Cell-Dyn 1800 2008 9140390e

Introduction
We welcome you to the role of Operator of the CELL-DYN 1800 System. Your
instrument, which includes state-of-the-art technology, is designed to function
consistently and dependably on a daily basis.
The CELL-DYN 1800 System is backed by dedicated professionals who excel in
engineering, training, and technical expertise. As a valued customer, we will teach
you how to operate, maintain, and troubleshoot your system.
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
If you need information or help in diagnosing a problem, technical assistance is
available by telephone. In the US, this service is available 24 hours a day, seven
days a week by calling Abbott Diagnostics Customer Service at:
1-877-4ABBOTT (1-877-422-2688).
For customer support in Canada, call: 1-800-387-8378
For customer support outside the US and Canada, call your local Customer Service
representative.
For correspondence, the address in the US is:
Abbott Diagnostics Division
Customer Service
200 Abbott Park Road
Abbott Park, IL 60064, USA
Proprietary Statement
The entire contents of this manual are copyrighted 2004, 2006 and 2008 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 media may be reproduced, stored, retrieved,
or transmitted in any form or by any means without the prior written permission of
Abbott Laboratories.
Patent Statement
The following U.S. Patents are relevant to the CELL-DYN 1800 or its components.
There are other such patents and patent applications in the United States and
worldwide: 4,745,071, 5,227,304, 5,958,781, and 6,740,527.
CELL-DYN® 1800 System Operator’s Manual i

9140390E—June 2008
Instrument Disclaimer
All operating instructions must be followed. In no event shall Abbott Laboratories
be responsible for failures, errors, or other liabilities resulting from a customer’s
noncompliance with the procedures and precautions outlined herein.
Pictorial Disclaimer
All samples (printouts, graphics, displays or screens, etc.) are for information and
illustration purposes only and shall not be used for clinical or maintenance
evaluations.
Regulatory and Safety Agency Approvals

In Vitro Diagnostic Directive 98/79/EC
Legal Manufacturer ABBOTT LABORATORIES
Authorized Representative ABBOTT
Max-Planck-Ring 2
65205 Wiesbaden
Germany
+49-6122-580
UL 61010A-1 Approved
CAN/CSA - C22.2 No. 1010.1-92 Approved
IEC 61010-1 Approved
ETL Listed
ii CELL-DYN® 1800 System Operator’s Manual

9140390D—January 2006
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 Abbott Diagnostics
Customer Service 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 Diagnostics Customer Service: 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.
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 1800 Hematology System is manufactured by Abbott
Diagnostics Division, Abbott Laboratories, 200 Abbott Park Road,
Abbott Park, IL, 60064, USA. Please direct all inquiries concerning information in
this manual to the foregoing address.
NOTE: Direct all inquiries regarding equipment problems to Abbott Diagnostics
Customer Service. (U.S. customers only.)
CELL-DYN® 1800 System Operator’s Manual iii

9140390C—March 2004
Trademark Statements
CELL-DYN is a registered trademark of Abbott Laboratories. All other trademarks
are the property of their respective owners.
iv CELL-DYN® 1800 System Operator’s Manual

9140390E—June 2008
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
BUSY Busy LYSE Lyse
COM1 Communication Port 1 MAX POWER Maximum Power
COM2 Communication Port 2 MODEL Model Number
Electrical Hazard POWER Power

Symbol
DETERGENT Detergent Reagent READY Ready
DILUENT Diluent Reagent REV Revision
FAULT Fault SERVICE DISK Service disk
FREQUENCY Frequency SN Serial number
INSTALLATION DISK Installation Disk WASTE Waste
KEYBOARD Keyboard WASTE SENSOR Waste sensor
LINE VOLTAGE Line Voltage
LPT1 First Parallel Printer

Port
Reagent related
CN-FREE DIFF LYSE Cyanide-Free Differential Lyse
DETERGENT Detergent Reagent
DILUENT Diluent Reagent
ENZYMATIC CLEANER CONCENTRATE Enzymatic Cleaner Concentrate
LOT Batch Code
Use By
CELL-DYN® 1800 System Operator’s Manual v

9140390E—June 2008
Calibrator/Control related
ASSAY VALUE Assay Value
CONTROL ASSAY DISK Control Assay Disk
CN-FREE DIFF LYSE Cyanide-Free Differential Lyse
MEAN RANGE Mean Range
MEAN VALUE Mean Value
PARAMETER Parameter
SYSTEM System
TOLERANCE LIMIT Tolerance Limit
WB CAL Whole Blood Calibrator
WB CONTROL L Whole Blood Control, Low Level
WB CONTROL N Whole Blood Control, Normal Level
WB CONTROL H Whole Blood Control, High Level
WB CONTROL TRI-LEVEL Whole Blood Control, Tri-Level
Miscellaneous
EC REP Authorized Representative in the European Community
Biological Risk
REF Catalog Number
CE-mark
IVD In Vitro Diagnostic Medical Device
Date of Manufacture
Manufacturer
Consult instructions for use
8oC
Temperature Limitation (Example shows “Store at 2ºC–8ºC”)
2oC
vi CELL-DYN® 1800 System Operator’s Manual

9140390E—June 2008
Miscellaneous (Continued)
Caution, consult accompanying documents (Note: for instrument
reagents)
Caution, risk of danger / Caution, consult accompanying documents
(Note: for Instruments)
Separate collection for electrical and electronic equipment waste per

Directive 2002/96/EC in the European Union
Instrument Labeling
The following labels are affixed to the CELL-DYN 1800 System:
The CELL-DYN 1800 System is CE Marked to the European In Vitro Diagnostic

Directive, which encompasses the requirements of the EMC and Safety Directives,
and have the following labels:
ABBOTT DIAGNOSTICS DIVISION

Abbott Laboratories
Abbott Park, IL 60064 USA
MODEL
SN
REF REV
MADE IN USA PN 9230010K
Serial Number Label, Rear Panel
ABBOTT
Max-Planck-Ring 2
65205 Wiesbaden
Germany
+49-6122-580 PN 9230751A
CE Mark Label, Rear Panel
ABBOTT LABORATORIES
Diagnostics Division
Abbott Park, IL 60064 USA
Abbott
Diagnostics Division
EC REP ABBOTT
Max-Planck-Ring 2
65205 Wiesbaden
Germany
+49-6122-580 PN 9231514A
CE Mark Label, Rear Panel
9221514A.indd 1 1/16/2008 12:16:45 PM
CELL-DYN® 1800 System Operator’s Manual vii

9140390E—June 2008
CAUTION: Do not handle Solution Container unless properly protected.
VORSICHT: Die Reagenzbehlter nur ordnungsgem gesichert bewegen.
ATTENTION : Ne pas manipuler le flacon de solution sans protection
approprie.
PRECAUCIN: no maneje el recipiente de la soluci n a menos que est protegido adecuadamente.
ATTENZIONE: Non maneggiare il recipiente della soluzione se non si
protetti in modo adeguato.
ATENO: no manipular o recipiente da soluo sem estar devidamente protegido.
VIGTIGT: Beholderen med oplsning m ikke hndteres, medmindre brugeren er korrekt beskyttet.
VIKTIGT: Anvnd skyddsklder vid hantering av lsningsbehllarna.
ΠΡΟΣΟΧΗ: Χρησιμοποιείτε το Δοχείο Ρυθμιστικού διαλύματος μόνο αφού λάβετε τις
κατάλληλες προφυλάξεις.
UPOZORNĚNÍ: Nemanipulujte s nádobou obsahující roztok, pokud není řádně zabezpečena.
Consult instructions for use. / Siehe Packungsbeilage. / Consulter les instructions
d’utilisation. / Consulte las instrucciones de uso. / Consultare le istruzioni per l’uso. /
Consultar as instrues de utilizao. / Se brugsanvisningen. / Ls tillhrande
dokumentation. / Συμβουλευτείτε τις οδηγίες χρήσης. / Viz návod k použití.
PN 9230334
Reagent Handling (Inlet) Label, Left Panel
CAUTION: Consult instructions for use.

VORSICHT: Siehe Packungsbeilage.
ATTENTION : Consulter les instructions d’utilisation.
PRECAUCIN: Consulte las instrucciones de uso.
ATTENZIONE: Consultare le istruzioni per l’uso.
ATENO: Consultar as instrues de utilizao.
VIGTIGT: Se brugsanvisningen.
VIKTIGT: Ls tillhrande dokumentation.
ΠΡΟΣΟΧΗ: Συμβουλευτείτε τις οδηγίες χρήσης.
UPOZORNĚNÍ: Viz návod k použití.
PN9239401
Syringe Panel Label, Left Panel
Biological Risk
PN 9231446
Biological Risk Label, Front Panel and Reagent Inlet Panel
PN 9231477A
Biohazard Label, Front Panel and Reagent Inlet Panel
viii CELL-DYN® 1800 System Operator’s Manual

9140390E—June 2008
CAUTION: Install 10 mL Syringe(s), check that all syringe fittings are secure, and re-insert Normally Closed Valve Tubing before Power ON.
VORSICHT: Vor dem Einschalten des Systems die 10 ml-Spritze einsetzen, sicherstellen, dass der Spritzenanschluss gesichert ist und gegebenenfalls
den Schlauch f r das normalerweise geschlossene Ventil wieder einsetzen.
ATTENTION : Installer une (des) seringue(s) de 10 ml, vrifier que les raccords sont bien fixs et reconnecter les tubulures des vannes normalement fermes
avant d’allumer l’appareil.
PRECAUCIN: instale la/s jeringa/s de 10 ml, compruebe que todas las juntas de las jeringas estn bien apretadas e inserte de nuevo el tubo de la vlvula,
normalmente cerrada, antes de ENCENDER.
ATTENZIONE: Prima dell’accensione, installare la siringa (o le siringhe) da 10 ml, assicurarsi che tutte le connessioni siano ben fissate e reinserire il tubo delle valvole
normalmente chiuse.
ATENO: instalar seringa(s) de 10 ml, verificar se esto devidamente colocadas e voltar a inserir o tubo da vlvula normalmente fechada antes de ligar o
equipamento.
VIGTIGT: Installering af 10 ml-sprjte(r): kontrollr, at alle sprjtebeslag er fastgjorte og st slangen tilbage p den normalt lukkede ventil, inden systemet tndes.
VIKTIGT: Anslut 10 mL-sprutan, kontrollera att alla sprutor r ordentligt anslutna och teranslut slangen till den normalt slutna ventilen innan instrumentet sls p (ON).
ΠΡΟΣΟΧΗ: Τοποθετήστε μία ή περισσότερες σύριγγες των 10ml, ελέγξτε ότι όλοι οι σύνδεσμοί τους είναι ασφαλισμένοι και
επανατοποθετήστε το σωληνάριο της φυσιολογικά κλειστής βαλβίδας πριν από την ενεργοποίηση του συστήματος (ΟΝ).
Consult instructions for use. / Siehe Packungsbeilage. / Consulter les instructions d’utilisation. / Consulte las instrucciones de uso./ Consultare le
istruzioni per l’uso. / Consultar as instrues de utilizao. / Se brugsanvisningen. / Ls tillhrande dokumentation./
Συμβουλευτείτε τις οδηγίες χρήσης. PN 9230233
Caution 10 mL Syringe Label, Front Panel Membrane Keypad
CAUTION: When removing

the Aperture Plate, use care to
avoid spilling on components
located below.
VORSICHT: Beim Entfernen der Kapillarscheibe
vorsichtig vorgehen, um Spritzer auf den unmittelbar
darunter befindlichen Komponenten zu vermeiden.
ATTENTION : Retirez la plaque d’ouverture avec
prcaution afin de ne pas renverser de liquide sur les
composants situs en dessous.
PRECAUCIN: Retire la placa de abertura con
cuidado para evitar salpicar los componentes
localizados debajo.
ATTENZIONE: Rimuovere con cautela la piastra di
apertura (Aperture Plate) per evitare di bagnare i
componenti sottostanti.
Consult instructions for use.
Siehe Packungsbeilage.
Consulter les instructions d’utilisation.
Consulte las instrucciones de uso.
Consultare le istruzioni per l’uso.
PN 9230231
Aperture Plate Removal Label (Front), Flow Panel
ATENO: retirar a placa da abertura com

cuidado para evitar salpicar lquido sobre
os componentes localizados por baixo.
ADVARSEL: Undg at spilde p de nedre
komponenter ved udtagning af tllepladen.
VIKTIGT: Var frsiktig nr aperturplattan avlgsnas fr
att undvika spill p komponenterna nedanfr.
ΠΡΟΣΟΧΗ: Αφαιρείτε την πλάκα διόδου με
προσοχή ώστε να αποφεύγετε τη διάχυση στα
υλικά που βρίσκονται από κάτω.
Συμβουλευτείτε τις οδηγίες χρήσης.
UPOZORNĚNÍ: Při vyjímání měřicí destičky
zabraňte polití okolních součástí kapalinou.
Consultar as instrues de utilizao.

Se brugsanvisningen.
Ls tillhrande dokumentation.
Συμβουλευτείτε τις οδηγίες
χρήσης.
Viz návod k použití.
PN 9230231
Aperture Plate Removal Label (Back), Flow Panel
CELL-DYN® 1800 System Operator’s Manual ix

9140390E—June 2008
NOTES
x CELL-DYN® 1800 System Operator’s Manual

9140390E—June 2008
Master Table of Contents
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i
Customer Support . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i
Proprietary Statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i
Patent Statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i
Instrument Disclaimer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ii
Pictorial Disclaimer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ii
Regulatory and Safety Agency Approvals . . . . . . . . . . . . . . . . . . . . . . ii
Abbott Instrument Warranty. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iii
Trademark Statements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iv
Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . v
Instrument Labeling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vii
How to Use This Manual. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . How to Use-1

Manual Organization . . . . . . . . . . . . . . . . . . . . . . . . . . . . How to Use-1
Manual Construction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . How to Use-3
Text Conventions Used in This Manual . . . . . . . . . . . . . . How to Use-4
Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . How to Use-6
Revision Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . How to Use-7
Revision Log. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . How to Use-11
Use or Function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1

Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
System Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5
Front Panel, Version A . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7
Upper Front Cover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7
LED Indicator Lights . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7
Lower Front Cover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7
Sample Aspiration Probe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7
Touch Plate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7
Front Panel, Version B . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8
Upper Front Cover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8
LED Indicator Lights . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8
Display Bezel Cover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8
Sample Aspiration Probe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8
Touch Plate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8
Sampling Section . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9
CELL-DYN® 1800 System Operator’s Manual Master Table of Contents-1

9140390E—June 2008
WBC Metering Assembly. . . . . . . . . . . . . . . . . . . . . . . . . . 1-11
von Behrens WBC Transducer Assembly . . . . . . . . . . . . . 1-11
HGB Flow Cell Assembly . . . . . . . . . . . . . . . . . . . . . . . . . 1-11
Diluent Normally Closed Valve . . . . . . . . . . . . . . . . . . . . . 1-11
Left Side Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-12
Waste Sensor Connector. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-13
Detergent Inlet Tubing Connector . . . . . . . . . . . . . . . . . . . . . . 1-13
Diluent Inlet Tubing Connector . . . . . . . . . . . . . . . . . . . . . . . . 1-13
Lyse Inlet Tubing Connector . . . . . . . . . . . . . . . . . . . . . . . . . . 1-13
Waste Outlet Tubing Connector . . . . . . . . . . . . . . . . . . . . . . . . 1-13
Normally Closed Valve . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-13
Syringes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-13
Rear Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-14
Power Cord Connector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-14
Right Side Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-15
Main Power Switch. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-15
PC Keyboard Connector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-15
RS-232 Serial Interface Connectors (2) . . . . . . . . . . . . . . . . . . 1-15
Parallel Interface Connector . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-15
Floppy Disk Drive . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-15
Computer Section . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-16
Data Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-16
Liquid Crystal Display (LCD) Screen/Membrane Keypad . . . 1-17
Audio . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-17
Reagent System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-18
Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-18
CELL-DYN 1800 Reagents . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-18
Reagent Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-19
Reagent Handling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-19
Background Count . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-19
Controls and Calibrator. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-20
Controls. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-20
Calibrator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-20
Consumables. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-21
Installation Procedures and Special Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1

Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
Initial Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Inventory. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Accessory Kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Unpacking. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4
Space Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4
Waste Disposal Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5
Master Table of Contents-2 CELL-DYN® 1800 System Operator’s Manual

9140390E—June 2008
Power Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6
Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7
Printer Installation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7
Installing the Printer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7
Self-Test Printouts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8
Bar Code Scanner Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9
Installing the Bar Code Scanner . . . . . . . . . . . . . . . . . . . . . . . . . 2-9
Inspection and Tubing Installation . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9
Reagent Tubing and Waste Line Tubing . . . . . . . . . . . . . . . . . 2-10
Normally Closed Valves . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-12
Diluent Syringe Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-13
Inspecting the Flow Panel. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-14
Opening/Removing Front Covers, Version A . . . . . . . . . . . . . 2-14
Opening Front Covers, Version B . . . . . . . . . . . . . . . . . . . . . . 2-15
StartUp . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-17
Operator ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-17
Sequence Number . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-17
Conditioning of WBC/RBC Metering Tubes . . . . . . . . . . . . . . 2-17
Relocation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-19
Moving the Instrument . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-19
Principles of Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1

Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
Sample Analysis Cycle Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
Open Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
Aspiration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
Dilution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
Pre-Dilute Aspiration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
Cell Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4
Electrical Impedance Measurement . . . . . . . . . . . . . . . . . . . 3-4
Volumetric Metering. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4
Coincidence Loss Correction . . . . . . . . . . . . . . . . . . . . . . . . 3-5
Parameter Reporting Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6
WBC Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8
Hemoglobin Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8
RBC/PLT Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8
MCV, HCT, RDW Determination . . . . . . . . . . . . . . . . . . . . . . . 3-8
MPV, PCT, PDW Determination . . . . . . . . . . . . . . . . . . . . . . . . 3-8
MCH and MCHC Determination . . . . . . . . . . . . . . . . . . . . . . . . 3-9
Results Displayed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9

9140390E—June 2008
Data Stored . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9
Instrument Rinsing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9
WBC Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-11
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-11
WBC Measurement Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-11
WBC Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-13
WBC Histograms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-13
RBC/PLT Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-15
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-15
RBC/PLT Measurement Process . . . . . . . . . . . . . . . . . . . . . . . . . . 3-15
PLT Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-15
RBC Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-17
RBC Histograms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-17
RBC Count . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-17
MCV . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-17
HCT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-17
MCH . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-17
MCHC. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-17
RDW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-17
PLT Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-19
PLT Histogram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-19
PLT Count . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-19
MPV . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-19
PCT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-19
PDW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-19
Hemoglobin Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-21
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-21
Hemoglobin Measurement Process . . . . . . . . . . . . . . . . . . . . . . . . 3-21
System-Initiated Messages and Data Flags . . . . . . . . . . . . . . . . . . . . . . . . 3-23
Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-23
Interfering Substances . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-23
System-Initiated Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-24
Parameter Data Flags . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-25
Dispersional Data Alerts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-25
Suspect Parameter Flags . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-26
Suspect Population Flags . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-27
CELL-DYN 1800 Region Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-31
CELL-DYN 1800 Lysate-Modified White Cell Regions . . . . . 3-31
References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-33

9140390E—June 2008
Performance Characteristics and Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
Physical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
Power Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5
Power Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5
Consumption . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5
Transport and Storage Specifications . . . . . . . . . . . . . . . . . . . . . 4-5
Bar Code Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7
Specifications for Bar Code Labels . . . . . . . . . . . . . . . . . . . . . . . . . 4-7
Specifications for Bar Code Symbologies . . . . . . . . . . . . . . . . . . . . 4-8
Operational Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-9
Operating Environment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-9
Cycle Times (Ready to Ready) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-9
Aspiration Volume (Whole Blood). . . . . . . . . . . . . . . . . . . . . . . . . . 4-9
Measurement Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11
Measurement Channel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11
WBC and Differential . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11
RBC and PLT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11
HGB . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11
Performance Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-13
Background Counts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-13
Linearity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-13
Carryover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-14
Precision . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-15
Hemogram Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-15
WBC Differential Parameters . . . . . . . . . . . . . . . . . . . . . . . 4-15
Correlation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-16
Bias . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-16
Mode-to-Mode Bias . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-16
Performance Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-17
WBC Differential . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-17
References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-19
Operating Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1

Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
Instrument Start Up. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3
Manual Start-Up Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3
Auto Start-Up Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4
Program Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5
MAIN MENU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6
Setup Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-9
Using the SETUP Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-9

9140390E—June 2008
Selecting Display and Print Options. . . . . . . . . . . . . . . . . . . . . . . . 5-13
Entering or Changing the Date and Time . . . . . . . . . . . . . . . . . . . . 5-14
To Change the Date and Time . . . . . . . . . . . . . . . . . . . . . . . . . 5-15
Automatic Start-Up and Shutdown. . . . . . . . . . . . . . . . . . . . . . . . . 5-16
To Select Auto Start-Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-16
To Change Auto Shutdown . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-17
Patient Limit Sets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-18
Changing Patient Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-20
Changing Panic Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-21
Reagent Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-22
Creating the Reagent Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-24
Quality Control Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-25
X-B Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-27
Changing Values in the X-B Function . . . . . . . . . . . . . . . . 5-27
Lab ID Setup. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-29
Setting Up A Laboratory ID File . . . . . . . . . . . . . . . . . . . . 5-29
Control File Setup (Low, Normal, High) . . . . . . . . . . . . . . . . . 5-30
Selecting a Specific Control File . . . . . . . . . . . . . . . . . . . . 5-30
Entering the Lot Number . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-31
Entering the Expiration Date . . . . . . . . . . . . . . . . . . . . . . . . . . 5-32
Selecting Westgard® Rules . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-33
Entering Range Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-34
Entering Mean/Limits. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-35
Rep File Setup. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-36
Setting Up a Replicate File . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-37
Entering the Replicate ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-38
Computer Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-39
Units Selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-40
Help/Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-41
Routine Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-43
Daily Start-Up Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-43
Running a Background Count . . . . . . . . . . . . . . . . . . . . . . . . . 5-43
Performing Daily Quality Control . . . . . . . . . . . . . . . . . . . . . . 5-43
Run Menu Screen Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-44
RUN Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-46
Clear Orifice/Clear Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-48
Pre-Dilute . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-48
Specimen Type . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-49
Parameter Select . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-50
Print Report. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-50
Help/Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-50
Main . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-50

9140390E—June 2008
Specimen Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-51
Interfering Substances. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-51
Specimen Stability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-52
Specimen Collection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-52
Entering an Operator ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-53
Entering a Specimen ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-54
Bar Code Scanner Entry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-56
Running Specimens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-57
Running Specimens—Pre-Dilute Mode . . . . . . . . . . . . . . . . . . . . . 5-59
Removing a Pre-Diluted Solution from the Pre-Mixing Cup . . . . . 5-62
Using the Data Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-63
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-63
Data Log Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-64
Edit ID. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-66
Display Specimen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-67
Find Specimen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-68
Reject from X-B/Accept to X-B . . . . . . . . . . . . . . . . . . . . . . . . 5-70
Transmit Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-71
Print Datalog . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-73
Help/Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-74
Main . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-74
Daily Shutdown . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-75
Power OFF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-77
References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-79
Calibration Procedures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1

Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
When to Calibrate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
Calibration Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3
General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3
Calibration Methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3
Calibration Temperature Specification. . . . . . . . . . . . . . . . . . . . 6-3
Calibration Materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4
Commercial Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4
Whole Blood Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4
Whole Blood Calibration Guidelines . . . . . . . . . . . . . . . . . . . . . 6-4
Requirements for Fresh Whole Blood Specimens . . . . . . . . . . . 6-5
Requirements for Reference Whole Blood Calibration . . . . . . . 6-5
Reference Methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-6
WBC, RBC, and PLT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-6
HGB . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-6
MCV . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-6
Calibration Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-9

9140390E—June 2008
Pre-Dilute . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-10
Auto-Cal Select. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-11
Enter Factor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-12
Print. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-12
Help/Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-12
Main . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-12
Calibration Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-13
Pre-Calibration Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-13
Calibration Temperature Specification. . . . . . . . . . . . . . . . . . . 6-14
Within-Sample Precision . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-14
Auto Calibration Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-15
Auto-Cal Ranges for Calibrator and Fresh Whole Blood. . . . . 6-15
Preparing for Auto Calibration . . . . . . . . . . . . . . . . . . . . . . . . . 6-15
Entering Reference Values—Calibrator . . . . . . . . . . . . . . . . . . 6-15
Performing an Auto Calibration Run—Calibrator . . . . . . . . . . . . . 6-16
Determining Reference Values—Fresh Whole Blood . . . . . . . 6-18
Entering Reference Values—Fresh Whole Blood . . . . . . . . . . 6-18
Performing an Auto Calibration Run—Fresh Whole Blood . . . . . 6-19
Enter Factor Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-21
Determining Reference Values—Calibrator. . . . . . . . . . . . . . . 6-21
Performing an Enter Factor Calibration Run—Calibrator . . . . 6-21
Performing an Enter Factor Calibration Run—
Fresh Whole Blood . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-23
Pre-Dilute Mode Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-25
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-25
Determining Reference Values—Pre-Dilute . . . . . . . . . . . . . . . . . 6-25
Auto-Cal Calibration Procedure . . . . . . . . . . . . . . . . . . . . . . . . 6-26
Enter Factor Calibration Procedure . . . . . . . . . . . . . . . . . . . . . 6-26
Preparing Pre-Diluted Solution Using the [1/250 DILUTION]
Method—Calibrator. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-27
Preparing Pre-Diluted Solution Using the [1/250 DILUTION]
Method—Fresh Whole Blood . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-29
Preparing Pre-Diluted Solution Using the [10 mL DISPENSE]
Method—Calibrator. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-31
Method—Fresh Whole Blood . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-33
Activating the Pre-Dilute Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-36
Pre-Dilute Auto-Cal Procedure—Calibrator . . . . . . . . . . . . . . 6-36
Pre-Dilute Auto-Cal Procedure—Fresh Whole Blood . . . . . . . 6-39
Pre-Dilute Enter Factor Procedure—Calibrator . . . . . . . . . . . . 6-41
Pre-Dilute Enter Factor Procedure—Fresh Whole Blood . . . . 6-43
References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-45

9140390E—June 2008
Operational Precautions and Limitations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
Limitations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
Location Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
Calibration Temperature Specification. . . . . . . . . . . . . . . . . . . . 7-2
Reagent Storage and Handling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3
Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
Warning Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
Signal Words. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
Safety Icons. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
Hazard Information and Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3
General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3
Biohazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3
Handling and Disposing of Biohazardous Material . . . . . . . . . . . . . 8-3
Chemical Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4
Electrical Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4
Physical and Mechanical Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5
References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-7
Service and Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1

Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1
Preventive Maintenance Schedule . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-3
Flow Panel Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-5
Decontamination Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-7
Maintenance Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-9
Special Protocols Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-11
Daily Maintenance Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-15
Daily Start-Up Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-15
Daily Shutdown Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-16
Prolonged Shutdown Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-17
Weekly Maintenance Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-19
Performing Auto-Clean. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-19
Cleaning the Aspiration Probe Exterior . . . . . . . . . . . . . . . . . . . . . 9-22
Monthly Maintenance Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-25
Rinsing the Lyse Inlet Line. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-25
Rinsing the Reagent Inlet Tubing . . . . . . . . . . . . . . . . . . . . . . . . . . 9-28
Semi-annual Maintenance Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-31
Cleaning the Printer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-31
As-Required Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-33
Obtaining Technical Assistance or Parts . . . . . . . . . . . . . . . . . . . . 9-34

9140390E—June 2008
Cleaning the HGB (Hemoglobin) Flow Cell . . . . . . . . . . . . . . . . . 9-35
Cleaning the Pre-Mixing Cup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-39
Emptying Instrument Waste . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-41
Cleaning/Replacing the Aperture Plates. . . . . . . . . . . . . . . . . . . . . 9-43
Removing the Aperture Plates . . . . . . . . . . . . . . . . . . . . . . . . . 9-44
Cleaning the Aperture Plates . . . . . . . . . . . . . . . . . . . . . . . . . . 9-46
Installing the RBC/PLT Aperture Plate . . . . . . . . . . . . . . . . . . 9-47
Installing the WBC Aperture Plate . . . . . . . . . . . . . . . . . . . . . . 9-48
Filling the Transducers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-49
Cleaning/Replacing the Aspiration Probe . . . . . . . . . . . . . . . . . . . 9-51
Cleaning the Aspiration Probe Interior. . . . . . . . . . . . . . . . . . . 9-52
Removing the Aspiration Probe . . . . . . . . . . . . . . . . . . . . . . . . 9-54
Installing the Aspiration Probe . . . . . . . . . . . . . . . . . . . . . . . . . 9-56
Cleaning the Aspiration Probe Interior. . . . . . . . . . . . . . . . . . . 9-58
Removing the Aspiration Probe . . . . . . . . . . . . . . . . . . . . . . . . 9-60
Installing the Aspiration Probe . . . . . . . . . . . . . . . . . . . . . . . . . 9-62
Cleaning/Replacing the Aspiration Probe Wash Block . . . . . . . . . 9-64
Removing the Aspiration Probe Wash Block. . . . . . . . . . . . . . 9-65
Cleaning the Aspiration Probe Wash Block . . . . . . . . . . . . . . . 9-66
Installing the Aspiration Probe Wash Block . . . . . . . . . . . . . . 9-67
Cleaning/Replacing Syringes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-69
Cleaning/Replacing the Diluent Syringe . . . . . . . . . . . . . . . . . 9-70
Removing the Diluent Syringe . . . . . . . . . . . . . . . . . . . . . . 9-70
Cleaning the Diluent Syringe . . . . . . . . . . . . . . . . . . . . . . . 9-72
Installing the Diluent Syringe . . . . . . . . . . . . . . . . . . . . . . . 9-73
Replacing the Diluent Syringe . . . . . . . . . . . . . . . . . . . . . . 9-76
Cleaning/Replacing the Sample Syringe . . . . . . . . . . . . . . . . . 9-79
Removing the Sample Syringe . . . . . . . . . . . . . . . . . . . . . . 9-79
Cleaning the Sample Syringe . . . . . . . . . . . . . . . . . . . . . . . 9-81
Installing the Sample Syringe . . . . . . . . . . . . . . . . . . . . . . . 9-82
Cleaning/Replacing the Lyse Syringe . . . . . . . . . . . . . . . . . . . 9-84
Removing the Lyse Syringe . . . . . . . . . . . . . . . . . . . . . . . . 9-84
Cleaning the Lyse Syringe . . . . . . . . . . . . . . . . . . . . . . . . . 9-86
Installing the Lyse Syringe . . . . . . . . . . . . . . . . . . . . . . . . . 9-87
Draining/Cleaning the Vacuum Accumulator . . . . . . . . . . . . . . . . 9-89
Cleaning the Bar Code Scanner Lens . . . . . . . . . . . . . . . . . . . . . . . 9-92
Cleaning the “Y” Fitting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-93
Supplemental Aperture Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . 9-97
Preparing the Instrument for Extended Periods of Non-Use
or Shipping. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-100
Cleaning the Flow System . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-101
Cleaning Tubing and Instrument Exterior . . . . . . . . . . . . . . . 9-102
References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-105

9140390E—June 2008
Troubleshooting and Diagnostics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1
Diagnostics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-3
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-11
Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-11
Troubleshooting Tips and Techniques . . . . . . . . . . . . . . . . . . . . . 10-12
Obtaining Technical Assistance . . . . . . . . . . . . . . . . . . . . . . . . . . 10-12
Customer Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-13
Troubleshooting Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-14
Power ON Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-14
Power OFF Procedure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-14
Initializing the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-15
Replacing Reagents. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-15
Replaceable Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-15
Index of Error Messages and Conditions . . . . . . . . . . . . . . . . . . . . . . . . . 10-17
Observed or Mechanical Errors or Condition. . . . . . . . . . . . . 10-17
Data Problems. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-18
Screen Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-19
Calibration Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-55
Alarm Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-55
Clearing Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-55
Fault Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-55
Flags (For PLT Only) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-55
Calibration Temperature Specification . . . . . . . . . . . . . . . . . . 10-55
Allowable Values Exceeded . . . . . . . . . . . . . . . . . . . . . . . . . . 10-56
Reference Check Failures . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-56
Precision Check Failures . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-56
Correcting Mean and Factor Failures . . . . . . . . . . . . . . . . . . . 10-57
Printer Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-59
Printer Not Ready Message . . . . . . . . . . . . . . . . . . . . . . . . . . 10-59
Paper Feed Failure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-59
Incomplete Printout. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-59
Print Quality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-59
Bar Code Scanner Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-61
Scanner Not Responding . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-61
Bar Code Label Quality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-61
References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-63

9140390E—June 2008
Quality Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-1
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-1
When to Run QC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-1
QC Methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-1
Control Material . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-2
Quality Control Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-3
Guidelines for Running Controls . . . . . . . . . . . . . . . . . . . . . . . . . . 11-3
Control Material Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-4
Quality Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-5
QC Setup. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-5
Program Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-5
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-6
Quality Control Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-9
Using Quality Control. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-10
X-B File . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-10
Low Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-12
Normal Control. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-13
High Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-14
Replicates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-15
View QC Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-15
Help/Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-21
Return . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-22
Performing a QC Run . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-23
Rejecting/Accepting Specimens . . . . . . . . . . . . . . . . . . . . . . . 11-25
Deleting Specimens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-26
Purging Control Files . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-27
X-B Analysis Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-29
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-29
Lower/Upper Acceptance Limits . . . . . . . . . . . . . . . . . . . . . . . . . 11-30
Establishing the Target Value. . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-30
Interpreting X-B Results. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-31
Analyzing Control Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-33
Levey-Jennings Graphs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-33
Modified Westgard® Rule Analysis. . . . . . . . . . . . . . . . . . . . . . . 11-34
Modified Westgard® Rules for the CELL-DYN 1800 . . . . . . . . 11-34
Rule Violations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-35
References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-37

9140390E—June 2008
Printers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-1
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-1
Printer Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-1
Printer Components, Installation, and Operations . . . . . . . . . . 12-1
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-1
Bibliography . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Bibliography-1
Bibliography . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Bibliography-1
Clinical Laboratory Guidelines and Standards . . . . . Bibliography-1
Biosafety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Bibliography-2
Reference Tables. . . . . . . . . . . . . . . . . . . . . . . . . . . . Bibliography-2
Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Bibliography-2
Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Glossary-1
Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Glossary-1
Appendix A . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1
CELL-DYN Equipment, Parts, and Accessories . . . . . . . . . . . . . . . A-2
CELL-DYN 1700/1800 Accessory Kit (L/N 03H54-01) . . . . . . . . . A-3
CELL-DYN 1800 Reagent Line Kit (L/N 91072-01) . . . . . . . . . . . A-3
CELL-DYN Reagents. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-4
CELL-DYN Controls and Calibrators . . . . . . . . . . . . . . . . . . . . . . . A-4
CELL-DYN Consumables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-5
Appendix B . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-1
Appendix C . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-1
Error Message Logsheet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-2
Carryover Worksheet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-2
CELL-DYN Lyse Reagent Log . . . . . . . . . . . . . . . . . . . . . . . . . C-3
CELL-DYN Diluent Reagent Log . . . . . . . . . . . . . . . . . . . . . . . C-4
CELL-DYN Detergent Reagent Log . . . . . . . . . . . . . . . . . . . . . C-5
Enter Factor Open Mode Whole Blood Calibration
Worksheet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-6
Enter Factor Pre-Dilute Mode Whole Blood Calibration
Worksheet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-7
CELL-DYN 1800 Pre-Calibration Procedures Check List. . . . . . . . . . . . . . C-8
Appendix D . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-1
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-3
Bar Code Function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-4
Understanding the Label’s Code. . . . . . . . . . . . . . . . . . . . . . . . . . . . D-4

9140390E—June 2008
Bar Code Types and Characteristics. . . . . . . . . . . . . . . . . . . . . . . . . D-5
Code 39. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-5
Code 128. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-5
Interleaved 2 of 5 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-5
Codabar. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-5
Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-7
Bar Code Label Formats . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-7
Bar Code Label Characters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-8
Bar Code Check Digit Formats. . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-9
Bar Code Label Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-10
Bar Code Label Placement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-11
CELL-DYN Bar Code Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-11
Setup Information for Check Digits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-13
References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-15
Appendix E . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-1
Appendix F. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F-1
Normal Sample Guideline: The Rule of Three. . . . . . . . . . . . . . . . . F-1
Assay Verification Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F-1
Establishing Mean Values for Commercial QC Materials . . . . . . . . . . . . . . F-3
Establishing the Mean. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F-3
References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F-5
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Index-1

9140390E—June 2008
List of Figures
Use or Function
Figure 1.1 CELL-DYN 1800 System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
Figure 1.2 Front View, Version A . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7
Figure 1.3 Front View, Version B . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8
Figure 1.4 Sampling Section and Flow Panel . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9
Figure 1.5 Lower Left Side Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-12
Figure 1.6 Rear Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-14
Figure 1.7 Right Side Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-15
Figure 1.8 LCD Screen / Membrane Keyboard . . . . . . . . . . . . . . . . . . . . . . . . 1-17
Installation Procedures and Special Requirements

Figure 2.1 Parallel Interface Port Connector . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8
Figure 2.2 Reagent Inlet Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-10
Figure 2.3 Tubing and Container Installed. . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11
Figure 2.4 Diluent Normally Closed Valve . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-12
Figure 2.5 Diluent Syringe Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-13
Figure 2.6 CELL-DYN 1800 Front Covers, Version A . . . . . . . . . . . . . . . . . . 2-14
Figure 2.7 CELL-DYN 1800 Front Covers, Version B . . . . . . . . . . . . . . . . . . 2-15
Figure 2.8 Flow Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-16
Principles of Operation
Figure 3.1 Regional Alerts and Possible Causes . . . . . . . . . . . . . . . . . . . . . . . 3-31
Operating Instructions
Figure 5.1 LCD Screen / Membrane keyboard . . . . . . . . . . . . . . . . . . . . . . . . . 5-5
Figure 5.2 MAIN MENU Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-7
Figure 5.3 MAIN MENU Hierarchy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-8
Figure 5.4 SETUP Menu Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-11
Figure 5.5 SETUP Menu Hierarchy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-12
Figure 5.6 SETUP Screen–Printer Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-13
Figure 5.7 DATE/TIME Setup Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-14
Figure 5.8 AUTO START-UP Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-16
Figure 5.9 AUTO SHUTDOWN Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-17
Figure 5.10 PATIENT LIMITS Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-18
Figure 5.11 PATIENT LIMITS Menu Hierarchy . . . . . . . . . . . . . . . . . . . . . . . 5-19
Figure 5.12 PATIENT LIMITS Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-20
Figure 5.13 PANIC LIMITS Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-21
Figure 5.14 REAGENT LOG Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-22
CELL-DYN® 1800 System Operator’s Manual List of Figures–1

9140390D—January 2006
Figure 5.15 REAGENT LOG Menu Hierarchy . . . . . . . . . . . . . . . . . . . . . . . . . 5-23
Figure 5.16 DILUENT LOG Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-24
Figure 5.17 QC SETUP Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-25
Figure 5.18 QUALITY CONTROL SETUP Hierarchy. . . . . . . . . . . . . . . . . . . 5-26
Figure 5.19 X-B SETUP Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-27
Figure 5.20 LAB ID SETUP Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-29
Figure 5.21 LOW CONTROL Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-30
Figure 5.22 LOT NUMBER SETUP Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-31
Figure 5.23 EXPIRATION DATE SETUP Screen . . . . . . . . . . . . . . . . . . . . . . 5-32
Figure 5.24 WESTGARD® RULE SETUP Screen. . . . . . . . . . . . . . . . . . . . . . 5-33
Figure 5.25 RANGE ENTRY SETUP Screen . . . . . . . . . . . . . . . . . . . . . . . . . . 5-34
Figure 5.26 MEAN/LIMITS SETUP Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-35
Figure 5.27 REPLICATES Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-36
Figure 5.28 REPLICATE FILE SETUP Screen . . . . . . . . . . . . . . . . . . . . . . . . 5-37
Figure 5.29 REPLICATE ID SETUP Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . 5-38
Figure 5.30 COMPUTER SETUP Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-39
Figure 5.31 UNITS SELECTION Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-40
Figure 5.32 HELP Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-41
Figure 5.33 FAULT LOG Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-42
Figure 5.34 RUN Menu Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-46
Figure 5.35 RUN MENU Hierarchy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-47
Figure 5.36 OPERATOR ID Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-53
Figure 5.37 SPECIMEN TYPE Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-54
Figure 5.38 PATIENT SPECIMEN ID ENTRY Screen . . . . . . . . . . . . . . . . . . 5-55
Figure 5.39 Scan of Bar Code Label . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-56
Figure 5.40 Running a Specimen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-57
Figure 5.41 Running a Specimen—Pre-Dilute Mode (steps 1–4) . . . . . . . . . . . 5-59
Figure 5.44 Removing a Pre-Diluted Solution from the Pre-Mixing Cup . . . . . 5-62
Figure 5.45 DATA LOG Menu Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-64
Figure 5.46 DATA LOG MENU Hierarchy . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-65
Figure 5.47 EDIT SPECIMEN ID Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-66
Figure 5.48 DISPLAY SPECIMEN Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-67
Figure 5.49 DATA LOG SEARCH Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-68
Figure 5.50 DATA LOG SEARCH Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-69
Figure 5.51 Reject from X-B/Accept to X-B Screen . . . . . . . . . . . . . . . . . . . . . 5-70
Figure 5.52 TRANSMIT DATA Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-71
Figure 5.53 CONFIRM/CANCEL DATA TRANSMIT Screen . . . . . . . . . . . . 5-72
Figure 5.54 PRINT DATALOG Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-73
List of Figures–2 CELL-DYN® 1800 System Operator’s Manual

9140390D—January 2006
Calibration Procedures
Figure 6.1 CALIBRATION Menu Hierarchy . . . . . . . . . . . . . . . . . . . . . . . . . . 6-7
Figure 6.2 CALIBRATION Menu Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-9
Figure 6.3 PRE-DILUTE Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-10
Figure 6.4 AUTO CAL SELECT Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-11
Figure 6.5 ENTER FACTOR Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-12
Figure 6.6 1/250 DILUTION Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-27
Figure 6.7 CELL-DYN Counting Cup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-28
Figure 6.8 1/250 DILUTION Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-29
Figure 6.9 CELL-DYN Counting Cup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-30
Figure 6.10 10mL DISPENSE Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-31
Figure 6.11 CELL-DYN Counting Cup with Micropipette . . . . . . . . . . . . . . . . 6-32
Figure 6.12 10mL DISPENSE Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-33
Figure 6.13 CELL-DYN Counting Cup with Micropipette . . . . . . . . . . . . . . . . 6-35
Service and Maintenance

Figure 9.1 CELL-DYN 1800 Flow Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-5
Figure 9.2 Maintenance Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-10
Figure 9.3 SPECIAL PROTOCOLS Menu Flowchart . . . . . . . . . . . . . . . . . . 9-12
Figure 9.4 Prolonged Shutdown Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-17
Figure 9.5 Performing Auto Clean Procedure (steps 1–6) . . . . . . . . . . . . . . . . 9-20
Figure 9.6 Performing Auto Clean Procedure (steps 7–11) . . . . . . . . . . . . . . . 9-21
Figure 9.7 Cleaning the Aspiration Probe Exterior . . . . . . . . . . . . . . . . . . . . . 9-23
Figure 9.8 Rinsing the Lyse Inlet Line (steps 1–6) . . . . . . . . . . . . . . . . . . . . . 9-26
Figure 9.9 Rinsing the Lyse Inlet Line (steps 7–12) . . . . . . . . . . . . . . . . . . . . 9-27
Figure 9.10 Rinsing the Reagent Inlet Line (steps 1–6). . . . . . . . . . . . . . . . . . . 9-29
Figure 9.11 Rinsing the Reagent Inlet Line (steps 7–12). . . . . . . . . . . . . . . . . . 9-30
Figure 9.12 Cleaning the HGB Flow Cell (steps 1–5) . . . . . . . . . . . . . . . . . . . . 9-36
Figure 9.13 Cleaning the HGB Flow Cell (steps 6–8) . . . . . . . . . . . . . . . . . . . . 9-37
Figure 9.14 Cleaning the HGB Flow Cell (steps 9–12) . . . . . . . . . . . . . . . . . . . 9-38
Figure 9.15 Cleaning the Pre-Mixing Cup (steps 1–2) . . . . . . . . . . . . . . . . . . . 9-39
Figure 9.16 Cleaning the Pre-Mixing Cup (steps 3–7) . . . . . . . . . . . . . . . . . . . 9-40
Figure 9.17 Waste Outlet Tubing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-41
Figure 9.18 Instrument Waste Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-41
Figure 9.19 Instrument Waste Drainage. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-42
Figure 9.20 Dummy Plug into SENSOR Connector Port . . . . . . . . . . . . . . . . . 9-42
Figure 9.21 Removing the Aperture Plates (steps 1–3) . . . . . . . . . . . . . . . . . . . 9-44
Figure 9.22 Removing the Aperture Plates (steps 4–8) . . . . . . . . . . . . . . . . . . . 9-45
Figure 9.23 Cleaning the Aperture Plates (steps 1–5) . . . . . . . . . . . . . . . . . . . . 9-46
Figure 9.24 Installing the RBC/PLT Aperture Plate (steps 1–2) . . . . . . . . . . . . 9-47
Figure 9.25 Installing the WBC Aperture Plate (steps 1–2). . . . . . . . . . . . . . . . 9-48
Figure 9.26 Filling the Transducers (steps 1–5). . . . . . . . . . . . . . . . . . . . . . . . . 9-49

9140390D—January 2006
Figure 9.27 Filling the Transducers (steps 6–9). . . . . . . . . . . . . . . . . . . . . . . . . 9-50
Figure 9.28 Cleaning the Aspiration Probe Interior Version A (steps 1–3). . . . 9-52
Figure 9.31 Removing the Aspiration Probe Version A (steps 1–5) . . . . . . . . . 9-55
Figure 9.32 Installing the Aspiration Probe Version A (steps 1–5) . . . . . . . . . . 9-56
Figure 9.33 Installing the Aspiration Probe Version A (steps 6–8) . . . . . . . . . . 9-57
Figure 9.34 Cleaning the Aspiration Probe Interior Version B (steps 1–3). . . . 9-58
Figure 9.37 Removing the Aspiration Probe Version B (steps 1–5) . . . . . . . . . 9-61
Figure 9.38 Installing the Aspiration Probe Version B (steps 1–5) . . . . . . . . . . 9-62
Figure 9.39 Installing the Aspiration Probe Version B (steps 6–8) . . . . . . . . . . 9-63
Figure 9.40 Removing the Aspiration Probe Wash Block (steps 1–3) . . . . . . . 9-65
Figure 9.41 Cleaning the Aspiration Probe Wash Block (steps 1–4). . . . . . . . . 9-66
Figure 9.42 Installing the Aspiration Probe Wash Block (steps 1–4) . . . . . . . . 9-67
Figure 9.43 Installing the Aspiration Probe Wash Block (steps 5–7) . . . . . . . . 9-68
Figure 9.44 CELL-DYN 1800 Syringes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-69
Figure 9.45 Removing the Diluent Syringe (steps 1–4). . . . . . . . . . . . . . . . . . . 9-70
Figure 9.46 Removing the Diluent Syringe (steps 5–8). . . . . . . . . . . . . . . . . . . 9-71
Figure 9.47 Cleaning the Diluent Syringe (steps 1–2) . . . . . . . . . . . . . . . . . . . . 9-72
Figure 9.48 Diluent Syringe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-73
Figure 9.49 Installing the Diluent Syringe (steps 1–6) . . . . . . . . . . . . . . . . . . . 9-74
Figure 9.50 Installing the Diluent Syringe (steps 7–11) . . . . . . . . . . . . . . . . . . 9-75
Figure 9.51 Replacing the Diluent Syringe (steps 1–6) . . . . . . . . . . . . . . . . . . . 9-77
Figure 9.52 Replacing the Diluent Syringe (steps 7–12) . . . . . . . . . . . . . . . . . . 9-78
Figure 9.53 Removing the Sample Syringe (steps 1–4). . . . . . . . . . . . . . . . . . . 9-79
Figure 9.54 Removing the Sample Syringe (steps 5–8). . . . . . . . . . . . . . . . . . . 9-80
Figure 9.55 Cleaning the Sample Syringe (steps 1–2) . . . . . . . . . . . . . . . . . . . . 9-81
Figure 9.56 Installing the Sample Syringe (steps 1–4) . . . . . . . . . . . . . . . . . . . 9-82
Figure 9.57 Installing the Sample Syringe (steps 5–9) . . . . . . . . . . . . . . . . . . . 9-83
Figure 9.58 Removing the Lyse Syringe (steps 1–4) . . . . . . . . . . . . . . . . . . . . . 9-84
Figure 9.59 Removing the Lyse Syringe (steps 5–8) . . . . . . . . . . . . . . . . . . . . . 9-85
Figure 9.60 Cleaning the Lyse Syringe (steps 1–4) . . . . . . . . . . . . . . . . . . . . . . 9-86
Figure 9.61 Installing the Lyse Syringe (steps 1–6). . . . . . . . . . . . . . . . . . . . . . 9-87
Figure 9.62 Installing the Lyse Syringe (steps 7–11). . . . . . . . . . . . . . . . . . . . . 9-88
Figure 9.63 Checking for Liquid in the Vacuum Accumulator (steps 1–4). . . . 9-89
Figure 9.64 Draining and Cleaning the Vacuum Accumulator (steps 1–4) . . . . 9-90
Figure 9.65 Draining and Cleaning the Vacuum Accumulator (steps 5–8) . . . . 9-91
Figure 9.66 Cleaning the Bar Code Scanner Lens (steps 1–3). . . . . . . . . . . . . . 9-92
Figure 9.67 Cleaning the “Y” Fitting (steps 1–5) . . . . . . . . . . . . . . . . . . . . . . . 9-94
Figure 9.68 Cleaning the “Y” Fitting (steps 6–11) . . . . . . . . . . . . . . . . . . . . . . 9-95
Figure 9.69 Cleaning the “Y” Fitting (steps 12–17) . . . . . . . . . . . . . . . . . . . . . 9-96

9140390D—January 2006
Figure 9.70 Supplemental Aperture Cleaning Procedure (steps 1–2) . . . . . . . . 9-97
Figure 9.71 Supplemental Aperture Cleaning Procedure (steps 3–7) . . . . . . . . 9-98
Figure 9.72 Supplemental Aperture Cleaning Procedure (steps 8–12) . . . . . . . 9-99
Figure 9.73 Cleaning the Flow System (steps 1–5) . . . . . . . . . . . . . . . . . . . . . 9-101
Figure 9.74 Cleaning Tubing and Instrument Exterior (steps 1–4) . . . . . . . . . 9-102
Figure 9.75 Cleaning Tubing and Instrument Exterior (steps 5–8) . . . . . . . . . 9-103
Troubleshooting and Diagnostics

Figure 10.1 DIAGNOSTICS Menu Hierarchy. . . . . . . . . . . . . . . . . . . . . . . . . . 10-4
Figure 10.2 CELL-DYN 1800 Flow Panel Diagram . . . . . . . . . . . . . . . . . . . . 10-16
Quality Control
Figure 11.1 QUALITY CONTROL Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-6
Figure 11.2 QUALITY CONTROL Menu Hierarchy . . . . . . . . . . . . . . . . . . . . 11-7
Figure 11.3 X-B FILE (Show Graphs) Screen . . . . . . . . . . . . . . . . . . . . . . . . . 11-10
Figure 11.4 X-B FILE (Show Data) Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-11
Figure 11.5 VIEW QC LOG (Low Control) Screen . . . . . . . . . . . . . . . . . . . . 11-12
Figure 11.6 VIEW QC LOG (Normal Control) Screen . . . . . . . . . . . . . . . . . . 11-13
Figure 11.7 VIEW QC LOG (High Control) Screen . . . . . . . . . . . . . . . . . . . . 11-14
Figure 11.8 VIEW QC LOG (Replicates) Screen . . . . . . . . . . . . . . . . . . . . . . 11-15
Figure 11.9 LEVEY-JENNINGS Screen – WBC/PLT Parameters . . . . . . . . . 11-16
Figure 11.10 LEVEY-JENNINGS Screen – RBC Parameters . . . . . . . . . . . . . 11-17
Figure 11.11 VIEW QC LOG (Accept Specimen) Screen. . . . . . . . . . . . . . . . . 11-18
Figure 11.12 PURGE QC LOG Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-19
Figure 11.13 WRITE QC TO DISK Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-20
Figure 11.14 VIEW QC LOG (Delete Specimen) Screen . . . . . . . . . . . . . . . . . 11-21
Figure 11.15 QC TYPE Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-23
Figure 11.16 VIEW QC LOG (Reject Specimen) Screen . . . . . . . . . . . . . . . . . 11-25
Figure 11.17 VIEW QC LOG (Delete Specimen) Screen . . . . . . . . . . . . . . . . . 11-26
Figure 11.18 PURGE QC LOG (Purge Specimen) Screen . . . . . . . . . . . . . . . . 11-27
Figure 11.19 X-B SETUP (Target Value) Screen . . . . . . . . . . . . . . . . . . . . . . . 11-31
Bar Codes
Figure D.1 Bar Code Label Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-10
Figure D.2 Tube Labeling Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-11
Sample Reports
Figure E.1 Sample Data Log Report. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-1
Figure E.2 Sample QC Log File Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-1
Figure E.3 Sample Specimen Data Report (Normal Specimen). . . . . . . . . . . . . E-2
Figure E.4 Sample Specimen Data Report (Abnormal Specimen). . . . . . . . . . . E-3
Figure E.5 Sample Levey-Jennings Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-4
Figure E.6 Sample Fault Log Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-5

9140390E—June 2008
NOTES

9140390D—January 2006
List of Tables

Table 2.1 Instrument Power Source Requirements. . . . . . . . . . . . . . . . . . . . . . 2-6
Table 3.1 Parameter Reporting Terms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7
Performance Characteristics and Specifications

Table 4.1 Physical Dimensions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
Table 4.2 Dimensions after Packaging for Shipment . . . . . . . . . . . . . . . . . . . . 4-3
Table 4.3 Power Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5
Table 4.4 Character Count for Bar Code Labels. . . . . . . . . . . . . . . . . . . . . . . . 4-8
Table 4.5 Linearity Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-14
Table 4.6 Carryover—Open and Pre-Dilute Modes . . . . . . . . . . . . . . . . . . . . 4-14
Table 4.7 Within-Sample Precision of the Hemogram Parameters . . . . . . . . 4-15
Table 4.8 Precision of the WBC Differential Parameters. . . . . . . . . . . . . . . . 4-15
Table 4.9 Whole Blood Correlation Results . . . . . . . . . . . . . . . . . . . . . . . . . . 4-16
Table 4.10 CELL-DYN 1800 Microscopy . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-17
Reference Tables
Table B-1: Potential Causes of Erroneous Results with Automated
Cell Counters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-1
Table B-2: Reference Intervals (Normal Values) for Automated
Blood Counters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-3
CELL-DYN® 1800 System Operator’s Manual List of Tables–1

9140390E—June 2008
NOTES
List of Tables–2 CELL-DYN® 1800 System Operator’s Manual

9140390D—January 2006
How to Use This Manual
Manual Organization
The major sections of the manual and their contents are as follows:
Front Matter
The pages following the Master Table of Contents contain an Introduction that
includes customer support information, and proprietary, patent, and trademark
statements.
Section 1: Use or Function

This section provides an overall description of the system. It names the major
system components and describes their uses or functions.
Section 2: Installation Procedures and Special Requirements

This section provides detailed instructions for system setup and configuration. It
explains proper location, requirements, and steps for installation.
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.
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 explains the procedures for daily startup and shutdown, sample
collection and handling, and routine operation of the instrument including use of
the data log and sample analysis.
Section 6: Calibration Procedures

This section describes the calibration process. It discusses calibration materials,
guidelines, and methods.
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.
CELL-DYN® 1800 System Operator’s Manual How to Use This Manual-1

9140390A—March 2003
Section 9: Service and Maintenance
This section discusses routine maintenance and cleaning on a daily, weekly,
monthly, and as required basis. Also included are detailed instructions for
removing and cleaning certain 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. This
section also includes Calibration Troubleshooting and Printer Troubleshooting
sections.
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.
Section 12: Printers

This section reviews the setup and use of a printer for text and graphics output.
Bibliography
This section contains a listing of reference sources for the user who wishes more
background information about the system or a topic discussed in this manual.
Glossary
This appendix contains the words and terms used in hematology as they apply to
the CELL-DYN 1800, as well as terms that describe the actual operation, principles
of operation, and components of the instrument.
Appendices
Appendix A
This appendix lists the part numbers of components, accessories, controls,
reagents, and consumables associated with the CELL-DYN 1800 System for user
convenience when placing orders.
Appendix B
This appendix contains a table on potential causes of erroneous results, and a
reference table which relates to default values (Patient Limits).
Appendix C
This appendix contains log and worksheet templates you can copy and use in your
laboratory.
Appendix D
This appendix contains information on installation, setup and use of the optional
bar code scanner.
How to Use This Manual-2 CELL-DYN® 1800 System Operator’s Manual

9140390A—March 2003
Appendix E
This appendix contains Sample Data Log, QC Log, Levey-Jennings, Fault Log,
and Specimen Data Reports.
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.

9140390A—March 2003
Text Conventions Used in This Manual
In this manual, procedural instructions are explained in logical groups, using
numbered steps. Illustrations and drawings appear where they are useful to the
explanation. Text conventions are as follows:
Menu Name
The menu name is printed in bold, uppercase, sans serif letters; for example,
SETUP menu.
Softkeys (Screen Label Keys)

Directly below the screen is a row of eight unlabeled, pressure-sensitive softkeys
that correspond to screen labels or menu options found on the lower segment of the
display screen. Pressing one of these softkeys initiates the action specified by a
corresponding screen label. Screen labels are shown in bold, uppercase, sans serif
letters enclosed in brackets; for example, [QUALITY CONTROL].
Data Entry Field Names

Fields that accept data entered by the Operator have their names shown in regular,
mixed-case font enclosed within carats < >.
PC Keyboard (Keys)
In some cases, the Operator must utilize the keys on the PC keyboard. Pressing the
F1 through F8 function keys will initiate the action specified by a corresponding
screen label. The alphanumeric keys (including punctuation symbols) may be used
to enter specimen identification in a data entry field. Additional function keys such
as the [ ] Enter key and the [ESC] key may be utilized as well. Special function
keys, such as the arrow keys, may appear as a symbol substituted for the word.
Instructions for special function keys will read; for example “Press the [↑] arrow
key.”
The Print Screen key on the PC keyboard can be used to print the screen as it is
displayed on the LCD. This allows the Operator an option to print the screen when
the [PRINT] key is not available.
NOTE: Press the Print Screen key only when the screen is at a static state.
Pressing the key during an instrument action (e.g., Run cycle) may not
print the screen properly.
Instrument Status
Instrument status is displayed in uppercase, regular letters; for example, READY.
Screen Messages
Screen messages or other screen displays will appear in bold, Courier letters, for
example, Waste Full.

9140390A—March 2003
Information Presentation Examples
Menu name Bold, UPPERCASE, sans serif font SETUP menu

MAIN MENU
DATA LOG menu
Softkeys Bold, UPPERCASE, sans serif font, enclosed [QUALITY CONTROL]

(Screen Label Keys) within brackets [ ] [DATA LOG]
Field names Regular, Mixed-Case, enclosed within carats < > <Spec ID>
PC Keyboard (Keys) Regular, Mixed-Case, enclosed within brackets [ ] [←] or [Esc]
Instrument Status Regular, UPPERCASE READY
BUSY
Screen Message Bold, Courier Font Waste Full

9140390A—March 2003
Safety
Throughout the manual, signal words and icons appear where the nature of the
information warrants special attention.
NOTE: The note signal word appears adjacent to an important point of
information that is relevant to the current subject matter.
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 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. Examples of the standard warning conventions, including signal words
(e.g., Caution) and symbols are shown below.
CAUTION: Do not handle Solution Container unless properly protected.

VORSICHT: Die Reagenzbehlter nur ordnungsgem gesichert bewegen.
ATTENTION : Ne pas manipuler le flacon de solution sans protection
approprie.
PRECAUCIN: no maneje el recipiente de la soluci n a menos que est protegido adecuadamente.
ATTENZIONE: Non maneggiare il recipiente della soluzione se non si
protetti in modo adeguato.
ATENO: no manipular o recipiente da soluo sem estar devidamente protegido.
VIGTIGT: Beholderen med oplsning m ikke hndteres, medmindre brugeren er korrekt beskyttet.
VIKTIGT: Anvnd skyddsklder vid hantering av lsningsbehllarna.
ΠΡΟΣΟΧΗ: Χρησιμοποιείτε το Δοχείο Ρυθμιστικού διαλύματος μόνο αφού λάβετε τις
κατάλληλες προφυλάξεις.
UPOZORNĚNÍ: Nemanipulujte s nádobou obsahující roztok, pokud není řádně zabezpečena.
Consult instructions for use. / Siehe Packungsbeilage. / Consulter les instructions
d’utilisation. / Consulte las instrucciones de uso. / Consultare le istruzioni per l’uso. /
Consultar as instrues de utilizao. / Se brugsanvisningen. / Ls tillhrande
dokumentation. / Συμβουλευτείτε τις οδηγίες χρήσης. / Viz návod k použití.
PN 9230334
Reagent Handling (Inlet) Label, Left Panel
For detailed safety information, refer to Section 7: Operational Precautions and

Limitations, and Section 8: Hazards in this manual.

9140390C—March 2004
Revision Status
Document Control Pages Revised and

Revision Date Section(s) Revised
Number(s) Added
New Release March/2003 N/A N/A
Ref 07H80-01
text 9140390A
9140390B December/2003 Introduction All
Master Table of Contents All
List of Figures All
List of Tables All
How To Use This Manual p. 7
1: Use or Function pp. 1-14 and 1-15
2: Installation pp. 2-3; 2-4; 2-10; 2-13
Procedures and Special
Requirements
3: Principles of pp. 3-8; 3-17; 3-19
Operation
4: Performance p. 4-9
Characteristics and
Specifications
5: Operating Instructions All
6: Calibration pp. 6-5; 6-7; 6-24; 6-45
7: Operational p. 7-2
Precautions and
Limitations
9: Service and All
Maintenance
10: Troubleshooting and pp. 10-4; 10-13; 10-17
Diagnostics through 10-19; 10-24
through 10-29; 10-38
and 10-39
11: Quality Control All
Bibliography p. 1
Glossary pp. 5; 8; 9; 12 through 14
Appendix A p. 1
Appendix C All
Index All

9140390B—December 2003
Number(s) Added
9140390C March/2004 Introduction pp. i; iii and iv; vi
List of Figures All
How To Use This Manual pp. 6; 8 through 10
1: Use or Function pp. 1-5; 1-7 through 1-20
2: Installation pp. 2-4; 2-6; 2-8; 2-14
Procedures and Special through 2-17; 2-19 and
Requirements 2-20
3: Principles of p. 3-6
Operation
4: Performance pp. 4-1; 4-3; 4-8; 4-13
Characteristics and
Specifications
5: Operating Instructions pp. 5-33; 5-72
6: Calibration pp. 6-7; 6-12 through
6-14; 6-20; 6-22; 6-24;
6-38; 6-40; 6-42; 6-44
8: Hazards p. 8-4
9: Service and pp. 9-1; 9-5; 9-33
Maintenance through 9-41; 9-44
through 9-46; 9-49 and
9-50; 9-52 through 9-106
10: Troubleshooting and pp. 10-12 through 10-14;
Diagnostics 10-16 and 10-17; 10-19
through 10-29; 10-32
and 10-33; 10-36; 10-38
through 10-41; 10-43;
10-49; 10-52 and 10-53;
10-56 and 10-57; 10-59;
10-61
11: Quality Control pp. 11-3; 11-5; 11-26;
11-37 and 11-38
Appendix A pp. 1; 4 and 5
Appendix B p. 3
Appendix C pp. 6 through 8
Appendix D p. 9
Index All

9140390C—March 2004
Number(s) Added
9140390D January/2006 Introduction pp. i and ii; iv through vi
List of Figures All
List of Tables All
How To Use This Manual pp. 9 and 10
1: Use or Function p. 1-20
3: Principles of pp. 3-23 through 3-26;
Operation 3-29; 3-33
4: Performance pp. 4-5; 4-13; 4-15
Characteristics and through 4-20
Specifications
5: Operating Instructions pp. 5-1; 5-51 through
5-74; 5-79
6: Calibration pp. 6-1; 6-4 through 6-6;
6-43; 6-45
8: Hazards p. 8-3
9: Service and pp. 9-53; 9-58; 9-60;
Maintenance 9-67; 9-72; 9-76; 9-85;
9-91
10: Troubleshooting and pp. 10-17; 10-25; 10-39
Diagnostics
11: Quality Control p. 11-1
12: Printers p. 12-1
Bibliography pp. 1 through 3
Glossary pp. 2 and 3; 9; 12 and 13
Appendix A p. 2
Appendix B pp. 1 and 2
Index All
9140390E June/2008 Introduction pp. i; iv through viii; ix
and x
List of Figures p. 5
List of Tables p. 1
How To Use This Manual pp. 9 through 12

9140390E—June 2008
Number(s) Added
2: Installation pp. 4; 16
Requirements
4: Performance pp.9; 17
Characteristics and
Specifications
5: Operating Instructions p. 52
6: Calibration pp. 1; 3; 5; 14 through 18
7: Operational All
Precautions and
Limitations
9: Service and p. 22; 80 and 81
Maintenance
10: Troubleshooting and pp. 30; 55 and 56
Diagnostics
11: Quality Control pp. 3 through 38
Glossary pp. 3 and 4; 9
Appendix A All
Appendix B All
Appendix C All
Appendix D All
Appendix E All
Appendix F All
Index All

9140390E—June 2008
Revision Log
Instructions: Use this log to provide a permanent record to verify that revised sections(s) and/or page(s) have
been added to this manual.
1. Enter the document control number of the revised section. This number can be found in the footer. Make
an entry for each section you receive and place in the manual.
2. Record the revision date, also found in the footer.
3. Enter the software version of your CELL-DYN 1800 System. This information is displayed on the MAIN
MENU screen.
4. Write your initials or signature to verify that you have placed the revised page(s) in the manual.
5. Enter the date that you added the revised section to the manual.
Document Software Revision Date

Revision Date
Control No. Version Incorporated by Incorporated

9140390E—June 2008
NOTES

9140390E—June 2008
Section 1 Use or Function
Section 1 Use or Function
Overview
The CELL-DYN 1800 is an automated, multiparameter hematology analyzer

designed for in vitro diagnostic use in the clinical laboratory. It is menu-driven,
controlled by a microprocessor, and comes in an Open System model.
Figure 1.1 CELL-DYN 1800 System
The CELL-DYN 1800 is built with an open sampling section. The instrument
aspirates blood from an open specimen tube held up to the sample aspiration probe.
The CELL-DYN 1800 accepts specimens from several types of containers, all of
which are to be prepared with di-potassium EDTA anticoagulant. See the Sampling
Section description later in this section for detailed acceptable container
information.
CELL-DYN® 1800 System Operator’s Manual 1-1

9140390A—March 2003
Use or Function
Overview Section 1
NOTES
1-2 CELL-DYN® 1800 System Operator’s Manual

9140390A—March 2003
Use or Function
Section 1 Intended Use
Intended Use

intended for in vitro diagnostic use in the clinical laboratory.

9140390A—March 2003
Use or Function
Intended Use Section 1
Indications for Use

The CELL-DYN 1800 is designed to classify the following formed elements of
EDTA-anticoagulated blood:
White Blood Cell Parameters

• WBC—White Blood Cell or leukocyte count
• GRAN—Granulocyte absolute count
• %GRAN—Granulocyte percent
• LYM—Lymphocyte absolute count
• %LYM—Lymphocyte percent
• MID—Mid-range absolute count
• %MID—Mid-range percent
Platelet Parameters
• PLT—Platelet or thrombocyte count
• MPV—Mean Platelet Volume
• PDW†—Platelet Distribution Width
• PCT†—Plateletcrit
Red Blood Cell Parameters

• RBC—Red Blood Cell or erythrocyte count
• HCT—Hematocrit
• MCV—Mean Cell Volume
• RDW—Red Cell Distribution Width
Hemoglobin Parameters
• HGB—Hemoglobin concentration
• MCH—Mean Cell Hemoglobin
• MCHC—Mean Cell Hemoglobin Concentration
† Clinical significance has not been established for these parameters; therefore,
they are not reportable in the U.S.

9140390A—March 2003
Use or Function
Section 1 System Components
System Components
The CELL-DYN 1800, a single unit instrument, is described below.

The instrument contains the hardware to aspirate, dilute, and analyze a whole blood
specimen. The unit contains the following major components:
• Front Panel
— Upper Front Cover
— Three LED (Light Emitting Diode) Indicator Lights: READY, BUSY, and
FAULT
— Lower Front Cover or Display Bezel Cover
— Sample Aspiration Probe
— Touch Plate
• Left Side Panel
— Diluent Inlet Tubing Connector
— Waste Outlet Tubing Connector
— Waste Sensor Connector
— Lyse Inlet Tubing Connector
— Detergent Inlet Tubing Connector
— Normally Closed Valve
— Lyse Syringe
— Diluent Syringe
— Sample Syringe
• Right Side Panel
— Main Power Switch
— PC Keyboard Connector
— Two RS-232 Serial Interface Connectors
— Parallel Interface Connector
— Floppy Disk Drive
• Rear Panel
— Power Cord Connector
• Computer Section
— Liquid Crystal Display (LCD) Screen/Membrane Keypad
— Audio

9140390C—March 2004
Use or Function
System Components Section 1
The printer and bar code scanner, both separate optional components, are described
in Section 12: Printers and in Appendix A: Parts and Accessories, respectively.
NOTE: In this manual, the terms left and right are used as you would use them if
you were facing the instrument. The front is the side you are facing, and
the rear is the side farthest away from you.

9140390A—March 2003
Use or Function
Front Panel, Version A

The CD1800 instrument has one of two Front Cover configurations. Version A,
where the covers can be removed or opened and Version B, where the cover and
Bezel Display Cover can be opened.
1 Upper Front Cover

2 LED Indicator Lights
3 Lower Front Cover 2
4 Sample Aspiration
Probe
5 Touch Plate
1
4
3
5
Figure 1.2 Front View, Version A
Upper Front Cover

The Upper Front Cover protects the upper Flow Panel. Access to the upper flow
panel is necessary to view the operation of the flow panel components and to
perform certain maintenance procedures. Always leave the Upper Front Cover
closed during operation to reduce the electronic noise level.
LED Indicator Lights

Three Light Emitting Diode (LED) indicator lights show the current operating state
of the instrument. These lights are labeled READY, BUSY, and FAULT.
Lower Front Cover

The Lower Front Cover protects the lower section of the Flow Panel. Access to the
lower flow panel is necessary to view the action of the lower flow panel
components and to perform certain maintenance procedures. Always leave the
lower front cover on during operation to reduce the electronic noise level.
Sample Aspiration Probe

The Sample Aspiration Probe is used to aspirate whole blood from an opened
collection tube. After each aspiration, waste liquid on the outside of the probe is
removed as the probe is drawn through the Wash Block.
Touch Plate
The Touch Plate is a spring-loaded plate located directly behind the sample
aspiration probe. Pressing the Touch Plate starts the selected run cycle.

9140390C—March 2004
Use or Function
Front Panel, Version B

1 Upper Front Cover
2 LED Indicator Lights
3 Display Bezel Cover 2
4 Sample Aspiration
Probe 3
5 Touch Plate
1
Figure 1.3 Front View, Version B
Upper Front Cover

The Upper Front Cover protects the left section of the flow panel. Access to the left
section is necessary to view the operation of the flow panel components and to
perform certain maintenance procedures. Always leave the Upper Front Cover
closed during operation to reduce the electronic noise level.
LED Indicator Lights

Three Light Emitting Diode (LED) indicator lights show the current operating state
of the instrument. These lights are labeled READY, BUSY, AND FAULT.
Display Bezel Cover

The Display Bezel Cover protects the right section of the flow panel. Access to the
right section is necessary to perform certain maintenance procedures. Always leave
the Display Bezel Cover closed during operation to reduce the electronic noise
level.
Sample Aspiration Probe

The Sample Aspiration Probe is used to aspirate whole blood from an opened
collection tube. After each aspiration, waste liquid on the outside of the probe is
removed as the probe is drawn through the Wash Block.
Touch Plate
The Touch Plate is a spring-loaded plate located directly behind the sample
aspiration probe. Pressing the Touch Plate starts the selected run cycle.

