assistance is obtained by calling the CELL-DYN Hematology Customer
Support Center. 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
3. Description of the problem
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
Customer Support
United States: 1 (800) CELL DYN or 1 (800) 235-5396
Abbott Diagnostics Customer Support Center:
200 Abbott Park Road
Abbott Park, Il 60064
Canada: 1(800) 387-8378
For customers outside the U.S., call your local Abbott Hematology Customer
Support Representative.
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Section 10 Troubleshooting and Diagnostics
Troubleshooting Procedures
The procedures in this section are for troubleshooting purposes only. A specific procedure should be performed under one of the following conditions:
1. To correct a problem described in this section
2. At the request of an Abbott Customer Support Specialist.
WARNING: Potential Biohazard. Follow established biosafety practices when performing maintenance, service or troubleshooting procedures.
Refer to
Section 8: Hazards for additional information.
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 Specialist.
Troubleshooting the Background Count
NOTE: For the appropriate corrective action for unacceptable background counts,
1. Determine which parameter(s) exceed the background count specifications:
WBC, RBC, PLT, HGB, NOC.*
* Background counts for NOC are available in the Data Log.
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. To do this in closed mode, you must have a sample tube filled with diluent/sheath to aspirate for a background count.
5. Note the lot number of the reagent. Is it a new lot?
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Troubleshooting and Diagnostics
Troubleshooting Procedures Section 10
6. Configure the RUN screen to display the appropriate graphic for the parameter(s) for which the background exceeds the specifications:
Parameter Appropriate Graphic
WBC
RBC
WBC histogram/scatterplots
RBC and PLT histograms/scatterplots
PLT
HGB
RBC and PLT histograms/scatterplots
WBC, RBC and PLT histograms
NOC NOC histogram
Obtain several printouts of this information by running multiple background cycles.
NOTE: Instructions for customizing the RUN screen display are given in
Section 5: Operating Instructions ; Subsection:
Set Up Instructions,
Customize Report, Customize Displayed Report .
7. Configure the Data Log to display values for WBC, RBC, PLT, HGB, and
NOC. Obtain printouts of the Data Log, including the sequence numbers of the background cycles.
NOTE: Instructions for customizing the display and printout of the Data
Log are given in Section 5: Operating Instructions ;
Subsection:
Using the Data Log, Data Log Set Up Procedures .
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 that contain a small amount of reagent to maintain the supply within the system. This supply must be depleted before installing the new reagent.
NOTE: There is no reservoir for either the HGB Lyse reagent or WBC lyse reagent. The amount of lyse contained in the lyse supply tubing is sufficient to maintain the system’s supply. The lyse tubing is drained and filled by pressing the appropriate reagent key displayed on the REAGENT
RESERVOIR screen described below.
To ensure that the new reagent is actually in the system, proceed as follows:
1. From the first SPECIAL PROTOCOLS screen, press [REAGENT RESERVOIR] .
2. From the REAGENT RESERVOIR screen, press the soft key for the desired reagent and follow the instructions given on the screen.
3. Wipe the reagent line with a lint-free wipe before placing it in the new container. Place the line in the container and secure the cap.
4. Press the appropriate soft key to refill the reservoir.
5. Run five Background counts before assessing the results.
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Section 10 Troubleshooting and Diagnostics
Troubleshooting the “Sampling error-incomplete aspiration” 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 in the sample tubing above the appropriate probe or needle.
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.
Troubleshooting a Flow Error Message
1. The flow error messages indicate a problem with the kinetic rate of the WBC,
RBC/PLT, or NOC measurements. The kinetic information is only available immediately after the cycle is finished. Therefore, the screen should be printed immediately after the flow error occurs.
2. From the first DIAGNOSTICS MENU screen, press [CNT RATE SUMMARY] .
3. Press the appropriate [COUNT RATE] key (WOC, RBC, PLT, or NOC) to display the data for the kinetic rate. Press [PRINT] to obtain a printout.
4. Press the appropriate [COUNT GRAPH] key to display the graph of the kinetic data. Press [PRINT] to obtain a printout.
5. Configure the RUN screen to display the Size/Complexity scatterplot and the
NLM histogram. (If necessary, refer to the instructions given in Section 5:
Operating Instructions ; Subsection:
Customize Displayed Report .) Obtain several printouts. This information can help to determine if the flow is erratic or just momentarily interrupted.
Troubleshooting Imprecise or Inaccurate Data
1. Obtain a normal blood sample. Select an empty QC file and run a minimum of ten Open Mode runs into the file. Obtain a printout.
2. Run a minimum of nine Closed Mode runs into the same file. (For the
CELL-DYN 3200SL, 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. Obtain printouts of related data as indicated in the following steps.
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Troubleshooting and Diagnostics
Troubleshooting Procedures Section 10
4. WBC:
• 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:
Size-Cmp (0—10)
Grn-Lob (90D—90)
WBC 0—90 deg
RBC 90—10 deg
• Printout 2:
N-L-M histogram
M-P histogram
NOC histogram
If necessary, refer to the directions given in
Instructions for customizing the display.
• Obtain printouts of the kinetic data for WBC for several samples. From the first DIAGNOSTICS MENU screen, press [CNT RATE SUMMARY] . Press
[WOC CNT RATE] to display the data for the kinetic rate followed by
[PRINT] to obtain a printout. Press [WOC CNT 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.
• Configure the Data Log to display and print WBC values. (If necessary,
refer to the instructions given in Section 5: Operating Instructions .) Print
the results for the last 100 cycles.
5. RBC, HGB, MCV and PLT:
• Configure the RUN screen to display the RBC and PLT histograms/scatterplots. 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.
• Obtain a printout of the X-B data. In the MAIN MENU , press [QUALITY
CONTROL] followed by [X-B FILE] . If necessary, press [X-B RBC DATA] to display the X-B RBC data and press [PRINT] to obtain a printout.
• Check the Hemoglobin Reference and verify that its values are within
2050 ± 250.
• Check the hemoglobin Flow Cell if the reference value is <1800.
• If the Hemoglobin Reference Value is >2300, call your Hemotology
Customer Support Center.
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Section 10 Troubleshooting and Diagnostics
6. NOC:
• Follow the instructions given in step 5 for WBC, substituting the [NOC CNT] key for the [WOC CNT] key for displaying and printing rate and graph data.
Troubleshooting Imprecise or Inaccurate Data
– – – - Probable Cause – – – –
1. Improper Sample Mixing
– – – - Corrective Action – – –
1. Verify all samples are well-mixed prior to analysis. (Refer to
.)
2. Dirty Syringe(s)
3. Leaking Syringe(s)
4. Dirty Shear Valve
5. Dirty/Obstructed Y valve
6. Worn Sample Transfer Pump Tubing
1. Inspect/Clean syringe as directed is Section 9:
Nonscheduled Maintenance Procedures
.
1. Inspect syringe for evidence of leaks.
2. Verify syringe connectors are secure.
3. Remove/Clean /Replace syringe as directed in
Section 9: Service and Maintenance ;
Subsection: Nonscheduled Maintenance
.
1. Clean shear valve as directed in
Section 9: Service and Maintenance ;
1. Clean Y valve as directed in Section 9: Service and Maintenance ;
1. Inspect/Replace sample transfer pump tubing as
directed in Section 9: Service and Maintenance ;
Subsection: Nonscheduled Maintenance
.
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Troubleshooting and Diagnostics
Troubleshooting Procedures
NOTES
Section 10
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Section 10 Troubleshooting and Diagnostics
Instrument Conditions and Messages
Overview
Instrument conditions can be divided into two categories, those that generate messages, and those that do not. The messages will be displayed in the Status Box and/or the Bulletin Line.
NOTE:
For information on Suspect Parameter Flags, refer to Section 3:
; Subsection: Operational Messages and Data
Instrument messages fall into two categories:
1. Status Messages — inform the operator of the instrument’s status or prompt the operator to take action relative to the last operator entry
2. Fault Messages — indicate fault or error detection
The status conditions are listed in Table 10.1. This table defines each message and indicates its display location.
The fault conditions and messages are listed as follows:
• General fault conditions are listed in Table 10.2.
• Sample-Related fault conditions are listed in Table 10.3.
• Non-functional fault conditions are listed in Table 10.4.
Each of the tables is designed with the Message or Condition, display location (if applicable), and additional information 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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Troubleshooting and Diagnostics
Instrument Conditions and Messages
NOTES
Section 10
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Section 10 Troubleshooting and Diagnostics
Tables for Instrument Conditions and Messages
Index of Table 10.1: Status Conditions
Condition Page
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Tables for Instrument Conditions and Messages Section 10
Table 10.1 Status Conditions
Each message is followed by one of the abbreviations shown below indicating where that message appears on the screen:
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 finished, press [RUN] to prime the system and bring the instrument to the READY state. Resume operation when the cycle is finished.
Standby /SB
– – – – – – – – – – – – – – – – – Explanation/Action– – – – – – – – – – – – – – – –
The instrument has entered the STANDBY state.
Press [RUN] or [PRIME] to prime the system and bring the instrument to the
READY state. Resume operation when the cycle is finished.
Initialized /SB
The Analyzer hardware initialization is completed.
Press [RUN] to prime the system and bring the instrument to the READY state.
Resume operation when the cycle is finished.
Unpinching valves /SB
– – – – – – – – – – – – – – – – – Explanation/Action– – – – – – – – – – – – – – – –
The Analyzer was in standby for a predetermined time period and therefore the valves are being exercised to be sure that tubing is not pinched shut.
Analyzer status will change back to STANDBY when the unpinching operation is completed.
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Section 10 Troubleshooting and Diagnostics
Table 10.1 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 READY indicator light 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.
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.
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Troubleshooting and Diagnostics
Tables for Instrument Conditions and Messages Section 10
Table 10.1 Status Conditions (Continued)
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 on the new line /BL
– – – – – – – – – – – – – – – – – Explanation/Action– – – – – – – – – – – – – – – –
The Work List already contains a bar code number that has been entered.
It is not possible to enter the same bar code number twice in the Work List. If appropriate, delete the previous entry and re-enter the number.
Sample Loader is busy /BL
– – – – – – – – – – – – – – – – – Explanation/Action– – – – – – – – – – – – – – – –
An action was requested during Sample Loader operation and the Sample Loader cannot perform it.
Press the [STOP LOADER] soft key before requesting the desired action.
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 Sample Loader is not busy /BL
– – – – – – – – – – – – – – – – – Explanation/Action– – – – – – – – – – – – – – – –
The [CHANGE SAMPLER] key was pressed while the Sampler Loader was busy.
Press the [STOP LOADER] soft key before pressing [CHANGE SAMPLER] .
Loader Status 143: samples completed /BL
– – – – – – – – – – – – – – – – – Explanation/Action– – – – – – – – – – – – – – – –
The last rack in the load zone has been processed. NOTE: The Sample Loader halts.
No corrective action is necessary. When you wish to run additional samples in the Sample Loader, load racks and press the [START LOADER] key.
