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CELL-DYN
®
3200 System Operator’s Manual
i
9140181K—July 2002
Foreword
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.
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
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.
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CELL-DYN
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3200 System Operator’s Manual
9140181K—July 2002
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
iii
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
UL1262 Approved
CSA 22.2 # 151 Approved
IEC 1010-1 Approved
In Vitro Diagnostic Directive 98/79/EC
Legal Manufacturer Abbott Laboratories
Abbott Park, Il 60064 US
Authorized Representative ABBOTT
Max-Planck-Ring 2
65205 Wiebaden
Delkenheim, Germany
iv
CELL-DYN
®
3200 System Operator’s Manual
9140181K—July 2002
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.
CELL-DYN
®
3200 System Operator’s Manual
v
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 Section 8:
Hazards.
Instrument/Power related
Alternating Current
Input
Power
Busy
Pressure 1
Communications Port 1 Pressure 2
Communications Port 2 Pressure 3
Fault Ready
Frequency Revision
Fuse
Serial number
Fuses Service disk
High Speed Serial Link
Set-Up disk
Installation Disk
Shear Valve
Keyboard Touch
Line frequency select
Trap
Line Voltage Vacuum 1
Line Voltage Select
Video Graphics Adapter
First Parallel Printer
Port
Vent
Second Parallel Printer
Port
Waste
Maximum power Waste sensor
Model number
Y-Valve
Peristaltic Pump
$&,1387 32:(5
%86< 35(66
&20 35(66
&20 35(66
)$8/7 5($'<
)5(48(1&< 5(9
)86( 61
)86(6 6(59,&(',6.
+66/ 6(783',6.
,167$//$7,21',6. 6+($59$/9(
.(<%2$5' 728&+
/,1()5(46(/(&7 75$3
/,1(92/7$*( 9$&
/,1(92/7$*(6(/(&7 9*$
/37 9(17
/37 :$67(
0$;32:(5 :$67(6(1625
02'(/ <9$/9(
3(5, 67$/7 ,&3803
vi
CELL-DYN
®
3200 System Operator’s Manual
9140181K—July 2002
Reagent related
Cyanide-Free Hemoglobin/Nucleated Optical Count Lyse
Diluent
Diluent/Sheath
Enzymatic Cleaner Concentrate
Expiration Date
Hemoglobin
Hemoglobin
Hemoglobin Lyse
Lot Number
Red Blood Cell
Sheath
Storage temperature. (Example shows “Store at 2º–8ºC”)
White Blood Cell
White Blood Cell Lyse
Calibrator/Control related
Control Assay
Whole Blood Calibrator
Whole Blood Control
Whole Blood Control, High
Whole Blood Control, Low
Whole Blood Control, Normal
&1)5((+*%12&/<6(
',/8(17
',/8(176+($7+
(1=<0$7,&&/($1(5&21&(175$7(
+(02*/2%,1
+*%
+*%/<6(
/27
5%&
6+($7+
8
o
C
2
o
C
:%&
:%&/<6(
&21752/$66$<
:+2/(%/22'&$/,%5$725
:+2/(%/22'&21752/
:%&21752/+
:%&21752//
:%&21752/1
CELL-DYN
®
3200 System Operator’s Manual
vii
9140181K—July 2002
Miscellaneous
Authorized Representative
Consult instructions for use
Date of Manufacture
For In Vitro Diagnostic Use
Legal Manufacturer
List Number
(&5(3
,9'
5()
viii
CELL-DYN
®
3200 System Operator’s Manual
9140181K—July 2002
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:
Laser Label, Front Panel
Laser Label, Rear Panel
Serial Number Label, Rear Panel
AVOID DIRECT EXPOSURE TO BEAM.
NICHT DIREKT IN DEN LASERSTRAHL BLICKEN.
EVITER TOUTE EXPOSITION DIRECTE
AU FAISCEAU LASER.
NO SE EXPONGA DIRECTAMENTE AL RAYO LASER.
EVITARE OGNI ESPOSIZIONE DIRETTAAL RAGGIO.
LASER LIGHT WHEN OPEN.
BEI OFFENER ABDECKUNG TRITT
LASERSTRAHL AUS.
RAYON LASER SI OUVERT.
RADIACION LASER SI SE ABRE.
LUCE LASER SE APERTO.
DANGER
GEFAHR DANGER
PELIGRO PERICOLO
PN 9230701D
Class l Laser Product
per
lEC 825-1[1993]
PN 9230702A
ABBOTT DIAGNOSTICS
A wholly owned subsidiary of Abbott Laboratories
Abbott Park IL. 60064
THIS PRODUCT CONFORMS TO
THE APPLICABLE REQUIREMENTS
OF 21 CFR SUBCHAPTER J
AT THE DATE OF MANUFACTURE
MANUFACTURED DATE
MODEL NO.
SERIAL NO.
LIST NO. REV
CELL-DYN
®
3200 System Operator’s Manual
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9140181K—July 2002
Voltage Label, Rear Panel
CE Label
Solution Container Label, Rear Panel
WARNING
WARNUNG
MISE EN GARDE
ADVERTENCIA
AVVERTENZA
: SET FOR 120 VOLTS
When operation at other line voltage is required, refer to operation manual for detailed instructions.
: FUER 120 VOLT EINGESTELLT
Ist der Betrieb mit einer anderen Netzspannung erforderlich, entnehmen Sie die genauen
Anweisungen der Bedienungsanleitung.
: PARAMETRE POUR UTILISATION SUR 120 VOLTS
Si une utilisation à une tension de réseau différente est requise, reportez-vous au Manuel
Technique pour de plus amples informations.