9140390C—March 2004
Use or Function
Sampling Section
1 Diluent Normally
Closed Valve
2 Sample Aspiration 1 2
Probe
3 Wash Block 11
4 von Behrens RBC/
PLT Transducer 3
Assembly
5 RBC/PLT Metering
Assembly
6 Start Switch
7 WBC Metering
Assembly
10
8 HGB Flow Cell
Assembly 9 4
9 Pre-Mixing Cup
10 von Behrens WBC
Transducer Assembly
11 Pre-Amplifier Module
12 Vent Lines
12 8 7 5 12
Figure 1.4 Sampling Section and Flow Panel

9140390C—March 2004
Use or Function
Specimen Tubes
Any size specimen tube with a cap can be used with the CELL-DYN 1800 Open
System. Specimen tubes must be used in accordance with the manufacturer’s
recommendation. Specimen tubes’ minimum specified volumes must meet or
exceed 50µL. This primarily impacts microtubes.
Probe Assembly
When the Operator holds a specimen tube up to the aspiration probe and presses
the touch plate to activate the run cycle, the probe aspirates a measured amount of
the sample. The probe then raises and rotates until it is positioned above the
Pre-Mixing Cup where the probe ejects a measured amount of the sample into the
Pre-Mixing Cup. The probe then aspirates the diluted solution from the Pre-Mixing
Cup and delivers the solution to the RBC/PLT Mixing Chamber for the second
dilution process.
Wash Block
After each aspiration, the probe assembly moves through the Wash Block which
rinses the outside of the probe with diluent. Used diluent is routed to the waste
container.
RBC/PLT Metering Assembly

The RBC/PLT Metering Assembly contains a precision-bore glass tube with a set
of optical detectors, one upper and one lower, mounted on it. It is used to meter a
fixed volume of the RBC/PLT dilution during the RBC/PLT measurement portion
of each cycle.
von Behrens RBC/PLT Transducer Assembly

• The von Behrens RBC/PLT Transducer Assembly contains the fluidics and
hardware required for accurate measurement of the diluted red blood cells
and platelets. The primary components of this assembly are:
• The RBC/PLT Transducer—The transducer contains two chambers. The
Mixing Chamber on the left is used to mix the RBC/PLT dilution. The
Counting Chamber on the right contains the divider plate used to prevent
cells that have traversed the aperture from recirculating into the sensing zone.
• Electrodes—There are two noncorrosive, electrically conductive plates, one
positively charged and one negatively charged. One electrode is located in
each transducer chamber. The electrodes conduct a constant current flow
through the aperture during the RBC/PLT measurement portion of each
cycle.
• RBC/PLT Aperture Plate—This plate is inserted into a slot between the two
transducer chambers. A jewel containing the aperture is heat-embedded into
the plate.

9140390C—March 2004
Use or Function
WBC Metering Assembly

The WBC Metering Assembly contains a precision-bore glass tube with a set of
optical detectors, one upper and one lower, mounted on it. It is used to meter a fixed
volume of WBC/HGB dilution during the WBC measurement portion of each
cycle.
von Behrens WBC Transducer Assembly

The von Behrens WBC Transducer Assembly contains the fluidics and hardware
required for accurate measurement of the diluted white blood cells. The primary
components of this assembly are:
• WBC Transducer—The transducer contains two chambers. The Mixing
Chamber on the left is used to mix the WBC/HGB dilution. The Counting
Chamber on the right contains the divider plate used to prevent cells that have
traversed the aperture from recirculating into the sensing zone.
• Electrodes—There are two noncorrosive, electrically conductive plates, one
positively charged and one negatively charged. One electrode is located in
each transducer chamber. The electrodes conduct a constant current flow
through the aperture during the WBC measurement portion of each cycle.
• WBC Aperture Plate—This plate is inserted into a slot between the two
transducer chambers. A jewel containing the aperture is heat embedded into
the plate.
HGB Flow Cell Assembly

The HGB Flow Cell Assembly contains the following components:
• A fully enclosed (light-tight), flow-through glass cuvette
• An LED light source
• An interference filter used to obtain the ICSH (International Committee for
Standardization in Hematology) recommended wavelength of 540 nm
(nanometers)
• A photodetector for measuring the light transmitted
Diluent Normally Closed Valve

The Diluent Normally Closed Valve on the Flow Panel prevents diluent from
escaping through the Wash Block in the event of a sudden power shutoff.

9140390C—March 2004
Use or Function
Left Side Panel

The components on the lower Left Side Panel of the instrument are depicted in the
following figure. The functional description of each component follows.
A Reagent Inlet Panel Reagent Inlet Panel

1 Waste Sensor
Syringe Panel
2 Detergent A
B
3 Diluent
4 Lyse
5 Waste
6 Normally Closed
Valve
B Syringe Panel
1 Lyse Syringe
2 Diluent Syringe
A1
3 Sample Syringe
A2
A3
A4
A5 A6
B1 B2 B3
Figure 1.5 Lower Left Side Panel

9140390C—March 2004
Use or Function
Waste Sensor Connector

The Waste-Full Sensor Plug connects to the Waste Sensor Connector Port. When
the electrical sensor is tripped, the Waste-Full message is generated and the
READY status is inhibited until the situation is corrected. The system interprets a
disconnected plug the same way as a full waste container. Therefore, if the waste
is routed to a drain, a dummy plug must be inserted in the connector.
Detergent Inlet Tubing Connector

This color-coded (green) port is used to connect the Detergent Inlet Tubing with its
associated cap, weighted end, and label.
Diluent Inlet Tubing Connector

This color-coded (red) port is used to connect the Diluent Inlet Tubing with its
associated cap, weighted end, and label.
Lyse Inlet Tubing Connector

This color-coded (blue) port is used to connect the WBC/HGB Lyse Inlet Tubing
with its associated cap, weighted end, and label.
Waste Outlet Tubing Connector

This color-coded (black) port is used to connect the Waste Outlet Tubing.
Normally Closed Valve

The Normally Closed Valve prevents the lyse from draining back into the reagent
container when the instrument power is turned OFF.
Syringes
The instrument contains three syringes: Lyse, Diluent, and Sample.
• The Lyse Syringe delivers a specific volume of lyse to the WBC Mixing
Chamber for the white cell count and hemoglobin measurement.
• The Diluent Syringe delivers a specific volume of diluent to dilute the blood
in the mixing chambers.
• The Sample Syringe aspirates and dispenses a specific volume of specimen.

9140390C—March 2004
Use or Function
Rear Panel
The components visible on the Rear Panel of the instrument are depicted in the
following figure. The functional description of each component follows.
1 Power Cord
Connector
Figure 1.6 Rear Panel
Power Cord Connector

This receptacle is used to connect the Main Power Cord to the instrument.

9140390C—March 2004
Use or Function
Right Side Panel

The components visible on the Right Side Panel of the instrument are depicted in
the following figure. The functional description of each component follows.
1 Main Power Switch

2 PC Keyboard
Connector
3 RS-232 Serial I
Interface Connectors
1
4 Parallel Interface
Connector
5 Floppy Disk Drive
2 3 4
Figure 1.7 Right Side Panel
Main Power Switch

This is the main power switch for the instrument.
PC Keyboard Connector
This port is used to connect the PC Keyboard to the instrument.
RS-232 Serial Interface Connectors (2)

These ports are used to connect a serial 9-pin connector to an optional external
device that accepts serial data in ASCII format.
Parallel Interface Connector

This port is used to connect the 25-pin Printer Cable from a printer.
Floppy Disk Drive

A 1.44 Megabyte (MB) 3.5-inch floppy disk drive is located on the right side panel
of the instrument. All disks used on the CELL-DYN 1800 should be 1.44 MB
3.5-inch, high-density floppy disks.

9140390C—March 2004
Use or Function
Computer Section
The computer section includes the microprocessor, LCD screen, membrane
function keys, and audio.
CELL-DYN 1800 operations are controlled by high-speed microprocessors that
monitor system status, perform the various analytical routines used by the
instrument, perform diagnostic checks, and store result data.
Serial data (ASCII format) may be transferred to an external computer through an
RS-232 connector on the Right Side Panel (COM1). Data transmission may be
done either automatically as samples are processed or by command of the Operator.
Data may be output to an online printer through the Parallel Interface Connector.
Data Storage
Hard Disk Drive

A Hard Disk Drive is used to store the User Interface Software and Patient Data
Log. It has sufficient capacity to store 10,000 run cycles, including numeric and
graphics data.
Floppy Disk Drive

The floppy disk drive (see Right Side Panel earlier in this section) is used to load
QC assay values from a diskette, and to transfer QC data from a QC file to a
diskette.

9140390C—March 2004
Use or Function
Liquid Crystal Display (LCD) Screen/Membrane Keypad

The Liquid Crystal Display (LCD) screen displays alphanumeric and graphical
data. Keys on the membrane keypad generate an audible tone when pressed. For
descriptions of LCD screen elements and special function keys, refer to the legend
for Figure 1.8.
1 Current menu/screen
title, status of the
instrument, and 1
Operator prompts,
instructions, error, and
fault messages
2 Display area: analysis
results, setup
selections, and other
Operator information
3 Softkeys perform
functions
2
corresponding to soft
key labels (see 4) on
the LCD screen
4 Softkey labels used to
4
perform actions
relating to current
menu, to go to other
menus, or return to the
previous screen
3
Figure 1.8 LCD Screen / Membrane Keyboard
Audio
An audio device is used to emit a tone when keys are pressed and to alert the
Operator when certain events occur.

9140390C—March 2004
Use or Function
Reagent System Section 1
Reagent System
Introduction
A specifically formulated reagent system for CELL-DYN 1800 instruments
provides optimal system performance. Use of reagents other than those specified
in this manual is not recommended, as instrument performance can be affected.
Each instrument is tested at the factory using the specified reagents, and all
performance claims are generated using these reagents. For information on
ordering CELL-DYN reagents, refer to Appendix A: Parts and Accessories.
CAUTION: If any reagent has been frozen, it must not
be used.
CELL-DYN 1800 Reagents
Diluent
CELL-DYN Diluent is formulated to do the following:
• Act as the diluent for the WBCs, RBCs, PLTs, and HGB
• Maintain the cell volume of each RBC and PLT during the count and sizing
portion of the measurement cycle
• Provide a conductive medium for impedance counting and sizing of cells and
platelets
• Rinse the sample probe and flow systems
CN-Free Diff Lyse

CELL-DYN CN-Free Diff Lyse (cyanide-free) is formulated to meet the following
requirements:
• Rapidly lyse the RBC and minimize the resultant cell stroma
• Alter the WBC membrane to allow the cytoplasm to slowly diffuse and
shrink the membrane around the nucleus and any granules that may be
present
• Convert hemoglobin to a modified hemoglobin complex that is measurable
at 540 nm (The quaternary ammonium lysate participates to form a
chromagen for hemoglobin measurement.)
Detergent
CELL-DYN 1800 Detergent is formulated to meet the following requirements:
• Provide an optically clear solution that is used to obtain the Zero Reference
during the HGB measurement cycle
• Provide proper meniscus formation in both metering tubes and maintain it
during each run cycle
• Rinse both counting chambers, both metering tubes, and the HGB Flow Cell
with minimal bubble formation

9140390C—March 2004
Use or Function
Section 1 Reagent System
CELL-DYN Enzymatic Cleaner

CELL-DYN Enzymatic Cleaner is formulated to effectively remove protein
buildup and provide detergent cleaning within the instrument. It is used in
scheduled and unscheduled maintenance.
Reagent Storage
Reagents must be stored at room temperature to ensure optimal performance,
except the Enzymatic Cleaner, which should be stored at a temperature between
2ºC and 8ºC (between 36ºF and 46ºF). All reagents should be protected from direct
sunlight, extreme heat, and freezing during storage. Temperatures lower than 0ºC
(32ºF) can cause reagent layering that changes the tonicity and conductivity of the
reagents. If any reagent has been frozen, it must be disposed of according to
federal, state, and local regulations.
Each length of reagent inlet tubing is attached to a cap that minimizes evaporation
and contamination during use. Ensure that all reagent caps are not damaged, and
are securely attached to containers during use. Reagent quality can deteriorate with
time. Therefore, use all reagents before the expiration date on the label.
Reagent Handling
When handling reagents, pay special attention to the following:
• Wear protective gloves when handling reagents.
• Never transfer the contents of a reagent container to an unmarked container
or other reagent container.
• Thoroughly clean all spills. Remove any dried residue in and around the
reagent inlet connectors located on the Left Side Panel of the instrument.
• Dispose of reagents and waste fluids according to federal, state, and local
ordinances.
• Always wash your hands after handling reagents.
Background Count
Always run a Background Count after installing a fresh container of reagent. Refer
to Section 5: Operating Instructions, Subsection: Routine Operation for specific
instructions on how to run a Background Count. Values reported must be within the
following specifications:
• WBC ≤ 0.5 K/µL
• RBC ≤ 0.05 M/µL
• HGB ≤ 0.1 g/dL
• PLT ≤ 10 K/µL

9140390C—March 2004
Use or Function
Reagent System Section 1
Controls and Calibrator

Controls and Calibrator are reference materials used to test, set, and monitor
CELL-DYN 1800 performance. For information on ordering CELL-DYN controls
and calibrators, refer to Appendix A: Parts and Accessories.
Controls
Day-to-day verification of system calibration is performed using CELL-DYN
controls.
Quality Control is discussed in Section 11: Quality Control.
Calibrator
Calibration of the directly-measured parameters can be performed using
CELL-DYN Calibrator and CELL-DYN 22 Calibrator. Calibration is discussed in
Section 6: Calibration Procedures.

9140390D—January 2006
Use or Function
Section 1 Consumables
Consumables
For information on ordering parts, accessories, reagents, controls, calibrators, and

consumables, please refer to Appendix A: Parts and Accessories.

9140390A—March 2003
Use or Function
Consumables Section 1
NOTES

9140390A—March 2003
Section 2 Installation Procedures and Special Requirements
Section 2 Installation Procedures and Special Requirements
Overview
Installation of the CELL-DYN 1800 System should be performed by an Abbott-

authorized representative to ensure that all system components are functioning
correctly and to verify system performance. Installation procedures must be
repeated if the instrument is moved from the original installation site.
NOTE: Installation of the CELL-DYN 1800 System by an unauthorized or
untrained person could result in damage to the system and may void the
warranty. Never attempt to install the system without an Abbott-
authorized representative present.
This section provides general requirements for a successful installation.

9140390A—March 2003
Overview Section 2
NOTES

9140390A—March 2003
Section 2 Initial Preparation
Initial Preparation
Inventory
Confirm that the CELL-DYN 1800 System shipment contains the following:
• CELL-DYN 1800 System
• Accessory Kit
• Reagents Kit
• Controls and Calibrator
• Enzymatic Cleaner
• Operator’s Manual
• Facilitator’s Guide (optional)
• Installation Guide and Checklist (optional)
• Pre-Install Checklist (optional)
• Printer (optional)
• Bar Code Scanner (optional)
• LIS Interface Specification (optional)
Accessory Kit
Confirm that the Accessory Kit contains the following:
• Power Cord
• Keyboard Cover
• Allen Wrench 3/32"
• Allen Wrench 7/64"
• Aperture Brush
• Reagent Line Kit
• Printer Cable
• Calibrator/Control Mixing and Handling Instructions
• Fuse, SB 2.5 amps 250 V (2)*
• Fuse, SB 5.0 amps 220/240 V (2)*
• Silicon Tubing (S2)
• Waste Dummy Plug
*For CELL-DYN 1700 System use only.

Initial Preparation Section 2
Visually inspect these items for damage. If there is any damage, contact Abbott
Diagnostics Customer Service at one of the numbers listed below:
US: 1-877-4ABBOTT or 1-877-422-2688
Canada: 1-800-387-8378
Customers Outside
the U.S. and Canada: Call your local Hematology Customer Support
Representative
Unpacking
Remove the instrument from the shipping container and visually inspect for
damage. If there is any damage, contact Abbott Diagnostics Customer Service.
CAUTION: The CELL-DYN 1800 System weighs approximately 124 lbs
(56 kg). Obtain assistance when moving or use a mechanical lifting device.
Space Requirements
Select an appropriate location for the CELL-DYN 1800 System. The instrument
requires 1.5 linear feet (18 inches or 46 cm) of countertop space. Allow sufficient
space on the countertop or below the instrument for the diluent, lyse, and detergent
containers. Provide space below the instrument for the waste container (if one is used).
Allow at least 6 inches (15 cm) of space on the right and left sides of the instrument
for air flow. Do not position the instrument so that it is difficult to operate the main
power switch. Make sure there is adequate room around the instrument to perform
necessary procedures or service, and to allow the instrument to be easily
disconnected from its power source.
A constantly circulating internal air stream is required to cool circuitry and
components whenever the power is ON.
NOTE: To ensure the instrument and reagents function properly, it is important to
maintain the temperature between 68°F and 86°F (20°C and 30°C).
Place the instrument:
• On a stable, level surface
• On a nonporous, non-absorbing work surface and flooring which can be
easily cleaned and disinfected using recommended procedures
• Away from direct sunlight
• Away from the path of a cooled air or heated air outlet
• Far from a centrifuge, X-ray equipment, video display terminal, computer, or
copier
• In an area that will not block the ventilation openings.
Place the lyse, diluent, and detergent reagents below the instrument.
CAUTION: Do not use mobile telephones, wireless telephones, mobile
radios, or any other radio-frequency (RF) transmitting devices in the same
room as the instrument.

9140390E—June 2008
Section 2 Initial Preparation
Waste Disposal Requirements

WARNING: Potential Biohazard. Observe all biosafety and chemical
hazard precautions for waste disposal. For a detailed description of the
hazards associated with the CELL-DYN 1800 System, refer to Section 8:
Hazards.
Observe the following requirements for waste routing and disposal:

• Allow room for a suitable, properly labeled waste container below the unit
and within approximately 40 inches (120 cm) of the waste outlet, or position
the instrument to permit the waste to be routed directly to a drain suitable for
disposal of waste that could present a biological or chemical hazard.
• If routing to a waste container, ensure the waste sensor is properly connected.
• If the waste is routed to a drain, make sure the dummy plug is inserted into
the WASTE SENSOR connector.
• Users are responsible for disposing of waste in accordance with local, state,
and federal regulations.
CAUTION: Waste container must be stored below the instrument, never
above.
CAUTION: 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 instrument components are located away from
possible waste overflow.

9140390A—March 2003
Initial Preparation Section 2
Power Requirements
Be sure that the system is located at the desired site before attempting any
connections. A grounded power outlet is required. An AC voltage regulator/line
conditioner is required for optimum performance if the local power supply is
subject to fluctuations or irregularities. If required, a suitable line conditioner can
be obtained from a computer supply source. Refer to the Instrument Power Source
Requirements table for instrument power requirements.
Insert the power cord into the power cord connector on the rear panel. Do not turn
the power ON at this time. Proceed with the installation.
CAUTION: Check all connectors for particles or foreign material that can
impair electrical contact when connections are made.
Table 2.1 Instrument Power Source Requirements
Nominal Line
Operative Range Operating Cycles
Voltage
100 90–110 VAC 50/60 Hz
120 110–130 VAC 50/60 Hz
220 200–240 VAC 50/60 Hz
240 220–260 VAC 50/60 Hz
The CELL-DYN 1800 is designed for low power consumption. During periods of
routine daily operation, power should be left ON. It is recommended that the power
be left ON for brief periods of non-use (overnight and weekends).

9140390C—March 2004
Section 2 Installation
Installation
Printer Installation
Overview
The printer must provide Printer Control Language, Release 3 (PCL3) or ESC/P
compatibility. Refer to the printer manual for a detailed description of the printer
components, installation procedures, and operating instructions. To set up the
printer, refer to Section 5: Operating Instructions, Subsection: Setup
Instructions.
Installing the Printer

To install the printer, proceed as follows:
1. Find a suitable location adjacent to the instrument and a convenient location
for keeping any operations or other reference manuals that come with the
printer.
2. Remove the printer from the shipping container.
3. Visually inspect the printer and report any damage to your supplier.
4. Make certain the printer is turned OFF.
5. Assemble the printer as directed in the printer manual.
6. Connect the power cord to the printer. Do not plug the power cord into a
grounded outlet until you are ready to power ON.
7. Follow installation instructions carefully to be sure that the printer is
connected to the correct port on the instrument (see Figure 2.1).
8. Install the ink cartridge and load the paper as directed in the printer manual,
making certain the printer is adjusted to accept paper of the correct size.
9. Plug the power cord into a grounded outlet and turn ON the printer.
NOTE: Additional printer supplies may be obtained from most computer or
office supply stores.

9140390A—March 2003
Installation Section 2
1 Printer Port
Figure 2.1 Parallel Interface Port Connector
Self-Test Printouts
Refer to the printer operations manual. Run self-test printouts before using the
printer for the first time. These self-tests may be run any time to verify proper
printer operation.
NOTE: The CELL-DYN 1800 software automatically controls and adjusts most
print conditions for the printer, including page width. Occasionally, a few
settings may need to be changed in the printer’s software for correct
operation. If printing is not what you expect, refer to the printer manual
for guidance in making adjustments. If you have additional questions or
experience any problems, call Abbott Diagnostics Customer Service for
assistance, at 1-877-4ABBOTT (U.S. only). Customers outside the U.S.,
contact your local Hematology Customer Support Representative for
assistance.

9140390C—March 2004
Bar Code Scanner Installation

Overview
The bar code scanner is a hand-held scanner with an LED light that can read and
interpret bar codes that meet the specifications described in Appendix D: Bar
Codes. Refer to the CELL-DYN 1800 Intermec ScanPlus 1800 Trigger-Activated
Hand-Held Bar Code Scanner User’s Guide for a detailed description of the bar
code scanner components, installation procedures, and operating instructions.
Installing the Bar Code Scanner

To assemble and install the bar code scanner, proceed as follows:
1. Find a suitable, convenient location adjacent to the instrument for storing the
CELL-DYN 1800 Intermec ScanPlus 1800 Trigger-Activated Hand-Held
Bar Code Scanner User’s Guide that comes with the bar code scanner.
2. Remove the bar code scanner from the shipping container.
3. Visually inspect the bar code scanner and report any damage to your supplier.
4. Install the bar code scanner as directed in the Scanner Installation section of
the CELL-DYN 1800 Intermec ScanPlus 1800 Trigger-Activated
Hand-Held Bar Code Scanner User’s Guide.
Inspection and Tubing Installation

Overview
In order for the instrument to operate correctly, you must install all reagent and
waste tubing, and the Diluent Syringe, before the power is turned ON.
Materials Required
• Powder-free gloves, lab coat, safety glasses
• CELL-DYN CN-Free Diff Lyse
• CELL-DYN Diluent
• CELL-DYN Detergent
• Reagent inlet tubing and waste outlet tubing
• Waste container (or appropriate drain) and dummy plug
• KIMWIPES® or other lint-free absorbent pads

9140390A—March 2003
Reagent Tubing and Waste Line Tubing

To connect reagent (diluent, lyse, and detergent) tubing and waste line tubing,
proceed as follows:
1. Locate the reagent line tubing in the Accessory Kit.
2. Inspect each length of tubing carefully for damage or cracks.
3. Attach the nonweighted end of the tubing with the Green Detergent label to
the Green Connector on the Left Side Panel of the instrument. Wipe the
outside of the tubing with a damp lint-free pad and place the weighted end
into the CELL-DYN Detergent container. Secure the cap. Place the container
below the instrument level.
1 Waste Sensor Reagent Inlet Panel

Connector Syringe Panel
2 Detergent Connector A
B
(Green)
3 Diluent Connector
(Red)
4 Lyse Connector (Blue)
5 Waste Connector
(Black)
6 Normally Closed Valve
A1
A2
A3
A4
A5 A6
B1 B2 B3
Figure 2.2 Reagent Inlet Panel
4. Attach the nonweighted end of the tubing with the Red Diluent label to the
Red Connector. Wipe the outside of the tubing with a damp lint-free pad and
place the weighted end into the container of CELL-DYN Diluent. Secure the
cap. Place the container below the instrument level.
5. Attach the nonweighted end of the tubing with the Blue Lyse label to the Blue
Connector. Wipe the outside of the tubing with a damp lint-free pad and place
the weighted end into the container of CELL-DYN CN-Free Diff Lyse.
Secure the cap. Place the container below the instrument level.

6. Attach the Waste Outlet Tubing to the Black 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 hazards. Be sure
that the tubing is secured to the drain hole. Place the waste container below
the instrument level.
1 Waste Sensor
Connector
2 Detergent Connector
(Green)
3 Diluent Connector
(Red)
4 Lyse Connector (Blue)
5 Waste Connector
(Black)
1
2
3
4
5
Figure 2.3 Tubing and Container Installed
7. Locate the Waste-Full Sensor Plug attached to the cap’s electrode wires.
Insert the plug into the Waste Sensor connector located on the Reagent Inlet
Panel. When the waste tubing is placed directly into a drain, insert a dummy
plug into the Waste Sensor Connector. If a dummy plug is not inserted, the
Waste Full alert is activated. For information on ordering a Waste
Dummy Plug, refer to Appendix A: Parts and Accessories.

9140390A—March 2003
Normally Closed Valves

Before shipment, the diluent tubing normally inserted into the Normally Closed
Valve on the left side panel, and on the front panel, is removed. To ensure correct
system operation, the appropriate tubing must be completely inserted in each valve
before the instrument power is turned ON.
1 Normally Closed
Valve 1
2 Slot 2
3 Side View of Valve
Figure 2.4 Diluent Normally Closed Valve
Left Side Panel

1. Locate the Normally Closed Valve (black octagon) on the lower left side of
the instrument. Carefully stretch the tubing between your hands and insert it
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.
NOTE: Check the tubing on either side of the valve to ensure the tubing is
not pinched or crimped and will allow fluid to flow unimpeded.
Front Panel
1. On the upper left portion of the flow panel, locate the Diluent Normally
Closed Valve, (black octagon) and the removed diluent tubing.
2. 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 message Diluent Empty may be displayed and the
flow system will not function properly.
3. Confirm that both ends of the diluent tubing are firmly attached to the
connectors.

9140390A—March 2003
Diluent Syringe Installation

Before shipment, the Diluent Syringe is removed, cleaned, and reinstalled in the
dispenser. It is not attached at the Luer-Lok® Fitting of the three-way directional
valve. A protective cap is attached to the Luer-Lok® Fitting. Follow the directions
below to reattach the Diluent Syringe. Refer to the following figure.
1 Luer-Lok® Fitting
2 Rod 1
3 Knurl Nuts
4 Holding Clamp 2
5 Counterclockwise
Figure 2.5 Diluent Syringe Assembly
1. Locate the dark-colored plastic cover on the left side of the instrument. Using
the two finger holes in the cover, lift the cover up and pull it out to gain access
to the Diluent Syringe.
2. Remove the two Knurl Nuts on the Holding Clamp by turning them
counterclockwise. Remove the front section of the Holding Clamp. Save the
Knurl Nuts and the block.
3. Locate and unscrew the protective cap attached to the Luer-Lok® Fitting for
shipment.
4. Move the barrel of the syringe upward until it touches the Luer-Lok® thread.
Turn the syringe counterclockwise (as viewed from above) until it is securely
in place. The syringe should be finger-tight—do not overtighten.
5. Replace the front section of the Holding Clamp and secure it with the two
Knurl Nuts removed in step 2 above. Tighten the Knurl Nuts finger-tight
only.

Inspecting the Flow Panel

The Upper Front Cover and Lower Front Cover must be open to gain access to the
flow panel.
Opening/Removing Front Covers, Version A

To open the Upper Front Cover, and remove the Lower Left Front Cover, proceed
as follows:
NOTE: The right front cover is not intended to be removed by the operator.
1. Swing the Upper Left Front Cover to the side so the upper portion of the flow
panel is exposed.
1 Upper Front Cover

2 Lower Front Cover
Figure 2.6 CELL-DYN 1800 Front Covers, Version A
2. Locate the holding screw on the upper right side of the Lower Left Front
Cover; turn it counterclockwise. Remove the screw and save it. The screw
must be reinstalled to ship the instrument. Tilt the right side of the cover to
clear the display cover recess. Grasping the lower front cover with both
hands, slide the cover to the left so that the tab on the left top of the cover
slides out of its clip.
3. Tilt the top of the cover slightly forward to clear the black plastic guides from
the bottom of the unit and lift cover.
4. Slide cover to the left and out, and set aside.

9140390C—March 2004
Opening Front Covers, Version B

To open the Upper Front Cover, proceed as follows:
1. Insert fingers into recess found on right underside of Cover and pull the
Cover forward. Swing the Upper Front Cover completely to the left until it
stays open.
2. Locate the Knob on the metal plate attached to the Display Bezel Cover.
Rotate the knob counterclockwise ¼ turn to release it.
3. Lift the lower left edge of the Display Bezel Cover and pull the Cover
forward. Swing the Display Bezel Cover completely to the right until it stays
open.
1 2
3 4
Figure 2.7 CELL-DYN 1800 Front Covers, Version B

9140390C—March 2004
1 Diluent Normally
Closed Valve
1
2 Sample Aspiration
Probe
3 Wash Block 11
4 von Behrens RBC/ 2
PLT Transducer
Assembly
5 RBC/PLT Metering
Assembly 3
6 Start Switch
7 WBC Metering
Assembly
8 HGB Flow Cell
10 4
Assembly 9
9 Pre-Mixing Cup
10 von Behrens WBC
Transducer Assembly
12 Vent Lines
6
12 8 7 5 12
Figure 2.8 Flow Panel
4. Inspect the flow panel (refer to Figure 2.8) for obvious damage and to ensure
the following:
• Tubing is properly positioned under all solenoid pinch valves.
• WBC and RBC aperture plates are inserted and levers are closed.
• If there is any damage, contact Abbott Diagnostics Customer Service.
When the inspection of the flow panel is complete, close the Display Bezel Cover,
lifting up the lower left edge as it shuts. Lock the Display Bezel Cover by rotating
the Knob clockwise ¼ turn. Swing the Upper Front Cover until it is shut. Turn the
instrument power ON.

9140390E—June 2008
StartUp
The CELL-DYN 1800 is designed for low power consumption. Whenever the
power is applied, an initialization cycle is performed to place mechanical and
electrical components in the “home” position, to drain any liquid in the Internal
Waste Bottles and Mixing Chambers to the waste system and, when appropriate, to
place the unit in the INITIALIZED state.
1. Confirm that the instrument, printer, and (optional) bar code scanner power
plugs are inserted into grounded power outlets.
2. Set the printer power switch ON. Confirm that printer paper is installed and
feeding correctly.
3. Set instrument power switch ON. The screen illuminates within 15 to 30
seconds and the message Initializing appears in the status box. When
the cycle is complete, the message Initialized is displayed.
4. To prime the instrument, press the [PRIME/RUN] key. This operation primes
the flow system with reagents and performs a Normal Background count.
Make sure there are no bubbles in the Counting Chambers, no diluent in the
Pre-Mixing Cup, and no leakage in the instrument. Then reattach the Lower
Front Cover and close the Upper Front Cover.
NOTE: If Background Counts remain out of range after three runs, refer to
the Error Messages and Conditions table in Section 10:
Troubleshooting and Diagnostics and follow established
laboratory operating procedures.
Operator ID
An identification number for the current Operator is enterable only when the MAIN
MENU screen is displayed. When the instrument has been Initialized or is in
STANDBY, the MAIN MENU screen is displayed with the cursor flashing at the
<Operator ID> field.
Type a one- to three-digit ID number using the numeric keys on the PC Keyboard,
then press [←] (Enter).
NOTE: An Operator ID number is not required for instrument operation.
Sequence Number
The sequence number displayed below the <Operator ID> field automatically
increments by one each time a run cycle is initiated by pressing the Touch Plate.
The Operator cannot change or enter the sequence number.
Conditioning of WBC/RBC Metering Tubes

Complete this cleaning and wetting of metering tubes as part of the initial
Installation Procedures by performing Auto Clean. Follow the procedure as
described in Section 9: Service and Maintenance, Subsection: Weekly
Maintenance Procedures, Performing Auto-Clean.

9140390C—March 2004
NOTES

9140390A—March 2003
Section 2 Relocation
Relocation
CAUTION: When moving the CELL-DYN 1800 to a different location,

follow this relocation procedure to avoid damaging the instrument or
exposing personnel to potentially infectious materials.
Moving the Instrument

To move the instrument, proceed as follows:
1. Shut down the system using the procedure described in Section 9:
Service and Maintenance, Subsection: As-Required Maintenance.
2. Prepare the new area before moving the instrument. See Initial Preparation
at the beginning of this section:
• Space Requirements
• Waste Requirements
• Power Requirements
3. Move the instrument to the new location.
CAUTION: The CELL-DYN 1800 weighs approximately 124 lbs (56 kg).
Obtain assistance when moving or use a mechanical lifting device.
4. Install the instrument in accordance with Installation in this section.

5. Set power to ON
6. Run Background Counts (refer to Section 5: Operating Instructions,
Subsection: Routine Operation) until results are within appropriate
specifications. If Background Counts remain out of range after three runs,
refer to the Error Messages and Conditions table in Section 10:
Troubleshooting and Diagnostics and follow established laboratory
operating procedures.
This completes initial installation and startup procedures. Calibration, discussed in
Section 6: Calibration Procedures, is the next procedure to be completed when
installing the CELL-DYN 1800.

9140390C—March 2004
Relocation Section 2
NOTES

9140390C—March 2004
Section 3 Principles of Operation
Section 3 Principles of Operation
Overview
The CELL-DYN 1800 is designed to automatically perform the following

functions:
• Aspirate and dilute whole blood
• Count, size, and classify cells present in a whole blood specimen
• Analyze raw data collected
• Output results to the display, printer, and on-line computer
The principles the CELL-DYN 1800 uses to measure, count, and calculate the
hematological parameters are discussed in Sample Analysis Cycle Overview, later
in this section. Subsequent subsections discuss the measurement process for White
Blood Cells, Red Blood Cells, Platelets, and Hemoglobin (WBCs, RBCs, PLTs,
and HGB). The System-Initiated Messages and Data Flags subsection discusses
the instrument-generated flags (alerts or warnings) resulting from one or more of
the following states:
• Measured parameters outside pre-defined limits
• Sample abnormality
• Interference in the measurement process
• Detection of an abnormal subpopulation

9140390A—March 2003
Overview Section 3
NOTES

9140390A—March 2003
Section 3 Sample Analysis Cycle Overview
Sample Analysis Cycle Overview
Open Mode
Aspiration
The CELL-DYN 1800 aspirates approximately 30 µL (microliters) of whole blood
from an open collection tube that has been held under the Sample Aspiration Probe,
and transfers the sample to the Pre-Mixing Cup.
Dilution
A 7.5-milliliter (mL) volume of diluent is added to the Pre-Mixing Cup to achieve
a dilution ratio of 1:251.
• The diluted sample is then divided into two samples.
• 100 µL of the 1:251 sample dilution are aspirated and mixed with an
additional 5 mL of diluent in the RBC/PLT mixing chamber to create a
dilution ratio of 1:12801. A specimen of the 1:12801 dilution is analyzed to
generate results for the red blood cell and platelet parameters.
• The remainder of the 1:251 sample dilution is mixed with 1.0 mL of lyse
reagent in the WBC Mixing Chamber. The lyse reagent ruptures the
membrane of each red blood cell causing cytoplasm and hemoglobin to be
quickly released. The red blood cell membrane (ghost) that remains is less
than 2 femtoliters (fL).
The lyse reagent also compresses the membrane of each white blood cell
(leukocyte). This causes cytoplasm to slowly diffuse from the cell as the
membrane shrinks around the nucleus and any cytoplasmic granules that may
be present. This dilution is used to measure the number and modified size of
the white blood cells and the amount of hemoglobin released.
Volumetric metering is used in both the WBC Counting Chamber and the RBC
Counting Chamber to ensure that a precise amount of diluted specimen is measured
during each count cycle.
Pre-Dilute Aspiration
In the Pre-Dilute Mode, whole blood is pre-diluted with diluent to a ratio of 1:251
(using 40 µL of sample to 10 mL of diluent) and then poured into the Pre-Mixing
Cup. The sample is then processed in the same manner as stated above. For
directions on preparing pre-diluted solutions, refer to Section 5: Operating
Instructions, Running Specimens—Pre-Dilute Mode.

9140390A—March 2003
Sample Analysis Cycle Overview Section 3
Cell Measurement
The CELL-DYN 1800 uses two independent measurement methods; they are:
• Electrical Impedance Method for determining WBC, RBC, and PLT data
• Modified Methemoglobin Method for determining HGB1
During each instrument cycle, the sample is aspirated, diluted, and mixed before
each parameter is measured.
Electrical Impedance Measurement

Electrical impedance is used to count and size blood cells. This method is based on
the measurement of changes in electrical resistance produced by a particle
suspended in a conductive diluent as it passes through an aperture of known
dimensions.
An electrode is submerged in the liquid on each side of the aperture to create an
electrical pathway. As each particle passes through the aperture, a transitory change
in the resistance between the electrodes occurs, producing a measurable electrical
pulse. The number of pulses generated indicates the number of particles that pass
through the aperture. The amplitude of each pulse is essentially proportional to the
particle volume.
Each pulse is amplified and compared to internal reference voltage channels. These
channels are delineated by calibrated size discriminators to accept only pulses of a
certain amplitude. Thus, the pulses are sorted into various size channels according
to their amplitude.
Volumetric Metering
An accurate cell count cannot be obtained unless the precise volume of diluted
whole blood that passes through the aperture during the count cycle is known.2
The CELL-DYN 1800 uses a syringe method to regulate the count cycle and to
make sure that a precise volume of sample is analyzed for the measurement.
The WBC and RBC/PLT metering assemblies contain a precision-bore glass tube
fitted with two optical detectors. This tube ensures that a precise amount of diluted
specimen is measured during each count cycle. The exact amount is determined by
the distance between the two optical detectors.
Detergent is used to create a meniscus in the metering tube. The amount of time
required for the meniscus to travel from the upper detector to the lower detector is
called the count time and is measured in seconds. The count portion of the cycle is
initiated when the meniscus reaches the upper detector. The count cycle stops when
the meniscus reaches the lower detector. The count time is displayed on the RUN
screen. The computer monitors the count time to detect any variation from the
expected values. Variation may be caused by debris in the aperture, vacuum
fluctuation, or air bubbles in the metering tube. If significant variation is detected,
the RUN screen displays the message FLOW ERR or CLOG, and no WBC or
RBC/PLT data is displayed. A clog indicates the flow was too slow, most likely
caused by debris in the aperture. Flow errors indicate the flow was too fast, often
caused by bubbles in the metering tube.

9140390A—March 2003
Coincidence Loss Correction

Two or more cells can enter the aperture sensing zone simultaneously during a
measurement cycle. The resistance change created in this situation generates a
single pulse with a high amplitude and increased pulse area. Thus, it appears that
one large cell has passed through the aperture. Consequently, the cell count is
falsely decreased. This count reduction, referred to as coincidence passage loss, is
statistically predictable because it has a direct relationship to the effective volume
of the aperture and the amount of dilution. Each total cell count is automatically
corrected for coincidence passage loss.

9140390A—March 2003
Parameter Reporting Conventions

Parameter results can be expressed in different terms depending on the unit of
measurement selected. See Section 5: Operating Instructions, Subsection: Setup
Instructions.
Parameter report units are presented in exponential units. Examples include
10E9/L, meaning 109/L, and 10E3/µL, meaning 103/µL.
Numerical results are presented in formats that depend on the magnitude of the
results, as shown in the following examples:
• PLT 250 K/µL
• HGB 14.5 g/dL
• RBC 4.25 M/µL
• MCV 109.5 fL
The following exponents are used in reporting numerical results (for number of
cells, cell volumes, or grams of material per quantity of whole blood):
• 103 K (kilo)
• 106 M (mega)
• 109 G (giga)
• 1012 T (tera)
• 10-12 p (pico)
• 10-15 f (femto)
Reporting terms for all parameters under each unit type are listed in the following
Parameter Reporting Terms table.

9140390C—March 2004
Table 3.1 Parameter Reporting Terms
Parameter Factory1 SI2 SI3 SI4
WBC K/µL G/L G/L 10E9/L
LYM %L %L %L %L
MID %M %M %M %M
GRA %G %G %G %G
RBC M/µL T/L T/L 10E12/L
HGB g/dL g/L mmol/L g/L
HCT % L/L L/L %
MCV fL fL fL fL
MCH pg pg fmol pg
MCHC g/dL g/L mmol/L g/L
RDW % % % %
PLT K/µL G/L G/L 10E9/L
MPV fL fL fL fL
PCT† % mL/L mL/L %
PDW† 10(GSD) 10(GSD) 10(GSD) 10(GSD)
† Clinical significance has not been established for these parameters. Therefore, they are not reportable in the
U.S.
1 United States
2 Standard International
3 (HGB/MCHC in mmol/L, MCH in fmol)
4 (HCT/PCT in %)

9140390A—March 2003
WBC Analysis
Electrical impedance is used to count the White Blood Cells (WBC) as they pass
through the aperture of the von Behrens WBC transducer. As each cell is drawn
through the aperture, a change in electrical resistance occurs generating an
equivalent voltage pulse. The number of pulses sensed during each cycle
corresponds to the number of white cells counted. The amplitude of each pulse is
essentially proportional to the cell volume.
The CELL-DYN 1800 uses electronic sizing to determine three distinct white cell
subpopulations. Cells correlating to lymphocytes are included in the small cell
subpopulation. Cells correlating to granulocytes (neutrophils) are included in the
large cell population. The remaining cells correlating to monocytes, basophils,
eosinophils, blasts, and other precursor white cells are generally included in the
mid-size cell population.
Hemoglobin Analysis
After the WBCs have been counted and sized, the remainder of the lysed dilution
is transferred to the Hemoglobin (HGB) Flow Cell Assembly. In the flow cell, the
CELL-DYN 1800 measures the ability of the dilution to absorb light at a
wavelength of 540 nm (nanometers).
RBC/PLT Analysis
The 1:12801 dilution is pulled through the aperture of the transducer bath where
electrical impedance is used to count the red blood cells (RBC) and platelets (PLT)
as they pass through the aperture.
MCV, HCT, RDW Determination

The CELL-DYN 1800 determines the mean cell volume (MCV) from the RBC
size-distribution data. Hematocrit (HCT) results are calculated from the RBC count
and the MCV value as follows:
RBC x MCV
HCT (Hematocrit) = 10
RBC Distribution Width (RDW) is the coefficient of variation of RBC
heterogeneity determined from the RBC size-distribution data.
MPV, PCT, PDW Determination

An algorithm is used to analyze the PLT histogram to obtain Mean Platelet Volume
(MPV). Results for the Plateletcrit (PCT†) are calculated from the PLT count and
MPV as follows:
PLT x MPV
PCT = 1,000
PLT Distribution Width (PDW†) is the geometric standard deviation (GSD) of the
PLT size-distribution.
† Clinical significance has not been established for these parameters. Therefore,

MCH and MCHC Determination

Mean Cell Hemoglobin (MCH) and Mean Cell Hemoglobin Concentration
(MCHC) values are calculated automatically whenever appropriate parameters are
measured, for example, red blood cell count (RBC), hematocrit (HCT), and
hemoglobin (HGB).
Results for the Mean Cell Hemoglobin (MCH) are calculated from the HGB and
RBC count as follows:
MCH = (HGB/RBC) x 10
Results for the Mean Cell Hemoglobin Concentration (MCHC) are calculated from
the HGB and RBC count as follows:
MCHC = (HGB/HCT) x 100
Results Displayed
Results are calculated and displayed on the RUN screen. Size distribution data for
lyse reagent-modified WBCs and subpopulations, RBCs, and PLTs are displayed
in numeric values on the display screen and as numeric values and histograms on
a hardcopy printed from the RUN menu.
Data Stored
Up to 10,000 run cycles are automatically stored in the Data Log on the hard disk
drive.
Instrument Rinsing
The probe assembly is rinsed internally when diluent is dispensed during sample
dilution, and externally with diluent after each run cycle.
The von Behrens WBC Transducer, and the von Behrens RBC/PLT Transducer are
rinsed with diluent. The HGB flow cell is rinsed with detergent.

9140390A—March 2003
NOTES

9140390A—March 2003
Section 3 WBC Measurement
WBC Measurement
Overview
The electrical impedance method is used to obtain WBC data. Cells are counted
and sized as they pass through the aperture of the von Behrens WBC Transducer.
WBC Measurement Process

The 1:251 WBC/HGB dilution is delivered to the WBC mixing chamber where it
is bubble-mixed with 1.0 mL of lyse reagent. A metered volume of the lysed
sample is drawn through the aperture into the Counting Chamber by vacuum. The
WBCs are then counted by impedance. If the pulse generated is above the WBC
lower threshold, it is counted as a WBC.
As cells exit the aperture, they tend to swirl around and may re-renter the sensing
zone and be counted a second time. This causes the counts to be falsely elevated.
The divider plate located in the von Behrens WBC Transducer Counting Chamber
minimizes the occurrence of these recirculating cells.

9140390A—March 2003
WBC Measurement Section 3
NOTES

9140390A—March 2003
Section 3 WBC Parameters
WBC Parameters
WBC Histograms
The White Blood Cell (WBC) data is plotted in histogram format with the WBC
size distribution data on the X-axis and the relative number of cells on the Y-axis.
Results of each count are displayed to the left of the histogram on the RUN screen.
Once the total WBC count is determined, the instrument calculates the absolute
number of cells in each subpopulation by multiplying the WBC count by the
percentage of each subtype. The results are expressed as follows:
• WBC #K/µL (thousands per microliter)
• LYM % (percent)
• GRAN % (percent)
• MID % (percent)

9140390A—March 2003
WBC Parameters Section 3
NOTES

9140390A—March 2003
Section 3 RBC/PLT Measurement
RBC/PLT Measurement
Overview
The electrical impedance method is used to obtain RBC/PLT data. Cells are
counted and sized as they pass through the aperture of the von Behrens RBC/PLT
Transducer.
RBC/PLT Measurement Process

The 1:12801 RBC/PLT dilution is delivered to the RBC/PLT Mixing Chamber
where it is bubble-mixed. A precise volume of the diluted specimen is drawn by
vacuum through the aperture into the Counting Chamber. The RBCs and PLTs are
then counted by impedance. If the pulse generated is above the PLT lower
threshold, the pulse is counted as a PLT. If the pulse generated is above the RBC
lower threshold, the pulse is counted as an RBC.
As cells exit the aperture, they tend to swirl around and may re-enter the sensing
zone and be counted a second time. This could cause the counts to be falsely
elevated. A divider plate located in the von Behrens RBC/PLT Transducer
Counting Chamber minimizes the occurrence of these recirculating cells.
PLT Measurement
Pulses counted in the RBC/PLT dilution between 2 fL and 24 fL are included in the
PLT data. If the raw PLT count is below a predetermined value, the instrument
automatically continues to count PLTs for an extended count period. The results
from the two count periods are averaged. The PLT data is plotted as a histogram.
An algorithm analyzes the histogram to eliminate interference and thus determine
the lower and upper thresholds for the count.
If no interference is detected, the lower and upper thresholds are set at 2 fL and
24 fL, respectively. If interference is detected, the thresholds float to determine the
best separation between the interference and the PLT population. The lower
threshold switches between the 2-fL and the 3-fL regions, and the upper threshold
switches between the 20-fL and the 24-fL regions. Once the thresholds have been
determined, the PLT count is derived from the data between them.
Interference in the upper threshold region is generally caused by microcytic RBCs.
Lower threshold interference is usually caused by electronic noise, cell fragments,
or similar artifacts. Therefore, after the PLT upper threshold has been determined,
the data between it and the RBC lower threshold are re-evaluated.
If the interference in either threshold region exceeds a predetermined limit, the PLT
count is flagged accordingly. The flags are discussed in System-Initiated Messages
and Data Flags later in this section.

9140390A—March 2003
RBC/PLT Measurement Section 3
NOTES

9140390A—March 2003
Section 3 RBC Parameters
RBC Parameters
RBC Histograms
The Red Blood Cell (RBC) data is plotted in a histogram format with the RBC size
distribution data on the X-axis, and the relative number of cells on the Y axis.
Results of each count are displayed to the left of the histogram on the RUN screen.
RBC Count
The RBC count is directly measured, and the number of RBCs is expressed as
follows (U.S. units):
RBC = # X M/µL (millions per microliter)
MCV
The Mean Cell Volume (MCV) is the average volume of individual RBCs. The
MCV is derived from the RBC size-distribution data. MCV is reported in
femtoliters (fL).
HCT
The Hematocrit (HCT) is the ratio of RBCs to plasma. The HCT is calculated from
the RBC count and the MCV as follows:
RBC x MCV
HCT = 10
MCH
The Mean Cell Hemoglobin (MCH) is the average amount of hemoglobin
contained in the RBC. The MCH is calculated from the RBC and HGB as follows:
HGB
MCH = x 10
RBC
MCHC
The Mean Cell Hemoglobin Concentration (MCHC) is the ratio of the weight of
HGB to the volume of the average RBC. MCHC is calculated from the HGB and
the HCT as follows:
HGB
MCHC = x 100
HCT
RDW
Red Cell Distribution width (RDW) is a measure of the heterogeneity of the RBC
population. The CELL-DYN 1800 reports RDW as a percent (%) coefficient of
variation. The RDW is derived from the RBC histogram.

RBC Parameters Section 3
NOTES

9140390A—March 2003
Section 3 PLT Parameters
PLT Parameters
PLT Histogram
Platelet (PLT) data is plotted in a histogram format with PLT size-distribution data
on the X-axis and the relative number of cells on the Y-axis. Results of each count
are displayed to the left of the histogram on the RUN screen.
PLT Count
The PLT Count is derived from the PLT histogram after the data have been
analyzed by the PLT algorithm. The PLT count is expressed as follows
(U.S. units):
PLT = # K/µL (thousands per microliter)
MPV
The Mean Platelet volume (MPV) is derived from the PLT histogram after the PLT
count has been determined. The MPV is reported in femtoliters (fL).
PCT
The Plateletcrit (PCT†), the product of the PLT and MPV, is analogous to the
Hematocrit. PCT is calculated as follows:
PLT x MPV
PCT = 1,000
PDW
Platelet Distribution Width (PDW†) is a measure of the heterogeneity of the PLT.
Each PDW is expressed as geometric standard deviation (GSD). Each PDW xx.x
10 (GSD) result is derived from the platelet histogram data and is reported as 10
(GSD).
† Clinical significance has not been established for this parameter; therefore, it is
not reportable in the U.S.

PLT Parameters Section 3
NOTES

9140390A—March 2003
Section 3 Hemoglobin Measurement
Hemoglobin Measurement
Overview
A modified Methemoglobin method is used for the colorimetric determination of
hemoglobin (HGB). A portion of the lysed, diluted sample from the WBC Mixing
Chamber is used for HGB measurement. A low-energy Light-Emitting Diode
(LED) is used as the light source. A filtered photodetector with a wavelength of
540 nm measures the transmitted light.
Hemoglobin Measurement Process

A zero or blank reading is first obtained to provide a reference to which the sample
signal is compared. Lyse reagent lyses the diluted RBCs and converts the released
HGB to a chromogen. The sample is then transferred to the HGB flow cell where
HGB concentration is measured. The sample enters the flow cell from the bottom;
this allows any bubbles to exit the flow cell so they will not interfere with the
reading.
The LED shines through the HGB flow cell and a 540 nm narrow-bandwidth filter
onto a photo detector. The HGB concentration is directly proportional to the
absorbency of the sample. When the HGB measurement is completed, the HGB
flow cell is rinsed with detergent.
Reference and sample readings are compared to determine the HGB concentration
of the sample.
The result is expressed in grams of HGB per deciliter (g/dL) of whole blood.

9140390A—March 2003
Hemoglobin Measurement Section 3
NOTES

9140390A—March 2003
Section 3 System-Initiated Messages and Data Flags
System-Initiated Messages and Data Flags
Introduction
System-initiated messages and data flags appear on the RUN menu and on printed
reports. The CELL-DYN 1800 continuously monitors instrument conditions and
specimen data attributes that can affect instrument operations or sample analysis
results. When an abnormality is present, either in the instrument itself or in the
sample data, a display message or a parameter flag (alert or warning) appears on
the display screen.
Instructions for interpreting all flags, numeric, and histogram data must be
incorporated into your laboratory’s procedure manual and used to determine the
need for further action and/or review of results.
Interfering Substances
It is important to note that there are commonly occurring interfering substances that
can affect the results reported by hematology analyzers. While the
CELL-DYN 1800 has been designed to detect and flag many of these substances,
it may not always be possible to do so. The following indicates the substances that
may interfere with each of the listed parameters.
WBC: Fragile WBCs, neutrophil aggregates, lytic-resistant RBCs, NRBCs, PLT
clumps, cryofibrinogen, cryoglobulin, paraproteins.
RBC: Elevated WBC count, increased numbers of giant PLTs, auto-
agglutination, 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, cryofibrinogen,
cryoglobulins, PLT clumping, increased numbers of giant PLTs.
For additional information on interfering substances, refer to the table provided in
Appendix B: Reference Tables.
For a detailed description of the flags that are generated, refer to
Section 3: Principles of Operation, Subsection: System-Initiated Messages and
Data Flags.

9140390D—January 2006
System-Initiated Messages and Data Flags Section 3
System-Initiated Messages
System-initiated messages are a means by which the CELL-DYN 1800 notifies the
Operator about the status of the system and potential or actual problems. The
messages can be generated when sensors detect certain hardware and fluidic fault
conditions, and when the software identifies problematic quality control and
patient data conditions. These messages are generated by the following instrument
conditions:
• Fault conditions
• Status conditions
• Alarm conditions
When a fault condition is present, the status box displays the current instrument
state and the red Light-Emitting Diode (LED) on the instrument’s front panel is
illuminated. The message field displays the type of fault. The instrument cannot
process specimens and may be inoperable. The Operator must take steps to correct
the situation and re-initialize the system.
When a status condition is present the LED does not illuminate, but information
will appear in the message field. The instrument is still operable, but the Operator
must perform specific tasks associated with the message.
When an alarm condition (e.g. Waste Full) is present, the status box displays
the ALARM message and the red LED is illuminated. The message field will display
an appropriate message. The instrument will not perform specimen processing
functions until the Operator takes corrective action. It will, however, allow the
Operator to perform some other tasks, such as setup and printing reports.
When necessary, data is suppressed. Causes of and detailed steps for correcting
fault, status, and alarm conditions are provided in Section 10: Troubleshooting
and Diagnostics. After correcting a condition, repeat the sample analysis for any
specimen tested during the time period when the messaged condition occurred.
Flag: No display for measured parameters.
Cause: No result is displayed when the measurement count time is unacceptable.
A message pertaining to the probable cause is displayed to the right of the
affected measurement histogram. When the time for fluid to reach either
detector is too long, CLOG is displayed. When the time to reach either
detector is too short, FLOW ERR is displayed.
Action: Press [CLEAR ORIFICE]. Rerun the specimen when the system is in the
READY state. If CLOG appears again, follow the instructions in
Section 9: Service and Maintenance to clean the aperture plates. If FLOW
ERR appears again:
1. Go to the SPECIAL PROTOCOLS menu.
2. Press [REAGENT PRIME] to refill the Flow System.

9140390D—January 2006
Parameter Data Flags

The CELL-DYN 1800 displays a parameter flagging message when a sample
exhibits any reportable abnormalities. The messages are created when one of the
following sample abnormalities is present:
• Dispersional data alerts
• Suspect parameter flags
• Suspect population flags
Dispersional Data Alerts

There are three levels of limits for the CELL-DYN 1800:
1. Patient Limits are established closest to the normal or typical patient results
and are set according to the type of patient samples to be run. Patient limits
can be defined by the Operator.
2. Panic Limits are set outside the Patient Limits but inside the reportable range.
Panic limits serve to alert the Operator that results deviate from the normal
range by a significant degree. Panic limits can be defined by the Operator.
3. Printed Report Ranges are set by the system software and reflect the defined
limits of the screen display and printer output. These ranges cannot be
changed by the operator.
If results for a parameter fall between the upper Patient Limit and the upper Panic
Limit, the results are highlighted (white lettering on blue background) on the
screen. On the printout, the results are underlined and the letter “H” is printed in
the Flag field. If results for a parameter fall between the lower Patient Limit and
the lower Panic Limit, the results are highlighted (white lettering on blue
background) on the screen. On the printout, the results are underlined and the letter
“L” is printed in the Flag field.
If results for a parameter fall between the upper Panic Limit and the upper Printed
Report Range Limit, the results are highlighted (white lettering on red background)
on the screen, and the letters “HH” are printed in the Flag field on the printout. If
results for a parameter fall between the lower Panic Limit and the lower Printed
Report Range Limit, the results are highlighted (white lettering on red background)
on the screen, and the letters “LL” are printed in the Flag field on the printout.
It is suggested that one Patient Limit Set or the Panic Limits be used to enter
instrument-specific laboratory action limits. A result that falls outside a laboratory
action limit can also indicate the need for the operator to follow a laboratory
protocol, such as repeating the sample, performing a smear review or notifying the
physician. In cases where a cellular abnormality is present that alters cellular
morphology to the extent that the cells do not fit the criteria used by the instrument
to generate a flag, dispersional data alerts may be the only flag(s) that will alert the
operator to a potentially erroneous result.
Action: When a result is flagged with a limits alert, it is recommended that you
follow your laboratory’s review criteria which may include review of a
stained smear to verify the result and to check for the presence of any
additional abnormality.

9140390D—January 2006
If results for a parameter exceed the upper end of the Printed Report Range, a
numeric result does not appear on the screen or Specimen Report. Instead, “greater
than” symbols (>>>>) appear.
Alert messages pertaining to specimens, either patient or Quality Control (QC), are
displayed in place of, or next to, the affected result(s). All run, Data Log, or QC
results for the affected parameter(s) are displayed in inverse video and underlined
on the graphics printout. The name of each flag, the location of the flag on the
display, the cause of the flag, and the action to be taken are as follows:
Flag: > > > > “greater than” symbols are displayed instead of a numeric value
for measured parameters.
Cause: The parameter result exceeds the upper end of the Printed Report Range.
Action: Dilute externally and run specimen again. (For specific instructions, refer
to the Error Messages and Conditions table in
Section 10: Troubleshooting and Diagnostics.)
Suspect Parameter Flags

These flags are generated after the instrument evaluates the measured data for a
particular parameter or group of parameters. The result may be suspect due to
interfering substances or the inability of the instrument to measure a particular
parameter due to a sample abnormality. The name of each flag, how it is displayed,
the cause of the flag, and the action to be taken are given in the following
explanations.
Flag: LYM R0 or RM is displayed between the absolute and percent results of
LYM.
NOTE: RM means more than one alert within the same subpopulation.
Cause: This flag can be caused by:
• Nucleated RBCs
• Platelet clumps
• Giant platelets
• Cryoglobulins
• Incomplete lysis of RBCs
• Small lymphocytes such as those found in chronic lymphocytic
leukemia
• Fibrin clots
• Shift in WBC cell distribution due to EDTA anticoagulant equilibration
Action: Check the specimen for clots or agglutination. Rerun specimen 20 minutes
after collection. Follow your laboratory’s review criteria or review a
stained smear to confirm the differential results and verify the WBC.
Redraw and rerun the specimen as required.

9140390D—January 2006
Flag: LRI - Lower Region Interference is displayed after the PLT result.
Cause: LRI is generally non-biologic and can be caused by:
• Debris (dirty aperture)
• Contaminated reagent
• Electronic noise
• Microbubbles
Action: Check the Background Count. Refer to Section 5: Operating
Instructions. If the Background Count exceeds the limits, troubleshoot
accordingly. If the Background Count is within limits, perform another run
on the same specimen. If the flag persists, review a stained smear to
determine the cause of the interference and verify the PLT count by a
different method.
Flag: URI - Upper Region Interference is displayed after the PLT result.
Cause: URI is generally due to biologic interference. The flag can be caused by:
• Microcytic RBCs
• Schistocytes
• Giant platelets
• Sickle cells
• Platelet clumps
NOTE: An irregular platelet histogram can indicate the presence of platelet
clumps.
Action: Review the MCV and the PLT histogram. If the MCV is low and/or the
histogram indicates an overlap (poor separation in the upper discriminator)
in the RBC and PLT populations, review a stained smear to determine the
cause and confirm the PLT count.
Flag: LRI URI–Multiple region interference is displayed after the PLT result.
Cause: Interference is present in both the upper and lower regions of the platelet
histogram.
Action: Use the actions given for LRI and URI flags.
Suspect Population Flags

These suspect flags are generated when the evaluation of measured WBC data by
the instrument indicates the possible presence of an abnormal subpopulation.
Follow your laboratory’s protocol whenever a suspect population flag is present.
Instructions for interpreting flags should be incorporated into the laboratory’s
review criteria for abnormal results.
Increased or decreased lytic action can also generate flags. The name of each flag,
how it is displayed, the cause of the flag, and the action to be taken are given in the
following explanations:
NOTE: RM means more than one alert within the same subpopulation.

9140390A—March 2003
Flag: LYM R1 is displayed between the absolute and percent results of LYM.
• Lymphocytosis
• Lymphopenia
• Cryoglobulins
• Shift in WBC cell distribution due to EDTA anticoagulant
equilibration.
Flag: LYM R2 is displayed between the absolute and percent results of LYM.
• Lymphocytosis
• Lymphopenia
• Blasts
• Variant lymphocytes
• Plasma cells
• Basophilia
equilibration.
Flag: MID R2 or RM is displayed between the absolute and percent results of
MID.
• Lymphocytosis
• Lymphopenia
• Blasts
• Variant lymphocytes
• Plasma cells
• Basophilia
• Monocytosis
equilibration.

9140390A—March 2003
Flag: MID R3 or RM is displayed between the absolute and percent results of

MID.
• Eosinophilia
• Blasts
• Agranular neutrophils
• Plasma cells
• Basophilia
• Bands
equilibration.
Flag: GRAN R3 or RM is displayed between the absolute and percent results of
GRAN.
• Granulocytosis
• Neutropenia
• Eosinophilia
• Agranular neutrophils
• Bands
equilibration.
Flag: GRAN R4 or RM is displayed between the absolute and percent results of
GRAN.
• Hypersegmented neutrophils
• Granulocytosis
• Neutropenia
• Immature granulocytes
Action: For all of the above Suspect Population Flags, check the specimen for clots
or agglutination. Rerun specimen 20 minutes after collection. Follow your
laboratory’s review criteria or review a stained smear to confirm the
results. Redraw and rerun the specimen as required.
Flag: No MPV result displayed (data suppressed).
Cause: The PLT histogram did not meet expected criteria (for example,
non-lognormal distribution).
Action: Review a stained smear for abnormal PLT morpholgy or the presence of
PLT aggregates and follow your laboratory’s review criteria. Verify the
PLT count.

9140390D—January 2006
NOTES

9140390A—March 2003
Section 3 CELL-DYN 1800 Region Alerts
CELL-DYN 1800 Region Alerts
Histograms are used to graphically show the average size of cells within a specific
cell population, the distribution of cells around a mean, and the presence of
significant subpopulations. Histograms provide additional information to
specimen results. Histogram review for specimens with flagged results (abnormal
size distribution) gives the technologist another valuable interpretive tool.
Region Alerts help direct technologists to specific regions of the WBC histogram
to determine potential abnormal cell types which may require further analysis
through slide review. Cells not meeting normal criteria trigger an alert (Flag). This
alert appears on the screen and also on the hard copy printout, next to the category
of cell flagged. The CELL-DYN 1800 utilizes five alerts: R0, R1, R2, R3, R4 plus
a multiple alert indicated by RM.
CELL-DYN 1800 Lysate-Modified White Cell Regions

Example of a Normal 3-Part Differential Curve
SMALLEST CELLS LAR
GESTS
CELL
R0 R1 R2R2 R3 R3 R4
R0
–Region
0
R1
–Region
1
R2
–Region
2 W BC
R3
–Region
3
R4
–Region
4 L
Y M MID GR
AN
100 200 300 400
Figure 3.1 Regional Alerts and Possible Causes

LYM R0 or RM MID R2 or RM GRAN R3 or RM
Platelet clumps Basophilia Granulocytosis
Giant platelets Blasts/Plasma cells Neutropenia
Nucleated RBCs Monocytosis Eosinophilia
Incomplete lysis of RBCs Lymphocytosis Agranular neutrophils
Cryoglobulins Lymphopenia Bands
Small lymphocytes Variant lymphocytes
Fibrin clots
LYM R1 MID R3 or RM GRAN R4 or RM
Cryoglobulins Bands Granulocytosis
Lymphocytosis Blasts/Plasma cells Neutropenia
Lymphopenia Eosinophilia Hypersegmented neutrophils
Basophilia Immature granulocytes
Agranular neutrophils
LYM R2
Variant lymphocytes
Lymphocytosis
Lymphopenia
Basophilia
Blasts/Plasma cells

9140390A—March 2003
CELL-DYN 1800 Region Alerts Section 3
NOTES

9140390A—March 2003
Section 3 References
References
1. Clinical and Laboratory Standards Institute/NCCLS. Reference and Selected

Procedures for the Quantitative Determination of Hemoglobin in Blood:
Approved Standard-Third Edition. CLSI/NCCLS document H15-A3 [ISBN
1-56238-425-2]. Clinical and Laboratory Standards Institute, 940 West
Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2000.
2. International Committee for Standardization in Haematology, The
Assignment of Values to Fresh Blood used for Calibrating Automated Cell
Counters, Clinical and Laboratory Hematology 1988, 10:203-212.

9140390D—January 2006
References Section 3
NOTES

9140390A—March 2003
Section 4 Overview
Section 4 Performance Characteristics and Specifications

Overview
This section contains detailed information about the CELL-DYN 1800 System.
The performance data contained in this section was generated at Abbott
Diagnostics Division, Santa Clara, California, U.S.A.
Included in this section are:
• Physical Specifications
• Power Specifications
• Bar Code Specifications
• Operational Specifications
• Measurement Specifications
• Performance Specifications
• Performance Characteristics
Interface specifications are not included in this section but can be obtained by
calling the Abbott Diagnostics Customer Service or by contacting your local
Abbott representative.

9140390C—March 2004
Overview Section 4
NOTES

9140390A—March 2003
Section 4 Physical Specifications
Physical Specifications
The physical dimensions for the CELL-DYN 1800 are listed in the tables below.
Table 4.1 Physical Dimensions
Dimension Instrument
Height 17 5/8" (45 cm)
Width 26" (66 cm)
Depth 21" (53 cm)
Weight 124 lbs (56 kg)
Table 4.2 Dimensions after Packaging for Shipment
Dimension Instrument
Height 32" (81 cm)
Width 38 1/2" (98 cm)
Depth 28 1/2" (72 cm)
Weight 232 lbs (105 kg)
NOTE: Refer to your printer operations manual for printer physical

specifications.

9140390C—March 2004
Physical Specifications Section 4
NOTES

9140390A—March 2003
Section 4 Power Specifications
Power Specifications
Power Requirements
Table 4.3 Power Requirements
Instrument Input Requirements
Operative
Voltage Frequency Max Current BTU/Hr
Range
Instrument 100 VAC 90–110 VAC 50/60 ± 3Hz 9 amps 3075

120 VAC 110–140 VAC 50/60 ± 3Hz 7.5 amps 3075
220 VAC 200–240 VAC 50/60 ± 3Hz 4.1 amps 3075
240 VAC 220–260 VAC 50/60 ± 3Hz 3.8 amps 3075
Consumption
Instrument: Average ≤ 300 watts (1030 BTU per hour)
Maximum ≤ 900 watts (3075 BTU per hour)
Printer: Refer to the printer manual for input power requirements for the
printer.
Transport and Storage Specifications

There are no specific environmental conditions for transport or storage.

9140390D—January 2006
Power Specifications Section 4
NOTES

9140390A—March 2003
Section 4 Bar Code Specifications
Bar Code Specifications
Specifications for Bar Code Labels

Quality and clarity in printed bar code labels is critical. High contrast (very dark
bars and clean white spaces) is essential for the bar code scanner to measure the
difference in light reflection between the bars and spaces. The bars of the code must
be printed with precise edges. The dimensional accuracy of the bars must be
consistent throughout the label, and consistent from label to label. Labels on tubes
must be placed in conformance with the distances listed in the specifications.
Bar code labels must meet the following specifications to be used with the
CELL-DYN 1800 System:
• Reflective contrast between bars and label background: > 70%
• Minimum printer resolution: 200 dpi (dots per inch)
• Maximum label length: 51 mm (2.0 in.)
• Minimum label length: 12.7 mm (0.5 in.)
• Maximum label width: 31.8 mm (1.25 in.)
• Minimum distance of the bottom bar of the bar code from the bottom of the
tube: 12.7 mm (0.5 in.)
• Minimum distance of the top bar of the bar code symbol from the bottom of
the tube cap: 5.08 mm (0.2 in.)
• Width of the quiet zones: 5.08 mm (0.2 in)
NOTE: For more information on the placement of the labels on specimen
tubes, refer to Appendix D: Bar Codes.

9140390A—March 2003
Bar Code Specifications Section 4
Specifications for Bar Code Symbologies

Use these specifications to determine whether a type of bar code symbology and
the associated characters will work on the CELL-DYN 1800 System.
• Symbology
– Code 39
– Interleaved 2 of 5
– Codabar
– Code 128 (ANSI® standard)
• Characters:
– All alphanumeric characters enterable from a PC keyboard.
Table 4.4 Character Count for Bar Code Labels
Bar Code Minimum Characters Maximum Characters

Symbology Name per Specimen ID per Specimen ID
Code 39 1 16
Interleaved 2 of 5* 1 16
Codabar 3 16
Code 128 1 16
(ANSI® standard)
Bar Code Labels and specifications are discussed in detail in Appendix D:

Bar Codes.
NOTE: The maximum number of characters includes any check digits within the
code (except for Code 128).
* Interleaved 2 of 5 symbology requires a bar code specimen ID to have an even
number of characters. If the check digit is enabled, the specimen ID may consist
of an odd number of characters, up to 15. If the check digit is not enabled, the
effective range for a specimen ID is 2 to 14 characters.

9140390C—March 2004
Section 4 Operational Specifications
Operational Specifications
Operating Environment
Indoor Use
Laboratory Temperature: 20ºC–30ºC (68ºF–86ºF)
Relative Humidity: 10%–85%, RHNC
Cycle Times
(Ready to Ready)
The cycle times in the normal condition are equal to or less than:
• Auto Start-Up: 250 seconds
• Run: 60 seconds*
• Run-Pre-Dilute Mode: 60 seconds
• Auto-Calibration: 60 seconds
• Auto Shutdown 230 seconds
* A run cycle with a platelet recount is ≤ 90 seconds.
Aspiration Volume
(Whole Blood)
• Open Mode 30 µL
• Pre-Dilute Mode 40 µL

9140390E—June 2008
Operational Specifications Section 4
NOTES

9140390A—March 2003
Section 4 Measurement Specifications
Measurement Specifications
Measurement Channel
The CELL-DYN 1800 has two impedance channels, one for WBC impedance
count and one for RBC and PLT.
WBC and Differential

• Method: Electrical impedance with volumetric metering
• Aperture Size: 100 µm in diameter x 60 µm in length
• Dilution: One part whole blood in 284 parts diluent and lyse
RBC and PLT

• Method: Electrical impedance with volumetric metering
• Aperture Size: 60 µm in diameter x 70 µm in length
• Dilution: One part whole blood in 12,801 parts diluent
HGB
• Method: Modified Methemoglobin with autoblank
• Light Source: LED
• Wavelength: 540 nm
• Dilution: One part whole blood in 284 parts diluent and lyse

9140390A—March 2003
Measurement Specifications Section 4
NOTES

9140390A—March 2003
Section 4 Performance Specifications
Performance Specifications
CELL-DYN 1800 performance has been verified during evaluations performed on

systems operated at Abbott Laboratories.
NOTE: Stated performance specifications apply only when the CELL-DYN 1800
is maintained and operated in accordance with the stated guidelines in this
manual, using the specified diluent, lyse, detergent, and Enzymatic
Cleaner reagents. Any system component change (e.g., recalibration,
reagent lot) can affect the observed results.
Background Counts
Background values must be within the following specifications:
WBC ≤ 0.5 K/µL
RBC ≤ 0.05 M/µL
HGB ≤ 0.1 g/dL
PLT ≤ 10 K/µL
NOTE: Background Specification applies only to WBC, RBC, HGB, and PLT
parameters. There are no background specifications for other parameters.
Any value for a parameter other than the ones listed under Background
Counts should be disregarded.
Linearity
Linearity specifications are determined by analyzing dilutions of a sample of
commercially available control material that contains no interfering substances and
displays no suspect parameter flags. Specifications are determined by taking
multiple measurements on each dilution to minimize the effect of imprecision.
The following table provides useful information concerning system performance
and laboratory requirements under U.S. regulations (Clinical Laboratory
Improvement Amendments of 1988, CLIA-88) and similar requirements in other
countries. In the U.S., CLIA-88 sets the laboratory’s method performance
characteristics validation requirements at any value beyond the limits identified in
the manufacturer’s regulatory submission to the Food and Drug Administration
(FDA); these are represented by the Analytic Measurement Range (AMR) for each
parameter, as established by Abbott.
The Printed Report Ranges (PRR) are the defined limits of the screen display and
printer output. If a result for a parameter exceeds the upper limit of the PRR,
“greater than” symbols (>>>>) appear on the screen or Specimen Report instead of
a numeric result. Refer to Section 10: Troubleshooting and Diagnostics,
Subsection: Index of Error Messages and Conditions, Data Problems for
instructions for diluting specimens when a result(s) is replaced with >>>>.