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Section 10 Troubleshooting and Diagnostics
Table 10.1 Status Conditions (Continued)
Loader Warning 145: unload area full /BL
– – – – – – – – – – – – – – – – – Explanation/Action– – – – – – – – – – – – – – – –
The unload area contains 5 racks. NOTE: The Sample Loader halts.
No corrective action is necessary. When you wish to run additional samples in the Sample Loader, remove the racks from the unload area and press the [START
LOADER] key.
Loader Warning 146: unload area nearly full /BL
– – – – – – – – – – – – – – – – – Explanation/Action– – – – – – – – – – – – – – – –
The unload area contains 4 racks.
No corrective action is necessary. If a rack is being processed and there are no other faults, the Sample Loader will continue to operate.
Loader Status 158: load zone empty /BL
– – – – – – – – – – – – – – – – – Explanation/Action– – – – – – – – – – – – – – – –
The load zone empty sensor is not sensing the presence of a rack in the load zone.
NOTE: The Sample Loader halts.
When you wish to run samples in the Sample Loader, load tubes in racks and press the [START LOADER] key.
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Troubleshooting and Diagnostics
Tables for Instrument Conditions and Messages Section 10
Index of Table 10.2: General Fault Conditions
Condition Page
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Section 10 Troubleshooting and Diagnostics
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Troubleshooting and Diagnostics
Tables for Instrument Conditions and Messages Section 10
Table 10.2 General Fault Conditions
Each message is followed by one of the abbreviations shown below indicating where that message appears on the screen:
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 FAULT indicator light on the Analyzer status indicator panel is illuminated in red.
– – – – Probable Cause – – – –
1. A situation that prevents the
READY state has been detected. See the DIAGNOSTICS MENU screen or the SPECIAL PROTOCOLS MENU screen, whichever is indicated, for more information.
2. A diagnostic test was run using one of the DIAGNOSTICS MENU screen keys.
3. A Special Protocols procedure is in progress.
4. System malfunction.
– – – – Corrective Action – – –
1. From the first DIAGNOSTICS MENU screen, press [FAULT REPORT] followed by [PRINT] to obtain a printout describing the problem.
Refer to the appropriate table for corrective action.
2. The instrument must be initialized when the diagnostic test in progress is finished. Initialize the Analyzer by pressing the [INITIALIZATION] key on the second DIAGNOSTICS
MENU screen.
3. Check the SPECIAL PROTOCOLS
MENU screen and perform the action necessary to complete the procedure.
4. If the message occurs repeatedly, contact your Abbott Hematology
Customer Support Center.
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Section 10 Troubleshooting and Diagnostics
Table 10.2 General Fault Conditions (Continued)
Uninitialized/ SB
– – – – Probable Cause – – – –
1. Main power switch is ON but the
Analyzer is not responding.
– – – – Corrective Action – – –
1. Turn the system OFF.
2. Ensure that all cables on the back of the instrument are properly attached.
3. Turn the System ON.
4. If the problem persists, contact your
Abbott Hematology Customer
Support Center.
Initialization Failed
Bottom of screen (MAIN MENU is not displayed)
– – – – Probable Cause – – – –
1. The instrument software was unable to initialize. The CELL-DYN software does not display the MAIN
MENU screen.
– – – – Corrective Action – – –
1. Initialize the Analyzer by following the instructions in the Power OFF and Power ON procedures given in
Section 5: Operating Instructions ;
Subsection: Operation Overview .
If the Analyzer does not initialize, press the Print Screen key on the computer keyboard to document any screen messages, then contact your Abbott Hematology Customer
Support Center.
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Troubleshooting and Diagnostics
Tables for Instrument Conditions and Messages Section 10
Table 10.2 General Fault Conditions (Continued)
Printer (Graphics or Ticket) Unavailable/SB
– – – - Probable Cause – – – –
1. The print buffer (the memory area where the information is stored while awaiting printing) is full.
– – – - Corrective Action – – –
1. Press the [STOP PRINTING] key on the CUSTOMIZE PRINTED REPORT screen for the appropriate printer.
2. The printer is turned OFF.
3. The printer is not on-line.
4. The power cord is loose or disconnected. The interface cable is loose or disconnected.
5. Printer cable is connected to the wrong port.
2. Turn the printer power switch ON.
3. Check that the printer “on-line” indicator is illuminated. If necessary, refer to the printer manual for assistance.
4. Check the power cable connection on the printer and power outlet.
Make sure the connections are secure. Check the interface cable connectors on the printer and
Analyzer. Make sure the connections are secure. Press
[PRINT REPORT] . If the message is still displayed, turn the printer power switch OFF and ON to reset the printer.
5. Ensure that the graphics printer cable is attached to the graphics printer port (LPT1) and the ticket printer cable is attached to the ticket printer port (LPT2).
10-42 CELL-DYN ® 3200 System Operator’s Manual
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Section 10 Troubleshooting and Diagnostics
Table 10.2 General Fault Conditions (Continued)
Diluent/Sheath, HGB Lyse, or WBC Lyse empty/ SB and BL
– – – - Probable Cause – – – –
1. Container is empty.
– – – - Corrective Action – – –
1. Install a new container of reagent.
Press [CLEAR FAULT] to resume operation.
NOTE: Do not pour any remaining reagent into the new container.
2. Reagent inlet tubing is crimped or obstructed.
2. Inspect the whole length of 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. An incorrect reagent or a nonconductive liquid is connected to the inlet tube.
5. Appropriate syringe not mounted properly.
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. Check proper mounting of syringes.
6. The Luer fitting connection on the top of the appropriate syringe is loose.
7. WBC Lyse or HGB Lyse only: tubing in solenoid valve is pinched or not fully inserted.
6. Verify the Luer connection on the top of syringes is secure.
8. Circuitry malfunction.
7a.Check tubing in N/C valves 23
(WBC Lyse) or 28 (HGB Lyse) is not pinched or obstructed; replace as necessary.
7b.Verify tubings are fully inserted in solenoids 23, 25 (WBC Lyse) and
28, 24 (HGB Lyse).
8. Contact your Abbott Hematology
Customer Support Center.
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Troubleshooting and Diagnostics
Tables for Instrument Conditions and Messages Section 10
Table 10.2 General Fault Conditions (Continued)
External waste full/ SB and BL
– – – - Probable Cause – – – –
1. Waste container full.
– – – - Corrective Action – – –
1. Empty the waste container and/or replace it. Press [CLEAR FAULT] to resume operation.
NOTE: Make sure the Analyzer rinse process has been completed before removing the waste tube.
2. Waste sensor connector is loose or disconnected.
3. Shorted wire(s) or electrode(s) on the waste cap.
2. Reconnect the waste sensor connector and then press [CLEAR
FAULT] .
3. Visually inspect wires and electrodes and call for technical assistance.
4. Circuitry malfunction.
4. If the message appears repeatedly, contact your Abbott Hematology
Customer Support Center.
Shear valve position fault/ BL
– – – - Probable Cause – – – –
1. The Shear Valve did not rotate properly or in the allotted time.
– – – - Corrective Action – – –
1. Clean the Shear Valve. Then, initialize the Analyzer by pressing the [INITIALIZATION] key on the second DIAGNOSTICS MENU screen. If the message appears again, reboot the system. NOTE: If you wish to use the Sample Loader, reset the racks before initializing or rebooting the System.
2. Sensor or cable malfunction.
2. If the problem occurs repeatedly, contact your Abbott Hematology
Customer Support Center.
10-44 CELL-DYN ® 3200 System Operator’s Manual
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Section 10 Troubleshooting and Diagnostics
Table 10.2 General Fault Conditions (Continued)
RBC diluent syringe overpressure/ BL
NOTE: Diluent/Sheath syringe attempted to move up and pressure exceeding the allowed limit was detected in the Diluent/Sheath line.
– – – - Probable Cause – – – –
1. A blockage obstructs the Diluent/
Sheath reagent distribution through the flow system.
– – – - Corrective Action – – –
1. Try to initialize the system.
2. If you cannot open Right Front
Cover/Door contact your Abbott
Hematology Customer Support
Center.
3. If you can open the Right Front
Cover/Door, remove the Diluent/
Sheath and WBC Lyse syringes from their brackets (make sure the syringes stay connected to the Luer fittings) and initialize the Analyzer.
4. Clean the 10 mL syringe.
5. Clean the Shear Valve.
6. Verify tubing in solenoids 26 and 27 is not pinched; replace if necessary.
Vacuum accumulator 1 wet/ BL
Vacuum accumulator 2 wet /BL
– – – - Probable Cause – – – –
7. If still unable to resolve the problem, contact Hematology
Customer Support Center.
1. The internal vacuum accumulator has filled with liquid beyond allowable limits.
– – – - Corrective Action – – –
1. From the second DIAGNOSTICS
MENU screen, press the [DRAIN
ACCUMULAT] key. When the cycle is finished, initialize the Analyzer by pressing the [INITIALIZATION] key on the second DIAGNOSTICS
MENU screen. If the fault recurs, repeat this action. If the fault persists, contact your Abbott
Hematology Customer Support
Center.
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Troubleshooting and Diagnostics
Tables for Instrument Conditions and Messages Section 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 name.
– – – - Probable Cause – – – –
1. An internal Analyzer flow sequence was not completed in the allotted time.
– – – - Corrective Action – – –
1. Record the characters in the brackets.
2. Initialize the Analyzer by pressing the [INITIALIZATION] key on the second DIAGNOSTICS MENU screen. Continue processing samples.
3. If the problem recurs, contact your
Abbott Hematology Customer
Support Center.
Command sent at incorrect time <x> /BL
– – – - Probable Cause – – – – – – – - Corrective Action – – –
1. The Analyzer received a command from the System Software at the incorrect time and could not process it.
1. Record the characters in the brackets.
2. Initialize the Analyzer by pressing the [INITIALIZATION] key on the second DIAGNOSTICS MENU screen. Continue processing samples.
3. If the problem recurs, contact your
Abbott Hematology Customer
Support Center.
10-46 CELL-DYN ® 3200 System Operator’s Manual
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Section 10 Troubleshooting and Diagnostics
Table 10.2 General Fault Conditions (Continued)
Data acquisition overlap /BL
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.
– – – - Probable Cause – – – – – – – - Corrective Action – – –
1. The timing of communication between the Analyzer and the
System Software is incorrect.
1. Record what happened when the message was displayed.
2. Initialize the Analyzer by pressing the [INITIALIZATION] key on the second DIAGNOSTICS MENU screen.
Continue processing samples.
3. If the fault recurs, contact your
Abbott Hematology Customer
Support Center.
List mode data phase error /BL
– – – - Probable Cause – – – – – – – - Corrective Action – – –
1. The order of the data received for display on the screen was incorrect.
1. Record what happened when the message was displayed.
2. Initialize the Analyzer by pressing the [INITIALIZATION] key on the second DIAGNOSTICS MENU screen.
Continue processing samples.
