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Abbott - Cell Dyn - 3700 - User Manual
Abbott - Cell Dyn - 3700 - User Manual
Introduction
Foreword . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i
Customer Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i
Proprietary Statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i
Patent Statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ii
Instrument Disclaimer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ii
Pictorial Disclaimer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ii
Abbott Instrument Warranty . . . . . . . . . . . . . . . . . . . . . . . . iii
Safety Agency Approvals . . . . . . . . . . . . . . . . . . . . . . . . . . . . iv
Trademark Statements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iv
Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iv
Instrument Labeling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . viii
Conventions Used in This Manual . . . . . . . . . . . . . . . . . . . xiii
Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xv
Revision Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xvi
Revision Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xix
Chapter 2: Installation
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
Initial Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Inventory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Package Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Space Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4
Waste Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5
Power Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5
Chapter 6: Calibration
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-1
When to Calibrate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
Open and Closed Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2
Calibration Methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3
Calibration Materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3
Calibration Procedural Summary . . . . . . . . . . . . . . . . . . . 6-11
Conventions Used in this Chapter . . . . . . . . . . . . . . . . . . 6-11
Calibration Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-13
Calibration Menu Flowchart . . . . . . . . . . . . . . . . . . . . . . 6-13
Calibration Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-14
Open Sampler/Closed Sampler Soft Key . . . . . . . . . . . . . 6-15
Print Soft Key . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-15
Main Soft Key . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-16
Enter Factor Soft Key . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-16
Calibration Log Soft Key . . . . . . . . . . . . . . . . . . . . . . . . . . 6-18
Auto-Calibrate Soft Key . . . . . . . . . . . . . . . . . . . . . . . . . . 6-19
Pre-Calibration Procedures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-27
Calibration Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-27
Pre-Calibration Procedures Checklist . . . . . . . . . . . . . . . . 6-29
Auto-Cal Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-33
Auto-Cal Sample Capacity . . . . . . . . . . . . . . . . . . . . . . . . 6-34
Auto-Cal Methodology . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-34
Calibration Requirements for Auto-Cal . . . . . . . . . . . . . . 6-35
Auto-Cal Using Calibrator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-37
Starting Auto-Cal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-37
Entering the Reference Values . . . . . . . . . . . . . . . . . . . . . 6-37
Collecting the Calibration Data . . . . . . . . . . . . . . . . . . . . 6-38
Calibration Factor Calculation . . . . . . . . . . . . . . . . . . . . . 6-40
Determining Which Parameters Need Calibration . . . . . 6-41
Calibrating All Parameters . . . . . . . . . . . . . . . . . . . . . . . . 6-43
Calibrating Individual Parameters . . . . . . . . . . . . . . . . . . 6-44
Completing Open Mode Calibration . . . . . . . . . . . . . . . . 6-44
Auto-Cal Calibration Criteria Worksheet . . . . . . . . . . . . . 6-45
Chapter 8: Hazards
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-1
Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
Warning Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
Hazard Information and Precautions. . . . . . . . . . . . . . . . . . . . . . .8-3
General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3
Biohazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3
Handling and Disposing of Biohazardous Materials . . . . . 8-4
Chemical Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4
Electrical Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5
Physical and Mechanical Hazards . . . . . . . . . . . . . . . . . . . 8-6
Laser Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-6
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-11
Chapter 9: Maintenance
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-1
Preventive Maintenance Schedule . . . . . . . . . . . . . . . . . . . 9-2
Analyzer Flow Panel Components Diagram . . . . . . . . . . . . 9-2
Decontamination Procedures . . . . . . . . . . . . . . . . . . . . . . . 9-4
Special Protocols Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-5
Emptying the Transducers . . . . . . . . . . . . . . . . . . . . . . . . . 9-6
Draining the Reagent Reservoirs . . . . . . . . . . . . . . . . . . . . 9-7
Accessing the Maintenance Log . . . . . . . . . . . . . . . . . . . . . 9-8
Accessing the Shear Valve . . . . . . . . . . . . . . . . . . . . . . . . . . 9-9
Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-27
Procedure: MCV or MPV Calibration . . . . . . . . . . . . . . . 13-28
Pre-Calibration Procedures . . . . . . . . . . . . . . . . . . . . . . . 13-28
Determining the Calibration Factors for MCV and MPV 13-29
Entering the Calibration Factor . . . . . . . . . . . . . . . . . . . 13-29
Quality Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-31
Adding New Animal Types . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-33
Adding a New Configuration File . . . . . . . . . . . . . . . . . . 13-34
Customizing the Display . . . . . . . . . . . . . . . . . . . . . . . . 13-36
Turning on the Gains Template . . . . . . . . . . . . . . . . . . . 13-37
Preparing the Samples . . . . . . . . . . . . . . . . . . . . . . . . . . 13-38
Running the Samples . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-38
Determining the Variance . . . . . . . . . . . . . . . . . . . . . . . 13-39
Baso Box Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-46
Vet Package Suggestions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-49
Examples of Customer-Defined Default Codes . . . . . . . 13-50
Turning The Vet Package Off . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-53
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-55
Bibliography
Bibliography . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Bibliography-1
Appendix C
Appendix C . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Appendix C-1
List of Figures
Figure 5.46: Data Log Screen Showing Accept Into X-B Key 5-128
Figure 5.47: Customize Display for Data Log Screen . . . . . . 5-129
Figure 5.48: Customize Display Showing Standard Groups . 5-130
Figure 5.49: Customize Printout for Data Log Screen . . . . . 5-132
Figure 5.50: Print Data Log Screen . . . . . . . . . . . . . . . . . . . . 5-134
Figure 5.51: Customize Display for Data Log Screen
Showing Standard Groups . . . . . . . . . . . . . . . . . . . . . . . . 5-135
Figure 5.52: Customize Printout for Data Log Screen
Showing Customized Print Group . . . . . . . . . . . . . . . . . . 5-138
Figure 5.53: Display Specimen Screen . . . . . . . . . . . . . . . . . 5-140
Figure 5.54: Edit Specimen Screen . . . . . . . . . . . . . . . . . . . . 5-142
List of Tables
NOTES
Customer Service
United States: 1 (877) 4ABBOTT or 1 (877) 422-2688
For customers outside the US, call your local Customer Service
Representative.
Intended Use
The CELL-DYN 3700 System is a multiparameter, automated
hematology analyzer designed for in vitro diagnostic use in
clinical laboratories.
Proprietary Statement
The entire contents are copyright 2000, 2003, 2004, and 2007 by
Abbott Laboratories. Abbott Laboratories’ software programs are
protected by copyright. All rights are reserved. This software was
developed solely for use with Abbott Laboratories’ equipment and
for in vitro diagnostic applications as specified in the operating
instructions. No part of this document may be reproduced, stored,
or transmitted in any form or by any means (electronic,
mechanical, photocopied, recorded, or otherwise) without the
prior written permission of Abbott Laboratories.
Instrument Disclaimer
All operating instructions must be followed. In no event shall
Abbott be responsible for failures, errors, or other liabilities
resulting from customers’ 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.
UL 61010A-1 Approved
CSA C22.2 No. 1010.1 Approved
IEC 1010-1 Approved
Trademark Statements
CELL-DYN, and CELL-DYN HemCal are registered trademarks of
Abbott Laboratories.
MAPSS is a trademark of Abbott Laboratories.
CONTRAVES, COULTER, EPSON, EPSON STYLUS, HEMOGARD,
Luer-Lok, MICROLINE, OKIDATA, PLEXIGLAS, TEFLON, TYGON,
VACUTAINER, and Westgard are not trademarks of Abbott
Laboratories.
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 Chapter 8: Hazards.
Off
ON
HGB Hemoglobin
8oC
Storage temperature. (Example shows “Store at 2º–8ºC”)
2 oC
Calibrator/Control related
CONTROL Control
PARAMETER Parameter
SYSTEM System
Miscellaneous
Legal Manufacturer
Manufacturer
Date of Manufacture
DANGER
GEFAHR DANGER
PELIGRO PERICOLO
ABBOTT DIAGNOSTICS
A wholly owned subsidiary of Abbott Laboratories
Abbott Park IL. 60064
THIS PRODUCT CONFORMS TO
THE APPLICABLE REQUIREMENTS
OF 21 CFR SUBCHAPTER J
AT THE DATE OF MANUFACTURE
MANUFACTURED DATE
MODEL NO.
SERIAL NO.
CE Label
PN 9230334
CAUTION –
CLASS 3B LASER LIGHT WHEN OPEN.
AVOID EXPOSURE TO BEAM.
PN 9230701
DATE OF MANUFACTURE
Biological Risk
PN 9231446
ABBOTT
Max-Planck-Ring 2
65205 Wiesbaden
Germany
+49-6122-580 PN 9230751A
WARNING: SET FOR 120 VOLTS / ACHTUNG: FR 120 VOLT EINGESTELLT /
MISE EN GARDE : UTILISATION A 120 VOLTS / ADVERTENCIA: 120 VOLTIOS /
AVVERTENZA: CONFIGURATO A 120 VOLT / AVISO: CONFIGURADO PARA 120 VOLTS /
ADVARSEL: KONFIGURERET TIL 120 V / VARNING: INSTLLD FR 120 VOLT /
ΠΡΟΕΙΔΟΠΟΙΗΣΗ: ΧΡΗΣΗ ΣΤΑ 120 VOLTS
Consult instructions for use if different voltage is required. / Ist der Betrieb mit einer anderen
Netzspannung erforderlich, in der Bedienungsanleitung nachlesen. / Si une utilisation une
tension diffrente est requise, consulter les instructions d’utilisation. / Consulte las instrucciones de
uso si la tensin es distinta. / Per un voltaggio diverso, consultare le istruzioni per l’uso. /
Se for necessria uma voltagem diferente, consultar as instru
es de utiliza o. /
Se brugermanualen, hvis der er behov for drift med en anden netspnding. / L
s tillhrande
dokumentation om en annan sp
nning behvs. / Για χρήση σε άλλη τάση ρεύματος,
συμβουλευτείτε τις οδηγίες χρήσης.
PN 9230003F
ABBOTT
Max-Planck-Ring 2
65205 Wiesbaden
Germany
+49-6122-580 PN 9230963
9230751A
PN
MAIN MENU
KEYS
SUBMENU
KEYS
TOGGLE
KEYS
TOGGLE
KEYS
MAIN MENU
Ready
MAIN MENU
Ready
Instructions: Use this log to provide a permanent record to verify that revised chapter(s) and/or
page(s) have been added to this manual.
1. Record the document control number of the revised section in the first column. You will find the
number in the footer. Make an entry for each chapter you receive and place in the manual.
2. Record the revision date, also found in the footer, in the second column.
3. Record the current CELL-DYN 3700 System software version in the third column.
4. Write your initials or signature in the fourth column to verify that you have placed the revised
page(s) in the manual.
5. Record the date that you added the revised section to the manual in the fifth column.
Document Revision
Control Revision Software Incorporated Date
Number Date Version by Incorporated
Overview
NOTES
Intended Use
NOTES
System Components
The two main modules of the CELL-DYN 3700 System are depicted
in the following two figures. (The Sample Loader Module included
with the CELL-DYN 3700SL System is illustrated and described in
Chapter 2: Installation and Chapter 12: Sample Loader.)
Analyzer:
The Analyzer contains the hardware to aspirate, dilute, and
analyze each whole blood specimen.
Data Station:
The Data Station contains a Flat Panel Display Monitor, a
Keyboard, and a CPU (Central Processing Unit).
Analyzer
Overview
The Analyzer is the central unit of the CELL-DYN 3700 System. It
aspirates and dilutes whole blood specimens, transports and
analyzes the prepared dilutions, and rinses fluidic components in
preparation for the next specimen. Except for those components
directly related to the Closed Sample Processing Method
(automated or manual), the CELL-DYN 3700CS System and
CELL-DYN 3700SL System are identical. In the description of
components on the following pages, those components applicable
to only one of the systems will be identified as such. A complete
description of the automated Sample Loader can be found in
Chapter 12: Sample Loader.
Front Panel
The components visible on the front of the Analyzer are depicted
in the following figure. The functional description of each
component follows.
Open
Sample
Aspiration
Probe
Tube
Retainer
Closed Sample Touch Plate
Aspiration Module
Touch Plate
The Touch Plate is located directly behind the Open Sample
Aspiration Probe. Pressing the Touch Plate starts the selected run
cycle for both the Open Mode and Closed Mode on the
CELL-DYN 3700CS System. If the Closed Sampler Mode is selected
on the CS instrument, the cycle will begin only if a tube has been
properly inserted in the holder. On the CELL-DYN 3700SL System,
the Touch Plate is used for Open Mode only.
Flow Panel
The major components of the Flow Panel are depicted in the
following figure. The functional description of each component
follows.
Figure 1.4:
Chapter 1
Overflow
Chamber
Optical
Aerosol WOC Flow Mounting Bench
Filter Cell Cover Bracket Assembly
Wash
Block
HGB
Flow Cell
WIC Metering
Assembly
Mounting Open
Bracket Sample
Aspiration
Probe
von Behrens
RBC/PLT
Transducer
Assembly
Touch
Waste Plate
Chamber 1
Vacuum WOC Metering Syringe RBC/PLT Diluent Syringe
(contains Sheath Reagent) HGB/WIC Lyse Syringe (contains Diluent)
RBC/PLT Accumulator (contains HGB/WIC Lyse)
Diluent Drain Line RBC/PLT Waste
Overpressure Chamber 2 WOC Sheath Syringe HGB/WIC Diluent Syringe
Metering
Sensor Assembly (contains Sheath Reagent) (contains Diluent)
System Description
System Components
1-9
System Description
System Components Chapter 1
Wash Block
The Wash Block rinses the outside of the Open Sample Aspiration
Probe with Diluent. It air dries the probe and routes the external
and internal rinses to a waste chamber.
Syringe Assembly
The Syringe Assembly contains a set of five syringes: two
WIC/HGB Syringes operated by the same stepper motor and
three others (RBC Diluent, WOC Sheath, and WOC Metering
Syringes), each operated by a separate stepper motor.
Waste Chambers
Two Waste Chambers collect the waste liquid from the Analyzer
Flow Panel.
Aerosol Filter
The Aerosol Filter is used to filter aerosols out of the air that leaves
the instrument.
Overflow Chamber
The Overflow Chamber collects excess fluid from the Mixing
Chambers.
Sample
Loader
Connector
Diluent
Reservoir
Waste
Sensor Sheath
Port Reservoir
Diluent
Inlet Tube
Fitting Detergent
Reservoir
Sheath
Inlet Tube
Fitting
Air Intake
Filter
Detergent
Inlet Tube
Fitting
WIC/HGB
Lyse Inlet
Tube Fitting
Waste Normally
Outlet Tube Analyzer Serial
Number Label Closed Valves
Fitting
Figure 1.5: Analyzer Left Side Panel Components
Solenoid Valves
The Solenoid Valves are used to control pressure and vacuum. The
three valves in the top row control the hydraulic pressure to the
system. The three valves in the bottom row control the vacuum
used to fill the reagent reservoirs.
Diluent Reservoir
The Diluent Reservoir maintains the Diluent supply in the Analyzer.
Sheath Reservoir
The Sheath Reservoir maintains the Sheath Reagent supply in the
Analyzer.
Detergent Reservoir
The Detergent Reservoir maintains the Detergent supply in the
Analyzer.
Rear Panel
The components visible on the Rear Panel of the Analyzer are
depicted in the following figure. The functional description of
each component follows.
Fans
Line Frequency
and Voltage
Select Switches
Fuse
Analyzer
Power
Receptacle
RS-232
Test Interface
Port
Data
Station
Port
Fans
Three fans cool the internal components of the Analyzer.
PN 9230003E
100V 50HZ
120V 50HZ
220V 50HZ
240V 50HZ
100V 60HZ
120V 60HZ
220V 60HZ
240V 60HZ
Fuse
An 8-amp (100/120V)T (Slo-Blo) or 4-amp (220/240V)T (Slo/Blo)
fuse protects the Analyzer from power surges.
Data Station
The CELL-DYN 3700 operations are controlled by high-speed
microprocessors that monitor system status, perform the various
analytical routines used by the instrument, perform diagnostic
checks, and store result data.
Serial data (ASCII format) may be output to a Laboratory
Information System (LIS) through an RS-232 connector. Data
transmission may be performed either automatically as samples
are processed or by command of the operator. Parallel data may be
output to an on-line printer.
The Data Station Computer consists of:
• 80486 microprocessor (IBM AT compatible)
• VGA graphics
The results are stored on the hard drive for the most recent 10,000
cycles. Complete graphical data are also stored for the most recent
10,000 cycles.
Screen
Monitor
Soft Keys
Monitor
Power Switch
Contrast Control
Brightness Control
CPU
Standard Computer
Keyboard
Screen
A 15-inch diagonal, high-resolution Screen with 16-color
illumination displays all alphanumeric and graphic data.
Soft Keys
A row of eight unlabeled pressure-sensitive soft keys is located
directly below the screen. Each key generates an audible tone
when pressed and initiates a function defined by the screen label
currently displayed directly above it.
Brightness Control
The Brightness Control adjusts the brightness of the Data Station
screen.
Contrast Control
The Contrast Control adjusts the contrast of the Data Station
screen.
Rear Components
The rear components located on the Data Station and monitor are
depicted in the following figure. The functional description of
each component follows.
Monitor Monitor
Serial Number Video
Cable
Power
Outlet Soft Key
Connector Interface
Cable
Com 2/
CPU Serial RS 232
Number Label Com 1/
External
Fan Computer
Analyzer
Port
Monitor
Video
Cable
Port
Keyboard LPT 1
Data Station Graphics
Port Soft Key Printer
Power Plug Interface
Connector CPU Port
Monitor Port LPT 2
Voltage Power (“Touch” Port) Ticket Printer
Selector Port Port
Figure 1.9: Data Station — Rear Components
Fan
The Fan cools the Data Station computer.
Analyzer Port
The Analyzer Port is used to connect the cable from the Data
Station to the Analyzer.
Keyboard Port
The Keyboard Port is used to connect the Standard Computer
Keyboard to the Data Station.
Voltage Selector
The Voltage Selector sets the line voltage for the Data Station.
1 2 3 4 5 6
Figure 1.10: Control Button – Front View
Touch Screen
The Touch Screen allows commands to be transferred from the
Flat Panel Monitor to the Data Station computer. A row of eight
touch keys is displayed on the screen. Each key generates an
audible tone when pressed and initiates the function defined by
the screen label.
Screen Controls
Controls are described in order from left to right.
Cable Connections
Cable connections are described in order from left to right.
Printer
The Printer is discussed in detail in Chapter 11: Printers.
Sample Loader
The Sample Loader is discussed in detail in Chapter 12: Sample
Loader.
Reagent System
Overview
The Reagent System is formulated specifically for the CELL-DYN
3700 instrument flow systems in order to provide optimal system
performance. Use of reagents other than those specified in this
manual is not recommended as instrument performance can be
affected. Each CELL-DYN System is checked at the factory using
the specified reagents and all performance claims were generated
using these reagents.
Before operating the instrument for the first time, make sure each
reagent line is connected to the appropriate inlet and reagent
container.
CELL-DYN Reagents
Diluent
CELL-DYN Diluent is formulated to meet the following
requirements:
• Act as the Diluent for the WBCs (for the Impedance count
only), RBCs, PLTs, and HGB.
• Maintain the stable diluted cell volume of each red cell and
platelet during the count and sizing portion of the
measurement cycle.
• Provide acceptable background counts equal to or less than:
WIC: 0.30 x 103/µL (109/L)
RBC: 0.03 x 106/µL (1012/L)
PLT: 10.0 x 103/µL (109/L)
HGB: 0.2 g/dL (g/L)
HGB/WIC Lyse
CELL-DYN HGB/WIC Lyse is formulated to meet the following
requirements:
• Rapidly lyse the red blood cells and minimize the resultant
stroma.
• Strip the white cell cytoplasm leaving the nuclear membrane
intact so the white cell nuclei can be enumerated.
• Convert hemoglobin to a modified hemiglobincyanide
complex that is measurable at 540 nm. (The quaternary
ammonium lysate participates as a chromagen.)
Detergent
CELL-DYN Detergent is formulated to meet the following
requirements:
Sheath Reagent
CELL-DYN Sheath Reagent is formulated to meet the following
requirements:
• Osmotically lyse the red cells.
• Maintain the light scattering properties of the WBCs for the
duration of the measurement period.
• Serve as a Sheath fluid for the hydrodynamic focusing
process.