9140390D—January 2006
Performance Specifications Section 4
Because the PRR are wider than the AMR, values can be displayed/printed that are
beyond the limits of the AMR. In order to report patient results beyond the AMR,
your laboratory must perform validation studies of this expanded range (often
called the “Clinically Reportable Range”). Alternatively, your laboratory may
choose to report patient results as greater than or less than the specific AMR upper
or lower limit, respectively, as determined by the Laboratory Director. (see also
Section 3: Principles of Operation, Subsection: Dispersional Data Alerts).
Table 4.5 Linearity Specifications
Analytic Measurement Absolute Relative

Parameter Printed Report Range
Range Deviation* Deviation*
WBC 0.0–99.9 K/µL 0.8–99.2 K/µL ± 0.4 ≤ 3.0%
RBC 0.00–7.00 M/µL 0.23–6.62 M/µL ± 0.1 ≤ 2.5%
HGB 0.0–24.0 g/dL 0.8–22.7 g/dL ± 0.3 ≤ 2.0%
MCV** 0–200 fL 51–172 fL ± 3.0 ≤ 3.0%
PLT 0–999 K/µL 12–981 K/µL ± 12 ≤ 4.0%
MPV** 0.0–20.0 fL 4.0–32.7 fL ± 1.0 ≤ 3.0%
* From line of identity, whichever value is greater. Applies to actual mean values obtained in reference to the
expected value.
** Derived from polystyrene microspheres.
Carryover
The table below shows carryover percent for WBC, RBC, HGB, and PLT.
Carryover is determined by running specimens with elevated concentrations of
WBCs, RBCs, HGB, and PLTs. Each specimen is run in triplicate followed by three
background cycles. Carryover is calculated using the following formula:
(Background1 - Background3)
Percent Carryover = x 100
(High Specimen Run3 - Background3)
Table 4.6 Carryover—Open and Pre-Dilute Modes
Parameter Level Tested Acceptable Limit
WBC 98.9 K/µL < 1.0%
RBC 6.13 M/µL < 0.5%
HGB 22.3 g/dL < 0.8%
PLT 928 K/µL <1.0%

9140390A—March 2003
Section 4 Performance Specifications
Precision
Samples used to verify precision values should have results that fall within the
laboratory’s reference interval (normal range). These samples must not display any
suspect parameter flags.
Hemogram Parameters
Precision is a check on routine instrument operation. The table below presents the
results of precision specifications for the hemogram parameters for specimens run
in the Open Mode. The stated CV% in these tables represents the instrument
precision from N=20 replicate runs.
Table 4.7 Within-Sample Precision of the Hemogram Parameters
CV%
Parameter Range (95% Confidence
Limit)
WBC 5.0–10.2 K/µL ≤ 2.5%
RBC 4.31–5.52 M/µL ≤ 1.7%
HGB 12.8–16.0 g/dL ≤ 1.2%
MCV 80.9–95.6 fL ≤ 1.5%
PLT 158–423 K/µL ≤ 6.0%
MPV 7.0–12.3 fL ≤ 6.0%
WBC Differential Parameters

Precision specifications for the WBC differential parameters are given as a range
of tolerance for each of the WBC subpopulations.
Table 4.8 Precision of the WBC Differential Parameters
Parameter Result Tolerance
%LYM ± 3.1%
%MID ± 1.6%
%GRAN ± 3.5%
This specification is based on running within-sample precision runs of N=20 with

fresh whole blood.
The Result Tolerances for the WBC differential parameters were determined by
obtaining the difference of individual results in N=20 determinations of the same
sample from the mean of the determinations.

9140390D—January 2006
Performance Specifications Section 4
Correlation
Evaluation of the correlation of the CELL-DYN 1800 Open Mode is shown in the
table below. This data was computed from regression analysis of data obtained
from studies performed on whole blood samples (a minimum of 100 normal and
100 abnormal) analyzed against a reference instrument using similar technology.
Comparable results were obtained from studies performed on whole blood
specimens (a minimum of 40 normal and abnormal) run in the Pre-Dilute Mode.
Table 4.9 Whole Blood Correlation Results
Parameter Correlation Coefficient
WBC ≥ 0.98
%LYM ≥ 0.92
%MID ≥ 0.60
%GRAN ≥ 0.92
RBC ≥ 0.98
HGB ≥ 0.98
HCT ≥ 0.98
MCV ≥ 0.98
RDW ≥ 0.92
PLT ≥ 0.98
MPV ≥ 0.92
Bias
Bias in the CELL-DYN 1800 is measured by the correlation coefficient, because
the restricted range of many hematology parameters precludes the use of a fitted
linear-regression equation to ascertain the bias magnitude, such as is recommended
in CLSI/NCCLS document EP9-A2.1 Also note that this restricted range, along
with the known imprecision of the standard comparative methods, places an upper
limit to the degree of correlation that can be expected for several of the measured
parameters.
Mode-to-Mode Bias
The CELL-DYN 1800 can be calibrated to agree with reference values within the
allowable calibration ranges. Both modes of operation, Open and Pre-Dilute, 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
modes is clinically insignificant.

9140390D—January 2006
Section 4 Performance Characteristics
Performance Characteristics
WBC Differential
Assessment of accurracy of instrument WBC differentials compared to manual
microscopy is based upon studies prescribed by CLSI Standard H-20A2 (Reference
leukocyte differential count (proportional) and evaluation of instrumental
methods). As there are more than 3 WBC types apparent microscopically, and the
CELL-DYN 1800 separates WBC types based on size only, the following logic is
used to simplify microscopic findings into the 3-part CELL-DYN 1800
differential:
Table 4.10 CELL-DYN 1800 Microscopy
CELL-DYN 1800 Microscopy
GRAN Segmented neutrophils

Band neutrophils
Metamyelocytes
Myelocytes
Promyelocytes
MID Monocytes
Eosinophils
Basophils
Promonocytes
Blasts
LYM Lymphocytes
Variant lymphocytes
Prolymphocytes
Plasma cells
Smudge cells
The principles of CLSI H20-A are used to generate a Bayesian (truth table) analysis
of the CELL-DYN 1800 differential performance. In this analysis, the
CELL-DYN 1800 differential is the “test” method that is compared to microscopy
as the “reference” method.
The following data are based upon microscopic evaluatio of 277 blood films in a
population where the prevalence of abnormality (morphological plus
distributional) was approximately 53%. Those microscopic WBC differential
results were compared to 3 CELL-DYN 1800 instruments.
• Agreement = 90.3 – 94.2%
• Sensitivity = 89.9 – 93.3%
• Specificity = 90.1 – 96.1%

9140390E—June 2008
Performance Characteristics Section 4
• Predictive Value of a Positive Result = 91.0 – 96.4%

• Predictive Value of a Negative Result = 89.2 – 92.4%
Predictive value performance is highly dependent upon prevalence of abnormality
in the study population.

9140390D—January 2006
References
1. Clinical and Laboratory Standards Institute/NCCLS. Method Comparison

and Bias Estimation Using Patient Samples; Approved Guideline—Second
Edition. CLSI/NCCLS document EP9-A2 [ISBN 1-56238-472-4]. Clinical
and Laboratory Standards Institute, 940 West Valley Road, Suite 1400,
Wayne, Pennsylvania 19087-1898 USA, 2002.
2. Clinical and Laboratory Standards Institute/NCCLS. Reference Leukocyte
Differential Count (Proportional) and Evaluation of Instrumental Methods:
Approved Standard. CLSI/NCCLS document H20-A [ISBN 1-56238-131-
8]. Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite
1400, Wayne, Pennsylvania 19087-1898 USA, 1992.

9140390D—January 2006
NOTES

9140390D—January 2006
Section 5 Operating Instructions
Section 5 Operating Instructions
Overview
This section discusses the operation of the CELL-DYN 1800 System as follows:
• Instrument Start Up
• Program Operation
• Setup Instructions
• Routine Operation
• Specimen Analysis
• Specimen Collection and Handling
• Using the Data Log
• Shutdown
• Power OFF
Additional system operations information is 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

9140390D—January 2006
Overview Section 5
NOTES

Section 5 Instrument Start Up
Instrument Start Up
After initial installation, the CELL-DYN 1800 power switch must be set to ON at
all times, except as specified for maintenance or long periods of non-use. The
instrument has been designed to automatically maintain itself when it is idle. If the
instrument is idle for four hours (or other Operator-definable duration), an
Automatic Shutdown cycle is initiated. The instrument is placed in STANDBY at
the end of the Automatic Shutdown cycle.
Power to the printer may remain ON or OFF at the Operator’s discretion. For
complete instructions on printer operation, refer to Section 12: Printers and the
printer operations manual.
A complete procedure for powering the system ON is given in Section 5:
Operating Instructions, Subsection: Setup Instructions. The procedure to turn
the system OFF is given in Power OFF at the end of this section.
NOTE: The instrument may be started manually or by using the Auto Start-Up
function.
For a description of the screen elements referred to in this section, see the LCD
screen in Figure 1.8 in Section 1: Use or Function, Subsection: System
Components.
Manual Start-Up Procedure

To manually start up the CELL-DYN 1800, proceed as follows:
1. Confirm that the power plugs for the instrument and printer are inserted into
a grounded power outlet.
2. Set the printer switch to ON. Confirm that the printer paper is installed and
feeding correctly.
NOTE: Power to the printer may remain ON or OFF at the discretion of the
Operator. Refer to Section 12: Printers and the printer operations
manual for complete instructions on printer operation. For
instructions on Printer Setup, refer to Selecting Display and Print
Options later in this section.
3. Check to see that all reagent tubing is properly connected to the correct inlets
and that there is sufficient volume of reagent in the reagent containers.
4. Set the instrument power switch to ON.
5. When INITIALIZED is displayed in the MAIN MENU screen status box,
press [PRIME/RUN] to bring the instrument to the READY state.
NOTE: If the instrument is ON, and STANDBY or INITIALIZED is
displayed in MAIN MENU screen status box, you can process
specimens and perform maintenance functions. To turn off the
equipment, refer to Power OFF at the end of this section.

Instrument Start Up Section 5
6. Prior to running patient specimens, run Background Counts until results are
within appropriate specifications (refer to Running a Background Count
later in this section). If Background Counts remain out of range after three
runs, refer to the Error Messages and Conditions table in Section 10:
Troubleshooting and Diagnostics.
7. Perform a QC Run (See Section 11: Quality Control) before running Patient
Specimens using CELL-DYN 16 Tri-Level or CELL-DYN 22 Tri-Level
control material.
Auto Start-Up Procedure

When the instrument is in the STANDBY state, the Automatic Start-Up cycle will
initialize the instrument, prime the flow system, and check the Background Counts
(refer to Running a Background Count later in this section) at a specified time
each day, bringing the system to the READY state. To activate the Auto Start-Up
option and desired intervals at which it should activate, refer to Section 5:
Operating Instructions, Subsection: Setup Instructions.
Prior to running patient specimens, perform the Daily Quality Control checks as
directed in Performing Daily Quality Control within this section.
After the CELL-DYN 1800 has been idle (i.e., no patient specimens have been run,
nor Operator maintenance functions performed) for more than four hours and is in
the READY or PRIMED state, it enters a STANDBY state.

Section 5 Program Operation
Program Operation
CELL-DYN 1800 operations are menu driven and activated by a membrane

keypad on the instrument’s front panel. Alternatively, the Operator can access
menus by pressing one of the function keys (F1 through F8) on the PC keyboard.
These function keys correspond with the menu labels beginning at the left of the
screen and moving to the right. The maximum number of labels is eight; F1 through
F8.
1 Current menu/screen
title, status of the
instrument, and 1
Operator prompts,
instructions, error, and
fault messages
2 Display area:
Analysis results, setup
selections, and other
Operator information
3 Softkeys perform
functions
2
corresponding to soft
key labels (see 4) on
the LCD screen
4 Softkey labels indicate
4
actions relating to the
current menu, or other
menus to go to,
including return to the
previous screen
3
Figure 5.1 LCD Screen / Membrane keyboard

Program Operation Section 5
MAIN MENU
When the instrument is powered ON, the MAIN MENU screen is displayed. The
MAIN MENU screen is divided into four sections:
• The upper left corner shows the current version of the instrument software.
• The status box is displayed in the top center of the screen in inverse video.
This box appears on every screen to show the following:
– Menu in use
– Analyzer status
– Other applicable information, such as report or file identity, and any
existing Operator-correctable fault conditions
• The upper right corner shows the current date, time, Operator ID, and the
sequence number.
• The cursor is positioned at the <Operator ID> field when the MAIN MENU
screen is displayed. An Operator ID of up to three digits may be entered. This
Operator ID will be displayed on all other screens and printed on all reports.

Section 5 Program Operation
• Eight softkeys that show up as highlighted boxes above their corresponding

membrane keys. Each of the following keys and the functions they provide
are explained throughout this manual:
[SETUP]
[PRIME/RUN] (toggles between PRIME and RUN)
[DATA LOG]
[QUALITY CONTROL]
[CALIBRATION]
[DIAGNOSTICS]
[HELP/ERROR]
[SPECIAL PROTOCOLS]
Figure 5.2 MAIN MENU Screen

Program Operation Section 5
MAIN MENU
MAIN MENU
SETUP PRIME/
PATIENT DATA QUALITY CALIBRATION DIAG- HELP/ SPECIAL
RUN LOG CONTROL NOSTICS ERROR PROTOCOLS
RUN
FAULT HELP RETURN

LOG
LEAVE
HELP
PRINT HELP
PATIENT RETURN
Figure 5.3 MAIN MENU Hierarchy

Section 5 Setup Instructions
Setup Instructions
Using the SETUP Menu

The SETUP menu is used to review and make changes to the following:
• Date and time
• Data formatting on the display screen and to output devices such as printers
and computers
• Patient Limits (all eighteen parameters) and the four basic parameters for
Panic Limits (WBC, HGB, HCT, and PLT)
• Reagent Logs
• Control files, replicate files, and X-B Program
• Units of measure
The SETUP menu is accessed through the MAIN MENU screen. The options
accessible from the SETUP menu are used to configure the instrument according
to the laboratory’s requirements. The SETUP menu is used to review and change
options for data format to output devices such as printers and computers and to
select the units of measure, display, and print format options.
The following print options are available on the SETUP menu.
1. X-B Moving Average Program—When this option is enabled, the X-B
Moving Average Program is activated.
2. Automatic Increment of Specimen ID Number—When this option is turned
ON, the specimen ID number entered will automatically increase by one for
the next specimen, provided the specimen type selected is Patient, and a valid
specimen ID number (0–999999999) was entered. The Auto Increment
function will be suspended if the Operator changes the specimen type from
Patient, the Operator enters a new specimen ID number (either manually or
with the bar code scanner), or an invalid (alphanumeric) specimen ID is
entered.
NOTE: If the Auto Increment function is suspended, Auto will be
displayed at the end of the comment line on the RUN menu. To
restart the function, a new numeric specimen ID must be entered
within the valid range.
3. Print Histograms—The WBC, RBC, and PLT histograms are printed with
each specimen report.
4. Print PCT, PDW—The PCT† and PDW† results are printed with each
specimen report.
5. Print ALERTED LYM/%L, *MID/%M, GRAN/%G Results—The results for
these flagged parameters are printed on the specimen report.
† Clinical significance has not been established for these parameters; therefore,

Setup Instructions Section 5
6. Print ALERTED PLT Results—The results for a flagged PLT are printed on
the specimen report.
7. Automatic Graphics Printout—A specimen report is automatically printed on
the Graphics Printer.
8. Print Manual Differential Grid for ALERTED Specimens—When this option
is enabled, a specimen report with Manual Differential Grid for ALERTED
specimens only will be printed on the Graphics Printer.
9. Print Manual Differential Grid for NON-ALERTED Specimens—When this
option is enabled, a specimen report with Manual Differential Grid for
NON-ALERTED specimens only will be printed on the Graphics Printer.
NOTE: To enable/disable (ON/OFF), the print options 1–9 available on the
SETUP menu, press the [ ] (Enter) key.
10. Enter Printer Type—This option allows the Operator to select the printer
control language: 1–(ESC/P) format; or 2–PCL-3 format.
11. Number of lines for customized header (0 to 4):—Up to four lines
(78 characters) are accepted per entry.
NOTE: To enter the header text press the [ ] (Enter) key twice. The
cursor will move into the text box at the bottom of the screen. Using
the keys on the PC keyboard, enter a header of up to 78 characters
per line.
12. Print current Date/Time and Software Version—When this option is enabled,
the current date, time, and software version are printed.

In addition to allowing for the selection of Display and Print options, the SETUP
menu also provides access to the following submenus:
[DATE/TIME] Set date and time, and select date format.
[PATIENT LIMITS] Enter, review, and change values in patient limit sets
(1–4) and panic limits.
[REAGENT LOG] Select a specific reagent type: diluent, detergent, or
lyse.
[QC SETUP] Set up control files, replicate files, and the X-B
program.
[COMPUTER SETUP] Configure the instrument for data transmission to an
external computer.
[UNITS SELECTION] Select units of measurement for specimen results.
[HELP/ERROR] View HELP text or errors in the Fault Log.
[MAIN] Return to the MAIN MENU screen.
Figure 5.4 SETUP Menu Screen

SETUP MENU
SETUP
DATE/ PATIENT REAGENT QC COMPUTER UNITS HELP/ MAIN

TIME LIMITS LOG SETUP SETUP SECTION ERROR
FAULT HELP RETURN

LOG
LEAVE
HELP
PRINT HELP RETURN
Figure 5.5 SETUP Menu Hierarchy

Selecting Display and Print Options

To review or change print and display options, proceed as follows:
1. From the MAIN MENU screen, press [SETUP].
2. Press the [↑] or [↓] arrow keys to move through the options until the cursor
is at Enter Printer Type. Using the numeric keys on the PC keyboard, select
1 for ESC/P format or 2 for PCL format to select the printer used.
Figure 5.6 SETUP Screen–Printer Setup
3. Press the [↑] or [↓] arrow keys to move through the options and press the
[ ] (Enter) key to toggle between <ON> and <OFF> for the selected print
options (e.g., Print PCT†, PDW†).
4. Use the numeric keys on the PC keyboard to enter the number of lines for the
customized header.
5. Use the alphanumeric keys (Y/N) on the PC keyboard to print the current date
and time or software version.
6. Press [MAIN] to return to the MAIN MENU screen.
NOTE: The default selection on the RUN screen includes display of all
individual parameters except PCT† and PDW.† If PCT† and PDW†
are not displayed, their values will not be transmitted to the LIS.
† Clinical significance for these parameters have not been established, therefore

Entering or Changing the Date and Time

An internal, battery-powered clock maintains the date and time which are
displayed in the upper right portion of the screen. The CELL-DYN 1800 can
display any date between 1 January 2000 and 31 December 2079. Multiple date
format options allow the Operator to select the desired date format.
The [DATE/TIME] key allows the Operator to enter the date in one of the
following formats:
• mm/dd/yy (month, day, year)
• dd/mm/yy
• yy/mm/dd
• yy/dd/mm
NOTE: Date re-entry is not required when a new format option is selected
and the current date is correct.
The clock differentiates between A.M. and P.M., and the Operator enters the time
using four digits in the following format:
• hh:mm (hour:minutes)
When entering a new time, use a 24-hour clock. (For example, 01 for 1 AM, 13 for
1 PM, and 00 for 12 midnight.)
NOTE: Although time is entered using a 24-hour format (00:00–23:59), the
display screen shows the time as “am” or “pm”.
Figure 5.7 DATE/TIME Setup Screen

To Change the Date and Time

To enter or change the date and time, proceed as follows:
1. From the SETUP menu, press [DATE/TIME].
2. The DATE/TIME SETUP menu is displayed.
3. Using the numeric keys on the PC keyboard, select the number (1 through 4)
for the desired date format option.
4. Using the alphanumeric keys on the PC keyboard, enter the new date and
time.
5. Press the [ ] (Enter) key to accept the new date or time.
6. Press [RETURN] to return to the SETUP menu.

Automatic Start-Up and Shutdown

The DATE/TIME SETUP menu also allows the Operator to activate the Auto Start
Up function, and change the time for Auto Shutdown.
The Auto Start-Up function allows the Operator to set the time at which the
instrument will automatically initialize and prime the instrument for specimen
processing.
The Auto Shutdown function allows the Operator to choose the number of idle
hour(s) will remain before the instrument executes the Auto Shutdown procedure.
To Select Auto Start-Up

To set up Automatic Start-Up, proceed as follows:
1. Press [AUTO STARTUP]. On the AUTO START-UP menu, verify that the
Automatic Analyzer Start-up option is ON. (With the cursor positioned on
this option, use the [ ] (Enter) key to toggle between ON and OFF).
Figure 5.8 AUTO START-UP Screen
2. Move the cursor to the appropriate space on the Time line. Using the numeric
keys on the PC keyboard, enter the hour and minute for automatic start-up of
the instrument.

To Change Auto Shutdown

The default time for Auto Shutdown is four hours. The default time is displayed in
the status box. To select the idle hour at which the instrument performs automatic
shutdown, and goes into the STANDBY state, proceed as follows:
1. Press the [←] and [→] arrow keys to place the cursor on the number of idle
hours (2, 3, or 4) before Auto Shutdown is to occur. Press the [ ] (Enter)
key to accept the change.
Figure 5.9 AUTO SHUTDOWN Screen
2. Press [RETURN] twice to return to the SETUP menu.

Patient Limit Sets

There are five Patient Limit Sets available on the CELL-DYN 1800. Patient limits
within each limit set on the CELL-DYN 1800 are factory set at installation and act
only as a guide. Each limit set has a default name assigned at the factory.
NOTE: Because the limits are Operator definable, individual laboratories should
modify them based on their patient population.
The five limit set selections available on the CELL-DYN 1800 are as follows:
[LIMIT SET 1]
[LIMIT SET 2]
[LIMIT SET 3]
[LIMIT SET 4]
[PANIC LIMITS]
Figure 5.10 PATIENT LIMITS Screen
Upper and lower alert limits for patient specimen results can be entered, viewed,
and changed as necessary. For a discussion of the alerts displayed on the screen and
printed on the graphics printout when specimen results fall outside the patient
limits or panic limits, refer to Section 3: Principles of Operation, Subsection:
System-Initiated Messages and Data Flags.

PATIENT LIMITS MENU
PATIENT LIMITS
LIMIT LIMIT LIMIT PANIC PRINT HELP/ RETURN

SET 2 SET 3 SET 4 LIMITS ERROR
LIMIT
SET 1
PRINT HELP/ RETURN

ERROR
FAULT PRINT HELP RETURN

LOG
LEAVE
HELP
PRINT HELP RETURN
FAULT HELP RETURN

LOG
LEAVE
HELP
PRINT HELP RETURN
Figure 5.11 PATIENT LIMITS Menu Hierarchy

Changing Patient Limits

To enter, review, or change upper and lower limits for patient specimen results,
proceed as follows:
1. At the SETUP menu press [PATIENT LIMITS]. The PATIENT LIMITS
menu for Limit Set 1 is displayed. Press [LIMIT SET 2], [LIMIT SET 3], or
[LIMIT SET 4] to display the default values for the desired limit set.
Figure 5.12 PATIENT LIMITS Screen
2. Use the [↑] and [↓] arrow keys to move between rows of parameters.
3. Use the [←] and [→] arrow keys to select the desired lower or upper
parameter range.
4. Use the numeric keys on the PC keyboard to change values, pressing the [ ]
(Enter) key to accept the new limits.
NOTE: Panic Limits are set outside the Patient Limits, but inside the
reportable range, and serve to alert the Operator that results deviate
from the normal range by a significant degree.

Changing Panic Limits

To enter, review, or change upper and lower panic limits for patient specimen
results, proceed as follows:
1. At the SETUP menu press [PATIENT LIMITS]. The PATIENT LIMITS
menu for Limit Set 1 is displayed. Press [PANIC LIMITS]. The PANIC
LIMITS menu is displayed with upper and lower default limits for the
following parameters: WBC, HGB, HCT and PLT.
Figure 5.13 PANIC LIMITS Screen
3. Use the [←] and [→] arrow keys to select the desired lower or upper
parameter range.
NOTE: Panic Limits are set outside the Patient Limits, but inside the reportable
range, and serve to alert the Operator that results deviate from the normal
range by a significant degree.

Reagent Log
[REAGENT LOG] allows the Operator to select a specific reagent type: diluent,
detergent, or lyse. The Reagent Log also allows the Operator to enter, review, or
print the reagent log which consists of the following: package size, lot number,
expiration date, and open date for up to 12 packages per reagent.
Figure 5.14 REAGENT LOG Screen

REAGENT LOG MENU
REAGENT LOG
DILUENT DETERGENT LYSE HELP/ RETURN

LOG LOG LOG ERROR
DELETE PRINT HELP/ RETURN

ENTRY LOG ERROR
FAULT PRINT HELP RETURN

LOG
LEAVE
PRINT HELP RETURN HELP
FAULT HELP RETURN

LOG
LEAVE
PRINT HELP RETURN HELP
Figure 5.15 REAGENT LOG Menu Hierarchy

Creating the Reagent Log

To create a Reagent Log, proceed as follows:
1. In the SETUP menu, press [REAGENT LOG]. The REAGENT LOG
menu is displayed.
2. Select the desired Reagent Log by pressing [DILUENT LOG],
[DETERGENT LOG], or [LYSE LOG].
Figure 5.16 DILUENT LOG Screen
The selected log screen is displayed with the cursor positioned on the first
blank line of the log.
3. Using the alphanumeric keys (including punctuation symbols) on the PC
keyboard, enter the package size, lot number, expiration date, and open date.
Press the [ ] (Enter) key after each entry to store the data and to
automatically advance the cursor to the next field on the same line.
Repeat this process until all entries for the Reagent Log are complete.
NOTE: Type the date entries using the same date format as the system’s
main <Date/Time> field—seen in the upper right-hand corner of
the display. For example, if the main Date/Time format is
29 Jan 2000, then enter 29/01/00 for the date entries.
4. Press [PRINT LOG] to print the log.
5. Press [RETURN] to return to the REAGENT LOG menu.

Quality Control Setup

The QC SETUP menu allows access to submenus where the Operator can edit the
lot number and expiration date for the selected control files, enter means and range
values for the selected control file, replicate file, or X-B program, select which
Westgard® Rules will be applied to quality control results, and create an
identification file for the CELL-DYN user.
Parameter results for any control run that fall outside of these entered limits are
displayed with white lettering on a blue background, underlined on the printout and
printed with an asterisk (*). From the MAIN MENU screen, press [SETUP], then
[QC SETUP] to access the QC SETUP menu.
When [QC SETUP] is pressed, the following softkeys are available:
[X-B SETUP]
[LAB ID SETUP]
[LOW CONTROL]
[NORMAL CONTROL]
[HIGH CONTROL]
[REP FILE SETUP]
[HELP/ERROR]
[RETURN]
Figure 5.17 QC SETUP Screen

QUALITY CONTROL SETUP MENU

QC SETUP
X-B LAB ID LOW NORMAL HIGH REP FILE HELP/ RETURN

SETUP SETUP CONTROL CONTROL CONTROL SETUP ERROR*
PRINT HELP/ RETURN

ERROR*
FILE HELP/ RETURN

SETUP ERROR*
RANGE MEAN/ HELP/ RETURN

ENTRY LIMITS ERROR*
LOAD PRINT HELP/ RETURN

FROM DISK ERROR*
CONFIRM CANCEL
LOAD LOAD
FILE HELP RETURN

SETUP ERROR*
RANGE REPLICATE HELP

MEANS/ RETURN
ENTRY ID ERROR*
LIMITS
LOT
NUMBER
PRINT HELP RETURN

ERROR*
FAULT HELP RETURN

LOG
LEAVE
HELP
PRINT HELP RETURN
Figure 5.18 QUALITY CONTROL SETUP Hierarchy

* HELP/ERROR configuration applies throughout menu

X-B Setup
X-B Setup is used to review or change the X-B (Moving Average) program upper
and lower acceptance limits, target values, and action limits for the red cell indices
(MCV, MCH, and MCHC). Calculated data for each batch (20 specimens) is
compared to an established X-B target and limits to determine if the X-B batch data
is acceptable. To eliminate bias from grossly abnormal specimen results, data
acceptance limits are set, via the X-B SETUP menu, to automatically exclude
these specimens from the program.
NOTE: MCV, MCH, and MCHC from patient specimens are automatically
included when the program is turned on.
NOTE: Use of the X-B Moving Average Program is recommended only for labs
that run at least 100 patient specimens per day.
Changing Values in the X-B Function

To change values for the X-B (Moving Average) program, proceed as follows:
1. In the QC SETUP menu, press [X-B SETUP].
The X-B SETUP menu is displayed, and the cursor is on the MCV lower
limit.
Figure 5.19 X-B SETUP Screen
3. Use the [←] and [→] arrow keys to select the lower/upper limits, target value,
or action limit for the desired parameter.

5. Press [RETURN] to return to the QC SETUP menu.
6. Press [RETURN] to return to SETUP menu.
NOTE: When the entries are saved, the software checks to see if any entries
would result in the upper limit being less than the lower limit. If this
situation occurs, the limits are automatically reversed.

Lab ID Setup
Lab ID Setup is used to create an identification file for the CELL-DYN user. The
following information can be entered into a laboratory’s ID file: customer ID#,
institution name, address, phone, and laboratory contact.
NOTE: Lab ID Setup must be completed prior to downloading QC data to a
floppy disk.
Setting Up A Laboratory ID File

To set up the ID file for your laboratory, proceed as follows:
1. In the QC SETUP menu, press [LAB ID SETUP].
2. Use the [↑] and [↓] arrow keys to move between laboratory data
identification fields.
Figure 5.20 LAB ID SETUP Screen
3. Use the alphanumeric keys (including punctuation symbols) on the PC

keyboard to enter or change data in the desired fields.
4. Press the [ ] (Enter) key to accept the values.
5. Press [RETURN] to return to the QC SETUP menu.
6. Press [RETURN] to return to SETUP menu.

Control File Setup

(Low, Normal, High)
Low Control, Normal Control, and High Control keys allow the Operator to access
four separate control files (for each level of control) to enter, review, change, or
print data pertaining to selected file(s), to turn any of the six Westgard® Rules ON
or OFF in each of the four control files, and to change Range Entry and Mean/
Limits in each of the four control files. Any run result exceeding these entered
limits is highlighted in inverse video on the screen and underlined on the graphics
printout.
Selecting a Specific Control File

To select a desired control file, proceed as follows:
1. In the QC SETUP menu, press the corresponding key for the desired type of
control to be updated: [LOW CONTROL], [NORMAL CONTROL], or
[HIGH CONTROL].
2. Use the [↑] and [↓] arrow keys to select one of four control files displayed.
Figure 5.21 LOW CONTROL Screen
3. Press [FILE SETUP] to display the File Setup screen which allows the
Operator to edit the lot number and expiration date for the selected control
file, to select which Westgard® Rule will be applied to quality control results,
and to change Range Entry and Means/Limits in each of the four files.
4. Use the [↑] and [↓] arrow keys to move between the lot number, expiration
date, or Westgard® Rules.

Entering the Lot Number

To enter the lot number, proceed as follows:
1. Using the alphanumeric keys (including punctuation symbols) on the PC
keyboard, enter the lot number (up to nine characters) from the control tube
or assay sheet.
NOTE: The reagent lot number from a control tube may also be entered
using the Bar Code Scanner.
Figure 5.22 LOT NUMBER SETUP Screen
2. Press the [ ] (Enter) key to accept the lot number.

Entering the Expiration Date

To enter the lot number expiration date, proceed as follows:
1. Using the numeric keys on the PC keyboard, type the expiration date from
the control tube or assay sheet.
Figure 5.23 EXPIRATION DATE SETUP Screen
2. Press the [ ] (Enter) key to accept the date.

Selecting Westgard® Rules

Westgard® Rules can be applied to the analysis of QC results, with Westgard® Rule
warnings viewable on screen and printed on reports.
To select which Westgard® Rules will be applied to QC analysis, proceed as
follows:
1. Using the [↑] and [↓] arrow keys to select the desired Westgard® Rule.
Figure 5.24 WESTGARD® RULE SETUP Screen
2. Press the [ ] (Enter) key to turn the desired rule ON or OFF.

9140390C—March 2004
Entering Range Limits

To enter the selected control file’s range limits, proceed as follows:
1. To enter control range limits, press [RANGE ENTRY] in the selected control
file’s SETUP menu.
2. Use the [↑] and [↓] arrow keys to move between parameters.
Figure 5.25 RANGE ENTRY SETUP Screen
3. Use the [←] and [→] arrow keys to select the lower or upper limits for the
selected parameter.
4. Use the numeric keys on the PC keyboard to enter values for the desired
parameter.
NOTE: Press [LOAD FROM DISK] to load control assay data from a
floppy disk into the selected QC file. [CONFIRM LOAD] and
[CANCEL LOAD] are used to load assay values from disk, or to
cancel the load operation, respectively.

Entering Mean/Limits
To enter the parameter and limit values for the selected control file, proceed as
follows:
1. Press [MEAN/LIMITS] in the selected control file’s SETUP menu.
2. Use the [↑] and [↓] arrow keys to move between parameters.
Figure 5.26 MEAN/LIMITS SETUP Screen
3. Use the [←] and [→] arrow keys to select the mean or limits for the selected
parameter.
4. Use the numeric keys on the PC keyboard to enter values for the desired
parameter.
NOTE: Press [LOAD FROM DISK] to load control assay data from a
floppy disk into the selected QC file. [CONFIRM LOAD] and
[CANCEL LOAD] are used to load assay values from disk, or to
cancel the load operation, respectively.

Rep File Setup

Replicate File Setup allows the Operator to access one of nine replicate files to
enter, review, change, or print data pertaining to the selected file, to turn any of the
six Westgard® Rules ON or OFF in each of the files, and to change Range Entry
and Mean/Limits in each of the files. Replicate files are designated for use with
replicate “control” specimens, such as the following:
• Retained patient specimens
• Different shift control specimens
• Parallel testing of new lot numbers
• Precision check specimens
• Calibration verification specimens
For each replicate file, the Operator can enter values for any parameter (up to 18),
with mean and limits, or upper and lower range.
Figure 5.27 REPLICATES Screen

Setting Up a Replicate File

To set up a replicate file, proceed as follows:
1. In the [QC SETUP] menu, press [REP FILE SETUP] to display the
REPLICATES menu.
Figure 5.28 REPLICATE FILE SETUP Screen
2. Use the [↑] and [↓] arrow keys to select the desired replicates, and press
[FILE SETUP]. The File Setup screen for the desired replicate file
(REPLIC1 to REPLIC9) is displayed.
NOTE: The <Lot Number> field is automatically displayed. To set the
<Replicate ID> field, press [REP ID].

Entering the Replicate ID

In the REPLICATE ID menu, [LOT NUMBER] toggles to [REPLICATE ID]
allowing the Operator to enter the Replicate ID number.
To enter a replicate ID, proceed as follows:
1. Press [REPLICATE ID].
Figure 5.29 REPLICATE ID SETUP Screen
2. Use the alphanumeric keys (including punctuation symbols) on the PC

keyboard, enter the replicate ID (up to nine characters).
3. Press the [ ] (Enter) key to accept the Replicate ID number.

Computer Setup
Computer setup allows the Operator to configure the instrument for automatic data
transmission to an external (host) computer, or to a Laboratory Information System
(LIS).
Setting Up the Instrument for Data Transmission

To configure the instrument for automatic data transmission, proceed as follows:
1. In the SETUP menu, press [COMPUTER SETUP].
Figure 5.30 COMPUTER SETUP Screen
2. Press the [ ] (Enter) key to toggle between ON and OFF selections.

3. Press the [↑] and [↓] arrow keys to move through the selections on the
display screen.
4. Using the numeric keys on the PC keyboard to enter the following:
• Time-out
• Data bits
• Stop bits
• Parity
• Computer Baud Rate
5. Press the [ ] (Enter) key to confirm the values.

Units Selection
Units Selection allows the Operator to select one of the following four units of
measure for specimen results:
1 = FACTORY (United States)
2 = SI UNITS
3 = SI UNITS (HGB/MCHC in mmol/L, MCH in fmol)
4 = SI UNITS (HCT/PCT† in %)
NOTE: Verify reference ranges when changing units of measurement.
The default setting is 1 = FACTORY (United States). SI units are System
International Units.
Entering or Changing Units of Measure

To enter or change units of measure, proceed as follows:
1. From the SETUP menu, press [UNITS SELECTION].
Figure 5.31 UNITS SELECTION Screen
2. Using the numeric keys on the PC keyboard, enter the number associated
with the desired unit of measure.
† Clinical significance for these parameters have not been established, therefore

Help/Error
HELP/ERROR allows the Operator to view and print up to sixteen previous errors
in a Fault Log, or view Help text. Pressing [HELP] allows the Operator to view the
Help text. The [LEAVE HELP] key allows the Operator to return to the previous
screen.
Figure 5.32 HELP Screen

If a Fault Log exists, the [FAULT LOG] key will appear. Pressing [FAULT LOG]
allows the Operator to view the errors in the Fault Log.
Figure 5.33 FAULT LOG Screen

Section 5 Routine Operation
Routine Operation
Routine operation of the CELL-DYN 1800 proceeds from the RUN menu, which
is accessed in the MAIN MENU screen. Information and procedures related to the
RUN menu and submenus accessed from it are presented on the following pages.
When the green READY light on the front panel is illuminated and the READY
message appears in the status box of the RUN menu, the instrument is ready for
specimen analysis.
The instrument is not ready to run specimens when the amber-colored BUSY light
is illuminated. This means another activity is taking place, as indicated by the
current status box message.
Daily Start-Up Procedures

Running a Background Count
Run a Background Count on a daily or regular basis as follows:
1. Perform a specimen run without placing a specimen under the sample
aspiration probe. Press the [RUN] key in the MAIN MENU screen. Then
press the [SPECIMEN TYPE] key followed by [NORMAL BACKGRND].
Press the Touch Plate. (Only reagents are cycled through the system.)
NOTE: All previous results displayed on the current RUN screen will be
deleted.
2. Note results that are displayed when the run cycle has been completed.
3. Repeat the procedure if the Background Counts do not fall within the
following acceptable ranges:
• WBC ≤ 0.5 K/µL
• RBC ≤ 0.05 M/µL
• HGB ≤ 0.1 g/dL
• PLT ≤ 10 K/µL
If the results are unacceptable, perform a third run. If the results are still
unacceptable, refer to Section 10: Troubleshooting and Diagnostics.
Performing Daily Quality Control

On a daily basis, before running patient specimens, perform Quality Control (QC)
procedures according to your laboratory’s protocol. For QC Run instructions, refer
to Section 11: Quality Control, Subsection: Quality Control Procedures.
When Background Counts and Quality Control results are acceptable, patient
specimens can be analyzed.

Routine Operation Section 5
Run Menu Screen Display

The upper left corner of the RUN menu displays the following demographic data
fields:
1. <Next ID#:> accepts the ID number for the next specimen to be run. Up to
sixteen characters may be entered. For more information about this feature,
refer to Specimen Analysis later in this section.
NOTE: If the Auto Increment function is turned ON, “AUTO” will appear
to the right of the <Cmt:>.
2. <Patient:> accepts the patient’s name. Up to sixteen alphanumeric characters
may be entered.
3. <Sex (M/F):> accepts sex information of the patient. Only M or F is accepted;
all other characters are ignored.
4. <DOB:> accepts the patient’s date of birth using the format designated in the
SETUP menu.
5. <Dr> accepts the doctor’s name. Up to twenty-two characters may be entered.
6. <Collected><at> accepts the date and time the specimen was taken from the
patient. For date, use month and day only. For time, use the format designated
in the DATE/TIME SETUP menu.
7. <Cmt:> accepts comments. Up to sixteen characters may be entered.
The Status Box is displayed in the top center of the RUN menu. It contains the
following information:
• Menu in use
• Status of the instrument (for example, READY)
• Fault messages
• Informative messages (during the run cycle) such as the following:
– Aspirating
– Dispensing
– Remove specimen
– Counting
– Recount
– Rinsing
Below the status box: Results displayed on the RUN screen are identified
according to specimen type. A patient specimen is identified by the ID number.
Directly below the status box: When [PRE-DILUTE] is selected, the message
Pre-Dilute Mode is displayed in inverse video.

The upper right corner of the RUN menu displays the following information:
• Current date and time
• Operator ID—identification of the current Operator
• Sequence number—automatically incremented as specimens are run
• Limit set (1 to 4, defaults to 1)—only when Patient is the selected specimen
type
• X-B status—if the X-B program was activated in the SETUP menu

RUN Menu
The [PRIME/RUN] key on the MAIN MENU screen is used to display the RUN
menu. A description of the function of each softkey is given in this section.
Instructions for running specimens and using the Data Log are provided later in this
section. The following softkeys are displayed on the RUN menu:
[CLEAR ORIFICE] / [CLEAR ALARM] (toggles between these two keys)
[PRE-DILUTE]
[SPECIMEN TYPE]
[PARAMETER SELECT]
[PRINT REPORT]
[HELP/ERROR]
[MAIN]
Figure 5.34 RUN Menu Screen

RUN MENU
RUN
PRE- SPECIMEN PARAMETER PRINT HELP/ MAIN

DILUTE TYPE SELECT REPORT ERROR*
CLEAR
ORIFICE
CLEAR
ALARM
FILE HELP/ RETURN

SETUP ERROR*
PATIENT QC NORMAL ELECTRICAL HELP/ RETURN

SPECIMEN TYPE BACKGRND BACKGRND ERROR*
LOW NORMAL HIGH REPLICATE HELP/ RETURN

ERROR*
FILE HELP/ RETURN

SETUP ERROR*
FAULT HELP RETURN

LOG
LEAVE
HELP
PRINT HELP RETURN
Figure 5.35 RUN MENU Hierarchy


Clear Orifice/
Clear Alarm
The [CLEAR ORIFICE] key is the default key that appears on the RUN menu.
When a fault occurs on the instrument, this key changes to [CLEAR ALARM].
[CLEAR ORIFICE] initiates the aperture cleaning sequence that flushes the WBC
and RBC/PLT apertures to remove obstructions. When [CLEAR ORIFICE] is
pressed, the message Clearing Orifice is displayed in the status box.
[CLEAR ALARM] is used to reset the instrument after the Operator has corrected
the problem. When [CLEAR ALARM] is pressed, the message Clearing
Alarm is displayed in the status box.
NOTE: Do not press [CLEAR ALARM] until you have corrected the problem.
Pre-Dilute
[PRE-DILUTE] turns the Pre-Dilute Mode run cycle ON and OFF. The Pre-Dilute
Method is used when the amount of blood sample available is insufficient for
accurate analysis using the normal run cycle. When ON, the Pre-Dilute Mode
message appears directly below the status box. This soft key is highlighted in dark
blue. The Sample Aspiration Probe is raised and placed over the RBC/PLT Mixing
Chamber. This allows the Operator to open the Upper Front Cover and pour a pre-
diluted 40-µL sample to 10-mL diluent solution into the Pre-Mixing Cup (initial
dilution bath). The Operator presses the Touch Plate, and the instrument processes
the sample.
NOTE: For instructions on opening/removing the Front Covers, refer to Section
2: Installation Procedures and Special Requirements, Subsection:
Opening/Removing Front Covers, Version A, or Opening Front Covers,
Version B. The procedure for preparing pre-diluted samples is provided
in Running Specimens—Pre-Dilute Mode later in this section. The
procedure to calibrate in the Pre-Dilute Mode is discussed in detail in
Section 6: Calibration Procedures, Subsection: Pre-Dilute Auto-Cal
Procedure—Calibrator.

Specimen Type
[SPECIMEN TYPE] is used to select the type of specimen that will be run. When
[SPECIMEN TYPE] is pressed, the following soft keys are available:
[PATIENT SPECIMEN]
[QC TYPE]
[NORMAL BACKGRND]
[ELECTRICL BACKGRND]
[HELP/ERROR]
[RETURN]
Patient Specimen
[PATIENT SPECIMEN] is used to run patient specimens. Patient identification
may be entered on the RUN menu after this key is pressed. Results from this run
option are stored in the Data Log. Only patient specimens can be included in the
X-B program.
QC (Quality Control) Type

[QC TYPE] is used to select the QC CONTROL FILES submenu displaying
[LOW CONTROL], [NORMAL CONTROL], [HIGH CONTROL], and
[REPLICATES]. Data from these control runs is automatically stored in the
designated QC file and in the Data Log.
Normal Background
[NORMAL BACKGRND] is used to select a special run mode and to display the
background results. Normal Background is used to determine the absence of
contaminants and particulates, and the interference of reagents (diluent, detergent,
lyse). Results from this run option are identified by the designation BACKGRD in
the Data Log. A Normal Background will be automatically run as part of the startup
sequence, and should be run immediately prior to running a patient or control
specimen if the system has been idle for fifteen minutes or more.
Electrical Background
[ELECTRICL BACKGRND] is used to select the run mode for Electrical
Background counts. Electrical Backgrounds are used to check for electrical
interference in the system. (Aperture current is turned OFF during this cycle.)
Results from this run option are identified by the designation ELEC BKGD in the
Data Log.
NOTE: Electrical backgrounds are normally only run as part of a troubleshooting
sequence. Refer to Section 10: Troubleshooting and Diagnostics.

Help/Error
[HELP/ERROR] accesses a menu that has a [FAULT LOG] key and [HELP] key.
If a fault is pending, when [HELP/ERROR] is pressed, a list of up to sixteen
previous errors will be displayed. Otherwise, pressing [FAULT LOG] allows the
Operator to view the errors.
Pressing [HELP] allows the Operator to view the Help text. The [↑] and [↓] arrow
keys are used to view additional Help information, if there is more than one screen
of text. Press [LEAVE HELP] to exit the Help information screen.
Return
Press [RETURN] to return to the RUN menu.
Parameter Select
[PARAMETER SELECT] allows the Operator to choose the parameters to be
displayed and printed. The Operator can designate individual or all parameters to
be ON or OFF.
Print Report
[PRINT REPORT] is used to print a copy of the current run data. It is used when
the automatic graphics print feature is set to OFF. (When no paper is in the printer,
the message Printer NOT READY/PRESS HELP/ERROR KEY appears in
the status box.)
Help/Error
If a fault is pending when [HELP/ERROR] is pressed, a list of up to sixteen
Main
Press [MAIN] to return to the MAIN MENU screen.

Section 5 Specimen Analysis
Specimen Analysis
This section provides guidelines and instructions for routine specimen analysis.
For more information, refer to Section 3: Principles of Operation, Subsection:
Sample Analysis Cycle Overview.
• Perform Background counts and Quality Control according to laboratory
protocol.
• Specimens must be well-mixed and checked for clots before they are run.
• Always enter specimen identification before performing a specimen analysis
run.
• Specimens can be analyzed whenever READY is displayed in the status box
on the RUN menu.
All performance statements given in this manual were generated from specimens
collected in K2EDTA anticoagulant.
Interfering Substances
It is important to note that there are commonly occurring interfering substances that
can affect the results reported by hematology analyzers. While the
CELL-DYN 1800 has been designed to detect and flag many of these substances,
it may not always be possible to do so. The following indicates the substances that
may interfere with each of the listed parameters.
WBC: Fragile WBCs, neutrophil aggregates, lytic-resistant RBCs, NRBCs, PLT
clumps, cryofibrinogen, cryoglobulin, paraproteins.
RBC: Elevated WBC count, increased numbers of giant PLTs, auto-
agglutination, 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, cryofibrinogen,
cryoglobulins, PLT clumping, increased numbers of giant PLTs.
For additional information on interfering substances, refer to the table provided in
Appendix B: Reference Tables.
For a detailed description of the flags that are generated, refer to Section 3:
Principles of Operation, Subsection: System-Initiated Messages and Data Flags.

9140390D—January 2006
Specimen Analysis Section 5
Specimen Stability
Well-mixed whole blood specimens, collected in K2EDTA anticoagulant and
analyzed within 8 hours after collection, provide the most accurate results for
hemogram parameters. White blood cell size distribution can shift if specimens are
tested within the first 30 minutes following collection or more than 8 hours after
collection. In particular, specimens tested within 30 minutes may be associated
with false Suspect Population Flags due to WBC population shifts. If flagging does
occur, follow corrective action(s) listed in section 10 before reporting results.
Small shifts may be observed for MCV and MPV within this 30-minute post
collection interval. Please note that published studies indicate that MPV results can
be affected by EDTA for up to 2 hours after collection. Most accurate MPV results
are obtained between 2 and 8 hours after collection.3, 4
The stability of capillary specimens collected in microcollection tubes can vary
depending on the tube manufacturer. Refer to the manufacturer’s package insert for
stability claims.
Specimen Collection
All specimens must be collected per the tube manufacturer’s directions and
disposed of using proper techniques.1, 2 A minimum of 50 µL must be collected for
micro-collection specimens. This ensures an adequate amount of blood for the
30 µL aspiration.
NOTE: Refer to Section 4: Performance Characteristics and Specifications for
minimum specimen volume requirements to ensure accurate results. For
additional information on collecting venous and capillary specimens,
refer to the most current editions of CLSI documents H3 (venipuncture)
and H4 (capillary collection).

9140390E—June 2008
Entering an Operator ID
The Operator ID is entered from the MAIN MENU screen. When this screen is
selected, the cursor is positioned in the <Operator ID> entry field.
1. From the RUN screen, press [MAIN].
2. At the cursor prompt in the <Operator ID> field, enter an Operator
identification (of up to three characters) using the numeric keys on the PC
keyboard.
Figure 5.36 OPERATOR ID Setup
3. Press [ ] (Enter) to save the ID number if it is less than three characters.

NOTE: The Operator ID is displayed on all screens and printed on all
reports. It is also retained in the QC Logs and the Data Log.

9140390D—January 2006
Entering a Specimen ID
The ENTER ID screen is used for entering a specimen identification of up to 16
alphanumeric characters.
Manual Entry
To enter a specimen ID, proceed as follows:
1. From the RUN screen, press [SPECIMEN TYPE].
Figure 5.37 SPECIMEN TYPE Screen
2. In the SPECIMEN TYPE screen, press [PATIENT SPECIMEN].

9140390D—January 2006
Figure 5.38 PATIENT SPECIMEN ID ENTRY Screen
3. The cursor is placed in the <NEXT ID#> entry field. Use the alphanumeric
keys (including punctuation symbols) on the PC keyboard to enter a
specimen ID of up to 16 characters.

9140390D—January 2006
Bar Code Scanner Entry

When using a bar code scanner to scan a specimen ID into the CELL-DYN 1800
system, be sure to configure the bar code scanner for bar code label symbologies
used in your lab. (Refer to Section 4: Performance Characteristics and
Specifications, Subsection: Bar Code Specifications.)
To scan a specimen ID from a bar code label, proceed as follows:
1. While in the RUN screen, hold the bar code scanner two to five inches away
from the bar code labeled patient specimen tube, and aim directly at the bar
code.
Figure 5.39 Scan of Bar Code Label
2. Squeeze the trigger handle on the underside of the scanner to activate the red
light beam. Aim the beam to scan horizontally across the entire bar code
length. A successful scan will be indicated by an audible tone.
NOTE: Entering a new specimen ID by scanning a bar code will prepare for
the next specimen by clearing the parameter display and advancing
the sequence number if prior specimen results were displayed.
If the scanner fails to read the bar code label, refer to the Error Messages and
Conditions table in Section 10: Troubleshooting and Diagnostics.

9140390D—January 2006
Running Specimens
NOTE: Prior to running Patient Specimens, perform Daily Start-Up Procedures
detailed earlier in this section.
When the READY message is displayed on the RUN screen, the instrument is ready
to run specimens. To run patient specimens, proceed as follows:
1. With the cap tightly secured on the specimen tube, slowly invert the tube 10
to 15 times.
2. Remove the cap from the pre-mixed specimen tube.
3. Place the tube under the aspiration probe and raise the tube so that the end of
the probe is deeply immersed in the specimen.
4. Press the Touch Plate to activate the run.
1 2
3 4
Figure 5.40 Running a Specimen
5. When the sample has been aspirated from the tube, the probe will move up
through the Wash Block. Remove the specimen tube and replace the cap.
6. After the cycle is completed, run results are displayed on screen and the
aspiration probe moves into position to accept a new specimen. The current
run data is saved to the Data Log.
NOTE: For an explanation of results that fall outside of acceptable ranges,
see Section 3: Principles of Operation, Subsection: System-
Initiated Messages and Data Flags.
7. If Automatic Graphics Printout has been specified in the SETUP menu, a
report is printed according to the parameters selected during the Setup
Procedure.

9140390D—January 2006
8. If Automatic Graphics Printout has not been specified in the SETUP menu,
press [PRINT REPORT] to obtain a copy of the results. The print report
format is the only method to be used for reporting patient results.
NOTE: If the system has been idle for 15 minutes or more, a normal
background should be run immediately prior to running patient
specimens.

9140390D—January 2006
Running Specimens—Pre-Dilute Mode

To run specimens in the Pre-Dilute Mode, proceed as follows:
1. In the MAIN MENU screen, press [SPECIAL PROTOCOLS]. Press
[MORE] twice.
2. Position the sample tube so that the probe is well within the sample, press the
[1/250 DILUTION] soft key. The Analyzer will aspirate a sample aliquot
(40µL), followed by the prompt “Ready to dispense: Please
place cup under probe and press DISPENSE key”.
3. Hold a clean CELL-DYN Counting Cup under the sample aspiration probe.
Hold the cup at a slight angle so that the fluid dispensed from the probe flows
down the side of the cup to the bottom—if the cup is held straight, the force
of the dispensing fluid may cause fluid to splash out of the cup.
NOTE: Use only CELL-DYN Counting Cups. Using other cups may cause
spurious results.
CAUTION: Allowing fluid to splash out of the cup may adversely affect
results.
WARNING: Potential Biohazard. The Aspiration Probe is sharp and

potentially contaminated with infectious material. Avoid contact with the
tip of the probe.
4. Press [1/250 DISPENSE] to activate the Dispense Mode. (This key is now
highlighted in dark blue.)
1 2
3 4
Figure 5.41 Running a Specimen—Pre-Dilute Mode (steps 1–4)

9140390D—January 2006
The sample aliquot and 10 mL of diluent will be dispensed by the sample probe into
the plastic cup.
WARNING: Potential Biohazard. Consider all specimens and reagents,
controls, calibrators, etc. that contain human blood or serum as potentially
infectious. Use established, good laboratory working practices when
handling specimens. 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.
5. Fold the cup once at the upper crease, grip in the middle of the fold, and invert
a minimum of five times to thoroughly mix the blood and diluent. This initial
1:250 dilution is stable for 20 minutes and must be thoroughly remixed by
inversion before pouring it into the Pre-Mixing Cup when the Pre-Diluent
Mode is selected. To exit the SPECIAL PROTOCOLS menu, press MAIN
key.
6. From the MAIN menu, press the [RUN] Key. In the RUN menu, press
[PRE-DILUTE] to activate the Pre-Dilute Mode. The sample aspiration
probe is raised and positioned over the RBC/PLT Mixing Chamber, Pre-
Dilute Mode is displayed on the screen, and the [PRE-DILUTE] key is
highlighted in dark blue indicating that the Pre-Dilute Mode has been
activated.
7. Open the Upper Front Cover.
CAUTION: To prevent damage to the sample aspiration probe, always
confirm that the probe has been raised before attempting to open the Upper
Front Cover.
When READY appears on the screen, mix the folded Counting Cup by
inverting it several times, and carefully pour the specimen into the Pre-
Mixing Cup.
CAUTION: If the a pre-diluted solution is inadvertently poured into the
Pre- Mixing Cup after the dilution is made but before leaving the SPECIAL
PROTOCOLS menu, follow the instructions in Removing a Pre-Diluted
Solution from the Pre-Mixing Cup within this section. Otherwise the flow
sequence of the instrument will be incorrect, resulting in overfilling of the
WBC transducer and carryover of the pre-dilution into the next analysis.

9140390D—January 2006
5 6
8. Press the Touch Plate to start the Pre-Dilute cycle. The status box on the RUN
menu displays messages to indicate the various stages of the cycle.
When the cycle is complete, the results are displayed on the screen.
If Automatic Graphics Printout has been specified in the SETUP menu, a
report is printed according to the parameters selected during the setup
procedure. If Automatic Graphics Printout has not been specified in the
SETUP menu, press [PRINT REPORT] to obtain a copy of the results. The
print report format is the only method to be used for reporting patient results.
9. When you have finished running specimens in the Pre-Dilute Mode, close the
Upper Front Cover.
To return to the Open Sample Mode, press [PRE-DILUTE]. The Sample
Probe returns to the down position, and the [PRE-DILUTE] key is no longer
highlighted.
8 9

9140390D—January 2006
Removing a Pre-Diluted Solution from the Pre-Mixing Cup

Pouring a pre-diluted solution into the Pre-Mixing Cup before leaving the
SPECIAL PROTOCOLS menu will have several undesirable consequences.
When the instrument is returned to the Pre-Dilute Mode, the pre-diluted solution
will be transferred to the Mixing Chamber (and added to the rinse solution which
is already in the chamber). As a result, the specimen/rinse mixture will contaminate
the Mixing Chamber glassware above the level of the normal rinsing action, and
may overflow into the two tubes (waste and vent) at the top of the Mixing Chamber.
In addition, the mixture will not completely drain out of the Mixing Chamber at the
end of the cycle, resulting in carryover to the next specimen dilution.
If a pre-diluted solution has been inadvertently poured into the Pre-Mixing Cup prior
to leaving SPECIAL PROTOCOLS and returning to the RUN or CALIBRATION
menu, perform the following steps:
1. In the SPECIAL PROTOCOLS menu, press [MORE] until [DRAIN BATHS]
selection appears. Press [DRAIN BATHS]. When the drain cycle is finished,
press [FILL BATHS]. This will leave clean diluent in the Mixing Chamber.
2. Return to the 10 mL DISPENSE screen and perform the 10 mL Dispense
Procedure to dispense 10 mL of clean diluent into a CELL-DYN Counting Cup.
3. Pour the 10 mL of clean diluent into the Pre-Mixing Cup. Press [MORE]
until [DRAIN BATHS] selection is available again and repeat the [DRAIN
BATHS] and [FILL BATHS] cycles.
4. Press [MAIN] to return to the MAIN MENU screen, and press [RUN].
1 2
3 4
Figure 5.44 Removing a Pre-Diluted Solution from the Pre-Mixing Cup
5. If necessary, leave the Pre-Dilute Mode. Press [NORMAL

BACKGROUND], and verify that the Background Counts are within the
acceptable limits.
6. Continue with the instructions for running in the Pre-Dilute Mode.

9140390D—January 2006
Section 5 Using the Data Log
Using the Data Log
Overview
Specimen results will automatically be saved in the data log when a run is
performed from the RUN menu.
The Data Log stores patient specimen data (including numeric and graphic data) in
a log format. The information is stored chronologically by sequence number. The
sequence number starts at zero (0), increases with each run up to 9,999, and then
resets back to zero (0). Only the last 10,000 run cycles performed on the RUN
screen of the instrument are stored.
When the number of samples in the Data Log reaches 10,000, the Data Log will be
full. From then on, any new specimen run will cause the oldest entry in the log to
be dropped, and data for the new run to be added.
Each data log screen can display results for up to sixteen (16) specimens. Use the
[←] or [→] arrow keys to scroll through the complete list of parameters for all
specimens displayed. Use the [↑] or [↓] arrow keys to scroll through the specimens.

9140390D—January 2006
Using the Data Log Section 5
Data Log Menu

When [DATA LOG] is pressed, the DATA LOG menu is displayed and the
following softkeys are available:
[EDIT ID] (Appears only when the cursor is atop a record for a patient specimen)
[DISPLAY SPECIMEN]
[FIND SPECIMEN]
[REJECT FROM X-B / ACCEPT TO X-B]
[TRANSMIT DATA]
[PRINT DATALOG]
[HELP/ERROR]
[MAIN]
Figure 5.45 DATA LOG Menu Screen

9140390D—January 2006
DATA LOG MENU
DATA LOG
EDIT DISPLAY FIND REJECT

LYSE TRANSMIT PRINT HELP/ RETURN
ID SPECIMEN SPECIMEN LOGX-B
FROM DATA DATALOG ERROR*
ACCEPT
LYSE
LOGX-B
FROM
PREVIOUS DISPLAY FIND TRANSMIT TRANSMIT PRINT HELP/ RETURN

SPECIMEN SPECIMEN SPECIMEN SPECIMEN DATA REPORT ERROR*
NEXT EDIT
SPECIMEN DEMOGRAPH
CONFIRM DISPLAY FIND TRANSMIT TRANSMIT PRINT HELP/ CANCEL

EDIT SPECIMEN SPECIMEN SPECIMEN DATA REPORT ERROR† EDIT
PREVIOUS DISPLAY FIND SEARCH SEARCH TRANSMIT HELP/ RETURN

SPECIMEN SPECIMEN SPECIMEN FORWARD BACKWARD DATA ERROR*
PRINT HELP RETURN
FAULT LEAVE
LOG HELP
PRINT HELP RETURN
Figure 5.46 DATA LOG MENU Hierarchy


9140390D—January 2006
Edit ID
[EDIT ID] is used to change the number of a specific specimen ID among those
displayed on the DATA LOG menu. When the cursor is positioned on a patient
specimen, this key is displayed; otherwise it is blank. After a new specimen ID
number has been typed in, press [ ] (Enter) to accept the entry. Press the [ESC]
key or asterisk [*] key to cancel the entry.
Figure 5.47 EDIT SPECIMEN ID Screen

9140390D—January 2006
Display Specimen
[DISPLAY SPECIMEN] is used to display the record of the specific specimen
indicated by the position of the cursor. When this key is pressed, the DISPLAY
SPECIMEN menu is displayed and the following keys are available:
[PREVIOUS SPECIMEN]
[NEXT SPECIMEN]
[EDIT DEMOGRAPH]
[TRANSMIT SPECIMEN]
[PRINT REPORT]
[HELP/ERROR]
[RETURN]
Figure 5.48 DISPLAY SPECIMEN Screen
[PREVIOUS SPECIMEN] is used to display the previous specimen in the Data

Log.
[NEXT SPECIMEN] is used to display the next specimen in the Data Log.
[EDIT DEMOGRAPH] is used to edit the patient demographics section of Patient
Specimens only (this key does not appear for other specimen types). Press
[CONFIRM EDIT] to save the changes. Press [CANCEL EDIT] to cancel this
function.
[TRANSMIT SPECIMEN] is used to transmit the specimen results to a
Laboratory Information System (LIS).
[PRINT REPORT] is used to print the specimen results on a graphics printout.
9140390D—January 2006
Find Specimen
[FIND SPECIMEN] is used to find a specimen using the sequence number,
specimen ID number, or patient name from the DATA LOG menu. When [FIND
SPECIMEN] is pressed, three entries appear in the upper left corner of the
screen—<Sequence #>, <Spec ID>, and <Name>—and the cursor is positioned in
the <Sequence #> field. The Operator can place the cursor in the <Spec ID> field
or <Name> field using the [↑] or [↓] keys. Type in the Sequence #, Spec ID, or
Name and press [ ] (Enter) to find the specimen.
Figure 5.49 DATA LOG SEARCH Screen

9140390D—January 2006
The Operator can also use the [SEARCH FORWARD] and [SEARCH
BACKWARD] to find additional specimens.
Figure 5.50 DATA LOG SEARCH Screen

9140390D—January 2006
Reject from X-B/

Accept to X-B
The Operator can toggle between [REJECT FROM X-B] and [ACCEPT TO
X-B] keys to either exclude or include specimens in the X-B Analysis.
NOTE: Only specimens that were initially included in the X-B Analysis,
indicated by a “B” to the left of the sequence number, can be rejected and
reaccepted using [REJECT FROM X-B] and [ACCEPT TO X-B].
When the cursor is placed on one of these specimens, either the [REJECT
FROM X-B] or [ACCEPT TO X-B] is displayed. When the cursor is
placed on a specimen that was not initially included in the X-B Analysis,
neither key is displayed.
To include specimens in the X-B Analysis, use the [ ] (Enter) key to turn ON the
X-B Moving Average Program in the SETUP menu before running samples.
• To reject the results of a specific sample, move the cursor to the sequence
number of that sample and press [REJECT FROM X-B]. The “B” to the left
of the sequence number is deleted and an “R” is displayed to the right of the
specimen ID number.
• To reaccept the results of a specimen previously rejected, press [ACCEPT
TO X-B]. The “R” is deleted and a “B” reappears to the left of the sequence
number.
Figure 5.51 Reject from X-B/Accept to X-B Screen

9140390D—January 2006
Transmit Data
[TRANSMIT DATA] is used to transmit one or more specimen records in the Data
Log to a Laboratory Information System (LIS). Records may be transmitted singly
or in batches as designated by the sequence numbers.
When [TRANSMIT DATA] is pressed, the <Start 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.
If the number is valid, the system accepts the entry and the <End Sequence #> field
appears in the upper left corner of the screen. The Operator should type in the
ending sequence number. If transmitting only one specimen, the system begins
transmitting automatically.
Figure 5.52 TRANSMIT DATA Screen
If transmitting more than one specimen, press [CONFIRM TRANSMIT] or

[CANCEL TRANSMIT]. If [CONFIRM TRANSMIT] is pressed, the system
begins transmitting the list of records to the host computer.
NOTE: Use the [ESC] key or asterisk [*] to cancel this function and return to the
DATA LOG menu. Use the Backspace key or [←] arrow key to cancel an
entry and retype the sequence number.

9140390D—January 2006
Figure 5.53 CONFIRM/CANCEL DATA TRANSMIT Screen
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. To transmit histogram data, the Automatic
Transmission of Histograms option in the Computer Setup option of the SETUP
menu must be turned ON (refer to Selecting Display and Print Options earlier in
this section), and the Operator must first press [DISPLAY SPECIMEN] to select
and display an individual specimen, then press [TRANSMIT SPECIMEN].

9140390D—January 2006
Print Datalog
[PRINT DATALOG] is used to print one or more specimen records in the Data
Log. When [PRINT DATALOG] is pressed, the <Start 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. If
the number is valid, the system accepts the entry and <End Sequence #> field
appears in the upper left corner of the screen. The Operator should type in the
ending sequence number.
Figure 5.54 PRINT DATALOG Screen
NOTE: Use the [ESC] key or asterisk [*] to cancel this function and return to the
DATA LOG menu. Use the Backspace key or [←] 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. To print histogram data, the Print Histograms
option in the SETUP menu must be turned ON (refer to Selecting Display and
Print Options earlier in this section), and the Operator must first press [DISPLAY
SPECIMEN] to select and display an individual specimen, then press [PRINT
REPORT].
NOTE: On the DATA LOG screen, the letters B, K, O, or P next to the date
indicate the following:
B = Background Count, K = Flow/Clog errors, O = Open Mode or
P = Predilute Mode.

9140390D—January 2006
Help/Error
If a fault is pending when [HELP/ERROR] is pressed, a list of up to sixteen
Main
[MAIN] is used to return the Operator to the MAIN MENU screen.

9140390D—January 2006
Section 5 Daily Shutdown
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 because the instrument goes into a STANDBY state automatically if it has been
idle for four hours or some other duration specified by the Operator (see Automatic
Start-Up and Shutdown earlier in this section). Before the instrument enters the
STANDBY state, the flow panel is automatically rinsed.
If desired, the Operator may place the instrument in STANDBY by pressing
[DAILY SHUTDOWN] in the SPECIAL PROTOCOLS menu. When this key is
pressed or when Automatic Shutdown is initiated, the following occurs:
1. The Flow System is rinsed.
2. The timer control, which periodically opens all of the solenoid valves to
prevent pinched tubing, is set.
3. When the instrument enters the STANDBY state, the LCD backlight will turn
off after 15 minutes of non-use.
NOTE: The Operator may turn the backlight on by pressing any key on the
PC keyboard. However, the instrument must be initialized to run
patient specimens.
The Daily Shutdown cycle takes approximately 3–4 minutes.
For a more thorough cleaning of the instrument prior to Daily Shutdown, perform
the Auto Clean procedure (refer to Section 9: Service and Maintenance,
Subsection: Daily Maintenance Procedures.)

Daily Shutdown Section 5
NOTES

Section 5 Power OFF
Power OFF
When the power is required to be OFF, the Operator must perform the same
procedures described in Daily Shutdown within this section.
1. From the MAIN MENU screen, press [SPECIAL PROTOCOLS].
2. Press [DAILY SHUTDOWN].
3. When the Daily Shutdown cycle is complete, turn the instrument power
switch to OFF.
4. To restore power, follow the procedures described in Section 2: Installation
Procedures and Special Requirements, Subsection: StartUp.

Power OFF Section 5
NOTES

References
1. Clinical and Laboratory Standards Institute/NCCLS. Procedures for the

Collection of Diagnostic Blood Specimens by Venipuncture; Approved
Standard—Fifth Edition. CLSI/NCCLS document H3-A5 [ISBN 1-56238-
515-1]. Clinical and Laboratory Standards Institute, 940 West Valley Road,
Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2003.
2. Clinical and Laboratory Standards Institute/NCCLS. Procedures and
Devices for the Collection of Diagnostic Capillary Blood Specimens;
Approved Standard—Fifth Edition. CLSI/NCCLS document H4-A5 [ISBN
1-56238-538-0]. Clinical and Laboratory Standards Institute, 940 West
Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2004.
3. Thompson CB, Diaz DD, Quinn PG, Lapins M, Kurtz SR, Valeri CR. The role
of anticoagulation in the measurement of platelet volumes. Am J Clin Pathol
1983 Sep;80(3):327-32.
4. McShine RL, Sibinga S, Brozovic B. Differences between the effects of
EDTA and citrate anticoagulants on platelet count and mean platelet volume.
Clin Lab Haematol 1990;12(3):277-85.

9140390D—January 2006
NOTES

Section 6 Calibration Procedures
Overview
Calibration is a procedure that confirms the accuracy of the CELL-DYN 1800 and
must conform to guidelines established by the regulatory and accrediting agencies
in your locality.
The instrument is initially calibrated at the factory prior to shipment. Calibration
must be confirmed during installation by the Operator. The instrument is
electronically stable and should not require frequent recalibration when it is
operated and maintained according to recommendations in this manual.
The following parameters can be calibrated:
• WBC
• RBC
• HGB
• MCV
• PLT
• MPV (Factory Calibration Only)
When to Calibrate
Scheduled calibration of the CELL-DYN 1800 must conform to the guidelines
established by regulatory agencies.
Calibration must be confirmed on a regular basis according to your laboratory’s
standards and protocols. Built-in Quality Control programs on the
CELL-DYN 1800 are designed to provide continual monitoring and confirmation
of instrument calibration. The laboratory should make the decision to recalibrate
based on the performance of the CELL-DYN 1800 System in these Quality Control
programs. The programs include statistical computations and modified Westgard
Rules for commercial or patient controls and monitoring of patient samples for
RBC parameters using Bull’s Moving Average Program (X-B).
Criteria must be established for calibration verification. Criteria to include:
• when there is a reformulation of a vendor’s reagent or when switching to a
different reagent vendor
• when indicated by quality control data
• following major maintenance or service
• when directed by an Abbott communication
• at least every 6 months
Calibration must be considered the last step in a troubleshooting sequence.
Frequent unnecessary recalibrations can mask an underlying problem with the
instrument’s performance.