3. If the fault recurs, contact your
Abbott Hematology Customer
Support Center.
Message acknowledgment time out /BL
– – – - Probable Cause – – – –
1. Communication between the
Analyzer and the Data Module did not occur when expected.
– – – - Corrective Action – – –
1. Record what happened when the message was displayed.
2. Initialize the Analyzer by pressing the [INITIALIZATION] key on the second DIAGNOSTIC MENU screen.
Continue processing samples.
If the fault recurs, contact your
Abbott Hematology Customer
Support Center.
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Troubleshooting and Diagnostics
Tables for Instrument Conditions and Messages Section 10
Table 10.2 General Fault Conditions (Continued)
Runtime error /BL
– – – - Probable Cause – – – –
1. An illegal software operation was requested by the Analyzer.
– – – - Corrective Action – – –
1. Record what happened when the message was displayed.
2. Initialize the Analyzer by pressing the [INITIALIZATION] key on the second DIAGNOSTICS MENU screen. Continue processing samples. If the fault recurs, contact your Abbott Hematology Customer
Support Center.
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 Module.
1. Power OFF and ON again.
2. If the fault recurs, contact your
Abbott Hematology Customer
Support Center.
Bad monitor command /BL
NOTE: This message pertains to a software execution monitor on the Analyzer, not the video display screen (CRT).
– – – - Probable Cause – – – – – – – - Corrective Action – – –
1. During the initialization process, the
Data Module and Analyzer did not communicate properly.
1. Initialize the Analyzer by pressing the [INITIALIZATION] key on the second DIAGNOSTICS MENU screen.
If the fault recurs, power OFF and
ON again. Contact your Abbott
Hematology Customer Support
Center if the message appears repeatedly.
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Section 10 Troubleshooting and Diagnostics
Table 10.2 General Fault Conditions (Continued)
Message retransmission failure /BL
Communication from the Data Module to the Analyzer failed.
– – – - Probable Cause – – – – – – – - Corrective Action – – –
1. A hardware failure or system error has occurred.
1. Initialize the Analyzer by pressing the [INITIALIZATION] key on the second DIAGNOSTICS MENU screen. If the message appears again, reboot the System.
NOTE: If you wish to use the
Sample Loader, reset the racks before initializing or rebooting the System.
2. If the message appears repeatedly, contact your Abbott Hematology
Customer Support Center.
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Troubleshooting and Diagnostics
Tables for Instrument Conditions and Messages Section 10
Table 10.2 General Fault Conditions (Continued)
HSSL failure – bad incoming messages /BL
NOTE: HSSL stands for High Speed Serial Link.
The Data Module received unrecognizable messages from the Analyzer.
– – – - Probable Cause – – –
1. The communication line has become noisy, possibly due to a partial break in the line.
– – – - Corrective Action –
1. Initialize the Analyzer by pressing the [INITIALIZATION] key on the second DIAGNOSTICS MENU screen. If the message appears again, power OFF the Analyzer.
Then reseat both ends of HSSL cable and make sure the connections are secure. Power
Analyzer ON.
NOTE: For the location of the
HSSL connectors on the rear panel of the Data
Module, refer to
NOTE: If you wish to use the
Sample Loader, reset the racks before initializing or rebooting the System.
2. If the message appears repeatedly, contact your Abbott Hematology
Customer Support Center.
10-50 CELL-DYN ® 3200 System Operator’s Manual
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Section 10 Troubleshooting and Diagnostics
Table 10.2 General Fault Conditions (Continued)
HSSL failure – bad outgoing commands /BL
The Analyzer received unrecognizable messages from the Data Module.
– – – - Probable Cause – – – – – – - Corrective Action –
1. The communication line has become noisy, possibly due to a partial break in the line.
1. Initialize the Analyzer by pressing the [INITIALIZATION] second
key on the
DIAGNOSTICS MENU screen. If the message appears again, power OFF the Analyzer.
Then reseat both ends of HSSL cable and make sure the connections are secure. Power
Analyzer ON.
NOTE: For the location of the
HSSL connectors on the rear panel of the Data
;
NOTE: If you wish to use the
Sample Loader, reset the racks before initializing or rebooting the System.
2. If the message appears repeatedly, contact your Abbott Hematology
Customer Support Center.
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Troubleshooting and Diagnostics
Tables for Instrument Conditions and Messages Section 10
Table 10.2 General Fault Conditions (Continued)
HSSL failure – receiver hardware error /BL
The HSSL receiver on the Data Module malfunctioned.
– – – - Probable Cause – – – – – – - Corrective Action –
1. A hardware failure on the HSSL card has occurred.
1. Initialize the Analyzer by pressing the [INITIALIZATION] key on the second DIAGNOSTICS MENU screen. If the message appears again, power OFF the Analyzer.
Then reseat both ends of HSSL cable and make sure the connections are secure. Power
Analyzer ON.
NOTE: For the location of the
HSSL connectors on the rear panel of the Data
Module, refer to
NOTE: If you wish to use the
Sample Loader, reset the racks before initializing or rebooting the System.
2. If the message appears repeatedly, contact your Abbott Hematology
Customer Support Center.
Monitor power-on self-test error /BL
NOTE: This message pertains to a software execution monitor on the Analyzer, not the video display monitor.
A failure occurred during self-test.
(e.g., test pattern not successfully read from memory)
– – – - Probable Cause – – –
1. A failure in the Analyzer hardware has occurred.
– – – - Corrective Action –
1. Reboot the System.
NOTE: If you wish to use the
Sample Loader, reset the racks before rebooting the
System.
2. If the message appears repeatedly, contact your Abbott Hematology
Customer Support Center.
10-52 CELL-DYN ® 3200 System Operator’s Manual
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Section 10 Troubleshooting and Diagnostics
Table 10.2 General Fault Conditions (Continued)
Missing download program /BL
Download program not present on Data Module.
– – – - Probable Cause – – – – – – - Corrective Action –
1. Installation error, damaged hard disk, or erased hard disk.
1. Reboot the System.
NOTE: If you wish to use the
Sample Loader, reset the racks before rebooting the
System.
2. If the message appears repeatedly, contact your Abbott Hematology
Customer Support Center.
Missing flow sequence /BL
Flow sequence not present on Data Module.
– – – - Probable Cause – – –
1. Installation error, damaged hard disk, or erased hard disk.
– – – - Corrective Action –
1. Reboot the System.
NOTE: If you wish to use the
Sample Loader, reset the racks before rebooting the
System.
2. If the message appears repeatedly, contact your Abbott Hematology
Customer Support Center.
Invalid substitutable parameter /BL
Size or structure of parameter (e.g., gain) is invalid.
– – – - Probable Cause – – – – – – - Corrective Action –
1. A software error has occurred.
1. Reboot the System.
NOTE: If you wish to use the
Sample Loader, reset the racks before rebooting the
System.
2. If the message appears repeatedly, contact your Abbott Hematology
Customer Support Center.
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Troubleshooting and Diagnostics
Tables for Instrument Conditions and Messages Section 10
Table 10.2 General Fault Conditions (Continued)
DMA controller error during list mode acquisition /BL
NOTE: DMA stands for Direct Memory Access.
A memory access control problem occurred during data acquisition.
– – – - Probable Cause – – –
1. A failure in the Analyzer hardware has occurred.
– – – - Corrective Action –
1. Initialize the Analyzer by pressing the [INITIALIZATION] key on the second DIAGNOSTICS MENU screen. If the message appears again, reboot the System.
NOTE: If you wish to use the
Sample Loader, reset the racks before initializing or rebooting the System.
2. If the message appears repeatedly, contact your Abbott Hematology
Customer Support Center.
DMA controller setup error /BL
A problem occurred during setup of the memory access controller.
– – – - Probable Cause – – – – – – - Corrective Action –
1. A failure in the Analyzer hardware has occurred.
1. Initialize the Analyzer by pressing the [INITIALIZATION] key on the second DIAGNOSTICS MENU screen. If the message appears again, reboot the System.
NOTE: If you wish to use the
Sample Loader, reset the racks before initializing or rebooting the System.
2. If the message appears repeatedly, contact your Abbott Hematology
Customer Support Center.
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Section 10 Troubleshooting and Diagnostics
Table 10.2 General Fault Conditions (Continued)
Download program timeout /BL
The allotted time for program downloading was exceeded.
– – – - Probable Cause – – – – – – - Corrective Action –
1. A failure in the Analyzer hardware, possibly related to the HSSL cable, card, or memory, has occurred.
1. Check the HSSL cable connections.
Then, initialize the Analyzer by pressing the [INITIALIZATION] key on the second DIAGNOSTICS MENU screen. If the message appears again, reboot the System.
NOTE: For the location of the
HSSL ports, refer to
NOTE: If you wish to use the
Sample Loader, reset the racks before initializing or rebooting the System.
2. If the message appears repeatedly, contact your Abbott Hematology
Customer Support Center.
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Troubleshooting and Diagnostics
Tables for Instrument Conditions and Messages Section 10
Table 10.2 General Fault Conditions (Continued)
Download flow sequence timeout /BL
The allotted time for flow sequence downloading was exceeded.
– – – - Probable Cause – – – – – – - Corrective Action –
1. The flow sequence did not compile, possibly due to interruption by a fatal fault, an improperly seated
Tower Cover or door, or a fluidics problem.
1. Reboot the System.
NOTE: If you wish to use the
Sample Loader, reset the racks before rebooting the
System.
2. If the message appears repeatedly, contact your Abbott Hematology
Customer Support Center.
Command transmission timeout
The Data Module did not receive acknowledgment of a command sent to the
Analyzer within the allotted time.
– – – - Probable Cause – – – – – – - Corrective Action –
1. A failure in the Analyzer hardware, possibly due to an unplugged or damaged HSSL cable, has occurred.
2. A software error has occurred.
1. Check the HSSL cable connections.
Then, initialize the Analyzer by pressing the [INITIALIZATION] key on the second DIAGNOSTICS MENU screen. If the message appears again, reboot the System.
NOTE: For the location of the
HSSL ports, refer to
NOTE: If you wish to use the
Sample Loader, reset the racks before initializing or rebooting the System.
2. If the message appears repeatedly, contact your Abbott Hematology
Customer Support Center.
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Section 10 Troubleshooting and Diagnostics
Table 10.2 General Fault Conditions (Continued)
Message reception timeout /BL
The Analyzer did not receive acknowledgement of a command sent to the Data
Module within the allotted time.
– – – - Probable Cause – – –
1. A communication error, possibly due to a loose HSSL cable, has occurred.
– – – - Corrective Action –
1. Check the HSSL cable connections.
Then, initialize the Analyzer by pressing the [INITIALIZATION] key on the second DIAGNOSTICS MENU screen. If the message appears again, reboot the System.
NOTE: For the location of the
HSSL ports, refer to
NOTE: If you wish to use the
Sample Loader, reset the racks before initializing or rebooting the System.