• Provide sufficient wetting action to prevent accumulation of
air bubbles in the WOC flow system.
• Provide a WOC background count equal to or less than
0.3 x 103/µL (109/L).
Enzymatic Cleaner
CELL-DYN Enzymatic Cleaner is formulated to effectively remove
protein buildup within the instrument.
Controls
Day-to-day verification of System calibration is performed using
CELL-DYN controls. Running these stabilized reference products
every day of operation is recommended to test instrument
accuracy.
Calibrator
Calibration of the directly measured parameters can be performed
using CELL-DYN Calibrators. Calibration is discussed in detail in
Section 6: Calibration Procedures.
NOTES
Overview
NOTES
Initial Preparation
Inventory
The instrument is shipped from the factory with the following:
Package Inspection
All crates should be inspected for damage. If there is any damage, or if
any crates or boxes are missing, call Abbott Diagnostics Customer
Service for assistance (at 1-877-4ABBOTT in the US).
The reagents needed for installation may be shipped separately
from the instrument. This shipment includes: Diluent, HGB/WIC
Lyse Reagent, Sheath Reagent, and Detergent.
The calibrator and controls needed for the installation may be
shipped separately from the instrument.
The Enzymatic Cleaner is shipped separately.
Space Requirements
The CELL-DYN 3700 System requires approximately five linear
feet of space on a countertop. In addition, sufficient space is
required beneath for Diluent, WIC/HGB Lyse, Sheath Reagent,
Detergent, and the waste container (if one is used).
Six inches of space behind and on the left side of the Analyzer
must be allowed for air flow in order to maintain the constant
circulating internal air stream required to cool circuitry and
components whenever the power is ON. Six inches of space must
also be allowed behind the Data Station for air flow. The Data
Station may be placed in direct contact with the right side of the
Analyzer. If possible, there should be 24 inches of space above and
to either side of the Analyzer for service access.
Waste Requirements
A suitable properly labeled waste container must be located near
enough to the CELL-DYN 3700 System to connect to the Analyzer
Waste Outlet Tube, or the instrument must be positioned to
permit the waste to be routed directly to a drain. The drain must
be suitable for disposal of waste with possible biological and
chemical hazard. Ensure that the waste outlet tube is secured in
the drain hole and all System Components are located away from
possible waste overflow.
Regulations on permissible substances, and their amounts, for
disposal in public sewer systems vary from state to state and even
community to community. Customers are advised to be
knowledgeable of all applicable local, state, and federal
requirements, and the contents of the effluent streams, before
disposing of waste in public sewer systems.
Make sure the waste line is connected to the appropriate outlet
and routed to a suitable waste container or drain. If the waste is
routed to a waste container, make sure the Waste Sensor is
properly connected.
If an external waste container is used, the Waste Full Sensor Plug
(attached to the cap’s electrode wires) should be inserted into the
Waste Sensor Connector on the Left Side Panel of the Analyzer. If
the waste tube is placed directly into a drain, the “Dummy” Plug
provided in the Accessory Kit must be inserted into the Waste
Sensor Connector or the EXTERNAL WASTE FULL alert will be
activated.
Power Requirements
Three power outlets are required for the CELL-DYN 3700SL System
and three are required for the CELL-DYN 3700CS System. A
grounded power outlet and voltage regulator are required for
optimum performance. Refer to Chapter 4: System Specifications
for the electrical requirements for each system.
NOTES
Printer Installation
Overview
Remove the printer(s) from its shipping container and visually
inspect it for damage. Find a suitable location adjacent to the
instrument. Be sure the printer power switch is in the OFF
position. Retain the manuals shipped with the printer(s) and store
them in a convenient location.
Monitor Monitor
Serial Number Video
Cable
Power
Outlet Soft Key
Connector Interface
Cable
Com 2/
CPU Serial RS 232
Number Label Com 1/
External
Fan Computer
Analyzer
Port
Monitor
Video
Cable
Port
Keyboard LPT 1
Data Station Graphics
Port Soft Key Printer
Power Plug Interface
Connector CPU Port
Monitor Port LPT 2
Voltage Power (“Touch” Port) Ticket Printer
Selector Port Port
Figure 2.1: Data Station Rear Components
Self-Test Printouts
Run any self-test printouts (as directed in the printer manual)
before using the printer for the first time. These self-tests may be
run any time to verify proper printer operation.
9. Position the ticket so that the lower red line on the paper
shield (located between the print head and the paper) is
positioned where the first line of printing should occur.
NOTE: When the Top of Form is set, the position is
retained in the printer memory until it is reset.
10. Press the Sel key to select the printer. The printer is now
ready to print.
Self-Test Printouts
Run any self-test printouts indicated in the printer manual before
using the Ticket Printer for the first time. These self-tests may be
run any time to verify proper printer operation.
Tube
Rack
5. Place five racks in the open area to the left of the tower and
five racks in the open area to the right of the tower. Push all of
the right side racks toward the Analyzer. Pull all of the left side
racks away from the Analyzer. All ten racks must be in place
for proper operation.
NOTE: Be sure each rack is placed with its bar coded rack
ID label and open slot facing toward the Analyzer.
Power On
Turn the Sample Loader Power Switch on the Left Side Panel ON.
When the initialization process is complete, the light above the
Sample Loader Start key will flash. This indicates that the Sample
Loader is ready to start processing samples. The message AUTO
SAMPLER READY is displayed in the Data Station bulletin line.
Instrument Installation
Reagent Tubing Installation
Materials
1. Lint-free pads
2. CELL-DYN Reagents
Procedure
1. Place the reagents in a suitable location below the Analyzer.
Sufficient space is required below for Diluent, WIC/HGB
Lyse, Sheath Reagent, Detergent, and the waste container
(if one is used).
NOTE: Never place the reagents above the Analyzer, in
direct sunlight, or in the path of a cooled or heated air
outlet.
2. Remove the Reagent Inlet Tubing and the Waste Tubing from
the Accessory Kit.
3. Inspect each length of tubing carefully for damage or cracks.
4. Attach the non-weighted end of the Detergent Tubing (the
tubing with the green label) to the Green Detergent Fitting
on the Left Side Panel of the Analyzer. (See the following
figure.) Wipe the outside of the tubing with a damp lint-free
pad and place the weighted end into the container of
CELL-DYN Detergent. Secure the cap.
5. Attach the non-weighted end of the Diluent Tubing (the
tubing with the red label) to the Red Diluent Fitting on the
Left Side Panel of the Analyzer. 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.
6. Attach the non-weighted end of the WIC/HGB LYSE Tubing
(the tubing with the blue label) to the Blue WIC/HGB Lyse
Fitting on the Left Side Panel of the Analyzer. Wipe the
outside of the tubing with a damp lint-free pad and place the
weighted end into the container of CELL-DYN WIC/HGB
Lyse. Secure the cap.
7. Attach the non-weighted end of the Sheath Tubing (the
tubing with the purple label) to the Purple Sheath Fitting on
the Left Side Panel of the Analyzer. Wipe the outside of the
tubing with a damp lint-free pad and place the weighted end
into the container of CELL-DYN Sheath. Secure the cap.
Waste Sensor
Connector
Waste Outlet
Fitting
Normally Closed
Valves
Normally Closed
Valves
Relocation
NOTES
Overview
NOTES
Sample Aspiration
NOTES
WBC Analysis
WBCs are analyzed in two separate channels: Optical (WOC) and
Impedance (WIC).
WOC Measurement
WBC Optical Count (WOC) measurement is performed as follows:
1. The WOC Sheath Syringe dispenses 1.6 mL of Sheath Reagent
through the Shear Valve, where it picks up the 32-µL WOC
sample segment.
2. The sample segment and sheath are then routed to the WOC
Mixing Chamber, where the dilution is bubble-mixed. The
final dilution is 1:51.
NOTE: The ratio 1:51 represents 1 part in a total of 51
parts, not 1 part plus 51 parts.
3. The WOC Peristaltic Pump transfers the WOC dilution from
the WOC Mixing Chamber to the Sample Feed Nozzle in the
WOC Flow Cell.
4. A stream of WOC Sheath Reagent is directed through the
Flow Cell.
5. The WOC Metering Syringe injects 78 µL of the WOC
dilution into the Flow Cell sheath stream. The dilution is
hydrodynamically focused into a narrow stream.
(Hydrodynamic focusing is discussed later in this chapter.)
WIC Measurement
WBC Impedance Count (WIC) measurement is performed as follows:
1. The WIC/HGB Diluent Syringe dispenses 5.25 mL of Diluent
through the Shear Valve, where it picks up the 20-µL WIC/HGB
sample segment.
2. The segment and Diluent are then routed to the Mixing
Chamber in the von Behrens WIC Transducer. At the same
time, the WIC/HGB Lyse Syringe delivers 0.75 mL of WIC/HGB
Lyse to the Mixing Chamber.
3. The dilution is then bubble-mixed. The final WIC/HGB
dilution is 1:301.
4. The dilution is pulled through the aperture by vacuum. A
process known as volumetric metering (discussed later in
this chapter) ensures that 200 µL of the dilution are used for
the measurement.
5. Electrical Impedance (discussed later in this chapter) is used
to count the WBCs as they traverse the aperture.
6. When the count portion of the cycle is completed, the aperture
is automatically cleaned by the Aperture Cleaning Circuit.
RBC/PLT Analysis
1. The RBC Diluent Syringe dispenses 7.2 mL of Diluent
through the Shear Valve, where it picks up the 0.74-µL
RBC/PLT sample segment.
2. The sample segment and Diluent are then routed to the Mixing
Chamber of the von Behrens RBC/PLT Transducer, where the
dilution is bubble-mixed. The final dilution is 1:9,760.
3. The dilution is pulled through the aperture by vacuum. The
volumetric metering process ensures that 100 µL of the
dilution are used for the measurement.
4. Electrical Impedance (discussed later in this chapter) is used
to count the RBCs and PLTs as they traverse the aperture.
Reticulocyte Analysis
Reticulocytes are discussed in Chapter 14: Reticulocyte Package.
Hemoglobin Analysis
1. After 200 µL of the WIC/HGB dilution are metered through
the WIC aperture, the remaining dilution is transferred to
the HGB Flow Cell.
2. The HGB concentration is measured spectrophotometrically.
This process is discussed in detail later in this chapter.
Results Displayed
All data are transmitted to the Data Station for analysis. Results
are computed for all parameters and are displayed on the Data
Station RUN Screen. Results are also stored in a log format called
the Data Log.
Instrument Rinsed
1. The Open Sample Aspiration Probe is rinsed internally and
externally with Diluent.
2. The needle used in both the automated and the manual
Closed Mode is rinsed internally and externally with Diluent.
3. The WIC Mixing Chamber and the RBC/PLT Mixing
Chamber are rinsed with Diluent.
4. The WOC Mixing Chamber is rinsed with Sheath Reagent.
5. The WIC Metering Tube and the RBC/PLT Metering Tube are
rinsed with detergent.
6. The HGB Flow Cell is rinsed with detergent.
NOTES
WBC Analysis
WIC/WOC Interaction
The WIC (WBC Impedance Count) interacts with the WOC (WBC
Optical Count) to produce the final reported WBC value. Two
methods are provided because both measurements have strengths
and limitations. Because the limitations of each method differ,
providing both methods enhances the instrument’s ability to provide
a more accurate WBC count in the presence of certain interfering
substances and pathological conditions. A data analysis algorithm
automatically evaluates each measurement and selects the
appropriate result to report. The algorithm used by the CELL-DYN
3700 System is divided into three main areas: 1) the WOC decision
tree, to analyze and output the WOC data; 2) the WIC decision tree,
to analyze and output the WIC data; and 3) a WIC/WOC comparison
decision tree, to compare the two outputs.
The WOC decision tree calculates the WOC result for the WBC
count and the Differential count. It evaluates the results for
correctness and flagging. Finally, the algorithm outputs the WOC
with appropriate flags to the WIC/WOC comparison decision tree.
The WIC decision tree evaluates the WIC for correctness and
flagging and outputs the WIC to the WIC/WOC comparison
decision tree.
The WIC/WOC comparison decision tree compares the two
outputs for a difference between the results. If a clinically
significant difference exists, results are further evaluated to
determine the cause. Depending on the nature of the cause (the
type of interference), the algorithm reports either the WOC value
or the WIC value, whichever is more accurate, with the
appropriate flags (or no flags) as the reported WBC.
WIC Measurement
Overview
The WBC Impedance Channel is used for the determination of the
WIC. A 1:301 dilution of the sample is made with Diluent and
WIC/HGB Lyse. The WIC/HGB Lyse Reagent lyses the RBCs and
strips the cytoplasm from the WBCs. The WBC nuclei are counted
using the impedance method as they pass through the 100 x 77–µm
aperture in the von Behrens WIC Transducer. The 200-µL volume
of sample that is analyzed is precisely regulated by the WIC
Metering Assembly. WIC data are collected in 256 channels. The
WIC data may be presented in a histogram at the request of the
operator.
Volumetric Metering
An absolute cell count cannot be obtained unless the precise
volume of diluted whole blood that passes through the aperture
during the count cycle is known.1 The CELL-DYN 3700 System
utilizes the Volumetric Metering process to regulate the count
cycle and ensure that a precise volume of sample is analyzed for
the WIC measurement.
The WIC Metering Assembly contains a precision-bore glass tube fitted
with two optical detectors. (See the following figure.) The distance
between the detectors is set to precisely measure 200 µL. Detergent is
added to the Diluent in the metering tube to create a meniscus in the
liquid. When the WIC cycle is initiated, the liquid flows down the
metering tube.
Start
Detector
(Count
Initiated)
Meniscus
Count
Time
Stop
Detector
(Count
Completed)
WOC Analysis
The CELL-DYN 3700 System uses laser-based flow cytometric
techniques to analyze the WBC subpopulations. The first part of
this section gives a brief introduction to the principles of flow
cytometry.2 The second part of this section gives a detailed
description of the WOC measurement and the WBC differential
analysis.
Various Angles
of Scattered Light
Focused
Laser Beam Sample Stream
Sheath Stream
Sample
Feed Nozzle
90° Scatter
0° Scatter
90°D Scatter
10° Scatter
Sheath Reagent
The Sheath Reagent is an integral part of the WOC analysis. WBCs
diluted in the Sheath Reagent maintain cellular integrity that is
close to their native state. The structure of the basophils changes
slightly due to the water-soluble nature of the basophilic granules.
Cylindrical
Lens
10° Light
700 μm Scatter
Slit Photodiode
Front
Surface
Mirror
0° Light
125 μm WBC Scatter
Vertical Imaging Flow Obscuration Photodiode
Slit Cell Bar Perforated
Lens Mirror
WBC Scatterplots
90° Lobularity
Mononuclear-Polymorphonuclear Separation
The scatter information is plotted with the 90° scatter on the
Y axis and the 10° scatter on the X axis. (The 90°/10° scatterplot
is shown in the preceding figure.) Two populations of cells are
clearly seen on the display. The mononuclear cells fall in the
cluster in the lower left corner of the scatterplot and the
polymorphonuclear cells fall in the cluster above and to the right
of them.
The instrument uses a dynamic threshold to determine the best
separation between the two populations. Each cell is then
identified as a MONO or a POLY. Once each cell is identified, it
retains this classification no matter where it appears on other
scatterplots.
Polymorphonuclear Separation
The scatter information is plotted with the 90°D scatter on the
Y axis and the 90° scatter on the X axis. (The 90°D/90° scatterplot is
shown in the preceding figure.) Only the polymorphonuclear cells
are plotted on this scatterplot. The mononuclear cells have been
identified and therefore do not interfere in the further
classification of the polymorphonuclear cells.
Two populations of polymorphonuclear cells are clearly seen on
the display. The neutrophils fall in the lower of the two clusters.
The eosinophils fall in the upper cluster. The instrument uses a
dynamic threshold to determine the best separation between the
two populations. Each cell is then classified as a NEUT or an EOS.
All cells scatter a certain amount of 90°D light. The eosinophils
scatter more 90°D light than any of the other cells because of the
unique nature of granules they contain. This property of the
eosinophils is used to positively identify them and thus clearly
differentiate them from the neutrophil population.
Mononuclear Mononuclear
Separation Identification
0° Size
0° Size
Mononuclear Separation
The scatter information is plotted with the 0° scatter on the Y axis
and the 10° scatter on the X axis. (The 0°/10° scatterplot is shown
in the following figure.) The mononuclear cells are plotted on this
scatterplot. The algorithm also uses the orientation of the
neutrophil cluster to aid in classifying the mononuclears. Three
populations of mononuclear cells are clearly seen on the display.
There are three populations of mononuclears because basophils
are included in the mononuclear cluster. Typically, basophils are
granulated cells and therefore more complex than the
mononuclear cells. However, the basophilic granules are water
soluble and dissolve in the Sheath Reagent. Consequently, the
degranulated basophil becomes a less complex cell that falls into
the mononuclear cluster.
All particles in this region are excluded from the WBC count and
the Differential.
Other Scatterplots
90°/0°
The scatter information is plotted with the 90° scatter on the
Y axis and the 0° scatter on the X axis.
90°D/0°
The scatter information is plotted with the 90°D scatter on the
Y axis and the 0° scatter on the X axis.
90°D/10°
The scatter information is plotted with the 90°D scatter on the
Y axis and the 10° scatter on the X axis.
All scatterplots may be displayed and printed at operator request.
WBC Histograms
The CELL-DYN 3700 System can also present the WBC scatter
information as two histograms. The WIC can also be presented in
histogram format (shown in the following figure). These
histograms can be displayed and printed at the operator's request.
MONO-POLY Histogram
The Mononuclear-Polymorphonuclear Scatter information is
plotted with the relative number of cells on the Y axis and the
mononuclear and polymorphonuclear size distribution data on
the X axis.
NWBC-LYM-MONO Histogram
The Non-WBC-Lymphocyte-Monocyte Scatter information is
plotted with the relative number of cells on the Y axis and the
non-WBC, lymphocyte, and monocyte size distribution data on
the X axis.
WIC Histogram
The WIC data are plotted with the relative number of cells on the
Y axis and the WIC size distribution data on the X axis.
WBC Parameters
WBC Flagging
For a detailed discussion of the WIC/WOC algorithm and all of
the WBC flagging messages, refer to Operational Messages and
Data Flagging within this chapter.
RBC/PLT Analysis
Overview
An impedance channel is used for the determination of RBC and
PLT data. A 1:9,760 dilution of the sample is made with the
Diluent. The cells are counted and sized using the impedance
method as they pass through the 60 x 70–µm aperture in the
von Behrens RBC/PLT Transducer. Dynamic thresholding separates
the PLTs from the RBCs. The 100-µL volume of sample that is
analyzed is precisely regulated by the RBC/PLT metering assembly.
Data is collected in 256 channels for both RBCs and PLTs.
RER
The RER (Red Cell Editing Ratio) is a process of pulse editing that
is applied to the RBC pulses before the MCV is derived. The
instrument compensates for the aberrant pulses produced by the
non-axial and coincidence passage of the RBCs through the
aperture. These pulses are included in the RBC count but
eliminated from the RBC sizing determination.
Volumetric Metering
An absolute cell count cannot be obtained unless the precise
volume of diluted whole blood that passes through the aperture
during the count cycle is known.1 The CELL-DYN 3700 System
utilizes the Volumetric Metering process to regulate the count
cycle and ensure that a precise volume of sample is used for the
RBC/PLT measurement.
Start
Detector
(Count
Meniscus Initiated)
Count
Time
Stop
Detector
(Count
Completed)
RBC Parameters
RBC Count
The red blood cell count (RBC count) is directly measured, gives
the number of RBCs, and is expressed as follows:
RBC = # x 106/µL (1012/L)
Counts below 1.0 x 106/µL (1012/L) are displayed to three decimal
places.
The RBC count is automatically corrected for the WBC count, and
the corrected RBC count is displayed on the main RUN screen.
MCV
The mean corpuscular volume (MCV) is the average volume of the
individual red blood cells. The MCV is derived from the RBC size
distribution data and is expressed in femtoliters.