9140390E—June 2008
Overview Section 6
NOTES

9140390A—March 2003
Section 6 Calibration Guidelines
Calibration Guidelines
General Information
The CELL-DYN 1800 system analyzes two types of samples:
• Whole blood samples
• Pre-diluted samples
Calibration Methods
Calibration is performed using appropriate reference material (Calibrator) or fresh
whole blood. It is accomplished either automatically or manually, depending on the
Operator’s needs or preferences.
The automatic method is carried out using the [AUTO CAL SELECT] key. One
of the following three methods can be utilized to automatically calibrate the
instrument:
• Calibrator
• Fresh Whole Blood
• Polystyrene microspheres
Performed by an authorized Abbott representative only
The manual method requires that the Operator enter the calibration factors directly
using the [ENTER FACTOR] key. The Enter Factor Method may be preferred
when calibrating with whole blood specimens.
Calibration Temperature Specification

Calibrate the instrument within the Operating Temperature range of 20°C to 30°C
(68°F to 86°F). When the instrument is calibrated, always record the ambient
temperature in you laboratory. Control and Patient Specimens should be analyzed
at temperatures as close to the calibration temperature as possible but no greater
than ± 4°C (± 7°F) from the temperature at which the instrument was calibrated.
NOTE: The above instructions apply to the following CELL-DYN Calibrators
and Controls:
• CELL-DYN Calibrator
• CELL-DYN 16 Controls
• CELL-DYN 22 Calibrator
For other manufacturer’s calibrator and control products, follow the instructions
provided in the package insert.

9140390E—June 2008
Calibration Guidelines Section 6
Calibration Materials
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 (29 CFR Part
1910.1030) or other equivalent biosafety procedures.1
The CELL-DYN 1800 uses calibrator (commercially-prepared reference material)

or fresh whole blood.
Commercial Calibration
For commercial calibration, follow the directions given in the package insert. Be
certain to carefully read and follow directions given for mixing and handling.
Whole Blood Calibration

Calibration with fresh whole blood is accomplished by performing multiple
analysis of each specimen using acceptable reference methodology and calculating
the mean reference value for each parameter.
CAUTION: Never use a hemoglobin standard that is designed specifically
for use with cyanmethemoglobin reagents (the CELL-DYN 1800 uses a
Modified Methemoglobin method).
Whole Blood Calibration Guidelines

Calibration with fresh whole blood specimens is an alternative to calibration with
a commercial calibrator. Because specimens used in place of a calibrator are
assayed by reference methods, this is referred to as a Reference Whole Blood
Calibration.
Fresh whole blood specimens can also be used for an Instrument-to-Instrument
Calibration after each instrument has been independently calibrated with a
commercial calibrator or a Reference Whole Blood Calibration.
The first part of this section gives the requirements for fresh whole blood
specimens used for calibration. The second part discusses the requirements for a
Reference Whole Blood Calibration and the reference methods that should be used.
The last part describes the requirements and procedure for an Instrument-to-
Instrument Calibration.

9140390D—January 2006
Requirements for Fresh Whole Blood Specimens

The following requirements must be observed for fresh whole blood specimens
used for calibration:
• The ICSH recommends that fresh specimens be less than four hours old.2
Specimen age must not exceed eight hours at the conclusion of the calibration
procedure.
• All parameter values must be within the laboratory’s normal range. The
following ranges are programmed for the reference values that can be entered
in the Auto Calibration program. Results outside these limits cannot be
entered.
WBC 5.0–15.0 K/µL
RBC 3.50–6.00 M/µL
HGB 4.0–24.0 g/dL
MCV 80.0–100.0 fL
PLT 150–450 K/µL
• All cellular morphology must be normal.
• No known interfering substances are present (for example, lipemia, icterus).
See Section 3: Principles of Operation; Subsection: System-Initiated
Messages and Data Flags and in Section 5: Operating Instructions,
Subsection: Specimen Analysis.
• All specimens must be properly collected in tubes containing the EDTA
anticoagulant used by the laboratory.
• Each tube must contain at least 90% of the nominal collection volume of
blood.
Requirements for Reference Whole Blood Calibration

Minimum requirements for a Reference Whole Blood Calibration are described in
the following list. Specimens used must meet the requirements for fresh whole
blood specimens described earlier in this section. Additional specimens and/or
more repetitions of the specimens can be used to achieve calibration accuracy
beyond CLSI/NCCLS recommendations.
1. A minimum of five different specimens run in duplicate is required for
adequate whole blood calibration.
2. Specimens must be assayed by reference methodology and on the
CELL-DYN 1800 instrument.
3. No more than two hours should elapse between the CELL-DYN 1800
instrument run and the assay by reference methodology. If specimens are run
on the CELL-DYN 1800 System first, assay by reference methodology must
be completed within one hour. (Certain reference methodologies are sensitive
to RBC swelling caused by in vitro deoxygenation.)

9140390E—June 2008
4. Mean values must be calculated for each parameter for each sample from the
reference assay results. These mean parameter values can then be entered in
the Auto Calibration program as reference values for each sample.
5. If Auto-Cal is not being used, the mean parameter values must be averaged
to obtain the cumulative mean value for each parameter. The worksheet
provided in Appendix C: Sample Logs and Worksheets can be used to assist
with calculation of the reference mean values and can be duplicated as
needed.
Reference Methods
Reference values for a Reference Whole Blood Calibration must be determined
according to the following ICSH recommendations.
WBC, RBC, and PLT

Reference values for white blood cells, red blood cells, and platelets can 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
methemoglobin method or a reliably-calibrated hemoglobinometer or hematology
analyzer.
NOTE: DO NOT attempt to calibrate the CELL-DYN 1800 instrument with a
hemoglobin standard designed for the calibration of specific reference
cyanmethemoglobin methods. The instrument uses a modified
methemoglobin method which is not designed to analyze these standards
directly.
MCV
Reference values for the mean cell volume can 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 can be determined by multiple
analyses using the CLSI/NCCLS method for Packed Cell Volume (PCV).3
Use only plain (non-anticoagulated) capillary tubes. Be certain to verify
the proper operation of the microhematocrit centrifuge and the timer as
recommended by CLSI/NCCLS.

9140390D—January 2006
CALIBRATION MENU
CALIBRATION
PRE- AUTO CAL ENTER PANIC PRINT HELP/ MAIN

DILUTE SELECT FACTOR LIMITS ERROR*
PRE- CALI- WHOLE MPV PRINT HELP/ RETURN

DILUTE BRATOR BLOOD LATEX ERROR*
CLEAR RESET PRINT HELP/ RETURN

ORIFICE FACTORS ERROR*
FAULT HELP RETURN

LOG
LEAVE
HELP
PRINT HELP RETURN
CONFIRM RESET ALL PRINT HELP/ CANCEL

RESET TO 1.00 ERROR* RESET
RESTORE RESET ALL PRINT HELP/ RETURN

FACTORS TO 1.00 ERROR*
Figure 6.1 CALIBRATION Menu Hierarchy


9140390C—March 2004
NOTES

9140390A—March 2003
Section 6 Calibration Menu
Calibration Menu
Calibration of the CELL-DYN 1800 instrument is performed in the

CALIBRATION menu. To enter the CALIBRATION menu, press
[CALIBRATION] in the MAIN MENU screen.
NOTE: The system defaults to the Whole Blood Open Sample Factors screen. A
brief description of each soft key, displayed at the bottom of the
CALIBRATION menu, and its function is given below.
When [CALIBRATION] is pressed, the [CALIBRATION] menu is displayed and
the following keys are available.
[PRE-DILUTE]
[AUTO CAL SELECT]
[ENTER FACTOR]
[PRINT]
[HELP/ERROR]
[MAIN]
Figure 6.2 CALIBRATION Menu Screen

9140390A—March 2003
Calibration Menu Section 6
Pre-Dilute
[PRE-DILUTE] is used to prepare the instrument for analyzing pre-diluted
samples by raising the Aspiration Probe to allow the Operator to remove the Front
Cover from the instrument and pour a diluted specimen of calibrator or fresh whole
blood into the Pre-Mixing Cup.
Figure 6.3 PRE-DILUTE Screen

9140390A—March 2003
Section 6 Calibration Menu
Auto-Cal Select
[AUTO CAL SELECT] is used to display the AUTO-CAL menu, allowing the
Operator to choose a method for calibration of the instrument. (The Operator may
choose Calibrator or Whole Blood. The [MPV LATEX] key is used only by an
authorized Abbott representative.)
Figure 6.4 AUTO CAL SELECT Screen

9140390A—March 2003
Calibration Menu Section 6
Enter Factor
[ENTER FACTOR] is used to display the Enter Whole Blood Factor screen and
allows the Operator to enter calibration factors for each of the five displayed
parameters.
Figure 6.5 ENTER FACTOR Screen
Print
[PRINT] is used to print the current calibration factors as shown on screen.
Help/Error
[HELP/ERROR] accesses a menu that has Softkeys for [FAULT LOG], [HELP]
and [RETURN]. If a fault is pending, when [HELP/ERROR] is pressed a list of
up to sixteen previous errors will be displayed. Otherwise, pressing [FAULT LOG]
allows the operator to view the errors.
Pressing [HELP] allows the operator to view the Help text. The [↑] and [↓] arrow
Main
[MAIN] is used to return to the Operator to the MAIN MENU screen.
NOTE: The [ABANDON] key will be displayed once the calibraton is in process.
This can be used to stop the calibration process without deleting the factor
and Mean Factor for specimens already run.

9140390C—March 2004
Pre-Calibration Guidelines
It is advisable to perform calibration at a time when it can be completed without
interruption. The Pre-Calibration Procedures in this subsection help verify proper
instrument performance to ensure a successful calibration. These steps must be
completed just prior to beginning the calibration process itself. If problems are
detected during these checks, do not attempt to calibrate the instrument. If
necessary, call Abbott Diagnostics Customer Service for assistance. After the
problems have been resolved, repeat the Pre-Calibration Procedures to verify
proper performance. Review the following guidelines before beginning any
calibration procedure. A checklist that can be copied is in Appendix C: Sample
Logs and Worksheets.
1. Always ensure that daily, weekly, and monthly scheduled maintenance is
current before calibrating the instrument. Instrument cleanliness is essential
for accurate calibration. Each laboratory must perform any additional
maintenance according to its requirements.
NOTE: Print the current Calibration Factors before starting calibration.
2. Use only recommended specimen tubes. See Section 1: Use or Function,
Subsection: System Components.
3. Use only the recommended CELL-DYN 1800 Reagents and CELL-DYN
Calibrator material. See Section 1: Use or Function, Subsection: Reagent
System.
4. Accurately follow CELL-DYN Calibrator package insert instructions and
ensure that the expiration date has not passed.
5. Confirm that reagent containers have enough reagent to complete calibration
procedures and replace reagent as necessary.
6. Confirm that the waste container is no more than half full—empty it if
necessary as described in Section 2: Installation Procedures and Special
Requirements, Subsection: Waste Disposal Requirements.
7. Confirm that normal Background Counts and instrument precision is within
limits. If the system has been idle for fifteen minutes or more, a normal
background should be run immediately prior to running any calibration
specimens. See Section 4: Performance Characteristics and Specifications,
Subsection: Performance Specifications.
CAUTION: If problems are detected during calibration, DO NOT
ATTEMPT TO CALIBRATE THE INSTRUMENT. If necessary, call the
local Abbott Diagnostics Customer Service for assistance. After any
problems have been resolved, repeat the calibration procedure and perform
Quality Control runs to verify proper performance.

9140390C—March 2004
Calibration Procedures Section 6

and Controls:
Within-Sample Precision
Precision is a check on routine instrument operation and should always be run prior
to instrument calibration.
Samples used to verify instrument precision should have results that fall within the
laboratory’s reference interval (normal range). These samples should not display
any suspect parameter flags and should be less than four hours old.
Performing a Precision Run

Prior to performing a precision run, the Operator must locate an empty replicate
file. If one cannot be found, a file that contains data must be purged. If the file to
be purged contains data that must be kept as documentation, print the file prior to
purging. Refer to Section 11: Quality Control, Subsection: Using Quality
Control.
To perform a precision run, proceed as follows:
1. From MAIN MENU screen, press [RUN]. Choose [SPECIMEN TYPE],
[QC TYPE], and then [REPLICATES].
2. Using the [↑] and [↓] arrow keys, select an empty replicate file (0 appears in
column under # Specimen). Press [RETURN] to return to the RUN menu.
3. Run the specimen in the selected replicate file to achieve a total of 20 valid
runs. (Refer to Section 5: Operating Instructions, Subsection: Running
Specimens.)
4. After performing 20 valid runs, press [MAIN] to return to the MAIN MENU
screen.
5. From the MAIN MENU screen, press [QUALITY CONTROL] followed by
[REPLICATES] to display replicate files.
6. Using the [↑] and [↓] arrow keys, highlight the replicate file that contains the
precision data. Press [VIEW QC LOG] followed by [PRINT QC LOG] to
print the file.

9140390E—June 2008
7. The CV% will be calculated by the instrument, displayed at the bottom of the
VIEW QC LOG screen, and printed at the bottom of the Replicate File
printout. Confirm that results are within appropriate specifications.
8. If all parameters are within specifications, proceed with calibration. For
results that fall outside of appropriate specifications, refer to Section 10:
Troubleshooting and Diagnostics, Index of Error Messages and
Conditions, or contact Abbott Diagnostics Customer Service for assistance.
Auto Calibration Procedure

The Auto Cal method allows the Operator to automatically calibrate the
CELL-DYN 1800 using calibrator or whole blood. Through the AUTO CAL
SELECT menu, the Operator enters reference or target values, runs samples, and
the instrument compares the results with previously entered values. A mean factor
for each selected parameter, based on the total number of runs from all specimens,
is also calculated. With the Calibrator Method, one specimen is used for
calibration. With the Fresh Whole Blood Method, multiple specimens are used.
Auto-Cal Ranges for Calibrator and Fresh Whole Blood

The following ranges are programmed for the reference values that may be entered
in the Auto Calibration program. Values exceeding these limits cannot be entered.
Parameter Lower Limit Upper Limit

WBC 5.0 15.0
RBC 3.50 6.00
HGB 4.0 24.0
MCV 80 100
PLT 150 450
Preparing for Auto Calibration

1. From the MAIN MENU screen, press [CALIBRATION] to go to the
CALIBRATION menu. The system defaults to the Current Whole Blood
Open Sample Factors screen.
2. Press [AUTO CAL SELECT] to go to the AUTO CALIBRATION menu.
3. Press [PRINT] to print the current Calibration Factors.
4. Press [CALIBRATOR] to display the CALIBRATOR CALIBRATION
menu.
Entering Reference Values—Calibrator

1. Use the [↑] or [↓] arrow keys to place the cursor on the first parameter to be
calibrated. Use the [ ] (Enter) key to toggle between YES and NO to select
the parameters for calibration. When YES is displayed next to the parameter,
the cursor is positioned in the <Value field> for that parameter.

9140390E—June 2008
2. While referring to the calibrator assay sheet from the selected CELL-DYN
Calibrator kit, use the numerical keys on the PC keyboard to enter a reference
value of up to three digits for each parameter to be calibrated. As each value
is entered, the field accepts the value and the cursor automatically moves to
the next parameter. Use the arrow keys to skip a parameter. The reference or
target value must be within the factory set ranges or the value will not be
accepted.
Auto Calibration Factors

Calibration factors are calculated by comparing measured values of five
hematology parameters to a calibrator assay sheet bearing reference values. The
accuracy of the calibrated parameter value is dependent on how the parameter
passes the calibration limits criteria during the Auto Calibration procedure.
Calibration limits criteria require that any one parameter must pass the three
conditions below to be valid for that parameter:
• Within the absolute range allowed
• Does not exceed the allowed percent difference from reference value
• Within the precision check limits
The instrument automatically determines if calibration was successful by
computing calibration factors when three valid runs are complete. The software
allows up to five runs in order to acquire the data necessary to validate calibration.
Absolute Allowable Range

Measured calibration parameter cannot exceed (above or below) the Absolute
Range.
Reference Check
Measured calibration parameter cannot exceed an allowable percentage from a
reference value.
Precision Check
Measured calibration parameter must fall within an allowable difference from the
lowest value to the highest value, known as the Precision Check limit.
Performing an Auto Calibration Run—Calibrator

When at least one valid reference value has been entered in the Calibrator
Calibration screen, READY appears in the status box. To perform an auto
calibration run with calibrator, proceed as follows:
1. 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.
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.

9140390E—June 2008
2. Remove the cap from the well-mixed calibrator tube and place the tube under
the aspiration probe. Raise the tube so that the end of the probe is deeply
immersed in the calibrator material.
3. Press the Touch Plate to start the Auto Calibration cycle.
4. When the calibrator has been drawn from the tube, the probe will move up
through the Wash Block. Remove the calibrator tube and replace the cap.
5. The instrument performs RUN 1 and displays the values in the RUN 1
column. If a flow error, a clog, or other fault message appears on the display
screen during the run cycle, press [CLEAR ORIFICE].
NOTE: Do not use the displayed values from an Auto Calibration cycle to
manually calculate new calibration factors.
6. Mix the calibrator according to the directions given in the package insert.
7. Repeat steps 2, 3, and 4 for RUN 2 and RUN 3 measurements Mix the
calibrator between runs.
WARNING: Potential Biohazard. The probe is sharp and potentially
contaminated with infectious material. Avoid any contact with the probe.
NOTE: The Auto Calibration program automatically compares the results

of the first run of the calibrator with the parameter Reference
Values entered for that specimen to verify that the difference is
within acceptable limits. If any of the runs fails this Reference
Check, the results are highlighted and no calibration factor will be
calculated for that parameter. Refer to Calibration
Troubleshooting in Section 10: Troubleshooting and
Diagnostics.
8. After three qualifying runs, the system automatically calculates the Factor
and Mean Factor for each parameter to be calibrated.
NOTE: If after three runs the Factor and Mean Factor have not been
calculated, the following conditions may exist:
> < is displayed in the Factor column and a Mean Factor will not
be calculated and displayed if the instrument fails the Precision
Check. After three qualifying runs, the instrument performs a
Precision Check for each parameter being calibrated before
determining the Factor and Mean Factor for that parameter. Refer
to Calibration Troubleshooting in Section 10: Troubleshooting
and Diagnostics.
>>> or <<< is displayed in the Factor column and a Mean Factor is

not calculated if the instrument fails the Allowable Limits used for
calculating the Mean Factor.
9. Press [RETURN] to save the Calibration Factors.
10. Press [PRINT] to print a copy of the New Calibration Factors.
11. Press [RETURN] to return to the [CALIBRATION] menu.

9140390E—June 2008
13. Press [RUN] to display the RUN menu.

14. Run three levels of controls and confirm that the results obtained for all
parameters are within the control limits specified on the assay sheet or within
your own established laboratory ranges for the current lot number.
To confirm calibration, run QC according to your laboratory’s standards and
protocols. Refer to Section 11: Quality Control.
Determining Reference Values—Fresh Whole Blood

Use the following procedure to determine the Reference Mean Values that will be
used in the Calibration Procedure for Auto-Calibration with fresh whole blood.
1. Go to a reference hematology instrument or use the appropriate hematology
method with five specimens of fresh whole blood. Label the five specimens
#1 through #5. Run a minimum of three replicates from specimen #1 and
calculate a mean for each parameter to be calibrated. Be sure the means
derived from each of the remaining specimens are clearly identified.
2. Repeat this procedure for each of the remaining four specimens.
3. The Reference Mean Values obtained on the reference hematology
instrument or hematology methods will be used to calibrate your
CELL-DYN 1800 System. The same blood specimens run on the reference
hematology instrument will be run on the CELL-DYN 1800 System to be
calibrated.
Entering Reference Values—Fresh Whole Blood

Before performing a Calibration with Fresh Whole Blood, enter calibration
reference values as follows:
1. In the CALIBRATION menu, press [AUTO CAL SELECT] to display the
AUTO CALIBRATION menu.
2. Press [WHOLE BLOOD] to display the WHOLE BLOOD
CALIBRATION menu.
the cursor is positioned in the value field for that parameter.
4. Select specimen #1 that was run on the reference instrument. Using the
Reference Mean Value derived from the reference instrument, enter the
corresponding mean for each parameter to be calibrated. As each value is
entered, the field accepts the value and the cursor automatically moves to the
next parameter. Use the [↑] or [↓] arrow keys to skip a parameter.

9140390E—June 2008
Performing an Auto Calibration Run—Fresh Whole Blood

When at least one valid reference value has been entered in the Whole Blood
Calibration screen, READY appears in the status box. To perform a calibration run,
proceed as follows:
1. With the cap tightly secured on the specimen tube, slowly invert the tube 10
to 15 times. Do not shake the specimen.
controls, calibrators, etc., that contain human blood or serum as potentially
2. Remove the cap from the specimen tube and place the tube under the
aspiration probe. Raise the tube so that the end of the probe is deeply
immersed in the specimen.
3. Press the Touch Plate to start the Auto Calibration cycle.
4. When the whole blood sample has been drawn from the tube, the probe will
move up through the Wash Block. Remove the specimen tube and replace the
cap.
5. The instrument performs RUN 1 and displays the values in the RUN 1
column. If a flow error, a clog error, or other fault message appears on the
display screen during the run cycle, press [CLEAR ORIFICE].
NOTE: The Auto Calibration Program automatically compares the results
of the first run of the whole blood specimen with the parameter
Reference Mean Values entered for that specimen to verify that the
difference is within acceptable limits. If any of the runs fails this
Reference Check, the results are highlighted and no calibration
factor will be calculated for that parameter. Refer to Calibration
Troubleshooting in Section 10: Troubleshooting and
Diagnostics.
6. Remix the specimen by inverting the tube 10 to 15 times
7. Repeat steps 2, 3, and 4 for RUN 2 and RUN 3 measurements. Mix the whole
blood specimens between runs.
8. After three qualifying runs, the instrument automatically calculates the
Factor and Mean Factor for each parameter to be calculated.

9140390A—March 2003
NOTE: If after three runs the Factor and Mean Factor have not been
calculated, it may be due to one of the following conditions:
> < is displayed in the Factor column and a Mean Factor will not
be calculated and displayed if the instrument fails the Precision
Check. After three qualifying runs, the instrument performs a
Precision Check for each parameter being calibrated before
determining the Factor and Mean Factor for that parameter. Refer
to Calibration Troubleshooting in Section 10: Troubleshooting
and Diagnostics.
>>> or <<< is displayed in the Factor column and a Mean Factor is

not calculated if the instrument fails the Allowable Limits used for
calculating the Mean Factor.
9. Repeat steps 1 through 4 for the remaining four reference specimens. Enter
the new Reference Mean Values that correspond to each of the remaining
reference specimens before running the specimens: for example, enter the
Reference Mean Values for specimen #4, then run specimen #4, etc. A new
Factor for each parameter to be calibrated will be calculated each time three
runs are completed for a sample. The Mean Factor for each parameter will be
based on the total number of runs. When all five specimens have been run in
triplicate (15 runs), the instrument is calibrated.
12. Press [RETURN] to return to the CALIBRATION menu.
parameters are within control limits specified on the assay sheet or within
NOTE: If the results for any parameter are consistently out, obtain
technical assistance by contacting Abbott Diagnostics Customer
Service.

9140390C—March 2004
Enter Factor Procedure

The Enter Factor calibration method is used to enter a predetermined factor to
adjust calibration when a consistent bias exists between the CELL-DYN 1800
System and a comparison instrument. A percent Bias Factor can be determined and
entered through the ENTER FACTOR menu to change calibration within ± 20%
for any of the directly measured parameters—WBC, RBC, HGB, MCV, PLT, MPV.
Calibrator or Fresh Whole Blood may be used to calibrate the instrument with the
Enter Factor Calibration method. A set of worksheets is provided in Appendix C:
Sample Logs and Worksheets that can be used for Whole Blood Enter Factor
Calibration.
Determining Reference Values—Calibrator

To determine calibrator reference values for the Enter Factor calibration method,
follow steps 1 through 8 of Performing an Enter Factor Calibration Run—
Calibrator.
NOTE: No more than two hours should elapse between determining the
Reference Mean Values and performing the calibration.
Performing an Enter Factor Calibration Run—Calibrator

To perform an Enter Factor calibration run with calibrator, proceed as follows:
1. Open an empty replicate file. See Section 5: Operating Instructions,
Subsection: Rep File Setup.
2. 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.
3. Remove the cap from the calibrator tube and place the tube under the
4. Press the Touch Plate to activate the Enter Factor calibration cycle.
6. The results of the run are placed in the replicate file selected in step 1.
If a flow error, a clog error, or other fault message appears on the display
screen during the run cycle, press [CLEAR ORIFICE] and repeat the run.
7. Mix the calibrator according to the directions provided in the package insert.
8. Repeat steps 3, 4, and 5 two more times to ensure the results of a total of three
runs are placed in the replicate file.
controls, calibrators, etc., that contain human blood or serum as 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.
9. Press [MAIN], then [QUALITY CONTROL] followed by [REPLICATES].

Select the appropriate replicate file.

9140390A—March 2003
10. Press [VIEW QC LOG] then [PRINT QC LOG] to print the Summary
Report for the selected replicate file.
11. Press [RETURN] to return to the MAIN MENU screen, then press
[CALIBRATION] to display the Whole Blood Open Sample Factors screen.
12. Press [PRINT] to obtain a copy of the current calibration factors that will be
used in determining the new Calibration Factors.
13. To determine the New Calibration Factor:
Use the Reference Mean Values determined in steps 3 through 8. Enter this
information in the Enter Factor Calibration Worksheet provided in
Appendix C: Sample Logs and Worksheets to calculate the new Calibration
Factor for each parameter as follows:
Calibrator Calibration:
Calibrator Mean x Current Open Mode New Open Mode
=
CELL-DYN Mean Calibration Factor Calibration Factor
For example, if the Reference Mean Value for WBC is 6.6, the CELL-DYN
Mean for WBC is 7.1, and the current Calibration Factor is 0.98, then:
6.6 x 0.98 = 0.91

7.1
and 0.91 is the New Open Mode Calibration Factor.

14. With the CALIBRATION menu displayed, press [ENTER FACTOR].
15. Use the [↑] or [↓] arrow keys to select the first factor to be changed. Enter
the three-digit New Calibration Factor calculated from step 12. The cursor
automatically advances to the next factor. Use the [↑] or [↓] arrow keys to
select a parameter.
NOTE: [RESTORE FACTORS] is used to recall factors, stored on the
Hard Disk, corresponding to the Open or Pre- Dilute Mode.
[RESET ALL TO 1.00] is used to reset all factors displayed on the
screen to 1.00.
16. Press [RETURN] to save the calibration factors.
To confirm calibration of the CELL-DYN 1800 System, run QC according to

your laboratory’s standards and protocols. Refer to Section 11: Quality
Control.
Service.

9140390C—March 2004
Performing an Enter Factor Calibration Run—Fresh Whole Blood

To perform an Enter Factor calibration run with fresh whole blood, proceed as
follows:
2. Take specimen #1 of the fresh whole blood and mix well by gently inverting
the tube 10 to 15 times. Do not shake the tube.
3. Remove the cap from the specimen tube and place the tube under the
immersed in the specimen.
4. Ensure that the status box reads READY. Press the Touch Plate to activate the
Enter Factor calibration cycle.
5. When the sample has been drawn from the tube, the probe will move up
6. The results of the run are placed in the replicate file selected in step 1. Run
this specimen two more times. If a flow error, a clog error, or other fault
message appears on the display screen during the run cycle, press [CLEAR
ORIFICE] and repeat the run.
7. Mix the specimen by inverting it a minimum of five times.
8. Repeat steps 3, 4, and 5 one more time to ensure the results of a total of two
runs are placed in the replicate file. Repeat this duplicate run for each of the
remaining specimens, for a total of 10 runs. Run all specimens in the same
replicate file to obtain a CELL-DYN Mean for all parameters.
WARNING: Potential Biohazard. Consider all specimens potentially
9. Press [MAIN], then [QUALITY CONTROL] followed by [REPLICATES].

Select the appropriate replicate file.
10. Press [VIEW QC LOG] then [PRINT QC LOG] to print the Summary
Report for the selected replicate file.
11. Press [RETURN] to return to MAIN MENU screen, then press
[CALIBRATION] to display the Whole Blood Open Sample Factors screen.
12. Press [PRINT] to obtain a copy of the current calibration factors that will be
used in determining the new Calibration Factors.

9140390A—March 2003
13. To determine the New Calibration Factor:
Use the Reference Mean Values determined in steps 3 through 8. Enter this
information in the Enter Factor Calibration Worksheet provided in
Appendix C: Sample Logs and Worksheets to calculate the new Calibration
Factor for each parameter as follows:
Whole Blood Calibration:

Reference Mean x Current Open Mode = New Open Mode
Mean for WBC is 7.1, and the current Calibration Factor is 0.98, then:
6.6 x 0.98 = 0.9

7.1

14. With the CALIBRATION menu displayed, press [ENTER FACTOR].
select a parameter.
Hard Disk, corresponding to the Open or Pre-Dilute mode.
screen to 1.00.
Service.

9140390C—March 2004
Section 6 Pre-Dilute Mode Calibration
Pre-Dilute Mode Calibration
Overview
The Pre-Dilute Calibration Method prepares the CELL-DYN 1800 to accurately
measure pre-diluted specimens. The procedure for calibrating the Pre-Dilute Mode
and the type of specimens used are similar to the Calibrator and Fresh Whole Blood
Methods described earlier in this section. However, for Pre-Dilute Calibration each
calibration specimen is pre-diluted, using one of the following two methods:
1. Automated Pre-Dilute Method with CELL-DYN Counting Cups using the
[1/250 DILUTION] key from the SPECIAL PROTOCOLS menu.
NOTE: DO NOT use the [1/250 DILUTION] Method to calibrate the
instrument unless you also intend to use the [1/250 DILUTION]
Method to run pre-diluted patient specimens.
2. Manual Method with 40 µL (microliter) end-to-end micropipettes and
CELL-DYN Counting Cups using the [10 mL DISPENSE] key from the
SPECIAL PROTOCOLS menu
NOTE: Use only CELL-DYN Counting Cups. Using other cups may cause
spurious results.
Each of these methods is discussed in this subsection.
Determining Reference Values—Pre-Dilute

For specific material requirements used in the calibration process, refer to
Requirements for Fresh Whole Blood Sample and Auto-Cal Ranges for
Calibrator and Fresh Whole Blood earlier in this section.
Calibrator
To determine calibrator reference values for the Pre-Dilute Calibration Mode, use
the appropriate three-digit reference assay values from the sheet enclosed with the
calibrator material.
Fresh Whole Blood

To determine fresh whole blood reference values for the Pre-Dilute Calibration
mode, run five specimens of fresh whole blood on a reference instrument. If you
use the CELL-DYN 1800 as your reference instrument, you must calibrate using
either calibrator or fresh whole blood before calibrating the Pre-Dilute Mode.
Use the following procedure to determine the reference values that will be used in
the calibration procedure for the Pre-Dilute Mode. Use the same specimens run on
the reference instrument to prepare pre-diluted solutions, using either the [1/250
DILUTION] Method or the [10 mL DISPENSE] Method.

9140390A—March 2003
Pre-Dilute Mode Calibration Section 6
Auto-Cal Calibration Procedure

1. Go to a reference instrument or to the appropriate hematology method with
five specimens of fresh whole blood. Label the five specimens #1 through #5.
Run a minimum of three replicates from specimen #1 and calculate a mean
for each parameter to be calibrated. Be sure the means derived from each of
the remaining specimens are clearly identified for that specimen.
2. Repeat this procedure for each of the remaining four specimens.
3. The mean values obtained on the reference instrument or hematology
methods will be used in the calibration process of your CELL-DYN 1800.
The same blood specimens run on the calibrated hematology instrument will
be run on the CELL-DYN 1800 to be calibrated.
Enter Factor Calibration Procedure

1. Go to a reference instrument or to the appropriate hematology method with
five specimens of fresh whole blood. Label the five specimens #1 through #5.
Run a minimum of two replicates from each of the five specimens (in the
order numbered on the tube).
2. Calculate the mean for all ten values for each parameter to be calibrated.
3. The mean value for all fifteen runs for each parameter obtained on the
reference instrument or hematology methods will be used in the calibration
process of your CELL-DYN 1800. The same blood specimens run on the
calibrated hematology instrument will be run on the CELL-DYN 1800 to be
calibrated.

9140390A—March 2003
Preparing Pre-Diluted Solution Using the [1/250 DILUTION] Method—

Calibrator
To prepare a pre-diluted solution of calibrator using the [1/250 DILUTION]
method, proceed as follows:
1. From the MAIN MENU screen, press [SPECIAL PROTOCOLS]. Press
[MORE] twice.
2. Obtain the specimen of calibrator and 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.
3. Obtain three CELL-DYN Counting Cups. (Use only CELL-DYN cups as
other cups may cause spurious results.)
4. Remove the cap from the calibrator tube and place the tube under the
5. Press [1/250 DILUTION] to activate the cycle.
Figure 6.6 1/250 DILUTION Screen
7. Hold a clean CELL-DYN Counting Cup under the aspiration probe at a slight
angle so that the fluid dispensed from the probe flows down the side of the
cup to the bottom. If the cup is held straight, the force of the dispensing fluid
may cause fluid to splash out of the cup.

9140390A—March 2003
8. Press [1/250 DILUTION]. (This key is now highlighted in dark blue.) A

diluted sample dispenses into the Counting Cup.
9. Remove the cup after the solution has been dispensed. Fold the cup once at
the upper crease, grip firmly in the middle of the fold, and invert the cup a
minimum of five times to thoroughly mix the blood and diluent.
controls, calibrators, etc., that contain human blood or serum as potentially
1 Fold at Crease
2 Solution
Figure 6.7 CELL-DYN Counting Cup
10. Repeat steps 4 through 8 two more times to obtain a total of three cups of
diluted sample.
NOTE: The pre-diluted solutions are stable for 20 minutes. Therefore, the
Operator must prepare the dilutions as efficiently as possible and
run them as soon as possible.
11. When all of the cups of diluted samples have been prepared, press [MAIN] to
return to the MAIN MENU screen. Proceed with the instructions in
Activating the Pre-Dilute Mode within this section. Then proceed with the
instructions in either Pre-Dilute Auto-Cal Procedure—Calibrator or Pre-
Dilute Enter Factor Procedure—Calibrator within this section.

9140390A—March 2003
Preparing Pre-Diluted Solution Using the [1/250 DILUTION] Method—

Fresh Whole Blood
To prepare a pre-diluted solution of fresh whole blood using the [1/250
DILUTION] method, proceed as follows:
1. From MAIN MENU screen, press [SPECIAL PROTOCOLS]. Press
[MORE] twice.
2. Mix the fresh whole blood specimens by gently inverting the tubes 10–15
times.
3. Obtain fifteen CELL-DYN Counting Cups. Label three cups as #1, three cups
as #2, and the remaining sets of three cups as #3, #4, and #5. (Use only
CELL-DYN cups as other cups may cause spurious results.)
4. Starting with specimen #1, remove the cap from the specimen tube and place
the tube under the aspiration probe. Raise the tube so that the end of the probe
is deeply immersed in the specimen.
5. Press [1/250 DILUTION] to activate the cycle.
Figure 6.8 1/250 DILUTION Screen
6. When the sample has been drawn from the tube, the probe will move up

9140390A—March 2003
8. Press [1/250 DISPENSE]. (This key is now highlighted in dark blue.) A

diluted sample dispenses into the Counting Cup.
9. Remove the cup after the solution has been dispensed. Fold the cup once at
the upper crease, grip firmly in the middle of the fold, and invert the cup a
minimum of five times to thoroughly mix the blood and diluent.
WARNING: Potential Biohazard. Consider all and reagent, controls,
calibrators, etc., that contain human blood or serum as potentially
1 Fold at Crease
2 Solution
Figure 6.9 CELL-DYN Counting Cup
10. Repeat steps 4 through 8 two more times using Specimen #1 and the two
remaining cups labeled #1. Then repeat steps 4 through 8 three more time for
each of the remaining specimens [e.g., 3 cups of specimen #2, 3 cups of
specimen #3, etc.] to obtain a total of 15 diluted samples. Make sure the cups
numbers correspond to the proper specimen number.
NOTE: The pre-diluted solutions are stable for 20 minutes. Therefore, the
Operator must prepare the dilutions as efficiently as possible and
run them as soon as possible.
11. When all of the cups of diluted samples have been prepared, press [MAIN] to
return to the MAIN MENU screen. Proceed with the instructions in
Activating the Pre-Dilute Mode within this section. Then proceed with the
instructions in either Pre-Dilute Auto-Cal Procedure—Fresh Whole Blood
or Pre-Dilute Enter Factor Procedure—Fresh Whole Blood within this
section.

9140390A—March 2003

Method—Calibrator
To prepare a pre-diluted solution of calibrator using the [10mL DISPENSE]
method, proceed as follows:
[MORE] twice.
2. Press [10 mL DISPENSE] to activate the dispense mode. (This key is now
Figure 6.10 10mL DISPENSE Screen
3. Obtain three CELL-DYN Counting Cups. (Use only CELL-DYN Counting

Cups, as other cups may cause spurious results.)
5. Press [10 mL DISPENSE] to dispense 10 mL (milliliters) of diluent into the
cup.
6. Repeat steps 4 and 5 two or more times to obtain a total of three cups of
diluent. (It may be advisable to dispense extra 10-mL aliquots of diluent into
additional CELL-DYN Counting Cups in case extra pre-diluted samples need
to be made for any reason.)
7. Obtain a specimen of calibrator and 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.

9140390A—March 2003
8. Obtain a 40-µL end-to-end micropipette. Hold the micropipette near one end,
but so that both ends are visible. Insert the tip of the other end into the
specimen. Tilt the micropipette at an angle that will allow the calibrator
material to flow completely to the opposite end.
9. Remove the micropipette from the sample and carefully roll the outside of the
micropipette across a lint-free pad slightly dampened with diluent to remove
all excess blood. Gently wipe the outside of the micropipette, if necessary. Do
not remove any of the sample from inside the micropipette while wiping the
outside.
NOTE: The micropipette is calibrated to contain exactly 40 µL of sample.
Check both ends of the micropipette to make sure that it is still
completely full of blood after the outside has been wiped.
10. Drop the filled micropipette immediately into one of the CELL-DYN
Counting Cups containing 10 mL of diluent, which were prepared in the
preceding steps. Fold the cup once at the upper crease (with the micropipette
still inside), grip in the middle of the fold, and invert a minimum of 15 to 20
times to thoroughly mix the blood and diluent. Mix until the fluid inside the
capillary is the same color as the rest of the fluid.
1 Solution
2 Micropipette
3 Fold at Crease
Figure 6.11 CELL-DYN Counting Cup with Micropipette
11. Repeat steps 7 through 10 two more times, using the two remaining cups of
diluent and two new micropipettes, to obtain a total of three diluted samples.

9140390A—March 2003
12. Proceed with the instructions in Activating the Pre-Dilute Mode later in this
section. Then proceed with the instructions in either Pre-Dilute Auto-Cal
Procedure—Calibrator or Pre-Dilute Enter Factor Procedure—Calibrator
within this section.

Method—Fresh Whole Blood
To prepare a pre-diluted solution of fresh whole blood using the [10 mL
DISPENSE] method, proceed as follows:
[MORE] twice.
2. Press [10 mL DISPENSE] to activate the dispense mode. (This key is now
Figure 6.12 10mL DISPENSE Screen
3. Obtain fifteen CELL-DYN Counting Cups and label three cups as #1, three
cups as #2, and the remaining sets of three cups as #3, #4, and #5. (Use only
CELL-DYN Counting Cups, as other cups may cause spurious results.)
4. Select one of the CELL-DYN Counting Cups labeled #1, and hold it at a
slight angle so that the fluid dispensed from the probe flows down the side of
the cup to the bottom. If the cup is held straight, the force of the dispensing
fluid may cause fluid to splash out of the cup.
5. Press [10 mL DISPENSE] to dispense 10 mL (milliliters) of diluent into the
cup.

9140390A—March 2003
6. Repeat steps 4 and 5 two or more times using the two remaining cups labeled
#1. Then repeat steps 4 and 5 three more times for each of the remaining four
samples to obtain a total of fifteen cups of diluent. (It may be advisable to
dispense extra 10-mL aliquots of diluent into additional CELL-DYN
Counting Cups in case extra pre-diluted samples need to be made for any
reason.)
NOTE: The pre-diluted solutions that will be prepared in the following
steps are stable for 20 minutes. It would be difficult to prepare the
total of fifteen dilutions (three from each of the five whole blood
samples) within the 20-minute stability period. Therefore, three
dilutions will be prepared of each whole blood sample and the three
will be run in the calibration method of choice (either Auto Cal or
Enter Factor), before the next three dilutions are prepared from the
next whole blood sample.
7. Mix the fresh whole blood specimens by gently inverting the tubes 10–15
times.
8. Obtain a 40-µL end-to-end micropipette. Hold the micropipette near one end,
but so that both ends are visible. Insert the tip of the other end into the sample.
Tilt the micropipette at an angle that will allow the calibrator material to flow
completely to the opposite end.
9. Remove the micropipette from the sample and carefully roll the outside of the
micropipette across a lint-free pad slightly dampened with diluent to remove
all excess blood. Gently wipe the outside of the micropipette, if necessary. Do
not remove any of the sample from inside the micropipette while wiping the
outside.
NOTE: The micropipette is calibrated to contain exactly 40 µL of sample.
Check both ends of the micropipette to make sure that it is still
completely full of blood after the outside has been wiped.
10. Drop the filled micropipette immediately into one of the CELL-DYN
Counting Cups labeled #1 containing 10 mL of diluent, which were prepared
in the preceding steps. Fold the cup once at the upper crease (with the
micropipette still inside), grip in the middle of the fold, and invert a minimum
of 15 to 20 times to thoroughly mix the blood and diluent. Mix until the fluid
inside the capillary is the same color as the rest of the fluid.

9140390A—March 2003
1 Solution
2 Micropipette
3 Fold at Crease
Figure 6.13 CELL-DYN Counting Cup with Micropipette
11. Repeat steps 7 through 10 two more times, using the remaining two cups
labeled #1.
Return to this step after the three dilutions have been run. Repeat steps 7
through 10 three more times for the next whole blood sample, using
appropriately labeled cups and new micropipettes. Make sure the cup
numbers correspond to the proper sample number. Proceed with the
instructions in Activating the Pre-Dilute Mode within this section. Then
proceed with the instructions in either Pre-Dilute Auto-Cal Procedure—
Fresh Whole Blood or Pre-Dilute Enter Factor Procedure—Fresh Whole
Blood within this section.
12. When all of the cups of diluted sample have been prepared, press [MAIN] to
return to the MAIN MENU screen.

9140390A—March 2003
Activating the Pre-Dilute Mode

1. In the CALIBRATION menu, press [PRE-DILUTE] to activate the
Pre-Dilute Mode. The aspiration probe is raised and positioned over the
RBC/PLT Mixing Chamber, and the Pre-Dilute Mode screen is displayed.
2. Remove the Upper Front Cover. See Section 2: Installation Procedures and
Special Requirements, Subsection: Inspection and Tubing Installation.
CAUTION: To prevent damage to the Sample Aspiration Probe, always
confirm that the probe has been raised before attempting to remove the
Upper Front Cover.
Pre-Dilute Auto-Cal Procedure—Calibrator

To perform the Pre-Dilute Auto-Cal Procedure with Calibrator, proceed as follows:
1. In the Pre-Dilute Mode, press [AUTO CAL SELECT] to display the AUTO
CALIBRATION menu. Press [PRINT] to print the current calibration
factors.
2. Press [CALIBRATOR].
4. Enter the corresponding three-digit reference assay value for each parameter
to be calibrated from the sheet enclosed with the calibrator material.
As each value is entered, the field accepts the value and the cursor
automatically moves to the next parameter. Use the [↑] or [↓] arrow keys to
skip a parameter.
5. Select one of the counting cups of the diluted calibrator obtained under either
the [1/250 DILUTION] Method or the [10 mL DISPENSE] Method
described earlier.
6. Remix the pre-diluted sample by closing the cup and folding once at the
upper crease. Gripping firmly at the middle of the fold, mix the counting cup
again by inverting it several times, and carefully pour the specimen into the
Pre-Mixing Cup.

9140390A—March 2003
CAUTION: if the [10 mL DISPENSE] Method was used, the

micropipette is still inside the cup; be careful when pouring to prevent it
from falling into the Pre-Mixing Cup.

CAUTION: If a pre-diluted solution has been inadvertently poured into

the Pre-Mixing Cup prior to returning to the RUN or CALIBRATION
menu, it will be necessary to follow the instructions in Section 5: Operating
Instructions, Subsection: Removing a Pre-Diluted Solution from the Pre-
Mixing Cup. Otherwise the flow sequence of the instrument will be
incorrect, resulting in overfilling of the WBC Transducer and carryover of
the pre-dilution into the next analysis.
7. When READY appears in the status box, press the Touch Plate to activate the
Pre-Dilute cycle. The instrument performs RUN 1 measurement and displays
the values in the RUN 1 column.
reference values entered for that sample to verify that the difference
is in within acceptable limits. If any of the runs fails this Reference
Check, the results are highlighted and no calibration factor will be
calculated for that parameter.
8. Repeat steps 6 and 7 two more times using the remaining two diluted
counting cups to obtain results for RUN 2 and RUN 3. The Factor and Mean
Factor for each parameter to be calibrated are calculated by the system after
three “successful” runs. The calibration factors are saved and the instrument
is now calibrated.
If after five specimen runs the Factor and Mean Factor have not been
calibrated, it may be due to one of the following conditions:
> < is displayed in the Factor column and a Mean Factor will not be
calculated and displayed if the instrument fails the Precision Check. After
three “good” runs, the instrument performs a Precision Check for each
parameter being calibrated before determining the Factor and Mean Factor
for that parameter. Refer to Section 10: Troubleshooting and Diagnostics,
Subsection: Calibration Troubleshooting.
>>> or <<< is displayed in the Factor column and a Mean Factor is not
calculated if the instrument fails the Allowable Limits used for calculating
the Mean Factor.

9140390A—March 2003

14. Run three levels of controls (low, medium, and high) in the Pre-Dilute Mode.
Confirm that the results obtained for all parameters are within control limits
specified on the assay sheet or within your own established laboratory ranges
for the current lot number.
Service.

9140390C—March 2004
Pre-Dilute Auto-Cal Procedure—Fresh Whole Blood

To perform the Pre-Dilute Auto-Cal Procedure with Fresh Whole Blood, proceed
as follows:
1. In the Pre-Dilute Mode, press [AUTO CAL SELECT] to display the AUTO
CALIBRATION menu. Press [PRINT] to print the current calibration
factors.
2. Press [WHOLE BLOOD].
4. Select Specimen #1 that was run on the reference instrument (see Pre-Dilute
Mode Calibration, Determining Reference Values—Pre-Dilute within this
section).
Using the means derived from the reference instrument, enter the
corresponding mean for each parameter to be calibrated. As each value is
entered, the field accepts the value and the cursor automatically moves to the
next parameter. Use the [↑] or [↓] arrow keys to skip a parameter.
5. Select one of the cups of diluted specimen labeled #1 obtained under either
the [1/250 DILUTION] Method or the [10 mL DISPENSE] Method
described earlier.
6. Remix the pre-diluted specimen by closing the cup and folding once at the
upper crease. Gripping firmly at the middle of the fold, mix the counting cup
again by inverting it several times, and carefully pour the specimen into the
Pre-Mixing Cup.
CAUTION: If the [10 mL DISPENSE] Method was used, the


menu, it will be necessary to follow the instructions in Section 5: Operating
7. When READY appears on the screen, press the Touch Plate to activate the
Pre-Dilute cycle. The instrument performs RUN 1 measurement and displays
the values in the RUN 1 column.

9140390A—March 2003

reference values entered for that specimen to verify that the
difference is in within acceptable limits. If any of the runs fails this
Reference Check, the results are highlighted and no calibration
factor will be calculated for that parameter. Refer to Section 10:
Troubleshooting and Diagnostics, Subsection: Calibration
Troubleshooting.
8. Repeat steps 6 and 7 two more times using the remaining two diluted
counting cups labeled #1 to obtain results for RUN 2 and RUN 3. Repeat
steps 4 through 7 three more times for each of the remaining four specimens.
Remember to enter the new values that correspond with each of the
remaining four specimens before running the specimen. A new factor for
each parameter to be calibrated will be calculated each time three runs are
completed for a specimen. When all five specimens have been run in
triplicate (15 runs), the instrument is calibrated.
If after five specimen runs the Factor and Mean Factor have not been
calibrated, it may be due to one of the following conditions:
> < is displayed in the Factor column and a Mean Factor will not be
calculated and displayed if the instrument fails the Precision Check. After
three “good” runs, the instrument performs a Precision Check for each
parameter being calibrated before determining the Factor and Mean Factor
for that parameter.
>>> or <<< is displayed in the Factor column and a Mean Factor is not
calculated if the instrument fails the Allowable Limits used for calculating
the Mean Factor.
14. Run three levels of controls (low, medium, and high) in the Pre-Dilute Mode.
Confirm that the results obtained for all parameters are within control limits
specified on the assay sheet or within your own established laboratory ranges
for the current lot number.
Service.

9140390C—March 2004
Pre-Dilute Enter Factor Procedure—Calibrator

To perform the Pre-Dilute Enter Factor Procedure with Calibrator, proceed as
follows:
2. Be sure that READY is displayed in the status box on the RUN menu, and
that the results will go into the empty replicate file chosen in step 1.
3. Remix the pre-diluted calibrator in the CELL-DYN Counting Cup by closing
the cup and folding once at the upper crease. Gripping firmly, invert it a
minimum of five times.
4. Carefully pour the dilution into the Pre-Mixing Cup.


menu, it will be necessary to follow the instructions Section 5: Operating
5. Press the Touch Plate to start the Pre-Dilute cycle.

6. When the cycle is complete, make sure that there are no Flow Error or Clog
messages, then repeat steps 3 through 5 with the remaining two pre-diluted
solutions of the calibrator.
7. Repeat steps 3 through 5, making sure that the instrument is in the
PRE-DILUTE RUN menu before pouring each of the diluted solutions into
the Pre-Mixing Cup.
8. Repeat step 7 with the remaining two calibrator specimens for a total of 3
valid runs (no Flow Err or Clog messages).
9. Press [MAIN], then [QUALITY CONTROL], followed by
[REPLICATES], and select the replicate file which was just used to store the
calibration results.
10. Press [VIEW QC LOG] and press [PRINT QC LOG] to print the summary
report for the selected replicate file. Press [MAIN] to return to the MAIN
MENU screen.

9140390A—March 2003
11. Press [CALIBRATION] to display the Whole Blood Pre-Dilute Mode

Sample Factors screen. Press [PRINT] to obtain a copy of the current Pre-
Dilute Mode Calibration Factors which will be used in determining the new
calibration factors.
12. To determine the new calibration factor: Use the reference mean values
determined in Pre-Dilute Mode Calibration, Determining Reference
Values—Pre-Dilute within this section and the CELL-DYN Mean values
determined in steps 4 through 10. Enter this information in the Enter Factor
Pre-Dilute Mode Worksheet provided in Appendix C: Sample Logs and
Worksheets to calculate the New Pre-Dilute Mode Calibration Factor for
each parameter as follows:
Calibrator Calibration:
Calibrator Mean x Current Pre-Dilute Mode = New Pre-Dilute Mode

Mean for WBC is 7.1, and the current Pre-Dilute Calibration Factor is 0.98,
then:
6.6 x 0.98 = 0.91

7.1
13. With the PRE-DILUTE CALIBRATION menu displayed, press [ENTER

FACTOR].
select a parameter.
Hard Disk, corresponding to the Open or Pre-Dilute mode.
screen to 1.00.
16. Press [PRINT] to print a copy of the Pre-Dilute Calibration Factors.
18. Run three levels of controls using the Pre-Dilute Mode. Confirm that the
results obtained for all parameters are within the control limits specified on
the assay sheet or within your own established laboratory ranges for the
current lot number.
protocols. Refer the Section 11: Quality Control.
Service.

9140390C—March 2004
Pre-Dilute Enter Factor Procedure—Fresh Whole Blood

To perform the Pre-Dilute Enter Factor Procedure with fresh whole blood, proceed
as follows:
2. Be sure that READY is displayed in the status box on the RUN menu, and
that the results will go into the empty replicate file chosen in step 1.
3. Remix the pre-diluted specimen in Counting Cup #1 by closing the cup and
folding once at the upper crease. Gripping firmly, invert it a minimum of five
times.
4. Carefully pour the dilution into the Pre-Mixing Cup.


menu, it will be necessary to follow the instructions Section 5: Operating
Instructions, Subsection: Rep File Setup. Otherwise the flow sequence of
the instrument will be incorrect, resulting in overfilling of the WBC
Transducer and carryover of the pre-dilution into the next analysis.
5. Press the Touch Plate to start the Pre-Dilute cycle.

6. When the cycle is complete, make sure that there are no Flow Error or Clog
messages, then repeat steps 3 through 5, making sure that the instrument is in
the PRE-DILUTE RUN menu before pouring each of the diluted solutions
into the Pre-Mixing Cup.
7. Repeat steps 3 through 5, making sure that the instrument is in the PRE-
DILUTE RUN menu before pouring each of the diluted solutions into the
Pre-Mixing Cup.
8. Repeat step 7 with the remaining three specimens for a total of 15 valid runs
(no Flow Err or Clog messages).
9. Press [MAIN], then [QUALITY CONTROL], followed by
[REPLICATES], and select the replicate file which was just used to store the
calibration results.
10. Press [VIEW QC LOG] and press [PRINT QC LOG] to print the summary
report for the selected replicate file. Press [MAIN] to return to the MAIN
MENU screen.

9140390D—January 2006
11. Press [CALIBRATION] to display the Whole Blood Pre-Dilute Mode

Sample Factors screen. Press [PRINT] to obtain a copy of the Current Pre-
Dilute Mode Calibration Factors which will be used in determining the new
calibration factors.
12. To determine the new calibration factor: Use the reference mean values
determined in Pre-Dilute Mode Calibration, Determining Reference
Values—Pre-Dilute within this section and the CELL-DYN Mean values
determined in steps 4 through 10. Enter this information in the Enter Factor
Pre-Dilute Mode Worksheet in Appendix C: Sample Logs and Worksheets
to calculate the New Pre-Dilute Mode Calibration Factor for each parameter
as follows:
Whole Blood Calibration:
Reference Mean x Current Pre-Dilute Mode = New Pre-Dilute Mode

Mean for WBC is 7.1, and the current Open Mode Calibration Factor is 0.98,
then:
6.6 x 0.98 = 0.91

7.1
13. With the PRE-DILUTE CALIBRATION menu displayed, press [ENTER

FACTOR].
select a parameter.
Hard Disk, corresponding to the Open or Pre- Dilute mode.
screen to 1.00.
16. Press [PRINT] to print a copy of the Pre-Dilute Calibration Factors.
18. Run three levels of controls using the Pre-Dilute Mode. Confirm that the
results obtained for all parameters are within the control limits specified on
the assay sheet or within your own established laboratory ranges for the
current lot number.
Service.

9140390C—March 2004
References
1. Occupational Safety and Health Administration, Department of Labor. 29

CFR Part 1910, 1030. Occupational Exposure to Bloodborne Pathogens.
2. International Committee for Standardization in Haematology (ICSH).
Protocol for Evaluation of Automated Blood Cell Counters. Clinical and
Laboratory Haematology 1984; 6:69-84.
3. Clinical and Laboratory Standards Institute/NCCLS. Procedure for
Determining Packed Cell Volume by the Microhematocrit Method; Approved
Standard—Third Edition. CLSI/NCCLS document H7-A3 [ISBN 1-56238-
413-9]. Clinical and Laboratory Standards Institute, 940 West Valley Road,
Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2000.

9140390D—January 2006
NOTES

9140390A—March 2003
Section 7 Operational Precautions and Limitations
Section 7 Operational Precautions and Limitations
Overview
This section provides information describing actions or conditions that can

adversely affect the CELL-DYN 1800 instrument or its performance.
Limitations
designed for in vitro diagnostic use in the clinical laboratory.
• System components have been designed for optimal performance.
Substituting reagents, calibrators, controls, and components manufactured by
other companies may adversely affect instrument performance.
• Follow the recommended maintenance schedules and procedures as outlined
Section 9: Service and Maintenance.
• During the warranty period, all service and repair must be performed by
Abbott-authorized representatives.
Location Requirements
Once the CELL-DYN 1800 has been installed, it must be checked by a trained
Operator to verify system performance and to ensure that all system components
are functioning correctly.
Choosing a location for the instrument is an important consideration, as placement
can affect proper instrument functioning, operating safety, and ease of use.
Location requirements to consider are listed below:
• The location must have non-porous, non-absorbent work surfaces, and
flooring that can be easily cleaned and disinfected using recommended
procedures.
• Place the instrument on a hard, level surface away from:
– Patient areas
– Direct sunlight
– The path of a cooled air or heated air outlet
– Drying ovens, centrifuges, X-ray equipment, computers, video terminals,
copiers, and ultrasonic cleaners
CAUTION: Do not use mobile telephones, wireless telephones, mobile
radios, or any other radio-frequency (RF) transmitting devices in the same
room as the instrument.

9140390E—June 2008
Operational Precautions and Limitations
Overview Section 7
• Allow enough space to ensure proper ventilation, as follows:

– Countertop: 1.5 linear feet (18 inches or 46 cm)
– Around the instrument: a minimum of 6 inches (15 cm) to ensure that the
air vents and fans are not blocked and to allow for maintenance
procedures
– Below the instrument: sufficient space for reagents and waste container (if
one is used)
• Before operating the instrument for the first time, verify that each reagent line
is connected to the appropriate tubing inlet and reagent container.
• Allow adequate space around the instrument to perform necessary
maintenance procedures, and to allow the instrument to be easily
disconnected from its power source.
• Keep reagent containers below the instrument.
• Make sure the waste outlet tubing is connected to the appropriate outlet and
securely routed to a container suitable for collection of waste that may
contain biological or chemical hazards. If the waste is routed to a waste
container, ensure the waste sensor is properly connected. If the waste is
routed to a drain, make sure a dummy plug is inserted in the SENSOR port.
WARNING: 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.
For additional information, see Section 2: Installation Procedures and Special

Requirements, Subsection: Inspection and Tubing Installation.

and Controls:

9140390E—June 2008
Section 7 Overview
Reagent Storage and Handling

Reagents used with the CELL-DYN 1800 require special care as follows:
• Before operating the instrument for the first time, make sure each reagent line
is connected to the appropriate inlet and reagent container.
• Store reagents, calibrators, and controls according to the directions on the
label and package inserts.
• Protect reagents from extreme heat and freezing during storage.
Temperatures below 32°F (0°C) can cause layering that changes the tonicity
and conductivity of the reagent. If freezing occurs, do not use the reagent.
Dispose of reagent in accordance with federal, state, and local regulations.
• Protect reagents from direct sunlight, evaporation, and contamination. Use
the reagent container cap attached to each inlet tubing to minimize
evaporation and contamination.
• Never add remaining reagent from a container being replaced to a freshly
opened container. This can contaminate the new reagent.
• Never use a hemoglobin standard designed for use with Reference
Methemoglobin Methodology directly on the CELL-DYN 1800. The
CELL-DYN 1800 uses a modified methemoglobin method which is not
designed to analyze these standards.

9140390E—June 2008
Overview Section 7
NOTES

9140390E—June 2008
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 1800 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 which could result in minor 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.
Safety Icons
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.

9140390A—March 2003
Hazards
Overview Section 8
NOTES

9140390A—March 2003
Hazards
Section 8 Hazard Information and Precautions
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 (29 CFR Part
1910.1030)1 or other equivalent biosafety procedures.
WARNING: Potential Biohazard. The Sample Aspiration Probe is sharp

and potentially contaminated with infectious material. Avoid contact with
the tip of the probe.
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 tuberculoidal disinfectant such as 0.5% sodium hypochlorite
solution (refer to formula in Section 9: Service and Maintenance, Subsection:
Decontamination Procedures).
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
Preparing the Instrument for Extended Periods of Non-Use or Shipping as
appropriate. Remove and dispose of contaminated disposables in accordance with
local, state, and federal regulations.
Handling and Disposing of Biohazardous Material

Dispose of liquid and solid waste in accordance with local, state, and federal
regulations. Probes, 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.

9140390D—January 2006
Hazards
Hazard Information and Precautions Section 8
Chemical Hazards
Prevent exposure to chemicals used in the operation and maintenance of the
CELL-DYN 1800 System (including reagents) by using appropriate personal
protective equipment, work procedures, and information on Material Data Safety
Sheets (MSDS). For information or Material Data Safety Sheets (MSDS) contact
Abbott Diagnostics Customer Service at: 1-877-4ABBOTT (1-877-422-2688).
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 1800 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 OFF 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, such as those 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.
• Keep liquids away from all electrical connectors (such as electrical outlets)
or communication connectors (such as the LIS connector COM1).
• Keep the floor dry.
• The electrical circuit spacing of the CELL-DYN 1800 System is based on
pollution degree (1) and altitude [up to 2000M (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.

9140390C—March 2004
Hazards
Section 8 Hazard Information and Precautions
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.
• Use caution when performing any maintenance procedure on the Syringe
Panel, as moving parts can pinch.
• 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.
• Use assistance or a mechanical lifting device when moving or lifting the
instrument.
• Use proper lifting techniques when moving reagent cubitainers.

9140390A—March 2003
Hazards
Hazard Information and Precautions Section 8
NOTES

9140390A—March 2003
Hazards
References
1. Occupational Safety and Health Administration, 29 CFR Part 1910.1030.

Department of Labor. Occupational Exposure to Bloodborne Pathogens.

9140390A—March 2003
Hazards
NOTES

9140390A—March 2003
Section 9 Service and Maintenance
Section 9 Service and Maintenance
Overview
The CELL-DYN 1800 has been designed to require minimal routine maintenance.
The Operator must routinely perform the scheduled maintenance procedures
described in this section in order to ensure optimum performance. Failure to
perform the scheduled maintenance procedures may result in inaccurate or
imprecise analysis of whole blood specimens.
This section describes recommended preventive maintenance procedures and
provides instructions for preparing the instrument for extended periods of
inactivity.
NOTE: After you have performed any maintenance procedure, run Background
Counts (run without specimen) until results are within specifications.
The maintenance schedule outlined on the following page will minimize
operational problems with the CELL-DYN 1800. The recommended intervals are
based on instruments operating in laboratories that process specimens from a
general patient population. These intervals are affected by several factors,
including the following:
• Number of specimens processed
• Work load schedule
• Operating environment
• Patient population being analyzed
Each laboratory must assess its own situation and modify these recommended
intervals as necessary.
A diagram of the analyzer flow panel is included in this section to assist in
component identification and location. To order any parts, accessories, or
consumables, refer to Appendix A: Parts and Accessories.
IMPORTANT: Overdue maintenance is usually indicated by an increase in
imprecision of one or more of the directly-measured parameters. This imprecision
is due to carryover or dilution/sampling inconsistencies. If this occurs on more than
a random basis, perform the appropriate maintenance more frequently than
indicated.
CAUTION: Gloves should be worn during the maintenance procedures.
They should be powder-free before performing the maintenance, as powder
may cause instrument problems.
If you encounter any trouble performing any of these procedures, contact Abbott
Diagnostics Customer Service at 1-877-4ABBOTT (1-877-422-2688).

9140390C—March 2004
Overview Section 9
NOTES

Section 9 Preventive Maintenance Schedule
Preventive Maintenance Schedule
Perform the following procedures at scheduled intervals:
Daily
• Perform Daily Startup (initialize from a STANDBY state)
• Perform Daily Shutdown
Weekly
• Perform Auto Clean
• Clean the Aspiration Probe Exterior
Monthly
• Rinse the Lyse Inlet Line
• Rinse the Reagent Inlet Line
Semiannual
• Clean the Printer
As Required
• Clean the HGB Flow Cell
• Clean the Pre-Mixing Cup
• Empty Instrument Waste
• Clean/Replace the Aperture Plates
• Clean/Replace the Aspiration Probe
• Clean/Replace the Aspiration Probe Wash Block
• Clean/Replace Syringes
• Drain/Clean the Vacuum Accumulator
• Clean the Bar Code Scanner Lens
• Clean the “Y” Fitting
• Supplemental Aperture Cleaning
• Prepare the Instrument for an Extended Period of Non-Use or Shipping

Preventive Maintenance Schedule Section 9
NOTES

Section 9 Flow Panel Components
Flow Panel Components
The following figure illustrates the CELL-DYN 1800 Flow Panel components that
may be inspected, cleaned, or replaced during normal maintenance procedures.
Valve Function
1-1 RBC/PLT Transducer*
Drain
1-2 RBC/PLT Count
3-2 3-1
1-3 RBC/PLT Metering Tube
Vent 8
1-4 RBC/WBC Isolator Vacuum 9
1-5 RBC/WBC Isolator Drain 3-4
1-6 RBC/WBC Backflush 3-6
2-1 WBC Metering Tube Vent
2-2 Pre-Mix Cup Bubble Mix 3-5
2-3 RBC/PLT Mixing Chamber 3-3
Bubble Mix 1-6
2-4 RBC/PLT Transducer* Fill 4-6 10
2-5 RBC/PLT Mixing Chamber
Drain
1-1
2-6 HGB Reference
2-7 HGB Sample 1 5 1-4
3-1 Probe Wash Normally 2
4-8 1-3
Closed Valve
3-2 Probe Wash Drain Vacuum 1-2
2-1
Wash 4-7
3-4 Pre-Mix Cup Fill 4-3 2-2 4
3-5 WBC Transducer* Drain
3-6 WBC Mixing Chamber Vent 4-5 7
2-3
4-3 WBC Count
12 3 2-4 6
4-4 WBC Transducer* Fill
4-5 HGB Sample/WBC Mix 2-5
Chamber Drain 1-5
4-6 Lyse Inlet/WBC Mix 4-4
Chamber Drain 2-7
4-7 WBC Mix Chamber Bubble 2-6
11 11
Mix
4-8 Pre-Mixing Cup Wash/
Sample Transfer
Assembly Name
1 WBC Transducer*
2 Pre-Mixing Cup
3 WBC Metering
4 Start Switch
5 RBC/PLT Transducer*
6 RBC/PLT Metering
7 Vacuum Isolator
9 Sample Aspiration Probe
10 Wash Block
11 Vent Lines
12 HGB Flowcell
For additional description of Flow Panel Assembly, see Figure 1.4 Sampling Section and Flow Panel.
Figure 9.1 CELL-DYN 1800 Flow Panel
* von Behrens transducers

9140390C—March 2004
Flow Panel Components Section 9
NOTES

Section 9 Decontamination Procedures
Decontamination Procedures
The OSHA Bloodborne Pathogen Rule (29 CFR Part 1910.1030)1 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 Sample Aspiration Probe is 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
B-A
X =
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:
5.25 - .5 X = 9.5
X =
.5
Add 9.5 parts deionized water to 1 part bleach to obtain a 0.5% sodium
hypochlorite solution, or for example, 9.5 mL of deionized water to 1.0 mL of
bleach (5.25% sodium hypochlorite), to obtain a 0.5% solution of sodium
hypochlorite (in the example, 10.5mL).
If the instrument is to be shipped, it must be decontaminated prior to shipment. This
is accomplished by pressing the [CLEAN FOR SHIPPING] key in the SPECIAL
PROTOCOLS menu. Instructions for this procedure are given later in this section
in Preparing the Instrument for Extended Periods of Non-Use or Shipping.

Decontamination Procedures Section 9
NOTES

Section 9 Maintenance Log
Maintenance Log
Abbott recommends that CELL-DYN 1800 Operators keep a record of scheduled

and unscheduled maintenance procedures in an instrument logbook.
CELL-DYN 1800 Operators are granted specific permission to photocopy the
sample page of a typical maintenance log as shown on the following page.
Update the Maintenance Log in a timely manner by entering the month and year on
each page as appropriate, and checking off or writing your initials next to each task
completed.

Maintenance Log Section 9
Month ____________________ Year _____________

Day 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
DAILY Daily Startup
Daily Shutdown
WEEKLY Auto Clean
Clean Aspiration
Probe Exterior
MONTHLY Rinse Lyse
Inlet Lines
Rinse Reagent
Inlet Lines
SEMI-ANNUAL Clean Printer
AS-REQUIRED Clean HGB
Flow Cell
Clean Pre-
Mixing Cup
Empty
Instrument
Waste
Clean/Replace
Aperture Plate
Clean/Replace
Aspiration Probe
Clean/Replace
Aspiration Probe
Wash Block
Clean/Replace
Syringes
Clean/Drain
Vacuum
Accumulator
Clean Bar Code
Scanner Lens
Clean
“Y” Fitting
Supplemental
Aperture
Cleaning
Prepare
Instrument for
Extended Period
of Non-Use or
Shipping
Figure 9.2 Maintenance Log

Section 9 Special Protocols Menu
Special Protocols Menu
Many of the preventive maintenance procedures required for the CELL-DYN 1800
are automated and accessed through the SPECIAL PROTOCOLS menu. The
SPECIAL PROTOCOLS menu features the following softkeys and options:
• [DAILY SHUTDOWN] prepares the instrument for short periods of
inactivity (72 hours or less) with power remaining ON, for a prolonged
period of inactivity (up to 2 weeks) with power turned OFF, and for some
maintenance operations. When the Daily Shutdown cycle is complete, the
instrument is placed in STANDBY.
• [LYSE PRIME] primes the instrument with lyse.
• [REAGENT PRIME] primes the instrument with diluent and detergent.
• [AUTO CLEAN] flushes and cleans the entire fluidics system with enzyme
solution.
• [MORE] provides access to additional maintenance functions.
• [HELP/ERROR] displays help information for the selected menu, and
allows the Operator to display any fault in the Fault Log.
• [MAIN] returns the Operator to the MAIN MENU screen.
In the MAIN MENU screen, press [SPECIAL PROTOCOLS] to access the
SPECIAL PROTOCOLS menu. There are three levels in the SPECIAL
PROTOCOLS menu. At the first two levels, the [MORE] key allows the Operator
to access a submenu. At the third level, the [MORE] key returns the Operator to
the main SPECIAL PROTOCOLS menu. A brief description of each soft key,
displayed at the bottom of the SPECIAL PROTOCOLS menu, and its function is
given below.