2. If the message appears repeatedly, contact your Abbott Hematology
Customer Support Center.
Data acquisition timeout /BL
The Analyzer exceeded the allotted time for data acquisition.
– – – - Probable Cause – – –
1. An Analyzer or Data Module software timing error has occurred
– – – - Corrective Action –
1. Initialize the Analyzer by pressing the [INITIALIZATION] key on the second DIAGNOSTICS MENU screen. If the message appears again, reboot the System.
NOTE: If you wish to use the
Sample Loader, reset the racks before initializing or rebooting the System.
2. If the message appears repeatedly, contact your Abbott Hematology
Customer Support Center.
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Troubleshooting and Diagnostics
Tables for Instrument Conditions and Messages Section 10
Table 10.2 General Fault Conditions (Continued)
Overflow in the HSSL queue /BL
The buffer for Analyzer-to-Data Module communication overflowed.
– – – - Probable Cause – – – – – – - Corrective Action –
1. The Analyzer message rate was too high for the Data Module to keep up with.
1. Reboot the System.
NOTE: If you wish to use the
Sample Loader, reset the racks before rebooting the
System.
2. If the message appears repeatedly, contact your Abbott Hematology
Customer Support Center.
Analyzer is not communicating its mode /BL
The Analyzer is not communicating whether it is an SL or CS model.
– – – - Probable Cause – – –
1. An Analyzer software setup error has occurred.
– – – - Corrective Action –
1. Reboot the System.
NOTE: If you wish to use the
Sample Loader, reset the racks before rebooting the
System.
2. If the message appears repeatedly, contact your Abbott Hematology
Customer Support Center.
Tower/Loader Fault 3: transmission failure /BL
A transmission acknowledgment failure occurred between the Analyzer and the module that controls the tower and loader.
– – – - Probable Cause – – –
1. A failure of the electronics or communication hardware has occurred.
– – – - Corrective Action –
1. Reboot the System.
NOTE: If you wish to use the
Sample Loader, reset the racks before rebooting the
System.
2. If the message appears repeatedly, contact your Abbott Hematology
Customer Support Center.
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Section 10 Troubleshooting and Diagnostics
Table 10.2 General Fault Conditions (Continued)
Tower/Loader Fault 5: communication failure /BL
A communication failure occurred between the Analyzer and the module that controls the tower and loader.
– – – - Probable Cause – – –
1. A communication timing or handshake error has occurred.
– – – - Corrective Action –
1. Reboot the System.
NOTE: If you wish to use the
Sample Loader, reset the racks before rebooting the
System.
2. If the message appears repeatedly, contact your Abbott Hematology
Customer Support Center.
Tower/Loader Fault 16: direct command parameter error /BL
The Analyzer command given to the module that controls the tower and loader is invalid.
– – – - Probable Cause – – –
1. A software error has occurred.
– – – - Corrective Action –
1. Reboot the System.
NOTE: If you wish to use the
Sample Loader, reset the racks before rebooting the
System.
2. If the message appears repeatedly, contact your Abbott Hematology
Customer Support Center.
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Troubleshooting and Diagnostics
Tables for Instrument Conditions and Messages Section 10
Table 10.2 General Fault Conditions (Continued)
Tower/Loader Fault 17: motor command timing error /BL
A motor in the Sample Loader was busy (e.g., in motion) when a command was received and could not respond.
– – – - Probable Cause – – –
1. A mechanical problem in the Tower or Sample Loader has occurred.
– – – - Corrective Action –
1. Check for an obstruction in the
Tower or Sample Loader and, if one is found, remove it. Reboot the
System.
NOTE: If you wish to use the
Sample Loader, reset the racks before rebooting the
System.
2. If the message appears repeatedly, contact your Abbott Hematology
Customer Support Center.
Tower/Loader Fault 18: invalid direct command /BL
The Analyzer command given to the module that controls the tower and loader is invalid.
– – – - Probable Cause – – – – – – - Corrective Action –
1. A software error has occurred.
1. Reboot the System.
NOTE: If you wish to use the
Sample Loader, reset the racks before rebooting the
System.
2. If the message appears repeatedly, contact your Abbott Hematology
Customer Support Center.
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Section 10 Troubleshooting and Diagnostics
Table 10.2 General Fault Conditions (Continued)
Tower/Loader Fault 19: invalid process command /BL
The Analyzer command given to the module that controls the tower and loader is invalid.
– – – - Probable Cause – – –
1. A software error has occurred.
– – – - Corrective Action –
1. Reboot the System.
NOTE: If you wish to use the
Sample Loader, reset the racks before rebooting the
System.
2. If the message appears repeatedly, contact your Abbott Hematology
Customer Support Center.
Loader Fault 40: mix head stuck in angle position /BL
The Mix Head failed to return to its vertical position.
– – – - Probable Cause – – – – – – - Corrective Action –
1. A mechanical problem is preventing the Mix Head from rotating downward.
2. A failure of the magnetic reed sensor or related electronics has occurred.
1. Remove the Loader Cover. Check for an obstruction that is preventing the Mix Head from rotating downward. If an obstruction is found, remove it and rotate the Mix
Head to its vertical position.
Reinstall the Loader Cover, reset the racks, and reset the Sample
Loader by pressing the following keys in order:
[CLEAR FAULT] ,
[START LOADER] ,
[RESET LOADER] .
2. If the message appears repeatedly, contact your Abbott Hematology
Customer Support Center.
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Troubleshooting and Diagnostics
Tables for Instrument Conditions and Messages Section 10
Table 10.2 General Fault Conditions (Continued)
Loader Fault 41: mix head stuck in vertical position /BL
The Mix Head failed to move from its vertical position.
– – – - Probable Cause – – – – – – - Corrective Action –
1. A mechanical problem is preventing the Mix Head from rotating upward.
2. A failure of the magnetic reed sensor or related electronics has occurred.
1. Remove the Loader Cover. Check for an obstruction that is preventing the Mix Head from rotating upward and, if one is found, remove it.
Reinstall the Loader Cover, reset the racks, and reset the Sample
Loader by pressing the following keys in order:
[CLEAR FAULT] ,
[START LOADER] ,
[RESET LOADER] .
2. If the message appears repeatedly, contact your Abbott Hematology
Customer Support Center.
Loader Fault 42: mix head not at top position /BL
The Mix/Lift Assembly failed to reach its top position.
– – – - Probable Cause – – –
1. A mechanical problem is preventing
Mix/Lift Assembly is from moving upward.
2. A failure of the optical sensor or related electronics has occurred.
– – – - Corrective Action –
1. Remove the Loader Cover. Check for an obstruction that is preventing the Mix/Lift Assembly from moving upward and, if one is found, remove it. Then, reinstall the
Loader Cover, reset the racks, and reset the Sample Loader by pressing the following keys in order:
[CLEAR FAULT] ,
[START LOADER] ,
[RESET LOADER] .
2. If the message appears repeatedly, contact your Abbott Hematology
Customer Support Center.
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Section 10 Troubleshooting and Diagnostics
Table 10.2 General Fault Conditions (Continued)
Loader Fault 43: mix head stuck at top position /BL
The Mix/Lift Assembly failed to move from its top position.
– – – - Probable Cause – – – – – – - Corrective Action –
1. A mechanical problem is preventing the Mix/Lift Assembly from moving downward.
1. Remove the Loader Cover. Check for an obstruction that is preventing the Mix/Lift Assembly from moving downward and, if one is found, remove it. Then, reinstall the
Loader Cover, reset the racks, and reset the Sample Loader by pressing the following keys in order:
[CLEAR FAULT] ,
[START LOADER] ,
[RESET LOADER] .
2. A failure of the optical sensor or related electronics has occurred.
2. If the message appears repeatedly, contact your Abbott Hematology
Customer Support Center.
Loader Fault 44: load zone empty detector malfunction
The system failed to retract mechanical arms after detecting that the load zone is empty.
NOTE: This fault does not lead to a Sample Loader halt because any rack currently in the mixing zone is unaffected.
– – – - Probable Cause – – –
1. A mechanical problem has prevented the rack arms in the load zone from retracting.
2. A failure of the sensor, loader mechanics, or related electronics has occurred.
– – – - Corrective Action –
1. Visually check for an obstruction that is preventing the rack arms in the load zone from retracting and, if one is found, press the STOP
LOADER key to halt the Sample
Loader. Remove the obstruction.
Then, resume Sample Loader operation by pressing the following keys in order:
[START LOADER] ,
[RESUME LOADER] .
2. If the message appears repeatedly, contact your Abbott Hematology
Customer Support Center.
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Table 10.2 General Fault Conditions (Continued)
Loader Fault 45: unload zone full detector malfunction /BL
The system failed to retract mechanical arms in unload zone.
– – – - Probable Cause – – – – – – - Corrective Action –
1. A mechanical problem has prevented the rack arms in the unload zone from retracting.
2. A failure of the sensor or sample loader mechanics has occurred.
1. Check for an obstruction that is preventing the rack arms in the unload zone from retracting and, if one is found, remove it. Then, reset the racks and Sample Loader operation by pressing the following keys in order:
[START LOADER] ,
[RESUME LOADER] .
2. If the message appears repeatedly, contact your Abbott Hematology
Customer Support Center.
Loader Fault 46: unload zone nearly full detector malfunction /BL
The system is detecting an unload zone nearly full condition (4 racks in unload zone) even though there are fewer than 4 racks in the unload zone.
– – – - Probable Cause – – – – – – - Corrective Action –
1. A mechanical problem has prevented the rack arms in the unload zone from retracting.
2. A failure of the sensor or sample loader mechanics has occurred.
1. Check for an obstruction that is preventing the rack arms in the unload zone from retracting and, if one is found, remove it. Then, reset the racks and Sample Loader operation by pressing the following keys in order: [START LOADER] ,
[RESUME LOADER] .
2. If the message appears repeatedly, contact your Abbott Hematology
Customer Support Center.
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Section 10 Troubleshooting and Diagnostics
Table 10.2 General Fault Conditions (Continued)
Listed are Sample Loader-related error messages referring to tube positions 3 and
4, which are Mixing Stations 1 and 2 respectively. (Refer to Figure 13.7.)
Loader Fault 47: tube stuck in position 3 /BL
The sensor for tube position 3 in the mixing zone is sensing the presence of a tube when the tube should be lifted clear of the rack by the Mix Head
– – – - Probable Cause – – –
1. The Mix Head has failed to lift the tube in position 3.
a. The tube in position 3 has liquid on it.
b. The tube in position 3 either has a loose bar code label or too many bar code labels.
c. The Mix Head Tube Grippers are dirty.
– – – - Corrective Action –
1. The Mix Head has failed to lift the tube in position 3.
a. Dry the tube in position 3. Then, reset the racks and reset the
Sample Loader by pressing the following keys in order:
[CLEAR FAULT] ,
[START LOADER] ,
[RESET LOADER] .
b. If the bar code label is loose, secure it in place. If multiple bar code labels are on the tube, remove them and carefully apply a single bar code label. Then, reset the racks, and reset the
Sample Loader.