HCT
The hematocrit (HCT) is the ratio of red blood cells to plasma and
is expressed as a percentage of the whole blood volume. The HCT
is calculated from the RBC count and the MCV as follows:
MCH
The mean corpuscular hemoglobin (MCH) is the average amount
of hemoglobin contained in the red blood cell, expressed in
picograms. The MCH is calculated from the RBC and the HGB as
follows:
MCH = (HGB/RBC) x 10
MCHC
The mean corpuscular hemoglobin concentration (MCHC) is the
ratio of the weight of hemoglobin to the volume of the average
red blood cell, expressed in percent. It is calculated from the HGB
and the HCT as follows:
MCHC = (HGB/HCT) x 100
RDW
Red cell distribution width (RDW) is a measure of the
heterogeneity of the RBC population. The CELL-DYN 3700 System
reports a relative RDW equivalent to a CV in percent. The RDW is
derived from the RBC histogram using the width of the RBC
distribution at 50% of the peak height.
RBC Flagging
For a detailed discussion of the RBC flagging messages, refer to
Operational Messages and Data Flagging within this chapter.
Reticulocytes
Reticulocytes are transitional red cells between nucleated red cells
(NRBCs) and the so-called mature erythrocytes. The CELL-DYN
3700 System reports the reticulocyte percent, the Immature
Reticulocyte Fraction (IRF), and will report the reticulocyte
absolute number if the RBC value is entered.
PLT Parameters
PLT Count
The platelet count (PLT count) is derived from the PLT histogram
after the PLT data have been analyzed by the platelet algorithm.
The PLT count is expressed as follows:
MPV
The mean platelet volume (MPV) is derived from the PLT
histogram after the PLT count has been determined. The MPV is
expressed in femtoliters.
PCT
The plateletcrit (PCT) is the product of the PLT count and the
MPV, and it is analogous to the hematocrit. It is expressed in
percent and is calculated as follows:
PCT = (PLT x MPV)/10,000
PDW
The platelet distribution width (PDW) is a measure of the
heterogeneity of the PLT population. It is expressed as the
geometric standard deviation.
NOTE: Clinical significance has not been established for
PCT and PDW. Therefore, they are not reportable in the
U.S. They are provided for laboratory use only.
Platelet Flagging
For a detailed discussion of the PLT flagging messages, refer to
Operational Messages and Data Flagging within this chapter.
Hemoglobin Analysis
Overview
The HGB channel is used for the colorimetric determination of
hemoglobin. A 1:301 dilution of the sample is made with the
Diluent and the WIC/HGB lyse reagent in the mixing chamber of
the WIC transducer. This dilution is used for the WIC count and the
HGB measurement. Traditionally, the HGB concentration is
measured using a modified hemiglobincyanide method. However,
in an effort to create a safe, environmentally-responsible
atmosphere, the CELL-DYN 3700 System can use a cyanide-free
reagent. This reagent converts HGB to a hemiglobinhydroxylamine
complex. A filtered LED with a wavelength of 540 nm is the light
source. A photodetector measures the light that is transmitted.
HGB Parameters
The Hemoglobin is directly measured and is expressed in grams of
hemoglobin per deciliter of whole blood.
Introduction
Operational messages and data flags appear on the Data Station
RUN screen and on printed reports. They can also be transmitted
to a laboratory computer system. The CELL-DYN 3700 System
monitors instrument conditions and data criteria that may affect
the displayed results. These messages and flags are used to alert the
operator. Instructions for interpreting all flags and numeric, scatter,
and histogram data should be incorporated into the laboratory’s
procedure and used to determine the need for further action and/or
review of results. Messages are divided into the following categories:
• Instrument Fault and Status Messages
• Parameter Flagging Messages
Dispersional Data Alerts
Suspect Parameter Flags
Suspect Population Flags
Interpretive Messages
Detailed descriptions of these messages are given in this section.
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 3700 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
HBG: 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.
Suspect Suspect
Parameter Population Interpretive
Parameter Dispersional Data Alerts Flags Flags Messages
Result underlined on
graphics printout when
limits exceeded
G
BAND FLAG ESTIMATE R
REGION %: A
N
IG FLAG ESTIMATE L
R
REGION %:
T
Y
BLAST FLAG ESTIMATE
REGION %: MONO-POLY LOBULARITY
10 deg 0 deg
PRINT RETURN
WBC Descriptors
The descriptors discussed in this section are displayed on the
screen to provide additional information about the reported WBC
value. A descriptor is displayed next to the WBC value only when
the WIC and WOC differed by a clinically significant percentage
and, consequently, the appropriate WBC as indicated by the
descriptor is displayed. If no descriptor or WBC Suspect Parameter
Flag is present, the WOC is the chosen value.
WIC
There is a clinically significant difference between the WIC and
WOC values and the algorithm selected the WIC count as the most
accurate WBC. Refer to Subsection: Flagging Summary, WBC
Descriptors within this section for action to be taken when the
WIC Descriptor is displayed.
WOC
There is a clinically significant difference between the WIC and
WOC values and the algorithm selected the WOC count as the
most accurate WBC. Refer to Subsection: Flagging Summary,
WBC Descriptors within this section for action to be taken when
the WOC Descriptor is displayed.
S
I
Z
E
Dynamic
Threshold
N1
Region
COMPLEXITY
Figure 3.14: Scatterplot with Increased Stroma in the N1 Region
When the stroma is >2.9% of the total WBC and WOC is higher
than WIC, the WIC count is selected and the RRBC (Resistant RBC)
flag is displayed alerting the user to run the specimen in the
Resistant RBC Mode. The WOC count time is extended in the
Resistant RBC Mode, enabling complete lysis of the lyse-resistant
RBCs in order to produce a correct WOC value.
DFLT (NLMEB)
The DFLT flag indicates that default (preset) criteria were used to
determine the five-part differential. This is caused by the presence
of abnormal cell clusters that the instrument cannot reliably
discriminate between, or by a low number of cells in a specific
subpopulation. Descriptors in parentheses are added to the flag to
indicate which subpopulation(s) is (are) suspect, based on the
criteria used. The descriptors are N, L, M, E, and B.
(N=Neutrophils, L=Lymphocytes, M=Monocytes, E=Eosinophils,
and B=Basophils.) The following criteria can cause the DFLT flag:
NOTES
Flagging Summary
WBC Descriptors
A descriptor is displayed next to the WBC value to indicate that
WIC and WOC differed by a clinically significant percentage and
the appropriate WBC as indicated by the descriptor is displayed.
WIC
Cause Action
There is a clinically significant Review a stained smear and follow
difference between the WIC and your laboratory’s protocol to
WOC values, and/or a kinetic confirm the WIC result.
decline in the WOC count rate was
detected, and the count in the N1
(stroma) region of the scatterplot
is less than 2.9% of the total WBC.
The algorithm selected the WIC
count as the most accurate WBC.
WOC
Cause Action
There is a clinically significant Review a stained smear and follow
difference between the WIC and your laboratory’s protocol to
WOC values and, therefore, the confirm the WOC result.
algorithm selected the WOC count
as the most accurate WBC.
WBC Flags
WBC Flag — displayed next to the WBC result
Cause Action
1. A clinically significant If the NRBC and/or RRBC flags are
difference exists between the displayed with the WBC flag,
WIC and WOC values and the repeat the specimen using the
algorithm is unable to Resistant RBC cycle to eliminate
determine the most accurate interference caused by lytic-
WBC value. The algorithm resistant RBCs. If the flag persists,
selects what is estimated to be review a stained smear for the
the best count for the reported presence of NRBCs which may
WBC value and the WBC flag is affect the WIC count and verify the
displayed indicating that the LYM value. Verify the WBC value
result is suspect. by an alternate method according
to your laboratory’s protocol.
Cause Action
2. There is a kinetic decline in the
WOC count rate. A kinetic
decline generally indicates the
presence of fragile WBCs that
gradually disintegrate in the
Sheath Reagent. When a kinetic
decline is detected and the
count in the N1 (stroma)
region of the scatterplot is less
2.9% of the total WBC, then:
• WIC, which is estimated to
be the most accurate result,
is the reported WBC. (Over
range will be displayed if
the value is greater than
99.9 x 103/µL.)
• The WBC Suspect
Parameter Flag is displayed
next to the WBC result.
• The FWBC or RRBC Suspect
Population Flag may also be
displayed.
• No WBC Differential
results are displayed.
• If the WBC result is greater
than 99.9 x 103/µL., the
hemoglobin result is
suppressed and displayed as
<<<<.
• When the hemoglobin
result is displayed as <<<<,
MCH and MCHC results are
not displayed.
Cause Action
Default (preset) criteria were used to Examine a stained smear to verify
determine the five-part differential the differential values for the
and therefore, some of the subpopulation(s) identified by the
populations are suspect. Descriptors, descriptor(s).
in parentheses, are added to the flag
to indicate which subpopulation(s)
is (are) suspect, based on the criteria
used. The descriptors are N, L, M, E,
and B. (N=Neutrophils,
L=Lymphocytes, M=Monocytes,
E=Eosinophils, B=Basophils.) The
following criteria can cause the DFLT
flag:
1. A default (preset) value or
threshold was used to deter-
mine the five-part differential.
2. A valley was not detected within
the region that usually separates
a given cell population from an-
other cell population.
3. There is an abnormally low
number of cells in a specific
subpopulation.
PLT Flags
Cause Action
Interference in the lower Check the background count. If it
threshold region (1–3 fL) is greater exceeds the limits, troubleshoot
than a predetermined limit. This is accordingly. If it is within limits,
generally non-biologic repeat the specimen. If the flag
interference. The flag may be persists, review a stained smear to
caused by: determine the cause of the
interference and verify the PLT
Debris (dirty aperture)
count.
Contaminated reagent
Electronic noise
Microbubbles
Cause Action
Interference in the upper Review the MCV and the PLT
threshold region (15–35 fL) is histogram. If the MCV is low and/
greater than a predetermined or the histogram indicates an
limit. This is generally biologic overlap (poor separation at the
interference. The flag may be upper discriminator) in the RBC
caused by: and PLT populations, review a
stained smear to determine the
Microcytic RBCs
cause and verify the PLT count.
Schistocytes
Giant Platelets
Sickle Cells
Platelet Clumps
NOTE: A “bumpy” platelet histogram may indicate the presence
of platelet clumps.
Cause Action
Interference is present in both the Follow the guidelines given above
upper and lower regions of the PLT for the LRI and URI flags.
histogram.
Cause Action
The PLT count was <120 K/µL and, Repeat the specimen. If the flag is
therefore, a platelet recount was no longer displayed and there are
performed. The difference no other data invalidating flags,
between the count and recount the PLT count is reportable. If the
values exceeds expected limits. flag persists, review a stained
smear and verify the PLT count
WBC Flags
BAND — displayed next to the NEU %
Cause Action
1. The count in the region of scatter Review a stained smear for the
(on the 0°/10° plot) where presence of bands and follow your
bands are typically located is laboratory’s review criteria. When
>12.5% of the total WBC count. bands are present, they are included
in the total neutrophil count.
2. The ratio of suspected bands to
mature neutrophils is >50%.
3. The CV of the neutrophil cluster
on the 0° axis exceeds expected
criteria.
Cause Action
The count in the region of scatter Review a stained smear for the
(on the 0°/10° plot) where presence of immature granulocytes
immature granulocytes are and follow your laboratory’s review
typically located is >3% of the total criteria. When IGs are present,
WBC count. they are included in the total
neutrophil count.
Causes Action
The count in the region of scatter Review a stained smear for the
(on the 90°/0° plot) where blasts presence of blasts and follow your
are typically located is >1% of the laboratory’s review criteria. When
total WBC count. blasts are present, they are typically
included in the monocyte count.
Cause Action
1. The count in the region of scatter Review a stained smear for the
on the size/complexity (0°/10°) presence of variant lymphocytes
scatterplot where variant and/or smudge cells and follow
Lymphs are typically located is your laboratory's review criteria.
>10% of the total WBC count. When variant lymphocytes or
smudge cells are present, they are
2. The absolute lymphocyte or the
included in the lymphocyte count.
absolute mononuclear (including
basophils) count exceeds expected
criteria and the ratio of
lymphocytes to monocytes
exceeds a predetermined limit.
3. The ratio of neutrophils to
lymphocytes falls below
expected criteria.
4. The WIC/WOC comparison
indicates the suspected presence
of variant lymphocytes.
Causes Action
A non-WBC population is present Review a stained smear and follow
in the N1 region below the dynamic your laboratory's review criteria to
WBC threshold on the size/ determine the cause of the elevated
complexity (0°/10°) scatterplot. count in the N1 region. If NRBCs
The count in the N1 region is are present and correction of the
greater than 2.9% of the total WBC. WBC is required, correct the WIC
The WIC value is equal to the WOC value and use the resultant number
value and WOC is the reported to confirm the WOC. If no other
WBC. The cell types that may be Suspect Parameter flags are
present in the N1 region are: present, the corrected WIC (or
confirmed WOC) value is
Low levels of NRBCs
reportable. If something other
Unlysed RBCs than NRBCs caused the elevated
PLT clumps count in the N1 region, follow
your laboratory’s protocol for
Giant PLTs reporting the WBC result.
FWBC (Fragile White Blood Cells) — displayed next to the Mono % result
Causes Action
The presence of fragile WBCs is Review a stained smear and follow
suspected. A kinetic decline in the your laboratory's review criteria to
WOC count rate was detected and confirm the LYM values and the
the count in the N1 (stroma) reported WBC value. If no suspect
region of the scatterplot is less than parameter flags are present, the
2.9% of the total WBC. The confirmed WBC and Differential
algorithm selects WIC, estimated may be reported.
to be the best count for the
reported WBC value, and displays
the WBC flag to indicate that the
result is suspect.
Causes Action
The presence of NRBCs is suspected. Review a stained smear for the
The WIC count is higher than the presence of NRBCs and follow your
WOC and the WOC is the reported laboratory's review criteria. If
value. The count in the N1 region, NRBCs are present they should be
below the dynamic WBC threshold quantified according to your
on the size/complexity (0°/10°) laboratory's procedure. If
scatterplot, is greater than 2.9% of correction of the WBC is required,
the total WBC. Cell types that may correct the WIC value and use the
be present in the N1 region: resultant number to confirm the
WOC result. If no other Suspect
NRBCs
Parameter Flags are present, the
PLT clumps corrected WIC (or confirmed
Giant PLTs. WOC) value is reportable. If the
WBC flag is displayed with the
NRBC flag, repeat the specimen
using the Resistant RBC cycle to
eliminate possible interference
from any lytic-resistant RBCs that
may be present with the NRBCs.
RRBC (Resistant Red Blood Cells) — displayed next to the Mono % result
Causes Action
The presence of lyse-resistant RBCs is Repeat the specimen using the
suspected. The WOC count is higher Resistant RBC cycle to eliminate
than the WIC count and there is a interference from any lytic-resistant
significant amount of stroma RBCs that may be present. (The
present (>2.9% of the total WBC) in Resistant RBC cycle reduces the
the N1 region, below the dynamic number of flags generated. However,
WBC threshold on the size/ an increase in false positive band
complexity (0°/10°) scatterplot. flags may be evident.) The
appropriate WBC value is selected
as indicated by the descriptor. If the
WBC flag is displayed, review a
stained smear to determine the
cause of the interference. Verify the
WBC value by an alternate method
according to your laboratory’s
protocol.
RBC Flag
Cause Action
One or more of the following Review a stained smear for abnormal
parameters exceeds expected RBC or PLT morphology and follow
limits: your laboratory’s review criteria.
PLT Flag
Cause Action
The PLT histogram did not meet Review a stained smear for abnormal
expected criteria (non-log PLT morphology or the presence of
normal distribution). PLT aggregates and follow your
laboratory’s review criteria. Verify
the PLT count.
Interpretive Messages
Interpretive messages appear only on the graphics report and are
generated when the numeric limits entered in the Patient Limit
Sets are exceeded. (See Set Up Instructions in Chapter 5:
Operating Instructions for an explanation). These messages are
printed only when the Interpretive Report option is selected on
the CUSTOMIZE REPORT Screen. The Interpretive messages are
summarized below.
WBC Messages
Message Cause
Leukopenia Result falls below the lower limit for WBC.
Leukocytosis Result exceeds the upper limit for WBC.
Neutropenia Result falls below the lower limit for Neutrophil
absolute number.
Neutrophilia Result exceeds the upper limit for Neutrophil
absolute number.
Lymphopenia Result falls below the lower limit for Lympho-
cyte absolute number.
Lymphocytosis Result exceeds the upper limit for Lymphocyte
absolute number.
Monocytosis Result exceeds the upper limit for Monocyte
absolute number.
Eosinophilia Result exceeds the upper limit for Eosinophil
absolute number.
Basophilia Result exceeds the upper limit for Basophil
absolute number.
Message Cause
Anemia Result falls below the lower limit for RBCs.
Polycythemia Result exceeds the upper limit for RBCs.
Microcytic RBC Result falls below the lower limit for MCV.
Macrocytic RBC Result exceeds the upper limit for MCV.
Hypochromic Result falls below the lower limit for MCHC.
Hyperchromic Result exceeds the upper limit for MCHC.
Anisocytosis Result exceeds the upper limit for RDW.
PLT Messages
Message Cause
Thrombocytopenia Result falls below the lower limit for PLTs.
Thrombocytosis Result exceeds the upper limit for PLTs.
Microcytic PLT Result falls below the lower limit for MPV.
Macrocytic PLT Result exceeds the upper limit for MPV.
NOTES
References
NOTES
Overview
NOTES
Physical Specifications
Table 4.1: Dimensions
Analyzer with Display Graphics
Sample Loader CPU Monitor Ticket Printer Printer
Height 27" (68 cm) 6.4” (16.3 cm) 15” (38.1 cm) 6" (15 cm) 13" (33 cm)
Width 30" (76 cm) 16.9” (42.9 cm) 14” (35.5 cm) 16.5" (41 cm) 19" (48 cm)
Depth 31" (79 cm) 17.3” (43.9 cm) 16” (40.6 cm) 14.5" (39 cm) 24" (61 cm)
Weight 288 lb (131kg) 32 lb (14.5 Kg) 30 lb (13.6 Kg) 16.5 lb (7.5 kg) 14.3 lb (6.5 kg)
Power Specifications
Table 4.2: Power Specifications
Analyzer Input Requirements
Setting Range Frequency
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
Consumption
Analyzer: 900 watts
Data Station: 300 watts
Graphics Printer: 110 watts
Ticket Printer: 145 watts
Sample Loader: 50 watts
1550 watts maximum (5200 BTU per hour)
Operational Specifications
Operating Environment
Indoor Use
Temperature Patient Samples:
Room Temperature (15–30°C)
Instrument: 15–30°C
Batch Size
1–100 tubes per batch
Throughput
Maximum throughput = 90 samples/hour
NOTES
Physical Specifications
Table 4.3: Dimensions
Display Graphics
Analyzer CPU Monitor Ticket Printer Printer
Height 24" (61 cm) 6.4” (16.3 cm) 15” (38.1 cm) 6" (15 cm) 13" (33 cm)
Width 30" (76 cm) 16.9” (42.9 cm) 14” (35.5 cm) 16.5" (41 cm) 19" (48 cm)
Depth 22" (56 cm) 17.3” (43.9 cm) 16” (40.6 cm) 14.5" (39 cm) 24" (61 cm)
Weight 190 lb (86 kg) 32 lb (14.5 Kg) 30 lb (13.6 Kg) 16.5 lb (7.5 kg) 14.3 lb (6.5 kg)
Power Specifications
Table 4.4: Power Specifications
Analyzer Input Requirements
Setting Range Frequency
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
Consumption
Analyzer: 900 watts
Data Station: 300 watts
Graphics Printer: 110 watts
Ticket Printer: 145 watts
1550 watts maximum (5200 BTU per hour)
Operational Specifications
Operating Environment
Temperature Patient Samples:
Room Temperature (15–30°C)
Instrument: 15–30°C
NOTES
Measurement Specifications
Measurement Channels
• Laser Optics for WOC (WBC Optical Count) and WBC
Differential
• Two impedance channels, one for WIC (WBC Impedance
Count) and one for both RBC and PLT
• Hemoglobin Absorbance
Wavelength 632.8 nm
HGB
Method Modified hemiglobincyanide or modified
hemiglobinhydroxylamine
Performance Specifications
Background Counts (Acceptable Up to Limits Listed)
WIC <0.30
WOC <0.30
RBC <0.03
HGB <0.20
PLT <10.0
RETIC <100 counts/count cycle
NOTE: Background counts must be within acceptable
limits before running controls and patient specimens.
Precision
Samples that are used to verify precision specifications should
have results that fall within the laboratory's normal range. These
samples should not display any of the following WBC descriptors
or Suspect Parameter Flags:
WBC
WIC
WOC
RBC MORPH
LRI
URI
LURI
PLTR
Fragile RBCs
ERL
ENC
The stated precision values are applicable to the Open, Closed
Sampler, and Sample Loader Modes.