Special Protocols Menu Section 9
SPECIAL PROTOCOLS MENU

SPECIAL
PROTOCOL
DAILY PATIENT LYSE REAGENT AUTO MORE HELP/ MAIN

SHUTDOWN LIMITS PRIME PRIME CLEAN ERROR*
START HELP/ RETURN

CLEAN ERROR*
LEVEL 1
CLN SAMPL CLEAN DIL CLN LYSE PROBE DRAIN MORE HELP/ MAIN
SYRINGE SYRINGE SYRINGE HOME BATHS ERROR*
SYRINGE SYRINGE SYRINGE PROBE REFILL
DOWN DOWN DOWN DOWN BATHS
RESTORE SYRINGE SYRINGE
SYRINGE UP UP
RESTORE RESTORE
SYRINGE SYRINGE
LEVEL 2
1/50 1/250 LYSE CLEAN FOR 10 mL MORE HELP/ MAIN

DILUTION DILUTION PRIME SHIPPING DISPENSE ERROR*
HELP RETURN
FAULT LEAVE
LOG HELP
PRINT HELP
PATIENT RETURN
Figure 9.3 SPECIAL PROTOCOLS Menu Flowchart


Section 9 Special Protocols Menu
First Level Subfunction Keys When [MORE] is Pressed
Clean Sample Syringe

[CLN SAMPL SYRINGE] is used to prepare the Sample Syringe for removal and
cleaning. When sequentially pressed, this key changes to [SYRINGE DOWN],
[RESTORE SYRINGE], then back to [CLN SAMPL SYRINGE].
Clean Dil Syringe

[CLEAN DIL SYRINGE] is used to move the Diluent Syringe up, allowing the
Operator to remove the Syringe Drive Nut. When sequentially pressed, this key
changes to [SYRINGE DOWN], [SYRINGE UP], [RESTORE SYRINGE],
then back to [CLEAN DIL SYRINGE].
Clean Lyse Syringe

[CLN LYSE SYRINGE] is used to prepare the Lyse Syringe for removal and
cleaning. When sequentially pressed, this key changes to [SYRINGE DOWN],
[SYRINGE UP], [RESTORE SYRINGE], then back to [CLN LYSE
SYRINGE].
Probe Home/Probe Down

[PROBE HOME] is used to move the Sample Aspiration Probe up and position it
over the von Behrens RBC/PLT Transducer (the “home” position). When
sequentially pressed, this key changes to [PROBE DOWN] then back to [PROBE
HOME].
Drain Baths/Refill Baths

[DRAIN BATHS] is used to drain the transducers prior to cleaning. When
sequentially pressed, this key changes to [REFILL BATHS] to refill the
transducers when cleaning is finished then back to [DRAIN BATHS].
More
[MORE] is used to provide access to the second level of SPECIAL
PROTOCOLS menu subfunction keys.
Help/Error
[HELP ERROR] accesses a menu that has a [FAULT LOG] key, [HELP] key and
[RETURN] key. If a fault is pending, when [HELP/ERROR] is pressed a list of
Pressing [HELP] allows the operator to view the Help text. The [→] arrow key is
used to view additional Help information, if there is more than one screen of text.
Press [LEAVE HELP] to exit the Help information screen.
Main

Special Protocols Menu Section 9
Second Level Subfunction Keys When [MORE] is Pressed Twice
1/50 Dilution
[1/50 DILUTION] is used to make a 1-to-50 sample dilution (uses 100 µL of
sample and 5 mL of diluent). This function is for Abbott Service Representatives
only.
1/250 Dilution
[1/250 DILUTION] is used to make a 1-to-250 sample dilution when preparing
pre-diluted samples (uses 40 µL of sample and 10 mL of diluent).
Clean for Shipping

[CLEAN FOR SHIPPING] is used to clean the instrument’s components—such
as transducers, tubing, waste system—prior to shipment or an extended period of
inactivity (two or more weeks).
10 mL Dispense
[10 mL DISPENSE] is used to dispense 10 mL of diluent when preparing pre-
diluted samples.
More
[MORE] is used to provide access to the main SPECIAL PROTOCOLS menu
subfunction keys.
Help/Error
[HELP ERROR] accesses a menu that has a [FAULT LOG] key, [HELP] key and
[RETURN] key. If a fault is pending, when [HELP/ERROR] is pressed a list of
Pressing [HELP] allows the operator to view the Help text. The [→] arrow key is
used to view additional Help information, if there is more than one screen of text.
Press [LEAVE HELP] to exit the Help information screen.
Main

Section 9 Daily Maintenance Procedures
Daily Maintenance Procedures
WARNING: Potential Biohazard. Wear gloves, labcoats, 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 practices.
Daily Start-Up Procedure

The CELL-DYN 1800 will likely have been idle (i.e., no samples have been run nor
maintenance operations performed) and will be in the STANDBY state when the
Operator is ready to perform daily maintenance tasks. The following procedure takes
the instrument from the STANDBY to a READY state for analyzing specimens.
Materials Required
• CELL-DYN 16 Tri-Level and CELL-DYN 22 Tri-Level Controls
• Reagents
• Printer paper, if needed
Procedure
To perform the Daily Startup Procedure, proceed as follows:
1. Check the reagent levels and replace reagent(s) as needed.
2. Empty waste as needed.
3. Check printer paper supply and add paper, if necessary.
4. Check tubing in the Normally Closed Valves for crimps; correct if necessary.
5. Check that the diluent tubing is properly connected to its inlet.
6. Check that the tubing to the lyse bottle is properly connected.
7. From the MAIN MENU screen press [PRIME/RUN] to begin the startup
cycle. When READY appears in the status box, perform the maintenance
functions, if required.
8. Press [MAIN] to return to the MAIN MENU screen, then [SPECIAL
PROTOCOLS].
9. Run Background Counts (see Section 5: Operating Instructions,
Subsection: Routine Operation) to ensure that all parameters are within
specification limits. If Background Counts remain out of range after three
10. Perform QC runs (see Section 11: Quality Control) according to your
laboratory’s standards and protocols. If QC run results are unacceptable,
repeat QC runs. If still unacceptable, refer to Section 10: Troubleshooting
and Diagnostics.
12. Update the Maintenance Log.
Daily Maintenance Procedures Section 9
Daily Shutdown Procedure

If shutdown time is expected to be 72 hours or less, follow the procedure below:
Materials Required
Procedure
To perform Daily Shutdown, proceed as follows:
1. From the MAIN MENU screen press [SPECIAL PROTOCOLS].
2. Press [DAILY SHUTDOWN] to begin this cycle. PROCESS ACTIVE
appears on the screen. The Daily Shutdown cycle takes approximately three
minutes.
3. Wait for STANDBY to appear in the status box.
NOTE: When the instrument is in STANDBY the READY indicator light
is flashing.
4. Empty or replace the waste container, as needed.
5. If shutdown time will exceed 72 hours, perform the procedure outlined in
Preparing the Instrument for Extended Periods of Non-Use or Shipping
later in this section.

Section 9 Daily Maintenance Procedures
Prolonged Shutdown Procedure

If shutdown time is expected to exceed 72 hours, power should be turned OFF. If
the shutdown time is expected to exceed two weeks, refer to Preparing the
Instrument for Extended Periods of Non-Use or Shipping later in this section.
Materials Required
Procedure
To perform prolonged shutdown, perform the Rinsing the Lyse Inlet Line and
Rinsing the Reagent Inlet Tubing procedures described in this section. Complete
the Perform Daily Shutdown Procedure described in this section, then proceed as
follows:
1. Turn the power OFF.
2. Immediately after the power is turned OFF remove the tubing in the
Normally Closed Valve at the top of the Flow Panel under the Upper Front
Cover.
3. Remove the tubing in the Normally Closed Valve on the lower Left side of
the instrument.
CAUTION: Do not forget to reinsert the tubing securely in the Normally
Closed Valves before turning the instrument back ON. Refer to Section 2:
Installation Procedures and Special Requirements, Subsection:
Inspection and Tubing Installation.
1 2
3 4
Figure 9.4 Prolonged Shutdown Procedure

Daily Maintenance Procedures Section 9
NOTES

Section 9 Weekly Maintenance Procedures
Weekly Maintenance Procedures

Performing Auto-Clean
The Auto Clean option allows the Operator to drain and clean the entire fluidics
system of the instrument.
Materials Required
• Standard specimen tube containing room temperature, undiluted Enzymatic
Cleaner
Procedure
To perform Auto Clean to drain and clear the entire fluidics system, proceed as
follows:
1. From the MAIN MENU screen press [SPECIAL PROTOCOLS].
2. Press [AUTO CLEAN] to begin the Auto Clean cycle.
3. Remove the cap from a room temperature tube of undiluted Enzymatic
Cleaner, and place the tube under the aspiration probe. Raise the tube so that
the end of the probe is deeply immersed in the Enzymatic Cleaner.
4. Press [START CLEAN]. The enzymatic solution is aspirated and the
message PROCESS ACTIVE is displayed on the screen. (The complete
cycle takes approximately seven minutes.)
5. When the enzymatic solution has been drawn from the tube, the probe will
move up through the Wash Block, and the Remove Specimen message
appears on the display screen.
6. Remove the specimen tube and replace the cap. After the cycle is completed,
the aspiration probe moves into position to accept a new specimen.

Weekly Maintenance Procedures Section 9
1 2 3
4 5 6
Figure 9.5 Performing Auto Clean Procedure (steps 1–6)


8. From the MAIN MENU screen, press [RUN] followed by [SPECIMEN
TYPE] and [NORMAL BACKGROUND].
Subsection: Routine Operation to ensure that all parameters are within
specification limits. If Background Counts remain out of range after three
10. Press [RETURN], followed by [MAIN] to return to the MAIN MENU
screen.
7 8 9
10 11
Figure 9.6 Performing Auto Clean Procedure (steps 7–11)

Cleaning the Aspiration Probe Exterior

During each run cycle, the Wash Block rinses whole blood from the outside of the
Sample Aspiration Probe. However, the exterior portion of the probe should be
routinely cleaned to ensure it moves freely through the Wash Block. This procedure
can be done at any time (at least weekly) or in conjunction with other routine
cleaning procedures.
Procedure
To clean the aspiration probe exterior, proceed as follows:
1. With the power ON and the aspiration probe down, carefully wipe the outside
of the probe several times with a lint-free pad that has been dampened with
diluted enzymatic cleaner (one part deionized water to one part enzymatic
cleaner). Then wipe the outside of the probe with a lint-free pad that has been
dampened with deionized water.
CAUTION: Moving the probe while wiping it may require reinitialization.
2. In the MAIN MENU screen, press [RUN] and followed by [SPECIMEN

TYPE] and [NORMAL BACKGRND].
screen.

9140390E—June 2008
1 2 3
5
4
Figure 9.7 Cleaning the Aspiration Probe Exterior

NOTES

Section 9 Monthly Maintenance Procedures
Monthly Maintenance Procedures

Rinsing the Lyse Inlet Line

The purpose of rinsing the Lyse Inlet tubing is to prevent salt buildup from
hardening the tubing over long periods of time.
Materials Required
• Paper towel
• Container of warm, deionized water
Procedure
To rinse the Lyse Inlet line, proceed as follows:
1. Remove the tubing from the Lyse Reagent Container and place the end of the
tubing into a container of warm deionized water. (The Lyse Tubing should
still be attached to the Reagent Inlet Panel.)
2. In the MAIN MENU screen, press [SPECIAL PROTOCOLS].
3. Press [LYSE PRIME] to begin the Lyse Priming cycle which flushes warm
water through the tubing.
NOTE: Disregard any Lyse Empty alarm and proceed to the next step.
4. After the fill cycle is complete, press [CLEAR ALARM], continuing to press
the key several more times after each cycle until enough water is drawn up to
rinse clean the tubing and syringe.
5. After rinsing, remove the lyse tubing from the water and place the wet end on
a paper towel. Press [CLEAR ALARM] again to cycle air through the tubing
and syringe.
6. Remove excess water from the lyse tubing and place the tubing into the Lyse
container. Check for damaged cap. If the cap is broken or cracked, replace it
with a new cap. (See Appendix A: Parts and Accessories, Subsection:
CELL-DYN Equipment, Parts, and Accessories). Press [LYSE PRIME].

Monthly Maintenance Procedures Section 9
1 2 3
4 5 6
Figure 9.8 Rinsing the Lyse Inlet Line (steps 1–6)

7. Observe the Lyse Syringe to ensure that Lyse is flowing into the syringe.
After the fill cycle is complete, press [LYSE PRIME] again. Continue
pressing the key a few more times until enough Lyse is drawn up to fill the
Lyse tubing and syringe.
9. Press [RUN] followed by [SPECIMEN TYPE] and [NORMAL
BACKGRND].
screen.
7 8 9
10 11 12
Figure 9.9 Rinsing the Lyse Inlet Line (steps 7–12)

Rinsing the Reagent Inlet Tubing

The purpose of rinsing the diluent and detergent Reagent Inlet tubing is to prevent
salt buildup from hardening the tubing over long periods of time.
Materials Required
• Paper towel
• Container of warm, deionized water
Procedure
To rinse either Reagent Inlet tubing, proceed as follows:
1. Remove the tubing from the Reagent Container and place the end of the
tubing into a container of warm deionized water. (The Reagent Tubing should
still be attached to the Reagent Inlet Panel.)
2. In the MAIN MENU screen, press [SPECIAL PROTOCOLS].
3. Press [REAGENT PRIME] to begin the Reagent Priming cycle which
flushes warm water through the tubing.
NOTE: Disregard any Reagent Empty alarm and proceed to the next step.
4. After the fill cycle is complete, press [CLEAR ALARM], continuing to press
the key several more times after each cycle until enough water is drawn up to
rinse clean the tubing and syringe.
5. After rinsing, remove the reagent tubing from the water and place the wet end
on a paper towel. Press [CLEAR ALARM] again to cycle air through the
tubing and syringe.
6. Remove excess water and replace the tubing into the Reagent container.
Check for damaged cap. Press [REAGENT PRIME].

1 2 3
4 5 6
Figure 9.10 Rinsing the Reagent Inlet Line (steps 1–6)

7. Observe the Reagent Syringe to ensure that Reagent is flowing into the
syringe. After the fill cycle is complete, press [REAGENT PRIME] again.
Continue pressing the key a few more times until enough Reagent is drawn
up to fill the reagent tubing and syringe.
BACKGRND].
screen.
7 8 9
10 11 12
Figure 9.11 Rinsing the Reagent Inlet Line (steps 7–12)

Section 9 Semi-annual Maintenance Procedures
Semi-annual Maintenance Procedures
Cleaning the Printer

Clean the printer every six months (or after about 300 hours of operation). Be sure
to turn the printer OFF and disconnect the power cord before cleaning. Use a clean,
dry cloth to dust the area around the carriage shaft and platen. Be sure to remove
any loose particles or paper. Do not use solvents or strong detergents on the cabinet.

Semi-annual Maintenance Procedures Section 9
NOTES

Section 9 As-Required Maintenance
As-Required Maintenance
As-required maintenance indications for the CELL-DYN 1800 include the

following:
• Shipping the instrument
• Storing the instrument
• More than three days of non-use
• When the reagent lines are suspected as the source of bacterial or fungal
contamination
• As required for troubleshooting
The procedures provided in this section are intended for CELL-DYN 1800
instrument Operators who can perform detailed maintenance or troubleshooting
procedures relating to clinical laboratory devices and equipment. Abbott
Diagnostics suggests that new or inexperienced users obtain technical assistance
from Abbott Diagnostics Customer Service.

9140390C—March 2004
As-Required Maintenance Section 9
Obtaining Technical Assistance or Parts

In the U.S., technical assistance for the CELL-DYN 1800 instrument is available
24 hours a day, seven days a week by calling Abbott Diagnostics Customer Service
at:
1-877-4ABBOTT (1-877-422-2688)
For customer support in Canada, call:
1-800-387-8378
For customer support outside the U.S. and Canada, call your local Hematology
Customer Support representative.
To order replacement parts, call Abbott Diagnostics Customer Service at:
1-877-4ABBOTT (1-877-422-2688).
To order replacement parts outside the U.S. and Canada, call your local
Hematology Customer Support representative.
WARNING: Potential Biohazard. Follow established biosafety practices
when performing service, maintenance, or troubleshooting procedures.
Refer to Section 7: Operational Precautions and Limitations, and
Section 8: Hazards for additional information.
CAUTION: Powder from the use of some gloves may cause instrument
problems. Wear powder-free gloves when performing maintenance
procedures.

9140390C—March 2004
Cleaning the HGB (Hemoglobin) Flow Cell

The CELL-DYN 1800 uses a sodium hypochlorite cleaning solution to ensure
thorough cleaning of the HGB flow cell.
Materials Required
• Cleaning solution of 10 mL 5% sodium hypochlorite (bleach) to 10 mL of
warm deionized water
• Hemostats
Procedure
To clean the HGB flow cell, proceed as follows:
1. From the MAIN MENU screen, press [RUN]. Ensure that the instrument has
been initialized, and READY is displayed in the status box.
Open/Remove Front Covers. (See Section 2: Installation Procedures and
Special Requirements, Subsection: Opening/Removing Front Covers,
Version A or Opening Front Covers, Version B).
2. Carefully pour the cleaning solution into the Pre-Mixing Cup.
3. Press [SPECIMEN TYPE].
4. Press [SHIFT] and the [#] key on the PC keyboard at the same time. The
GAIN ADJUST screen is displayed, and the cleaning solution in the Pre-
Mixing Cup is transferred to the WBC bath.
5. When READY is displayed in the status box, locate Valve 2-7 directly
underneath the HGB flow cell. Grip the center of Valve 2-7 (top and bottom
slots on valve plunger) with a pair of Hemostats.

9140390C—March 2004
1 2 3
4 5
Figure 9.12 Cleaning the HGB Flow Cell (steps 1–5)

9140390C—March 2004
6. While observing the solution level in the left side of the WBC bath, pull open
Valve 2–7 until 3/4 of the solution has drained out.
7. Close Valve 2–7 and allow the solution to soak for three to five minutes.
8. When the time has elapsed, open Valve 2–7 and drain the remainder of the
solution from the left side of the WBC bath. Close Valve 2-7 when WBC bath
is fully drained.
6 7

9140390C—March 2004
9. Reattach/close the Front Cover(s). (See Section 2: Installation Procedures

and Special Requirements, Subsection: Opening/Removing Front Covers,
Version A or Opening Front Covers, Version B), then close the Upper Front
Cover. Press [SPECIMEN TYPE], followed by [NORMAL
BACKGRND].
9 10
11 12

9140390C—March 2004
Cleaning the Pre-Mixing Cup

The Pre-Mixing Cup is a reservoir for diluted blood. The Pre-Mixing Cup must be
cleaned when visual inspection of the cup indicates a buildup of protein around the
insides of the cup.
Materials Required
• Container of deionized water
• Cotton-tipped swabs
Procedure
To clean the Pre-Mixing Cup, proceed as follows:
Open the Upper Front Cover. (See Section 2: Installation Procedures and Special
Requirements, Subsection: Opening/Removing Front Covers, Version A or
Opening Front Covers, Version B)
1. Dip the end of a cotton swab into the cup containing the deionized water.
2. Use the moistened cotton-tipped swab to clean the inside walls of the Pre-
Mixing Cup.
Close the Upper Front Cover.
1 2
Figure 9.15 Cleaning the Pre-Mixing Cup (steps 1–2)

9140390C—March 2004
3. From the MAIN MENU screen, press [RUN].

4. Press [RUN], followed by [SPECIMEN TYPE] and [NORMAL
BACKGRND].
6. Press [RETURN] to return to the MAIN MENU screen.
3 4 5
6
4 7
Figure 9.16 Cleaning the Pre-Mixing Cup (steps 3–7)

9140390C—March 2004
Emptying Instrument Waste

WARNING: Potential Biohazard. Instrument waste is potentially
infectious. Wear gloves, labcoat, and safety glasses, and follow practices as
specified in the OSHA Bloodborne Pathogen standard (29 CFR 1910.1030)
or other equivalent biosafety procedures.
Instrument waste is a common name for liquid medical waste that is produced by
a CELL-DYN 1800 instrument during blood analysis.
The waste exits the instrument through the waste outlet tubing attached to the
tubing connector port on the instrument’s left panel. Always replace the waste
container when the WASTE FULL alarm is displayed. The cap sensor is designed
to alarm when liquid is at a sufficient distance from the top; if not emptied, the
container will overflow.
Dispose of waste in accordance with local, state, and federal regulations.
Figure 9.17 Waste Outlet Tubing
Container Drain System

Instrument waste must always be stored below the instrument, never above. The
Waste Full Sensor Plug (part of the waste tubing) connects to the Waste Sensor
Connector Port. A message will alert you of a full waste container condition.
Figure 9.18 Instrument Waste Storage

9140390C—March 2004
Plumbed Drain System

The instrument waste can also exit directly into an approved drainage system.
Dispose of waste in accordance with local, state, and federal regulations. See
Section 2: Installation Procedures and Special Requirements, Subsection:
Waste Disposal Requirements.
Figure 9.19 Instrument Waste Drainage
For this option to function properly, it is necessary to insert the Dummy Plug into
the Sensor Connector Port. The Dummy Plug deactivates the Waste Full Sensor.
Figure 9.20 Dummy Plug into SENSOR Connector Port

Cleaning/Replacing the Aperture Plates

On rare occasions, debris buildup could clog the opening in the aperture plates. If
aperture clogs are suspected, first perform an Auto Clean Procedure. See
Section 9: Service and Maintenance, Subsection: Weekly Maintenance
Procedures. If the fault persists, clean the aperture plate using the procedures in
this section.
If the aperture plates become cracked or damaged, they must be replaced.
In either of these situations, use the following procedures:
Materials Required
• Aperture brush (included in the accessory kit)
• Small beaker or cup (50 mL)
• 20 drops of CELL-DYN Enzymatic Cleaner solution added to 20 mL of
warm deionized water OR a solution of 5 mL 5% sodium hypochlorite
(bleach) added to 15 mL of warm deionized water
• Deionized water for rinsing
NOTE: Cleaning solutions are most effective when prepared immediately
before use.
• Microscope (optional)
CAUTION: The aperture plate is a delicate instrument part that requires
special care and handling. Use only the brush provided in the accessory kit,
as other items or brushes can cause damage.

Removing the Aperture Plates

The aperture plates are located in the small openings between the two chambers of
the von Behrens WBC Transducer and the two chambers of the von Behrens
RBC/PLT Transducer.
Procedure
To remove the aperture plate, which requires draining the transducer bath, proceed
as follows:
1. From the MAIN MENU screen, press [SPECIAL PROTOCOLS] followed
by [MORE] then [PROBE HOME].
Open the Upper Front Cover, and remove the Lower Front Cover.
(See Section 2: Installation Procedures and Special Requirements,
Subsection: Opening/Removing Front Covers, Version A or Opening
Front Covers, Version B)
2. Press [PROBE DOWN].
3. Locate the von Behrens RBC/PLT Transducer and the von Behrens WBC
Transducer.
1 2
Figure 9.21 Removing the Aperture Plates (steps 1–3)

9140390C—March 2004
4. Press [DRAIN BATHS]. Liquid in both chambers of the von Behrens

RBC/PLT and WBC Transducers drains to the waste system.
5. Locate the two tagged red levers attached to the von Behrens RBC/PLT and
WBC Transducers. These levers hold the aperture plates securely in place.
Grasp each lever and swing it all the way to your right.
6. Grasp the RBC/PLT aperture plate, located in the slot separating the two
chambers of the von Behrens RBC/PLT Transducer, and gently pull it straight
out until the plate is free of the transducer.
7. Grasp the WBC aperture plate, located in the slot separating the two
chambers of the von Behrens WBC Transducer, and gently pull it straight out
until the plate is free of the transducer.
8. Carefully inspect the aperture plates for cracks. If damaged, discard the
aperture plates. You must install replacement plates to operate the instrument.
(See Installing the RBC/PLT Aperture Plate or Installing the WBC
Aperture Plate later in this section.)
4 5 6
7 8
Figure 9.22 Removing the Aperture Plates (steps 4–8)

9140390C—March 2004
Cleaning the Aperture Plates
Procedure
When the aperture plates have been removed, to clean them individually, proceed
as follows:
1. Prepare cleaning solution in a small beaker (see Materials Required).
NOTE: The cleaning solution is most effective when it is prepared each
time this procedure is performed.
2. Immerse the aperture plate in the cleaning solution for about 5 minutes.
3. Remove the aperture plate from the solution and clean debris from both sides
of the plate with an aperture brush dampened in the cleaning solution. Dab
the bristles into the center hole to dislodge any large particles.
4. Thoroughly rinse with a fine stream of deionized water.
5. Gently shake excess water from the plate before reinstalling it as directed in
the next procedure. Do not wipe or blot the aperture plate.
If possible, use a microscope to inspect the plate for debris. If debris remains,
repeat the cleaning procedure or contact Abbott Diagnostics Customer
Service (see Obtaining Technical Assistance or Parts earlier in this section).
1 2 3
4 5
Figure 9.23 Cleaning the Aperture Plates (steps 1–5)

9140390C—March 2004
Installing the RBC/PLT Aperture Plate
Procedure
To RBC/PLT aperture plate is identified with “R/P” etched in the plate and is
installed in the von Behrens RBC/PLT transducer. To install the RBC/PLT aperture
plate, proceed as follows:
1. Position the RBC/PLT aperture plate so the notch is on the lower portion of
the edge being inserted into the transducer. Slide the aperture plate gently
back into the slot between the two chambers of the von Behrens RBC/PLT
transducer until it is fully inserted and feels secure.
NOTE: It may be necessary to widen the aperture plate slot while inserting
the plate by carefully applying gentle pressure to the impedance
transducer chamber on the right.
2. Swing the red lever all the way to your left to secure the plate in place. (There
will be slight resistance as you move the red lever.) Be sure the aperture plate
is installed before going to the next step.
1 2
Figure 9.24 Installing the RBC/PLT Aperture Plate (steps 1–2)

Installing the WBC Aperture Plate
Procedure
To WBC aperture plate is identified with “WBC” etched in the plate and is installed
in the von Behrens WBC transducer. To install the WBC aperture plate, proceed as
follows:
1. Position the WBC aperture plate so the notch is on the lower portion of the
edge being inserted into the transducer. Slide the aperture plate gently back
into the slot between the two chambers of the von Behrens WBC transducer
until it is fully inserted and feels secure.
NOTE: It may be necessary to widen the aperture plate slot while inserting
the plate by carefully applying gentle pressure to the impedance
transducer chamber on the right.
2. Swing the red lever all the way to your left to secure the plate in place. (There
will be slight resistance as you move the red lever.)
NOTE: Be sure both the RBC/PLT and the WBC aperture plates are
installed before pressing the [REFILL BATHS] key.
1 2
Figure 9.25 Installing the WBC Aperture Plate (steps 1–2)

Filling the Transducers
Procedure
To fill the impedance transducer baths, proceed as follows:
1. Press [REFILL BATHS]. Both transducers are refilled. Check the right-hand
chambers of both transducers to ensure they are completely filled with liquid
and that no air bubbles are visible at the top of the chambers. If air bubbles
do appear, repeat draining and refilling the bath.
NOTE: If a fault or problem due to an aperture clog persists, contact Abbott
Diagnostics Customer Service (see Obtaining Technical
Assistance or Parts earlier in this section).
2. Press [PROBE HOME].
Reattach/close the Front Cover(s). (See Section 2: Installation Procedures
Version A or Opening Front Covers, Version B)
CAUTION: Running specimens with the front cover off causes erratic
results.

5. From the MAIN MENU screen, press [RUN], followed by [SPECIMEN
TYPE], and [NORMAL BACKGRND].
1 2 3
4 5
Figure 9.26 Filling the Transducers (steps 1–5)

9140390C—March 2004

7. Perform a QC Run using CELL-DYN 16 Tri-Level or CELL-DYN 22
Tri-Level control material (see Section 11: Quality Control) before running
patient specimens.
screen.
6 7
8 9
Figure 9.27 Filling the Transducers (steps 6–9)

9140390C—March 2004
Cleaning/Replacing the Aspiration Probe

The aspiration probe is designed to be placed into the specimen tube. The probe
also passes up and down through a small vertical channel in the aspiration probe
Wash Block. For these reasons, the probe must be as straight as possible while
performing these actions.
Sometimes the probe may become bent when it is not aligned properly, or when
there is a malfunction in one of the mechanisms that controls the probe movements.
If this happens, you must replace the probe.
Occasionally, a clot or other debris can become lodged in the aspiration probe. If
the Initialization procedure does not dislodge the obstruction, it may be necessary
to clean the probe using the following procedures.
Materials Required
• About 20 mL deionized water in a small beaker or container
• 10 drops of CELL-DYN Enzymatic Cleaner solution added to 10mL
deionized water in a small beaker or container (cleaning solution)
• 3/32" Allen wrench
• 10 mL Syringes
• Sample cup
WARNING: Potential Biohazard. The probe is sharp and potentially
contaminated with infectious materials. Avoid contact with the tip of the
probe.

Cleaning the Aspiration Probe Interior
Version A Procedure
To clean the aspiration probe, proceed as follows:
Open the Upper Front Cover (See Section 2: Installation Procedures and Special
1. Locate the silicone tubing attached to the top of the probe. Hold the 1/32"
silicone tubing to steady it and carefully pull up on the 1/16" Straight
Connector until it is free of the short tubing which remains attached to the top
of the probe. Place a sample cup beneath the probe to catch the rinse solution.
NOTE: Do not loosen the Probe Alignment Guide.
2. Fill a syringe with the cleaning solution prepared earlier. Insert the tip of the
syringe into the tubing at the top of the probe, and inject the solution to flush
the probe. Repeat the procedure using deionized water.
3. Hold the 1/32" silicone tubing to steady it and insert the 1/16" straight
connector completely into the 1/32" silicone tubing.
1 2
Figure 9.28 Cleaning the Aspiration Probe Interior Version A (steps 1–3)

9140390C—March 2004
4. Close the Upper Front Cover. From the MAIN MENU, press [RUN] followed
by [SPECIMEN TYPE] and [NORMAL BACKGRND].
4 5
6. Perform a QC run using CELL-DYN 16 Tri-Level or CELL-DYN 22

patient specimens.
screen.
6 7

9140390D—January 2006
Removing the Aspiration Probe
Version A Procedure
To remove the aspiration probe, proceed as follows:
2. Press [MORE] followed by [PROBE HOME]. Then open the Upper Front
Cover and press [PROBE DOWN] to lower the aspiration probe assembly
and place the probe in an accessible position.
CAUTION: Moving the probe while performing this procedure may
require initialization.
3. Locate the silicone tubing attached to the top of the aspiration probe. Hold
the probe and pull the short 1/32" tubing (attached to the probe) up until it is
free of the metal probe. The 1/16" straight connector should still be attached
to the short tubing.
4. Remove the retainer clip from the metal spacer attached to the probe.
CAUTION: Do not loosen the Allen screw on the Probe Alignment Guide.
The Alignment Guide determines the proper probe alignment and is Factory
Set. Also, do not loosen the Allen screw in the Alignment Guide of the
replacement probe.
5. Remove the probe by gently pulling it up through the Wash Block.

NOTE: If the probe is bent or unable to be removed from the top, hold the
probe to steady it while using a 3/32" Allen wrench to loosen the
Allen screw on the Probe Alignment Guide. Slide the Probe
Alignment Guide up and off the top of the probe until it is free of
the Wash Block.

9140390C—March 2004
1 2 3
4 5
Figure 9.31 Removing the Aspiration Probe Version A (steps 1–5)

9140390C—March 2004
Installing the Aspiration Probe
Version A Procedure
To install the aspiration probe, proceed as follows:
1. Hold the probe to steady it and insert the 1/32" Silicone Tubing onto the top
of the Aspiration Probe.
2. Lower the probe through the probe assembly arm and into the top of the Wash
Block.
3. Reattach the retainer clip by snapping the bent side of the clip under the probe
arm.
1 2 3
4 5
Figure 9.32 Installing the Aspiration Probe Version A (steps 1–5)

9140390C—March 2004
6. Perform a QC Run (see Section 11: Quality Control) before running patient
specimens using CELL-DYN 16 Tri-Level or CELL-DYN 22 Tri-Level
control material.
screen.
6 7
Figure 9.33 Installing the Aspiration Probe Version A (steps 6–8)

9140390C—March 2004
Cleaning the Aspiration Probe Interior
Version B Procedure
To clean the aspiration probe, proceed as follows:
Open the Upper Front Cover (See Section 2: Installation Procedures and Special
1. Locate the silicone tubing attached to the top of the probe. Remove the 1/16"
straight connector from the retainer clip by pushing the connector to the left.
Hold the 1/32" silicone tubing to steady it and carefully pull up on the 1/16"
Straight Connector until it is free of the short tubing which remains attached
to the top of the probe. Place a sample cup beneath the probe to catch the rinse
solution.
NOTE: Do not loosen the Probe Alignment Guide.
2. Fill a syringe with the cleaning solution prepared earlier. Insert the tip of the
syringe into the tubing at the top of the probe, and inject the solution to flush
the probe. Repeat the procedure using deionized water.
3. Hold the 1/32" silicone tubing to steady it and insert the 1/16" straight
connector completely into the 1/32" silicone tubing. Snap the straight
connector back into the upper part of the clip, under the tubing.
1 2
Figure 9.34 Cleaning the Aspiration Probe Interior Version B (steps 1–3)

9140390D—January 2006
4. Close the Upper Front Cover. From the MAIN MENU, press [RUN] followed
by [SPECIMEN TYPE] and [NORMAL BACKGRND].
4 5
6. Perform a QC run using CELL-DYN 16 Tri-Level or CELL-DYN 22

patient specimens.
screen.
6 7

9140390C—March 2004
Removing the Aspiration Probe
Version B Procedure
To remove the aspiration probe, proceed as follows:
2. Press [MORE] followed by [PROBE HOME].
Open the Upper Front Cover and press [PROBE DOWN] to lower the
aspiration probe assembly and place the probe in an accessible position.
CAUTION: Moving the probe while performing this procedure may
require initialization.
3. Locate the silicone tubing attached to the top of the aspiration probe. Remove
the 1/16" straight connector from the retainer clip by pushing the connector
to the left. Hold the probe and pull the short 1/32" tubing (attached to the
probe) up until it is free of the metal probe. The 1/16" straight connector
should still be attached to the short tubing.
4. Remove the retainer clip from the metal spacer attached to the probe.
CAUTION: Do not loosen the Allen screw on the Probe Alignment Guide.
The Alignment Guide determines the proper probe alignment and is Factory
Set. Also, do not loosen the Allen screw in the Alignment Guide of the
replacement probe.
5. Remove the probe by gently pulling it up through the Wash Block.

NOTE: If the probe is bent or unable to be removed from the top, hold the
probe to steady it while using a 3/32" Allen wrench to loosen the
Allen screw on the Probe Alignment Guide. Slide the Probe
Alignment Guide up and off the top of the probe until it is free of
the Wash Block.

9140390D—January 2006
1 2 3
4 5
Figure 9.37 Removing the Aspiration Probe Version B (steps 1–5)

9140390C—March 2004
Installing the Aspiration Probe
Version B Procedure
To install the aspiration probe, proceed as follows:
1. Hold the probe to steady it and insert the 1/32" Silicone Tubing onto the top
of the Aspiration Probe.
2. Lower the probe through the probe assembly arm and into the top of the Wash
Block.
3. Reattach the retainer clip by snapping the bent side of the clip under the probe
arm. Snap the straight connector back into the upper part of the clip, under
the tubing.
1 2 3
4 5
Figure 9.38 Installing the Aspiration Probe Version B (steps 1–5)

9140390C—March 2004
6. Perform a QC Run (see Section 11: Quality Control) before running patient
specimens using CELL-DYN 16 Tri-Level or CELL-DYN 22 Tri-Level
control material.
screen.
6 7
Figure 9.39 Installing the Aspiration Probe Version B (steps 6–8)

9140390C—March 2004
Cleaning/Replacing the Aspiration Probe Wash Block

The aspiration probe Wash Block is designed to wash and siphon off the liquid after
the probe is rinsed with diluent. The liquid is injected through the top port of the
block, and the waste liquid is drawn off through the bottom port of the block as the
probe is raised up through the block.
Sometimes a small clot or particle may obstruct the small channels in the block and
the probe will not be cleaned properly. The Auto Clean procedure does not remove
protein buildup in the block because the Enzymatic Cleaner is not aspirated into the
block. You may have to remove and clean the Wash Block manually.
Materials Required
• Container of about 50 mL of deionized water
• CELL-DYN Enzymatic Cleaner (use at room temperature but store at a
temperature between 2°C and 8°C, or between 36°F and 46°F)
• 10 mL Syringe with about 2" of tubing attached

9140390C—March 2004
Removing the Aspiration Probe Wash Block
Procedure
To remove the aspiration probe Wash Block, proceed as follows:
Open the Upper Front Cover, turn the power switch to OFF, and unplug the power
cord. Follow steps to remove the aspiration probe. (See Removing the Aspiration
Probe earlier in this section.)
1. Remove the thumbscrew that holds the Wash Block in place.
2. Pull the Wash Block off its mounting.
3. Carefully disconnect the lower line from the lower connector on the Wash
Block. Follow by disconnecting the upper line from the top of the Wash
Block.
1 2
Figure 9.40 Removing the Aspiration Probe Wash Block (steps 1–3)

9140390C—March 2004
Cleaning the Aspiration Probe Wash Block
Procedure
To clean the aspiration probe Wash Block, proceed as follows:
1. Prepare a container of 50 mL of deionized water mixed with five drops of
Enzymatic Cleaner.
2. Immerse the Wash Block in the solution and let it soak for 30 minutes.
3. Draw up about 3 mL of the diluted Enzymatic Cleaning solution into the
syringe with the tubing attached.
4. Remove the Wash Block from the cleaning solution, and attach the end of the
syringe tubing into one of the connectors of the Wash Block. Hold the Wash
Block over the sink with the exposed block’s openings aimed away from you.
Very lightly, dispense some of the solution through the syringe tubing into the
Wash Block until the liquid comes out of the exposed openings. Rinse and
dry the Wash Block.
1 2
3 4
Figure 9.41 Cleaning the Aspiration Probe Wash Block (steps 1–4)

9140390C—March 2004
Installing the Aspiration Probe Wash Block
Procedure
To install the aspiration probe Wash Block, proceed as follows:
1. Connect the wash lines to the Wash Block, connecting the lower wash line
first. Place the Wash Block on its mounting, leaving the thumb screw loose.
2. Reattach the fitting to the top of the probe. Replace the aspiration probe by
lowering the probe through the aspiration probe assembly arm and into the
top of the aspiration probe Wash Block.
NOTE: Make certain that the probe drops down through the Wash Block
and can move freely.
3. After the aspiration probe is placed securely and lined up through the Wash
Block, reattach the probe clip by snapping the bent side of the clip under the
probe arm.
4. Push the aspiration probe assembly arm to the right until the arm touches the
hard stop. While pushing the arm against the stop, tighten the thumbscrew on
the Wash Block.
1 2
3 4
Figure 9.42 Installing the Aspiration Probe Wash Block (steps 1–4)

9140390D—January 2006
5. Connect the power cord and turn the power switch ON.
6. Close the Upper Front Cover.
5 6
Figure 9.43 Installing the Aspiration Probe Wash Block (steps 5–7)

9140390C—March 2004
Cleaning/Replacing Syringes
The CELL-DYN 1800 instrument rarely requires syringe replacement. However,
syringe replacement can be required because of accidental breakage or other
unusual circumstance.
If syringe replacement is required, it is important to know the exact location of all
syringes. Syringes from left to right of the left-side panel are identifiable as shown
in the table below.
The syringe replacement procedure is provided on the following pages.
CAUTION: Use caution when performing any maintenance procedure on
the Syringe Panel as moving parts can pinch.
1 Lyse Syringe
(2.5 mL)
2 Diluent Syringe
(10 mL)
3 Sample Syringe
(100 µL)
1 2 3
Figure 9.44 CELL-DYN 1800 Syringes

9140390C—March 2004
Cleaning/Replacing the Diluent Syringe
Materials Required
• A large container of 2–3 inches of deionized water
• KIMWIPES® or other lint-free absorbent pads
• Deionized water
• A small container of diluent to refill the clean syringe
Removing the Diluent Syringe
Procedure
To remove the Diluent Syringe, proceed as follows:
1. Add 2 to 3 inches of deionized water to a container large enough to hold and
soak the Diluent Syringe.
2. Locate the dark plastic door on the left side of the instrument. Using the two
finger holes in the plastic door, slide the door up slightly and pull out to
expose the syringes. The Diluent Syringe is the large (10 mL) syringe in the
center.
4. Press [MORE], followed by [CLEAN DIL SYRINGE]. The syringe plunger
moves up.
1 2
3 4
Figure 9.45 Removing the Diluent Syringe (steps 1–4)

9140390C—March 2004
5. Remove the Drive Nut at the bottom of the plunger by holding the Calibration
Block with one hand and turning the Drive Nut clockwise (when viewed from
above). Use lint-free pads to absorb excess diluent.
6. Press [SYRINGE DOWN] to move the Drive Ring down, allowing the
syringe to be removed.
7. Completely remove the two Knurl Nuts and front section of the Syringe
Holding Clamp.
8. Hold the syringe by the barrel and turn the Luer-Lok® on the syringe top
clockwise (when viewed from above) to release it from its Luer fitting.
Dispense the diluent into a sink or an appropriate waste container.
CAUTION: Do not pull the syringe toward yourself. Gently pull the
Diluent Syringe straight down until it clears the bracket.
5 6
7 8
Figure 9.46 Removing the Diluent Syringe (steps 5–8)

9140390C—March 2004
Cleaning the Diluent Syringe
Procedure
To clean the Diluent Syringe, proceed as follows:
1. Fill a syringe with deionized water and aspirate the water into the syringe
until it is full.
2. Dry the syringe with lint-free pads.
CAUTION: Do not pull the plunger out of the barrel as it will damage the
syringe seal. If the plunger is pulled out, you must replace the Diluent
Syringe.
3. Refill the syringe with diluent.
1 2
Figure 9.47 Cleaning the Diluent Syringe (steps 1–2)

9140390D—January 2006
Installing the Diluent Syringe
Procedure
1 Luer-Lok®
2 Rod
1
3 Holding Clamp
4 Knurl Nuts 2
5 White Plug
6 Calibration Block
7 Drive Ring
8 Drive Nut
9 Clockwise 3
4
5
6
7
9
8
Figure 9.48 Diluent Syringe
To install the Diluent Syringe, proceed as follows:

1. Reinstall the syringe into the Luer fitting by holding the barrel and turning
the Luer-Lok®, located on the syringe top, turning it counterclockwise (when
viewed from above) until it is finger-tight.
CAUTION: Do not overtighten the syringe in its fitting.
2. Reinstall the front section of the Syringe Holding Clamp. Secure it with the
Knurl Nuts removed earlier. Install the Knurl Nuts with the larger hole facing
the screw. Tighten the Knurl Nuts finger-tight with the beveled edge towards
the Holding Clamp.
CAUTION: Do not overtighten.
3. Press [SYRINGE UP] to move the Drive Ring up.

4. Secure the plunger in the Drive Ring using the Drive Nut removed earlier.
Install the Drive Nut with the spacer (the long narrow end) facing up. Tighten
the Drive Nut to finger-tight while holding the Calibration Block.

9140390C—March 2004
CAUTION: Do not overtighten. A small gap between the plunger holder

and the Drive Nut is normal.
5. Press [RESTORE SYRINGE].

NOTE: Bubbles may be present during the first filling. If they do not
disappear, press [MORE] twice, then press [REAGENT PRIME]
to clear the bubbles.
6. Reinstall the dark plastic door on the left side panel of the instrument which
covers the syringes.
1 2 3
4 5 6
Figure 9.49 Installing the Diluent Syringe (steps 1–6)

9140390C—March 2004

BACKGRND]. Using the Touch Plate, run two to three Background Counts.
Watch the syringe action to make sure it fills and dispenses completely. Run
Background Counts (see Section 5: Operating Instructions, Subsection:
Routine Operation) until results are within appropriate specifications. If
Background Counts remain out of range after three runs, refer to the Error
Messages and Conditions table in Section 10: Troubleshooting and
Diagnostics.
patient specimens.
10. Press [RETURN], then [MAIN] to return to the MAIN MENU screen.
7 8 9
10 11
Figure 9.50 Installing the Diluent Syringe (steps 7–11)

9140390C—March 2004
Replacing the Diluent Syringe
Materials Required
• Replacement Diluent Syringe
Procedure
To replace the Diluent Syringe, proceed as follows:
1. Remove the Diluent Syringe from the instrument as described in steps 2
through 8 of the Removing the Diluent Syringe procedure.
2. Install the new syringe in its Luer-Lok fitting by turning it counterclockwise
(when viewed from above) until it is finger-tight.
3. Press [SYRINGE UP] so that the Calibration Block rests on top of the Drive
Ring.
4. Reinstall the front section of the Syringe Holding Clamp. Secure it with the
Knurl Nuts removed earlier. Tighten the Knurl Nuts finger-tight with the
beveled edge toward the Holding Clamp.

9140390D—January 2006
1 2 3
4 5 6
Figure 9.51 Replacing the Diluent Syringe (steps 1–6)
5. Install the Drive Nut with the spacer (the long narrow end) facing up. Tighten
the large Drive Nut to finger-tight while holding the Calibration Block.
CAUTION: Do not overtighten. A small gap between the plunger holder
and the Drive Nut is normal.

NOTE: Bubbles may be present during the first filling. If they do not
disappear, press [MORE] twice, then press [REAGENT PRIME]
to clear the bubbles.

9140390C—March 2004
7. Reinstall the dark plastic door on the left side of the panel of the instrument
which covers the syringes.
BACKGRND]. Using the Touch Plate, run two to three Background Counts.
Watch the syringe action to make sure it fills and dispenses completely. Run
Diagnostics.
7 8 9
10 11 122
Figure 9.52 Replacing the Diluent Syringe (steps 7–12)

patient specimens.
screen.

9140390C—March 2004
Cleaning/Replacing the Sample Syringe
Materials Required
• A large container of deionized water
• Replacement Sample Syringe
Removing the Sample Syringe
Procedure
To remove the sample syringe, proceed as follows:
soak the Sample Syringe.
expose the syringes. The Sample Syringe is the thin (100 µL) syringe on the
right.
4. Press [MORE] followed by [CLN SAMPL SYRINGE].
1 2
3 4
Figure 9.53 Removing the Sample Syringe (steps 1–4)

9140390C—March 2004
5. Using a 7/64" Allen wrench, loosen and remove the Allen screw.
7. When the syringe comes to a stop, gently push up on the plunger until it clears
the Drive Ring.
8. Hold the syringe by the glass barrel and turn it clockwise. Pull down to
remove the syringe.
CAUTION: Do not pull the syringe toward yourself. Gently pull the
Sample Syringe straight down until it clears the bracket.
NOTE: If there are saline crystals around the Luer-Lok fitting of the
syringe, soak the entire syringe in deionized water for five minutes.
Then, gently pull the plunger rod completely out of the barrel and
allow both pieces to soak for a few minutes.
CAUTION: Do not touch the tip of the plunger with your hands. Do not
pull or push the plunger when it is dry.
5 6
7 8
Figure 9.54 Removing the Sample Syringe (steps 5–8)

9140390E—June 2008
Cleaning the Sample Syringe
Procedure
To clean the Sample Syringe, proceed as follows:
1. Rinse the syringe in clean deionized water. Insert the plunger into the barrel
of the syringe and push it all the way forward. (If the syringe needs to be
replaced, a new syringe may be installed.)
NOTE: Before installing a new Sample Syringe, remove the plunger
adapter by unscrewing it (clockwise) from the bottom of the
plunger. Note the location of the split lockwasher and ensure it is in
place when reinstalling the new syringe. Screw the plunger adapter
from the old syringe into the new syringe.
2. Draw deionized water into the syringe so that the entire syringe is filled and
the plunger is withdrawn as far as possible. Push the plunger in all the way.
1 2
Figure 9.55 Cleaning the Sample Syringe (steps 1–2)

9140390E—June 2008
Installing the Sample Syringe
Procedure
To install the Sample Syringe, proceed as follows:
1. Remove the Sample Syringe from the instrument as described in steps 1
through 8 of the Cleaning/Replacing the Sample Syringe procedure.
Reinstall the syringe into the Luer-Lok® fitting by turning the barrel
counterclockwise (when viewed from above) to finger-tight.
2. Push the plunger adapter into the Drive Ring hole, then press [RESTORE
SYRINGE]. Guide the syringe through the Drive Ring and the Drive Ring
moves up. Adjust the position of the plunger adapter so that the white plunger
head is slightly touching the top of the glass barrel.
3. Using a 7/64" Allen wrench, tighten the Allen screw.
4. Press [MAIN], followed by [RUN] to display the RUN menu.
1 2
3 4
Figure 9.56 Installing the Sample Syringe (steps 1–4)

9140390C—March 2004
5. Press [SPECIMEN TYPE], followed by [NORMAL BACKGRND].

6. Using the Touch Plate, run two to three Background Counts. Watch the
syringe action to make sure it fills and dispenses completely. Run
Diagnostics.
patient specimens.
screen.
5 6 7
8 9
Figure 9.57 Installing the Sample Syringe (steps 5–9)

9140390C—March 2004
Cleaning/Replacing the Lyse Syringe
Materials Required
• Large container of deionized water
• Replacement Lyse Syringe
Removing the Lyse Syringe
Procedure
To remove the Lyse syringe, proceed as follows:
soak the Lyse Syringe.
expose the syringes. The Lyse Syringe is the medium (2.5 mL) syringe on the
left.
4. Press [MORE] followed by [CLN LYSE SYRINGE].
1 2
3 4
Figure 9.58 Removing the Lyse Syringe (steps 1–4)

9140390C—March 2004
5. Using a 7/64" Allen wrench, loosen and remove the Allen screw.
7. When the syringe comes to a stop, gently push up on the plunger until it clears
the Drive Ring.
8. Hold the syringe by the glass barrel and turn it clockwise. Pull down to
remove the syringe.
CAUTION: Do not pull the syringe toward yourself. Gently pull the Lyse
Syringe straight down until it clears the bracket.
5 6
7 8
Figure 9.59 Removing the Lyse Syringe (steps 5–8)

9140390D—January 2006
Cleaning the Lyse Syringe
Procedure
To clean the Lyse Syringe, proceed as follows:
1. Immerse the syringe in the container of deionized water prepared earlier.
Allow the syringe to soak for one or two minutes to dissolve any accumulated
salt deposits. (If the syringe needs to be replaced, a new syringe may be
installed.)
NOTE: Before installing a new Lyse Syringe, remove the Plunger Adapter
by unscrewing it (clockwise) from the bottom of the plunger. Note
the location of the split lockwasher and ensure it is in place when
reinstalling the new syringe. Screw the Plunger Adapter from the
old syringe into the new syringe.
2. While the syringe is still immersed, remove the plunger from the barrel.
Allow the syringe and plunger to soak for five minutes.
CAUTION: Do not touch the tip of the plunger with your hands. Do not
pull or push the plunger when it is dry.
3. Remove the plunger and syringe from the container and thoroughly rinse
each with clean deionized water.
4. Reassemble the syringe by inserting the plunger all the way into the barrel.
1 2
3 4
Figure 9.60 Cleaning the Lyse Syringe (steps 1–4)

9140390C—March 2004
Installing the Lyse Syringe
Procedure
To install the Lyse Syringe, proceed as follows:
1. Remove the Lyse Syringe from the instrument as described in steps 2 through
8 of the Cleaning/Replacing the Lyse Syringe procedure.
2. Reinstall the syringe into the Luer-Lok® fitting by turning the barrel
counterclockwise (when viewed from above) to finger-tight.
3. Press [SYRINGE UP] to move the Drive Ring up.

4. Guide the syringe plunger through the Drive Ring as the Drive Ring moves
up. Adjust the position of the plunger adapter so that the white plunger head
is slightly touching the top of the glass barrel.
5. Using a 7/64" Allen wrench, tighten the Allen screw.
1 2 3
4 5 6
Figure 9.61 Installing the Lyse Syringe (steps 1–6)

9140390C—March 2004
7. Press [MAIN], followed by [RUN] to display the RUN menu.

patient specimens.
screen.
7 8 9
10 11
Figure 9.62 Installing the Lyse Syringe (steps 7–11)

9140390C—March 2004
Draining/Cleaning the Vacuum Accumulator

Materials Required
• 10 mL Syringe
• Container of about 50 mL of deionized water
• Empty container
Check for Liquid in the Vacuum Accumulator

To check for liquid in the Vacuum Accumulator, proceed as follows:
1. Turn the instrument OFF.
2. Locate the end of the accumulator tubing next to the Reagent Inlet Panel on
the lower left side of the instrument. Carefully pull the tubing and Clamp free
of the instrument frame.
3. Pull the plug from the end of the tubing, and set the plug aside.
4. Place the tip of an empty syringe in the end of the tubing and remove the
Clamp. Aspirate the syringe to draw any liquid in the accumulator into the
syringe. If there is liquid present, proceed with the Drain and Clean the
Vacuum Accumulator procedure that follows.
NOTE: If there is no evidence of liquid, it is not necessary to clean the
Vacuum Accumulator unless you are troubleshooting a high
platelet background. Remove the syringe, replace the clamp and
plug, and put the tubing back inside the instrument frame.
1 2
3 4
Figure 9.63 Checking for Liquid in the Vacuum Accumulator (steps 1–4)

9140390C—March 2004
Drain and Clean the Vacuum Accumulator

To drain and clean the Vacuum Accumulator, proceed as follows:
1. Remove the syringe and allow the accumulator to completely drain into an
empty beaker. Use an empty syringe to aspirate any remaining fluid from the
tubing, then remove the syringe.
2. Fill a large empty syringe with deionized water. Insert the tip of the syringe
into the end of the accumulator tubing and inject deionized water into the
accumulator. Repeat this step until the accumulator has been filled with 400
to 500 cc of deionized water. Allow the accumulator to soak with deionized
water for 2 to 5 minutes.
Repeat step 1 to drain the accumulator of the deionized water.
3. Fasten the clamp and reinsert the plug into the end of the tubing. Carefully
put the tubing with clamp back inside the instrument frame.
4. Turn the instrument ON. Press [PRIME/RUN] to initialize.
1 2
3 4
Figure 9.64 Draining and Cleaning the Vacuum Accumulator (steps 1–4)

9140390C—March 2004
5. From the RUN screen press [SPECIMEN TYPE], followed by [NORMAL

BACKGRND].
5 6
7 8
Figure 9.65 Draining and Cleaning the Vacuum Accumulator (steps 5–8)

9140390D—January 2006
Cleaning the Bar Code Scanner Lens

The Bar Code Scanner Lens should be cleaned to prevent bar code misreads.
Materials Required
• Cotton-tipped swabs
• Container of about 50 mL of deionized water or denatured alcohol
• Lint-free cloth
Procedure
To clean the Bar Code Scanner Lens, proceed as follows:
1. Dampen a cotton swab with deionized water or denatured alcohol.
2. Gently swab the Bar Code Scanner lens.
3. Dry the lens with a lint-free cloth before scanner use.
NOTE: Do not use cleaning materials that may scratch the lens.
1 2
Figure 9.66 Cleaning the Bar Code Scanner Lens (steps 1–3)

9140390C—March 2004
Cleaning the “Y” Fitting

The “Y” fitting cleaning procedure is used to remove stubborn restrictions in the
“Y” fitting under the Pre-Mixing Cup and/or when the Pre-Mixing Cup is
overflowing.
Materials Required
• 25% cleaning solution
• Small beaker
• 10 mL syringes
• Plastic disposable pipettes
Procedure
To clean the “Y” fitting, proceed as follows:
been initialized, and READY is displayed in the status box. Press [MAIN] to
2. From the MAIN screen, press [SPECIAL PROTOCOLS].
3. Press [MORE].
4. Press [PROBE HOME].
Open/Remove Front Cover(s). (See Section 2: Installation Procedures and
5. Carefully remove the liquid inside the Pre-Mixing Cup with a disposable
pipette and discard according to local, state, and federal regulations.

9140390C—March 2004
1 2 3
4 5
Figure 9.67 Cleaning the “Y” Fitting (steps 1–5)

9140390C—March 2004
6. Locate the “Y” fitting below the Pre-Mixing Cup.

7. Carefully remove the tubing on all three sides of the “Y” fitting.
8. Place the “Y” fitting inside the beaker. Pour the cleaning solution into the
beaker. Soak for 5 minutes.
9. Attach tubing to a syringe and fill with water. Using the syringe, flush water
through all three sides of the fitting, verifying that water flows freely from all
three outlets.
CAUTION: Do not use hypodermic needles as they may puncture the
fitting and tubing.
10. Rinse off fitting with water and blot dry.

11. Replace tubing to all three sides of the “Y” fitting.
Reattach/close the Front Cover(s). (See Section 2: Installation Procedures
6 7 8
9 10 112

9140390C—March 2004

14. Press [RUN], then [SPECIMEN TYPE] and [NORMAL BACKGRND].
Subsection: Routine Operation) to verify the Pre-Mixing Cup is draining
completely and there are no leaks originating from the fitting. Verify that
background results are within appropriate specifications. If Background
Counts remain out of range after three runs, refer to the Error Messages and
12 13 14
15 16 17

9140390C—March 2004
Supplemental Aperture Cleaning

The supplemental aperture cleaning procedure is used to remove stubborn
restrictions in the RBC and WBC apertures, or when there is a marked increase in
the RBC and/or WBC count times that cannot be resolved through normal auto-
cleaning. If this procedure does not solve the problem, remove and clean the
aperture plates.
Materials Required
• Undiluted, unscented household bleach
• Add 9.5 parts deionized water to 1 part bleach to obtain a 0.5% sodium
hypochlorite solution, or for example, 9.5 mL of deionized water to 1.0 mL
of bleach (5.25% sodium hypochlorite), to obtain a 0.5% solution of sodium
hypochlorite.
• Small beaker
Procedure
To perform supplemental aperture cleaning, proceed as follows:
been initialized, and READY is displayed in the status box. Press [MAIN] to
Open the Upper Front Cover. (See Section 2: Installation Procedures and
2. Carefully pour 5 mL of the cleaning solution into the Pre-Mixing Cup.
1 2
Figure 9.70 Supplemental Aperture Cleaning Procedure (steps 1–2)

9140390C—March 2004
3. Carefully pour 5 mL of undiluted, unscented household bleach into the

mixing chamber of the RBC bath. Close the Upper Front Cover.
4. Wait two minutes to allow the Pre-Mixing Cup to soak. After the soak period,
press [SPECIMEN TYPE].
NOTE: DO NOT use [CLEAR ORIFICE] because it will drain the
cleaning solution from the cups.
5. Press shift and the [#] key on the PC keyboard at the same time. The GAIN
ADJUST screen is displayed, and the cleaning solution in the Pre-Mixing
Cup is transferred to the WBC bath. Both baths are bubble mixed. Wait
another two minutes for the baths to soak.
6. Press the Touch Plate to run three consecutive count cycles to aspirate the
cleaning solution through the RBC and WBC apertures. If a FLOW ERROR
or CLOG message displays, ignore it and continue to run the three counts.
7. Press [SPECIMEN TYPE].
3 4 5
6 7

9140390C—March 2004
8. Press [NORMAL BACKGRND].

9. Press [CLEAR ORIFICE] to reset the Running Average program and drain
the baths.
Subsection: Routine Operation) to verify the Pre-Mixing Cup is draining
completely and there are no leaks originating from the fitting. Verify that
background results are within appropriate specifications. If Background
Counts remain out of range after three runs, refer to the Error Messages and
11. Press [RETURN] to return to the MAIN MENU screen.
8 9 10
11 12
The instrument is ready to run specimens. It is recommended that the RBC and
WBC count times be recorded for future reference, to monitor protein build-up in
the apertures.

9140390C—March 2004
Preparing the Instrument for Extended Periods of Non-Use or

Shipping
Salt deposits and reagent residue can damage the flow system if not removed
before the CELL-DYN 1800 is shipped or stored (idle two weeks or longer).
Prepare the instrument for lengthy periods of non-use to help prevent such damage.
Materials Required
• Cotton gauze pads
• 250 mL containers for rinsing tubing (2)
• Two beakers, each filled with about 150 mL (5 oz) of deionized water
• Disinfectant (cleaning solution); a solution containing 0.5% sodium
hypochlorite. See the formula for mixing this solution under
Decontamination Procedures earlier in this section.
• Warm tap water
• Plastic bags: one each for detergent, diluent, lyse, and waste tubing
assemblies; a fifth bag is needed if the dummy plug is used.
• Packaging or cellophane tape
• Clean paper towels
• Cardboard disk drive protector
Proceed with the cleaning procedures on the following pages.

9140390C—March 2004
Cleaning the Flow System

The Clean for Shipping cycle rinses the flow system with deionized water and
purges liquid and air from it. The process, completed in stages, takes about 20
minutes. To clean the flow system, proceed as follows:
Open the Upper Front Cover.
1. From the MAIN MENU screen, press [SPECIAL PROTOCOLS], then
[MORE] twice.
2. Press [CLEAN FOR SHIPPING] and follow the prompts on the display
screen.
NOTE: Press the asterisk [*] key on the PC keyboard to cancel this
procedure and return to the SPECIAL PROTOCOLS menu.
3. When the INSTRUMENT READY FOR SHIPPING message appears on the
display screen, close the Upper Front Cover.
4. Turn the power switch to OFF.
5. Remove the power cord from the rear panel of the instrument and remove the
other end of the power cord from the wall outlet.
1 2 3
4 5
Figure 9.73 Cleaning the Flow System (steps 1–5)

9140390C—March 2004
Cleaning Tubing and Instrument Exterior

Dispose of reagents, waste, and containers in proper drains or receptacles when
performing the following procedure:
1. Remove the Waste Sensor plug from its fitting on the lower left side of the
instrument.
2. Remove all four tubing lines from the fittings on the lower left side of the
instrument.
NOTE: Keep all tubing lines clean to prevent contamination.
3. Remove the waste outlet tubing from its container.
4. Dispense some of the disinfectant cleaning solution into the waste outlet
tubing (saving a portion for cleaning the exterior of the instrument). If
necessary, press the tubing between thumb and forefinger to dislodge any
stubborn debris. Hold the waste outlet tubing under warm running water to
rinse it inside and out, taking special care to keep the sensor out of the basin
and away from the water.
1 2
3 4
Figure 9.74 Cleaning Tubing and Instrument Exterior (steps 1–4)

9140390C—March 2004
5. Dry removed tubing with a clean, dry cloth or paper towel.

CAUTION: Sensor contact with liquid could cause corrosion and
subsequent malfunction.
6. Place each length of tubing in a separate protective plastic bag and close it.
(Keep the waste line and waste sensor line together.) Place the bags in the
accessory kit.
7. Close any open covers and wipe the outer surface of the instrument with the
remainder of the disinfectant cleaning solution.
8. If required, refer to the printer manual for printer storage procedures. Update
the Maintenance Log.
5 6
7 8
Figure 9.75 Cleaning Tubing and Instrument Exterior (steps 5–8)

9140390C—March 2004
NOTES

9140390C—March 2004
References
1. Occupational Safety and Health Administration, Department of Labor. 29

CFR Part 1910.1030. Occupational Exposure to Bloodborne Pathogens.

9140390C—March 2004
NOTES

9140390C—March 2004
Section 10 Troubleshooting and Diagnostics
Section 10 Troubleshooting and Diagnostics
Overview
The CELL-DYN 1800 continuously monitors the status of the system and displays
information about the current instrument state in the status box (top center) and in
the message field (third line down) of the display screen. If an alarm condition is
present, ALARM appears in the message field.
The following Diagnostics subsection discusses the DIAGNOSTICS menu
softkeys. The remainder of this section is devoted to the Error Messages and
Conditions table which is alphabetized for quick reference. The Calibration
Troubleshooting section is located at the end of this section.

9140390A—March 2003
Overview Section 10
NOTES

9140390A—March 2003
Section 10 Diagnostics
Diagnostics
The main functions of the DIAGNOSTICS menu are as follows:

1. Check the system and fault status, identifying Operator-correctable and
service-correctable faults.
2. Perform diagnostics tests for troubleshooting and service.
3. Display and print data for troubleshooting and service.
This subsection describes the keypad labels available from the four
DIAGNOSTICS menu screens available when the instrument is Initialized and
Primed. These keys enable the Operator or Service Representative to obtain
information and execute programs that assist in troubleshooting.
When some keys are pressed, the message For Service Use Only is
displayed. The data these keys provide are meaningful only to trained Abbott Field
Service Representatives and are not useful to the Operator. If these keys are pressed
inadvertently, the system may have to be reinitialized.
In the MAIN MENU screen, press [DIAGNOSTICS] to display the main
DIAGNOSTICS menu. The DIAGNOSTICS menu has the following keys:
• [INITIALIZATION]
• [RAW DATA]
• [COUNT TEST] / [PRE-DIL TEST] / [ELEC BKGD TEST]
(toggles between choices)
• [MORE]
• [PRINTER OUTPUT]
• [HELP/ERROR]
• [MAIN]

9140390A—March 2003
Diagnostics Section 10
DIAGNOSTICS MENU
DIAGNOSTICS
DAILY INITIAL- RAW COUNT MORE PRINTER HELP/ MAIN

SHUTDOWN IZATION DATA TEST OUTPUT ERROR*
PRE-DIL
TEST
ELEC BKGD
TEST LEVEL 1
WBC RBC PLT SMOOTHING MORE PRINTER HELP/ MAIN

HISTOGRAM HISTOGRAM HISTOGRAM OFF OUTPUT ERROR*
SMOOTHING
ON
LEVEL 2
PROBE PROBE PLT SMOOTHING MORE PRINTER HELP/ MAIN

HOME UP HISTOGRAM OFF OUTPUT ERROR*
PROBE PROBE
DOWN DOWN
LEVEL 3
SYSTEM FAULT SERVICE SERVICE MORE PRINTER HELP/ MAIN

STATUS REPORT HEX CODES DEC CODE OUTPUT ERROR*
CLEAR
ALARM
FAULT HELP RETURN

LOG
LEAVE
HELP
PRINT HELP RETURN
Figure 10.1 DIAGNOSTICS Menu Hierarchy


Each of the DIAGNOSTICS menu keys is described below.
Initialization
[INITIALIZATION] is used to perform an Initialization cycle. During
initialization, all motors are first run through their “home” positions and all
circuitry is checked. When the cycle is completed, the system is Initialized.
[PRIME/RUN] must be pressed to bring the instrument to the READY state.
Raw Data
[RAW DATA] is used to display the raw measurement data for the last specimen
analyzed.
Count Test
[COUNT TEST] is used to run specimens and display count check data without
returning to the RUN menu. This key changes to [PRE-DIL TEST] when Pre-
Dilute Mode has been selected, and to [ELEC BKGD TEST] when Electrical
Background has been selected as the specimen type. The prompt Press Sample
Switch when ready or Press asterisk to cancel this
function is displayed in the upper left corner of the screen. Coded data relating
to specific cycle functions, raw measurement, and flow count time are displayed
for use in troubleshooting or service.
More
[MORE] displays a new menu and new soft keys that allow the Operator to
perform additional diagnostics to assist in troubleshooting. This key performs the
same function on all diagnostics menus: Level 1, Level 2, and Level 3.
Printer Output (all occurrences)

[PRINTER OUTPUT] allows the Operator to print any screen in the
DIAGNOSTICS menu by turning the printer output ON. No printing occurs at this
point; printing occurs only when another key, such as [RAW DATA] or [WBC
HISTOGRAM], is pressed.
When [PRINTER OUTPUT] is pressed, the key is highlighted (white on dark
blue), indicating that printer output is ON. Data will be displayed on the screen and
printed.
When pressed again, the key returns to its original (white on blue) format,
indicating that printer output is OFF. Data will be displayed on the screen. The
current printer status is displayed in the upper left section of the screen. This key
performs the same function on all diagnostics menus.

9140390A—March 2003
Help/Error (all occurrences)

[HELP/ERROR] accesses the HELP/ERROR screen with a [FAULT LOG] key
and a [HELP] key. The [FAULT LOG] key allows the Operator to view up to 16
errors including any pending fault. Pressing [HELP] allows the Operator to view
help messages. The [HELP/ERROR] key is available on each screen.
If a fault is pending and [HELP/ERROR] is pressed, the Fault Log is
automatically displayed. There are three major types of fault messages of concern
to the Operator:
• Data Invalidating Faults (DIF)—sample-dependent conditions such as Clog,
Flow Error, Count Overrange, etc.
• Device Faults (DEV)—system device faults such as Printer Out-of-Paper,
RS-232 Comm Error, etc.
• Field Service Faults (FSF)—serious faults that may require Abbott
Diagnostics Customer Service. They are mechanical, flow, or electronic
faults which will stop the instrument from completing a procedure. The
message Not Ready: See Diagnostics is also displayed in the Status
Box of the menu in which the fault occurred.
When the Not Ready: See Diagnostics message is displayed, additional
information about a pending fault can be obtained as follows:
• Go to the MAIN MENU screen, and press [DIAGNOSTICS] to access the
DIAGNOSTICS menu. The fault information will be displayed
immediately.
Main (all occurrences)

[MAIN] takes the Operator back to the MAIN MENU screen and performs the
same function on all diagnostics menus.

9140390A—March 2003
More (Level 1)
When [MORE] is pressed at the first level of the DIAGNOSTICS menu, the
second of four DIAGNOSTICS menu screens is displayed. The following keys are
displayed:
• [WBC HISTOGRAM]
• [RBC HISTOGRAM]
• [PLT HISTOGRAM]
• [SMOOTHING OFF] / [SMOOTHING ON] (toggles between choices)
• [MORE]
• [HELP/ERROR]
• [MAIN]
WBC Histogram
[WBC HISTOGRAM] is used to display the lysate-modified white cell count
(numeric) data accumulated in each of 256 size channels. Each line contains data
for 16 channels. For example, line one data is for channels 1 to 16, line two data is
for channels 17 to 32, etc. Each size channel equals 1.758 femtoliters.
RBC Histogram
[RBC HISTOGRAM] is used to display the red blood cell count (numeric) data
accumulated in each of 256 size channels. Each line contains data for 16 channels.
For example, line one data is for channels 1 to 16, line two data is for channels 17
to 32, etc. Each size channel equals 1 femtoliter.
PLT Histogram
[PLT HISTOGRAM] is used to display the platelet count (numeric) data
accumulated in each of 256 size channels. Each line contains data for 16 channels.
For example, line one data is for channels 1 to 16, line two data is for channels 17
to 32, etc. Each size channel equals 0.1367 femtoliters.
NOTE: All three histograms are displayed and printed as numeric data only.
Smoothing Off/On
This key toggles between [SMOOTHING OFF] and [SMOOTHING ON]. This
key is used to change the histogram display status. When smoothing is OFF and a
histogram key is pressed, raw histogram data is shown. When smoothing is ON and
a histogram key is pressed, normalized and threshold-edited histogram data is
shown. The number of the peak channel is also shown.

9140390A—March 2003
More (Level 2)
When [MORE] is pressed at the second level of the DIAGNOSTICS menu screen,
the third of four DIAGNOSTICS menu screens is displayed.
The following keys are displayed:
• [PROBE HOME] / [PROBE DOWN] (toggles between choices)
• [PROBE UP] / [PROBE DOWN] (toggles between choices)
• [MORE]
• [HELP/ERROR]
• [MAIN]
Probe Home
[PROBE HOME] is used to check the homing operation of the probe mechanism.
When pressed, this key is highlighted and changes to [PROBE DOWN].
Probe Up
[PROBE UP] is used to check the up and down motion of the probe mechanism.
When pressed, this key is highlighted and changes to [PROBE DOWN].

9140390A—March 2003
More (Level 3)
When [MORE] is pressed at the third level of the DIAGNOSTICS menu, the
fourth of four DIAGNOSTICS menu screens is displayed. The following keys are
displayed:
• [SYSTEM STATUS] / [CLEAR ALARM] (toggles between choices)
• [FAULT REPORT]
• [SERVICE HEX CODES]
• [SERVICE DEC CODE]
• [MORE]
• [HELP/ERROR]
• [MAIN]
System Status
[SYSTEM STATUS] displays or prints the current alarm status of the system.
Fault Report
[FAULT REPORT] displays a new screen that allows the Operator or service
personnel to review or print the current fault status. Whenever the message Not
Ready: See Diagnostics is displayed in the System Status Box, it is
directing the Operator to go to the DIAGNOSTICS menu and press this key.
Service Hex Codes

This screen is not for Operator use. It is for Service Personnel only.
Service Dec Code

This screen is not for Operator use. It is for Service Personnel only.
More
When [MORE] is pressed at the fourth level of the DIAGNOSTICS menu, the
Operator is returned to the main DIAGNOSTICS menu.
Help/Error
[HELP ERROR] accesses a menu that has a [FAULT LOG] key and [HELP] key.
If a fault is pending, when [HELP/ERROR] is pressed a list of up to sixteen
operator to view the errors.
Main
[MAIN] is used to return the Operator to the MAIN MENU screen.

9140390A—March 2003
NOTES

9140390A—March 2003
Section 10 Troubleshooting
Troubleshooting
This Troubleshooting Guide provides information to assist in problem

identification, isolation, and corrective action. Instructions for obtaining technical
assistance are included.
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 re-running controls.
WARNING: Potential Biohazard. Follow established biosafety practices
when performing maintenance, service or troubleshooting procedures.
Refer to Section 8: Hazards for additional information
Introduction
Understanding normal instrument operation is essential for identifying and
resolving operational problems. Effective troubleshooting requires a logical, step-
by-step approach to problem solving. Logical troubleshooting can be divided into
three steps as follows:
1. Problem Identification—requires the Operator to investigate not only what
is wrong but also to note what is right. The investigation should identify the
problem area and eliminate areas that are working correctly. Once this step is
done, move to the next step.
2. Problem Isolation—further classifies an instrument problem. These
problems are generally divided into three categories:
• Measurement related to sample analysis
• Software related
• Hardware component related
Typically, hardware and software problems are Operator-correctable with
technical assistance. Measurement problems are generally Operator-
correctable and are further subdivided into problems related to sample
handling, maintenance, or calibration.
3. Corrective Action—involves taking appropriate steps to correct the
problem. If the Operator can correct the problem, with or without technical
assistance, normal operation can quickly resume.