NOTE: For information concerning proper application of bar codes, refer to
c. Remove the Loader Cover.
Using a DYN-A-WIPE pad or lint-free wipe moistened with a
0.5% sodium hypochlorite solution, clean the Mix Head
Tube Gripper. (See the formula for mixing this solution under
;
Repeat with deionized water.
Dry the Mix Head thoroughly.
Then, reinstall the Loader Cover, reset the racks, and reset the
Sample Loader.
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Table 10.2 General Fault Conditions (Continued)
Loader Fault 47: tube stuck in position 3 /BL (Continued)
2. The tube position sensor is dirty.
3. A failure of the sensor or related electronics has occurred.
2. Remove the Loader Cover. Using a
DYN-A-WIPE pad or lint-free wipe moistened with lens cleaner or deionized water, clean the tube sensors (the tube position 3 sensor is on the right). Dry the sensors thoroughly. Then, reinstall the
Loader Cover, reset the racks, and reset the Sample Loader.
NOTE: For the location of the tube sensors, refer to the figure
3. If the message appears repeatedly, contact your Abbott Hematology
Customer Support Center.
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Section 10 Troubleshooting and Diagnostics
Table 10.2 General Fault Conditions (Continued)
Loader Fault 48: tube stuck in position 4 /BL
The sensor for tube position 4 in the mix zone is sensing the presence of a tube when the tube should be lifted clear of the rack.
– – – - Probable Cause – – –
1. The Mix Head has failed to lift the tube in position 4.
a. The tube in position 4 has liquid on it.
b. The tube in position 4 either has a loose bar code label or too many bar code labels.
c. the Mix Head Tube Grippers are dirty.
– – – - Corrective Action –
1. The Mix Head has failed to lift the tube in position 4.
a. Dry the tube in position 4. Then, reset the racks and reset the
Sample Loader by pressing the following keys in order:
[CLEAR FAULT] ,
[START LOADER] ,
[RESET LOADER] .
b. If the bar code label is loose, secure it in place. If multiple bar code labels are on the tube, remove them and carefully apply a single bar code label. Then, reset the racks, and reset the
Sample Loader.
NOTE: For information concerning proper application of bar codes, refer to
c. Remove the Loader Cover.
Using a DYN-A-WIPE pad or lint-free wipe moistened with a
0.5% sodium hypochlorite solution, clean the Mix Head
Tube Gripper. (See the formula for mixing this solution under
;
Repeat with deionized water.
Dry the Mix Head thoroughly.
Then, reinstall the Loader Cover, reset the racks, and reset the
Sample Loader.
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Table 10.2 General Fault Conditions (Continued)
Loader Fault 48: tube stuck in position 4 /BL (Continued)
2. The tube position sensor is dirty.
2. Remove the Loader Cover. Using a
DYN-A-WIPE pad or lint-free wipe moistened with lens cleaner or deionized water, clean the tube sensors (the tube position 4 sensor is on the left). Dry the sensors thoroughly. Then, reinstall the
Loader Cover, reset the racks, and reset the Sample Loader.
NOTE: For the location of the tube sensors, refer to the figure
3. A failure of the sensor or related electronics has occurred.
3. If the message appears repeatedly, contact your Abbott Hematology
Customer Support Center.
Tower Fault 49: tower cover open /BL
The circuit formed when the Tower Cover is in place has been broken.
– – – - Probable Cause – – – – – – - Corrective Action –
1. The Tower Cover has been removed or is not seated properly.
2. A failure of the sensor or related electronics has occurred.
1. Reinstall or reset the Tower cover.
Make sure the cover is held in position by the magnets on the instrument frame. Then reset the racks and reset the Sample Loader by pressing the following keys in order:
[CLEAR FAULT] ,
[START LOADER] ,
[RESET LOADER] .
2. Reset the racks and reset the
Sample Loader. If the message appears repeatedly, contact your
Abbott Hematology Customer
Support Center.
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Section 10 Troubleshooting and Diagnostics
Table 10.2 General Fault Conditions (Continued)
Tower Fault 50: probe stuck at home position /BL
NOTE: The home position for the probe is the uppermost position.
The sensor indicates that the probe is in the home position when the System does not expect the probe to be homed.
– – – - Probable Cause – – – – – – - Corrective Action –
1. A mechanical problem has prevented the probe from leaving the home position on the Aspiration
Tower.
1. Remove the Loader Cover. Check for an obstruction on the Aspiration
Tower that is preventing the probe from leaving the home position and, if one is found, remove it.
Then, reinstall the Loader Cover, reset the racks, and reset the Sample
Loader by pressing the following keys in order:
[CLEAR FAULT] ,
[START LOADER] ,
[RESET LOADER] .
2. A failure of the sensor or related electronics has occurred.
3. The tower, motor, or related electronics is defective.
2. Reset the racks and reset the
Sample Loader.
3. If the message appears repeatedly, contact your Abbott Hematology
Customer Support Center.
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Table 10.2 General Fault Conditions (Continued)
Tower Fault 100: probe unable to reach home position /BL
NOTE: The home position for the probe is the uppermost position.
The sensor system indicates that the probe is not in the home position when the system expects the probe to be homed.
– – – - Probable Cause – – – – – – - Corrective Action –
1. A mechanical problem has prevented the probe from reaching the home position on the Aspiration
Tower.
1. Remove the Loader Cover. Check for an obstruction on the Aspiration tower that is preventing the probe from reaching the home position and, if one is found, remove it.
Then, reinstall the Loader Cover, reset the racks, and reset the Sample
Loader by pressing the following keys in order:
[CLEAR FAULT] ,
[START LOADER] ,
[RESET LOADER] .
2. A failure of the sensor or related electronics has occurred.
3. The tower, tower motor, or related electronics is defective.
2. Reset the racks and reset the
Sample Loader.
3. If the message appears repeatedly, contact your Abbott Hematology
Customer Support Center.
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Section 10 Troubleshooting and Diagnostics
Table 10.2 General Fault Conditions (Continued)
Tower Fault 141: invalid tube height /BL
The tube height sensor system indicates that the tube at the Aspiration Station exceeds height specification.
– – – - Probable Cause – – –
1. The instrument cannot accommodate the height of the tube.
2. Failure of the sensor or related electronics has occurred.
3. The tube height sensor or sensor flag on the Tower is not moving into position properly.
a. The Guide Shafts are dirty.
– – – - Corrective Action –
1. To run the sample in the Sample
Loader, pour the sample into a tube without anti-coagulant that meets height specification. Then reset the racks and reset the Sample Loader by pressing the following keys in order:
[CLEAR FAULT] ,
[START LOADER] ,
[RESET LOADER] .
NOTE: For tube height specifications, refer to
.
2. Reset the racks and reset the
Sample Loader.
3. The tube height sensor or sensor flag on the Tower is not moving into position properly.
a. Remove the Loader Cover.
Using a DYN-A-WIPE pad or lint-free wipe moistened with isopropyl alcohol, clean the
Guide Shafts. Then, reinstall the
Loader cover, reset the racks, and reset the Sample Loader.
NOTE: The Guide Shafts are the three vertical bars on the tower.
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Table 10.2 General Fault Conditions (Continued)
Tower Fault 141: invalid tube height /BL (Continued) b. A mechanical problem is preventing the tube spinning assembly with tube height sensor flag from moving up and down properly.
b. Remove the Loader Cover.
Check for an obstruction that is preventing the tube spinning assembly with tube height sensor flag from moving up and down properly and, if one is found, remove it. Then, reinstall the
Loader Cover, reset the racks, and reset the Sample Loader.
c. The tube height sensor flag is bent or the tower sensors, motor, or related electronics are defective.
c. Contact your Abbott
Hematology Customer Support
Center.
Tower Fault 142: no tube present /BL
The tube height sensor did not sense a tube when one was expected.
– – – - Probable Cause – – – – – – - Corrective Action –
1. The tube being processed is too short.
2. A failure of the sensor or related electronics has occurred.
1. To run the sample in the Sample
Loader, pour the sample into a tube without anti-coagulant that meets height specifications. Then, reset the racks and rest the Sample
Loader by pressing the following keys in order:
[CLEAR FAULT] ,
[START LOADER] ,
[RESET LOADER] .
NOTE: For tube height specifications, refer to
2. Reset the racks and reset the
Sample Loader.
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Section 10 Troubleshooting and Diagnostics
Table 10.2 General Fault Conditions (Continued)
Loader Warning 144: excessive cycling /BL
NOTE: The Sample Loader halts.
Twenty rack advances have occurred without a tube being sensed in the mix zone or twenty-five rack advances have occurred after the last tube was processed.
– – – - Probable Cause – – – – – – - Corrective Action –
1. The System is functioning as intended.
1. No corrective action is necessary.
When you wish to run additional samples in the Sample Loader, load tubes in racks and press the keys in the following order:
[CLEAR FAULT] ,
[START LOADER] ,
[RESUME LOADER] .
2. The rack advance mechanism is not making contact with the racks.
3. Both tube sensors are dirty.
4. A failure of the sensor or related electronics, or loader mechanisms has occurred.
2. Check for an obstruction that is preventing the rack arms from extending and holding the racks against the loader wall so the racks can engage with the rack advance mechanism. If an obstruction is found, remove it. Then, reset the racks and reset the Sample Loader by pressing the following keys in order:
[CLEAR FAULT] ,
[START LOADER] ,
[RESET LOADER] .
3. Remove the Loader Cover. Using a
DYN-A-WIPE pad or lint-free wipe moistened with lens cleaner or deionized water, clean the tube sensors. Then, reinstall the Loader
Cover, reset the racks, and reset the
Sample Loader.
NOTE: For the location of the tube sensor, refer to the figure
4. If the message appears repeatedly, contact your Abbott Hematology
Customer Support Center.
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Table 10.2 General Fault Conditions (Continued)
Loader Fault 147: unload area hardware malfunction /BL
The sensor system is indicating that the unload area is full (contains 5 racks), but is not indicating that it is also nearly full (contains 4 racks).
– – – - Probable Cause – – –
1. One or more racks did not move properly in the unload area.
2. A failure of the sensor system or related electronics has occurred.
– – – - Corrective Action –
1. Check for an obstruction that is preventing rack movement in the unload area and, if one is found, remove it. Then, reset the racks and reset the Sample Loader by pressing the following keys in order:
[CLEAR FAULT] ,
[START LOADER] ,
[RESET LOADER] .
2. Reset the racks and reset the
Sample Loader. If the message appears repeatedly, contact your
Abbott Hematology Customer
Support Center.
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Section 10 Troubleshooting and Diagnostics
Table 10.2 General Fault Conditions (Continued)
Loader Fault 148: tube dropped during mixing /BL
A tube was sensed as missing from tube position 3 or 4 after the mixing cycle.
– – – - Probable Cause – – – – – – - Corrective Action –
1. A tube slipped out of a Tube Gripper in the Mix Head.
a. The tube has liquid on it.
b. The Mix Head Tube Gripper is dirty.