Hemogram Parameters
Precision specifications for the hemogram parameters are given
as a 95% confidence limit for the Coefficient of Variation (CV) of
at least 31 determinations of the same sample.
Linearity
Linearity specifications were determined by analyzing dilutions
of a commercially available linearity control material that
contains no interfering substances. Specifications are determined
by taking multiple measurements for each dilution to minimize
the effect of imprecision. The stated limits (refer to the following
table) are determined by regression through the origin (0,0),
throughout the linear reportable range.
Reticulocyte linearity was determined by running six levels of
reticulocyte control material prepared by mixing varying
concentrations of two stock preparations. The general method
described in CLSI/NCCLS Document EP6-A, Evaluation of the
Linearity of Quantitative Analytical Methods, was used.1
Specifically, six concentration levels were run in quadruplicate,
and the method of least squares regression was used for analysis
of the reticulocyte percentage result.
NOTE: Results that exceed the linear range must be
confirmed by diluting the specimen until the result falls
within the appropriate linear range and then correcting
that result for the dilution in order to obtain a reportable
result.
Accuracy
The CELL-DYN 3700 System can be calibrated to agree with
reference values within the allowable calibration ranges. Both
modes of operation, Open and Closed (CS and SL), may be
calibrated. Thus, it is possible to compensate for differences
between modes due to differing aspiration pathways. When each
mode is properly calibrated according to the directions given in
this manual, bias between the modes is clinically insignificant.
Hemogram Parameters
Carryover
Carryover is determined by running samples with high
concentrations of WBCs, RBCs, HGB, PLTs and Retics. Each
sample is run in triplicate followed by three background cycles.
Background1 – Background3
% Carryover = x 100
Sample3 – Background3
The Absolute Carryover is calculated as follows:
Absolute Carryover = |Background1 - Background3|
Table 4.10: Carryover for WBC, RBC, HGB, PLT and Retics
WBC RBC HGB PLT RETIC %
Level 90K/µL 7.5M/µL 22.5g/dl 1000 30,000
K/µL list mode
counts
Carryover <1.0% or <1.0% or <1.0% or <1.0% or <0.5%
(in % or <0.1 K/µL <0.03 M/µL <0.1 g/dL <10 K/µL
Absolute)
Performance Characteristics
Typical Precision
The pooled precision values (CVs) for the hemogram parameters
are based on the analysis of data from replicate runs of N=31. The data
were obtained from several CELL-DYN 3700 Systems over a period
of weeks and derived using samples with results in the normal
range. These precision values represent the typical performance
that can be expected from instruments that are maintained
properly, are operating in acceptable environmental conditions,
and are using only recommended reagents and supplies.
Abnormalities Evaluated
Table 4.16 lists the abnormalities and the number of cases of each
abnormality that were evaluated during the testing period.
Truth Table
The Truth Table showing the sensitivity and specificity and the
analysis of the false negative results is presented in this section.
The data are based on the evaluation of a total of 374 cases, many
of which had multiple abnormalities. Arbitration using the 95%
confidence envelope at the upper limit of the range was applied
to the manual differential results.
In the following table:
TP = True Positive
TN = True Negative
FP = False Positive
FN = False Negative
NOTES
References
NOTES
Overview
Instrument Logbook
Create a logbook for the instrument. This logbook should contain
all necessary calibration documentation and other information
that is pertinent to your instrument. Suggested sections that you
may wish to include in the logbook are:
Installation documentation
Your laboratory’s operating procedure
Quality control
Calibration
Maintenance
Reagent lot number changes
Troubleshooting and problem resolution
Printed fault reports
Service calls and problem resolution/service performed
Software upgrades
This logbook should be stored near the instrument and be
accessible to all operators and Abbott Service Personnel.
Screen
Soft Keys
When the Data Station is turned ON, the MAIN MENU screen,
depicted in the preceding figure, is displayed. The key labels
displayed across the bottom of this screen are used to access all of
the submenus that are available. The MAIN MENU screen displays
the following soft key labels:
SET UP
RUN
DATA LOG
RETIC DATA LOG*
QUALITY CONTROL
CALIBRATION
DIAGNOSTICS
SPECIAL PROTOCOLS
Each of these MAIN MENU keys, in turn, accesses its own hierarchy
of screens and options. The different menus allow the operator to
perform various functions, such as configuring the system for
operation, running specimens, performing calibration and
diagnostic functions, reviewing data, and printing customized
reports.
The MAIN MENU screen is depicted in the preceding figure.
The upper left-hand corner shows the current version of the
instrument software. The upper right-hand corner shows the
current date and time, the operator ID, and the sequence number.
The information in the upper right corner is displayed on every
screen during operation.
NOTE: The cursor is positioned at the <OPERATOR ID>
entry field when the MAIN MENU screen is displayed. An
operator ID of up to three alphanumeric characters may be
entered. (An operator ID may also be entered from the
CALIBRATION screen.) This operator ID will be displayed on
all other screens and printed on all reports.
The Status Box is displayed in the top center of the screen. This
box appears on every screen to show the following:
• Menu in use (such as MAIN MENU)
• Analyzer status (such as READY)
• Other applicable information such as report or file
identity and any existing fault messages
Finally, the MAIN MENU key labels are displayed across the bottom
of the MAIN MENU screen.
MAIN MENU
KEYS
SUBMENU
KEYS
TOGGLE
KEYS
TOGGLE
KEYS
Flowchart Conventions
Menus are shown as square-cornered rectangles in the flowcharts,
and soft keys are shown as round-cornered rectangles:
MAIN MENU
Ready
Menu Flowcharts
After pressing one of the MAIN MENU soft keys, the appropriate
submenu is displayed. From the submenus, more options are
available. The MAIN MENU options flowchart is shown on this page.
On the following pages, flowcharts show the submenus under
each MAIN MENU option.
MAIN MENU
Ready
SET UP MENU
Ready
CONFIRM CANCEL
STOP STOP
TURN X-B TURN X-B PRINT RETURN
RBC ON WBC ON
TURN X-B TURN X-B USA SI SI MOD SET 1 SET 2 SELECT RETURN
RBC OFF WBC OFF UNITS UNITS UNITS UNITS UNITS UNITS
MEANS/ PLACE
LIMITS PARAMETER
LOAD LOAD LOAD RETURN
LOW NORMAL HIGH
SELECT CANCEL STANDARD TOGGLE RETURN
PARAMETER SELECTION GROUPS ONE/ALL
PLACE CUSTOM
CONFIRM CANCEL LOT TOGGLE PRINT RETURN
UPDATE UPDATE NUMBER ON/OFF PARAMETER PLACEMENT
REPLICATE
ID
WBC RBC PLT DIFF LATEX CUSTOMIZE RETURN
GROUP GROUP GROUP GROUP SET PRINTOUT
TICKET CUSTOMIZE STOP CUSTOMIZE TOGGLE SET UP RESTORE BLANK CUSTOMIZE CUSTOMIZE SET UP
PRINTER HEADER HEADER DISPLAY PRINTOUT
DISPLAY PRINTING HEADER ON/OFF
RESTORE PRE-PRNTD GRAPHICS
HEADER TICKET PRINTER
BLANK CONFIRM CANCEL
TICKET STOP STOP
RUN
Ready
WORK LIST BAR CODE INSERT/ DELETE PURGE WORK LIST PRINT RETURN
ON ON DELETE ALL COMPLETED SET UP WORK LIST
WORK LIST BAR CODE
OFF OFF
CONFIRM CANCEL TOGGLE RETURN
DELETION DELETION ON/OFF
QC MENU
Ready
X-B RBC X-B WBC PRINT RETURN SELECT CANCEL STANDARD TOGGLE RETURN
GRAPHS GRAPHS PARAMETER SELECTION GROUPS ONE/ALL
X-B RBC X-B WBC PLACE CUSTOM
DATA DATA PARAMETER PLACEMENT
MOVE TO CANCEL
FILE MOVE
GROUP GROUP GROUP GROUP PRINT RETURN WRITE WRITE WRITE RETURN
1 2 3 4 LOW NORMAL HIGH
CALIBRATION
Ready
CONFIRM CANCEL
QUIT QUIT
DIAGNOSTICS MENU
Ready
FAULT EXECUTION CNT RATE CLEAR RAW DATA MORE PRINT MAIN
REPORT TIMES SUMMARY FAULTS SUMMARY
MOTOR PWR HOME EXERCISE SHEAR VAL SHEAR VAL PRINT DIAG-
CHECKING MOTORS MOTOR TIME DISPENSE NOSTICS
SHEAR VAL
ASPIRATE
WOC 1 WOC 2 CALC SCATTER SMOOTHING EXTENDED PRINT DIAG- STOP TRANSMIT DIAG-
DATA DATA CV GRAPHS ON/OFF WOC COUNT NOSTICS TRANSMISS MESSAGE NOSTICS
WOC 1 WOC 2
HISTOGRAM HISTOGRAM
SPECIAL PROTOCOLS
Ready
PRINT RETURN
Set Up Instructions
When the [SET UP] key on the MAIN MENU screen is pressed, the
SET UP MENU screen is displayed. (See the following figure.) The
options accessible from this screen are used to configure the
system according to the laboratory’s requirements. The function
of each soft key is discussed on the following pages, and setup
procedures are included where applicable.
SET UP The [SET UP] key is used to display the SET UP MENU screen. The
following soft key labels are displayed on this screen:
DATE/TIME
PATIENT LIMITS
REAGENT LOG
QC SET UP MENU
OPERATION SET UP
UNITS SELECTION
CUSTOMIZE REPORT
MAIN
These keys are used to set up the system for operation.
Enter desired date display option and/or set date and time:
1 1 1: Month/Day/Year
2: Day/Month/Year
3: Year/Month/Day
4: Year/Day/Month
RETURN
DATE/ The [DATE/TIME] key on the SET UP MENU is used to display the
TIME DATE/TIME SET UP screen (shown in the preceding figure). This
screen is used to enter the date and time. This screen allows the
operator to select the format for displaying the date and to change
the date and time as required. Four different date formats are
available. The circled numbers shown in the preceding figure
correspond to the following numbered options:
1. The Display Format Selection Box is used to select the format
in which the date is displayed:
1: Month/Day/Year
2: Day/Month/Year
3: Year/Month/Day
4: Year/Day/Month
2. The <DATE> entry field contains the operator-entered date.
3. The <TIME> entry field contains the operator-entered time.
Procedure: Date/Time
1. From the SET UP MENU screen, press the [DATE/TIME] key to
display the DATE/TIME SET UP screen.
2. Type the number of the desired format at the cursor.
3. Press the Enter key on the keyboard to save the entry and
advance the cursor to the <DATE> entry field.
4. Type the date in the selected format using one or two digits.
Separate the day, month, and year with a slash (/) or a
period (.). The entry order of the date should conform to
the date format just selected.
5. Press the Enter key on the keyboard to save the entry and
advance the cursor to the <TIME> entry field.
6. Type the time in the 24-hour (military) time format using
one or two digits. Separate the hours and minutes with a
colon (:) or a period (.).
7. Press the Enter key on the keyboard to save the entry.
8. Press the [RETURN] key to return to the SET UP MENU screen.
PATIENT The [PATIENT LIMITS] key on the SET UP MENU is used to display one
LIMITS of the four LIMIT SET screens. (See the preceding figure.) These
screens are used to enter upper and lower flagging limits for
groups of patient samples. (For example, limits may be entered for
adult males, adult females, neonates, etc.) The following soft key
labels are displayed when the [PATIENT LIMITS] key is pressed:
LIMIT SET 1*
LIMIT SET 2*
LIMIT SET 3*
LIMIT SET 4*
PRINT
RETURN
* The key label for the limit set displayed on the screen is not
shown.
Whenever one of the four limit set soft keys is pressed, a screen
for that limit set is displayed and the soft key for that limit set is
no longer displayed. Four different sets of limits can be entered.
WBC Messages
Leukopenia Result falls below the lower limit for WBC.
Leukocytosis Result exceeds the upper limit for WBC.
Neutropenia Result falls below the lower limit for
neutrophil absolute number.
Neutrophilia Result exceeds the upper limit for
neutrophil absolute number.
RBC Messages
Anemia Result falls below the lower limit for RBCs.
Polycythemia Result exceeds the upper limit for RBCs.
Microcytic RBC Result falls below the lower limit for MCV.
Macrocytic RBC Result exceeds the upper limit for MCV.
Hypochromic Result falls below the lower limit for
MCHC.
Hyperchromic Result exceeds the upper limit for MCHC.
Anisocytosis Result exceeds the upper limit for RDW.
PLT Messages
Thrombocytopenia Result falls below the lower limit for PLTs.
Thrombocytosis Result exceeds the upper limit for PLTs.
Microcytic PLT Result falls below the lower limit for MPV.
Macrocytic PLT Result exceeds the upper limit for MPV.
2. Use the arrow keys on the keyboard to move the cursor to the
desired limit entry field and type the desired number.
3. Press the Enter key on the keyboard to save the entry and
automatically advance the cursor to the next entry position.
4. Repeat steps 2 and 3 until all desired entries have been made.
5. To obtain a printout of the Limit Set, press the [PRINT] key.
6. Press the appropriate soft key to select another Limit Set and
repeat steps 2–5 to enter the desired limits.
7. Press the [RETURN] key to return to the SET UP MENU screen.
REAGENT The [REAGENT LOG] key is used to display one of the reagent logs.
LOG (The name of the displayed log is indicated in the Status Box.) Any
one of the other three reagent logs may be displayed by pressing
the appropriate soft key. The following soft key labels are
displayed when the [REAGENT LOG] key is pressed:
DELETE ENTRY
DILUENT LOG*
WIC/HGB LYSE LOG*
SHEATH LOG*
DETERGENT LOG*
PRINT LOG
MAIN
* The soft key for the reagent log currently displayed on the
screen is not shown.
CELL-DYN® 3700 System Operator’s Manual 5-19
9140320E — September 2004
Operating Instructions
Set Up Instructions Chapter 5
1. From the SET UP MENU screen, press the [REAGENT LOG] key
to display a REAGENT LOG screen.
2. Move the cursor to the oldest entry in the log.
3. Press the [DELETE ENTRY] key. The [COMPLETE DELETION] and
the [RESTORE ENTRY] keys will be displayed.
4. Press the [COMPLETE DELETION] key to delete the selected
entry and create a space at the bottom of the log.
5. If desired, a new entry may then be made as directed in the
preceding Reagent Log Entry Procedure.
NOTE: New entries may also be made by typing over old
entries without deleting them.
6. Press the [RETURN] key to return to the SET UP MENU screen.
Select a QC file with the arrow keys or enter a new file name.
QC SET UP The [QC SET UP MENU] key is used to display a list of the QC files
MENU (see the preceding figure). This is the first of a series of screens
and menu options that allow the operator to set up the QC files.
The following soft key labels are displayed when the
[QC SET UP MENU] key is pressed:
X-B SET UP
LAB ID SET UP
QC LIMITS
SET UP QC FILE
CUSTOMIZE DISPLAY
CUSTOMIZE PRINTOUT
RETURN
NOTE: QC Set up for Reticulocytes is described in
Chapter 14: Reticulocyte Package.
SET UP The [SET UP QC FILE] key is used to configure the selected QC file.
QC FILE Pressing this key will display a QC FILE SET UP screen from which
the lot number or replicate ID can be entered, and the Westgard
Rules selected. If the file is used for a commercial control, the lot
number and expiration date may be entered by pressing the
[LOT NUMBER] key. If the file is used for a patient control, the ID
number of the control may be entered by pressing the
[REPLICATE ID] key. When the [SET UP QC FILE] key is pressed, the
following soft key labels are displayed:
REPLICATE ID or
LOT NUMBER (This key label alternates between
these two selections when the soft
key is pressed.)
TOGGLE ON/OFF (This key label is present only when
the cursor is in one of the Westgard
Rule Selection fields.)
PRINT
RETURN
5. Use the arrow keys on the keyboard to move the cursor back
into the selected file.
6. Press the [SET UP QC FILE] key to display the QC FILE SET UP
screen.
Figure 5.12: QC Means/Limits Entry Screen Showing the Update From File
Key
If the [CONFIRM UPDATE] key is pressed, the mean value for each
parameter will be computed from the values in the file. The
parameter limits are set as follows:
WBC, PLT, RDW, and MPV: ± 10% of the computed mean
NEU, LYM, and MONO: ± 40% of the computed mean
Remaining Parameters: ± 5% of the computed mean
LOAD
FROM DISK
The [LOAD FROM DISK] key is used to enter the lot number,
expiration date, and assay values into a QC file directly from a
floppy disk. When this option is used, the lot number, expiration
date, mean value and limits (either for QC Range entry or QC
Means/Limits entry) are automatically entered in the selected file.
The values may be edited after they are displayed on the screen.
NOTE: The information is entered for each level, one level
at a time.
3. When the desired files have been named, use the Arrow keys
on the keyboard to move the cursor back to the first file
desired for data entry.
4. Press [QC LIMITS] followed by [MEANS/LIMITS] or
[RANGE ENTRY] to display the QC MEANS/LIMITS ENTRY or
RANGE ENTRY screen for the selected file.
5. Press [LOAD FROM DISK] to display the LOAD FROM DISK
screen.
6. Insert the disk containing the assay information for the
relevant lot number into the Data Station disk drive.
NOTE: Be certain to carefully check lot numbers. Be sure
the lot number on the disk matches the lot number that is
being put into use. If the lot number is included in the
filename, be sure the disk contains assay information for
that lot number.
7. Check the status box to be sure the correct file is selected and
press the appropriate soft key:
[LOAD LOW] to load the low control assay data.
[LOAD NORMAL] to load the normal control assay data.
[LOAD HIGH] to load the high control assay data.
8. The limits are displayed for the selected file. If desired, the
limits may be edited.
9. Press [RETURN] to return to the QC MENU screen.
10. Select the next file and repeat steps 7 and 8 to load the assay
data for the appropriate level of control.
11. When all the assay data has been loaded, remove the disk
from the disk drive.
Group 4: WBC %N %L %M %E %B
STANDARD
The [STANDARD GROUPS] key is used to select a predetermined
GROUPS group of parameters that will be placed on a designated page.
The display may be customized by selecting the individual
parameters, standard groups of parameters, or a combination of
the two.
On the CUSTOMIZE QC DISPLAY screen, the selections included in
Parameter Group 1 will be displayed (in the order indicated from
left to right) on the first VIEW QC LOG screen. The remaining
groups will be displayed on subsequent screens that are accessed
by pressing the right arrow key on the keyboard. The left arrow
key is used to page back through the screens to the first screen.
The VIEW QC LOG screen is discussed in Chapter 7: Quality Control.
TOGGLE The [TOGGLE ONE/ALL] key is used to customize one file only or all
ONE/ALL files the same way.
Group 4: WBC %N %L %M %E %B
The WBC, RBC, PLT, and DIFF Standard Groups are shown in the
preceding figure. They contain the following parameters:
WBC Group (Group 1):WBC, NEU, LYM, MONO, EOS, BASO
RBC Group (Group 2): RBC, HGB, HCT, MCV, MCH, MCHC,
RDW
PLT Group (Group 3): PLT, MPV, PCT, PDW
DIFF Group (Group 4): WBC, %N, %L, %M, %E, %B
SELECT PARAMETER or
PLACE PARAMETER (This key label alternates between
these two selections.)
STANDARD SELECTION
TOGGLE ONE/ALL
RETURN
TOGGLE The [TOGGLE ONE/ALL] key is used to customize one file only or all
ONE/ALL files the same way.
1 2 3
Parameter Lower/Upper Limits Target Value Action Limit
MCV 55.0/125. fL 89.9 fL 3.0 %
MCH 20.0/40.0 pg 30.5 pg 3.0 %
MCHC 24.0/44.0 g/dL 33.9 g/dL 3.0 %
The X-B WBC program is ON.