9140390A—March 2003
Troubleshooting Section 10
Troubleshooting Tips and Techniques

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.
This Troubleshooting Guide is designed to guide the Operator through a logical
series of steps to obtain information regarding the nature of the problem. A detailed
CELL-DYN 1800 Flow Panel diagram has been included for reference. If it is
necessary to call for technical assistance, this information must be communicated
to the Customer Service.
Obtaining Technical Assistance

If additional information or help is required, technical assistance can be obtained
by calling Abbott Diagnostics Customer Service. 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:
• Instrument model name
• Serial number of the analyzer
• Software version in use (displayed on MAIN MENU screen in the upper left
corner of the screen)
• Description of the problem
• The Fault Status Report, if possible, which is accessible through the
HELP/ERROR menus’ [FAULT REPORT] key
• The lot numbers and expiration dates of CELL-DYN reagents, calibrators,
and controls currently in use
• Instrument maintenance history
• Sufficient examples of data to facilitate the discussion including:
• Data from quality control reports as well as data from your last instrument
calibration

9140390C—March 2004
Customer Service
Technical assistance is available in the U.S. 24 hours a day, seven days a week by
calling Abbott Diagnostics Customer Service at:
1-877-4ABBOTT (1-877-422-2688)
1-800-387-8378
For customers outside the U.S. and Canada, call your local Hematology Customer
Support Representative.
For correspondence, the address in the U.S. is:
Abbott Diagnostics Division
Customer Service
200 Abbott Park Road

9140390C—March 2004
Troubleshooting Procedures
The procedures in this section are for troubleshooting purposes only. A specific
procedure must be performed when indicated in this chapter or at the request of
Abbott Diagnostics Customer Service.
Power ON Procedure
The power ON procedure is as follows:
1. Verify that all components are properly installed (for example, syringes, 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 instrument’s covers are properly installed.
5. If the instrument power has been turned OFF, verify that the fault or error has
been corrected before turning the instrument power back ON.
6. Turn the power switches ON in the following order:
a. Instrument
b. Printer
When the UNINITIALIZED message appears in the status box on the MAIN
MENU screen, prime the instrument. Follow the Startup procedures as defined in
Section 5: Operating Instructions, Subsection: Instrument Start Up.
Power OFF Procedure

It is not necessary to turn the system OFF under routine operating conditions. The
system must be turned OFF if certain services are performed, if the system is
moved, or if the system will be inactive for an extended period of time (longer than
three days or 72 hours).
When controlled conditions (such as emergency power tests) require the power to
be turned OFF, use the following procedure.
1. Perform any required maintenance that is due.
2. From the MAIN MENU screen press [SPECIAL PROTOCOLS] and then
press [AUTO CLEAN].
3. Perform an Auto Clean cycle. If necessary, refer to the directions given in
Section 9: Service and Maintenance, Subsection: Weekly Maintenance
Procedures.
4. When the Auto Clean cycle is complete, press [DAILY SHUTDOWN].
When the Daily Shutdown cycle is complete, the status box displays the
message: Standby.
NOTE: If the instrument will be inactive for more than four days, perform
the Preparing the Instrument for Extended Periods of Non-Use
or Shipping procedure as detailed in Section 9: Service and
Maintenance.

9140390C—March 2004
5. Turn the power switches OFF in the following order:

a. Instrument
b. Printer
NOTE: In an emergency situation, turn OFF the power switches, in any
order, as quickly as possible. Follow the Power ON procedure
as described earlier in this section when the emergency is over.
Initializing the System

The term Initialization refers to the instrument priming process that is necessary
after certain problems have been corrected. Initialization is a two-step process:
Initializing the hardware and software
Priming the instrument with reagents
During the initialization process, software is accessed and downloaded to the
instrument. Once this download is accomplished, all instrument motors and pumps
are moved to their prime positions. (Increased motor noises are normal during this
process.) When the initialization has been successfully completed, the message
READY is displayed in the status box in the RUN menu.
Replacing Reagents
If a reagent (or reagents) is suspected as the cause of a particular problem, replace
the reagent.
NOTE: To prime the instrument with replaced reagents, See Section 9:
Service and Maintenance, Subsection: Special Protocols Menu.
Replaceable Components
Procedures are given in Section 9: Service and Maintenance for those
components that can be replaced by the Operator.
WARNING: Potential Biohazard. Components can be contaminated
with infectious materials. Wear appropriate personal protective equipment
and follow biosafety practices as specified in the OSHA Bloodborne
Pathogen Rule (29 CFR 1910.1030)1 or equivalent biosafety procedures.

9140390A—March 2003
Valve Function
1-1 RBC/PLT Transducer*
Drain 3-2 3-1
1-2 RBC/PLT Count
1-3 RBC/PLT Metering Tube
8
Vent
1-4 RBC/WBC Isolator 9
Vacuum
3-4
1-5 RBC/WBC Isolator Drain 3-6
1-6 RBC/WBC Backflush
2-1 WBC Metering Tube Vent 3-5
2-2 Pre-Mixing Cup Bubble 3-3
Mix 1-6
4-6 10
Bubble Mix 1-1
2-4 RBC/PLT Transducer* Fill
2-5 RBC/PLT Mixing Chamber 1 5 1-4
Drain
2-6 HGB Reference 2 1-3
2-7 HGB Sample
4-8
1-2
3-1 Probe Wash Normally 2-1
Closed Valve
3-2 Probe Wash Drain 4-7
Vacuum 4-3 2-2 4
Wash 4-5 2-3 7
3-4 Pre-Mixing Cup Fill 12 3 2-4 6
3-5 WBC Transducer* Drain
3-6 WBC Mixing Chamber 2-5
Vent
1-5
4-3 WBC Count 4-4
4-4 WBC Transducer* Fill
2-7
4-5 HGB Sample/WBC Mix 11 11
2-6
Chamber Drain
4-6 Lyse Inlet/WBC Mix
Chamber Drain
4-7 WBC Mixing Chamber
Bubble Mix
4-8 Pre-Mixing Cup Wash/
Sample Transfer
Assembly Name
1 WBC Transducer*
2 Pre-Mixing Cup
3 WBC Metering
4 Start Switch
5 RBC/PLT Transducer*
6 RBC/PLT Metering
7 Vacuum Isolator
9 Sample Aspiration Probe
10 Wash Block
11 Vent Lines
12 HGB Flowcell
Figure 10.2 CELL-DYN 1800 Flow Panel Diagram

* von Behrens Transducers
For additional description of Flow Panel Assembly, see Figure 1.3 Sampling Section and Flow Panel.

9140390C—March 2004
Section 10 Index of Error Messages and Conditions
Index of Error Messages and Conditions
Observed or Mechanical Errors or Condition

Air in detergent line, but no message. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-20
Air in diluent reagent line, but no message . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-20
Air in lyse reagent line, but no message . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-20
Bacterial or fungal contamination of the flow system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-20
Bar code scanner light flashing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-21
Bar code scanner light not activated . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-21
Bar code scanner light on/no audible tone when bar code is scanned . . . . . . . . . . . . . . . . . . . . . . . . . . 10-21
Bar code scanner produces audible tone on read, but transmission of specimen ID does not occur . . . 10-21
Blood in tubing connected to Sample Aspiration Probe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-22
Contaminated, evaporated, or degraded reagents affecting any results . . . . . . . . . . . . . . . . . . . . . . . . . 10-22
Impedance aperture plate clog . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-22
Inaccurate sample dilution due to incorrect/inconsistent sample aspiration volume or incorrect/inconsistent
delivery of reagent . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-22
Incomplete printout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-23
Inconsistent formation of bubbles in the flow system and syringe or bubbles in HGB Flow Cell . . . . 10-23
Incorrect specimen ID on reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-24
Instrument flooded with diluent . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-24
Keypad selection entry not accepted . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-24
List mode data corrupt . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-24
Mechanical Position Fault . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-24
No power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-25
No screen display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-25
No screen labels displayed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-25
Patient results affected by heat within the instrument . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-26
Patient results corrupting in transfer from instrument to LIS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-26
Patient results incorrectly transmitted from the instrument to the printer . . . . . . . . . . . . . . . . . . . . . . . 10-26
Pre-Mixing Cup Overflow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-26
Printer not ready . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-26
Probe not properly washed. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-27
Sample carryover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-27
Solenoid valve failure resulting in inaccurate patient results. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-27
Specimen clotted or hemolyzed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-28
Specimen will not aspirate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-28
Run cycle will not stop. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-28
Waste accumulation in the pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-29
Waste container contaminating the entire flow system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-29
Waste container overflow. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-29
Waste full, but no message is displayed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-29

9140390D—January 2006
Index of Error Messages and Conditions Section 10
Data Problems
Background data is unacceptable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-30
“Greater than” symbols (>>>>) appear in place of HGB, WBC, RBC, or PLT results . . . . . . . . . . . . .10-31
Consistently low values (short sample) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-32
GRAN R3 or RM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-33
GRAN R4 or RM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-33
High MCV with high MCHC results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-33
High MCV with low MCHC (or high MCH) results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-34
High PLT. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-34
High WBC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-34
Imprecise or inaccurate patient results, even after changing (or installing) reagents. . . . . . . . . . . . . . .10-35
Imprecise results (poor precision) due to inconsistent bubble mixing in the mixing chambers. . . . . . .10-35
Inaccurate HGB readings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-36
Inaccurate patient results with different Operator running the same specimen . . . . . . . . . . . . . . . . . . .10-36
Inaccurate results due to possible undetected crack around orifice of aperture plate . . . . . . . . . . . . . .10-36
Inaccurate WBC/HGB reading due to incorrect/inconsistent injection of lyse. Decreased Lyse = WBC _,
HGB _ Increased Lyse = Inaccurate Diff . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-36
Low PLT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-37
Low WBC. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-37
LYM R2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-37
MID R2 or RM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-37
MID R3 or RM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-38
QC specimen results exceed acceptable limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-38
Results very erratic after changing lyse . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-39
Results are out-of-range immediately after calibrating . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-39
Results underlined on printout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-39
Spuriously high HGB, MCH, or MCHC results. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-40
Spuriously low HGB, MCH, or MCHC results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-41
Suspect Parameter Flag, LRI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-41
Suspect Parameter Flag, LRI URI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-42
Suspect Parameter Flag, LYM R0 or RM. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-42
Suspect Parameter Flag, URI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-42
Suspect Population Flag, LYM R1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-43
Unreliable patient results due to drifting values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-43
WBC and/or HGB data is invalid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-43
Westgard® Rule violation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-44
X-B data are out for MCH and/or MCHC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-44
X-B data are out for MCV . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-44

Screen Messages
Alarm Message Condition; Fault LED is illuminated . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-45
Clog message is displayed in place of Count Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-46
Detergent Empty message is displayed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-46
Diluent Empty message is displayed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-47
Fault Message Condition displayed in status box on screen; Fault LED is illuminated . . . . . . . . . . . . 10-47
Flow Err message is displayed in place of Count Time. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-48
Flow Err or Clog message displayed in place of both Count Times (WBC/RBC) . . . . . . . . . . . . . 10-49
Lyse Empty message is displayed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-51
Not Ready: See Diagnostics message is displayed. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-52
Pressure Limit Time-out. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-52
Results highlighted on screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-52
Status Condition message appears in message field; Fault LED is not illuminated . . . . . . . . . . . . . . . 10-52
Vacuum Limit Time-out . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-53
Waste Full message is displayed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-53

9140390C—March 2004
Error Messages and Conditions

OBSERVED or MECHANICAL Errors or Conditions
Air in detergent line, but no message
Probable Cause(s) Corrective Action(s)
An empty Detergent container Check Detergent container.
Air leak is in line above Detergent Check for air leak above Detergent Empty inline
Empty Sensor sensor. (See Section 9: Service and Maintenance,
Subsection: Flow Panel Components.)
Detergent Empty Sensor is Turn instrument power OFF.
malfunctioning Wait 30 seconds.
Turn instrument power ON.
If required, call Abbott Diagnostics Customer
Service.
Air in diluent reagent line, but no message
An empty Diluent container Check Diluent container.
Air leak is in line above Diluent Empty Check for air leak above Diluent Reagent Empty
Sensor inline sensor. (Section 9: Service and
Maintenance, Subsection: Flow Panel
Components.)
Diluent Empty Sensor is Turn instrument power OFF.
malfunctioning Wait 30 seconds.
Service.
Air in lyse reagent line, but no message
An empty Lyse container Check Lyse container.
Air leak is in line above Lyse Empty Check for air leak above Lyse Reagent Empty inline
Sensor sensor. (Section 9: Service and Maintenance,
Subsection: Flow Panel Components.)
Lyse Empty Sensor is malfunctioning Turn instrument power OFF.
Wait 30 seconds.
Service.
Bacterial or fungal contamination of the flow system

9140390C—March 2004

Inadequate routine maintenance Flush system. (See Section 9: Service and
Instrument is idle for a long period of Maintenance, Subsection: Preparing the
time Instrument for Extended Periods of Non-Use or
Shipping.)
Contaminated reagent
Perform Background Counts and observe
acceptable limits. (See Section 5: Operating
Instructions, Subsection: Routine Operation.)
Replace reagents.
Bar code scanner light flashing
Scanner not configured Verify scanner cable is connected to the keyboard
cable.
Reconfigure scanner. (See Appendix D: Bar Codes.)
Bar code scanner light not activated
Incorrect scanner installation Verify scanner cable is connected to the keyboard
cable. Point the scanner at a piece of paper and
squeeze the trigger to see if the red light is activated.
Disconnect scanner cable and reconnect.
Bar code scanner light on/no audible tone when bar code is scanned
cable.
Scanner incorrectly configured Reconfigure scanner. (See Appendix D: Bar Codes.)
Bar code label printer incorrectly Verify bar code label printer is configured for
configured symbology and options expected.
Poor bar code label quality Verify bar code labels are not smudged or damaged.
Check bar code label printer for malfunction.
Residue on bar code scanner lens Clean bar code scanner lens. (See Section 9:
Service and Maintenance, Subsection: Cleaning
the Bar Code Scanner Lens.)
Inadequate bar code label read distance Vary the read distance. Hold the scanner between 2
and 5 inches away from the bar code label.
Ensure that light beam scans across the entire length
of the bar code.
Vary angle of scanner up or down slightly.
Bar code scanner produces audible tone on read, but transmission of specimen ID does not occur

9140390C—March 2004

cable.
Blood in tubing connected to Sample Aspiration Probe
Sample line is drawing in air Check for air leak above and beyond probe.
Check tubing around aspiration probe is connected
properly.
Contaminated, evaporated, or degraded reagents affecting any results
Improper storage of reagents (reagent Observe expiration date and rotate stock to use the
frozen or exposed to extremely high oldest (unexpired) first.
temperature for a long period of time) Observe proper storage and handling instructions.
Expired reagent inadvertently used (See Section 7: Operational Precautions and
Reagent cap is off, damaged, or came Limitations.)
loose during storage Replace reagents.
Impedance aperture plate clog
The Impedance Transducer Aperture Clean The Aperture Plate. (Section 9: Service and
Plate has partial obstructions Maintenance, Subsection: As-Required
Maintenance.)
The Impedance Transducer bath is not Perform Drain and Fill of the Impedance
full Transducer.
Check that the bath is not leaking.
Possible plugs are in the outlet line of Check for outlet line flow of the Impedance
the Impedance Transducer or a pinch Transducer. Also check Pinch Valves 3–5 (WBC)
valve is not functioning and 2–5 (RBC) for proper drainage.
Defective sensor board Call Abbott Diagnostics Customer Service.
Diluent reagent may be contaminated Replace with a fresh container of diluent.
or have crystals
Vacuum/Pressure Pump may be Call Abbott Diagnostics Customer Service.
causing changes in fluidics
Impedance Transducer Sample Clear Orifice
Delivery Outlet flow is decreased Clean the Aperture Plate
Perform a reagent PRIME.
Inaccurate sample dilution due to incorrect/inconsistent sample aspiration volume or
incorrect/inconsistent delivery of reagent

9140390C—March 2004

Erratic/inconsistent stepper motor Check for correct positioning of Sample Aspiration
movement due to loss of lubrication, Probe.
corrosion, dried saline, or blood. If required, call Abbott Diagnostics Customer
Syringes sticking due to dried saline or Service.
degradation of plunger O-ring Clean/Replace syringes. (See Section 9: Service
Pump failure and Maintenance, Subsection: As-Required
Sample probe out of normal alignment Maintenance.)
Incomplete printout
Paper out Load Paper
Reprint current run data from the Data Log menu.
(See Section 5: Operating Instructions,
Subsection: Data Log Menu.)
Low ink level Check ink cartridge, replace if necessary.
Inconsistent formation of bubbles in the flow system and syringe or bubbles in HGB Flow Cell
Air is in lines Check for leaks in Lyse, Diluent, or Detergent
Turbulent flow syringe lines.
Check for pinched tubing around valve 2–6.
Perform Auto Clean. (See Section 9: Service and
Maintenance, Subsection: Weekly Maintenance
Procedures.)
Clean HGB flow cell. (See Section 9: Service and
Maintenance, Subsection: Monthly Maintenance
Procedures.)
Clean/Replace Syringes. (See Section 9: Service
and Maintenance, Subsection: As-Required
Maintenance.)

9140390C—March 2004

Incorrect specimen ID on reports
Inadvertent misidentification Use a checklist for procedures when changing
Operators.
Re-run patient specimen.
Observe proper technique for specimen ID entry.
(See Section 5: Operating Instructions,
Subsection: Specimen Analysis.)
Instrument flooded with diluent
Leaks in tubing Call Abbott Diagnostics Customer Service.
Keypad selection entry not accepted
Computer busy Check screen display for current status of
instrument.
Data is being transmitted Wait for transmission to complete.
List mode data corrupt
Electrostatic discharge Review hazards. (See Section 8: Hazards,
Electromagnetic interference Subsection: Electrical Hazards.)
Errors in data acquisition due to Review instrument installation. (See Section 2:
electrical interference Installation Procedures and Special
Requirements.)
Service.
Mechanical Position Fault
Aspiration Probe not in correct position Check for an obstruction in the movement path of
the aspiration probe assembly.
Clear the fault. Initialize the instrument.
If the fault is not clear, power off, wait for 30
seconds, and power on.

9140390C—March 2004

No power
Power cord is loose or not properly Check that prongs are not bent and that power cord
connected is properly connected to instrument and power
source.
Power Switch is turned OFF Turn Power Switch ON.
No voltage (or wrong voltage) at wall Confirm that fuse and site circuit breaker are
outlet adequate and that wall outlet has power.
Confirm that the instrument’s voltage selector
switch is correct for the power provided.
Defective Power Switch Call Abbott Diagnostics Customer Service.
Instrument malfunction Call Abbott Diagnostics Customer Service.
No screen display
Instrument power is OFF Turn instrument power ON.
Incoming power fluctutation Turn instrument power OFF.
Wait 30 seconds.
No screen labels displayed
Cycle in process, but not complete None; refer to the display screen for current status.
Incomplete data entry Press the [←] (Enter) key to abandon unfinished
Operator-entry process and redisplay the screen
label.
Wrong Software Installed Turn instrument power OFF and install correct
software. If problem is not resolved, call Abbott
Diagnostics Customer Service.

9140390D—January 2006

Patient results affected by heat within the instrument
Insufficient space behind analyzer Provide proper amount of air circulation to
Room temperature is too high maintain a stable temperature.
Patient results corrupting in transfer from instrument to LIS
Cable failure Verify proper cabling connections.
Electrical interference Use shielded cable.
Service.
Patient results incorrectly transmitted from the instrument to the printer
Communication protocol failure Reboot instrument and printer (shut down, then
restart).
Verify instrument and printer setup menus are
correct.
Service.
Pre-Mixing Cup Overflow
Fibrin or debris blocking drainage of Clean the Pre-Mixing Cup. (See Section 9: Service
Pre-Mixing Cup and Maintenance, Subsection: As-Required
Maintenance.)
Clean the “Y” fitting. (See Section 9: Service and
Maintenance, Subsection: As-Required
Maintenance.)
Printer not ready
Printer is not Online Turn printer Online.
Printer is not turned ON Turn printer ON.
Printer cable is not attached properly Check cable connection.

9140390C—March 2004

Probe not properly washed
Probe Wash Block Waste Drain is Replace Probe Wash Block.(See Section 9: Service
clogged and Maintenance, Subsection: As-Required
Probe Wash Block Waste Drain Pinch Maintenance)
Valve malfunctioning If required, call Abbott Diagnostics Customer
Diluent Wash Pinch Valve (3-1) Service.
malfunctioning
Wash Block Waste Pinch Valve (3-2)
malfunctioning
Keypad and/or circuitry malfunction Turn instrument power OFF.
Wait 30 seconds.
Sample carryover
Inadequate washing and/or rinsing of Check for crimped tubing or inadequate Diluent
sample aspiration or delivery flow around the Sample Aspiration Probe and Wash
mechanism Block.
Inadequate cleaning of orifice plate Perform CLEAR ORIFICE.
after WBC count is taken Perform Auto Clean. (See Section 9: Service and
Maintenance, Subsection: Weekly Maintenance
Procedures.)
Clean Impedance Aperture Plate. (See Section 9:
Service and Maintenance, Subsection:
As-Required Maintenance.)
Solenoid valve failure resulting in inaccurate patient results
Improper valve function Initialize the instrument.
Turn instrument power OFF.
Wait 30 seconds.
Service.

9140390C—March 2004

Specimen clotted or hemolyzed
Specimen collected in tubes with Observe proper storage and handling instructions,
inappropriate anticoagulant or and specimen stability information in Section 7:
collected in expired sample tubes Operational Precautions and Limitations.
Improper specimen handling and/or Redraw and run new specimen.
storage
Specimen is too old
Specimen collected in capillary or
microtube
Specimen will not aspirate
Fibrin or debris is in Sample Aspiration Check specimen tube for clots.
Probe Check Sample Aspiration Probe for debris; clean if
necessary. (See Section 9: Service and Maintenance,
Subsection: As-Required Maintenance.)
Redraw specimen as required.
Sample syringe malfunction Check that syringe is moving properly.
Check that syringe is properly installed.
Clean the sample syringe. (See Section 9: Service
and Maintenance, Subsection: As-Required
Maintenance.)
Sample Aspiration Probe not properly Confirm that tubing around Sample Aspiration
aligned Probe is connected properly.
Confirm that probe clip is properly secured.
Call Abbott Diagnostics Customer Service.
Vacuum or circuitry malfunction Turn instrument power OFF.
Wait 30 seconds.
Run cycle will not stop
Start switch is stuck Turn instrument power OFF.
Open/Remove Front Covers. (See Section 2:
Installation Procedures and Special
Requirements, Subsection: Opening/Removing
Front Covers, Version A or Opening Front
Covers, Version B), then check switch.

9140390C—March 2004

Waste accumulation in the pump
Leaks at connection Check waste drain line for obstructions.
Malfunction of pump head Turn instrument power OFF.
Wait 30 seconds.
Service.
Waste container contaminating the entire flow system
Waste container is improperly Follow instructions for proper handling of waste
positioned container. (See Section 9: Service and Maintenance,
Subsection: As-Required Maintenance)
Flush system. (See Section 9: Service and
Maintenance, Subsection: Preparing the
Instrument for Extended Periods of Non-Use or
Shipping)
Waste container overflow
Undetected waste full condition Replace waste tubing and cap sensor.
Check waste drain line for obstructions.
Wait 30 seconds.
Waste sensor dummy plug on the lower Clean the plug with alcohol and reinsert it.
left side of the instrument is dirty.
Waste full, but no message is displayed
Waste Sensor Plug is corroded Clean Plug with alcohol and reinsert.
Waste Sensor is not attached properly Attach Waste Sensor correctly.
Loose sensor wire in waste cap Contact Abbott Diagnostics Customer Service.

9140390C—March 2004
DATA Problems
Background data is unacceptable
Contaminated Diluent or Detergent Use a disinfectant solution containing
0.5% sodium hypochlorite for
cleaning and disinfecting the flow
system.
Change reagent and flush system. (See
Section 9: Service and Maintenance,
Subsection: As-Required
Maintenance.)
Leave the power ON.
Repeat system flush with deionized
water.
Change diluent and detergent and
repeat system flush.
Reagents are too cold Allow reagents to warm to room
temperature. (See Section 1: Use or
Function, Subsection: Reagent
Storage.)
Rerun Background Count.
Interference from other electrical Use dedicated power source or line
devices regulator.
Relocate instrument to an area free
from interfering devices.
Press [RUN], [SPECIMEN TYPE],
and [ELECTRICL BACKGRND].
Rerun Background Count.
Verify that electrical background is zero.
Contaminated Transducer bath or Perform AutoClean procedure. (See
Aperture plate Section 9: Service and Maintenance,
Subsection: Weekly Maintenance
Procedures.)
Clean Aperture Plate. (See Section 9:
Service and Maintenance,
Maintenance.)
Perform Supplemental Aperture
cleaning. (See Section 9: Service and
Maintenance, Subsection:

9140390E—June 2008
DATA Problems
Contaminated Lyse (WBC Clean the Lyse Syringe. (See Section 9:
background only) Service and Maintenance, Subsection:
Install fresh Lyse Reagent.
Diluent was frozen Replace with new reagent.
Vacuum Accumulator contaminated Clean the Vacuum Accumulator. (See
Maintenance.)
“Greater than” symbols (>>>>) appear in place of HGB, WBC, RBC, or PLT results
Data exceeds absolute or linear range For HGB or RBC, proceed as follows:
for that parameter 1. Dilute a 0.5 mL aliquot of well-
mixed whole blood with 0.5 mL
diluent (1:2 dilution) in a
specimen tube approved for use
on the instrument.
2. Close the container and invert it
10 to 15 times to mix.
3. Run the specimen as usual.
4. Multiply the RBC and HGB result
by 2 to obtain a reportable value.
For WBC or PLT, proceed as follows:
1. Dilute a 0.5 mL aliquot of well-
mixed whole blood as required in
a specimen tube approved for use
on the instrument.
for result,
Volume Volume dil multiply
Blood Diluent by:
0.5 mL 0.5 mL 1:2 2

0.5 mL 1.0 mL 1:3 3
0.5 mL 1.5 mL 1:4 4
0.5 mL 4.5 mL 1:10 10
2. Close the container and invert it

10 to 15 times to mix.
3. Run the specimen as usual.
4. Multiply each WBC and PLT
result by 2, 3, 4, or 10 (per ratio of
diluent to blood used above) to
obtain a reportable value.
Improper reagent delivery or sample Inspect syringes for proper operation.
aspiration Check all reagent lines for crimping.

9140390A—March 2003
DATA Problems
Consistently low values (short sample)
The specimen tube contains too little Small amounts of blood must be run in
blood for sampling duplicate to confirm results; redraw if
necessary.
Check to see if the sample is being
deposited in the Pre-Mixing Cup.
A blockage of the Sample Aspiration Perform Auto Clean (See Section 9:
Probe has occurred Service and Maintenance,
Procedures.) If problem persists,
repeat Auto Clean procedure.
Check if the delivery is in spurts, or if
a drop remains on the end of the probe.
Clean Sample Aspiration Probe. (See
Maintenance.)
Drawing in of air somewhere in Check specimens for clots.
tubing or fitting Check probe for blood clots.
Check probe for damage (bent or
crimped).
Clean or replace the Sample
Aspiration Probe.
Check for loose tubing at top of probe.
Pre-Mixing Cup is not draining Clean the Pre-Mixing Cup. (See
Maintenance.)
Clean the “Y” fitting. (See Section 9:
Maintenance.)
Solenoid or One-way Valve from Exercise Solenoid.
diluent may be malfunctioning Call Abbott Diagnostics Customer
Service.

9140390C—March 2004
DATA Problems
GRAN R3 or RM
Shift in WBC cell distribution due to Re-run specimen after 20 minutes of
EDTA anticoagulant equilibration. collection; redraw if necessary.
Granulocytosis If flag persists, check stained smear to
Neutropenia confirm differential.
Eosinophilia Check specimen for clots or
agglutination.
Agranular neutrophils
Bands
GRAN R4 or RM
Hypersegmented neutrophils If flag persists, check stained smear to
Granulocytosis confirm differential.
Neutropenia Check specimen for clots or
agglutination.
Immature granulocytes
High MCV with high MCHC results
Electronic malfunction Turn instrument power OFF.
Wait 30 seconds.
If required, call Abbott Diagnostics
Customer Service.

9140390C—March 2004
DATA Problems
High MCV with low MCHC (or high MCH) results
Impedance Aperture blockage Press [CLEAR ORIFICE].
Perform Auto-Clean. (See Section 9:
Procedures.)
Clean Aperture Plate. (See Section 9:
Maintenance.)
Perform Supplemental Aperture
Cleaning. (See Section 9: Service and
High PLT
Microcytic RBCs Check stained smear for possible
RBC inclusion bodies interference or sample abnormality.
WBC fragments Check specimen for hemolysis and
re-run.
Hemolysis
Cryoglobulins
High WBC
Nucleated RBCs Check stained smear for possible
Platelet clumping interference or sample abnormality.
Resistant RBCs Re-run specimen; redraw if necessary.
Cryoglobulins
Monoclonal antibodies
Heparin therapy

9140390A—March 2003
DATA Problems
Imprecise or inaccurate patient results, even after changing (or installing) reagents
Instrument was not used for a long Always prime the analyzer and run
period of time backgrounds after extended periods of
Contaminated or old reagent used nonuse.
Clean the Flow System. (See
Maintenance.)
Old reagent mixed with fresh reagent Observe proper handling of reagents
Improper handling of reagent lines by in Section 7: Operational
Operator, causing contamination Precautions and Limitations.
Reagent lines were placed into Observe color-coding of reagent caps

incorrect reagent containers or sinkers and reagent inlet tube
connectors.
Observe proper installation in
Section 2: Installation Procedures
and Special Requirements.
Clean the Flow System. (See
Maintenance.)
Imprecise results (poor precision) due to inconsistent bubble mixing in the mixing chambers
Mixing chamber malfunction Check for proper mixing in the mixing
chamber.
Using wire puller, exercise solenoids
4–7 (WBC mixing chamber bubble
mix) and 2–3 (RBC chamber bubble
mix).

9140390A—March 2003
DATA Problems
Inaccurate HGB readings
Contamination of HGB flow cell due Perform Auto-Clean, twice, if
to sample residue (organic build up) necessary. (See Section 9: Service
and Maintenance, Subsection:
Weekly Maintenance Procedures.)
HGB Flow Cell is rinsed after each
measurement check for proper flow to
and from HGB Flow cell (adequate
draining of Pre-Mixing Cup and no
leaks in lines around HGB Flow Cell).
Clean the HGB Flow Cell. (See
Subsection: Monthly Maintenance
Procedures.)
Inaccurate patient results with different Operator running the same specimen
Specimen tube shaken, rather than Observe the proper handling of
gently mixed specimens in Section 5: Operating
Instructions.
Inaccurate results due to possible undetected crack around orifice of aperture plate
Improperly installed Aperture Plate Replace the Aperture Plate. (See
Orifice cracked due to excessive force Section 9: Service and Maintenance,
when installed Subsection: As-Required
Maintenance.)
Other unknown causes
Inaccurate WBC/HGB reading due to incorrect/inconsistent injection of lyse. Decreased Lyse
= WBC _, HGB _ Increased Lyse = Inaccurate Diff
Sticking Lyse syringes due to dried Verify Lyse reagent.
saline or bubbles in syringe Clean the Lyse Syringe. (See
Improper delivery of lyse reagent Section 9: Service and Maintenance,
Maintenance.)
Call Abbott Diagnostics Customer
Service.

9140390C—March 2004
DATA Problems
Low PLT
Clotting Check specimen for clotting.
Heparin Check patient therapy.
Platelet clumping Check stained smear for possible
Giant platelets interference or sample abnormality.
Platelet satellitosis Re-run specimen.
Low WBC
Clotting Check specimen for clotting.
Smudge cells Check stained smear for possible
Uremia, plus immunosuppressants interference or sample abnormality.
Check patient laboratory history.
LYM R2
Lymphocytosis If flag persists, check stained smear to
Lymphopenia confirm differential.
Blasts Check specimen for clots or
agglutination.
Variant lymphocytes
Basophilia
MID R2 or RM
Blasts Check specimen for clots or
agglutination.
Variant lymphocytes
Plasma cells
Basophilia
Monocytosis

9140390A—March 2003
DATA Problems
MID R3 or RM
Eosinophilia If flag persists, check stained smear to
Blasts confirm differential.
Agranular neutrophils Check specimen for clots or
agglutination.
Plasma cells
Basophilia
Bands
QC specimen results exceed acceptable limits
Improper mixing or handling of QC Refer to Section 11: Quality Control,
specimen Subsection: Quality Control
Procedures.
Incorrect QC setup Check that expected QC values are
Running a control in an incorrect QC entered correctly. (See Section 11:
file Quality Control, Subsection: Quality
Control Procedures.)
Verify that the control is being run into
the correct control file.
Dilution error Re-run QC specimen. If problem
persists, perform Auto Clean. (See
Procedures.)
Insufficient or no dilution mixing. Open the Upper Front Cover.
Dirty Aperture Plate Press the Touch Plate and observe the
bubble mix in each bath and the Pre-
Mixing Cup.
Customer Service.

9140390C—March 2004
DATA Problems
Results very erratic after changing lyse
Internal temperature beyond the Replace Lyse reagent.
stability limits of Lyse during storage Keep Lyse away from heat.
Lyse is unstable at high temperature Observe proper storage and handling.
Customer Service.
Results are out-of-range immediately after calibrating
Calibrators and controls degraded due Observe expiration date and storage
to improper storage requirements on label.
Expired controls and calibrators used Observe proper storage and handling
Contaminated calibrators and instructions in Section 7: Operational
controls used Precautions and Limitations.
Rerun with fresh controls.
Results underlined on printout
Results are outside Operator-entered Confirm background data.
limits. Re-run specimen.
Recheck limits screen. (See Section 5:
Operating Instructions, Subsection:
Program Operation.) For QC, verify
that means and limits are correct in the
QC Setup menu, and adjust if
necessary. Verify that correct control
file number is being used.
If appropriate, view stained smear to
reconfirm count.
If the results exceed the Operator-
entered limit for WBC, RBC, HGB, or
PLT, follow established laboratory
operating procedures.

9140390D—January 2006
DATA Problems
Spuriously high HGB, MCH, or MCHC results
WBC value >50,000 Check stained smear for possible
Lipemic or high protein sample interferences or sample abnormality.
Hyperbilirubinemia Verify Lipemia or abnormal plasma
protein in specimen. Centrifuge an
aliquot of the specimen. Remove the
plasma and replace it with an equal
volume of diluent. Resuspend the red
blood cells. Re-run specimen.
Dirty HGB Flow Cell Clean HGB Flow Cell. (See
Low HGB reference (<1800) Section 9: Service and Maintenance,
Maintenance.)
Change Lyse Reagent.
Low RBC, Cold Agglutinins, Check specimen for clots, recollect if
Microcytic RBCs necessary.
Review a stained smear for possible
interference or sample abnormality.
Re-run specimen.
Low MCV, Giant Platelets, Review a stained smear for possible
Cryoglobulins, Hemolysis interferences or sample abnormality.
Re-run specimen.
Electronic malfunction In the DIAGNOSTICS menu, press
[RAW DATA]. Data will display and
print.
Check the results for HGB error, HGB
sample, and verify that HGB reference
is 2000 ± 200.
Customer Service.

9140390C—March 2004
DATA Problems
Spuriously low HGB, MCH, or MCHC results
Low HGB, microclots Check specimen for clots, and re-run.
High RBC, Cryoglobulins, Giant Review a stained smear for possible
platelets, Hemolysis, High WBC interferences or sample abnormality.
Re-run specimen.
High MCV, Autoagglutination, High Verify specimen age.
WBC, swollen RBCs Recollect, and re-run specimen.
Dirty HGB flow cell Clean HGB Flow Cell. (See
Electronic malfunction Section 9: Service and Maintenance,
HGB lamp failing
Maintenance.)
In the DIAGNOSTICS menu, press
[RAW DATA]. Data will display and
print.
Wait 30 seconds.
Customer Service.
Suspect Parameter Flag, LRI
Lower Region Interference, usually Perform Auto-Clean. See Section 9:
due to: Service and Maintenance,
Debris Subsection: Weekly Maintenance
Procedures.)
Contaminated reagent
If flag persists, check stained smear to
Electronic noise
confirm PLT count.
Microbubbles
Check normal background. See
Section 5: Operating Instructions,
Subsection: Routine Operation.)
Check that electrical background
results are zero.
Change reagent.
Check for interfering appliances
nearby.
Check for debris in probe, lines,
aperture.
Check for air leak in Diluent line.

9140390C—March 2004
DATA Problems
Suspect Parameter Flag, LRI URI
Multiple region interference, usually Use actions given for LRI and URI
due to: flags.
Interference in both the upper and
lower regions of the platelet
histogram
Suspect Parameter Flag, LYM R0 or RM
Platelet clumps If flag persists, check stained smear to
Incomplete Lysis of RBCs verify WBC and confirm differential.
Nucleated RBCs Check reagents (See Section 9:
Giant platelets
Cryoglobulins Maintenance.)
Small Lymphocytes found in Chronic Massage and reseat tubing in Lyse
Lymphocytic Leukemia (CLL) Normally Closed Valve.
Fibrin clots Check the specimen for clots or
agglutination.
Suspect Parameter Flag, URI
Upper Region Interference, usually Re-run specimen; redraw if necessary.
due to: If flag persists, check stained smear to
Microcytic RBCs confirm PLT count.
Schistocytes Check Lyse reagent flow and syringe
Giant platelets function.
Sickle cells Check reagents.
Platelet clumps Review the MCV and the PLT
histogram. If the MCV is low and/or
the histogram indicates an overlap in
the RBC and PLT populations, review
a stained smear to determine the cause
and confirm the PLT count.

9140390A—March 2003
DATA Problems
Suspect Population Flag, LYM R1
Cryoglobulins Check specimen for clots or
agglutination.
Unreliable patient results due to drifting values
Improper handling of reagents Observe proper handling of
Impedance count malfunctions specimens. (See Section 5: Operating
Instructions.)
Verify completion of Maintenance
Log Procedures.
Run controls and verify calibration.
Call Abbott Diagnostics Customer
Service.
WBC and/or HGB data is invalid
No Lyse Reagent was added Prime Lyse Reagent. From the MAIN
MENU screen, press [SPECIAL
PROTOCOLS], then [LYSE PRIME].
Lyse Reagent Syringe malfunction Observe Lyse Syringe for proper
vertical movement.
Check Lyse Syringe for bubbles. If
bubbles are present, clean the syringe.
(See Section 9: Service and
Confirm that lyse dispenses into the
von Behrens WBC Transducer in the
prime cycle.

9140390C—March 2004
DATA Problems
Westgard® Rule violation
Loss of precision Verify QC means and limits with assay
Loss of accuracy values.
Re-run questionable control level.
Perform a precision study and verify
calibration.
X-B data are out for MCH and/or MCHC
Dirty HGB Flow Cell Clean the HGB Flow Cell. (See
Maintenance.)
Amount or timing of lyse addition not Verify lyse reagent volume and
optimal replace if necessary. Check the Lyse
Inlet lines for crimps, cracks and
leaks. Prime the lyse reagent.
Rinse the Lyse Inlet Lines. (See
Procedures.)
X-B data are out for MCV
Dirty aperture Clean the Aperture Plate. (See Section 9:
Maintenance.)
Osmolarity change in diluent Replace Diluent lot.

9140390A—March 2003

Screen Messages
Alarm Message Condition; Fault LED is illuminated
Operator-correctable problems, such System is inoperable for specimen
as: processing (can print and set up
Waste full menus), but Operator must do tasks
required by the message, and then
Diluent empty
clear condition with softkey.
Lyse empty
Verify correct reagents are installed.
Detergent empty
Vacuum Accumulator wet
Clog message is displayed in place of Count Time
Debris, fibrin clots, or protein buildup Press [CLEAR ORIFICE] to
is restricting fluid flow through the backflush the aperture and reset the
aperture maximum count time. If situation
continues, perform the Auto-Clean
procedure. (See Section 9: Service
and Maintenance, Subsection:
Weekly Maintenance Procedures.)
Clean the Aperture Plates. (See
Maintenance.)
Perform the Supplemental Aperture
Cleaning. (See Section 9: Service and
Check the specimen for fibrin clots or
red blood cell agglutination.
Redraw and rerun the specimen as
required.

9140390A—March 2003
Screen Messages
Clog message is displayed in place of Count Time (continued)
Flow system blockage resulting from Verify correct reagents are installed.
pinched tubing or reagent particles Massage the tubing to remove any
may be in the Flow Panel. crimps, then reseat the tubing. (See
and Special Requirements,
Subsection: Inspecting the Flow
Panel.)
Check Diluent Syringe installation. If
the situation continues, perform the
maintenance procedures to prepare the
instrument for shipping. (See
Subsection: Preparing the
Instrument for Extended Periods of
Non-Use or Shipping.)
Detergent Empty message is displayed
Detergent container is empty Install a fresh container of detergent.
Press [CLEAR ALARM].
Run a Background Count.
Incorrect reagent was installed Install proper reagent.
Verify detergent tubing is correctly
installed.
Detergent is not being pulled into the Massage the tubing to remove any
flow system crimps, then reseat the tubing. (See
Subsection: Inspection and Tubing
Installation.)
Check for crimps in the detergent line
from inside the detergent container to
the Reagent Inlet Panel.
Verify that the reagent line is
completely immersed in the reagent.

9140390A—March 2003
Screen Messages
Diluent Empty message is displayed
Diluent container is empty Install a fresh container of diluent.
Run Background Count.
Check diluent tubing for correct
installation.
Run Background Count.
Diluent is not being pulled into flow Massage the tubing in the Normally
system Closed Valve to remove any crimps,
then reseat the tubing. (See Section 2:
Requirements, Subsection:
Inspection and Tubing Installation.)
Verify that the reagent line is
completely immersed in the diluent.
Check for crimps in the diluent line
from inside the diluent container to the
Reagent Inlet Panel.
Verify that the Diluent Syringe Knurl
Nut is tight.
Diluent Syringe is loose Verify Diluent Syringe is mounted
properly.
Fault Message Condition displayed in status box on screen; Fault LED is illuminated
Operator-correctable problems System is inoperable until Operator
takes steps to correct, and then clear
fault condition with softkey.

9140390A—March 2003
Screen Messages
Flow Err message is displayed in place of Count Time.
Air bubbles are trapped in the dilution Press [CLEAR ORIFICE] to
baths backflush the aperture and reset the
maximum count time.
Rerun the specimen. If the situation
occurs repeatedly, go to the
SPECIAL PROTOCOLS menu and
press [MORE], followed by [DRAIN
BATHS] to drain the liquid from each
transducer.
When the process is complete, press
[REFILL BATHS]. This process
removes any bubbles trapped inside
the transducers.
Clean the Aperture Plates. (See
Maintenance.)
Check the Diluent Syringe and the
tubing in the Diluent Normally Closed
Valve on the Flow Panel.
Normally Closed Valve tubing Remove the tubing in the Normally
pinched or not properly seated Closed Valves on the left side panel
and in the Diluent Normally Closed
Valve in the upper left corner of the
Flow Panel.
Massage the tubing to remove any
crimps.
Reseat the tubing in the valves. (See
Installation.)

9140390A—March 2003
Screen Messages
Flow Err or Clog message displayed in place of both Count Times (WBC/RBC)
Aperture plates installed in wrong Check aperture plate installation.
baths, and/or installed upside down Confirm that the aperture plate
marked “R/P” is installed in the von
Behrens RBC/PLT Transducer located
to the right of the probe. “WBC” is
installed in the von Behrens WBC
Transducer located to the left of the
probe.
Insufficient wetting of detergent Clear Orifice
reagent to form a good meniscus in Run three Background Counts
the metering tube Perform Auto Clean
Customer Service.
Insufficient liquid in the transducer. Open/Remove Front Covers (See
Air is drawn through the aperture. Section 2: Installation Procedures
Subsection: Opening/Removing
Front Covers, Version A or Opening
Front Covers, Version B) to gain
access to the Flow Panel.
Press the start switch. Observe the
action of the Diluent Syringe and the
fluid flow in and out of each
transducer.
If the syringe action is not complete,
clean the Diluent Syringe. (See
Maintenance-Cleaning/Replacing
the Diluent Syringe.)
Using a wire puller, exercise solenoids
4–4 (WBC transducer fill) and 2–4
(RBC transducer fill).
Customer Service.

9140390C—March 2004
Screen Messages
Flow Err or Clog message displayed in place of both Count Times (WBC/RBC) (continued)
Flow system leak Check the system for leaks or cracks.
Damaged aperture Check the aperture plates under a
microscope using a low-power
objective lens with external light
source. If damage is observed, replace
the aperture plate. (See Section 9:
Maintenance.)
Normally Closed Valve tubing Remove the tubing from the Normally
pinched or not seated properly Closed Valves on the left side panel
and Front Panel.
crimps.
Reseat the tubing. (See Section 2:
Requirements, Subsection:
Inspection and Tubing Installation.)

9140390A—March 2003
Screen Messages
Lyse Empty message is displayed
Lyse container is empty Install a fresh container of lyse.
Verify lyse tubing is mounted
properly.
No liquid was detected by the internal Confirm that the end of the lyse tubing
Lyse Sensor is immersed in reagent. When the
container is empty, replace it with a
fresh container of lyse.
Check the entire Lyse Inlet Tubing for
crimps.
Run a Background Count.
Lyse syringe not moving properly Verify Lyse Syringe is mounted
properly.
Clean Lyse Syringe. (See Section 9:
Maintenance.)
Lyse not being pulled into the flow Remove the tubing from the Lyse
system. Normally Closed Valve.
crimps, then reseat the tubing (See
Installation.)
Lyse Inlet Tubing is clogged Rinse the Lyse Inlet Lines. (See
Procedures.)

9140390A—March 2003
Screen Messages
Not Ready: See Diagnostics message is displayed
Instrument hardware malfunction In the MAIN MENU screen press
detected during routine operation or [DIAGNOSTICS], then [HELP/
initialization ERROR]. A message pertaining to
the computer-detected malfunction is
displayed with the required operation
action.
Customer Service.
Pressure Limit Time-out
Pressure Pump Failure Call Abbott Diagnostics Customer
Service.
Pressure Line tubing leak Call Abbott Diagnostics Customer
Service.
Unit is not being Operated within one Call Abbott Diagnostics Customer
of the Specified AC Input Voltage Service.
Ranges (See Section 2: Installation
Requirements)
Results highlighted on screen
Results are outside Operator-entered Confirm background data.
limits Re-run specimen.
Review stained smear to confirm, if
possible.
Check parameter limits screen. (See
Section 5: Operating Instructions,
Subsection: Program Operation.)
Status Condition message appears in message field; Fault LED is not illuminated
Operator-correctable problems, such System is operable, but Operator must
as: do tasks required by the message, and
Printer offline then clear the condition with softkey.
Out of paper
Drive not ready

9140390C—March 2004
Screen Messages
Vacuum Limit Time-out
Vacuum Pump Failure Call Abbott Diagnostics Customer
Service.
Vacuum Line tubing leak Call Abbott Diagnostics Customer
Service.
Unit is not being Operated within Call Abbott Diagnostics Customer
one of the Specified AC Input Service.
Voltage Ranges (See Section 2:
Installation Procedures and
Special Requirements)
Waste Full message is displayed
Liquid level in the waste container Remove the Waste Stopper Assembly
has tripped the sensors and empty the container.
Make sure the liquid is wiped from
inside the top of the cap, and the top of
the bottle to ensure seal.
Verify waste container is stored below
the instrument.
Waste Sensor Plug is not inserted Reinsert the plug into the receptacle.
completely in the lower Left Side Press [CLEAR ALARM].
Panel receptacle. An audible tone
sounds to alert the Operator.
Defective component Turn instrument power OFF.
Wait 30 seconds.
Customer Service.

9140390C—March 2004
NOTES

9140390A—March 2003
Section 10 Calibration Troubleshooting
Calibration Troubleshooting
Results from a Calibration Run can be rejected due to a system fault or because the
results were outside a predetermined range.
Alarm Indicators
If the CLEAR ALARM message appears on the display screen, an alarm condition
is present. Action must be taken to clear the alarm before proceeding.
Clearing Alarms
If an alarm condition is present, it may be necessary to repeat the Calibration Run.
See the Index of Error Messages and Conditions earlier in this section for
information on specific alarm conditions.
Fault Indicators
If a fault occurs, one of the following Fault Indicators will appear in the Run
column for that specimen:
“K” indicates a Clog
“FE” indicates a Flow Error
If one of these Fault Indicators appears, the results for that specimen will be
excluded from the Factor and Mean Factor calculations. It may be necessary to
repeat this run.
Flags (For PLT Only)

An interference may cause one of the following flags to appear in the Run column
for that specimen.
URI
LRI
LRI URI Multiple Region Interference: appears only if the specimen
generates both a URI and LRI)
For an explanation of the URI and LRI flags, refer to Section 3: Principles of
Operation, Subsection: System-Initiated Messages and Data Flags. If a flag
appears, the results will be excluded from the Factor and Mean Factor calculations.
It may be necessary to obtain a replacement specimen.


9140390E—June 2008
Calibration Troubleshooting Section 10

and Controls:
Allowable Values Exceeded

• Auto-Cal >>> or <<<—If the resultant Auto-Cal factors exceed allowable
values, then >>> (over range) or <<< (under range) is displayed. Verify the
results and, if the problem persists, contact the Abbott Diagnostics Customer
Service.
• Enter Factor—If a calibration factor entry is attempted exceeding the
allowable range, the instrument will not accept the entry.
• Printed Report Range—If the result for a specific parameter exceeds the
upper limit of this range, “greater than” symbols (>>>>) will be displayed
instead of a value, and the result will be excluded from the Factor and Mean
Factor calculation. It may be necessary to obtain a replacement specimen.
Reference Check Failures

For each parameter being calibrated, the instrument performs a Reference Check
on the result from each run. If a result fails the Reference Check, that result is
highlighted on the screen, indicating it will be excluded from the Factor and Mean
Factor calculation. It may be necessary to obtain a replacement specimen. If a
parameter result is highlighted, follow the procedure for Correcting Mean and
Factor Failures within this section.
Precision Check Failures

After three “good” runs, the instrument will perform a Precision Check for each
parameter being calibrated before determining the Factor and Mean Factor for that
parameter. If a parameter fails the Precision Check, the highlighted indicator > <
will be displayed in the Factor column instead of a value, and no Factor or Mean
Factor will be calculated for that parameter. (The Precision Check ensures that the
difference between the maximum value and the minimum value does not exceed
acceptable limits.)
If a Precision Check indicator is received, re-input the three-digit target calibration
value (derived from the calibrator assay sheet or from a reference instrument) for
that parameter and run the specimen again.

9140390E—June 2008
Section 10 Calibration Troubleshooting
Correcting Mean and Factor Failures

After three runs, if a Factor and Mean Factor have not been calculated for each
parameter to be calibrated, the Operator has the following choice:
1. Continue running specimens. The program allows the Operator to run a
maximum of five specimens to determine Factor and Mean Factor.
2. Press [ABANDON] to stop the calibration process for this specimen without
deleting the Factor and Mean Factor for specimens already run. Depending
on the calibration method being used, the CALIBRATOR CALIBRATION
menu, the WHOLE BLOOD CALIBRATION menu, or the MPV LATEX
CALIBRATION menu will be displayed.
CAUTION: Do not press [RESET FACTORS] between specimen runs.
This key is used to delete the Mean Factor for all specimens run prior to
pressing the key.
3. If after five runs the program has not calculated a Factor and Mean Factor,
the Operator should do the following:
• Press [RETURN] to return to the main CALIBRATION menu. Parameters
which have not been calibrated will have the previous calibration method in
the Method column and the previous calibration setting in the Factor column.
Press the appropriate soft key to return to the CALIBRATOR
CALIBRATION menu, or the WHOLE BLOOD CALIBRATION menu.
Use the arrow keys to place the cursor on the parameter(s) to be calibrated
and press [←] (Enter) to select the parameter. Enter a value for that parameter
and rerun the specimens.
• If after five runs the parameter(s) has not been calibrated, obtain technical
assistance by contacting Abbott Diagnostics Customer Service.

9140390C—March 2004
Calibration Troubleshooting Section 10
NOTES

9140390A—March 2003
Section 10 Printer Troubleshooting
Printer Troubleshooting
The CELL-DYN 1800 software automatically controls and adjusts most print
conditions. Occasionally, a few settings may need to be changed in the printer
software for correct operation. If print quality is not acceptable, or to solve other
printer problems, refer to the printer manual. If the problem is not resolved, call
Abbott Diagnostics Customer Service.
Printer Not Ready Message

If, during routine system operation, the Printer Not Ready message appears
on the CELL-DYN 1800 display screen, proceed as follows:
1. Ensure that the printer power switch is turned ON.
2. Check the paper supply.
3. When the SEL indicator is illuminated, indicating that the printer is operable,
press [PRINT REPORT] (or [PRINT] in the QC menu).
If the message is still displayed:
1. Check the printer cable to make certain it is securely connected to the parallel
port connector. See Section 1, Right Side Panel.
2. Turn the printer power OFF, wait about five seconds, and turn the power ON
again.
3. Press [PRINT REPORT] (or [PRINT] in the QC menu).
If the Printer Not Ready message is still displayed, there may be an
internal printer error. Contact Abbott Diagnostics Customer Service for
assistance.
Paper Feed Failure

If paper fails to feed properly, refer to the printer manual.
Incomplete Printout
Reprint current run data from the DATA LOG menu.
Print Quality
Change the print cartridge if the print quality is light.

9140390C—March 2004
Printer Troubleshooting Section 10
NOTES

9140390A—March 2003
Section 10 Bar Code Scanner Troubleshooting
Bar Code Scanner Troubleshooting
Successful transmission of a specimen ID from bar code label requires proper

installation and configuration of the bar code scanner. For discussion of bar code
scanner installation refer to Section 2: Installation Procedures and Special
Requirements, Subsection: Bar Code Scanner Installation or the
CELL-DYN 1800 Intermec ScanPlus 1800 Trigger-Activated Hand-Held Bar
Code Scanner User’s Guide. If the problem is not resolved, contact Abbott
Diagnostics Customer Service.
Scanner Not Responding

See Error Messages and Conditions table earlier in this section for corrective
action. If the problem is not resolved, call Abbott Diagnostics Customer Service.
Bar Code Label Quality

The quality and clarity of the printing of the bar code label is critical to a successful
bar code transmission. For specifications on bar code labels refer to Section 4:
Performance Characteristics and Specifications, Subsection: Bar Code
Specifications.

9140390C—March 2004
Bar Code Scanner Troubleshooting Section 10
NOTES

9140390A—March 2003
References
1. Occupational Safety and Health Administration, Department. Labor. 29 CFR

Part 1910, 1030. Occupational Exposure to Bloodborne Pathogens.
2. Gagne C, Auger PL, Moorjani S, Brun D, and Lupien PJ. Effect of
Hyperchylomicronemia in the Measurement of Hemoglobin. American
Journal of Clinical Pathology 1977;68:584-6.
3. Jerome SN, Roark MF, and Wanser C. Anemia Masked by Triglyceridemia.
Denver: Department of Pathology, General Rose Memorial Hospital and
University of Colorado Medical Center, 1974.

9140390A—March 2003
NOTES

9140390A—March 2003
Section 11 Quality Control
Overview
Quality Control (QC) procedures are used to determine the accuracy and precision
of the CELL-DYN 1800. These procedures, carried out using commercial controls,
allow the user to consistently and accurately evaluate instrument performance,
interpret laboratory data, and ascertain acceptability of analysis results.
The information presented in this section conforms to Abbott’s recommended QC
procedures for Abbott hematology instruments. We suggest that this information be
incorporated into your laboratory’s protocol or procedures manual. Refer to your
laboratory’s standard operating procedures and/or a quality assurance plan to check
for and ensure proper instrument performance and analysis accuracy.
Abbott suggests using a logbook for documenting QC tasks and results and that
you regularly create a backup disk of all QC log files. Refer to Section 9:
Service and Maintenance, Subsection: Maintenance Log.
When to Run QC
QC testing must be conducted according to established regulations and procedures
in your particular state or country. At a minimum, however, it is suggested that QC
testing be conducted as follows:
• After Daily Startup procedures are completed
• To confirm calibration
• When a reagent lot number has been changed
• After maintenance or component replacement
• When a new software version has been installed
• When there is an unusual shift or trend in sample results
• When there is a reason to suspect data or results
QC Methods
The CELL-DYN 1800 offers the following Quality Control (QC) options for
monitoring and validating instrument performance.
Commercial Controls—Numeric data obtained for each parameter is
automatically transmitted to a designated file (Low Control, Normal Control, or
High Control) when that control file is selected.
Replicate Specimen—This option works the same as the Commercial Controls
program. The Replicate Specimen QC option is nonspecific for specimen type, so
that data can be gathered from previously run specimens, additional commercial
control material, precision specimens, and calibration verification data.
X-B Analysis—This QC option is useful for troubleshooting and confirming the
calibration of the red blood cell parameters.

9140390D—January 2006
Quality Control
Overview Section 11
Control Material
Controls usually consist of fixed blood cells with assayed ranges for each measured
parameter. CELL-DYN 16 and CELL-DYN 22 controls provide three levels—
Low, Normal, and High—for each measured parameter.
Abbott recommends using CELL-DYN 16 Tri-Level and CELL-DYN 22
Tri-Level control materials for performing Quality Control procedures on the
CELL-DYN 1800.

Quality Control
Section 11 Quality Control Procedures
Quality Control Procedures
Guidelines for Running Controls

Quality Control (QC) procedures must be carried out in accordance with your
laboratory’s QC protocol and according to regulatory requirements, using the
following general guidelines:
• Ensure that the ambient laboratory temperature is within ± 4°C (± 7°F) from
the temperature at which the instrument was calibrated. Refer to Section 6:
Calibration Procedures, Subsection: Calibration Temperature
Specification, for detailed information.
• Prior to running patient specimens, run a minimum of two levels of control
on each day a test is run.
• If the instrument has been idle for fifteen minutes or more, a Normal
Background should be run immediately prior to running any control
specimens.
• Run controls for each measured parameter in the same manner as patient
specimens.
• Verify that control results are within the laboratory’s acceptable limits and
review the data for shifts or trends.
• If the control results fall within acceptable limits, record the results and begin
to process patient specimens.
• If QC results fall outside the laboratory’s acceptable limits, see Section 10:
Troubleshooting and Diagnostics or try another tube from the same lot of
control material. If the problem persists, contact Abbott Diagnostics
Customer Service.
• Do not report patient results if QC results fall outside the laboratory’s
acceptable limits.
• Verify the control file being used is the correct file in which means and limits
are updated.

9140390E—June 2008
Quality Control
Quality Control Procedures Section 11
Control Material Guidelines

Use the following guidelines for proper handling of control material:
• Check the condition of incoming control material. Be sure the tubes are at the
proper temperature and are not leaking. Check for gross hemolysis.
• Check the shelf life and open-tube stability dating. Do not use products
longer than recommended by the manufacturer, or the results may be
compromised.
• Always mix and handle commercial control materials according to the
directions given on the package insert. Proper mixing is essential for accurate
results.
• Carefully prepare the control product according to the directions on the
package insert.
• Never subject controls to excessive cold, heat, or agitation. Store controls at
recommended temperatures; if storing controls inside a refrigerator, place in
a central location. Do not store control or calibrator material in the refigerator
door.
Always run quality control according to the principles of good laboratory practice,
laboratory director’s requirements, and any regulatory or accreditation
requirements.

9140390E—June 2008
Quality Control
Quality Control
QC Setup
This subsection discusses the options available when [QC SETUP] is pressed in
the SETUP menu.
The options used to set up the QC files are available by pressing [SETUP] in the
MAIN MENU screen. The QC SETUP menu allows access to submenus where
the Operator can edit the lot number and expiration date for the selected control
files, and enter means and range values for each parameter specified on screen and
select which Westgard® Rules will be applied to Quality Control results. Parameter
results for any control run that fall outside of these entered limits are displayed in
reverse video and underlined on the printout to alert the Operator.
For details regarding setting up X-B files, Control files, and Replicate Files, see
Section 5: Operating Instructions, Subsection: Quality Control Setup.
Program Operation
CELL-DYN 1800 operations are menu-driven and activated by a membrane
keypad on the front panel of the instrument.
The QUALITY CONTROL menu allows the user to select one of the following 21
files, each one capable of holding data for up to 120 sample runs:
Four Low control files–Numbers 1, 2, 3, and 4
Four Normal control files–Numbers 1, 2, 3, and 4
Four High control files–Numbers 1, 2, 3, and 4
Nine Replicate files
All files, collectively known as the QC Log (QC LOG), are stored on the hard
drive.
QC file data can be downloaded to a floppy disk for submission to external QC
monitoring programs that compare instrument performance between different labs,
allowing you to determine the reliability of your laboratory testing. Refer to Write
QC to Disk later in this section.
QC file summary data currently stored in each file can be displayed and printed.
Each time a QC specimen is run, the number of specimens, mean, standard
deviation, and coefficient of variation for each parameter are calculated and
updated automatically in each file. The standard deviation does not show on the
screen, but does appear on printed reports. The Operator can, at any time, reject any
run with flagged (outside entered limits) data from this calculation. The Operator
can also delete any run from a QC file, or purge the entire QC file. Refer to
Rejecting/Accepting Specimens later in this section.

9140390E—June 2008
Quality Control
Quality Control Section 11
Westgard® Rules can be applied to the analysis of QC results, with Westgard® Rule
warnings viewable on screen and printed on reports. Levey-Jennings® graphs of
QC results can be printed. Refer to Analyzing Control Results later in this section.
This section provides information about menus and key functions as they relate to
QC procedures. For additional information about keys and their functions, refer to
Section 1: Use or Function, Subsection: System Components.
Overview
The QUALITY CONTROL (QC) menu is accessed from the MAIN MENU
screen. The QUALITY CONTROL screen displays the following (sofkeys) that
take the user to related submenus for performing specialized tasks:
[X-B FILE]
[LOW CONTROL]
[NORMAL CONTROL]
[HIGH CONTROL]
[REPLICATES]
[HELP/ERROR]
[MAIN]
Figure 11.1 QUALITY CONTROL Menu

9140390E—June 2008
Quality Control
QUALITY CONTROL MENU

QUALITY
CONTROL
X-B LOW NORMAL HIGH REPLI- MORE HELP/ MAIN

FILE CONTROL CONTROL CONTROL CATES ERROR*
VIEW START HELP/ RETURN

QC LOG CLEAN ERROR*
LEVEY- REJECT PURGE WRITE QC DELETE PRINT HELP/ RETURN

JENNINGS SPECIMEN QC LOG TO DISK SPECIMEN QC LOG ERROR*
ACCEPT
SPECIMEN
CONFIRM REJECT PURGE WRITE QC DELETE PRINT HELP/ CANCEL

DELETE SPECIMEN QC LOG TO DISK SPECIMEN ERROR* DELETE
RBC REJECT PURGE WRITE QC DELETE PRINT HELP/ RETURN

PAGE SPECIMEN QC LOG TO DISK SPECIMEN ERROR*
WBC/PLT
PAGE

PURGE SPECIMEN QC LOG TO DISK SPECIMEN ERROR* PURGE

WRITE SPECIMEN QC LOG TO DISK SPECIMEN ERROR* WRITE
SHOW REJECT PURGE WRITE QC DELETE PRINT HELP/ MAIN

GRAPHS SPECIMEN QC LOG TO DISK SPECIMEN ERROR*
SHOW
DATA
FAULT HELP RETURN

LOG
LEAVE
HELP
PRINT HELP RETURN
Figure 11.2 QUALITY CONTROL Menu Hierarchy


9140390E—June 2008
Quality Control
Quality Control Section 11
NOTES

9140390E—June 2008
Quality Control
Section 11 Quality Control Menu
Quality Control Menu
The Quality Control files contain specific specimen records that were selected for
inclusion in a particular control or replicate file prior to running those specimens.
The Operator can establish 21 QC files with each file storing a maximum of 120
runs. The QUALITY CONTROL menu allows the Operator to perform the
following functions:
• View the contents of a selected file currently stored in the QC log
• Select a QC file and view a selected sample
• View QC means and limits
• Purge QC files
• Accept and reject specimens from QC files
• Delete specimens from QC files
• Display and print Levey-Jennings graphs
• Write QC files to floppy disks
At the MAIN MENU screen, press [QUALITY CONTROL] to display the
QUALITY CONTROL menu. A brief description of each key, displayed at the
bottom of the QUALITY CONTROL menu, and its function follows.

9140390E—June 2008
Quality Control
Quality Control Menu Section 11
Using Quality Control

In the QUALITY CONTROL menu, press [LOW CONTROL], [NORMAL
CONTROL], [HIGH CONTROL], or [REPLICATES] to access the appropriate
screen. Use the arrow keys to select one of the four control files or one of the nine
replicate files.
Each screen display (page) may contain up to 10 specimens. To view the previous
page, use the Page Up key. To view the next page, use the Page Down key. Use the
[←] or [→] arrow keys to scroll through the complete list of parameters for all
specimens displayed on a page.
X-B File
The [X-B FILE] key is used to display and print data and graphs for the MCV,
MCH, and MCHC parameters, including date and time for each batch. The
following functions are available when [X-B FILE] is selected. Refer to X-B
Analysis Program later in this section.
Show Graphs/Show Data

The X-B RBC data can be reviewed as graphs by pressing the [SHOW GRAPHS]
key. [SHOW GRAPHS] is used to display the X-B graphs for RBC indices on the
X-B Data display screen. The graph displays the results for X-B batches 1–20, and
the lower and upper limits.
Figure 11.3 X-B FILE (Show Graphs) Screen

9140390E—June 2008
Quality Control
[SHOW DATA] is used to display the X-B data for RBC indices on the X-B Data
display screen. The screen displays the results for X-B batches 1–20, and the lower
and upper limits. The date and time that each batch was completed is also
displayed.
Figure 11.4 X-B FILE (Show Data) Screen

9140390E—June 2008
Quality Control
Low Control
[LOW CONTROL] is used to display the Low Control file names and the number
of specimens in each file. It also displays detailed QC information, such as limits,
standard deviation, and coefficient of variation for each parameter for each lot
number when the [VIEW QC LOG] key is pressed.
Figure 11.5 VIEW QC LOG (Low Control) Screen

9140390E—June 2008
Quality Control
Normal Control
[NORMAL CONTROL] is used to display the Normal Control file names and the
number of specimens in each file. It also displays detailed QC information, such as
limits, standard deviation, and coefficient of variation for each parameter for each
lot number when the [VIEW QC LOG] key is pressed.
Figure 11.6 VIEW QC LOG (Normal Control) Screen

9140390E—June 2008
Quality Control
High Control
[HIGH CONTROL] is used to display the High Control file names and the number
of specimens in each file. It also displays detailed QC information, such as limits,
standard deviation, and coefficient of variation for each parameter for each lot
number when the [VIEW QC LOG] key is pressed.
Figure 11.7 VIEW QC LOG (High Control) Screen

9140390E—June 2008
Quality Control
Replicates
[REPLICATES] is used to display the replicated file names and the number of
specimens in each file. It also displays detailed QC information, such as limits,
standard deviation, and coefficient of variation (CV%) for each parameter for each
replicate ID/lot number when the [VIEW QC LOG] key is pressed.
Figure 11.8 VIEW QC LOG (Replicates) Screen
View QC Log
The [VIEW QC LOG] is used to display detailed QC information in the selected
control file. When one of the four selected QC files is highlighted, the Operator
may view up to 10 of the specimens in that file by sequence number. The Operator
has the following options:
• Purge the QC log
• Display and print Levey-Jennings graphs for the QC file
• Accept, reject, or delete the specimen indicated by the flashing cursor
• Print the QC log
• Write QC files to a floppy disk

9140390E—June 2008
Quality Control
The following functions are available when a control file or replicate file is
selected.
Levey-Jennings
[LEVEY-JENNINGS] is used to display the LEVEY-JENNINGS menu for the
selected specimen.
Figure 11.9 LEVEY-JENNINGS Screen – WBC/PLT Parameters
[RBC PAGE]/[WBC/PLT PAGE] (toggle keys) is used to display Westgard®

Rule warnings for the selected QC file’s RBC parameter set which includes RBC,
MCV, HGB, HCT, RDW, MCH, and MCHC; and WBC/PLT parameter set which
includes WBC, LYM, MID, GRAN, PLT, and MPV. (The display screen defaults
to the WBC/PLT parameters.)

9140390E—June 2008
Quality Control
Figure 11.10 LEVEY-JENNINGS Screen – RBC Parameters
[PRINT] is used to print Levey Jennings graphs and Westgard® Rule warnings
WBC/PLT, and RBC parameters.
[HELP/ERROR] is used to access the HELP screen. If a Fault exists, the Fault
Log will appear giving the Operator the option to print the Fault Log. If there are
no faults, the HELP screen will appear.
When [RETURN] is pressed, the Operator is returned to the VIEW QC LOG
menu for the selected control file.

9140390E—June 2008
Quality Control
Reject/Accept Specimen
[REJECT SPECIMEN] is used to reject the specimen indicated by the flashing
cursor and places an “R” next to the <Sequence #> field. Specimen results are not
included in the calculation of the mean, standard deviation, or coefficient of
variation. Rejected specimens are also not used in determining Westgard® Rule
warnings or plotted on Levey-Jennings graphs.
When pressed, [REJECT SPECIMEN] changes to [ACCEPT SPECIMEN].
Press [ACCEPT SPECIMEN] to include the specimen in the statistical
calculation and to remove the “R” next to the <Sequence #> field.
Figure 11.11 VIEW QC LOG (Accept Specimen) Screen

9140390E—June 2008
Quality Control
Purge QC Log
[PURGE QC LOG] is used to permanently erase data from the control file. After
[PURGE QC LOG] is pressed, the screen label changes to [CONFIRM
PURGE]. Press [CONFIRM PURGE] to complete the purge. Press [CANCEL
PURGE] to cancel the purge, and return to the VIEW QC LOG menu.
NOTE: Once [CONFIRM PURGE] is pressed, data in the file is permanently
erased.
Figure 11.12 PURGE QC LOG Screen

9140390E—June 2008
Quality Control
Write QC to Disk
[WRITE QC TO DISK] is used to transfer QC data from a QC file onto a floppy
disk.
From the MAIN MENU screen, press [QUALITY CONTROL]. Insert a blank,
formatted disk in the floppy drive. Select the desired level of control (e.g., [LOW
CONTROL]), and use the [↑] or [↓] arrow keys to select the desired control file.
Press [VIEW QC LOG], followed by [WRITE QC TO DISK].
Figure 11.13 WRITE QC TO DISK Screen
Pressing [CONFIRM WRITE] transfers the selected control file’s data onto a disk
in the floppy disk drive. [CANCEL WRITE] cancels the data transfer process and
returns the Operator to the VIEW QC LOG menu for the selected control file.
NOTE: The data file will be saved in ASCII format. The ID file will consist of all
five customer-defined header lines, regardless of the number of header
lines selected. Header lines which contain information that should go in
the ID file but should not be printed on the reports should be turned OFF.

9140390E—June 2008
Quality Control
Delete Specimen
[DELETE SPECIMEN] is used to delete a specimen indicated by the flashing
cursor from the control file. When [DELETE SPECIMEN] is pressed, the
specimen on screen highlighted by the cursor is deleted from the QC file, and the
softkeys change to [CONFIRM DELETE] and [CANCEL DELETE].
[CONFIRM DELETE] allows the Operator to confirm the Delete Specimen
action. [CANCEL DELETE] cancels the Delete Specimen process and returns the
Operator to the VIEW QC LOG menu for the selected control file.
NOTE: Deleted specimens are not included in statistical calculations. Once
[CONFIRM DELETE] is pressed, selected specimen data is permanently
erased.
Figure 11.14 VIEW QC LOG (Delete Specimen) Screen
Print QC Log
[PRINT QC LOG] is used to print the displayed QC file.
Help/Error
If a fault is pending, when [HELP/ERROR] is pressed a list of up to sixteen
operator to view the errors.

9140390E—June 2008
Quality Control
Return
When [RETURN] is pressed, the Operator is returned to VIEW QC LOG menu
for the selected control file.

9140390E—June 2008
Quality Control
Performing a QC Run
If the system has been idle for fifteen minutes or more, run a background prior to
running any control specimens. Be sure to prepare the control product according to
directions on the package insert.
To perform a QC run, proceed as follows:
1. From the MAIN MENU screen, press [RUN].
2. From the RUN menu, press [SPECIMEN TYPE] followed by [QC TYPE].
Figure 11.15 QC TYPE Screen
3. Select the desired level of control (Low, Normal, High or Replicates).

NOTE: Prepare a permanent record (printed copy) of any files to be deleted
or purged, as required, according to your laboratory’s protocol. You
can also copy the QC Log before you purge it.
4. Using the [↑] and [↓] arrow keys, select the desired control file.
5. Press [RETURN].
6. Remove the cap from a well-mixed control specimen tube and place the open
tube under the Sample Aspiration Probe. Raise the tube so that the end of the
probe is deeply immersed in the specimen.
7. Press the Touch Plate to activate the run.
8. When the well-mixed control has been aspirated from the tube, and the probe
moves up through the Wash Block, remove the specimen tube and replace the
cap.