1. A tube slipped out of a Tube
Gripper in the Mix Head.
a. Remove the Loader Cover. Dry the tube. Then, reinstall the
Loader Cover, reset the racks, and reset the Sample Loader by pressing following keys in order:
[CLEAR FAULT] ,
[START LOADER] ,
[RESET LOADER] .
b. Remove the Loader Cover.
Using a DYN-A-WIPE pad or lint-free wipe moistened with a
0.5% sodium hypochlorite solution, clean the Mix Head
Tube Gripper. (See the formula for mixing this solution under
;
Repeat with deionized water.
Then, reinstall the Loader Cover, reset the racks, and reset the
Sample Loader.
2. A failure of the sensor system or related electronics has occurred.
3. A failure of the bladder or bladder pressure system has occurred.
2. Remove the Loader Cover. Using a
DYN-A-WIPE pad or lint-free wipe moistened with lens cleaner or deionized water, clean the tube sensors. Dry the sensors thoroughly. Then, reinstall the
Loader Cover, reset the racks, and reset the Sample Loader.
NOTE: For the location of the tube sensors, refer to the figure
3. Contact your Abbott Hematology
Customer Support Center.
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Table 10.2 General Fault Conditions (Continued)
Loader Fault 149: mix zone rack position error /BL
The tube position bar code number read was not the number expected.
– – – - Probable Cause – – – – – – - Corrective Action –
1. The rack did not advance.
a. A mechanical problem is preventing the rack from advancing.
b. The rack and/or Sample Loader
Tray are dirty.
c. A failure of the Air Cylinder or the Air Cylinder pressure system has occurred.
1. The rack did not advance.
a. Check for an obstruction that is preventing the rack from advancing and, if one is found, remove it.
b. Remove the Loader Cover.
Using a DYN-A-WIPE pad or lint-free wipe moistened with deionized water, clean the rack and Sample Loader Tray. Then, reinstall the Loader Cover, reset the racks, and reset the Sample
Loader by pressing the following keys in order:
[CLEAR FAULT] ,
[START LOADER] ,
[RESET LOADER] .
c. If the message appears repeatedly, contact your Abbott
Hematology Customer Support
Center.
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Section 10 Troubleshooting and Diagnostics
Table 10.2 General Fault Conditions (Continued)
Loader Fault 150: unexpected tube in position 4 after rack advance /BL
A tube was not sensed in tube position 3 before a rack advance, but a tube was sensed in tube position 4 after a rack advance.
– – – - Probable Cause – – –
1. The rack did not advance.
a. A mechanical problem is preventing the rack from advancing.
b. The rack and/or Sample Loader
Tray are dirty.
c. A failure of the Air Cylinder or the Air Cylinder pressure system has occurred.
– – – - Corrective Action –
1. The rack did not advance.
a. Check for an obstruction that is preventing the rack from advancing and, if one is found, remove it.
b. Remove the Loader Cover.
Using a DYN-A-WIPE pad or lint-free wipe moistened with deionized water, clean the rack and Sample Loader Tray. Then, reinstall the Loader Cover, reset the racks, and reset the Sample
Loader by pressing the following keys in order:
[CLEAR FAULT] ,
[START LOADER] ,
[RESET LOADER] .
c. If the message appears repeatedly, contact your Abbott
Hematology Customer Support
Center.
2. Tube sensor in position 3 is dirty.
3. A failure of the sensor system or related electronics has occurred.
2. Remove the Loader Cover. Using a
DYN-A-WIPE pad or lint-free wipe moistened with lens cleaner or deionized water, clean the tube sensors. Dry the sensors thoroughly. Then reinstall the
Loader Cover, reset the racks, and reset the Sample Loader.
3. If the message appears repeatedly, contact your Abbott Hematology
Customer Support Center.
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Table 10.2 General Fault Conditions (Continued)
Loader Fault 151: tube lost moving from position 3 to 4 /BL
A tube was sensed in tube position 3 before the rack advance, but a tube was not sensed in tube position 4 after the rack advance.
– – – - Probable Cause – – –
1. The rack did not advance.
a. A mechanical problem is preventing the rack from advancing.
b. The rack and/or Sample Loader
Tray are dirty.
c. A failure of the Air Cylinder or the Air Cylinder pressure system has occurred.
2. Tube sensor in position 4 is dirty.
3. A failure of the sensor system or related electronics has occurred.
– – – - Corrective Action –
1. The rack did not advance.
a. Check for an obstruction that is preventing the rack from advancing and, if one is found, remove it.
b. Remove the Loader Cover.
Using a DYN-A-WIPE pad or lint-free wipe moistened with lense cleaner or deionized water, clean the rack and Sample
Loader Tray. Then, reinstall the
Loader Cover, reset the racks, and reset the Sample Loader by pressing the following keys in order:
[CLEAR FAULT] ,
[START LOADER] ,
[RESET LOADER] .
c. If the message appears repeatedly, contact your Abbott
Hematology Customer Support
Center
2. Remove the Loader Cover. Using a
DYN-A-WIPE pad or lint-free wipe moistened with lens cleaner or deionized water, clean the tube sensors. Dry the sensors thoroughly. Then reinstall the
Loader Cover, reset the racks, and reset the Sample Loader.
3. If the message appears repeatedly, contact your Abbott Hematology
Customer Support Center.
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Section 10 Troubleshooting and Diagnostics
Table 10.2 General Fault Conditions (Continued)
Loader Fault 152: mix zone must be cleared for reset /BL
The sensor system indicates that a tube is present in tube position 4 immediately after the Sample Loader was reset, but a rack has not yet been pushed into the
mix zone.
– – – - Probable Cause – – – – – – - Corrective Action –
1. A rack remains in the mix zone when the Sample Loader is reset.
2. There is an obstruction at tube position 4 that is activating the sensor.
3. Tube sensor in position 4 is dirty.
4. A failure of the sensor system or related electronics has occurred.
1. Remove the rack from the mix zone. Then, reset the racks and reset the Sample Loader by pressing the following keys in order:
[CLEAR FAULT] ,
[START LOADER] ,
[RESET LOADER] .
2. Remove the Loader Cover. Check for an obstruction at tube position 4 that is activating the sensor and, if one is found, remove it. Then, reinstall the Loader Cover, reset the racks, and reset the Sample Loader.
3. Remove the Loader Cover. Using a
DYN-A-WIPE pad or lint-free wipe moistened with lens cleaner or deionized water, clean the tube sensors. Dry the sensors thoroughly. Then reinstall the
Loader Cover, reset the racks, and reset the Sample Loader.
4. If the message appears repeatedly, contact your Abbott Hematology
Customer Support Center.
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Table 10.2 General Fault Conditions (Continued)
Loader Fault 153: rack bar code read failure /BL
The rack bar code label (the first label on the rack) could not be read. This label has a two-digit rack number.
– – – - Probable Cause – – –
1. The window on the Bar Code
Reader is dirty.
2. The first rack bar code label is missing, scuffed, or dirty.
3. The rack from the mix zone was not removed and reset before the
[RESET LOADER] pressed.
key was
– – – - Corrective Action –
1. Remove the Loader Cover. Using a
DYN-A-WIPE pad or lint-free wipe moistened with isopropyl alcohol, lens cleaner or deionized water, clean the window on the Bar
Code Reader. Dry the window on the Bar Code Reader thoroughly.
Then, reinstall the Loader Cover, reset the racks, and reset the Sample
Loader by pressing the following keys in order:
[CLEAR FAULT] ,
[START LOADER] ,
[RESET LOADER] .
NOTE: For the location of the Bar
Code Reader, refer to
2. Clean or replace the rack bar code label. Then, reset the racks and reset the Sample Loader.
3. Reset the racks, then reset the
Sample Loader by pressing the following keys in order:
[CLEAR FAULT] ,
[START LOADER] ,
[RESET LOADER] .
If the message appears repeatedly, contact your Abbott Hematology
Customer Support Center.
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Section 10 Troubleshooting and Diagnostics
Table 10.2 General Fault Conditions (Continued)
Loader Fault 154: tube position bar code read failure /BL
A tube position bar code label (the second through tenth labels on the rack) could not be read.
– – – - Probable Cause – – –
1. The window on the Bar Code
Reader is dirty.
2. The tube position bar code label is scuffed or dirty.
– – – - Corrective Action –
1. Remove the Loader Cover. Using a
DYN-A-WIPE pad or lint-free wipe moistened with isopropyl alcohol, lens cleaner or deionized water, clean the window on the Bar
Code Reader. Dry the window on the Bar Code Reader thoroughly.
Then, reinstall the Loader Cover, reset the racks, and reset the Sample
Loader by pressing the following keys in order:
[CLEAR FAULT] ,
[START LOADER] ,
[RESET LOADER] .
NOTE: For the location of the Bar
Code Reader, refer to
.
2. Clean or replace the tube position bar code label. Then, reset the racks and reset the Sample Loader.
If the message appears repeatedly, contact your Abbott Hematology
Customer Support Center.
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Table 10.2 General Fault Conditions (Continued)
Loader Fault 156: bar code reader failure /BL
The tube sensors have sensed a tube, but the System was unsuccessful in reading both the rack and tube position bar code labels.
– – – - Probable Cause – – –
1. The window on the bar code reader is dirty.
2. The rack and tube position bar code labels are not present or are unreadable.
3. The Bar Code Reader cable has been disconnected, or the Bar code
Reader or related electronics has failed.
– – – - Corrective Action –
1. Remove the Loader Cover. Using a
DYN-A-WIPE pad or lint-free wipe moistened with isopropyl alcohol, lens cleaner or deionized water, clean the window on the Bar
Code Reader. Dry the window on the Bar Code Reader thoroughly.
Then, reinstall the Loader Cover, reset the racks, and reset the Sample
Loader by pressing the following keys in order:
[CLEAR FAULT] ,
[START LOADER] ,
[RESET LOADER] .
2. Replace the rack and tube position bar code labels with new labels.
Then, reset the racks and reset the
Sample Loader by pressing the following keys in order:
[CLEAR FAULT] ,
[START LOADER] ,
[RESET LOADER] .
3. Reset the racks and reset the
Sample Loader. If the message appears repeatedly, contact your
Abbott Hematology Customer
Support Center.
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Section 10 Troubleshooting and Diagnostics
Index of Table 10.3: Sample-Related Fault Conditions
Condition Page
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Table 10.3 Sample-Related Fault Conditions
Each message is followed by one of the abbreviations shown below indicating where that message appears on the screen:
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 (and
SAMPLING ERR
is printed) to the right of the MCHC result.
“
SAMPLING ERR
” is printed on all reports.
Results may look like background counts.
– – – - Probable Cause – – – – – – – - Corrective Action – – –
1. The blood sensor system did not detect a sufficient amount of sample at the expected time following aspiration.
1. Check the sample tube to be sure it contains a sufficient quantity of blood. Verify that the sample contains no clots.