Parameter Lower/Upper Limits Target Value Action Limit
LYM 0D 48/ 70 Channel 59 Channel 7.0 %
LYM 10D 51/ 67 Channel 59 Channel 5.0 %
NEU 0D 141/179 Channel 160 Channel 4.0 %
NEU 10D 128/170 Channel 149 Channel 5.0 %
NEU 90D 87/163 Channel 125 Channel 10.0 %
NEU 90DEP 11/ 31 Channel 21 Channel 19.0 %
NEU-EO 14.0/ 32.0 Degree 23.0 Degree 13.0 %
X-B The [X-B SET UP] key on the QC SET UP MENU screen is used to
SET UP display the X-B SET UP screen. (See the preceding figure.) This
screen is used to enter upper and lower acceptance limits, target
values, and action limits for the X-B Moving Average QC
Program. The following soft key labels are displayed when the
[X-B SET UP] key is pressed:
7. Press the [TURN X-B WBC ON] key to enable the X-B WBC
Program if this key label is displayed.
NOTE: When the X-B WBC Program is enabled, the screen
displays the message The X-B WBC Program is ON,
and the [TURN X-B WBC OFF] key is displayed.
To turn on the RETIC PKG you must enter to operator ID and the
instrument must be in Open mode. To turn on the VET PKG you must
exit the RETIC PKG.
OPERATION The [OPERATION SET UP] key on the SET UP MENU screen is used to
SET UP display the OPERATION SET UP MENU screen (see the preceding
figure). This screen allows the operator to select the type of bar
code used and configure the transmission to an on-line computer.
The Veterinary Package and the Reticulocyte Package for the
CELL-DYN 3700 System can be enabled or disabled from this
screen. The following soft key labels are displayed on the
OPERATION SET UP MENU screen:
SET UP
The [BAR CODE SET UP] key is used to display the BAR CODE SET UP
BAR CODE
SET UP screen, which is used to select the type of bar code to be read and
to enable or disable the Check Digit option for a specific bar
code. (See the preceding figure.) If the Check Digit option is
enabled, the Analyzer reads only the type of bar code selected. If
the option is disabled, the Analyzer ignores the selected bar code
and reads all four types of bar codes (Code 39, Interleaved 2 of 5,
Codabar, and Code 128).
COMPUTER The [COMPUTER SET UP] key on the OPERATION SET UP MENU screen
SET UP is used to display the COMPUTER SET UP screen (see the preceding
figure) and the following soft key labels:
REINIT INTERFACE
STOP TRANSMISS
TOGGLE ON/OFF
SET UP
The CELL-DYN 3700 System has the capability to transmit data to
an on-line computer (Laboratory Information System, or LIS).
Data can be transmitted automatically as each sample is run, or
data can be transmitted at the operator’s request. The CELL-DYN
3700 System can also receive patient information that is
transmitted to it by the on-line computer.
The COMPUTER SET UP screen is used to configure the
transmission format to meet the requirements of the LIS or on-
line computer. Instructions for using this option are given after
the following description of the soft keys.
CONFIRM STOP
CANCEL STOP
These keys confirm or cancel the Stop Transmission command.
3. For the last five options on the list, type the appropriate
information and press the Enter key on the keyboard to save
the entry and advance the cursor.
4. When all the information has been entered, press the
[REINIT INTERFACE] key to initialize the interface for the
selected configuration.
5. To obtain a printout of the configuration, press the Print
Screen key on the keyboard.
6. Press the [SET UP] key to return to the OPERATION SET UP
MENU screen.
7. Press the [RETURN] key to return to the MAIN MENU screen.
UNITS The [UNITS SELECTION] key on the SET UP MENU screen is used to
SELECTION display the UNITS SELECTION screen. This screen allows the
selection of the report units for the indicated parameters. Units
may be selected for each parameter individually or a set of units
may be selected by pressing the appropriate soft key. (See the
preceding figure.) The following soft key labels are displayed on
the UNITS SELECTION screen:
USA UNITS
SI UNITS
SI MOD UNITS
SET 1 UNITS
SET 2 UNITS
SELECT UNITS
RETURN
The units selected by each of the soft keys are shown on the
screen display in the preceding figure. The following table shows
an example of the same sample displayed with each of the four
units selections. Refer to Section: Reticulocyte Package,
Subsection: Retic Units Selection Softkey for information on
reticulocyte units.
Table 5.1: Report Units
Parameter Value Units Value Units Value Units Value Units Value Units
WBC* 5.32 K/µL 5.32 G/L 5.32 10e9/L 5.32 10e3/µL 53.2 10e2/µL
RBC 5.15 M/µL 5.15 T/L 5.15 10e12/L 5.15 10e6/µL 515. 10e4/µL
HGB 16.2 g/dL 162 g/L 10.1 mmol/L 162 g/L 16.2 g/dL
MCHC 34.1 g/dL 341 g/L 21.2 mmol/L 341 g/L 34.1 g/dL
PLT 323 K/µL 323 G/L 323 10e9/L 323 10e3/µL 32.3 10e4/µL
PDW**, *** 17.5 10GSD 17.5 10GSD 17.5 10GSD 17.5 10GSD 17.5 10GSD
*NEU, LYM, MONO, EOS, and BASO are reported in the same units as the WBC.
**Report Unit is Geometric Standard Deviation.
***Clinical significance has not been established for these parameters. Therefore, they are not
reportable in the US.
SET UP MENU
Ready
CUSTOMIZE
REPORT
PARAM PARAM PARAM PARAM CUSTOMIZE CUSTOMIZE SELECT SET UP RESTORE BLANK CUSTOMIZE CUSTOMIZE SET UP
SET 1 SET 2 SET 3 SET 4 PRINTOUT HEADER GRAPH HEADER HEADER DISPLAY PRINTOUT
ON PLT
ON MPV RBC Histogram PLT Histogram
Auto-Sampler Busy
PARAM PARAM PARAM CUSTOMIZE CUSTOMIZE SELECT SET UP
SET 2 SET 3 SET 4 PRINTOUT HEADER GRAPH
Using the [PARAM SET “X”] key, the display can be customized for
PARAM
SET “X” four different sets of parameters. Up to 20 individual parameters
and up to four scatterplots and/or histograms can be displayed in
each set. (The “empty” selection may be used to “blank” the
scatterplot or histogram display at the selected position.)
Individual parameters are listed in the left portion of the screen,
and the scatterplots and histograms are listed in the right portion.
GRAPHICS PRINTER or
TICKET PRINTER (This key label alternates
between these two selections
when the soft key is pressed.)
CUSTOMIZE DISPLAY
STOP PRINTING
CUSTOMIZE HEADER
TOGGLE ON/OFF
SET UP
When the [TICKET PRINTER] key is pressed, the key label changes
to [GRAPHICS PRINTER] and the following soft key labels are also
displayed:
BLANK TICKET or
PRE-PRNTD TICKET (This key label alternates
between these two selections when the
soft key is pressed.)
RESTORE HEADER (This key label appears only when the
[BLANK TICKET] key is selected.)
When the [CUSTOMIZE PRINTOUT] key is pressed, the screen that
was used for the last entry is displayed. A brief description of the
function of the soft keys is given in this section. For ease of
explanation, the keys are grouped according to the type of printer
selected. This section contains the following subsections:
• General Purpose Soft Keys
• Ticket Printer Soft Keys
• Graphics Printer Soft Keys
CONFIRM STOP
CANCEL STOP
These keys confirm or cancel the Stop Printing command. If the
[CONFIRM STOP] key is pressed, the print buffer (the memory area
where the material is stored while awaiting printing) is cleared
and the bulletin line displays the following message: PRINTING
STOPPED. RESET PAPER TO THE TOP OF THE PAGE.
TOGGLE The [TOGGLE ON/OFF] key enables or disables the option selected
ON/OFF by the position of the cursor. The key label is not displayed when
a numeric entry is required.
SET UP The [SET UP] key is used to return to the SET UP MENU screen.
BLANK TICKET or
PRE-PRNTD TICKET (This key label alternates between
these two selections when the soft
key is pressed.)
BLANK
TICKET The [PRE-PRNTD TICKET] key is used to customize the printed
PRE-PRINTD report for a preprinted ticket. The [BLANK TICKET] key is used to
TICKET
customize the printed report for a blank ticket.
GRAPHICS PRINTER
Figure 5.24: Customize Printed Report Screen for the Graphics Printer
Please enter the number of lines for the customize header (0..4) : 0
Print current Date/Time and Software Version : OFF
. . . . . . . 1. . . . . . . . 2 . . . . . . . . . 3 . . . . . . . . 4 . . . . . . . . 5 . . . . . . . . 6 . . . . . . . . 7 . . . .
Figure 5.25: Customize Printout Header Screen for the Graphics Report
BLANK The [BLANK HEADER] key is used to erase the current header.
HEADER
SET UP The [SET UP] key is used return to the SET UP MENU screen.
6. Press the Enter key on the keyboard to save the entry and
advance the cursor to the next entry field.
7. Repeat steps 5 and 6 for each line of the header.
8. Press the [SET UP] key to return to the SET UP MENU screen.
NOTES
Routine Operation
For more detailed information about the Sample Loader and the
use of bar codes labels, refer to Chapter 12: Sample Loader and
Appendix A: Bar Codes, respectively.
Run Menu
PLT K/uL
MPV fL PLT RBC
RUN The [RUN] key on the MAIN MENU screen is used to display the RUN
screen. (See the preceding figure.) The following soft key labels
are displayed on the RUN screen:
CLEAR APERTURES or
CLEAR FAULT or
PRIME (This key label alternates between
these three selections.)
WORK LIST
SPECIMEN TYPE
CUSTOMIZE REPORT
CHANGE SAMPLER or
TOGGLE AUTO ID (This key label alternates between
these two selections.)
PRINT TICKET
PRINT REPORT or
COLOR PRINT (This key label changes to [COLOR
PRINT] when the color printing
option is selected.)
MAIN
Run Screens
There are seven possible RUN screens, each customized for one of
the following different types of specimen: Patient, QC Specimen,
Background, Electrical Background, Latex, Resistant RBC, and
Auxiliary. These customized screens are accessed by pressing the
[SPECIMEN TYPE] key on each RUN screen and then choosing the
desired specimen type.
3. <SEX (M/F):/DOB: --/--/--> Used to enter the sex and birth date
of the patient.
4. <DR> Used to enter the name of the patient’s
physician. (Up to 22 characters may be entered.)
XB RBC or
XB WBC: If the XB RBC and/or XB WBC
Analysis is enabled, the file
status is displayed to the right of
the <DR> entry field.
WL: The status (OFF/ON) of the Work List is
displayed after the X-B status field.
5. <PARAM:/LIMITS:> Displays the number (1–4) of the
Parameter and Limit Sets that will be
applied to the sample results.
NOTE: Both Parameter and Limit Sets may be changed
after the sample has been run. Refer to the description of
the [EDIT SPECIMEN] key given in Using the Data Log within
this chapter.
PLT K/uL
MPV fL PLT RBC
Status Box
The Status Box is displayed in the top center of every RUN screen.
It contains the following information:
• Menu in use
• The Status of the Analyzer — the Ready, Not Ready and
Fault messages are displayed here
• Report or file identity for results currently displayed
Aspirating
Remove specimen
Dispensing
Counting
Extended Count
Rinsing
Ready
The top right-hand corner of the RUN screen displays the following
information:
• Current date and time
• Operator ID — identification of the current operator
• Sequence # — automatically incremented as samples are run
• Work List status — OFF/ON
• Selected sampler mode — Open Sampler or Closed Sampler
The center section of the RUN screen displays the results. A list
of the parameters and results is displayed on the left side.
Scatterplots and histograms are displayed on the right side. The
area between the parameter data and the graphic data is used to
display suspect flagging messages and count times. Examples of
the count times and some of the suspect flagging messages are
shown in the following two figures.
Figure 5.28: Run Screen Showing Count Times and Flagging Messages
Figure 5.29: Run Screen Showing Flagging Messages, RBC CLOG Message, and
RBC Up Time
Bulletin Line
The Bulletin Line is displayed immediately above the soft key
labels. Messages appear in this line to identify status or fault
conditions. An example of a Bulletin Line message (Auto-Sampler
Pause) is shown in the preceding figure.
When the system enters the Standby state while the RUN screen
is displayed, the [CLEAR APERTURES/CLEAR FAULT] key label will
change to the [PRIME] key label. Pressing the [PRIME] key primes
the system and brings it to the Ready state.
BAR CODE ON
1 1 1
--/--/--
WORK LIST BAR CODE INSERT/ DELETE PURGE WORK LIST PRINT RETURN
ON OFF DELETE ALL COMPLETED SET UP WORK LIST
The [WORK LIST] key is used to display the WORK LIST screen (see
WORK
LIST the preceding figure). The following soft key labels are displayed
on the WORK LIST screen:
WORK LIST ON or
WORK LIST OFF (This key label alternates between
these two selections.)
BAR CODE ON or
BAR CODE OFF (This key label alternates between
these two selections.)
INSERT/DELETE
DELETE ALL
PURGE COMPLETED
WORK LIST SET UP
PRINT WORK LIST
RETURN
These keys are used to create the Work List, which is used to
preassign specimen identification, display, and print criteria for
specimens that will be run. It is essentially a list of specimens
(including the preassigned information) that the operator intends
to run on the instrument. The Work List may be used with or
without bar code labels on the tubes. The functions of the Work
List keys are described in Routine Operation, Using the Work List
within this chapter.
SPECIMEN The [SPECIMEN TYPE] key on the RUN screen is used to select the
TYPE type of specimen that will be run. (See the preceding figure.)
When the [SPECIMEN TYPE] key is pressed, the screen displays a
list of the QC files and the following soft key labels:
PATIENT
QC SPECIMEN
BACKGROUND
ELECTRICL BACKGRND
LATEX
RESISTANT RBC
AUXILIARY
RETURN
The function of each key is discussed in the following section.
PATIENT The [PATIENT] key on the SPECIMEN TYPE screen is used to display
the RUN screen for patient samples. (See the preceding figure.)
Patient identification and demographics may be entered on the
RUN screen after this key is pressed. Results from this run option
are stored in the Data Log.
G
WBC K/uL R
NEU %N S A
LYM %L I N
Z L
MONO %M
E R
EOS %E T
BASO %B Y
WCT:
RBC M/uL COMPLEXITY LOBULARITY
HGB g/dL
HCT %
MCV fL
MCH pg
MCHC g/dL
RDW %
PLT K/uL
MPV fL RCT: PLT RBC
G
WBC K/uL R
NEU %N S A
LYM %L I N
Z L
MONO %M
E R
EOS %E T
BASO %B Y
WCT:
RBC M/uL COMPLEXITY LOBULARITY
HGB g/dL
HCT %
MCV fL
MCH pg
MCHC g/dL
RDW %
PLT K/uL
MPV fL RCT: PLT RBC
G
WBC K/uL R
NEU %N S A
LYM %L I N
Z L
MONO %M
E R
EOS %E T
BASO %B Y
WCT:
RBC M/uL COMPLEXITY LOBULARITY
HGB g/dL
HCT %
MCV fL
MCH pg
MCHC g/dL
RDW %
PLT K/uL
MPV fL RCT: PLT RBC
PLT K/uL
MPV fL PLT RBC
RESISTANT The [RESISTANT RBC] key is used to select the Resistant RBC mode.
RBC This mode is used to process specimens containing RBCs that are
lyse resistant. The sample is held in the WOC Mixing Chamber for
approximately 15 seconds longer than the normal mixing time. The
extra time enhances the osmotic lysing effect of the Sheath
Reagent and reduces interference from the lyse-resistant RBCs.
(The interference caused by these RBCs frequently generates WBC
and Differential flags. The Resistant RBC cycle reduces the
number of WBC and Differential flags generated.)
This key is available only when the Open Mode is selected.
Note: WBC
CONFIRM CANCEL
SPECIMEN SPECIMEN
Procedure: Auxiliary
1. Dilute the specimen with Diluent according to your
laboratory’s procedure.
2. If necessary, from the RUN screen press the
[CHANGE SAMPLER] key to select the Open Mode.
3. Press the [SPECIMEN TYPE] key followed by the [AUXILIARY]
key to select the Auxiliary Specimen Type.
PLT K/uL
MPV fL RCT: PLT RBC
When the cursor is positioned on the word AUTO (at the end of
the <NEXT ID> entry field), this key label changes to
[TOGGLE AUTO ID] and the auto increment feature is enabled (the
word AUTO is highlighted) or disabled. Refer to the Sample
Analysis section of this chapter for a discussion of the auto
increment feature.
Specimen Stability
Fresh whole blood specimens are recommended. The International
Committee for Standardization in Haematology (ICSH) defines a
fresh blood specimen as one processed within four hours after
collection.1
The hemogram parameters —RBC, HGB, HCT, MCV, MCH, MCHC,
RDW, PLT, and MPV— are stable (±5%) for up to 24 hours after
collection. The total WBC is stable (±5%) for up to 12 hours after
collection. The stability of the total WBC decreases to ±7% at
24 hours after collection.
The WBC Differential parameters — NEU, LYM, MONO, EOS, and
BASO — are stable (±10%) for up to 12 hours after collection. An
increase in false positive Suspect Population Flags may be seen on
samples processed less than 30 minutes after collection time or
more than 4 hours after collection time.
Stability studies conducted at Abbott indicate that specimens
exhibit increased stability when they are stored at room
temperature rather than in a refrigerator.
The stability of capillary specimens collected in microtainers may
vary depending on the microtainer manufacturer. Refer to the
manufacturer’s package insert for stability claims.
Specimen Collection
All specimens should be collected using proper technique and
following the tube manufacturer’s recommendations.
NOTE: For additional information on collecting venous
and capillary specimens, refer to CLSI/NCCLS Standards,
H3-A52 and H4-A5.3
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 3700 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.
Sample Analysis
Certain general guidelines should be followed when running
samples on either the Sample Loader or the Closed Sampler
instruments.
• Samples should not be run until the instrument has been
properly started up and daily QC checks have been
performed.
• The Ready message must be displayed in the Status Box on
the Data Station RUN screen before samples can be analyzed.
• Samples should be well mixed (a rotary mixer is preferred)
before they are run in the Open Mode or the Closed Mode on
the CELL-DYN 3700CS System. The Sample Loader
automatically mixes the samples before aspiration. However,
samples must be well mixed before they are placed in the
Sample Loader racks.
Operator ID
The operator should enter an Operator ID before running
samples. The Operator ID is displayed on all screens and printed
on the graphics report and the blank ticket report. It is also
retained in the QC Logs and the Data Log.
The operator ID can be entered from the MAIN MENU screen or the
CALIBRATION screen. When either screen is selected, the cursor is
positioned in the <OPERATOR ID> entry field. Type up to three
alphanumeric characters and press the Enter key on the keyboard
to save the ID number.
Specimen Identification
A specimen identification name or number can be entered in the
upper left-hand corner of the RUN screen. These entry fields are
made available by pressing the [SPECIMEN TYPE] key followed by
the [PATIENT] key.
1. A Specimen ID name or number of up to 12 characters can
be entered in the <NEXT ID> entry field.
Instrument Start Up
The Analyzer and Data Station power switches should be left ON
at all times. The instrument has been designed to automatically
maintain itself when it is idle. If the instrument is idle for five
minutes, a cleaning cycle will be automatically initiated. If the
instrument is idle for four hours, an automatic Shutdown Cycle
will be initiated. The instrument will be placed in the Standby
state at the end of the automatic Shutdown Cycle.
Power to the Printer may be left ON or OFF at the operator’s
discretion. For complete instructions on Printer operation, refer to
Chapter 11: Printers.
Power to the Sample Loader may be left ON or OFF at the
operator’s discretion. For complete instructions on Sample Loader
operation, refer to Chapter 12: Sample Loader.
A complete procedure for turning the system ON or OFF is given
in Chapter 10: Troubleshooting.
6. If the results are unacceptable, repeat the run. If the results are
still unacceptable, obtain a new bottle of the control, be sure
that it is warmed and mixed properly, and again repeat the run.
If the results are still unacceptable, run the other levels of
control material. If the results on all levels are unacceptable,
troubleshoot accordingly, as directed in Chapter 10:
Troubleshooting, Subsection: Troubleshooting Guide.
7. When the control results are acceptable, patient samples may
be analyzed.
Closed Mode QC
QC samples can be run on the Sample Loader using the “Q Labels,”
which are bar code labels that are available for the Sample Loader.
Each label is designated Qx, where x indicates the file number. If
these labels are placed on the control tubes, the results are
automatically transmitted to the file indicated by the label. QC
samples can also be run on the Sample Loader without these labels.
NOTE: Be sure the Work List is OFF before beginning
these procedures. If necessary, refer to Work List within
this chapter for instructions.
6. Be sure that all 10 racks (5 on each side) and the Safety Cover
are in place and press the Start key on the Sample Loader.