9140390E—June 2008
Quality Control
NOTE: If a flow error, clog, or other fault message appears on the display
screen during RUN cycle, press [CLEAR ORIFICE] or refer to
Section 10: Troubleshooting and Diagnostics and repeat the run.
9. Verify that control results are within your laboratory’s acceptable limits.
10. If the control results fall within acceptable limits, review the data for shifts or
trends, record the results, and begin to process patient specimens.
NOTE: If one or more result falls outside the laboratory’s acceptable limits,
review Section 10: Troubleshooting and Diagnostics. If the
problem persists, contact Abbott Diagnostics Customer Service.
Do not process patient specimens.
11. Press [PRINT REPORT] if a report of printed results is desired.

9140390E—June 2008
Quality Control
Rejecting/Accepting Specimens
Specimens can be rejected or accepted as needed. For example, one or more runs
can contain data that you do not wish to use in determining the mean, but do not
want to delete. To reject a specimen, proceed as follows:
1. From the MAIN MENU screen, press [QUALITY CONTROL].
2. From the QUALITY CONTROL menu, select the desired level of control
(e.g., [NORMAL CONTROL]. Use the [↑] and [↓] keys to select a specimen
you want to reject.
3. From the selected control file screen, press [VIEW QC LOG].
4. Press [REJECT SPECIMEN].
Figure 11.16 VIEW QC LOG (Reject Specimen) Screen
The letter “R” appears next to a rejected specimen and the key toggles to
[ACCEPT SPECIMEN]. The specimen data remains in the QC Log, but is
not used in QC statistical calculations.
5. Press [ACCEPT SPECIMEN] to include the data.
The “R” disappears, the key toggles to [REJECT SPECIMEN], and the data
is included in the statistical calculations.

9140390E—June 2008
Quality Control
Deleting Specimens
To delete unwanted run data for individual samples, such as that from a run
performed with an incorrect control material, or if a control was run in the wrong
file (e.g., Low Control run in a Normal or High Control file), proceed as follows:
(e.g., [NORMAL CONTROL]).
3. From the selected control file screen, press [VIEW QC LOG].
CAUTION: Because deleted data cannot be retrieved, make certain you
are deleting the correct specimen. You may also wish to print the file prior
to deleting the sample.
4. Press [DELETE SPEC].
Figure 11.17 VIEW QC LOG (Delete Specimen) Screen
5. Press either [CONFIRM DELETE] or [CANCEL DELETE], as

appropriate.
All data for the selected specimen is permanently deleted from the display
and, eventually, from the QC Log, and is not used for QC calculations.

9140390E—June 2008
Quality Control
Purging Control Files

To discard all data from a specific control file or to accommodate new data when
a control file is full, proceed as follows:
(e.g., [NORMAL CONTROL]).
3. From the selected control file, press [VIEW QC LOG].
CAUTION: Make certain that you really want to purge all samples. Data
cannot be retrieved once it has been purged. You may wish to print the file
prior to deleting the samples.
4. Press [PURGE QC LOG].
Figure 11.18 PURGE QC LOG (Purge Specimen) Screen
5. Press either [CONFIRM PURGE] or [CANCEL PURGE], as appropriate.

All current data for the selected control file is deleted. The assay means and
limits, however, are saved.

9140390E—June 2008
Quality Control
NOTES

9140390E—June 2008
Quality Control
Section 11 X-B Analysis Program
X-B Analysis Program
Overview
X-B Analysis is an automated means of monitoring instrument performance by
using the known stability of the red blood cell indices.
X-B represents the moving average of hematology values calculated using an
algorithm developed by Dr. Brian Bull. The X-B Analysis uses the Bull Algorithm
to monitor instrument performance by tracking the average red blood cell indices
in the patient population analyzed on the instrument.
The red blood cell indices, MCV, MCH, and MCHC, are known to be stable
because the red blood cell apparently functions best in a very narrow range of size
and hemoglobin content. Therefore, the body exerts tight physiologic control and
varies the number of red blood cells before altering the average volume or
hemoglobin concentration of those red blood cells. Consequently, the average red
blood cell indices of a given patient population will vary no more than 0.5% from
day to day and even year to year, providing the population does not change. The
X-B algorithm provides a means of utilizing this information for quality control on
the CELL-DYN 1800. It has been successfully used to monitor RBC indices by
Laboratories running more than 100 patient specimens per day.
The X-B algorithm analyzes the indices for MCV, MCH, and MCHC on the patient
samples run through the instrument in batches of 20. Current batch data are then
“smoothed” by using the mean from the previous batch in the calculation. As a
result, each newly calculated batch mean includes data from previous batches.
When the X-B Program is ON and Patient is the specimen type selected, the current
status of the X-B Program is displayed on the third line in the upper right corner of
the RUN screen (for example, X-B: N/IN, where N is the number of runs in the
current batch and IN indicates the last batch was within the target and limits for all
three parameters). In the DATA LOG menu, a “B” in front of a sequence number
indicates that the patient specimen is included in the current X-B batch.

9140390E—June 2008
Quality Control
X-B Analysis Program Section 11
Lower/Upper Acceptance Limits

The Lower and Upper Limits determine which patient results will be used in the
X-B moving average calculation. They should be set wide to exclude grossly
abnormal samples or Background Counts but should include at least 95% of the
patient results. That way only results that fall within the set limits will be used in
the calculation.
Target Value
The Target Value for X-B is similar to the assay value for a commercial control. It
is derived from the patient population analyzed on the instrument.
Action Limit
The Action Limit is the acceptable limit of variation around the Target Value.
Establishing the Target Value

A 1992 study2 by Dr. Bull collected data from 1,767 hospitals and yielded the
following mean values:
• MCV 90.0 fL
• MCH 30.5 pg
• MCHC 33.9 g/dL
These values confirmed values that Bull published in an earlier study.3
Consequently, the values shown above can be used as the Target Values to initiate
the X-B Program.
To establish X-B Target Values in the SETUP menu for MCV, MCH, and MCHC:
1. In the SETUP menu, use the [ ] (Enter) key to turn the X-B Moving
Average Program ON.
2. Press [QC SETUP] followed by [X-B SETUP]. Use the [←] and [→] arrow
keys to move the cursor to the Target Value column and enter the following:
• “90.” for MCV
• “30.5” for MCH
• “33.9” for MCHC

9140390E—June 2008
Quality Control
Section 11 X-B Analysis Program
Figure 11.19 X-B SETUP (Target Value) Screen
Laboratories such as pediatric hospitals and tumor centers with specialized patient
populations may need to verify these Target Values due to “abnormal” patient
populations. Target values may be verified by evaluating approximately 500
samples and comparing the X-B means for those samples to the entered Target
Values. This can be done as follows:
1. Collect data from at least 500 patients. Manually calculate the mean, SD, and
CV% for each index (MCV, MCH, and MCHC). The CV% on 500 samples
for each index should be less than 1.5%. (The 1.5% is one-half the allowable
± 3% action limit.) If the CV% is greater than 1.5%, an additional 500
samples should be evaluated.
2. If the CV% calculated in step 1 is less than 1.5%, enter the mean as the
Confirmed Target Value.
Interpreting X-B Results

A suggested protocol and guidelines for interpreting X-B data can be found in
Section 1 of Laboratory Hematology, An Account of Laboratory Techniques,
edited by I. Chanarin.4

9140390E—June 2008
Quality Control
X-B Analysis Program Section 11
NOTES

9140390E—June 2008
Quality Control
Section 11 Analyzing Control Results
Analyzing Control Results
Features exist on the CELL-DYN 1800 that provide information about control
results. If a problem is suspected, the Operator can do the following:
• Observe results for individual control specimens as they are analyzed, select
the desired QC file using the [↑] or [↓] arrow keys, then press [VIEW QC
LOG] in the QUALITY CONTROL menu.
• View modified Westgard® Rule warnings for selected parameters.
• View Levey-Jennings graphs to see if violations of modified Westgard®
Rules have occurred.
Levey-Jennings Graphs
Levey-Jennings graphs are a visual method of viewing quality control result data
for all parameters over time. These graphs allow the Operator to examine the
relationship of control result values to the established means and acceptable limits,
and to look for shifts and trends in results.
All 120 specimens in the QC file will be graphed. Up to 13 parameters can be
displayed on the Levey-Jennings QC report. The parameters include WBC, LYM,
MID, GRAN, PLT, MPV, RBC, MCV, HGB, HCT, RDW, MCH, and MCHC. If the
parameter range for a selected parameter is set to zero resulting in upper and lower
limits that are equal, a graph of that parameter will not appear on the report.
The graph label will include the parameter being graphed and Westgard® Rule
warnings for that parameter. Scale values on the left side of the graph indicate the
mean and upper and lower limits for that parameter stored in the QC file.
CAUTION: QC limits are assumed to be at ±2SD for Westgard® Rule
analysis and for Levey-Jennings graphs. It is crucial to ascertain that the QC
file range entered in the QC RANGE menu represents ±2SD for the
laboratory for each parameter before interpreting Levey-Jennings graphs
and Westgard® Rules.
Values in the QC file which are outside of the graph range will appear as a “+” at
the upper and lower edges of the graph. Refer to Appendix E: Sample Reports.
NOTE: Results from rejected specimens will not appear on the graph.

9140390E—June 2008
Quality Control
Analyzing Control Results Section 11
Modified Westgard® Rule Analysis

To allow for analysis of CELL-DYN 1800 system quality control results, a rule
exists to test control results against control limits to determine whether the
instrument shows acceptable accuracy and precision. The limits are derived from
the mean and standard deviation of control measurements when instrument
performance is stable and acceptable. The most common rule used in hematology
quality control is the mean ±2SD. Ninety-five percent of control results should fall
within ±2SD.
Quality control results detect random or systematic error. Random error may be
defined as an increase in the SD (loss of precision). Systematic error may be
defined as a shift in the mean value (loss of accuracy). A multi-rule quality control
procedure combines several control rules to improve the detection of both types of
error.
Westgard recommended a multi-rule approach to evaluating quality control
results.5 This approach has long been used in the chemistry laboratory.6 A set of
modified Westgard® Rules can be selected to monitor quality control results on the
CELL-DYN 1800 system.
Modified Westgard® Rules for the CELL-DYN 1800

The modified Westgard® Rules (Westgard’s nomenclature is given in parentheses)
available on the CELL-DYN 1800 are:
Rule 1 (13s) Value outside 3SD; a control result exceeded the mean by
± 3SD.
Rule 2 (22s) Two consecutive values outside the same 2SD; two consecutive
results fell outside 2SD on the same side of the mean.
Rule 3 (R4s) Two consecutive values outside opposite 2SD; one result was
greater than 2SD above the mean and the next result was greater
than 2SD below the mean. Consequently, the range between the
results is greater than 4SD.
Rule 4 (2 of 32s) Two of three consecutive values outside the same 2SD; two of
three consecutive results fell outside 2SD on the same side of the
mean.
Rule 5 (41s) Four consecutive values outside the same 1SD; four consecutive
results fell outside 1SD on the same side of the mean.
Rule 6 (12x) Twelve consecutive values on the same side of the mean; twelve
consecutive results fell on the same side of the mean.
The rules may be used singly or in combination, depending on Operator preference.
Selections are made in the QC SETUP screen (see Section 5: Operating
Instructions, Subsection: Quality Control Setup).

9140390E—June 2008
Quality Control
Section 11 Analyzing Control Results
When a rule is selected (turned ON), a plus sign is displayed to the right of the
parameter. A minus sign is displayed if a rule in not selected (turned OFF).
Violations for a parameter are recorded above the Levey-Jennings graph for that
parameter. Whenever a rule is violated, the number of the rule will be displayed to
the right of the parameter in place of the plus sign.
CAUTION: QC limits are assumed to be at ±2SD for Westgard® Rule
analysis and for Levey-Jennings graphs. It is crucial to ascertain that the QC
file range entered in the QC RANGE menu represents ±2SD for the
laboratory for each parameter before interpreting Levey-Jennings graphs
and Westgard® Rules.
The violations listed above the graphs represent the modified Westgard® Rule
status of the most recent control sample processed.
CAUTION: Do not use the values for mean range provided on the control
assay sheet in conjunction with Westgard® Rules Before using Westgard®
Rule® with commercial controls, establish the SD for each parameter on
your instrument and enter limits based on these SDs.
Rule Violations
Only the directly measured parameters need to be monitored with multiple rules.7
In Laboratory Quality Management, Cembrowski and Carey suggest a protocol for
using the Westgard® Rules in hematology. The following is a synopsis of that
protocol.
Because all three levels of control are typically used to monitor a hematology
analyzer, it is reasonable to consider all three at the same time. In other words,
check for rule violations across the three levels, not just within a particular level. If
the same rule is violated at more than one level, determine whether the violation
indicates a loss of precision or a loss of accuracy and troubleshoot accordingly.
Cembrowski suggests that the results for all three levels first be checked to see if
they are within their 2SD limits. If all three levels meet this criterion, the
instrument is in control.
If any control result exceeds the 2SD limits, check to see if it exceeds the 3SD
limits. If a result exceeds 3SD, there are two possibilities. There is either an
instrument problem or a problem with one particular level of control. Therefore, if
a result exceeds 3SD, run another vial of that control. If the problem persists, then
additional investigation is required.
Check to see if the 2 of 32s or R4s rules have been violated for any level or across
levels. If the problem is confined to one level of control, check for a 22s rule
violation for that level. Again, if the violations are confirmed to one level of
control, use another vial and possibly another lot. Verify and follow all storage,
mixing, and handling instructions provided in the control package insert. Check
expiration dates and data entry. Check to be sure that the control is run into the
correct file, and the means and limits have been entered correctly for the particular
lot number in use.

9140390E—June 2008
Quality Control
Analyzing Control Results Section 11
If a combination of rules has been violated across three levels, determine whether
the violations indicate a loss of precision or a loss of accuracy, and troubleshoot
accordingly. Do not process patient specimens. If necessary, call Abbott
Diagnostics Customer Service (at 1-877-4ABBOTT in the U.S.) for assistance. For
customer support outside the U.S. and Canada, call your Hematology Customer
Support Representative. Refer to the Error Messages and Conditions table in
Section 10: Troubleshooting and Diagnostics.
When the problem has been resolved, Cembrowski suggests that all levels be run
again in duplicate to confirm that the problem has in fact been corrected.

9140390E—June 2008
Quality Control
References
1. Steine-Martin, PhD, EA et al. Clinical Hematology—2nd Edition.

Philadelphia and New York: Lippincott-Raven, 1998. pp. 112-113.
2. Bull BS, Richardson-Jones A, Gibson M, Twedt D. A Method for the
Independent Assessment of the Accuracy of Hematology Whole Blood
Calibrators. American Journal of Clinical Pathology 1992; 98:623-29.
3. Bull BS, Hay KL. Are Red Blood Cell Indexes International? Archives of
Pathology and Laboratory Medicine 1985; 109:604-06.
4. Chanarin I. Laboratory Hematology: An Account of Laboratory Techniques.
New York: Churchill Livingstone. 1989.
5. Westgard J.O et al. A Multi-Rule Shewart Chart for Quality Control in
Clinical Chemistry. Clinical Chemistry 1981, 27:3:493-501.
6. Cembrowski GS, et al. Use of a Multirule Control Chart for the Quality
Control of PT and APTT Analysis. Laboratory Medicine June 1989; 418-
421.
7. Cembrowski GS, Carey RN. Laboratory Quality Management. Chicago:
ASCP Press. 190-192. 1989.

9140390E—June 2008
Quality Control
NOTES

9140390E—June 2008
Section 12 Printers
Section 12 Printers
Overview
This section gives a brief overview of printer specifications, and referral sources
relating to components, installation, operations, and maintenance.
Printer Specifications
IMPORTANT: The CELL-DYN 1800 System has been configured for and tested
with specific printers, such as the printer shipped with the
analyzer. For additional information about specific printer
capability with the CELL-DYN 1800 System, US Customers,
please contact the Customer Service Center at 1-877-4ABBOTT
(1-877-422-2688). Customers outside the US should contact your
local Hematology Customer Service Representative. Use of
printers other than those recommended by Abbott Laboratories
may lead to erroneous printer functionality.
The CELL-DYN 1800 is compatible with printers that support ESC-P or Printer
Control Language Release 3 (PCL-3). Any printer offering ESC-P or PCL-3
compatibility may be used to print reports generated by this instrument.
Reports are printed in standard format for US letter size paper (8 ½ in. by 11 in.).
Additionally, reports can be printed on A4 paper (8.267 in. x 11.69 in., or 210 mm x
297 mm). Before operating the printer, make certain that the printer is adjusted for
the correct size of paper.
Printer Components, Installation, and Operations

Refer to the printer manual for a detailed description of the printer components, and
for instructions on changing the ribbon or ink cartridge, loading paper, or
troubleshooting.
For normal use, the printer should require only paper and ink ribbons or cartridges,
available at most office supply or computer accessory retail outlets.
Refer to Section 2: Installation Procedures and Special Requirements,
Subsection: Printer Installation for instructions on installing the printer.
The 25-pin printer cable is connected to the parallel port connector on the right
panel of the CELL-DYN 1800 instrument. Refer to the printer manual for detailed
information on printer installation and operations.
Maintenance
Refer to the printer manual for printer maintenance instructions. Avoid spilling
liquids or dropping solid particles in the printer. Ensure there is an adequate supply
of paper in the feeder before using the printer. Depending on the operating
environment, a cover may be desirable during non-use.

9140390D—January 2006
Printers
Overview Section 12
NOTES

9140390A—March 2003
Section 1 Bibliography
Bibliography
Bibliography
Clinical Laboratory Guidelines and Standards

Bull BS, Hay KL. Are Red Blood Cell Indexes International. Archives of
Pathology and Laboratory Medicine 1985; 109:604-606.
Bull BS, Richardson-Jones A, Gibson M, Twedt D. A Method for the Independent
Assessment of the Accuracy of Hematology Whole Blood Calibrators. American
Journal of Clinical Pathology 1992; 98:623-29.
Cembrowski GS, et al. A Multi-rule Shewhart Chart for Quality Control of PT and
APTT Analyses. Lab Med 1989; 418-421.
Cembrowski GS, Carey RN. Laboratory Quality Management. P. 190, 1989.
Chanarin I. Laboratory Hematology: An Account of Laboratory Techniques. New
York: Churchill Livingstone. 1989.
Gagne C, Auger PL, Moorjani S, Brun D, and Lupien PJ. Effect of
Hyperchylomicronemia in the Measurement of Hemoglobin. American Journal of
Clinical Pathology 1977;68:584-6.
Jerome SN, Roark MF, and Wanser C. Anemia Masked by Triglyceridemia.
Denver: Department of Pathology, General Rose Memorial Hospital and
University of Colorado Medical Center, 1974.
International Committee for Standardization in Hematology (ICSH). Protocol for
Evaluation of Automated Blood Cell Counters. Clinical and Laboratory
Hematology 1984; 6:69-84.
International Committee for Standardization in Hematology (ICSH). The
Assignment of Values to Fresh Blood Used for Calibrating Automated Cell
Counters. Clinical and Laboratory Hematology 1988; 10:203-212.
McShine RL, Sibinga S, Brozovic B. Differences between the effects of EDTA and
citrate anticoagulatns on platelet count and mean platelet volume. Clin Lab
Haematol 1990; 12(3):277-85.
Clinical and Laboratory Standards Institute/NCCLS. Method Comparison and
Bias Estimation Using Patient Samples; Approved Guideline—Second Edition.
CLSI/NCCLS document EP9-A2 [ISBN 1-56238-472-4]. Clinical and Laboratory
Standards Institute, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania
19087-1898 USA, 2002.
Clinical and Laboratory Standards Institute/NCCLS. Procedure for Determining
Packed Cell Volume by the Microhematocrit Method; Approved Standard—Third
Edition. CLSI/NCCLS document H7-A3 [ISBN 1-56238-413-9]. Clinical and
Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne,
Pennsylvania 19087-1898 USA, 2000.
CELL-DYN® 1800 System Operator’s Manual Bibliography-1

9140390D—January 2006
Bibliography
Clinical and Laboratory Standards Institute/NCCLS. Procedure for the Collection

of Diagnostic Blood Specimens by Venipuncture; Approved Standard—Fifth
Edition. CLSI/NCCLS document H3-A5 [ISBN 1-56238-515-1]. Clinical and
Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne,
Clinical and Laboratory Standards Institute/NCCLS. Procedures and Devices for
the Collection of Diagnostic Capillary Blood Specimens; Approved Standard—
Fifth Edition. CLSI/NCCLS document H4-A5 [ISBN 1-56238-538-0]. Clinical
and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne,
Clinical and Laboratory Standards Institute/NCCLS. Reference and Selected
Procedures for the Quantitative Determination of Hemoglobin in Blood; Approved
Standard—Third Edition. CLSI/NCCLS document H15-A3 [ISBN 1-56238-425-
2]. Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400,
Clinical and Laboratory Standards Institute/NCCLS. Reference Leukocyte
Differential Count (Proportional) and Evaluation of Instrumental Methods:
Approved Standard. CLSI/NCCLS document H20-A [ISBN 1-56238-131-8].
Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400,
Steine-Martin, PhD, EA et al. Clinical Hematology—2nd Edition. Philadelphia and
New York: Lippincott-Raven, 1998. pp.112-113.
Thompson CD, Diaz DD, Quinn PG, Lapins M, Kurtz SR, Valeri CR. The role of
anticoagulation in the measurement of platelet volumes. Am J Clin Pathol 1983
Sep;80(3):327-32.
Westgard, JO, et al. A Multi-rule Shewhart Chart for Quality Control in Clinical
Chemistry. Clin Chem 1981; 27: 3: 493-501.
Biosafety
Occupational Safety and Health Administration, 29 CFR Part 1910.1030.
Department of Labor. Occupational Exposure to Bloodbourne Pathogens.
Reference Tables
Bessman, J D. Automated Blood Counts and Differentials. Baltimore:
Johns Hopkins University Press. 1986.
Cornbleet, J. Spurious Results from Automated Hematology Cell Counters.
Laboratory Medicine, August 1983. 14:509-514.
Theml, H. Pocket Atlas of Hematology. New York: Thieme. 1985.
Glossary
Barnett RN. Clinical Laboratory Statistics. Boston: Little, Brown and Company.
1979.
Brown BA. Hematology: Principles and Procedures. Philadelphia: Lea & Febiger.
1993.
Bibliography-2 CELL-DYN® 1800 System Operator’s Manual

9140390D—January 2006
Bibliography
Campbell MJ and Machin D. Medical Statistics: A Common Sense Approach.

New York: John Wiley & Son. 1993.
Dorland’s Pocket Medical Dictionary—25th Edition. Philadelphia, PA: W.B.
Sanders Company. 1985.
Hassard, Thomas H. Understanding Biostatistics. St. Louis, MO: Mosby - Year
Book, Inc. 1991.
Hillman RS and Finch CA. Red Cell Manual. Philadelphia: FA Davis Company.
1992.
International Committee for Standardization in Hematology (ICSH). Protocol for
Evaluation of Automated Blood Cell Counters. Clinical and Laboratory
Hematology. 1988; 10:203.
Jandl, MD, James H. BLOOD: Textbook of Hematology. Boston, MA/Toronto,
ONT, CAN: Little, Brown and Company. 1987.
Lewis SM and Verwilhen RL, editors. Quality Assurance in Haematology. London:
Bailliere Tindal. 1988.
Lotspeich-Steininger CA, Stiene-Martin EA, and Koepke JA. Clinical
Hematology: Principles, Procedures, Correlations. Philadelphia and New York:
JB Lippincott Company. 1992.
Merriam-Webster’s Collegiate Dictionary—10th Edition. Springfield, MA:
Merriam-Webster, Incorporated. 1993.
National Committee for Clinical Laboratory Standards. Internal Quality Control
Testing: Principles and Definitions. Approved Guideline. CLSI/NCCLS
Document C24-A. Wayne, PA. 1991.
National Committee for Clinical Laboratory Standards. Performance Goals for the
Internal Quality Control of Multichannel Hematology Analyzers. Proposed
Standard. CLSI/NCCLS Document H26-P. Wayne, PA. 1989.
National Committee for Clinical Laboratory Standards. Reference Leukocyte
Differential Count (Proportional) and Evaluation of Instrumental Methods.
Approved Guideline. CLSI/NCCLS Document H20-A. Wayne, PA. 1992.
Payton, PhD, Otto D. Research: The Validation of Clinical Practice. Philadelphia,
PA: F.A. Company. 1985.
Powers LW. Diagnostic Hematology: Clinical and Technical Principles. St. Louis:
The CV Mosby Company. 1989.
Roberts B, editor, on behalf of the British Committee for Standards in
Haematology. Standard Haematology Practice. Boston: Blackwell Scientific
Publications. 1991.
Stedman’s Medical Dictionary—26th Edition. Baltimore, MD: Williams and
Wilkins. 1995.
Van Nostrand’s Scientific Encyclopedia—8th Edition. New York, NY: Van
Nostrand Reinhold. 1995.
Webster’s Ninth New Collegiate Dictionary. Springfield, Mass: Merriam-Webster
Inc. 1990.
CELL-DYN® 1800 System Operator’s Manual Bibliography-3

9140390D—January 2006
Bibliography
NOTES
Bibliography-4 CELL-DYN® 1800 System Operator’s Manual

9140390A—March 2003
Section 1 Glossary
Glossary
Glossary
NOTE: The references provided in this Glossary, acquired from assorted

reference works, may have been revised to reflect their meanings
in relation to functions and operations of the CELL-DYN 1800
instrument.
absolute count The concentration of a cell type, expressed as a number per unit volume of
whole blood.
absorbance Use, by an atom or a molecule, of light energy to raise electrons from their
ground state orbitals to orbitals at higher energy levels.
accuracy The level of agreement between the estimate of a value (the result
generated by the method) and the “true” value. Accuracy has no numerical
value; it is measured as the amount of (or degree of) inaccuracy [ICSH].
agglutination The action of cells or other biological particles clumping or sticking

together because of an antigen to cause agglutination.
agglutinin An antibody present in the plasma or suspending media that reacts with an
agglutinogen to cause agglutination.
aggregation See agglutination.
alarm A warning message for the user, displayed on the LCD screen.
alerted results Measurement data that are flagged to indicate the possible presence of one
or more abnormal cell populations, interfering substances, problematic
conditions detected by the algorithm, or instrument malfunctions.
algorithm A step-by-step procedure typically mathematical in nature, coded into

computer software. On the CELL-DYN 1800 instrument, algorithms are
used to separate cell populations, determine concentration of cells, and flag
selected results.
aliquot A fractional part of a solution or specimen.
anisocytosis A variation in red blood cell size.
anticoagulant A substance that interferes with the normal clot-forming mechanism of

blood.
aperture An inlet or entrance to a cavity or channel. An opening of known

dimensions, which restricts or limits the passage of energy.
ASCII American Standard Code for Informational Interchange, a standard

computer code used to facilitate the interchange of information among
various types of data processing equipment.
CELL-DYN® 1800 System Operator’s Manual Glossary-1

9140390A—March 2003
Glossary
assay Examination and determination as to characteristics (as weight, measure,

quantity, or quality).
autoagglutination Nonspecific clumping together of cells due to physical/chemical factors.
automated hematology An instrument that accepts whole blood directly for analysis and outputs
analyzer results upon completion.
auto-calibration A selectable activity on the CELL-DYN 1800 system that steps the
Operator through the calibration process and automatically calculates a
calibration factor for each parameter being calibrated.
auto-clean A selectable activity available on the CELL-DYN 1800 that is used to

automatically clean the analyzer flow system.
Background Count A sample analysis run performed without a specimen to check system
performance; often used to determine whether reagents contain excessive
amounts of particulate matter.
band cell (band) An immature granulocyte in a state of development before segmentation

and maturity. Termed a “left shift” when present in high concentrations.
Usually present in circulation in extremely low concentrations.
basophil A granulocytic white blood cell usually present in circulation in extremely

low concentrations. Associate with histamine release, inflammation, and
allergy.
basophilia An increase in the absolute concentration of basophils in circulation. Often

seen in chronic myelogenous leukemia.
bias The numerical difference between the mean of a set of replicate

measurements and the true value [CLSI/NCCLS].
blast The first stage of a blood cell lineage which can be morphologically
identified on a stained smear. Normally present in bone marrow, but not in
circulating blood.
blood, whole A homogenous mixture of blood that has not been separated into cellular
and liquid components.
calibration The adjustment of a laboratory instrument to correct results to match

“truth” which is defined by standards or reference procedures.
calibration factor A multiplier obtained during calibration that can be applied to raw data to
obtain accurate results.
calibrator A material of known characteristics used in conjunction with a calibration

procedure to adjust a measurement accuracy. The values must be traceable
to a national or international reference preparation or method for
hematology.
Glossary-2 CELL-DYN® 1800 System Operator’s Manual

9140390D—January 2006
Glossary
carboxyhemoglobin A moderately stable union of carbon monoxide with hemoglobin; its

formation prevents the normal transfer of carbon dioxide and oxygen
during the normal circulation of blood; increasing levels result in varying
degrees of asphyxiation, including death.
carryover Significant interference from a previous specimen with the current

specimen results.
CBC Acronym for complete blood count. Includes WBC, RBC, HGB, HCT,
MCV, MCH, MCHC, and PLT.
cell A small, usually microscopic, mass of protoplasm bound externally by a

semipermeable membrane. Cells usually contain one or more nuclei and
various nonliving products.
centimeter (cm) A metric unit of measure equal to one-hundredth of a meter.
check digit An extra character in the bar code that permits verification of the bar code
label.
CLSI/NCCLS Acronym for the Clinical and Laboratory Standards Institute, formerly
NCCLS (National Committee for Clinical Laboratory Standards).
coagulation The process by which blood thickens into a coherent, viscous mass.
coefficient of variation (CV) A statistical calculation used to describe population heterogeneity. The
expression of the standard deviation as a percentage of the mean.
coincidence correction A statistical analysis process that adjusts the count for coincidence loss. In
the CELL-DYN 1800, analog circuitry automatically applies the
correction.
coincidence passage loss The simultaneous passage of two or more particles through a sensing zone
or orifice. The resulting interruption in the current flow is sensed as a
single pulse causing the loss of one or more cells from the count.
cold agglutinin An antibody in blood that, at low temperatures, aggregates compatible and
incompatible red blood cells. Also called cold hemagglutinin.
confidence limit A range of values within which it is confident (often 95 percent confident)
that the true but unknown population values lie.
control A substance used in routine practice for checking the performance of an

analytical process or instrument. These materials must be similar in
properties to and be analyzed in the same manner as patient specimens.
Control materials can have preassigned values [ICSH, CLSI/NCCLS].
control file A file for storage and retrieval of Quality Control run data.
control material A substance having assigned values and used in routine practice for
checking the performance of an analytical process or instrument. These
materials are similar in properties to patient specimens and are analyzed in
the same manner as patient specimens.

9140390E—June 2008
Glossary
corpuscle A living red or white blood cell not aggregated into continuous tissues.
correlation analysis An analysis of mathematical measurement of the extent to which two or

more phenomena or events compare.
correlation coefficient A statistic that indicates the degree to which two measurements are related,
expressed as a value from -1.0 to +1.0, with +1.0 indicating that results are
in total agreement, and -1.0 indicating that results are exact opposites (i.e.,
4 and -4). A 0.0 value indicates that the two measurements are unrelated.
count data Data measured by the analyzer for the purpose of deriving cell
concentration.
count duration Length of time over which the count measurement occurs, expressed in
seconds.
cryoglobulin Any of several proteins similar to gamma globulins that dissolve at 37°C
(98.6°F).
cyanmethemoglobin A hemoglobin derivative formed by cyanide and methemoglobin in the

measurement of blood hemoglobin concentration.
data log A file or repository that automatically accepts and stores all time-stamped
cycle data.
deionized water Water from which the ions have been removed.
deca (d) A prefix denoting the factor of ten (101).
differential Determination of the proportion of the various types of WBCs (normal and
abnormal).
diluent Solution used to dilute blood cells to provide a cell concentration suitable
for measurement.
dilution ratio The factor by which a given sample has been diluted before being counted.
This value is without dimension.
drift Variation or change in a system over time which significantly affects

performance.
EDTA Ethylenediaminetetracetic acid; an anticoagulant commonly used for

hematology cell counting; may be in the form of a liquid or powder as di-
potassium (K2) or tri-potassium (K3) salt.
enzymatic cleaner A specially formulated cleaning solution containing a mixture of

proteolytic enzyme and detergent for use on CELL-DYN instruments.
eosinophil A mature granulocytic white blood cell normally present in circulation in

low concentrations. Associated with host defense to certain parasites,
allergy, inflammation, and phagocytosis.
eosinophilia An increase in the absolute concentration of eosinophils in circulation.

9140390E—June 2008
Glossary
error, random Variation, with no distinct pattern, between successive analysis process
data. Often assumed to be a normal (Gaussian) distribution around a mean.
error, systematic Directional or patterned variation between values obtained and the values
expected.
erythrocyte A small, biconcave, disk approximately 7.5 µm in diameter, with no

nuclei. Erythrocytes are mature cells present in greater concentrations than
others in circulating blood (averaging 4.5 million cells per µL of whole
blood).
expiration date The date assigned by the manufacturer after which a product is no longer
acceptable for use. Reagents, controls, and calibrators have expiration
dates affixed during the manufacturing process.
extended count An extension of measurement time which automatically occurs whenever

a detected concentration for a particular cell type is not reached during the
normal measurement time.
fault Implying a failure. A detected condition that has failed internal acceptance
criteria. Fault indicators activate to alert the Operator.
femto (f) A prefix denoting one quadrillionth; the factor of 10-15.
femtoliter (fL) A unit of measure to express the volume of blood cells.
femotole (fmol) A unit of measure used to express the mean cell hemoglobin amount per
liter.
fibrin An insoluble protein that is essential to clotting of blood, formed from

fibrinogen by action of thrombin.
fibrinogen The major plasma protein that is the substrate for thrombin action to form
fibrin; coagulation factor I.
flag Written or displayed output intended to signal or attract attention. Flags are
generated by the instrument to alert the Operator to instrument
malfunctions that occur during sample processing, or to data abnormalities
detected during data analysis.
flag, dispersional A displayed or printed indication that signals the presence of cell
data alert concentrations and/or values that fall outside the Operator-selectable or
system-defined range.
flag, suspect parameter A displayed or printed indication that signals the presence of a substance
or condition that may affect the accuracy of a parameter’s measurement.
flag, suspect population A displayed or printed indication that signals the suspected presence of red
blood cell abnormalities, such as Anisocytosis, and/or the suspected
presence of abnormal white blood cells, for example, bands, immature
granulocytes, blasts, and variant lymphocytes.

Glossary
gain The amount of change in signal magnitude generated by an amplifier,

presented as a ratio of the output to input signals.
Gaussian distribution A statistical term used to describe a normal frequency distribution or

curve. The normal distribution is unimodal, bell-shaped and symmetrical
about the mean.
gram (g) The basic unit of mass in the metric system, equal to about 1/28th of an
ounce.
GRAN The identifier for the granulocyte percentage result, which is calculated as
a the percentage of granulocytes in the white blood cells.
granulocyte A white blood cell that contains prominent cytoplasmic granules:

neutrophils, eosinophils, and basophils.
granulocytosis An increase in the absolute concentration of granulocytes in circulation.
hematocrit (HCT) A determination of the ration of the volume of all formal elements in a
sample of blood to the total volume of the blood sample. This test measures
the percentage of packed erythrocytes in a volume of blood.
hemoglobin (HGB) A conjugated protein within the red blood cell that carries oxygen from the
lungs to the tissues, and carbon dioxide from the tissues to the lungs.
hemogram A complete blood count excluding the white blood cell differential.
hemolysis The destruction of red blood cells resulting in the liberation of hemoglobin.
heparin An anticoagulant that combines with and enhances anti-thrombin III to

prevent blood clotting. Not recommended for specimens being run on
hematology analyzers.
Hertz (Hz) The international unit of frequency, equal to one cycle per second.
HGB The identifier for the hemoglobin result, which is calculated as the mass of
hemoglobin per unit volume of whole blood.
histogram A frequency distribution of measurement intensity for cells passing

through a transducer on a hematology analyzer.
hyperbilirubinemia An abnormally large amount of bilirubin in the circulating blood, resulting

in clinically apparent icterus or jaundice when the concentration is
sufficient.
hyperglycemia An abnormally high concentration of glucose in the circulating blood,

especially with reference to a fasting level.
hypochromic Decreased hemoglobin content in the red blood cells. Low MCH and
decreased pigment on a stained smear.
ICSH An acronym for the International Committee for Standardization in

Haematology.

9140390A—March 2003
Glossary
impedance method A process that detects and sizes cells suspended in a conductive medium
as they are drawn through an aperture. Each cell creates a resistance to
current flow that is directly proportional to its own volume. Voltage pulses
indicate the passage and volume of cells.
imprecision The variation in the results of a set of replicates or paired (duplicate)

measurements, expressed as a standard deviation or coefficient of
variation. See also precision.
in vitro Outside the living body.
in vivo Within the living body.
inaccuracy The numerical difference between the mean of a set of replicate

measurements and the true value.
indices A group of calculated values for red blood cell properties: mean
corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), and
mean corpuscular hemoglobin concentration (MCHC).
interfering substances A specimen component or state that affects the accuracy of a parameter’s
measurement.
kilo (K) A prefix denoting one thousandth; the factor of 103.
kilogram (Kg) A metric unit of weight equal to 1000 grams.
LCD Liquid Crystal Display; a device for alphanumeric displays, as on digital

watches, using a pattern of tiny, sealed capsules which contain a
transparent liquid crystal that becomes opaque when an electric field is
applied to it; the contrast between transparent and opaque areas forms the
image of a number, letter, etc.
leukocyte (white blood cell) A type of cell, commonly referred to as a white blood cell (WBC), with
three main subpopulations in circulation: granulocytes, lymphocytes, and
monocytes.
Levey-Jennings graph A QC chart in which control values for a single level for a single parameter
are plotted in runs or days on the horizontal axis, and in parameter
concentration on the vertical axis. Parallel horizontal lines represent the
mean and the various SD intervals. Useful for trend analysis.
linearity The measure of the degree to which a curve approximates a straight line.
It also refers to overall system response (i.e., the final analytical answer
rather than the instrument output).
lipemia A condition in which there is a higher than normal concentration of lipids

(fats) in the blood, seen as a milky-looking plasma; can interfere with
hematology results obtained optically.
LIS An acronym for Laboratory Information System.

9140390A—March 2003
Glossary
liter (L) The basic metric unit of capacity equal to 1 cubic decimeter or 61.025
cubic inches (1.0567 liquid quarts or .908 dry quart).
LRI An acronym for lower region interference. A displayed or printed

indication of a detected abnormality specific to the lower platelet size
region requiring further review.
LYM The identifier for the lymphocyte result output as an absolute

concentration per unit volume of whole blood: # x 109/L or # x 103/µL.
lymphocyte Smallest and second most abundant type of leukocyte in the circulation
with round or slightly indented nucleus and azurophilic granules (not
always present) evident in the cytoplasm; mediates cellular immunity.
lymphocytosis An absolute increase in the concentration of lymphocytes in circulation.
lymphopenia An absolute decrease in the concentration of lymphocytes in circulation.
lyse Alteration or destruction of a cell or the reagents that causes it.
lysing agent/lytic agent Causes the cell membranes of red blood cells to rupture and release their
hemoglobin into the solution.
lysis The process of alteration or destruction of cells.
macrocytic (giant) PLT A large platelet.
macrocytic RBC (macrocyte) A large red blood cell in circulation.
macrocytosis An overall increase in large red blood cells in circulation. Associated with
deficiencies in vitamin B12 and folate, and with certain therapies.
mean An arithmetic average of the accepted values.
MCH An acronym for mean corpuscular hemoglobin. The identifier for the mean
(mean corpuscular corpuscular hemoglobin which is the average hemoglobin mass in red
hemoglobin) blood cells.
MCHC An acronym for mean corpuscular hemoglobin concentration. The

(mean corpuscular identifier for the mean corpuscular hemoglobin which is the average mass
hemoglobin concentration) of hemoglobin per unit volume in red blood cells.
MCV An acronym for mean corpuscular volume. The identifier for the mean
(mean corpuscular volume) corpuscular volume result which is the average volume of red blood cells.
metamyelocyte A cell present in the bone marrow that gives rise to a granulocyte and is not
normally present in circulation. The maturation phase between myelocyte
and band. Considered an immature granulocyte (IG).
metering, volumetric A method of determining the exact volume of a prepared sample that has
been measured.

Glossary
methemoglobin A brownish hemoglobin derivative formed in the blood by the oxidation of

hemoglobin, as by the action of certain drugs or in the decomposition of
the blood, and no longer able to combine reversibly with oxygen.
method, reference A clearly and exactly described technique for a particular determination. A
competent authority must judge whether the technique is sufficiently
accurate and precise determination for it to be used to assess the validity of
other laboratory methods. The accuracy of the reference method must be
established by comparison with a definitive method, if one exists. The
accuracy and degree of imprecision must be stated [CLSI/NCCLS].
microcytic PLT A small platelet in circulation.
microcytic RBC A small red blood cell in circulation.
microcytosis The overall increase in small red blood cells in circulation. May be
associated with iron deficiency, hereditary hemoglobin disorders,
sideroblastic anemias, chronic disorders, and renal failure.
microhematocrit method The determination of the packed cell volume (PCV) of red blood cells
using a small quantity of whole blood, a capillary tube, and a high-speed
centrifuge.
microliter (µL) One millionth of a liter. (10-6)
micrometer (µm) One millionth of a meter. (10-6)
monocyte White blood cell that is normally formed in lymph tissue; phagocytes.
Monocytes become macrophages as they leave the blood and enter body
tissue.
monocytosis An absolute increase in the concentration of monocytes in circulation.
moving average file A data repository that automatically accepts and stores the data in batch
means as they are calculated. The Operator may review either the data in a
summary log or Levey-Jennings graph format.
moving average program A statistical routine that monitors system performance as specimens are
run.
MPV An acronym for the mean platelet volume result, which is the measure of
the average platelet volume.
myelocyte A cell in bone marrow that gives rise to a granulocyte and is not normally
in circulation. Considered an immature granulocyte.
neutropenia Diminished number of neutrophils in the blood; can increase susceptibility

to bacterial or fungal infection.

9140390E—June 2008
Glossary
neutrophil A mature granulocytic white blood cell present in circulation in high

concentrations. Characterized by a segmented nucleus made up of two to
eight lobes, and a cytoplasm containing granules. Increase in neutrophils
can be caused by bacterial inflammation, tissue death, uremia, cancer, and
other disease conditions.
neutrophilia An absolute increase in the concentration of neutrophils in circulation.
nucleated red blood cell A nucleated cell present in the bone marrow that gives rise to a red blood
cell and is not normally present in circulation.
nucleus A cellular organelle that is essential to cell functions such as reproduction

and protein synthesis.
orifice See aperture.
packed cell volume The measure of the ratio of the volume occupied by the red blood cells to
the volume of whole blood.
parameter A term used in reference to the various tests performed by a hematology

analyzer.
PCT The identifier for the Plateletcrit result which is calculated as the
percentage of the collective volume of platelets relative to the volume of
the sample.
PDW The identifier for the platelet distribution width which is calculated as ten
times the geometric standard deviation of the platelet size distribution.
plasma The fluid part of whole blood as distinguished from the cells.
platelet An irregularly shaped, disklike cytoplasimc fragment of a megakaryocyte

that is shed in the marrow sinus and subsequently found in the peripheral
blood where it functions in clotting.
plateletcrit Measure of the total platelet volume; varies directly with platelet count.
PLT An acronym for platelet or platelet count. The identifier for the platelet
absolute concentration per result calculated as the number of platelets per
unit volume of whole blood.
poikilocytosis A morphological condition characterized by variable-shaped red blood

cells.
polychromatic A morphological abnormality characterized by the presence of an

increased number of red blood cells that have basophilic (blue-gray) tint
on Wright-stained smears, indicating the presence of cytoplasmic RNA.
polycythemia An increased concentration of red blood cells in circulation.
polymorphonuclear A white blood cell that has a segmented nucleus and contains granules, for
example, a mature granulocyte such as a neutrophil or eosinophil.

9140390A—March 2003
Glossary
precision The degree of agreement in the results of a set of replicate or paired

(duplicate) measurements. Precision has no absolute numerical value. It is
expressed as imprecision, which is a standard deviation or coefficient of
variation. See also imprecision.
promyelocyte A cell present in the bone marrow that gives rise to a granulocyte and is not
normally present in circulation. See also immature granulocyte.
QA An acronym for quality assurance.
QC An acronym for quality control.
QC file A repository that stores data automatically each time a control specimen is
run, for review and output in a summary or Levey-Jennings plot format.
The mean, SD, and CV calculations are automatically updated each time
data are received.
quality control (external) A system of retrospectively and objectively comparing results from
different laboratories by means of surveys organized by an external
agency. The main objective is to establish between-laboratory and
between-instrument comparability, if possible, with a reference standard
where one exists [ICSH].
quality control (internal) A set of procedures undertaken by the staff of the laboratory for continual
evaluation of the reliability of its work. The procedures determine whether
the test results are reliable enough to be released to the requesting
clinicians. These procedures should include tests on control material and
statistical analysis of patient data [ICSH].
range A measure of the dispersion of values. The difference between the largest
and the smallest of a group of measurements.
RBC An acronym for red blood cell or red blood cell count. The identifier for
the red blood cell result, which is calculated as the coefficient of variation
percentage of the red cell volume distribution.
RDW An acronym for red cell size distribution width. The identifier for red cell
size distribution width result, which is calculated as the coefficient of
variation percentage of the red cell volume distribution.
reagent A solution used to dilute, and in some cases, alter the cells in a whole blood
specimen, in preparation for measurement by the Analyzer.
red blood cell A bioconcave, circular disk approximately 7.5 µm in diameter, with no
nuclei. Red blood cells are mature cells present in greater concentrations
than others in circulating blood (averaging 5 million cells per microliter of
whole blood). Primary function is oxygen delivery to the tissues and
carbon dioxide removal. Also called erythrocytes.

9140390A—March 2003
Glossary
reference interval The normal range established by a testing site. Site variables, such as, the
test method, geographical location, interfering substances, age, and sex
will cause slight variations in reference intervals obtained by different
sites.
The normal range is determined by testing specimens collected from
between 100 and 300 normal healthy individuals and calculating a mean
and ±2SD. Test results for 95% of the normal population will be within this
established range.
reliability The extent to which an experiment, test, or measuring procedure yields the
same results on repeated trials.
reproducibility The ability of a procedure to obtain results during repeat analyses which
closely imitate, within specified limits, the results obtained initially.
RS232 Serial Port A nine-pin connector that provides connectivity to a computer or to a

Laboratory Information System.
sample The appropriately representative part of a specimen used in the analysis.
sample dilution The mixture of sample and reagent that is analyzed by a hematology
instrument.
sampling mode The means used by the Analyzer to aspirate a specimen.
sensitivity, analytical The minimal detectable value. The least quantity that can be discriminated
from the background noise [CLSI/NCCLS].
sensitivity, clinical A test’s ability to recognize individuals with the suspected illness for
which the test is being run. A method’s ability to obtain positive results in
correlation with positive results obtained by a reference method. The
percentage or proportion of patients with a well defined clinical disorder
who have test values that exceed the decision limit [CLSI/NCCLS].
sequence number An identifier assigned to each sample aspirated on the instrument. This
identifier is used to identify all of the data of the same sample.
setup data Operator-selectable criteria or entries that customize the system operation
and data output formats.
shift An abrupt change in results from specimens thought to be similar.
shistocyte A fragment of a red blood cell, commonly observed in the blood in

hemolytic anemia.
sickle cells A crescent shaped cell found in the peripheral (circulating) blood;
indicative of sickle cell anemia.
slope Represents a proportional systematic error. If both methods are in

agreement, the slope will be 1.0. A slope of 1.0 ± 0.05 is considered
acceptable agreement.

9140390D—January 2006
Glossary
specificity, analytical Freedom from measurement interference. The ability of an analytical

method to determine only the component being measured [CLSI/NCCLS].
specificity, clinical A test’s ability to recognize individuals without the suspected illness for
which the test is being run. A method’s ability to obtain negative results in
correlation with negative results obtained by a reference method. The
percentage or proportion of patients who do not have a well defined
clinical disorder who have test values that do not exceed the decision limit
[CLSI/NCCLS].
specimen Collected whole blood that is presented to the Analyzer for sampling.
stability The ability of a specimen, reagent, or control to maintain a constant

concentration of the analyte. May also refer to the ability of an analytical
system to avoid drift.
standard deviation (SD) A measure of the dispersion of a group of values around a mean. The
square root of the variance expressed in the same units as the
measurements themselves.
standard deviation index (SDI) A measurement of both the systematic and random error, denoting how
many standard deviations a particular number is from the mean. Used in
external quality control programs to relate the performance of a laboratory
with that of other participating laboratories. A perfect SDI is 0, and it
should always be less than 1.0.
status box The location on the CELL-DYN 1800 screen where messages requiring
Operator attention are displayed.
symbology Specific rules for grouping bars and spaces to form data characters, check
digit calculation, and check digit placement in a bar code.
syringe A device that consists of a hollow barrel fitted with a plunger used to
deliver or inject a precise volume of diluted sample.
thrombocyte Circulating cytoplasmic fragments of the megakaryocytes present in

moderate concentrations, averaging about 250,000/µL of whole blood.
Contain no nuclei and have some granules.
toggle key A key that changes to another function.
trend A situation in which results obtained from specimens thought to be similar

move in the same direction for several consecutive runs.
unit of measure A determinate quantity adopted as a standard of measurement. Associated

with a numerical result for a measured quantity or property.
uremia The abnormal presence of urinary constituents in the blood.
URI An acronym for upper region interference. A displayed or printed

indication of a detected abnormality specific to the upper platelet size
region requiring further review. This interference flag usually results from
the presence of large platelets or small red blood cells.

9140390D—January 2006
Glossary
VAC An acronym for Voltage Alternating Current.
Vacutainer® Tube Brand (trademark) name for Becton Dickinson-marketed test tubes which
contain a vacuum for easy blood withdrawal when obtaining blood by
venipuncture. The tubes must contain an anticoagulant (such as EDTA) to
prevent blood coagulation in order to be used with CELL-DYN systems.
verification A protocol or procedure followed to test the performance of a system or

component to ensure that it meets stated specifications.
WBC An acronym for white blood cell or white blood cell count. The identifier
for white blood cell result is calculated as the number of white blood cells
per unit volume of whole blood.
Westgard® Rules A multirule system described by Westgard for identifying out-of-control

QC results, based on control procedures described initially by Shewhart
and later by Levey and Jennings. Uses a set of statistical rules to assess and
validate QC data. On the CELL-DYN 1800 system, Westgard® Rules may
be turned ON and OFF.
white blood cell A cellular constituent of circulating blood that is present in lower
concentrations than red blood cells or platelets, averaging 7,000/µL of
whole blood. Primary function is to guard tissues against invasion by
foreign organisms or chemicals. Also called leukocytes.
X-B “X bar B”.The name for the moving average program developed by
(moving average program) Dr. Bull. The X (mathematically X) stands for the mean, and the B stands
for Bull. A statistical program that monitors system performance as
specimens are run. Any result for each monitored parameter (MCV, MCH,
and MCHC) that meets acceptance criteria is automatically included in a
current batch.
Y-intercept A representation of constant systematic error. The interpretation depends

on the substance being measured. A perfect correlation of two methods
will give a Y- intercept value of 0. The lower the number, the better the
correlation.

Appendix A Parts and Accessories
Appendix A–Parts and Accessories
To place an order for the products listed on the following pages, or for technical
assistance for the CELL-DYN instrument in the US, call 24 hours a day, seven days
a week to Abbott Diagnostics Customer Service at:
1-877-4ABBOTT (1-877-422-2688).
1-800-387-8378
For customer support outside the U.S. and Canada, call your local Hematology
Customer Support representative.
List numbers are unique indentifiers used when ordering products. List Numbers
and quantities provided in this Operator’s Manual are intended for guidance only
and are subject to change. US Customers, contact Abbott Diagnostics Customer
Support at 1-877-4ABBOTT (1-877-422-2688) for the most current information
regarding list numbers. Customers outside the US, contact your local Hematology
Customer Support Representative.
CELL-DYN® 1800 System Operator’s Manual Appendix A-1

9140390E—June 2008
Parts and Accessories
Appendix A–Parts and Accessories Appendix A
CELL-DYN Equipment, Parts, and Accessories

Abbott List Number/Part Number Description of Part Configuration
03H54-01 Accessory Kit 1

(NOTE: For a list of items in the
Kit, see the Accessory Kit Table)
07H80-01 Operator’s Manual 1
07H79-01 Interface Specifications 1
07H78-01 Keyboard 1
92274-01 Aperture Plate WBC 100 Micrometer
92264-01 Aperture Plate RBC 60 Micrometer
28561-01 Lyse Syringe 2.5 mL
04H36-01 Diluent Syringe 10 mL
28514-01 Sample Syringe 100 µL
21704-01 Waste Dummy Plug 1
93164-01 Sample Probe 1
54305-01 Aperture Brush 1
20005-01 Printer Cable 1
91012-01 Teal Line Filter Isolation 1
07H81-01 Bar Code Scanner 1
03H96-01 Pull Ring, Solenoid 1
99650-01 Code 39 Bar Code Labels 1000 pkg.
07H67-01 Lyse Cap for 960 mL container 5
07H67-02 Lyse Cap for 3.8 L or 20 L 5

container
Appendix A-2 CELL-DYN® 1800 System Operator’s Manual

9140390E—June 2008
CELL-DYN 1700/1800 Accessory Kit (L/N 03H54-01)

1403204 Keyboard Cover 1
5100161 * Fuse, SB 2.5 amps 250 V 2
60160-01 * Fuse, SB 5.0 amps 220/240 V 2
93501-01 Power Cord 1
5406753 Allen Wrench 3/32" 1
5406754 Allen Wrench 7/64" 1
54305-01 Aperture Brush 1
91072-01 Reagent Line Kit 1
20005-01 Printer Cable 1
9150143 Instructions for Mixing and Handling 1
93476-01 Silicon Tubing (S2) 1 (24")
* For CELL-DYN 1700 System use only.
CELL-DYN 1800 Reagent Line Kit (L/N 91072-01)

03H82-01 Reagent Line Assembly, Lyse (1L) 1
03H92-01 Detergent Line Inlet Assy 1
92161-02 Waste Line Assembly 1
92163-01 Diluent Line Inlet Assembly 1
92178-01 Lyse Line Inlet Tube 1

9140390E—June 2008
CELL-DYN Reagents
US-Only List Number International List Number Description of Part Configuration
07H84-01 07H84-01 CN-Free Diff Lyse (3.8L) 3.8 liter cube
07H84-02 07H84-02 CN-Free Diff Lyse (960mL) 1 x 960 mL bottle
08H18-04 99320-01 Detergent 20 liter cube
08H18-01 99326-01 Detergent 4 x 3.8 liter bottles
08H18-02 98329-01 Detergent 1 x 3.8 liter bottle
08H17-04 99220-01 Diluent 20 liter cube
08H17-05 99220-02 Diluent 3.8 liter cube
CELL-DYN Controls and Calibrators

99109-01 CELL-DYN 16 Tri-Level Control 12 x 2.5 mL; 4 of each

level
99105-01 CELL-DYN 16 Tri-Level Control (Half Pack) 6 x 2.5 mL; 2 of each

level
02H40-01 CELL-DYN 16 Normal Control 6 x 2.5 mL; 6 of

normal control
01H92-01 CELL-DYN 16 Control Assay Disk 1
99110-01 CELL-DYN Calibrator 2 x 2.5 mL
93111-01 CELL-DYN 22 Tri-Level Control 12 x 2.5 mL; 4 of each

level
99106-01 CELL-DYN 22 Tri-Level Control (Half Pack) 6 x 2.5 mL; 2 of each

level
99103-01 CELL-DYN 22 Normal Control 6 x 2.5 mL; 6 of

normal control
01H91-01 CELL-DYN 22 Control Assay Disk 1
99120-01 CELL-DYN 22 Calibrator 2 x 2.5 mL

9140390E—June 2008
CELL-DYN Consumables
99644-01 Enzymatic Cleaner Concentrate 2 x 50 mL
30005-01 OKIDATA® Graphics Paper 3000 sheets/pkg.
13401-01 Ribbon OKIDATA® 320 1
03H10-04 HP Printer Cartridge (Black) 1
99605-01 (US only) CELL-DYN Counting Cups 500/pkg.
99606-01 (US only) CELL-DYN Counting Cups 3000/pkg.
99605-02 (International) CELL-DYN Counting Cups 500/pkg.
99606-02 (International) CELL-DYN Counting Cups 3000/pkg.

9140390E—June 2008
NOTES

9140390E—June 2008
Appendix B Reference Tables
Appendix B—Reference Tables
This table provides a detailed list of interfering substances. Note that some of the
substances listed may not interfere with CELL-DYN 1800 results. Refer to the list
of interfering substances provided in this manual in Section 3: Principles of
Operation, Subsection: System-Initiated Messages and Data Flags and in
Section 5: Operating Instructions, Subsection: Specimen Analysis, for the
substances that commonly interfere with CELL-DYN 1800 results.
Table B-1: Potential Causes of Erroneous Results with Automated Cell Counters
Parameter Causes of Spurious Increase Causes of Spurious Decrease
White Cell Count Cryoglobulin, cryofibrinogen Clotting

(WBC) Heparin Smudge cells
Monoclonal proteins Uremia plus immunosuppressants
Nucleated red cells
Platelets clumping
Unlysed red cells
Red Cell Count Cryoglobulin, cryofibrinogen Autoagglutination

(RBC) Giant platelets Clotting
High white cell count (> 50,000/µL) Hemolysis (in vitro)
Microcytic red cells
Hemoglobin (HGB) Carboxyhemoglobin (> 10%) Clotting

Cryoglobulin, cryofibrinogen
Hemolysis (in vivo)
Heparin
High white cell count (> 50,000/µL)
Hyperbilirubinemia
Lipemia
Monoclonal proteins
Hematocrit Cryoglobulin, cryofibrinogen Autoagglutination

(Automated) (HCT) Giant platelets Clotting
High white cell count (> 50,000/µL) Hemolysis (in vitro)
Hyperglycemia (> 600 mg/dL) Microcytic red cells
Hematocrit (HCT) Hyponatremia Excess EDTA

(Microhematocrit) Plasma trapping Hemolysis (in vitro)
Hypernatremia
CELL-DYN® 1800 System Operator’s Manual Appendix B-1

9140390E—June 2008
Reference Tables
Appendix B—Reference Tables Appendix B
Table B-1: Potential Causes of Erroneous Results with Automated Cell Counters
Mean Cell Volume Autoagglutination Cryoglobulin, cryofibrinogen
(MCV) High white cell count (> 50,000/µL) Giant platelets
Hyperglycemia Hemolysis (in vitro)
Reduced red cell deformability Microcytic red cells
Swollen red cells
Mean Cell High white cell count (> 50,000/µL) Spuriously low hemoglobin
Hemoglobin (MCH) Spuriously high hemoglobin Spuriously high red cell count
Spuriously low red cell count
Mean Cell Autoagglutination High white cell count (> 50,000/µL)

Hemoglobin Clotting Spuriously low hemoglobin
Concentration Hemolysis (in vivo and in vitro) Spuriously high hematocrit
(MCHC)
Spuriously high hemoglobin
Spuriously low hematocrit
Platelets (PLT) Cryoglobulin, cryofibrinogen Clotting

Hemolysis (in vivo and in vitro) Giant platelets
Microcytic red cells Heparin
Red cell inclusions Platelet clumping
White cell fragments Platelet satellitosis
SOURCE: Cornbleet, J. “Spurious Results from Automated Hematology Cell Counters.” Laboratory Medicine,
1983. August 14: 509-514.
Appendix B-2 CELL-DYN® 1800 System Operator’s Manual

9140390E—June 2008
Table B-2: Reference Intervals (Normal Values) for Automated Blood Counters
Adult Male Adult Female Children Children Children
Parameter
>18 Years >18 Years at 1 Month at 2 Years at 10 Years
WBC (K/µL) 4.6–10.2 4.6–10.2 5.0–20.0 6.0–17.0 5.0–13.0
Lymphocytes (K/µL) 0.6–3.4 0.6–3.4 6.0mv 6.3mv 3.1mv

Lymphocytes (%)
10–50 10–50 55mv 60mv 40mv
Monocytes (K/µL) 0–0.9 0–0.9

Monocytes (%) 0–12 0–12 6mv 5mv 4mv
Eosinophils (K/µL) 0–0.7 0–0.7

Eosinophils (%) 0–7 0–7 3mv 2mv 2mv
Basophils (K/µL) 0–0.2 0–0.2

Basophils (%) 0–2.5 0–2.5 0.5mv 0.5mv 0.5mv
Neutrophils (K/µL) 2.0–6.9 2.0–6.9 3.8mv 3.5mv 4.4mv

Neutrophils (%) 37–80 37–80 30mv 30mv 50mv
RBC (M/µL) 4.69–6.13 4.04–5.48 3.9–5.9 3.8–5.4 3.8–5.4
Hemoglobin (g/dL) 14.1–18.1 12.2–16.2 15–18 11–13 12–15
Hematrocit (%) 43.5–53.7 37.7–47.9 44mv 37mv 39mv
MCV (fL) 80–97 80–97 91mv 78mv 80mv
MCH (pg) 27.0–31.2 27.0–31.2 33mv 27mv 25mv
MCHC (g/dL) 31.8–35.4 31.8–35.4 35mv 33mv 34mv
Platelets (K/µL) 142–424 142–424 277mv 300mv 250mv
RDW (%) 11.6–14.8 11.6–14.8 N/A N/A N/A
SOURCES:
• Theml H. Pocket Atlas of Hematology. Stuttgart and New York: Thieme. 1985.
• Bessman J D. Automated Blood Counts and Differentials. Baltimore: Johns Hopkins University Press.
1986.
NOTES:
• mv denotes mean value
• For adult black males and females, normal WBC is 2.9–7.7 K/µL
• For adult black males and females, normal RBC, HGB, and HCT is 5% less
• For children aged 6 months to 18 years, mean MCV value is approximately 75 fL + (0.8 x age in years)
• For newborns, MCV is 88–114 fL and RDW is 14.9–18.7%.
CELL-DYN® 1800 System Operator’s Manual Appendix B-3

9140390E—June 2008
Reference Tables
Appendix B—Reference Tables Appendix B
NOTES
Appendix B-4 CELL-DYN® 1800 System Operator’s Manual

9140390E—June 2008
Appendix C Sample Logs and Worksheets
Appendix C—Sample Logs and Worksheets
The logs and worksheets in this section are templates for you to copy and use in
your laboratory. These include the following:
• Error message logsheet
• Carryover Worksheet
• CELL-DYN Lyse Reagent Log
• CELL-DYN Diluent Reagent Log
• CELL-DYN Detergent Reagent Log
• Enter Factor Open Mode Whole Blood Calibration Worksheet
• Enter Factor Pre-dilute Mode Whole Blood Calibration Worksheet
• Pre-Calibration Procedures Check List
CELL-DYN® 1800 System Operator’s Manual Appendix C-1

9140390E—June 2008
Sample Logs and Worksheets
Appendix C—Sample Logs and Worksheets Appendix C
Error Message Logsheet
Instrument Serial Number:____________________
Date Tech Time Sequence # Observation Resolution
Carryover Worksheet
Row Number WBC RBC HGB PLT
1 Sample Run 3
2 Background Run 1
3 Background Run 3
4 Row #2 – Row #3 Absolute Carryover
5 Row #1 – Row #3
6 (Row #4 ÷ Row #5) x 100 = Carryover %
Appendix C-2 CELL-DYN® 1800 System Operator’s Manual

9140390E—June 2008
CELL-DYN Lyse Reagent Log
Expiration Date Lot Number Open Date Operator ID

9140390E—June 2008
CELL-DYN Diluent Reagent Log

9140390E—June 2008
CELL-DYN Detergent Reagent Log

9140390E—June 2008
Enter Factor Open Mode Whole Blood Calibration Worksheet
Date:____________________________________
Name:___________________________________
Calculate all calibration factors to two decimal places.
New Open Sample Calibration Factors
Reference Mean
x Current Open Mode Calibration Factor = New Open Mode Calibration Factor
CELL-DYN 1800 Mean
For example, if the Reference Mean Value for WBC is 6.6, the CELL-DYN Mean for WBC is 7.1, and the
current Calibration Factor is 0.98, then:
6.6 x 0.98 = 0.91

7.1
Reference CELL-DYN Calibration New Calibration

÷ x = Range*
Mean 1800 Mean Factor Factor
WBC ÷ x = 0.70–1.30
RBC ÷ x = 0.80–1.20
HGB ÷ x = 0.50–1.50
MCV ÷ x = 0.70–1.30
PLT ÷ x = 0.70–1.30
* If factor exceeds limits, do not calibrate. Check all calculations Abbott Diagnostics Customer Service for
assistance.

9140390E—June 2008
Enter Factor Pre-Dilute Mode Whole Blood Calibration Worksheet
Date:____________________________________
Name:____________________________________
Calculate all calibration factors to two decimal places.
New Pre-Dilute Mode Calibration Factors
Open Mode Mean

x Current Pre-Dilute Mode Calibration Factor = New Pre-Dilute Mode Calibration Factor
Pre-Dilute Mode Mean
For example, if the Open Mode Mean Value for WBC is 6.6, the CELL-DYN Mean for WBC is 7.1, and the
current Calibration Factor is 0.98, then:
6.6 x 0.98 = 0.91

7.1
Pre-Dilute
New Pre-Dilute
Open Mode Pre-Dilute Mode
÷ x = Mode Calibra- Range*
Mean Mode Mean Calibration
tion
Factor
WBC ÷ x = 0.70–1.30
RBC ÷ x = 0.80–1.20
HGB ÷ x = 0.50–1.50
MCV ÷ x = 0.70–1.30
PLT ÷ x = 0.70–1.30
* If factor exceeds limits, do not calibrate. Check all calculations Abbott Diagnostics Customer Service for
assistance.

9140390E—June 2008
CELL-DYN 1800
Pre-Calibration Procedures Check List
Introduction
It is advisable to perform calibration at a time when it can be completed without interruption. The Pre-
Calibration Procedures help ensure proper instrument performance and a successful calibration. These
steps must be completed just before starting the calibration process. If problems are detected during these
checks, do not attempt to calibrate the instrument. If necessary, call Abbott Diagnostics Customer Service
for assistance. After the problems have been resolved, repeat the Pre-Calibration Procedures to verify
proper performance.
Instrument: _____________________________ Date ________________________________________
Operator: _______________________________
1. ___________ Ensure that all maintenance is current before calibrating the instrument. Refer to
the CELL-DYN 1800 Operator’s Manual Section 9: Service and Maintenance for
further information.
2. ___________ Confirm that reagent containers are at least one half full—replace them as
necessary.
3. ___________ Verify that the CELL-DYN Reagents have not reached the expiration date. Record
the reagent expiration dates and lot numbers in the spaces provided below.
Diluent: Lot # ___________ Expiration Date ____________
Detergent: Lot # ___________ Expiration Date ____________
Lyse Reagent: Lot # ___________ Expiration Date ____________
4. ___________ Verify that the calibrator has not reached the expiration date.
Lot # ___________ Expiration Date ____________
5. ___________ Confirm that the waste container is not more than half full—empty it, if necessary.
6. ___________ Confirm that Normal Background is within limits. Record the background results
below and attach a printout to this document. If the system has been idle for fifteen
minutes or more, a Normal Background should be run immediately prior to running
any calibration specimens.
WBC < 0.5 K/µL ___________________
RBC < 0.05 M/µL ___________________
HGB < 0.1 g/dL ___________________
PLT < 10.0 K/µL ___________________

9140390E—June 2008
7. ______ Verify instrument precision by analyzing a fresh, normal whole blood sample 20
times in succession. Run the sample in an empty replicate file and record the CVs
below and attach a file printout to this document. The CVs obtained should be less
than or equal to the CV% limits listed below. Refer to the CELL-DYN 1800
Operator’s Manual Section 5: Operating Instructions and Section 6: Calibration
Procedures for further information on using the replicate files.
Parameter CV% Limit CV

WBC < 2.5 ____________
RBC < 1.7 ____________
HGB < 1.2 ____________
MCV < 1.5 ____________
PLT < 6.0 ____________
MPV < 6.0 ____________
8. ______ If any problems are detected, document them with your corrective action in the
space provided:
________________________________________________________________
________________________________________________________________
________________________________________________________________
________________________________________________________________
________________________________________________________________
________________________________________________________________
________________________________________________________________
________________________________________________________________
________________________________________________________________
________________________________________________________________
________________________________________________________________
________________________________________________________________
________________________________________________________________
________________________________________________________________
________________________________________________________________
________________________________________________________________
________________________________________________________________
________________________________________________________________
________________________________________________________________
________________________________________________________________
________________________________________________________________

9140390E—June 2008
NOTES

9140390E—June 2008
Appendix D Bar Codes
Appendix D—Bar Codes
This section gives a brief overview of what bar coding is, how bar code labels are
used for data entry, and the different types of bar codes that may be used with the
CELL-DYN 1800.
CELL-DYN® 1800 System Operator’s Manual Appendix D-1

9140390E—June 2008
Bar Codes
Appendix D—Bar Codes Appendix D
NOTES
Appendix D-2 CELL-DYN® 1800 System Operator’s Manual

9140390E—June 2008
Overview
Bar coding is an automated method of gathering alphanumeric information and

transmitting it to a computer. Because it eliminates typing and associated errors,
bar coding offers speed, increased accuracy, and efficiency. The following are the
major elements in a bar coding system:
• The computer and appropriate software interprets and stores bar code data.
For the CELL-DYN 1800, this is accomplished by the scanner.
• The scanning device decodes the information on the bar code labels. The
CELL-DYN 1800 incorporates an optional bar code scanner that is attached
to the PC keyboard.
• The bar code labels contain the specimen identification codes.

9140390E—June 2008
Bar Codes
Bar Code Function

The bar code label contains the actual identifying data for specimens in the form of
a series of black bars and contrasting white spaces, which represent characters. The
arrangement of the code follows one of several sets of rules for bar code languages,
called symbologies.
The bar code scanner emits a small beam of light that scans the bar code symbol on
the label. The bars and spaces reflect the light into the bar code scanner in varying
amounts. Black bars reflect little light into the reader, while white spaces reflect
significantly more light. A light detector inside the bar code reader translates the
varying degrees of reflected light into electrical signals. The signals are then
converted into the sets of ones and zeros (the binary system used by computers)
that stand for numbers and letters.
Understanding the Label’s Code

In all bar code symbologies, the code consists of elements (single bars or white
spaces) and characters. In code 39, a commonly used symbology, each code
character contains nine elements, at least three of which must be wide. Wide
elements (whether they are bars or spaces) in this symbology have a binary value
of 1. Narrow elements have a binary value of 0.
Most contemporary bar code systems have several features in common. These
include the following:
• The Quiet Zone is the area immediately before and after the bar code symbol.
This zone enables the scanner to read the code properly.
• Start and Stop Characters indicate the beginning and end of the bar code
symbol. They allow the label to be scanned from either right to left or left to
right, ensuring that code information is transmitted correctly.
• Intercharacter Gaps act as spaces between each character in the bar code
symbol. Code 39 contains these gaps. However, there are other codes, such
as Interleaved 2 of 5, that do not use them.
• The Interpretation Line is an area at the bottom of the bar code label where
human-readable information can be placed. This may or may not be the same
data as in the label code.
• The Check Digit is an extra character in the bar code that permits verification
of the bar code label. This keeps the error rate as low as one for every billion
characters scanned.

9140390E—June 2008
Bar Code Types and Characteristics

The CELL-DYN 1800 reads four types of bar code labels:
• Code 39
• Code 128
• Interleaved 2 of 5
• Codabar
Code 39
Also referred to as code 3 of 9, Code 39 encodes 43 data characters: 0–9, A–Z, six
symbols, and spaces. Every Code 39 character has five bars and four spaces. Of
these nine elements, three are wide and six are narrow, making Code 39 a two-
width code.
Code 128
Code 128 has 106 different printed characters. Each character has three bars and
three spaces comprising 11 modules. Each printed character can have one of three
different meanings, depending on which of three different character sets is used.
Three different start characters tell the reader which of the character sets is initially
being used, and three shift codes permit changing the character set inside a symbol.
Interleaved 2 of 5
Interleaved 2 of 5 encodes the 10 numeric digits 0–9. The name is derived from the
method used to encode two characters that are paired together. Bars represent the
first character, and the interleaved spaces represent the second character. Each
character has two wide elements and three narrow elements, for a total of five
elements.
Codabar
Codabar uses four bars and three spaces to represent the 10 numeric digits 0–9 and
certain special characters. The code is characterized by four unique start/stop codes
and variable intercharacter spacing.