2. Clean the Open Sample Probe or the
Closed Sample Needle as directed in
or Unclogging the
Closed Sample Aspiration Needle to remove any obstructions.
3. Clean the Shear Valve as directed in
4. Clean the Y valve as directed in
.
5. Contact your Abbott Hematology
Customer Support Center.
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Section 10 Troubleshooting and Diagnostics
Table 10.3 Sample-Related Fault Conditions
3 consecutive incomplete aspirations /BL
– – – - Probable Cause – – – – – – – - Corrective Action – – –
1. During sample processing, three consecutive incomplete aspiration errors were detected and the Sample
Loader halted.
1. Correct the situation on the Analyzer as follows: Check the aspiration tubing for a plug or a pinch. Verify that last three tubes contained sufficient quantity of blood.
Clean the Closed Mode needle. (If necessary, refer to the instructions
given in Section 9: Service and
2. Press the [CLEAR FAULT] key followed by [RESUME LOADER] or
[RESET LOADER] displayed on the
RUN screen. The Sample Loader continues processing.
3. If unable to resolve this problem, contact your Abbott Hematology
Customer Support Center.
WOC Flow Error /BL
WOC FLOW ERROR
is displayed on the RUN screen to the right of the EOS results.
“
WOC FLOW ER
” is printed on the graphics report to the right of the NEU result.
Results for WBC and Differential are suppressed.
– – – - Probable Cause – – – – – – – - Corrective Action – – –
1. An increasing WOC count rate was detected in the optical flow cell during the WOC measurement.
2. Optical flow cell is dirty or contains bubbles.
1. Repeat the sample.
2. Empty/refill flow cell in Special
Protocols.
Run AutoClean and/or Extended
AutoClean.
3. Sample Dilution Delivery Problem.
3. Check/replace tubing in Sample
Transfer Pump.
Clean Sample Injection Syringe, check for leakage, and replace as necessary.
4. Dil/Sheath flow (partially
) obstructed.
4. Replace Diluent/Sheath Filter.
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Tables for Instrument Conditions and Messages Section 10
Table 10.3 Sample-Related Fault Conditions
NOC Flow Error /BL
NOC FLOW ERROR
is displayed on the RUN screen under the BASO result.
“
NOC FLOW ER
” is printed on the graphics report to the right of the LYM result.
Results for WBC and Differential are suppressed.
– – – - Probable Cause – – – – – – – - Corrective Action – – –
1. An increasing NOC count rate was detected in the optical flow cell during the NOC measurement.
2. Optical flow cell is dirty or contains bubbles.
1. Repeat the sample.
2. Empty/refill flow cell in Special
Protocols.
Run AutoClean and/or Extended
AutoClean
3. Sample Dilution Delivery Problem.
3. Check/replace tubing in Sample
Transfer Pump.
Clean Sample Injection Syringe, check for leakage and replace as necessary.
4. Diluent/Sheath flow (partially) obstructed.
4. Replace Diluent/Sheath Filter.
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Section 10 Troubleshooting and Diagnostics
Table 10.3 Sample-Related Fault Conditions
RBC Flow Error /BL
RBC FLOW ERROR
is displayed on the RUN screen to the right of the RDW result.
“
RBC FLOW ER
” is printed on the graphics report to the right of the RDW result.
Results for RBC, PLT, and related parameters are suppressed.
– – – - Probable Cause – – – – – – – - Corrective Action – – –
1. An increasing RBC count rate was detected in the optical flow cell during the RBC measurement.
2. Optical flow cell is dirty or contains bubbles.
1. Repeat the sample.
2. Empty/refill flow cell in Special
Protocols
Run AutoClean and/or Extended
AutoClean
3. Sample Dilution Delivery Problem.
3. Check/replace tubing in Sample
Transfer Pump.
Clean Sample Injection Syringe, check for leakage, and replace as necessary.
4. Diluent/Sheath flow (partially) obstructed.
4. Replace Diluent/Sheath Filter.
3 consecutive WOC flow errors /BL
3 consecutive NOC flow errors /BL
3 consecutive RBC flow errors /BL
– – – - Probable Cause – – – – – – – - Corrective Action – – –
1. Three consecutive flow error messages occurred during Sample
Loader operation.
1. Three consecutive flow errors of the same type will cause the Sample
Loader to halt. Refer to the three previous messages and
Troubleshooting Tips and
Techniques earlier in this section.
2. If unable to resolve this problem, contact your Abbott Hematology
Customer Support Center.
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Table 10.3 Sample-Related Fault Conditions
>>>> In Place of Results for WBC, RBC, HGB or PLT
– – – - Probable Cause – – – –
1. Data exceeds linear range for that parameter.
– – – - Corrective Action – – –
1. Dilute the sample with diluent/ sheath according to your laboratory procedures and rerun the sample.
Multiply the results by the dilution factor.
2. Improper reagent delivery or sample aspiration.
2. Inspect syringes for proper operation and check reagent Inlet
Lines for crimping.
High Rate of False Flagging
High number of false flags displayed on the RUN screen.
– – – - Probable Cause – – – – – – – - Corrective Action – – –
1. Dirty Diluent/Sheath Filter.
2. Contaminated WBC Lyse.
3. Dirty optical flow cell.
4. Debris is present in the system.
5. Optical gains have shifted.
1. Replace Diluent/Sheath Filter.
2. Replace WBC Lyse reagent. Clean
WBC lyse syringe.
3. In S PECIAL PROTOCOLS menu, follow procedure for emptying and refilling optical flow cell.
4. In the second SPECIAL PROTOCOL menu screen, perform an [ AUTO
CLEAN ] and/or [ EXTENDED
AUTOCLEAN ] cycle to clean the system.
5. Contact your Abbott Hematology
Customer Support Center.
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Section 10 Troubleshooting and Diagnostics
Index of Table 10.4: Non-Functional Fault Conditions
Condition Page
The Sample Loader does not respond when the START LOADER , RESUME , or RESET
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Tables for Instrument Conditions and Messages Section 10
Table 10.4 Non-Functional Fault Conditions
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.
Analyzer will not power ON
– – – - Probable Cause – – – –
1. Power cord is not securely connected to the Analyzer or is not connected to the power outlet.
2. Power source is defective.
3. Analyzer fuse has failed or is incorrect.
4. Defective power switch or other system malfunction.
– – – - Corrective Action – – –
1. Ensure that the power cord is securely connected to the Analyzer and verify that it is connected to the power outlet.
2. Turn the power switch OFF and connect the system to a different power source.Turn the power switch
ON.
3. Analyzer fuse is located above the power cord connector on the rear panel. Check the fuse as directed in the
4. Contact your Abbott Hematology
Customer Support Center.
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Section 10 Troubleshooting and Diagnostics
Table 10.4 Non-Functional Fault Conditions (Continued)
No screen display on the Display Monitor
– – – - Probable Cause – – – –
1. Display Monitor is not ON or is not connected to power source.
– – – - Corrective Action – – –
1. Verify the Display Monitor LED is
ON. If not, check that the power cord is securely connected to the power outlet. Try a different power source.
2. Display Monitor brightness control is turned down.
3. The Display Monitor interface connector (VGA, 25 pin) is not securely connected.
4. Defective Display Monitor or other component.
2. Adjust the brightness control under the front control panel of the Display
Monitor until the image is visible.
3. Locate the connector on the rear panel of the Data Module, reseat the cable and secure the connection properly.
NOTE: For the location of the
VGA connector, refer to
.
4. Contact your Abbott Hematology
Customer Support Center.
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Tables for Instrument Conditions and Messages Section 10
Table 10.4 Non-Functional Fault Conditions (Continued)
The FAULT indicator light 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 stopped operating.
– – – - Corrective Action – – –
1. From the first DIAGNOSTICS MENU screen, press [FAULT 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 th e second
DIAGNOSTICS MENU screen.
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 the second DIAGNOSTICS MENU screen.
The message “Please check signal cable” appears on the Display Monitor
– – – - Probable Cause – – – – – – – - Corrective Action – – –
1. The Display Monitor interface cable is not securely connected.
1. Locate the VGA connector (25 pin) on the Rear Panel of the Data
Module. Reseat the cable and secure the connection properly.
2. Defective Data Module component.
2. Contact your Abbott Hematology
Customer Support Center.
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Section 10 Troubleshooting and Diagnostics
Table 10.4 Non-Functional Fault Conditions (Continued)
Background count is outside acceptable limits
– – – - Probable Cause – – – –
1. Debris is present in the system.
– – – - Corrective Action – – –
1. In the second SPECIAL PROTOCOLS
MENU screen, perform an [AUTO
CLEAN] cycle to clean the system.
When the cycle is completed, run a
Background count.
2. The reagents are cold — less than
59 ° F (15 ° C).
3. The reagents are contaminated.
4. Diluent/Sheath filter is dirty.
5. Syringes are the source of contamination.
6. The Shear Valve is dirty.
2. Allow the reagents to warm to room temperature and then repeat the
Background count.
3. Replace the appropriate reagent according to the directions given in
Troubleshooting Reagent Problems cited earlier in this section.
4. Replace Diluent/Sheath filter.
5. Clean the appropriate syringe.
6. Clean the Shear Valve. Repeat the
Background count.
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Tables for Instrument Conditions and Messages Section 10
Table 10.4 Non-Functional Fault Conditions (Continued)
The PC keyboard is not operational
– – – - Probable Cause – – – –
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.
– – – - Corrective Action – – –
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 PC keyboard.
3. No action required. Refer to the screen for the Status Box message.
4. Keyboard entry is not possible on the displayed screen.
5. Computer, keyboard and/or circuitry malfunction.
4. No action required. Refer to the screen for the current Status Box message.
5. Power OFF the Analyzer. Then reset the Keyboard cable on the rear panel of the Data Module and power
Analyzer ON.
NOTE: For the location of the keyboard connector, refer to
;
contact your Abbott
Hematology Customer
Support Center.
The Sample Loader does not respond when the START LOADER,
RESUME, or RESET key is pressed
– – – - Probable Cause – – – – – – – - Corrective Action – – –
1. The internal power cord connecting the Sample Loader to the Analyzer is loose or disconnected.
2. Circuitry malfunction.
1. Contact your Abbott Hematology
Customer Support Center.
2. Press [FAULT REPORT] in the main
DIAGNOSTICS MENU and record any fault listed.
3. Turn the instrument OFF and ON again and prime the instrument.
4. If the problem persists, contact your
Abbott Hematology Customer
Support Center.
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Section 10 Troubleshooting and Diagnostics
Table 10.4 Non-Functional Fault Conditions (Continued)
The Sample Loader beeps but does not begin processing
– – – - Probable Cause – – – –
1. The internal cable that connects the
Sample Loader to the Analyzer is loose or disconnected.
– – – - Corrective Action – – –
1. Contact your Abbott Hematology
Customer Support Center.