7. The Sample Loader reads the Q Label and transmits the
results to the appropriate QC file.
8. When all controls have been run, press the [MAIN] key
followed by the [QUALITY CONTROL] key.
9. Use the arrow keys on the keyboard to move the cursor to the
desired file.
10. Press the [VIEW QC LOG] key to display the QC log.
11. Verify that the results are acceptable.
NOTE: Out-of-range results are displayed in color.
12. Repeat steps 8–10 for all controls that were run.
13. If the results are unacceptable, repeat the run. If the results
are still unacceptable, obtain a new tube of control, be sure
that it is warmed and mixed properly according to the
manufacturer’s recommendations, and again repeat the run.
If the results are still unacceptable, run the other levels of
control material. If the results on all levels are unacceptable,
troubleshoot accordingly, as directed in Chapter 10:
Troubleshooting, Subsection: Troubleshooting Guide.
14. When the control results are acceptable, patient samples may
be analyzed.
5. Be sure that all 10 racks (5 on each side) and the Safety Cover
are in place and press the Start key on the Sample Loader.
6. After the first control is aspirated, press the Pause key on the
Sample Loader.
7. After the results are displayed, press the [SPECIMEN TYPE] key.
8. Use the arrow keys on the keyboard to move the cursor to the
file for the next control to be run and press the [QC SPECIMEN]
key.
9. Press the Start key on the Sample Loader.
10. Repeat steps 6–9 until all levels of controls have been run.
11. When all of the controls have been run, press the [MAIN] key
followed by the [QUALITY CONTROL] key.
12. Use the arrow keys on the keyboard to move the cursor to the
desired file.
13. Press the [VIEW QC LOG] key to display the QC Log.
14. Verify that the results are acceptable.
NOTE: Out-of-range results are displayed in color.
15. Repeat steps 11–14 for all levels of controls that were run.
16. If the results are unacceptable, repeat the run. If the results
are still unacceptable, obtain a new tube of control, be sure
that it is warmed and mixed properly, and again repeat the
run. If the results are still unacceptable, run the other levels
of control material. If the results on all levels are
unacceptable, troubleshoot accordingly, as directed in
Chapter 10: Troubleshooting, Subsection: Troubleshooting
Guide.
17. When the control results are acceptable, patient samples may
be analyzed.
Running Samples
Two modes of running samples are available with the SL Model:
• Open Mode Analysis
The Open Sampler Mode aspirates the sample from an
opened collection tube. OPEN SAMPLER is displayed in the
upper right corner of the RUN screen when this mode is
selected. The Open Sample Aspiration Probe is available only
when this mode is selected.
4. Place the racks in the Sample Loader Tray with the slotted
side facing the Analyzer.
NOTE: All 10 racks must be in the tray (5 on each side)
for the Sample Loader to operate.
Daily Shutdown
It is not necessary to perform a Daily Shutdown Procedure, as the
instrument automatically goes into a Standby state if it has been
idle for four hours. If desired, the operator may place the
instrument in the Standby state by pressing the
[DAILY SHUTDOWN] key on the second SPECIAL PROTOCOLS screen.
NOTE: The instrument should not be turned off unless
directed to do so by an authorized Abbott Representative
or in case of emergency.
Running Samples
Two modes of running samples are available with the CS Model:
• Open Mode Analysis
The Open Sampler Mode aspirates the sample from an
opened collection tube. OPEN SAMPLER is displayed in the
upper right corner of the RUN screen when this mode is
selected. The Open Sample Aspiration Probe is available only
when this mode is selected.
• Closed Mode Analysis
The Closed Sampler Mode on Closed Sampler (CS) instruments
aspirates the sample from a closed collection tube that has been
inserted in the Closed Sampler Module. CLOSED SAMPLER is
displayed in the upper right corner of the RUN screen when this
mode is selected. The Wash Block moves down to the end of the
Open Sample Aspiration Probe when this mode is selected.
4. Press the Touch Plate located behind the probe to start the
cycle. The word BUSY on the Analyzer Status Indicator Panel
will be illuminated in yellow.
5. Remove the tube when the beep sounds.
6. When the cycle is completed, the word READY on the
Analyzer Status Indicator Panel will be illuminated in green,
and the results will be displayed on the RUN screen.
7. Repeat this procedure for subsequent samples.
Daily Shutdown
It is not necessary to perform a Daily Shutdown Procedure, as the
instrument automatically goes into a Standby state if it has been
idle for four hours. If desired, the operator may place the instrument
in the Standby state by pressing the [DAILY SHUTDOWN] key on the
second SPECIAL PROTOCOLS screen.
When the key is pressed or when the Automatic Shutdown is
initiated, the cycle:
• Rinses the Flow System.
• Sets the timer control that periodically opens all of the
solenoid valves to prevent pinched tubing.
WORK LIST ON or
WORK LIST OFF (This key label alternates between
these two selections.)
BAR CODE ON or
BAR CODE OFF (This key label alternates between
these two selections.)
INSERT/DELETE
DELETE ALL
PURGE COMPLETED
WORK LIST SET UP
PRINT WORK LIST
RETURN
WORK LIST BAR CODE INSERT/ DELETE PURGE WORK LIST PRINT RETURN
OFF OFF DELETE ALL COMPLETED SET UP WORK LIST
6. <SPECIMEN NAME>
The name entered in this field should be associated with the
identification number entered in the <SPECIMEN ID> field. Up
to 16 characters can be entered in this field.
7. <L> (Limit Set)
This field is used to enter the number of the Patient Limit Set
that will be used for flagging the sample. If no entry is made,
the default (pre-selected) Patient Limit Set will be used.
8. <P> (Parameter Set)
This field is used to enter the number of the Parameter Set
that will be used for the sample. If no entry is made, the
default (preselected) Parameter Set will be used.
9. <DOCTOR>
This field is used to enter the name of the patient’s physician.
10. <DATE OF BIRTH>
This field is used to enter the date of birth of the patient.
11. <S> (Status)
As the samples are processed, the status is indicated in this
field. The operator cannot enter information in this field.
The following codes may be displayed:
N Non-Alerted
The sample was not flagged in any way.
A Alerted
The sample was flagged because results exceeded
the selected Patient Limits or because a
morphological flag was generated.
F Fault
A Metering Fault (for WIC or RBC/PLT) or a
Sampling Error message was generated as the
sample was processed, either with or without the
Sample Loader; or a Mixing Error message was
generated as the sample was processed (only when
using the Sample Loader).
12. <RACK/TUBE>
As samples are processed on the Sample Loader, the rack
number and tube number (position of the tube in the rack)
are displayed in this field. The operator cannot enter
information in this field. The display shows RxTx (where x
indicates the number of the rack or tube).
TOGGLE RETURN
ON/OFF
The [WORK LIST SET UP] key on the WORK LIST screen is used to
WORK LIST
SET UP display the WORK LIST SET UP screen shown in the preceding
figure. The numbers on the screen correspond to the following
numbered options:
1. <Bar Code ID associated with:>
1 = 4-digit bar code
2 = Laboratory Specimen ID
This field is used to specify the type of bar code that will be
used when the Bar Code feature is ON. If option 2 is selected,
the bar code number must be entered in the <Specimen ID> field.
2. <Specimen Name entry selected>
This field is used to specify whether a specimen name will be
entered in the Work List.
3. <Patient Limits entry selected>
This field is used to specify which Patient Limits are assigned
to each sample. The default Patient Limit Set will be used if
no specification is made.
4. <Default Patient Limit Set (1..4)>
This field is used to specify the default (preassigned) Patient
Limit Set that will be automatically assigned to each sample
unless otherwise indicated in the Work List.
5. <Parameter Set entry selected>
This field is used to specify which Parameter Set will be
assigned to each sample. The Default Parameter Set will be
used if no specification is made.
6. <Default Parameter Set (1..4)>
This field is used to specify the default (preassigned)
Parameter Set that is automatically assigned to each sample
unless otherwise indicated in the Work List.
7. <Doctor Name entry selected>
This field is used to specify whether a doctor name will be
entered in the Work List.
8. <Date of Birth entry selected>
This field is used to specify whether the patient’s date of
birth will be entered in the Work List.
Type the number of the desired Limit Set (1-4) and press the
Enter key on the keyboard. The cursor advances to the
<Doctor Name> entry field.
As indicated earlier in the Work List section, two types of bar code
labels can be used on the Cell-Dyn 3700 as described in the
following paragraphs.
The CS model has a hand held Bar Code reader which can be used
to read the bar code labels for tubes processed in either mode.
5. Using the hand held bar code reader, scan the bar code label
on the tube. If the hand held reader is unavailable, type the
Specimen ID in the next ID field.
6. Aspirate the sample.
NOTE: Samples can be run with the WORK LIST screen
displayed. As the samples are processed, the status of each
sample is displayed in the <STATUS> field on the Work List.
Additional entries can be made to the Work List while
processing takes place.
NOTES
The Data Log stores all data and demographic information in a log
format for the last 10,000 cycles run on the CELL-DYN 3700
System. This record information is stored chronologically by
sequence number. Scatterplots and histograms are also stored for
all 10,000 records.
Seq Specimen ID WBC NEU LYM MONO EOS BASO Date Time Op
r 833 1912584436 3.83 2.30 .315 1.04 .012 .173 C07/21/98 14:40 rcs
r 834 1910952241 7.50 4.53 2.16 .536 .106 .141 C07/21/98 14:40 rcs
r 835 1912077932 .192 .052 .116 .012 .002 .010 C07/21/98 14:41 rcs
r 836 1911764321 6.26 4.99 .828 .252 .019 .176 C07/21/98 14:42 rcs
r 837 1911815501 4.37 2.75 .984 .519 .001 .116 C07/21/98 14:43 rcs
r 838 1911187621 7.07 6.02 .612 .218 .069 .150 C07/21/98 14:43 rcs
839 low ctrl 8.06 4.71 2.44 .621 .213 .074 O07/21/98 16:20 rcs
840 low ctrl 7.96 4.78 2.32 .601 .183 .080 O07/21/98 16:20 rcs
841 low ctrl 8.21 4.86 2.45 .598 .204 .099 O07/21/98 16:21 rcs
w 842 7.93 4.71 2.39 .557 .178 .092 K07/21/98 16:26 rcs
b 843 8.34 4.97 2.50 .551 .208 .114 O07/21/98 16:28 rcs
844 BACKGROUND .079 O07/21/98 16:30 rcs
Seq Specimen ID WBC NEU LYM MONO EOS BASO Date Time Op
When using the Edit Specimen ID feature in the Data Log, set up a
laboratory procedure to verify any Specimen ID that has been
manually edited in the Data Log by showing the content of the
Specimen ID before and after editing.
Such verification could be:
Printouts of the Data Log summary reports that show the edited
ID. These printouts should be signed, dated and saved to ensure
tracking of any changes to specimen identification within your
laboratory.
or
Re-running any specimen unintentionally identified with a Rack
and Tube Number, via Open or Closed Mode, to confirm that the
correct Specimen ID is applied.
DISPLAY The [DISPLAY SPECIMEN] key on the DATA LOG screen is used to
SPECIMEN display the results for the record indicated by the cursor position.
(See the preceding figure.) The following soft key labels are
displayed on the DISPLAY SPECIMEN screen:
PREVIOUS SPECIMEN This label key is not displayed when
the first specimen in the log is on the
screen.
NEXT SPECIMEN This label key is not displayed when the last
specimen in the log is on the screen.
EDIT SPECIMEN This label key is displayed for the
patient records only.
CUSTOMIZE REPORT
TRANSMIT SPECIMEN
PRINT TICKET
PRINT REPORT or
COLOR PRINT (The key label alternates between
these two selections, depending on
whether the Color Print option has
been enabled.)
RETURN
CONFIRM
CANCEL
These keys are used to [CONFIRM] or [CANCEL] the edits. The
Bulletin Line displays the following message: PRESS CONFIRM
TO SAVE CHANGES OR CANCEL TO CANCEL CHANGES. When
the [CONFIRM] key is pressed, the edited record is displayed.
SEQ #:
SPEC ID: DATA LOG SEARCH Dec 21 1998 15:56
NAME: Ready Operator ID rcs
Sequence # 0711
Seq Specimen ID WBC WIC WOC RBC HGB MCV RDW Date Time Op
700 BACKGROUND .006 .006 .006 0.00 .027 O07/20/98 14:38 rcs
b 701 1911937231 9.42 9.89 9.42 3.76 10.1 82.0 16.8 C07/20/98 14:42 rcs
r 702 1911359331 5.52 6.44 5.52 3.88 10.2 81.4 13.3 C07/20/98 14:43 rcs
703 1911883246 11.4 11.9 11.4 10.1 K07/20/98 14:43 rcs
704 LATEX 3.25 1.71 3.25 0.00 .081 O07/20/98 14:50 rcs
705 LATEX 3.25 1.64 3.25 0.00 .061 O07/20/98 14:51 rcs
706 BACKGROUND .035 .009 .035 0.00 .027 O07/20/98 14:53 rcs
r 707 1912696001 7.96 8.21 7.96 3.33 9.54 89.8 14.8 C07/20/98 14:57 rcs
708 1911187621 8.10 8.23 8.10 3.29 9.94 90.5 15.4 C07/20/98 14:57 rcs
r 709 1912395001 6.88 7.75 6.88 3.77 11.5 91.9 13.1 C07/20/98 14:58 rcs
710 1910851733 9.53 9.91 9.53 3.77 10.7 85.8 16.4 C07/20/98 14:59 rcs
711 BACKGROUND .013 .013 .013 .001 .027 O07/20/98 15:47 rcs
Seq Specimen ID WBC WIC WOC RBC HGB MCV RDW Date Time Op
FIND The [FIND SPECIMEN] key on the DATA LOG screen is used to locate a
SPECIMEN particular record by entering the sequence number, specimen ID
number, or patient name for the desired record. When this key is
pressed, the DATA LOG SEARCH screen is displayed. (See the
preceding figure.) If the record is not found in the Data Log, the
Bulletin Line displays the message NO ENTRY FOUND.
Seq Specimen ID WBC WIC WOC RBC HGB MCV RDW Date Time Op
700 BACKGROUND .006 .006 .006 0.00 .027 O12/20/98 14:38 rcs
b 701 1911937231 9.42 9.89 9.42 3.76 10.1 82.0 16.8 C12/20/98 14:42 rcs
r 702 1911359331 5.52 6.44 5.52 3.88 10.2 81.4 13.3 C12/20/98 14:43 rcs
703 1911883246 11.4 11.9 11.4 10.1 K12/20/98 14:43 rcs
704 LATEX 3.25 1.71 3.25 0.00 .081 O12/20/98 14:50 rcs
705 LATEX 3.25 1.64 3.25 0.00 .061 O12/20/98 14:51 rcs
706 BACKGROUND .035 .009 .035 0.00 .027 O12/20/98 14:53 rcs
r 707 1912696001 7.96 8.21 7.96 3.33 9.54 89.8 14.8 C12/20/98 14:57 rcs
708 1911187621 R 8.10 8.23 8.10 3.29 9.94 90.5 15.4 C12/20/98 14:57 rcs
r 709 1912395001 6.88 7.75 6.88 3.77 11.5 91.9 13.1 C12/20/98 14:58 rcs
710 1910851733 R 9.53 9.91 9.53 3.77 10.7 85.8 16.4 C12/20/98 14:59 rcs
711 BACKGROUND .013 .013 .013 .001 .027 O12/20/98 15:47 rcs
Seq Specimen ID WBC WIC WOC RBC HGB MCV RDW Date Time Op
Auto-Sampler Pause
EDIT DISPLAY FIND REJECT CUSTOMIZE TRANSMIT PRINT MAIN
ID SPECIMEN SPECIMEN FROM X-B DATA LOG DATA DATA LOG
Figure 5.45: Data Log Screen Showing Reject From X-B Key
Seq Specimen ID WBC WIC WOC RBC HGB MCV RDW Date Time Op
700 BACKGROUND .006 .006 .006 0.00 .027 O12/20/98 14:38 rcs
b 701 1911937231 9.42 9.89 9.42 3.76 10.1 82.0 16.8 C12/20/98 14:42 rcs
r 702 1911359331 5.52 6.44 5.52 3.88 10.2 81.4 13.3 C12/20/98 14:43 rcs
w 703 1911883246 11.4 11.9 11.4 10.1 K12/20/98 14:43 rcs
704 LATEX 3.25 1.71 3.25 0.00 .081 O12/20/98 14:50 rcs
705 LATEX 3.25 1.64 3.25 0.00 .061 O12/20/98 14:51 rcs
706 BACKGROUND .035 .009 .035 0.00 .027 O12/20/98 14:53 rcs
r 707 1912696001 7.96 8.21 7.96 3.33 9.54 89.8 14.8 C12/20/98 14:57 rcs
b 708 1911187621 R 8.10 8.23 8.10 3.29 9.94 90.5 15.4 C12/20/98 14:57 rcs
r 709 1912395001 6.88 7.75 6.88 3.77 11.5 91.9 13.1 C12/20/98 14:58 rcs
710 1910851733 R 9.53 9.91 9.53 3.77 10.7 85.8 16.4 C12/20/98 14:59 rcs
711 BACKGROUND .013 .013 .013 .001 .027 O12/20/98 15:47 rcs
Seq Specimen ID WBC WIC WOC RBC HGB MCV RDW Date Time Op
Auto-Sampler Pause
EDIT DISPLAY FIND ACCEPT CUSTOMIZE TRANSMIT PRINT MAIN
ID SPECIMEN SPECIMEN INTO X-B DATA LOG DATA DATA LOG
Figure 5.46: Data Log Screen Showing Accept Into X-B Key
WBC %N %L %M %E %B
Group 4:
CUSTOMIZE The [CUSTOMIZE DATA LOG] key on the DATA LOG screen is used to
DATA LOG customize the Data Log display. The CUSTOMIZE DISPLAY for Data
Log screen (see the preceding figure) and the following soft key
labels are displayed when the [CUSTOMIZE DATA LOG] key is pressed:
SELECT PARAMETER or
PLACE PARAMETER (This key label alternates between
these two selections.)
STANDARD GROUPS or
CUSTOM PLACEMENT (This key label alternates between
these two selections.)
CUSTOMIZE PRINTOUT
RETURN
WBC %N %L %M %E %B
Group 4:
CUSTOMIZE The [CUSTOMIZE PRINTOUT] key on the CUSTOMIZE DISPLAY for Data
PRINTOUT Log screen is used to customize the printout format of the Data
Log. (See the preceding figure.) The following soft key labels are
displayed when the [CUSTOMIZE PRINTOUT] key is pressed:
SELECT PARAMETER or
PLACE PARAMETER (This key label alternates between
these two selections.)
STANDARD SELECTION
RETURN
The CUSTOMIZE PRINTOUT for Data Log screen shows the order
(from left to right) in which the indicated parameters will be
printed. Procedures for Customizing the Data Log Printout are
included later in this section under Data Log Set Up Procedures.
Seq Specimen ID WBC NEU LYM MONO EOS BASO Date Time Op
r 833 1912584436 3.83 2.30 .315 1.04 .012 .173 C12/21/98 14:40 rcs
r 834 1910952241 7.50 4.53 2.16 .563 .106 .141 C12/21/98 14:40 rcs
r 835 1912077932 .192 .052 .116 .012 .002 .010 C12/21/98 14:41 rcs
r 836 1911764321 6.26 4.99 .828 .252 .019 .176 C12/21/98 14:42 rcs
r 837 1911815501 4.37 2.75 .984 .519 .001 .116 C12/21/98 14:43 rcs
r 838 1911187621 7.07 6.02 .612 .218 .069 .150 C12/21/98 14:43 rcs
839 low ctrl 8.06 4.71 2.44 .621 .213 .074 O12/21/98 16:20 rcs
840 low ctrl 7.96 4.78 2.32 .601 .183 .080 O12/21/98 16:20 rcs
841 low ctrl 8.21 4.86 2.45 .598 .204 .099 O12/21/98 16:21 rcs
842 7.93 4.71 2.39 .557 .178 .092 K12/21/98 16:26 rcs
b 843 8.34 4.97 2.50 .551 .208 .114 O12/21/98 16:28 rcs
844 BACKGROUND .079 O12/21/98 16:30 rcs
Seq Specimen ID WBC NEU LYM MONO EOS BASO Date Time Op
Auto-Sampler Ready
EDIT DISPLAY FIND REJECT CUSTOMIZE TRANSMIT PRINT MAIN
ID SPECIMEN SPECIMEN FROM X-B DATA LOG DATA DATA LOG
WBC %N %L %M %E %B
Group 4:
Figure 5.51: Customize Display for Data Log Screen Showing Standard
Groups
Standard Groups
The Data Log display may also be customized using
predetermined groups of parameters (Standard Groups) by
pressing the [STANDARD GROUPS] key on the CUSTOMIZE DISPLAY for
Data Log screen. The preceding figure shows the WBC Group
placed in GROUP 1, the RBC Group placed in GROUP 2, the PLT
Group placed in GROUP 3, and the Diff Group placed in GROUP 4.