9140390E—June 2008
Bar Codes
NOTES

9140390E—June 2008
Specifications
Bar Code Label Formats

The optional bar code scanner on the CELL-DYN 1800 System can read all four
label types listed below. Code size, collection tube length, and cap style limit the
number of digits to the following:
• Code 39—1 to 16 digits
• Code 128—1 to 16 digits
• Interleaved 2 of 5—1 to 16 digits
• Codabar—3 to 16 digits
The maximum number of characters includes any check digits within the code
(except for Code 128).
NOTE: Interleaved 2 of 5 symbology requires a barcode specimen ID to have an
even number of characters. If the check digit is enabled, the specimen ID
may consist of an odd number of characters, up to 15. If the check digit is
not enabled, the effective range for a specimen ID is 2 to 14 characters.

9140390E—June 2008
Bar Codes
Bar Code Label Characters

The CELL-DYN 1800 recognizes the following bar code label characters:
• A to Z • .
• a to z • /
• 0 to 9 • :
• ! • ;
• " • <
• @ • =
• # • >
• $ • ?
• % • {
• & • |
• ‘ • }
• ( • ~
• ) • [
• * • \
• + • ]
• , • ^
• - • _

9140390E—June 2008
Bar Code Check Digit Formats

Bar code Check Digits are used whenever the instrument is to read a specific type
of bar code. To enable or disable the check digit option, refer to the
CELL-DYN 1800 Intermec ScanPlus 1800 Trigger-Activated Hand-Held Bar
Code Scanner User’s Guide.
Check Digit specifications are as follows:
Bar Code
Symbology Elements per Character Characters
Name
Code 39 Each character has 9 elements: 36 alphanumeric characters: 0–9, A–Z,

5 bars and 4 spaces 6 symbols, and a character for a space
Interleaved Each character (2 digits) has 10 elements: 10 numeric characters: 0–9

2 of 5 5 bars and 5 spaces
Codabar Each character has 7 elements: 10 numeric characters: 0–9 and

4 bars and 3 spaces 6 additional characters
Code 128 Each character has 6 elements: All 128 ASCII characters and all
(ANSI® standard) 3 bars and 3 spaces 128 extended ASCII characters

9140390E—June 2008
Bar Codes
Bar Code Label Specifications

Bar code labels must be printed on good quality label stock and must meet the
following specifications:
• 0.2 inch minimum quiet zone on each end
• 0.5 inch minimum bar code length
• 2 inch maximum bar code label length
• 1.25 inch maximum bar code label width
• Maximum possible contrast between bars and background label.
Maxim um Label Width

1.25 inches
Min im um
Quiet Zone Maxim um
0.2 inches Label Length
2.0 inches
Min im um Bar Length

0.5 inches
Figure D.1 Bar Code Label Specifications

9140390E—June 2008
Bar Code Label Placement

The following two guidelines should be observed when placing bar code labels on
specimen tubes:
All labels should be placed on the tubes securely and without flaps sticking out. See
the following figure.
The bar code label should be placed on the tube just below the stopper with the bars
perpendicular to the length of the tube. Be sure that at least 0.10 inch (about 1/8
inch) of space is left between the bottom of the tube cap and the bar code symbol,
to satisfy the “quiet zone” requirement. See the following figure for proper
placement.
Figure D.2 Tube Labeling Specifications
CELL-DYN Bar Code Labels

CELL-DYN 4-digit Code 39 bar code labels, in rolls of 1000 labels each, can be
ordered with List Number 99650-01. These labels may be used for positive
specimen identification when laboratory-generated bar code labels are unavailable.

9140390E—June 2008
Bar Codes
NOTES

9140390E—June 2008
Setup Information for Check Digits
The optional bar code scanner on the CELL-DYN 1800 can read bar code labels
with different symbologies interchangeably. The bar code scanner automatically
identifies the symbology scanned.
All CELL-DYN 1800 supported symbologies may have check characters. Code 39,
Interleaved 2 of 5, and Codabar symbols can be read and printed with or without
check characters. Code 128 always has a check character which is read and printed
in the symbol.
NOTE: If the Operator generates bar code labels to be placed on tubes used on the
CELL-DYN 1800, it is important that the check digit option used in label
generation matches the check digit option enabled during bar code setup.
Refer to the CELL-DYN 1800 Intermec ScanPlus 1800 Trigger-
Activated Hand-Held Bar Code Scanner User’s Guide.

9140390E—June 2008
Bar Codes
NOTES

9140390E—June 2008
References
1. Computype, Inc., Bar Coding and Productivity, St. Paul, Minnesota.

2. AIM USA, Uniform Symbology Specification Code 39, Pittsburgh PA 15238-
2802, June 1993.
3. AIM USA, Uniform Symbology Specification Interleaved 2-of-5, Pittsburgh
PA 15238-2802, April 1993.
4. AIM USA, Uniform Symbology Specification Codabar, Pittsburgh PA
15238-2802, June 1993.
5. AIM USA, Uniform Symbology Specification Code 128, Pittsburgh PA
15238-2802, June 1993.

9140390E—June 2008
Bar Codes
NOTES

9140390E—June 2008
Appendix E Sample Reports
Appendix E—Sample Reports
Figure E.1 Sample Data Log Report
Figure E.2 Sample QC Log File Report
CELL-DYN® 1800 System Operator’s Manual Appendix E-1

9140390E—June 2008
Sample Reports
Appendix E—Sample Reports Appendix E
Figure E.3 Sample Specimen Data Report (Normal Specimen)
Appendix E-2 CELL-DYN® 1800 System Operator’s Manual

9140390E—June 2008
Figure E.4 Sample Specimen Data Report (Abnormal Specimen)

9140390E—June 2008
Sample Reports
Figure E.5 Sample Levey-Jennings Report

9140390E—June 2008
Figure E.6 Sample Fault Log Report

9140390E—June 2008
Sample Reports
NOTES

9140390E—June 2008
Appendix F Good Laboratory Practice
Appendix F—Good Laboratory Practice
This section gives a brief overview of good laboratory practices that may be used
with the CELL-DYN 1800.
Normal Sample Guideline: The Rule of Three

Over the years, clinicians and technologists have used a quick mathematical check
to ensure the patient’s hemoglobin and hematocrit parameters were consistent. The
hematocrit is roughly three times the hemoglobin. This simple formula works only
on normocytic, normochromic samples (that is, samples with MCV and MCHC
within normal limits). The hemoglobin and hematocrit (H & H) on CELL-DYN
instruments typically correlate within the narrow range of ±3% on normal samples.
If the calculated (HGB x 3) = HCT does not agree with the reported HCT, as
indicated by an increased frequency (>5%) of H & H outliers exceeding 3% HCT,
the system could be miscalibrated, malfunctioning, or the sample has pathology
requiring further investigation.1
Assay Verification Procedure

New control material lots must be analyzed in parallel with current lots prior to
their expiration dates. To accomplish the transition to a new lot of control material,
follow your laboratory’s protocol or proceed as follows:
1. Set up Low, Normal, and High control files for the new lot using three empty
files. Refer to Section 5: Operating Instructions, Subsection: Quality
Control Setup.
2. Verify the new control lot by running each level of control three times in its
respective file to ensure that the mean of all three runs is within the range
shown on the assay sheet.
3. Run the new controls twice a day for five days.
4. Use the mean of the 10 runs to verify that the new lot yields expected results.
5. Compare the mean to the range specified on the assay sheet. The mean should
fall within the range specified by the manufacturer in the package insert.
6. If the calculated mean falls within the range specified on the assay sheet, use
it in place of the manufacturer’s stated mean. (For details on updating means,
refer to Section 5: Operating Instructions, Subsection: Quality Control
Setup.)
7. When results for any parameter(s) are flagged (outside of Operator-defined
limits or reportable range), follow your laboratory’s procedure for out-of-
range results.
CELL-DYN® 1800 System Operator’s Manual Appendix F-1

9140390E—June 2008
Good Laboratory Practice
Appendix F—Good Laboratory Practice Appendix F
NOTES
Appendix F-2 CELL-DYN® 1800 System Operator’s Manual

9140390E—June 2008
Establishing Mean Values for Commercial

QC Materials
New lots of control material should be analyzed in parallel with current lots prior
to the expiration date of the current lots. To transition to a new lot of control
material, follow your laboratory’s protocol or proceed as follows:
1. Using empty control files, set up low, normal and high files for the new lot.
When the values for the new lot have been confirmed and updated
information entered, these files can be used for the remainder of the dating
period.
2. Verify the new lot of control material by running each level of control three
times in its respective file. Ensure that the mean values of the three runs for
each measurand fall within the ranges shown on the manufacturer’s assay
sheet.
3. Run each level twice a day for five days to calculate new mean values for
each measurand.
4. Compare the calculated mean values for each level to the recovery range
specified on the manufacturer’s package insert.
5. If the calculated mean falls within the specified range, enter it as the Assay
instead of the value on the manufacturer’s package insert.
Establishing the Mean

Three empty control files should be set up for the new lot number for each level of
control: Low, Normal, and High. If desired, the control files can then be used to run
the controls for the remainder of the dating period. It is not necessary to create
another file.
Each office or laboratory should establish its own ranges. These ranges may be
determined by evaluating data from a three to six month period (data from the
Interlaboratory QC program can be used) for a particular level of control.
Individual SD (standard deviation) values can be averaged as follows:
(N1 X SD12) + (N2 X SD22) + ... (Ni X SDi2)

Average SD =
(N1 + N2 + ... Ni)- 1
N = number of values in a group

SD = standard deviation of values in that group
i = the last group of values
The resulting long-term instrument standard deviation and the laboratory-
established mean for each lot number can be used to monitor overall instrument
performance.

9140390E—June 2008
NOTES

9140390E—June 2008
References
1. Clinical Laboratory Standards Institute/CLSI. Statistical Quality Control for

Quantitative Measurements: Principles and Definitions; Approved
Guideline Third Edition. CLSI Document C24-A3 (ISBN 1-56238-613-1).
CLSI, 940 West Valley Road, Suite 1400, Wayne, PA, 19087-1898 USA,
2006.
2. Clinical Laboratory Standards Institute/CLSI. Performance Goals for the
Internal Quality Control of Multichannel Hematology Analyzers; Approved
Standard. CLSI Document H26-A (ISBN 1-56238-312-4). CLSI, 940 West
Valley Road, Suite 1400, Wayne, PA, 19087-1898 USA, 2006.
3. Clinical Laboratory Standards Institute/CLSI. Reference Leukocyte
Differential Count (Proportional) and Evaluation of Instrumental Methods;
Approved Standard-Second Edition, CLSI Document H20-A2 (ISBN 1-
56238-628-X). CLSI 940 West Valley Road, Suite 1400, Wayne, PA,
19087-1898 USA, 2007.
4. Websters’ Ninth New Collegiate Dictionary. Springfield, MA: Merriam-
Webster Inc. 1990.

9140390E—June 2008
NOTES

9140390E—June 2008
Index
Index
A Auto Start-Up Procedure 5-4

Daily Quality Control 5-4
Abbott Instrument Warranty iii instrument Start-Up 5-4
Field Service iii Quality Control 5-4
Absolute Allowable Range 6-16 [STANDBY] 5-4
Accessory Kit 2-3 Auto-Cal Calibration Procedure 6-26
accuracy 11-1 Auto-Cal Ranges for Calibrator and Fresh Whole
Action Limit 11-30 Blood 6-15
Activating the Pre-Dilute Mode 6-36 Auto-Cal Select 6-11
[PRE-DILUTE] 6-36 [AUTO CAL SELECT] 6-11
agglutination 10-45 [MPV LATEX] 6-11
Air in detergent line 10-20 Auto-Cal >>>> or <<<< 10-56
Air in diluent reagent line 10-20 Auto-Clean 9-19, 10-45
Air in lyse reagent line 10-20 PROCESS ACTIVE 9-19
Alarm Indicators 10-55 START CLEAN 9-19
[CLEAR ALARM] 10-55 [AUTO CLEAN] 9-19
Alarm Message 10-45 Automatic Graphics Printout 5-10
algorithm 3-8 Automatic Increment of Specimen ID Number 5-
aliquots 6-31 9
Allowable Values Exceeded Automatic Start-Up and Shutdown 5-16
Enter Factor 10-56 Auto Shutdown 5-16
Printed Report Range 10-56 Auto Start Up 5-16
<<< under range 10-56 [AUTO STARTUP] 5-16
>>> (over range) 10-56
Analytic Measurement Range 4-13, 4-14
Analyzing Control Results 11-33 B
anticoagulant 1-1 Background Count 1-19
Aperture Plate 1-10 Background Counts 2-19, 4-13
Appendix A–Parts and Accessories A-1 Background data is unacceptable 10-30
Aspiration Bacterial or fungal contamination of the flow
Sample Aspiration Probe 3-3 system 10-20
whole blood 3-3 Bar Code Function D-4
Aspiration Volume 4-9 Bar Code Label Characters D-8
As-Required Maintenance 9-33 Bar Code Label Formats
Assay Verification Procedure Codabar D-7
expiration dates F-1 Code 128 D-7
asterisk [*] key 5-66, 5-71, 5-73, 9-101 Code 39 D-7
audible tone on read 10-21 Interleaved 2 of 5 D-7
Audio 1-17 Bar Code Label Placement D-11
Auto Calibration Factors 6-16 Bar Code Label Quality 10-61
Auto Calibration Procedure 6-15 Bar Code Label Specifications D-10
CELL-DYN® 1800 System Operator’s Manual Index-1

9140390E—June 2008
Index
Bar Code Labels 4-7 Pre-diluted samples 6-3

Bar code scanner 10-21 Whole blood samples 6-3
light flashing 10-21 Calibration Materials 6-4
light not activated 10-21 CALIBRATION MENU 6-7
light on/no audible tone when bar code is Calibration Menu 6-9
scanned 10-21 [AUTO CAL SELECT] 6-9
transmission of specimen ID does not [CALIBRATION] 6-9
occur 10-21 [ENTER FACTOR] 6-9
Bar Code Scanner 2-9 [HELP/ERROR] 6-9
Bar Code Scanner Entry 5-56 [MAIN] 6-9
sequence number 5-56 [PRE-DILUTE] 6-9
specimen ID 5-56 [PRINT] 6-9
Bar Code Scanner Installation 2-9 Calibration Methods 6-3
Bar Code Scanner Not Responding 10-61 specimens 6-3
Bar Code Scanner Troubleshooting 10-61 [AUTO CAL SELECT] 6-3
Bar Code Specifications 4-7 [ENTER FACTOR] 6-3
Bar Code Symbologies 4-8 Calibration Procedures 6-1, 6-13
Bar Code Types and Characteristics D-5 Overview 6-1
Codabar D-5 Calibration Temperature Specification 6-3, 6-
Code 128 D-5 14, 7-2, 10-55
Code 39 D-5 Calibration Troubleshooting 10-55
Interleaved 2 of 5 D-5 Calibrator 6-25
Bar Codes D-1 Carryover 4-14
Label Formats D-7 Cell Measurement 3-4
Overview D-3 Electrical Impedance Method 3-4
Specifications D-7 Modified Methemoglobin Method 3-4
Bias 4-16 CELL-DYN Bar Code Labels D-11
correlation coefficient 4-16 CELL-DYN Diluent Reagent Log C-4, C-5
Bibliography Bibliography-1 CELL-DYN Lyse Reagent Log C-3
Biohazards 8-3 CELL-DYN 1800 Flow Panel Diagram 10-16
cleaning spills 8-3 CELL-DYN 1800 Reagents
Decontamination Procedures 8-3 CN-Free Diff Lyse 1-18
infectious materials 8-3 Detergent 1-18
Preparing the Instrument for Extended Diluent 1-18
Periods of Non-Use or Shipping 8-3 Change Auto Shutdown 5-17
Sample Aspiration Probe 8-3 Change the Date and Time 5-15
Spills 8-3 changing ink cartridge 12-1
blood 1-1 Changing Panic Limits 5-21
Blood in tubing connected to Sample Aspiration PANIC LIMITS menu 5-21
Probe 10-22 Changing Patient Limits 5-20
Panic Limits 5-20
C changing ribbon 12-1
Changing Units of Measure 5-40
CALIBRATION 5-7 Check Digit Formats D-9
Calibration Guidelines 6-3 Characters D-9
General Information 6-3 Elements per Character D-9
Index-2 CELL-DYN® 1800 System Operator’s Manual

9140390E—June 2008
Index
Chemical Hazards 8-4 debris 9-43

chemical containers 8-4 Enzymatic Cleaner 9-43
reagents 8-4 Cleaning/Replacing the Aspiration Probe 9-51
Clean Dil Syringe 9-13 Allen wrench 9-51
[CLEAN DIL SYRINGE] 9-13 Enzymatic Cleaner 9-51
Clean for Shipping 9-14 Cleaning/Replacing the Aspiration Probe Wash
[CLEAN FOR SHIPPING] 9-14 Block 9-64
Clean Lyse Syringe 9-13 Enzymatic Cleaner 9-64
[CLN LYSE SYRINGE] 9-13 Cleaning/Replacing the Diluent Syringe 9-70
Clean Sample Syringe 9-13 Luer-Lok® 9-71
[CLN SAMPL SYRINGE] 9-13 Removing the Diluent Syringe 9-70
[RESTORE SYRINGE] 9-13 Cleaning/Replacing the Lyse Syringe 9-84
[SYRINGE DOWN] 9-13 Allen wrench 9-84
Cleaning the Aperture Plates 9-46 Removing the Lyse Syringe 9-84
Cleaning the Aspiration Probe Exterior 9-22 Cleaning/Replacing the Sample Syringe 9-79
Background Counts 9-22 Allen wrench 9-79
enzymatic cleaner 9-22 Removing the Sample Syringe 9-79
[NORMAL BACKGRND] 9-22 CLEAR ORIFICE 10-45
[SPECIMEN TYPE] 9-22 Clear Orifice/Clear Alarm 5-48
Cleaning the Aspiration Probe Interior 9-52, 9- [CLEAR ALARM] 5-48
58 [CLEAR ORIFICE] 5-48
Cleaning the Aspiration Probe Wash Block 9-66 Clearing Alarms 10-55
Cleaning the Bar Code Scanner Lens 9-92 CLOG 3-24
Cleaning the Diluent Syringe 9-72 Clog 10-45, 10-46
Cleaning the Flow System 9-101 CN-Free Diff Lyse
INSTRUMENT READY FOR SHIPPING 9- nucleus 1-18
101 Codabar D-5
Cleaning the HGB (Hemoglobin) Flow Cell 9-35 Code 128 D-5
READY 9-35 Code 39 D-5
SHIFT 9-35 coefficient of variation 3-8, 11-12, 11-15
[GAIN ADJUST] 9-35 Coincidence Loss Correction 3-5
[SPECIMEN TYPE] 9-35 Commercial Calibration 6-4
Cleaning the Lyse Syringe 9-86 Computer Section 1-5, 1-16
Cleaning the Pre-Mixing Cup 9-39 Audio 1-5
Cleaning the Printer 9-31 diagnostic 1-16
Cleaning the Sample Syringe 9-81 (LCD) Screen/Membrane Keypad 1-5
Cleaning the “Y” Fitting 9-93 COMPUTER SETUP 5-11, 5-39
Cleaning Tubing and Instrument Exterior 9-102 Computer Setup
Cleaning/Replacing Syringes 9-69 Data Transmission 5-39
Diluent Syringe 9-69 Laboratory Information System (LIS) 5-39
Lyse Syringe 9-69 Conditioning of WBC/RBC Metering Tubes 2-
Sample Syringe 9-69 17
Cleaning/Replacing the Aperture Plates 9-43 metering tubes 2-17
Aperture brush 9-43 Consistently low values (short sample) 10-32
clogs 9-43 Consumables 1-21
cracked 9-43 Container Drain System 9-41

9140390E—June 2008
Index
Contaminated reagents affecting any results 10- Daily Shutdown 5-75

22 PC keyboard 5-75
control 11-15 STANDBY 5-75
Control File Setup 5-30 timer control 5-75
expiration date 5-30 Daily Shutdown Procedure 9-16
FILE SETUP 5-30 DAILY SHUTDOWN 9-16
HIGH CONTROL 5-30 PROCESS ACTIVE 9-16
lot number 5-30 STANDBY 9-16
LOW CONTROL 5-30 Daily Start-Up 5-43, 9-15
Means/Limits 5-30 Data Invalidating Faults (DIF) 10-6
NORMAL CONTROL 5-30 DATA LOG 5-7
Range Entry 5-30 DATA LOG MENU 5-65
Westgard® Rules 5-30 Data Log Menu 5-64
Control Material 11-2 [DATA LOG] 5-64
Control Material Guidelines 11-4 [DISPLAY SPECIMEN] 5-64
commercial control 11-4 [EDIT ID] 5-64
hemolysis 11-4 [FIND SPECIMEN] 5-64
mix 11-4 [HELP/ERROR] 5-64
mixing 11-4 [MAIN] 5-64
stability 11-4 [PRINT DATALOG] 5-64
Controls and Calibrator 1-20 [REJECT FROM X-B / ACCEPT TO X-
Calibrator 1-20 B] 5-64
Controls 1-20 [TRANSMIT DATA] 5-64
Correcting Mean and Factor Failures 10-57 DATA Problems 10-30
Correlation 4-16 Data Problems 10-18
Count Test Data Storage 1-16
COUNT TEST 10-5 Hard Disk Drive 1-16
ELEC BKGD TEST 10-5 Data Stored 3-9
PRE-DIL TEST 10-5 Decontamination Procedure 9-7
Counting Cups 6-27, 6-31, 6-33 degraded reagents affecting any results 10-22
Creating the Reagent Log 5-24 Delete Specimen
[DETERGENT LOG] 5-24 [CANCEL DELETE] 11-21
[DILUENT LOG] 5-24 [CONFIRM DELETE] 11-21
[LYSE LOG] 5-24 [DELETE SPECIMEN] 11-21
[PRINT LOG] 5-24 Deleting Specimens 11-26
[REAGENT LOG] 5-24 [CANCEL DELETE] 11-26
customer 9-34 [CONFIRM DELETE] 11-26
Customer Service 10-13 [DELETE SPEC] 11-26
Customer Support i Detergent
Cycle Times 4-9 CELL-DYN Enzymatic Cleaner 1-19
platelet recount 4-9 Detergent Empty 10-46
Detergent Inlet Tubing Connector 1-13
D Determining Reference Values—Calibrator 6-21
Determining Reference Values—Fresh Whole
Daily Maintenance Procedures 9-15 Blood 6-18
Daily Quality Control 5-43 Determining Reference Values—Pre-Dilute 6-25

9140390E—June 2008
Index
Device Faults (DEV) 10-6 Diluent Inlet Tubing Connector 1-13

DIAGNOSTICS 5-7 Diluent Normally Closed Valve 1-11
Diagnostics 10-3 Diluent Syringe Installation 2-13
DIAGNOSTICS menu 10-3 Dilution
[COUNT TEST] / [PRE-DIL TEST] / [ELEC Counting Chamber 3-3
BKGD TEST] 10-3 fL 3-3
[DIAGNOSTICS] 10-3 leukocyte 3-3
[HELP/ERROR] 10-3 nucleus 3-3
[INITIALIZATION] 10-3 platelet 3-3
[MAIN] 10-3 reagent 3-3
[MORE] 10-3 red blood cell 3-3
[PRINTER OUTPUT] 10-3 white blood cell 3-3
[RAW DATA] 10-3 Dispersional Data Alerts 3-25
DIAGNOSTICS MENU 10-4 highlighted 3-25
Diagnostics Menu-More (Level 1) Panic Limit 3-25
[HELP/ERROR] 10-7 Printed Report Range 3-25
[MAIN] 10-7 (>>>>) 3-26
[MORE] 10-7 “HH” 3-25
[PLT HISTOGRAM] 10-7 “H” 3-25
[PRINTER OUTPUT] 10-7 “LL” 3-25
[RBC HISTOGRAM] 10-7 “L” 3-25
[SMOOTHING OFF] / [SMOOTHING Display Specimen 5-67
ON] 10-7 Laboratory Information System (LIS) 5-67
[WBC HISTOGRAM] 10-7 patient demographics 5-67
Diagnostics Menu-More (Level 2) [EDIT DEMOGRAPH] 5-67
[HELP/ERROR] 10-8 [HELP/ERROR] 5-67
[MAIN] 10-8 [NEXT SPECIMEN] 5-67
[MORE] 10-8 [PREVIOUS SPECIMEN] 5-67
[PRINTER OUTPUT] 10-8 [PRINT REPORT] 5-67
[PROBE HOME] / [PROBE DOWN] 10-8 [RETURN] 5-67
[PROBE UP] / [PROBE DOWN] 10-8 [TRANSMIT SPECIMEN] 5-67
Diagnostics Menu-More (Level 3) Drain and Clean the Vacuum Accumulator 9-90
[FAULT REPORT] 10-9 Drain Baths/Refill Baths 9-13
[HELP/ERROR] 10-9 [DRAIN BATHS] 9-13
[MAIN] 10-9 [REFILL BATHS] 9-13
[MORE] 10-9 Draining/Cleaning the Vacuum Accumulator 9-
[PRINTER OUTPUT] 10-9 89
[SERVICE DEC CODE] 10-9
[SERVICE HEX CODES] 10-9 E
[SYSTEM STATUS] / [CLEAR
ALARM] 10-9 Edit ID 5-66
different Operator running Inaccurate patient [EDIT ID] 5-66
results 10-36 [ESC] 5-66
Diluent Electrical Hazards 8-4
impedance 1-18 electrical cabling 8-4
Diluent Empty 10-47 electrical connector 8-4

9140390E—June 2008
Index
power OFF 8-4 [REPLICATE ID] 5-38

power ON 8-4 Entering Units of Measure 5-40
Electrical Impedance Measurement 3-4 Error Message Logsheet C-2
conductive diluent 3-4 ESC 5-71, 5-73
electrical impedance method 3-15 Establishing the Mean F-3
Emptying Instrument Waste 9-41 ranges F-3
[WASTE FULL] 9-41 standard deviation F-3
Enter Factor 6-12 Establishing the Target Value 11-30
[ENTER FACTOR] 6-12 fL 11-30
Enter Factor Calibration Procedure 6-26 [QC SETUP] 11-30
Enter Factor Calibration Run—Calibrator 6-21 [X-B SETUP] 11-30
Calibration Factor 6-22 evaporated reagents affecting any results 10-22
[ENTER FACTOR] 6-22
[RESET ALL TO 1.00] 6-22 F
[RESTORE FACTORS] 6-22
Enter Factor Open Mode Whole Blood Fault Indicator 10-55
Calibration Worksheet C-6 “FE” 10-55
Enter Factor Pre-Dilute Mode Whole Blood “K” 10-55
Calibration Worksheet C-7 Fault LED 10-47
Enter Factor Procedure 6-21 Fault Message Condition 10-47
Bias 6-21 Fault Report 10-9
Calibrator or Fresh Whole Blood 6-21 Not Ready
Enter Factor method 6-21 See Diagnostics 10-9
Entering Mean/Limits 5-35 fibrin clots 10-45
[CANCEL LOAD] 5-35 Field Service Faults (FSF) 10-6
[CONFIRM LOAD] 5-35 Filling the Transducers 9-49
[LOAD FROM DISK] 5-35 Background Counts 9-50
[MEAN/LIMITS] 5-35 [REFILL BATHS] 9-49
Entering or Changing the Date and Time 5-14 Find Specimen 5-68
[DATE/TIME] 5-14 Name 5-68
Entering or Changing Units of Measure 5-40 Sequence # 5-68
[UNITS SELECTION] 5-40 Spec ID 5-68
Entering Range Limits 5-34 [SEARCH BACKWARD] 5-69
[CANCEL LOAD] 5-34 [SEARCH FORWARD] 5-69
[CONFIRM LOAD] 5-34 First Level Subfunction Keys 9-13
[LOAD FROM DISK] 5-34 Flags (For PLT Only) 10-55
[RANGE ENTRY] 5-34 LRI 10-55
Entering Reference Values—Calibrator 6-15 LRI URI 10-55
Entering Reference Values—Fresh Whole URI 10-55
Blood 6-18 Floppy Disk Drive 1-16
[AUTO CAL SELECT] 6-18 Flow Err 10-48
[WHOLE BLOOD] 6-18 Flow Err message
Entering the Expiration Date 5-32 [DRAIN BATHS] 10-48
Entering the Lot Number 5-31 [REFILL BATHS] 10-48
Entering the Replicate ID Flow Err or Clog message 10-49, 10-50
[LOT NUMBER] 5-38 Flow Error 6-43

9140390E—June 2008
Index
Flow Panel Hard Disk Drive

Diluent Normally Closed Valve 2-16 Patient Data Log 1-16
HGB Flow Cell Assembly 2-16 User Interface Software 1-16
Pre-Amplifier Module 2-16 Hazard Information and Precautions
Pre-Mixing Cup 2-16 General 8-3
RBC/PLT Metering Assembly 2-16 whole blood 8-3
Sample Aspiration Probe 2-16 Hazard Information Precautions 8-3
Start Switch 2-16 Hazards
Vent Lines 2-16 Safety symbols 8-1
Von Behrens RBC/ PLT Transducer 2-16 Hazards Overview 8-1
Von Behrens WBC Transducer Assembly 2- HCT 1-4
16 Hematocrit 1-4, 3-17
Wash Block 2-16 plasma 3-17
WBC Metering Assembly 2-16 header 5-10
Flow Panel Components 9-5 HELP/ERROR 5-7, 5-11, 11-17
Fresh Whole Blood 6-25 Help/Error 5-41, 5-50, 6-12, 9-13, 9-14, 10-6,
Front Panel 1-5, 1-7, 1-8 10-9, 11-21
Display Bezel Cover 1-8 Data Invalidating Faults (DIF) 10-6
LED Indicator Lights 1-5, 1-7, 1-8 Device Faults (DEV) 10-6
Lower Front Cover 1-5, 1-7 Fault Log 5-41
Normally Closed Valve 2-12 Field Service Faults (FSF) 10-6
Sample Aspiration Probe 1-5, 1-7, 1-8 Not Ready
Touch Plate 1-5, 1-7, 1-8 See Diagnostics 10-6
Upper Front Cover 1-5, 1-7, 1-8 Status Box 10-6
[FAULT LOG] 5-42, 5-50, 5-74, 10-6
G [HELP/ERROR] 5-50, 5-74, 6-12
[HELP] 5-41, 5-50, 10-6
Glossary Glossary-1 [LEAVE HELP] 5-41, 5-50
GRAN 1-4 Hemoglobin Analysis 3-8
Granulocyte 1-4 Hemoglobin Measurement 3-21
GRAN R3 or RM 10-33 modified Methemoglobin method 3-21
GRAN R4 or RM 10-33 Hemoglobin Measurement Process 3-21
Greater than symbols (>>>>) 3-26, 4-13, 10-31 absorbency 3-21
Guidelines for Running Controls 11-3 Hemoglobin Parameters 1-4
shifts 11-3 Hemogram Parameters 4-15
trends 11-3 Precision check 4-15
HGB 1-4, 4-11, 6-6
H Hemoglobin 1-4
hemoglobin 6-6
Handling Disposing of Biohazardous Material 8- HGB Flow Cell Assembly 1-11
3 High Control 11-14
infectious substances 8-3 High Control file 11-14
liquid waste 8-3 High MCV with high MCHC results 10-33
medical waste 8-3 High MCV with low MCHC (or high MCH)
sharps 8-3 results 10-34
solid waste 8-3 High PLT 10-34

9140390E—June 2008
Index
High WBC 10-34 Instrument Rinsing 3-9

Histograms 5-9 von Behrens RBC/PLT Transducer 3-9
How to Use How to Use-1 von Behrens WBC Transducer 3-9
Instrument Start Up 5-3
I Auto Start-Up 5-3
Automatic Shutdown 5-3
Impedance aperture plate clog 10-22 STANDBY 5-3
Imprecise or inaccurate patient results 10-35 Intended Use 1-3
in vitro 1-1 Interface specifications 4-1
Inaccurate HGB readings 10-36 Interleaved 2 of 5 D-5
Inaccurate patient results with different Interpreting X-B Results 11-31
Operator 10-36
Inaccurate results due to possible undetected
crack 10-36
K
Inaccurate sample dilution 10-22 Keypad selection entry not accepted 10-24
Inaccurate WBC/HGB reading 10-36
Incomplete Printout 10-59 L
Incomplete printout 10-23
Inconsistent formation of bubbles in the flow LAB ID SETUP 5-29
system 10-23 Lab ID Setup 5-29
Incorrect specimen ID on reports 10-24 Left Side Panel 1-5, 1-12
Index of Error Messages and Conditions 10-17 Detergent Inlet Tubing Connector 1-5
Initial Preparation 2-3 Diluent Inlet Tubing Connector 1-5
Accessory Kit 2-3 Diluent Syringe 1-5
Inventory 2-3 Lyse Inlet Tubing Connector 1-5
Initialization 10-5 Lyse Syringe 1-5
[INITIALIZATION] 10-5 Normally Closed Valve 1-5
[PRIME/RUN] 10-5 Reagent Inlet Panel 1-12
Initializing the System 10-15 Sample Syringe 1-5
Initialization 10-15 Syringe Panel 1-12
Inspection and Tubing Installation 2-9 Waste Outlet Tubing Connector 1-5
tubing 2-9 Waste Sensor Connector 1-5
Installation 2-7 Levey-Jennings 11-15, 11-16
Installation Procedures and Special [LEVEY-JENNINGS] 11-16
Requirements 2-1 Levey-Jennings Graphs 11-33
Installing the Aspiration Probe 9-56, 9-62 Levey-Jennings 11-33
Installing the Aspiration Probe Wash Block 9-67 Westgard® Rule 11-33
Installing the Diluent Syringe 9-73 [QC RANGE] 11-33
Installing the Lyse Syringe 9-87 Linearity 4-13
Installing the RBC/PLT Aperture Plate 9-47 control material 4-13
Installing the Sample Syringe 9-82 fL 4-14
Installing the WBC Aperture Plate 9-48 imprecision 4-13
REFILL BATHS 9-48 Linearity Specifications 4-14
Instrument Disclaimer ii Liquid Crystal Display (LCD) Screen/Membrane
Instrument flooded with diluent 10-24 Keypad 1-17
Instrument Labeling vii List mode data corrupt 10-24

9140390E—June 2008
Index
Location Requirements 7-1 [PRIME/RUN] 5-3

reagent containers 7-2 MCH 1-4
reagent line 7-2 Mean Cell Hemoglobin 1-4
waste outlet tubing 7-2 MCH and MCHC Determination 3-9
Low Control 11-12 MCHC 1-4
Low Control file 11-12 Mean Cell Hemoglobin Concentration 1-4
Low PLT 10-37 MCV 1-4, 3-17, 6-6
Low WBC 10-37 Mean Cell Volume 1-4
Lower Front Cover 2-14 mean cell volume 6-6
remove 2-14 microhematocrit 6-6
Lower/Upper Acceptance Limits 11-30 Packed Cell Volume 6-6
Action Limit 11-30 MCV, HCT, RDW Determination 3-8
Target Value 11-30 Hematocrit 3-8
LRI 10-41 Mean and Factor Failures 10-57
LRI URI 10-42 [ABANDON] 10-57
Luer-Lok® 9-71 [RESET FACTORS] 10-57
LYM 1-4 Measurement Channel 4-11
Lymphocyte 1-4 impedance 4-11
LYM R0 or RM 10-42 Measurement Specifications 4-11
LYM R1 10-43 microcytic RBCs 3-15
LYM R2 10-37 micropipette 6-32, 6-34
Lyse Empty 10-51 MID 1-4
Lyse Inlet Tubing Connector 1-13 Mid-range 1-4
MID R2 or RM 10-37
M MID R3 or RM 10-38
Mode-to-Mode Bias 4-16
MAIN 5-11, 5-50, 5-74, 6-12, 9-13, 9-14, 10- Modified methemoglobin
6, 10-9 (hemoglobincyanide) 7-3
MAIN MENU 5-6, 5-8 Modified Westgard® Rules for the CELL-DYN
Operator ID 5-6 1800 11-34
status box 5-6 Monthly Maintenance Procedures 9-25
[CALIBRATION] 5-7 More 9-13, 9-14, 10-9
[DATA LOG] 5-7 [MORE] 9-13, 9-14, 10-5
[DIAGNOSTICS] 5-7 More Level 1
[HELP/ERROR] 5-7 [SMOOTHING OFF] / [SMOOTHING
[PRIME/RUN] 5-7 ON] 10-7
[QUALITY CONTROL] 5-7 More Level 2
[SETUP] 5-7 [PROBE HOME] / [PROBE DOWN] 10-8
[SPECIAL PROTOCOLS] 5-7 More Level 3
Maintenance 12-1 [SYSTEM STATUS] / [CLEAR
Maintenance Log 9-9 ALARM] 10-9
Manual Construction How to Use-3 More (Level 1)
Manual Organization How to Use-1 [HELP/ERROR] 10-7
Manual Start-Up Procedure 5-3 [MAIN] 10-7
reagent tubing 5-3 [MORE] 10-7
status box 5-3 [PLT HISTOGRAM] 10-7

9140390E—June 2008
Index
[PRINTER OUTPUT] 10-7 O

[RBC HISTOGRAM] 10-7
[WBC HISTOGRAM] 10-7 Observed or Mechanical Errors or Condition 10-
More (Level 1) DIAGNOSTICS menu 10-7 17
More (Level 2) OBSERVED or MECHANICAL Errors or
[HELP/ERROR] 10-8 Conditions 10-20
[MAIN] 10-8 Obtaining Technical Assistance 10-12
[MORE] 10-8 expiration dates 10-12
[PRINTER OUTPUT] 10-8 reagents 10-12
More (Level 2) DIAGNOSTICS menu 10-8 Obtaining Technical Assistance or Parts 9-34
More (Level 3) customer support 9-34
[FAULT REPORT] 10-9 Opening/Removing Front Covers 2-14
[HELP/ERROR] 10-9 Diluent Normally Closed Valve 2-16
[MAIN] 10-9 HGB Flow Cell Assembly 2-16
[MORE] 10-9 Pre-Amplifier Module 2-16
[PRINTER OUTPUT] 10-9 Pre-Mixing Cup 2-16
[SERVICE DEC CODE] 10-9 RBC/PLT Metering Assembly 2-16
[SERVICE HEX CODES] 10-9 Sample Aspiration Probe 2-16
More (Level 3) DIAGNOSTICS menu 10-9 Start Switch 2-16
Moving the Instrument Vent Lines 2-16
Background Counts 2-19 von Behrens RBC/ PLT Transducer
Shut down 2-19 Assembly 2-16
MPV 1-4 von Behrens WBC Transducer Assembly 2-
Mean Platelet Volume 1-4 16
MPV (Factory Calibration Only) 6-1 Wash Block 2-16
MPV, PCT, PDW Determination 3-8 WBC Metering Assembly 2-16
algorithm 3-8 Operating Environment 4-9
standard deviation 3-8 Operating Instructions 5-1
Overview 5-1
Operational Precautions and Limitations 7-1
N in vitro 7-1
New Calibration Factor 6-22 Limitations 7-1
no message 10-29 Overview 7-1
No power 10-25 Operational Specifications 4-9
No screen display 10-25 Operative Range 4-5
No screen labels displayed 10-25 Operator ID 2-17, 5-53
Normal Control 11-13 output devices 5-9
Normal Sample Guideline F-1
Normally Closed Valve 1-13 P
Normally Closed Valves 2-12
Front Panel 2-12 Paper Feed Failure 10-59
Left Side Panel 2-12 Parameter Data Flags 3-25
Not Ready parameter flagging message 3-25
See Diagnostics message 10-52 Parameter Reporting Conventions 3-6
results 3-6
unit of measurement 3-6

9140390E—June 2008
Index
Parameter Reporting Terms 3-7 Calibration Factor 6-24

Parameter Select 5-50 [ENTER FACTOR] 6-24
[PARAMETER SELECT] 5-50 [RESET ALL TO 1.00] 6-24
Patent Statement i [RESTORE FACTORS] 6-24
U.S. Patents i Physical Mechanical Hazards 8-5
Patient Limit 3-25 lifting 8-5
Patient Limit Sets 5-18 protective covers 8-5
alert limits 5-18 Physical Specifications 4-3
panic limits 5-18 Pictorial Disclaimer ii
patient limits 5-18 Platelet Parameters 1-4
[LIMIT SET 1] 5-18 PLT 1-4
[LIMIT SET 2] 5-18 Platelet 1-4
[LIMIT SET 3] 5-18 thrombocyte 1-4
[LIMIT SET 4] 5-18 PLT Histogram 10-7
[PANIC LIMITS] 5-18 platelet 10-7
PATIENT LIMITS 5-11 PLT Measurement 3-15
Patient Limits 5-20 extended count 3-15
PATIENT LIMITS MENU 5-19 microcytic RBCs 3-15
Patient results affected by heat within the PLT Parameters 3-19
instrument 10-26 MPV 3-19
Patient results corrupting 10-26 PCT 3-19
Patient results corrupting transfer from PDW 3-19
instrument to LIS 10-26 PLT Count 3-19
Patient results incorrectly transmitted 10-26 PLT Histogram 3-19
patient specimen 5-44 Plumbed Drain System 9-42
PCT 1-4 poor precision due to inconsistent bubble
Plateletcrit 1-4 mixing 10-35
PDW 1-4 Power Cord Connector 1-14
Platelet Distribution Width 1-4 Power OFF 5-77
Performance Characteristics 4-17 [DAILY SHUTDOWN] 5-77
Performance Specifications 4-13 Power OFF Procedure 10-14
reagent 4-13 [AUTO CLEAN] 10-14
verified 4-13 [DAILY SHUTDOWN] 10-14
Performing a Precision Run 6-14 Power ON Procedure 10-14
Performing a QC Run 11-23 Power Requirements 2-6, 4-5
Sample Aspiration Probe 11-23 BTU/Hr 4-5
[QC TYPE] 11-23 Frequency 4-5
[SPECIMEN TYPE] 11-23 Max Current 4-5
Performing an Auto Calibration Run— Operative Range 4-5
Calibrator 6-16 Voltage 4-5
Performing an Auto Calibration Run—Fresh Power Specifications 4-5
Whole Blood 6-19 Consumption 4-5
Performing an Enter Factor Calibration Run— Pre-Calibration Guidelines 6-13
Calibrator 6-21 expiration date 6-13
Performing an Enter Factor Calibration Run— instrument precision 6-13
Fresh Whole Blood 6-23 normal Background Counts 6-13

9140390E—June 2008
Index
reagent 6-13 Pre-Dilute Method [1/250 DILUTION]—Fresh

Pre-Calibration Procedures Check List C-8 Whole Blood 6-29
Precision 4-15 Pre-Dilute Method [10 mL DISPENSE]—
Precision Check 6-16, 10-56 Calibrator 6-31
Precision Check Failure Pre-Dilute Method [10 mL DISPENSE]—Fresh
> < 10-56 Whole Blood 6-33
PRE-DILUTE 5-44 Pre-Dilute Mode Calibration 6-25
Pre-Dilute 5-48, 6-10 Pre-Mixing Cup Overflow 10-26
opening/removing the Front Cover 5-48 Preparing for Auto Calibration 6-15
[PRE-DILUTE] 5-48, 6-10 [AUTO CAL SELECT] 6-15
Pre-Dilute Aspiration 3-3 [CALIBRATION] 6-15
Pre-Dilute Auto-Cal Procedure—Calibrator 6-36 [CALIBRATOR] 6-15
[CALIBRATOR] 6-36 [PRINT] 6-15
[1/250 DILUTION] 6-36 Preparing the Instrument for Extended Periods of
[10 mL DISPENSE] 6-36 Non-Use or Shipping 9-100
Pre-Dilute Auto-Cal Procedure—Fresh Whole Pressure Limit Time-out 10-52
Blood 6-39 Preventive Maintenance Schedule 9-3
[AUTO CAL SELECT] 6-39 As Required 9-3
[WHOLE BLOOD] 6-39 Daily 9-3
[1/250 DILUTION] 6-39 Monthly 9-3
[10 mL DISPENSE] 6-39 Semiannual 9-3
Pre-Dilute Enter Factor Procedure— Weekly 9-3
Calibrator 6-41 PRIME/RUN 5-7
calibration factor 6-42 Principles of Operation 3-1
Clog 6-41 Overview 3-1
Flow Err 6-41 PRINT 11-17
[ENTER FACTOR] 6-42 Print 6-12
[PRINT QC LOG] 6-41 [PRINT] 6-12
[REPLICATES] 6-41 Print ALERTED LYM/%L, *MID/%M, GRAN/
[RESET ALL TO 1.00] 6-42 %G Results 5-9
[RESTORE FACTORS] 6-42 Print ALERTED PLT Results 5-10
[VIEW QC LOG] 6-41 Print current Date/Time and Software Version 5-
[10 mL DISPENSE] 6-41 10
Pre-Dilute Enter Factor Procedure—Fresh Print Datalog 5-73
Whole Blood 6-43 asterisk [*] 5-73
calibration factor 6-44 histogram 5-73
Clog 6-43 <End Sequence #> 5-73
Flow Error 6-43 <Start Sequence #> 5-73
[PRINT QC LOG] 6-43 [ESC] key 5-73
[REPLICATES] 6-43 [PRINT DATALOG] 5-73
[RESET ALL TO 1.00] 6-44 Print Manual Differential Grid for ALERTED
[RESTORE FACTORS] 6-44 Specimen 5-10
[VIEW QC LOG] 6-43 Print Manual Differential Grid for NON-
[10 mL DISPENSE] 6-43 ALERTED Specimens 5-10
Pre-Dilute Method [1/250 DILUTION]— print options 5-9
Calibrator 6-27 Print PCT, PDW 5-9

9140390E—June 2008
Index
Print QC Log 11-21 Replicate files 11-5

[PRINT QC LOG] 11-21 Prolonged Shutdown 9-17
Print Quality 10-59 Normally Closed Valve 9-17
Print Report 5-50 Proprietary Statement i
[PRINT REPORT] 5-50 Purge QC Log 11-19
Printed Report 3-26 [CANCEL PURGE] 11-19
Printed Report Range 3-25, 3-26, 4-13, 4-14 [CONFIRM PURGE] 11-19
Printer Components 12-1 [PURGE QC LOG] 11-19
Printer Installation 2-7 Purging Control Files 11-27
Self-Test Printouts 2-8 [CANCEL PURGE] 11-27
Printer Maintenance 12-1 [CONFIRM PURGE] 11-27
Printer Not Ready 10-59 [PURGE QC LOG] 11-27
Printer not ready 10-26
Printer NOT READY/PRESS HELP/ERROR Q
KEY 5-50
Printer Operations 12-1 QC Methods 11-1
Printer Output 10-5 Commercial Controls 11-1
[PRINTER OUTPUT] 10-5 Replicate Specimen 11-1
[WBC HISTOGRAM] 10-5 X-B Analysis 11-1
Printer Specifications 12-1 QC SETUP 5-11
A4 paper 12-1 QC Setup 11-5
cartridge 12-1 [QC SETUP] 11-5
changing 12-1 QC specimen results exceed acceptable
ESC-P 12-1 limits 10-38
installing the printer 12-1 QUALITY CONTROL 5-7
parallel port connector 12-1 Quality Control 11-1
PCL-3 12-1 High control 11-5
printer cable 12-1 Low control 11-5
U.S. letter paper 12-1 Normal control 11-5
Printer Troubleshooting 10-59 Overview 11-1, 11-6
Printer Type 5-10 precision 11-1
Printers Program Operation 11-5
Overview 12-1 Replicate files 11-5
Probe Assembly 1-10 [HELP/ERROR] 11-6
Probe Home 10-8 [HIGH CONTROL] 11-6
Probe Home/Probe Down 9-13 [LOW CONTROL] 11-6
[PROBE DOWN] 9-13 [MAIN] 11-6
[PROBE HOME] 9-13 [NORMAL CONTROL] 11-6
Probe not properly washed 10-27 [REPLICATES] 11-6
Probe Up 10-8 [X-B FILE] 11-6
Program Operation 5-5, 11-5 QUALITY CONTROL MENU 11-7
High control 11-5 Quality Control Menu 11-9
Low control 11-5 [HELP/ERROR] 11-6
membrane keypad 5-5 [HIGH CONTROL] 11-6
Normal control 11-5 [LOW CONTROL] 11-6
PC keyboard 5-5 [MAIN] 11-6

9140390E—June 2008
Index
[NORMAL CONTROL] 11-6 reaccept results 5-70

[REPLICATES] 11-6 Reagent Handling 1-19
[X-B FILE] 11-6 Reagent Inlet Panel
Quality Control Procedures 11-3 Detergent 1-12
Quality Control Setup 5-25 Diluent 1-12
asterisk (*) 5-25 Lyse 1-12
Parameter results 5-25 Normally Closed Valve 1-12
QC SETUP menu 5-25 Waste 1-12
quality control results 5-25 Waste Sensor 1-12
[HELP/ERROR] 5-25 REAGENT LOG 5-11, 5-22
[HIGH CONTROL] 5-25 Reagent Log 5-22
[LAB ID SETUP] 5-25 REAGENT LOG MENU 5-23
[LOW CONTROL] 5-25 Reagent Storage 1-19
[NORMAL CONTROL] 5-25 Reagent Storage and Handling 7-3
[REP FILE SETUP] 5-25 hemoglobin 7-3
[RETURN] 5-25 modified methemoglobin
[X-B SETUP] 5-25 hemoglobincyanide 7-3
QUALITY CONTROL SETUP MENU 5-26 Reference Methemoglobin Methodology 7-3
Reagent System 1-18
R CELL-DYN 1800 Reagents 1-18
Reagent Tubing and Waste Line Tubing 2-10
Raw Data 10-5 Black Connector 2-11
[RAW DATA] 10-5 Blue Connector 2-10
RBC 1-4 Blue Lyse label 2-10
erythrocyte 1-4 Detergent Connector (Green) 2-10, 2-11
Red Blood 1-4 Detergent container 2-10
RBC and PLT 4-11 Diluent Connector (Red) 2-10, 2-11
RBC Histogram 10-7 Green Connector 2-10
red blood cell count 10-7 Green Detergent label 2-10
RBC PAGE/WBC/PLT PAGE 11-16 Lyse Connector (Blue) 2-10, 2-11
RBC Parameters 3-17 Normally Closed Valve 2-10
HCT 3-17 reagent line tubing 2-10
MCH 3-17 reagent tubing 2-10
MCHC 3-17 Red Connector 2-10
RBC Count 3-17 Red Diluent label 2-10
RBC Histograms 3-17 Waste Connector (Black) 2-10, 2-11
RDW 3-17 Waste Full 2-11
RBC/PLT Analysis 3-8 waste line tubing 2-10
RBC/PLT Aperture Plate 1-10 Waste Outlet Tubing 2-11
RBC/PLT Measurement 3-15 Waste Sensor Connector 2-10, 2-11
electrical impedance method 3-15 Reagents Contaminated, evaporated 10-22
RBC/PLT Measurement Process 3-15 Rear Panel 1-5, 1-14
Counting Chamber 3-15 Power Cord Connector 1-5
RBC/PLT Metering Assembly 1-10 Red Blood Cell Parameters 1-4
RDW 1-4 Reference Check 6-16, 10-56
Red Cell Distribution Width 1-4 Reference Methods 6-6

9140390E—June 2008
Index
Reference Tables B-1 Calibration 6-5

Region Alerts 3-31 Results are out-of-range immediately after
Regulatory and Safety Agency Approvals ii calibrating 10-39
ETL ii Results Displayed 3-9
In Vitro Diagnostic Directive ii Results highlighted on screen 10-52
Reject from X-B/ 5-70 results reject 5-70
Reject from X-B/Accept to X-B 5-70 Results underlined on printout 10-39
[ACCEPT TO X-B] 5-70 Results very erratic after changing lyse 10-39
[REJECT FROM X-B] 5-70 RETURN 11-17
Rejecting/Accepting Specimens 11-25 Return 11-22
Specimens rejected accepted 11-25 Revision Log How to Use-11
[ACCEPT SPECIMEN] 11-25 Revision Status How to Use-7
[REJECT SPECIMEN] 11-25 Right Side Panel 1-5, 1-15
“R” 11-25 Floppy Disk Drive 1-5, 1-15
Reject/Accept Specimen 11-18 Main Power Switch 1-5, 1-15
[ACCEPT SPECIMEN] 11-18 Parallel Interface Connector 1-5, 1-15
[REJECT SPECIMEN] 11-18 PC Keyboard Connector 1-5, 1-15
Relocation 2-19 RS-232 Serial Interface Connectors (2) 1-5,
Moving the Instrument 2-19 1-15
Removing a Pre-Diluted Solution from the Pre- Rinsing the Lyse Inlet Line 9-25
Mixing Cup 5-62 [CLEAR ALARM] 9-25
[CALIBRATION] 5-62 [LYSE PRIME] 9-25
[DRAIN BATHS] 5-62 Rinsing the Reagent Inlet Line 9-28
[FILL BATHS] 5-62 [CLEAR ALARM] 9-28
[NORMAL BACKGROUND] 5-62 [REAGENT PRIME] 9-28
Removing the Aperture Plates 9-44 Routine Operation 5-43
[DRAIN BATHS] 9-45 BUSY 5-43
[SPECIAL PROTOCOLS] 9-44 READY 5-43
Removing the Aspiration Probe 9-54, 9-60 RUN menu 5-43
Removing the Aspiration Probe Wash Block 9- RS-232 Serial Interface Connectors 1-5
65 Rule of Three F-1
Rep File Setup 5-36 hematocrit F-1
Replicate File Setup 5-36 hemoglobin F-1
Westgard® Rules 5-36 Rule Violations 11-35
Replaceable Components 10-15 Run cycle will not stop 10-28
Replacing Reagents 10-15 RUN MENU 5-47
reagent 10-15 RUN Menu 5-46
Replacing the Diluent Syringe 9-76 [CLEAR ALARM] 5-46
replicate ID/lot number 11-15 [CLEAR ORIFICE] 5-46
Replicates 11-15 [HELP/ERROR] 5-46
Reportable Range Limit 3-25 [MAIN] 5-46
Requirements for Fresh Whole Blood [PARAMETER SELECT] 5-46
Specimens 6-5 [PRE-DILUTE] 5-46
anticoagulant 6-5 [PRINT REPORT] 5-46
collection volume 6-5 [SPECIMEN TYPE] 5-46
Requirements for Reference Whole Blood Run Menu Screen Display

9140390E—June 2008
Index
Auto Increment function 5-44 Sample Data Log Report E-1

patient specimen 5-44 Sample Fault Log Report E-5
Status Box 5-44 Sample Levey-Jennings Report E-4
<Cmt Sample Logs and Worksheets C-1
> 5-44 Sample QC Log File Report E-1
<Collected><at> 5-44 Sample Reports E-1
<DOB Sample Specimen Data Report (Abnormal
> 5-44 Specimen) E-3
<Dr> 5-44 Sample Specimen Data Report (Normal
<Next ID# Specimen) E-2
> 5-44 Sampling Section 1-9
<Patient Diluent Normally Closed Valve 1-9
> 5-44 HGB Flow Cell Assembly 1-9
<Sex (M/F) Pre-Amplifier Module 1-9
> 5-44 Pre-Mixing Cup 1-9
[PRE-DILUTE] 5-44 RBC/PLT Metering Assembly 1-9
Run Screen Display Menu 5-44 Start Switch 1-9
Running a Background Count 5-43 Vent Lines 1-9
Running Specimens 5-57 von Behrens RBC/ PLT Transducer
aspiration probe 5-57 Assembly 1-9
Automatic Graphics Printout 5-58 von Behrens WBC Transducer Assembly 1-9
Touch Plate 5-57 Wash Block 1-9
Running Specimens—Pre-Dilute Mode 5-59 WBC Metering Assembly 1-9
aliquot 5-60 Scanner Not Responding 10-61
Counting Cup 5-59 Screen Messages 10-19, 10-45
Pre-Dilute Mode 5-60 Second Level Subfunction Keys 9-14
Pre-Mixing Cup 5-60 Selecting Display and Print Options 5-13
sample aspiration probe 5-59 Printer Type 5-13
[PRE-DILUTE] 5-60 Selecting Westgard® Rules 5-33
[PRINT REPORT] 5-61 Semi-annual Maintenance Procedures 9-31
[SPECIAL PROTOCOLS] 5-59 Sequence Number 2-17
1/250 dilution 5-59 sequence number 5-70
Service and Maintenance 9-1
S Background Counts 9-1
flow panel 9-1
Safety How to Use-6 Overview 9-1
Safety Icons 8-1 preventive maintenance procedure 9-1
biohazard symbol 8-1 Service Dec Code 10-9
electrical hazard symbol 8-1 Service Hex Codes 10-9
general hazard symbol 8-1 Setting Up a Replicate File
Sample Analysis Cycle Overview 3-3 [FILE SETUP] 5-37
Aspiration 3-3 [REP FILE SETUP] 5-37
Dilution 3-3 SETUP 5-7, 5-11
Sample Aspiration Probe 3-3 Setup Information for Check Digits D-13
sample aspiration probe 1-1, 5-43 Setup Instructions 5-9
Sample carryover 10-27 SETUP MENU 5-12

9140390E—June 2008
Index
SETUP Menu [DRAIN BATHS] 9-13

[COMPUTER SETUP] 5-11 [FAULT LOG] 9-13
[DATE/TIME] 5-11 [HELP ERROR] 9-13
[HELP/ERROR] 5-11 [HELP] 9-13
[MAIN] 5-11 [LEAVE HELP] 9-13
[PATIENT LIMITS] 5-11 [MAIN] 9-13
[QC SETUP] 5-11 [MORE] 9-13
[REAGENT LOG] 5-11 [PROBE DOWN] 9-13
[UNITS SELECTION] 5-11 [PROBE HOME] 9-13
Show Data/Show Graphs 11-10 [REFILL BATHS] 9-13
[SHOW DATA] 11-11 [RESTORE SYRINGE] 9-13
[SHOW GRAPHS] 11-10 [SYRINGE DOWN] 9-13
Shut down 2-19 First Level Subfunction Keys When [MORE]
Signal Words 8-1 is Pressed 9-13
CAUTION 8-1 Second Level Subfunction Keys
DANGER 8-1 [CLEAN FOR SHIPPING] 9-14
NOTE 8-1 [HELP ERROR] 9-14
WARNING 8-1 [MAIN] 9-14
Smoothing Off/On 10-7 [MORE] 9-14
histogram 10-7 [1/250 DILUTION] 9-14
SoftKeys [1/50 DILUTION] 9-14
[ACCEPT TO X-B] 5-70 [10 mL DISPENSE] 9-14
[Cancel LOAD] 5-34, 5-35 Second Level Subfunction Keys When
[CLEAR ALARM] 5-48 [MORE] is Pressed Twice 9-14
[DATE/TIME] 5-15 SPECIAL PROTOCOLS MENU 9-12
[ELECTRICL BACKGRND] 10-30 Special Protocols Menu 9-11
[FAULT LOG] 5-50 [AUTO CLEAN] 9-11
[HELP] 5-41 [DAILY SHUTDOWN] 9-11
[LEAVE HELP] 5-41, 5-50 [HELP/ERROR] 9-11
[PARAMETER SELECT] 5-50 [LYSE PRIME] 9-11
[PRINT REPORT] 5-50 [MAIN] 9-11
[REJECT FROM X-B] 5-70 [MORE] 9-11
[SHOW DATA] 11-11 [REAGENT PRIME] 9-11
[SHOW GRAPHS] 11-10 Specimen Analysis 5-51
[SPECIAL PROTOCOLS] 5-7, 6-27, 6-31, Specimen clotted or hemolyzed 10-28
6-33 Specimen Collection 5-52
[SPECIMEN TYPE] 5-54, 10-30 minimum 5-52
[1/250 DILUTION] 6-28 specimens 5-52
[10mL DISPENSE] 6-31 Specimen Collection and Handling 5-1
Solenoid valve failure 10-27 Specimen ID 5-54
Space Requirements 2-4 [PATIENT SPECIMEN] 5-54
Special Protocols [SPECIMEN TYPE] 5-54
First Level Subfunction Keys Specimen Stability 5-52
[CLEAN DIL SYRINGE] 9-13 anticoagulant 5-52
[CLN LYSE SYRINGE] 9-13 whole blood 5-52
[CLN SAMPL SYRINGE] 9-13 Specimen Tubes 1-10

9140390E—June 2008
Index
Specimen Type 5-49 lysis 3-26

Aperture 5-49 Nucleated RBCs 3-26
Electrical Background 5-49 RM 3-26
Help/Error 5-50 URI 3-27
Normal Background 5-49 Suspect Population Flags 3-27
Patient Specimen 5-49 Agranular neutrophils 3-29
QC (Quality Control) Type 5-49 Cryoglobulins 3-28
Return 5-50 Eosinophilia 3-29
[ELECTRICL BACKGRND] 5-49 GRAN R3 or RM 3-29
[HELP/ERROR] 5-49, 5-50 GRAN R4 or RM 3-29
[HELP] 5-50 Granulocytosis 3-29
[HIGH CONTROL] 5-49 Hypersegmented neutrophils 3-29
[LOW CONTROL] 5-49 Immature granulocytes 3-29
[NORMAL BACKGRND] 5-49 LYM R1 3-28
[NORMAL CONTROL] 5-49 LYM R2 3-28
[PATIENT SPECIMEN] 5-49 MID R2 or RM 3-28
[QC CONTROL FILES] 5-49 MID R3 or RM 3-29
[QC TYPE] 5-49 Monocytosis 3-28
[REPLICATES] 5-49 Neutropenia 3-29
[RETURN] 5-49, 5-50 RM 3-27
[SPECIMEN TYPE] 5-49 Symbols v
Specimen will not aspirate 10-28 Syringe Panel
specimens 11-15 Diluent Syringe 1-12
Specimens accepted 11-25 Lyse Syringe 1-12
Specimens rejected 11-25 Sample Syringe 1-12
Spuriously high HGB, MCH, or MCHC Syringes 1-13
results 10-40 System Components 1-5
Spuriously low HGB, MCH, or MCHC System Status 10-9
results 10-41 System-Initiated Messages 3-24
standard deviation 3-8 alarm condition 3-24
StartUp 2-17 clean the aperture plates 3-24
Counting Chambers 2-17 fault condition 3-24
INITIALIZED 2-17 FLOW ERR 3-24
Normal Background 2-17 No display for measured parameters 3-24
power ON 2-17 status condition 3-24
status box 2-17 [CLEAR ORIFICE] 3-24
Status Condition message 10-52 [REAGENT PRIME] 3-24
Supplemental Aperture Cleaning 9-97 System-Initiated Messages and Data Flags 3-23
CLOG 9-98
FLOW ERROR 9-98 T
Suspect Parameter Flags 3-26
Background Count 3-27 Target Value 11-30
Cryoglobulins 3-26 Text Conventions How to Use-4
LRI 3-27 Menu Name How to Use-4
LRI URI 3-27 PC Keyboard (Keys) How to Use-4
LYM R0 or RM 3-26 Screen Messages How to Use-4

9140390E—June 2008
Index
Softkeys How to Use-4 Using Quality Control 11-10

Text Conventions Data Entry Field Names How [HIGH CONTROL] 11-10
to Use-4 [LOW CONTROL] 11-10
Touch Plate 5-43, 11-23 [NORMAL CONTROL] 11-10
Trademark Statements iv [REPLICATES] 11-10
transfer from instrument to LIS 10-26 Using the Data Log 5-63
transfer QC data 11-20 Overview 5-63
transmission 10-21 Specimen results 5-63
Transmit Data 5-71 Using the SETUP Menu 5-9
histogram 5-72 Automatic Graphics Printout 5-10
[CANCEL TRANSMIT] 5-71 Automatic Increment of Specimen ID
[CONFIRM TRANSMIT] 5-71 Number 5-9
[DISPLAY SPECIMEN] 5-72 header 5-10
[ESC] 5-71 Histograms 5-9
[TRANSMIT DATA] 5-71 output devices 5-9
[TRANSMIT SPECIMEN] 5-72 Print ALERTED LYM/%L, *MID/%M,
Transport and Storage Specifications 4-5 GRAN/%G Results 5-9
Troubleshooting 10-11 Print ALERTED PLT Results 5-10
Corrective Action 10-11 Print current Date/Time and Software
Problem Identification 10-11 Version 5-10
Problem Isolation 10-11 Print Manual Differential Grid for
Troubleshooting and Diagnostics 10-1 ALERTED Specimens 5-10
alarm condition 10-1 Print Manual Differential Grid for NON-
Overview 10-1 ALERTED Specimens 5-10
Troubleshooting Procedures 10-14 print options SETUP 5-9
Troubleshooting Tips and Techniques 10-12 Print PCT, PDW 5-9
Printer Type 5-10
U X-B Moving Average Program 5-9
Understanding the Label’s Code D-4

Check Digit D-4
V
Intercharacter Gaps D-4 Vacuum Accumulator 9-90
Interpretation Line D-4 Vacuum Limit Time-out 10-53
Quiet Zone D-4 Values Exceeded 10-56
Start and Stop Characters D-4 VIEW QC LOG 11-12, 11-13, 11-14, 11-15
undetected crack around orifice of aperture plate View QC Log 11-15
Inaccurate results 10-36 Volumetric Metering 3-4
UNITS SELECTION 5-11 cell count 3-4
Units Selection 5-40 CLOG 3-4
Unpacking 2-4 FLOW ERR 3-4
Unreliable patient results due to drifting von Behrens RBC/PLT Transducer Assembly 1-
values 10-43 10
Upper Front Cover 2-14 Aperture Plate 1-10
open 2-14 Counting Chamber 1-10
URI 10-42 von Behrens WBC Transducer Assembly 1-11
Use or Function 1-1

9140390E—June 2008
Index
W Westgard® Rule Analysis 11-34

Westgard® Rules 11-34
Warning Conventions 8-1 Westgard® Rule violation 10-44
Wash Block 1-10 Westgard® Rules 5-33
Waste accumulation in the pump 10-29 Westgard“ Rules for the CELL-DYN 1800 11-34
Waste container contaminating the entire flow When to Calibrate 6-1
system 10-29 Bull’s Moving Average Program (X-B) 6-1
Waste container overflow 10-29 commercial patient controls 6-1
Waste Disposal Requirements 2-5 When to Run QC 11-1
Waste full but no message displayed 10-29 reagent 11-1
Waste Full message 10-53 shift 11-1
alert 10-53 trend 11-1
Waste Outlet Tubing Connector 1-13 White Blood Cell Parameters 1-4
Waste Sensor Connector 1-13 %GRAN 1-4
WBC 1-4 %LYM 1-4
leukocyte 1-4 %MID 1-4
WBC Analysis 3-8 WHOLE BLOOD CALIBRATION 10-57
aperture 3-8 Whole Blood Calibration 6-4
basophils 3-8 Whole Blood Calibration Guidelines 6-4
blasts 3-8 Within-Sample Precision 6-14
Electrical impedance 3-8 Precision 6-14
eosinophils 3-8 Write QC to Disk 11-20
granulocytes 3-8 transfer data and QC limits 11-20
lymphocytes 3-8 [CANCEL WRITE] 11-20
monocytes 3-8 [CONFIRM WRITE] 11-20
neutrophils 3-8 [QUALITY CONTROL] 11-20
WBC and Differential 4-11
WBC and/or HGB data is invalid 10-43
WBC Differential Parameters 4-15 X
GRAN 4-15 X-B Analysis Program 11-29
LYM 4-15 accept results 5-70
MID 4-15 algorithm 11-29
WBC Histogram 3-13, 10-7 Bull Algorithm 11-29
white cell count 10-7 hemoglobin 11-29
WBC Measurement 3-11 indices 11-29
electrical impedance method 3-11 Overview 11-29
WBC Measurement Process 3-11 red blood cells 11-29
Counting Chamber 3-11 reject results 5-70
WBC Metering Assembly 1-11 status 11-29
WBC Parameters 3-13 X-B 11-29
WBC, RBC, and PLT 6-6 N/IN 11-29
platelets 6-6 X-B Analysis 5-70, 11-29
red blood 6-6 “B” 11-29
white blood 6-6 X-B data are out for MCH and/or MCHC 10-44
Weekly Maintenance Procedures 9-19 X-B data are out for MCV 10-44
Westgard® Rule 11-17 X-B Data Display 11-11

9140390E—June 2008
Index
X-B File 11-10

Show Data 11-10
Show Graphs 11-10
X-B Moving Average Program 5-9, 5-70
X-B Results 11-31
X-B SETUP 5-27
X-B Setup 5-27
Changing Values 5-27
X-B (Moving Average) program 5-27
Symbols
(>>>>) 3-26
<End Sequence #> 5-71
<NEXT ID#> 5-55
<Sequence #> 11-18
<Start Sequence #> 5-71
<Value field> 6-15
<<< (under range) 10-56
> > > > “greater than” symbols 3-26
>>> (over range) 10-56
“B” 5-70
“greater than” symbols (>>>>) 10-56
“R” 5-70, 11-18
”Greater than” symbols (>>>>) 10-31

9140390E—June 2008
Index
NOTES

9140390E—June 2008

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Introduction

CELL-DYN® 1800 System Operator’s Manual i

Regulatory and Safety Agency Approvals

ii CELL-DYN® 1800 System Operator’s Manual

CELL-DYN® 1800 System Operator’s Manual iii

iv CELL-DYN® 1800 System Operator’s Manual

BUSY Busy LYSE Lyse

COM1 Communication Port 1 MAX POWER Maximum Power

COM2 Communication Port 2 MODEL Model Number

Electrical Hazard POWER Power

DETERGENT Detergent Reagent READY Ready

DILUENT Diluent Reagent REV Revision

FAULT Fault SERVICE DISK Service disk

FREQUENCY Frequency SN Serial number

INSTALLATION DISK Installation Disk WASTE Waste

KEYBOARD Keyboard WASTE SENSOR Waste sensor

LINE VOLTAGE Line Voltage

LPT1 First Parallel Printer

CN-FREE DIFF LYSE Cyanide-Free Differential Lyse

DETERGENT Detergent Reagent

DILUENT Diluent Reagent

ENZYMATIC CLEANER CONCENTRATE Enzymatic Cleaner Concentrate

LOT Batch Code

CELL-DYN® 1800 System Operator’s Manual v

ASSAY VALUE Assay Value

CONTROL ASSAY DISK Control Assay Disk

CN-FREE DIFF LYSE Cyanide-Free Differential Lyse

MEAN RANGE Mean Range

MEAN VALUE Mean Value

TOLERANCE LIMIT Tolerance Limit

WB CAL Whole Blood Calibrator

WB CONTROL L Whole Blood Control, Low Level

WB CONTROL N Whole Blood Control, Normal Level

WB CONTROL H Whole Blood Control, High Level

WB CONTROL TRI-LEVEL Whole Blood Control, Tri-Level

EC REP Authorized Representative in the European Community

REF Catalog Number

IVD In Vitro Diagnostic Medical Device

Consult instructions for use

vi CELL-DYN® 1800 System Operator’s Manual

Separate collection for electrical and electronic equipment waste per

The CELL-DYN 1800 System is CE Marked to the European In Vitro Diagnostic

ABBOTT DIAGNOSTICS DIVISION

Serial Number Label, Rear Panel

CE Mark Label, Rear Panel

CELL-DYN® 1800 System Operator’s Manual vii

Reagent Handling (Inlet) Label, Left Panel

CAUTION: Consult instructions for use.

Syringe Panel Label, Left Panel

Biological Risk Label, Front Panel and Reagent Inlet Panel

Biohazard Label, Front Panel and Reagent Inlet Panel

viii CELL-DYN® 1800 System Operator’s Manual

Caution 10 mL Syringe Label, Front Panel Membrane Keypad

CAUTION: When removing

Aperture Plate Removal Label (Front), Flow Panel

ATENO: retirar a placa da abertura com

Consultar as instrues de utilizao.

Aperture Plate Removal Label (Back), Flow Panel

CELL-DYN® 1800 System Operator’s Manual ix

x CELL-DYN® 1800 System Operator’s Manual

How to Use This Manual. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . How to Use-1

Use or Function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1

CELL-DYN® 1800 System Operator’s Manual Master Table of Contents-1