2. Circuitry malfunction.
2. Press [FAULT REPORT] in the main
DIAGNOSTICS MENU and record any fault listed.
3. Turn the instrument OFF and ON again and prime the instrument.
4. If the problem persists, contact your
Abbott Hematology Customer
Support Center.
The Display Monitor membrane touch keys are not operational
– – – - Probable Cause – – – – – – – - Corrective Action – – –
1. The computer is performing a function that inhibits the keys.
1. No action required. Wait for the computer to resume the operation.
Refer to the screen for the current
Status Box message.
2. There is an incomplete operator entry.
3. A data transmission to the printer or laboratory computer is in process.
4. Membrane keyboard or circuitry malfunction.
2. Complete the operator entry or press the ESC key on PC keyboard.
3. No action required. Wait until the transmission is completed.
4. Power OFF the Analyzer. Then reseat the Membrane Keypad cable on the rear panel of the Data Module and power Analyzer ON.
NOTE: For the location of the
Membrane Keypad
Interface connector, refer to
.
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Tables for Instrument Conditions and Messages
NOTES
Section 10
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Section 11 Quality Control
Section 11 Quality Control
Overview
QC Options
This section contains two major subsections: Quality Control Menu, and Quality
Control Guide. The Quality Control Menu describes the functions of the keys in the
QC MENU . The Quality Control Guide discusses the interpretation of QC data.
The CELL-DYN 3200 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 and some WBC Differential optical parameters. This QC option is useful for troubleshooting and confirming that the calibration of the red blood cell parameters has not changed.
20 QC Files — Utilizes commercial controls (low, normal, high) or fresh whole blood specimens to obtain statistical and graphical analyses. The data in each file is used 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 to detect drift and imprecision and to detect systematic or random error.
The above options may be used independently or in combination, depending on the operator’s preference. Each option is discussed in detail in this section.
Quality Control procedures, both internal and external, allow the operator to verify the performance of an analytical system. The use of Quality Control procedures in evaluating both commercial controls and patient samples facilitates the interpretation of laboratory data to ascertain acceptability of patient results.
The information in this section conforms to Abbott Laboratories’ recommended procedures for Quality Control for all Abbott hematology instruments. It is recommended that these guidelines be incorporated into the procedure manual for your laboratory. In addition, refer to your laboratory's Standard Operating
Procedures and/or Quality Assurance plan for additional Quality Control requirements.
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Quality Control
Overview
NOTES
Section 11
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Section 11 Quality Control
Quality Control Menu
QC Menu Softkeys
This section discusses the options available when the [QUALITY CONTROL] key is pressed. The options used to set up the QC Files are available from the QUALITY
CONTROL
menu (see Figure 11.1) and the
QC SET UP menu. Refer to Set Up QC
File in
Section 5: Operating Instructions for an explanation of these keys as they
will not be discussed in this section.
Figure 11.1 Quality Control Menu Screen
The following soft key labels are displayed when the [QUALITY CONTROL] key on the MAIN MENU screen is pressed:
X-B SET UP
X-B FILE
VIEW QC LOG
QC LIMITS*
SET-UP QC FILE*
CUSTOMIZE DISPLAY *
CUSTOMIZE PRINTOUT *
MAIN
* These keys are discussed in Section 5: Operating Instructions ;
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Quality Control
Quality Control Menu
X-B Set Up
Section 11
11-4
Figure 11.2 X-B Set Up Screen
The following soft key labels are displayed when the [X-B SET UP] key is pressed
TURN X-B RBC OFF (Key label alternates between ON/OFF selections)
TURN X-B WBC OFF (Key label alternates between ON/OFF selections)
RETURN
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Section 11
X-B File
Quality Control
Figure 11.3 X-B RBC Graphs Screen
The following soft key labels are displayed when the [X-B FILE] key is pressed:
X-B RBC DATA/GRAPHS (Key label alternates between selections)
X-B WBC DATA/GRAPHS (Key label alternates between selections)
RETURN
For a description of how the X-B Program works, refer to X-B Program Operation later in this section.
Show Graphs
When the [X-B RBC GRAPHS] key or [X-B WBC GRAPHS] key is pressed, the X-B
GRAPHS DISPLAY screen for the appropriate parameter is displayed. (Refer to
Show Data
When the [X-B RBC DATA] key or [X-B WBC DATA] is pressed, the X-B DATA DISPLAY
screen for the appropriate parameter is displayed. This screen is depicted in Figure
11.4. The screen displays the results for X-B batches 1–10 and the lower and upper
limits. The date and time that each batch was completed are also displayed. The
Page Down key on the keyboard is used to display batches 11–20. When batches
11–20 are displayed, the Page Up key on the keyboard is used to display batches
1–10.
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Quality Control
Quality Control Menu Section 11
11-6
Figure 11.4 X-B RBC Data Screen
The [PRINT] key is used to print the X-B data or graphs. When this key is pressed, the data for all 20 batches is automatically printed if the data is displayed. If the graphs are displayed, all ten of them are printed.
Return
The [RETURN] key is used to return to the QC MENU screen.
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Section 11
View QC Log
Quality Control
The [VIEW QC LOG] key is used to display the QC Log indicated by the position of the cursor.
Figure 11.5 The View QC Log Screen
Each QC Log display shows the following information (see Figure 11.5):
1. Upper Left Corner
L
OT 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 instead of the lot number and expiration date.
File name, the number of runs currently in the file and the file capacity
(e.g.,
39/120
indicates that the file contains
39
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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Quality Control
Quality Control Menu Section 11
4. The remainder of the screen displays the file information and the data. The
UPPER
and
LOWER LIMITS
and
TARGET MEAN
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
— Flow Error occurred
Background and latex samples use only the O or C codes.
6. The statistics are displayed below the data as follows:
N: the Number of runs used in the calculation
FILE MEAN: the Mean value for the number of runs used in the calculation
STD DEV: the Standard Deviation (+/-1) 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 screen:
PURGE QC LOG
LEVEY-JENNINGS
REJECT SPECIMEN/
ACCEPT SPECIMEN (Key label alternates between selections)
DELETE SPECIMEN
MOVE SPECIMEN
WRITE QC TO DISK
PRINT QC LOG
RETURN
The function of each of these keys is discussed in this section.
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Section 11 Quality Control
Purge QC Log
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:
& ONFIRM PURGE
CANCEL PURGE
These keys are used to [CONFIRM] or [CANCEL] the Purge QC Log command.
Levey-Jennings
The [LEVEY-JENNINGS] key is used to display the Levey-Jennings graphs of the
data in the QC file. (Refer to Figure 11.6.) The following soft key labels are
displayed when the [LEVEY-JENNINGS] key is pressed. The soft key for the group being displayed will not be shown.
GROUP 1
GROUP 2
GROUP 3
GROUP 4
PREVIOUS 10
NEXT 10
RETURN
Figure 11.6 The Levey-Jennings Menu Screen
If there are sufficient specimens in the QC file, when the [PREVIOUS 10] key is pressed, the [NEXT 10] key appears, allowing the operator to scroll both forward and
background through the file. (Refer to Figure 11.7.)
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Quality Control
Quality Control Menu Section 11
11-10
Figure 11.7 The Levey-Jennings Menu Screen Showing Next 10
Group
Each of the Group 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.
The [PRINT] key is used to print the Levey-Jennings graphs. When the [PRINT] key is pressed, all of the graphs are automatically printed.
Return
The [RETURN] key is used to return to the VIEW QC LOG screen.
Reject/Accept Specimen
The [REJECT SPECIMEN] key is used to exclude the results for the specimen indicated by the cursor position. 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. (Refer to
Figure 11.8.) The data is still displayed and stored in the file but is excluded from
the statistical calculation.
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Section 11 Quality Control
Figure 11.8 QC Log Screen With Rejected Results
When the [ACCEPT SPECIMEN] key is pressed, the “R” is deleted and the statistics are recomputed including those results.
Delete Specimen
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
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.
Move Specimen
The [MOVE SPECIMEN] key is used to move a QC result indicated by the cursor position to another QC file. When the [MOVE SPECIMEN] key is pressed, the QC
MENU screen is displayed, allowing the desired file to be selected. When the
[MOVE TO FILE] key is pressed, the result is moved to the indicated file.
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Quality Control Menu Section 11
Move Specimen Procedure
1. From the QC MENU screen, use the Arrow keys on the keyboard to move the cursor to the file containing the specimen to be moved.
2. Press [VIEW QC LOG] .
3. Use the Arrow keys on the keyboard to position the cursor at the result that is to be moved.
4. Press [MOVE SPECIMEN] to again display the VIEW QC LOG screen.
5. Use the Arrow keys on the keyboard to move the cursor to the file in which the results are to be placed.
6. Press [MOVE TO FILE] to move the results to the designated file.
NOTE: The result is moved to the end of the list of data that is currently in the file.
7. The VIEW QC LOG screen of the original file is displayed showing that the results have been moved.
Write QC to Disk
The [ WRITE QC TO DISK ] key enables the download of data from a QC file(s) to a floppy disk.
NOTE: The LAB ID SET UP must be completed prior to downloading QC data onto a disk. (Refer to
Section 5: Operating Instructions ;
Write QC to Disk Procedure
1. Place an appropriately-labeled blank diskette in the disk drive.
2. From the MAIN MENU screen, press [ QUALITY CONTROL ] .
3. Place the cursor on the desired QC file and press [ VIEW QC LOG ] .
4. Press [ WRITE QC TO DISK ] .
5. The following message is displayed on the screen:
1.Insert the diskette into disk drive (a:).
2.Press one of the following softkeys: a. [WRITE LOW] to transfer data into the low control disk file.
b. [WRITE NORMAL] to transfer data into the normal control disk file.
c. [WRITE HIGH] to transfer data into the high control disk file.
6. Press the desired softkey. The selected softkey will label the QC file accordingly.
7. Press [ RETURN ] .
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Section 11 Quality Control
8. Repeat steps 3-6 to write additional desired QC file levels to disk.
NOTE: The disk can store one QC file of each level. If more than one QC file of each level is saved, the new data will overwrite the previous data.
9. Remove the disk from the disk drive and send it to the CELL-DYN
Interlaboratory QC program for evaluation.
Print QC Log
The [PRINT QC LOG] key is used to print the entire QC log.
Return
The [RETURN] key is used to return to the QC MENU screen.
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Quality Control
Quality Control Menu
NOTES
Section 11
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Section 11 Quality Control
Quality Control Guide
The Guide is divided into three parts. The first part discusses the handling and running of control material. The second part discusses the Westgard ® Rules used on the CELL-DYN 3200 System and gives guidance for their application in the hematology laboratory. The third part discusses the X-B Analysis program in monitoring quality control.
All QC data should be reviewed according to your laboratory’s protocol.
CELL-DYN Controls
The following controls are recommended for use on the CELL-DYN 3200 System:
CELL-DYN 22 (Tri-level), 1 box, 2.5-mL tubes x 12 (List Number 93111-01)
CELL-DYN 26 (Tr