Auto-Sampler Ready
SELECT STANDARD RETURN
PARAMETER SELECTION
Figure 5.52: Customize Printout for Data Log Screen Showing Customized
Print Group
The CUSTOMIZE PRINTOUT for Data Log screen (see the preceding
figure) shows the group of parameters that will be printed on a Data
Log printout. A list of the available parameters is displayed under
the group. The parameters can be selected from the list and placed
in the desired position to customize the printout. In addition to
the usual hematologic parameters, the following parameters can
also be printed in the Data Log:
RUT1 and RUT2 RUT1 is the RBC/PLT Upper Metering
Time. RUT2 is the RBC/PLT Upper
Metering Time for an extended count.
RCT1 and RCT2 RCT1 is the RBC/PLT Count Time.
RCT2 is the RBC/PLT Count Time for
an extended count.
WUT WUT is the WIC Upper Metering Time.
WCT WCT is the WIC Count Time.
WIC WIC is the WBC Impedance Count.
WOC WOC is the WBC Optical Count.
Displaying a Record
A copy of the RUN screen may be displayed for all 10,000 records
in the CELL-DYN 3700 System Data Log. A record is displayed by
positioning the cursor at the desired record in the Data Log listing
and pressing the [DISPLAY SPECIMEN] key. The Status Box indicates
DISPLAY SPECIMEN on results displayed (or printed) from the Data
Log record. (See the following figure.)
3. Use the arrow keys on the keyboard to move the cursor to the
desired identifier: sequence number, specimen ID number,
or name.
4. Type the appropriate information and press the Enter key on
the keyboard to start the search.
NOTE: If necessary, you may press the Escape (ESC) key or
the Enter key on the keyboard to exit from the search
function and return to the DATA LOG screen.
Editing a Record
The Patient Demographics and the Parameter and Patient Limit
Sets may be edited for each record. (See the following figure.)
References
NOTES
Overview
When to Calibrate
Scheduled calibration of the CELL-DYN 3700 System should
conform to the guidelines established by regulatory agencies.
Calibration should be confirmed by running controls on a regular
basis according to the requirements governing quality control in
your laboratory. In keeping with good laboratory practices, this
should include daily confirmation and following a reagent lot
number change.
Unscheduled calibration is indicated following service
adjustments performed by Abbott Field Service Representatives
such as major component changes.
Calibration Methods
Two methods can be used to calibrate the CELL-DYN 3700 System:
• Auto-Cal is an automatic calibration program that is
incorporated into the Data Station software.
NOTE: Auto-Cal is available in the Open Mode only on
the CELL-DYN 3700SL System. Therefore, all references to
Closed Mode calibration with Auto-Cal pertain to the
CELL-DYN 3700CS System.
Calibration Materials
Two calibration materials can be used to calibrate the
CELL-DYN 3700 System:
• Commercial Calibrator
Calibration with CELL-DYN Calibrator is most efficiently
performed by calibrating the Open Mode. The Closed Mode
is then calibrated to match the Open Mode using fresh whole
blood samples.
• Fresh Whole Blood
Calibration with fresh whole blood is accomplished by
performing multiple analyses of each specimen by
acceptable reference methodology and calculating the mean
reference value for each parameter. The same specimens are
then analyzed on the CELL-DYN 3700 System in the Open
Mode. The Closed Mode is then calibrated to match the
Open Mode using another set of fresh whole blood
specimens. A detailed discussion of Reference Whole Blood
Calibration is given in the next section.
Overview
Calibration with fresh whole blood samples is an alternative to
calibration with a commercial calibrator. Since 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 samples may 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 samples 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.
Reference Methods
Reference values for a Reference Whole Blood Calibration should
be determined according to the following ICSH recommendations.
HGB
Reference values for hemoglobin may be determined using either
the reference cyanmethemoglobin method or a reliably calibrated
hemoglobinometer or hematology analyzer.
NOTE: DO NOT attempt to calibrate the CELL-DYN 3700
System with a hemoglobin standard designed for the
calibration of specific reference cyanmethemoglobin
methods. The instrument uses a modified
hemiglobincyanide or a modified
hemiglobinhydroxyalamine method which is not designed
to analyze these standards directly.
MCV
Reference values for the mean cell volume may be determined by
calculation from the reference microhematocrit and RBC
measurements or from multiple analyses on a reliably calibrated
hematology analyzer.
NOTE: Reference microhematocrit values may be
determined by multiple analyses using the CLSI/NCCLS
method for Packed Cell Volume (PCV).2 Use only plain
(non-anticoagulated) capillary tubes. Be certain to verify
the proper operation of the microhematocrit centrifuge
and the timer as recommended by CLSI/NCCLS.
NOTES
Technologist:____________________________Method:__________________________________________
___________________________________________________________________________________________
Reference Assays
Sample
ID 1 2 3 4 5 6 7 8 9 10 Mean
NOTES
Step Choices
NOTES
Calibration Menu
CALIBRATION
Ready
CONFIRM CANCEL
CLEAR CLEAR
CONFIRM CANCEL
QUIT QUIT
CONFIRM CANCEL
QUIT QUIT
Calibration Screen
Open Sampler
Open Sampler Calibration Factors:
CALIBRA- The CALIBRATION screen is accessed from the MAIN MENU screen by
TION pressing the [CALIBRATION] key. The CALIBRATION screen displays
the current calibration factors for the mode indicated, the
calibration method used, the date and time the factors were
entered, and the operator ID.
The following soft key labels are displayed on the CALIBRATION
screen:
ENTER FACTOR
CALIBRATN LOG
AUTO-CALIBRATE
OPEN SAMPLER or
CLOSED SAMPLER (This key label alternates between
these two selections when the soft
key is pressed.)
PRINT
MAIN
Open Sampler
Closed Sampler Calibration Factors:
RESTORE FACTORS
RESET ALL TO 1.000
RETURN
Open Sampler
Open Sampler Calibration Log
Date Time OpID WOC WIC RBC HGB MCV PLT MPV
12/20/98 14:15 rcs 1.05(E) 0.96(E) 0.84(E) 0.92(E) 0.88(E) 0.79(E) 1.00(F)
Comments:
CALIBRATN The [CALIBRATN LOG] key is used to display the CALIBRATION LOG
LOG screen for the Open or Closed Mode. The following soft key labels
are displayed when the [CALIBRATN LOG] key is pressed:
OPEN SAMPLER or
CLOSED SAMPLER (This key label alternates between
these two selections.)
PRINT LOG
RETURN
Open Sampler
Open sampler is selected. To calibrate using the
closed sampler (SL), refer to the manual mode to mode
calibration procedure given in the operator’s manual.
Open Sampler
WHOLE The [WHOLE BLOOD] key is used to display the WHOLE BLOOD AUTO-
BLOOD CAL screen. This screen accesses the Auto-Cal program that is used
to calibrate the instrument with fresh whole blood samples. The
following soft key labels are displayed on this screen:
CONFIRM CLEAR
CANCEL CLEAR
These keys are used to confirm or cancel the Clear Reference
Values command.
Open Sampler
INTERRUPT AUTO-CAL
QUIT AUTO-CAL
PRINT
RETURN
Open Sampler
RESULTS FOR SPECIMEN #1
Spec 1 Mean Factor
Parameter Value RUN1 Factor Factor(1) %Diff
WOC 7.30 ---- ---- ---- ----
WIC 7.30 ---- ---- ---- ----
RBC 4.24 ---- ---- ---- ----
HGB 12.9 ---- ---- ---- ----
MCV 90.0 ---- ---- ---- ----
PLT 244. ---- ---- ---- ----
Open Sampler
RESULTS FOR SPECIMEN #1
Spec 1 Mean Factor
Parameter Value RUN1 RUN2 RUN3 Factor Factor(1) %Diff
WOC 7.30 7.42 ---- ---- 0.980 ---- ----
WIC 7.30 7.42 ---- ---- 0.980 ---- ----
RBC 4.24 4.39 ---- ---- 0.970 ---- ----
HGB 12.9 13.0 ---- ---- 0.990 ---- ----
MCV 90.0 91.0 ---- ---- 0.990 ---- ----
PLT 244. 254. ---- ---- 0.960 ---- ----
REPEAT The [REPEAT SPECIMEN] key is displayed when the first run of the
SPECIMEN first specimen is completed (see the preceding figure). This key is
used to delete all results (runs) for the current specimen.
NOTE: This key deletes ALL RESULTS for ALL RUNS of the
current specimen. It does not delete one run only.
Open Sampler
Open Sampler
MPV The [MPV LATEX] key is used to display the MPV LATEX AUTO-CAL
LATEX screen (see the preceding figure).
Pre-Calibration Procedures
Calibration Guidelines
1. Always perform the daily, weekly, and monthly scheduled
maintenance as directed in Chapter 9: Maintenance before
calibrating the instrument. Instrument cleanliness is essential for
accurate calibration. Therefore, each laboratory should perform
any additional maintenance according to its requirements.
2. Use only recommended CELL-DYN reagents.
3. Verify the precision for the Open and Closed Modes prior to
calibration as directed in the Pre-Calibration Procedures
Checklist.
4. Precision should be verified for both WIC and WOC. This is
accomplished by configuring a QC file to display and print
both results.
NOTE: If necessary, refer to the directions for customizing
the display and printout of a QC file given in Chapter 5:
Operating Instructions, Subsection: Set-Up Instructions.
5. Select and process all whole blood samples according to the
requirements given in the Overview, Calibration Materials,
Whole Blood Calibration Guidelines within this chapter.
6. Be certain that any calibrator material is brought to room
temperature and mixed according to the manufacturer’s
instructions given in the package insert.
7. Be certain that the operator performing the calibration has
read and understands the information contained in the
package insert for the calibrator.
8. Be certain that the operator performing the calibration has
read and understands the calibration procedure(s).
NOTES
10.______ Confirm the Open Mode precision by analyzing a fresh, normal, whole blood sample 10
times in succession. Run the sample in an empty control file and record the CVs below or
attach a file printout to this document.
PARAMETER CV% LIMIT CV
WIC <2.8% ________
WOC <2.5% ________
RBC <1.5% ________
HGB <1.2% ________
MCV <1.0% ________
PLT <5.0% ________
11.______ a. CELL-DYN 3700SL System:
Confirm the Closed Mode precision of the Sample Loader by obtaining 15 mL of blood from
the same donor. Aliquot the blood into five 5-mL tubes that contain no anticoagulant. Run
each tube twice in succession. Run the samples in an empty control file and record the CVs
below or attach a file printout to this document.
PARAMETER CV% LIMIT CV
WIC <2.8% ________
WOC <2.5% ________
RBC <1.5% ________
HGB <1.2% ________
MCV <1.0% ________
PLT <5.0% ________
b. CELL-DYN 3700CS System:
Confirm the precision of the Closed Sampler by analyzing a fresh, normal, whole blood
sample 10 times in succession. Run the samples in an empty control file and record the
CVs below or attach a file printout to this document.
PARAMETER CV% LIMIT CV
WIC <2.8% ________
WOC <2.5% ________
RBC <1.5% ________
HGB <1.2% ________
MCV <1.0% ________
PLT <5.0% ________
12.______ If any problems are detected during the procedures outlined above, document them on
the following page.
Problems Detected
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NOTES
Auto-Cal Overview
Auto-Cal Methodology
The Auto-Cal program automatically computes a calibration
factor based on all acceptable data. (New factors are calculated
using 1.000 as the reference.)
NOTE: Because the instrument uses 1.000 as the
reference, results generated in the Auto-Cal mode may not
correlate with results previously seen in the RUN mode.
This DOES NOT indicate a problem.
• Calibrator Calibration
The Calibrator should be cycled for a minimum of 6 and a
maximum of 10 consecutive runs in the Open Mode. In
order to most efficiently use the Auto-Cal program, it is
suggested that the calibrator be cycled for nine consecutive
runs as if it were three separate calibrators. This is
accomplished by entering three for the number of runs for
each ‘calibrator’ and entering the assay value three times.
NOTE: For parameters with assigned values that exceed
the Auto-Calibration pre-set entry limits, use the manual
method for calibration.
NOTES
Starting Auto-Cal
1. From the MAIN MENU screen, press the [CALIBRATION] key.
2. If necessary, press the [OPEN SAMPLER] key to display the
Open Sampler calibration factors.
3. To obtain a printout of the Open Sampler Calibration
Factors displayed on the screen, press the [PRINT] key.
NOTE: These calibration factors are retained in the Auto-Cal
Calibration Log until 10 entries have been made. As each
subsequent entry is made, the oldest existing entry will be
deleted.
3. Type the desired number in the <# OF RUNS> field. Press the Enter
key on the keyboard to save the entry and advance the cursor.
NOTE: The calibrator should be cycled for a minimum of
6 and a maximum of 10 consecutive runs in the Open Mode.
In order to most efficiently use the Auto-Cal program, it is
suggested that the calibrator be cycled for 9 consecutive
runs as if it were three separate calibrators. This is
accomplished by entering three for the number of runs for
each calibrator and entering the assay value three times.
Calibration Limit
If the factor % difference for a particular parameter is greater than
the following value, the value has exceeded the Calibration Limit
and there may be an instrument problem.
Results greater than the Calibration Limit:
WIC/WOC >10%
RBC >10%
HGB >10%
MCV >10%
PLT >15%
1. Check to see if any component that could affect the
calibration was changed, as this could cause the factor %
difference to exceed the above limits. For example:
Shear Valve RBC/PLT Transducer
WOC Flow Cell RBC/PLT Aperture Plate
WIC Transducer Hemoglobin Flow Cell
WIC Aperture Plate Syringe(s)
Calibration Range
If the factor % difference falls within the following Calibration Range,
calibration is required for that parameter. That is, a new calibration
factor must be entered. Calibrate the Open Mode as directed in
this procedure, either for all parameters or for specific parameters.
Results within the Calibration Range:
WIC/WOC >1.5% but < 10%
RBC >1.0% but < 10%
HGB >1.0% but < 10%
MCV >1.0% but < 10%
PLT >3.0% but < 15%
If all parameters require calibration, continue with the next
section in this procedure, Calibrating All Parameters. If only
specific parameters require calibration, skip to Calibrating
Individual Parameters within this chapter.
NOTES
Starting Auto-Cal
1. From the MAIN MENU screen, press the [CALIBRATION] key.
2. If necessary, press the [OPEN SAMPLER] key to display the
Open Mode calibration factors.
3. To obtain a printout of the Open Mode Calibration Factors
displayed on the screen, press the [PRINT] key.
NOTE: These calibration factors are retained in the Auto-Cal
Calibration Log until 10 entries have been made. As each
subsequent entry is made, the oldest existing entry is
deleted.
1. Delete any existing values. Press the [CLEAR REF VALS] key
followed by the [CONFIRM CLEAR] key.
2. Type the appropriate information in the <SPEC ID> field, the
<# OF RUNS> field, and the parameter reference values field
for each whole blood sample to be used for the calibration.
Press the Enter key on the keyboard after each entry to save
it and advance the cursor.
NOTE: The <# OF RUNS> entered indicates the number of
times the sample will be consecutively cycled through the
instrument. Each sample may be run a maximum of 10
times.
Calibration Limit
If the factor % difference for a particular parameter is greater than
the following value, as the value has exceeded the Calibration
Limit and there may be an instrument problem.
Results greater than the Calibration Limit:
WIC/WOC >10%
RBC >10%
HGB >10%
MCV >10%
PLT >15%
1. Check to see if any component that could affect the
calibration has been changed, as this could cause the factor
% difference to exceed the above limits. For example:
Shear Valve RBC/PLT Transducer
WOC Flow Cell RBC/PLT Aperture Plate
WIC Transducer Hemoglobin Flow Cell
WIC Aperture Plate Syringe(s)
• If a component has been changed, then calibrate the
instrument as needed according to the directions in this
procedure.
• If no components have been changed and the factor %
difference exceeds these limits, do not calibrate. Confirm
that all Pre-Calibration procedures were completed, and
then call Abbott Diagnostics Customer Service for
assistance (at 1-877-4ABBOTT in the US).
2. Press the [QUIT AUTO-CAL] key followed by the [CONFIRM
QUIT] key to exit Auto-Cal.
3. Troubleshoot accordingly. Be certain to retain all necessary
documentation in the instrument logbook.
Calibration Range
If the factor % difference falls within the following Calibration Range,
calibration is required for that parameter. That is, a new Calibration
Factor must be entered. Calibrate the Open Mode as directed in
this procedure, either for all parameters or for specific parameters.
Results within the Calibration Range:
NOTES
NOTES
Guidelines
• The CELL-DYN Calibrator must be warmed and mixed
according to the directions given in the package insert and
run a minimum of six and a maximum of 10 times.
NOTE: For instructions on running the calibrator, refer to
Auto-Cal Overview, Calibration Requirements for
Auto-Cal within this chapter.
Calibration Limit
If the factor % difference for a particular parameter is greater than the
following value, there may be a computation error or an instrument
problem as the value has exceeded the Calibration Limit.
Results greater than the Calibration Limit:
WIC/WOC >10%
RBC >10%
HGB >10%
MCV >10%
PLT >15%
1. Recheck the numbers entered on the worksheet and then
recheck all calculations.
2. Check to see if any component has been changed that could
affect the calibration, as this could cause the factor %
difference to exceed the above limits. For example:
Shear Valve RBC/PLT Transducer
WOC Flow Cell RBC/PLT Aperture Plate
WIC Transducer Hemoglobin Flow Cell
WIC Aperture Plate Syringe(s)
• If a component has been changed, then calibrate the instrument
as needed according to the directions in this procedure.
• If no components have been changed, the calculations are
correct, and the factor % difference exceeds these limits, do
not calibrate. Confirm that all Pre-Calibration procedures
were completed, and then call Abbott Diagnostics Customer
Service for assistance (at 1-877-4ABBOTT in the US).
Calibration Range
If the factor % difference falls within the following Calibration
Range, calibration is required for that parameter. Calibrate the
Open Mode as directed in this procedure.
NOTES
Factor % Difference
NOTES
The Open Mode values for each sample are entered as the
reference values in the Auto-Cal program for the Closed Mode.
The samples are then run in the Closed Mode. The factor percent
difference computed by the Auto-Cal program is used to
determine which Closed Mode parameters require calibration.
Starting Auto-Cal
1. From the MAIN MENU screen, press the [CALIBRATION] key.
2. If necessary, press the [CLOSED SAMPLER] key to display the
Closed Mode Calibration Factors.
3. To obtain a printout of the Closed Mode Calibration Factors
displayed on the screen, press the [PRINT] key.
NOTE: These calibration factors are retained in the Auto-Cal
Calibration Log until 10 entries have been made. As each
subsequent entry is made, the oldest existing entry will be
deleted.
6. Run the first whole blood specimen one time. The reference
value, VALUE, and the results of the analysis, RUN1, will be
displayed on the WHOLE BLOOD AUTO-CAL, RESULTS FOR
SPECIMEN (N) screen.
The Auto-Cal program automatically compares the results of
the first run of each whole blood specimen with the
Parameter Reference Values entered for that specimen, to
verify that the difference is within acceptable limits.
• If the first run passes this internal Reference Check,
proceed to step 9.
• If the first run fails the Reference Check for any
parameter, the results are highlighted and the Bulletin
Line displays the following message: RESULT IS
OUTSIDE THE REFERENCE LIMITS. REPEAT THIS
SPECIMEN. Proceed to step 7.
7. The specimen may be repeated at this time by pressing the
[REPEAT SPECIMEN] key followed by the [CONFIRM REPEAT] key.
NOTE: When the repeat function is used, all the results
for that specimen will be automatically deleted.
Calibration Limit
If the factor % difference for a particular parameter is greater than
the following value, the value has exceeded the Calibration Limit
and there may be an instrument problem.