: CONFIGURADO PARA 120 VOLTIOS
Si se necesita otra tensión diferente a la indicada, consulte el Manual de Operaciones para
instrucciones más detalladas.
: CONFIGURATO PER 120 VOLT
Se la tensione è di voltaggio diverso, fare riferimento alle istruzioni dettagliate nel Manuale di
Impiego.
PN 9230003
CAUTION: DO NOT HANDLE
SOLUTION CONTAINER
UNLESS PROPERLY
PROTECTED. REFER TO
OPERATOR’S MANUAL FOR
INSTALLATION PROCEDURE.
PN 9230334
x
CELL-DYN
®
3200 System Operator’s Manual
9140181K—July 2002
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:
Laser Label, Front Panel
Laser Label, Rear Panel
Serial Number Label, Rear Panel
CAUTION –
CLASS 3B LASER LIGHT WHEN OPEN.
AVOID EXPOSURE TO BEAM.
PN 9230701
CLASS 1 LASER PRODUCT
PN 9230702
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
CELL-DYN
®
3200 System Operator’s Manual
xi
9140181K—July 2002
CE Mark Label, Rear Panel
Voltage Label, Rear Panel
Solution Container Label, Rear Panel
NOTE: The most current representation of these labels will be depicted in
graphics contained in this manual.
ABBOTT
Max-Planck-Ring 2
65205 Wiesbaden
Germany
+49-6122-580
ABBOTT LABORATORIES
Abbott Park, IL 60064 USA
PN 9230751
A
WARNING: SET FOR 120 VOLTS
When operation at other line voltage is required,
refer to Operator’s Manual for detailed instructions.
PN 9230003
E
CAUTION: DO NOT HANDLE
SOLUTION CONTAINER
UNLESS PROPERLY
PROTECTED. REFER TO
OPERATOR’S MANUAL FOR
INSTALLATION PROCEDURE.
PN 9230334
xii
CELL-DYN
®
3200 System Operator’s Manual
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NOTES
CELL-DYN
®
3200 System Operator’s Manual
xiii
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.
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CELL-DYN
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9140181K—July 2002
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
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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.
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CELL-DYN
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9140181K—July 2002
Text Conventions Used in This Manual
The following list summarizes the text conventions that are used in this manual:
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 pressure-
sensitive 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.
Information Presentation Examples
Menu name Sans serif font, all capital letters MAIN MENU
DATA LOG menu
Soft keys (screen label keys) Sans serif font, all capital letters,
enclosed in brackets
[RUN]
Keyboard/keypad keys Regular font, initial capital letters only
when appropriate
arrow keys
↑ arrow key
Enter key
ESC key
Page Up key
the pound (#) key
the asterisk (*) key
Status Regular font, all capital letters READY
STANDBY
INITIALIZED
Data entry field Regular font, enclosed in angle brackets <Operator ID> field
Screen message or other screen
display
Courier Waste Full
ON and OFF All caps, regular font ON
OFF
CELL-DYN
®
3200 System Operator’s Manual
xvii
9140181K—July 2002
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.
Safety
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 Section 8: Hazards.
Warnings are inserted throughout this manual to alert personnel to
potential hazards. The standard warning conventions including signal
words and symbols are described in Section 8: Hazards.
xviii
CELL-DYN
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3200 System Operator’s Manual
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Revision Status
Document Control
Number(s)
Revision
Date
Section(s)
Revised
Pages Revised
and Added
9140181H 10/01 All All
9340541B N/A All (new tabset) N/A
9140181J 3/02 Forward All
How To Use This
Manual
All
Master Table of
Contents
pp. 1 through 5; 12 through 14; 19
List of Figures p. 3
1: Use or Function pp. 1-1 and 1-2; 1-8; 1-18 and 1-19
2: Installation
Procedures and
Special
Requirements
pp. 2-3; 2-7; 2-15
3: Principles of
Operation
p. 3-7
4: Performance
Characteristics and
Specifications
pp. 4-4 and 4-5
5: Operating
Instructions
pp. 5-8; 5-10; 5-99
6: Calibration 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 All
9: Service and
Maintenance
pp. 9-12; 9-55 and 9-56
13: Sample Loader p. 13-1
Appendix B pp. B-1; B-3
Index All
CELL-DYN
®
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9140181K—July 2002
NOTE: For existing customers, pages of 9140181J will be changed to Revision K and sent with 9140181K
9140181K 7/02 Forward All
How To Use This
Manual
All
Master Table of
Contents
pp. 1 through 5; 10; 12 through 20
List of Figures pp. 3 and 4
List of Tables 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
3: Principles of
Operation
pp. 3-7; 3-16; 3-28; 3-31 through 3-36
4: Performance
Characteristics and
Specifications
pp. 4-4 and 4-5
5: Operating
Instructions
pp. 5-8; 5-10; 5-42 through 5-44; 5-86 and
5-87; 5-99; 5-128
6: Calibration 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 All
9: Service and
Maintenance
pp. 9-12; 9-21; 9-25; 9-46; 9-55 and 9-56;
9-59; 9-61
10:
Troubleshooting
and Diagnostics
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
pp. 14-20; 14-47; 14-61; 14-68 through
14-69
Appendix B pp. B-1; B-3
Index All
Document Control
Number(s)
Revision
Date
Section(s)
Revised
Pages Revised
and Added
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®
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Revision Log
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.
Conclusion
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.
Document
Control Number
Revision
Date
Software Version
Revision
Incorporated by
Date
Incorporated
/