Results greater than the Calibration Limit:
WIC/WOC >10%
RBC >10%
HGB >10%
MCV >10%
PLT >20%
1. Check to see if any component that could affect the calibration
was changed, as this could cause the factor % difference to
exceed the above limits. For example:
Shear Valve RBC/PLT Transducer
WOC Flow Cell RBC/PLT Aperture Plate
WIC Transducer Hemoglobin Flow Cell
WIC Aperture Plate Syringe(s)
• If a component was changed, then calibrate the instrument
as needed according to the directions in this procedure.
• If no components have been changed and the factor %
difference exceeds these limits, do not calibrate. Confirm
that all Pre-Calibration procedures were completed, and
call Abbott Diagnostics Customer Service for assistance
(at 1-877-4ABBOTT in the US).
2. Press the [QUIT AUTO-CAL] key followed by the [CONFIRM
QUIT] key to exit Auto-Cal.
3. Troubleshoot accordingly. Be certain to retain all necessary
documentation in the instrument logbook.
Calibration Range
If the factor % difference falls within the following Calibration
Range, calibration is required for that parameter. That is, a new
Calibration Factor must be entered. Calibrate the Closed Mode as
directed in this procedure, either for all parameters or for specific
parameters.
NOTES
Calibration Limit
If the factor % difference for a particular parameter is greater than
the following values, the value has exceeded the Calibration Limit
and there may be a computation error or instrument problem.
Calibration Range
If the factor % difference falls within the following Calibration
Range, calibration is required for that parameter. Calibrate the
instrument as directed in the following sections, either for all
parameters or for specific parameters.
Results within the Calibration Range:
WIC/WOC >1.75% but <10%
RBC >1.25% but <10%
HGB >1.25% but <10%
MCV >1.25% but <10%
PLT >3.50% but <20%
Calibration Confirmation
1. Run the same whole blood specimens into the “CLOSED
MEAN” file again by repeating the steps in Manual Mode to
Mode Calibration, Determining the Closed Mode Mean
within this chapter.
2. The Post-Calibration difference must be equal to or less than
the following:
WIC/WOC <1.75%
RBC <1.25%
HGB <1.25%
MCV <1.25%
PLT <3.50%
Calculate the Post-Calibration difference using the Mode to Mode
Post-Calibration Difference chart on the Manual Mode to Mode
Worksheet.
If the Post-Calibration difference exceeds these limits, verify that
all calculations were correct and that the new factors were
entered correctly. If no errors are detected, call Abbott
Diagnostics Customer Service for assistance (at 1-877-4ABBOTT
in the US).
Post-Calibration Procedures
Quality Control
Confirm calibration changes by running all levels of controls into
the appropriate QC files. If any parameters fall outside the limits,
proceed as follows:
1. Obtain new vials of the controls.
2. Warm and mix them properly and again run them into the
appropriate QC files.
If parameters still exceed the limits, proceed as follows:
1. Collect all the calibration documentation including the
Pre-Calibration worksheets. (Be certain you have recorded
lot numbers where indicated.)
2. Call Abbott Diagnostics Customer Service for assistance
(at 1-877-4ABBOTT in the US).
NOTE: Inform the Customer Support Specialist if a
reagent and/or lot number of reagent was changed just
prior to the calibration procedure.
Calibration Backup
The current calibration factors should be saved on the
CELL-DYN 3700 Set-Up Disk #1 whenever calibration is changed.
Data should also be saved whenever any setup information is
changed and after any service work is performed. The backup
procedure copies the following setup information from the Data
Station to the Set-Up Disk:
• Calibration Factors
• QC Limits
• Patient Limits
• Analyzer Module Set Points (for example, gains, dil factors
the [internal calibration factors] key, thresholds, pressure/
vacuum settings)
• RBC Editing Ratio
• Units Selection
NOTES
References
NOTES
Overview
The first section of this chapter describes the functions of the keys
in the QC MENU. Interpretation of the QC data is then discussed in
the Quality Control Guide.
QC MENU
Ready
X-B RBC X-B WBC PRINT RETURN SELECT CANCEL STANDARD TOGGLE RETURN
GRAPHS GRAPHS PARAMETER SELECTION GROUPS ONE/ALL
X-B RBC X-B WBC PLACE CUSTOM
DATA DATA PARAMETER PLACEMENT
MOVE TO CANCEL
FILE MOVE
GROUP GROUP GROUP GROUP PRINT RETURN WRITE WRITE WRITE RETURN
1 2 3 4 LOW NORMAL HIGH
Select a QC file with the arrow keys or enter a new file name.
QUALITY The following soft key labels are displayed on the QC MENU screen:
CONTROL
X-B SET UP*
X-B FILE
VIEW QC LOG
QC LIMITS*
SET-UP QC FILE*
CUSTOMIZE DISPLAY*
CUSTOMIZE PRINTOUT*
MAIN
*These keys are discussed in Chapter 5: Operating Instructions,
Subsection: Set Up Instructions, QC Set Up Menu Soft Key.
X-B RBC The [X-B RBC DATA] key is used to display the X-B data for RBC indices
DATA on the X-B FILE DISPLAY screen. (See the preceding figure.) This screen
X-B RBC displays the results for X-B batches 1–10 and the lower and upper
GRAPHS
limits. The date and time that each batch was completed are also
displayed. The Page Down key on the keyboard is used to display
batches 11–20. When batches 11–20 are displayed, the Page Up key on
the keyboard is used to display batches 1–10.
NOTE: The X-B RBC data can also be viewed as graphs by
pressing the [X-B RBC GRAPHS] key.
BATCH L0D L10D N0D N10D N90D N90DEP NEU-EO DATE TIME
NEU-EO
27.3
21.0
14.7
VIEW The [VIEW QC LOG] key is used to display the QC Log indicated by
QC LOG the position of the cursor. Each QC Log display shows the
following information (see the preceding figure):
1. Upper Left Corner
Lot Number and Expiration Date if the file was configured
for this type of control. If the file was configured for a
Replicate ID, it is displayed here.
File name, the number of runs currently in the file, and the
file capacity (e.g.: 29/120 indicates that the file contains 29
runs out of a possible 120).
The page number of the display and the total number of
pages in the file.
2. Status Box
Screen name, system status, and USE < OR > FOR MORE
DATA. This message indicates that the Left and Right arrow
keys on the keyboard should be used to display the other
groups of data.
The following soft key labels are displayed on the VIEW QC LOG
screen:
PURGE QC LOG
LEVEY-JENNINGS
REJECT SPECIMEN or
ACCEPT SPECIMEN (This key label alternates between
these two selections.)
DELETE SPECIMEN
MOVE SPECIMEN
WRITE QC TO DISK
PRINT QC LOG
RETURN
CONFIRM PURGE
CANCEL PURGE
These keys are used to confirm or cancel the [PURGE QC LOG]
command.
PLT:
270.
245.
220.
GROUP 1*
GROUP 2
GROUP 3
GROUP 4
PRINT
RETURN
* The soft key for the group currently shown on the screen is not
displayed.
GROUP Each of these keys is used to select the graphs for a group of data
1– 4 that corresponds to the groups selected in the Customize QC
Display option. Subsequent groups can be selected by pressing the
appropriate soft keys.
RETURN The [RETURN] key is used to return to the VIEW QC LOG screen.
REJECT The [REJECT SPECIMEN] key is used to exclude the results for the
SPECIMEN specimen indicated by the cursor position. When the key is
ACCEPT
SPECIMEN
pressed, the key label changes to [ACCEPT SPECIMEN], an “R” is
displayed in the column immediately left of the results, and the
statistics are recomputed excluding those results. (See the
preceding figure.) The data are still displayed and stored in the file
but are excluded from the statistical calculation.
When the [ACCEPT SPECIMEN] key is pressed, the “R” is deleted and
the statistics are recomputed including those results.
CONFIRM DELETION
CANCEL DELETION
These keys are used to confirm or cancel the delete command.
When the [CONFIRM DELETION] key is pressed, the results are
deleted from the file (the data are not displayed or stored in the
file) and the statistics are recomputed excluding those results.
Running Controls
Control Material
Abbott recommends using the CELL-DYN control materials for
performing quality control checks on the CELL-DYN 3700 System.
These controls should be run:
• After daily start up procedures are completed.
• After a reagent lot number change.
• After calibration (confirmatory step).
• After a service call or component replacement.
• In accordance with the laboratory’s quality control protocol.
• According to regulatory requirements.
The CELL-DYN controls can be run in any mode of operation:
Open Mode, CS Mode, or SL Mode.
NOTE: Controls for the Sample Loader and Closed
Sampler Modes are packaged in tubes with pierceable caps.
Assay Verification
New lots of control material should be analyzed in parallel with
current lots prior to their expiration dates. This may be
accomplished by running the new controls twice a day for five
days. The mean of the ten runs is then used to confirm the assay
value. A control file is set up for the new lot number to easily
establish the mean. If desired, this same control file can then be
used to run the control for the remainder of the dating period.
Creating another file is not required.
The expected ranges published by manufacturers are generally too
broad for effective quality control.1 Therefore, each laboratory
should establish acceptable ranges. These ranges may be
determined by evaluating three to six months of data (data from the
Interlaboratory QC Program may be used) for a particular level of
control. The individual SD values may be averaged as follows:
(N1 ×
(N1 x SD12)
SD12)+ (N2 x×
+(N2 SD2
SD222))+.
+. . (Ni×
(Ni
... xSDi2)
SD2 )
Average SD =
(N1(N+
1+NN22+ ..
.Ni)
+ ...Ni) -- 1 1
Westgard Rules
A control rule tests the control result against control limits to
determine whether the CELL-DYN 3700 System shows acceptable
accuracy and precision. The limits are derived from the mean and
standard deviation of control measurements obtained when
instrument performance is stable and acceptable. The most
common rule used in hematology quality control is the mean
± 2SD limits. Ninety-five percent of the control results should fall
within the ± 2SD limits.
Quality control rules detect random or systematic error. Random
error may be defined as an increase in the SD (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.
J. Westgard recommended a multi-rule approach to evaluating
quality control results.2 This approach has long been used in the
clinical laboratory3. A set of modified Westgard Rules can be used
to monitor quality control results on the CELL-DYN 3700 System.
NOTE: Do not use the values for mean range provided on
the control assay sheet in conjunction with Westgard
Rules. Before using Westgard Rules with commercial
controls, establish the SD for each parameter on your
instrument and enter limits based on these SDs. Refer to
Assay Verification within this section for how to establish
a long-term SD.
PLT:+-+-++
248.
226.
204.
Rule Violations
Only the directly measured parameters need to be monitored with
multiple rules.4 In reference 4 (pp. 190–192), Cembrowski
suggests a protocol for using the Westgard Rules in hematology.
The following is a synopsis of that protocol.
Since three levels of control are typically used to monitor a
hematology analyzer, it is reasonable to consider all three runs at
the same time. In other words, check for rule violations across the
three levels, not just within a particular level. If the same rule is
violated for more than one level, determine whether the violation
indicates a loss of precision or a loss of accuracy, and troubleshoot
accordingly.
Cembrowski suggests that the results for all three levels first be
checked to see if they are within their 2SD limits. If all three levels
meet this criterion, the instrument is in control.
If any control result exceeds the 2SD limits, check to see if it
exceeds the 3SD limits. If a result exceeds 3SD, there are two
possibilities. There is either an instrument problem or a problem
with the particular level of control. Therefore, if a result exceeds
3SD, run another bottle of that control. If the problem persists,
then additional investigation is required.
Check to see if either the 2 of 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 confined to one level of control, use another
bottle and possibly another lot. Check expiration dates and data
entry. Check to be sure that the control is run into the correct file.
If a combination of rules has been violated across the three levels,
determine whether the violations indicate a loss of precision or a
loss of accuracy, and troubleshoot accordingly. If necessary, call
Abbott Diagnostics Customer Service (at 1-877-4ABBOTT in the
US) for assistance.
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.
X-B Analysis
Overview
X-B analysis is an automated means of monitoring instrument
performance by using the known stability of the red cell indices.
“X-B” is used to indicate XB, which is the symbol for a moving
average of hematology values calculated using an algorithm
developed by Dr. Brian Bull of Loma Linda University. X-B RBC
analysis uses the Bull algorithm to monitor instrument performance
by tracking data in the patient population analyzed on the
instrument.
X-B RBC analysis works well using the data from the RBC indices
due to the narrow dynamic range of the indices in human
populations. However, it is difficult to use this approach when the
algorithm is applied to results that have a wide dynamic range of
values, such as the WBC Differential subpopulations.
Consequently, there has been no means of monitoring the WBC
Differential parameters in a similar manner.
A method of X-B analysis for WBC Differential parameters has been
developed for the CELL-DYN 3700 System using data obtained with
the MAPSSTM technology. This method uses a moving average
calculation that is similar to the one used in Dr. Bull’s algorithm. For
convenience, the method is called X-B WBC, even though it was not
developed by Dr. Bull. A detailed description is contained in X-B
Analysis for WBC within this chapter.
X-B Terminology
Target Value
The Target Value for X-B RBC 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.
Overview
The red cell indices (MCV, MCH, and MCHC) are known to be stable
because the red cell apparently functions best in a very narrow range
of size and hemoglobin content. Therefore, the body exerts tight
physiologic control and will vary the number of red cells before
altering the average volume or hemoglobin concentration of those
red cells. Consequently, the average red cell indices of a given patient
population will vary no more than 0.5 percent from day to day and
even year to year, providing the population does not change.5 The
X-B algorithm provides a means of utilizing this information for
quality control on the CELL-DYN 3700 System.
The X-B algorithm analyzes the indices on the patient samples run
through the instrument in batches of 20. The mean of each batch
is compared to a target value, and a percent deviation is
computed and compared to the acceptable limits. This is similar
to comparing the results of a commercial control run to the
appropriate assay value to determine whether the result falls
within the 2SD range. If the percent deviation exceeds acceptable
limits, the message: X-B OUT is displayed on the screen.
Each laboratory should establish its own target value for the RBC
indices. It is suggested that the process be started by using the
default values (preset values from Dr. Bull’s earlier studies)
displayed on the X-B SET UP screen or by entering the values from
Dr. Bull’s recent study described above. The 3% action limits may
be used or widened to 5% during the study and tightened to 3%
when the Target Values are confirmed. The default values for the
Lower/Upper Limits may also be used or widened depending on
the specimen population analyzed by the laboratory.
Collect data from 20 batches of 20 specimens each for a total of
400 specimens. Data collection should be from specimens which
represent the typical specimen population that is processed
through the instrument. When all 20 batches are complete, print
the X-B DATA DISPLAY screen for RBC. Calculate the mean, standard
deviation (SD), and coefficient of variation (CV) for MCV, MCH,
and MCHC. The CV for each index should be < 1.5%. If the CV for
each index meets these criteria, enter the calculated mean value as
the target value and set the action limits to 3%.
NOTE: Laboratories analyzing specialized patient
populations (as described above) may need to widen the
action limits slightly to accommodate results from these
abnormal patients.
Overview
Since the WBC Differential parameters have a wide dynamic
range, it is difficult to use a moving average algorithm to control
these results. Therefore, the CELL-DYN 3700 System uses data
obtained from the MAPSSTM technology used for the WBC
Differential measurement.
Five main subpopulations of WBCs, which can vary widely in
absolute number and percentage values, are identified by the
CELL-DYN 3700 System. Even though these parameters have varying
dynamic ranges, they maintain a relatively constant modal position
on each axis of the scatterplots. It is expected that these optical
characteristics of the WBC Differential subpopulations will remain
stable over time without impact from the wide dynamic ranges of the
individual parameters. This constant modal position, which is
sensitive to changes in the instrument’s optical measurement
process, can be monitored by the instrument and used to control the
WBC Differential parameters in much the same way that the RBC
indices are used to control the RBC parameters.
The CELL-DYN 3700 System monitors the modal positions of the
lymphocyte and neutrophil clusters on each axis of the 0°/10°
scatterplot. It also monitors the modal positions of the neutrophil
cluster on each axis and the angle of the neutrophil/eosinophil
separation on the 90°/90° depolarized scatterplot. These seven
measurements are then averaged for each batch of 20 patients using a
moving average calculation similar to that developed by Dr. Bull for
the RBC indices. For convenience, this process is called X-B WBC.
References
NOTES
Overview
Hazards
Warning Conventions
Signal Words
Symbols
The general hazard symbol identifies an activity or
area that may present a hazard to personnel or
equipment.
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.
Biohazards
WARNING: Potential Biohazard. Consider all
clinical specimens, reagents, controls, surfaces or
components that contain or have contacted blood,
serum, or other bodily fluid as potentially
infectious. Wear gloves, lab coats, and safety glasses,
and follow other biosafety practices as specified in
the OSHA Bloodborne Pathogen Rule (29CFR Part
1910.1030) or other equivalent biosafety
procedures.
Chemical Hazards
Prevent exposure to chemicals used in the operation and
maintenance of the CELL-DYN 3700 System (including reagents)
by using appropriate personal protective equipment, work
procedures, and information on Material Safety Data Sheets
(MSDS). Refer to Chapter 2: Installation, for an installation
procedure for chemical containers.
Electrical Hazards
Basic electrical hazard awareness is essential to the safe operation
of any hematology analyzer. Appropriate personnel (including
facilities personnel) should practice good habits of electrical
safety, which include the following:
• 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.
Laser Hazards
The CELL-DYN 3700 Analyzer and Sample Loader are Class 1
(Class I) Laser Products per IEC 60825-1. However, the analyzer
contains Class 3B and Class 2 lasers as well.
CAUTION –
CLASS 3B LASER LIGHT WHEN OPEN.
AVOID EXPOSURE TO BEAM.
PN 9230701
Protective
Cover
This label is located on the top surface of the sample loader. (Refer
to Figure 8.5.
Class 2 Laser
Caution Label
Figure 8.5: Class 2 Laser Caution Label Location
Class 1 Laser
Product Warning
Label
References
NOTES
Overview
Daily
1. Run the Auto-Clean Cycle.
2. Clean the Aspiration Needle.
Weekly
1. Clean the Shear Valve.
2. Replace the Sample Aspiration Peristaltic Pump Tubing.
3. Clean the Sample Loader Tray, Racks, and Safety Cover.
4. Run the Extended Auto-Clean Cycle if routinely running
reticulocyte counts.
Monthly
1. Clean the Reagent Syringes.
2. Clean the Analyzer Air Filters.
3. Replace the WOC Transfer Peristaltic Pump Tubing.
4. Run the Extended Auto-Clean Cycle.
Special Procedures
1. Adjust the Closed Sampler Tube Retainer (CS only).
2. Prepare for Inactivity or Shipping.
3. Repackage for Shipment.
Figure 9.1:
Chapter 9
Overflow
Chamber
Optical
Aerosol WOC Flow Mounting Bench
Filter Cell Cover Bracket Assembly
HGB
Flow Cell
WIC Metering
Assembly
Mounting Open
Bracket Sample
Aspiration
Probe
von Behrens
RBC/PLT
Transducer
Assembly
Touch
Waste Plate
Chamber 1
Vacuum WOC Metering Syringe RBC/PLT Diluent Syringe
(contains Sheath Reagent) HGB/WIC Lyse Syringe (contains Diluent)
RBC/PLT Accumulator (contains HGB/WIC Lyse)
Diluent Drain Line RBC/PLT Waste
Overpressure Chamber 2 WOC Sheath Syringe HGB/WIC Diluent Syringe
Metering
Sensor Assembly (contains Sheath Reagent) (contains Diluent)
Overview
Maintenance
9-3
Maintenance
Overview Chapter 9
Decontamination Procedures
The OSHA Bloodborne Pathogen Rule (29 CFR Part 1910.1030)
requires the decontamination of laboratory equipment prior to
servicing or shipment:
• Decontaminate the instrument by performing the Auto-
Clean cycle. This cycle flushes all of the fluid pathways with
reagents to purge any waste from the fluid pathways. The
Open Mode Sample Probe and the Closed Sample Needle (CS
Model) or Sample Loader Needle (SL Model) are
automatically rinsed after every cycle. The surfaces of the
instrument should be wiped with a nonabrasive detergent
solution to remove any soiling, then wiped with a
tuberculocidal disinfectant, such as a 0.5% sodium
hypochlorite solution.
To calculate the percent (%) sodium hypochlorite concentration
desired see the following formula:
A = Percent (%) of sodium hypochlorite solution desired
B = Percent (%) of sodium hypochlorite stock solution (as
purchased)
X = Parts of water to be mixed with one part of the sodium
hypochlorite stock solution
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= X = 9.5
.5
SPECIAL The SPECIAL PROTOCOLS screen is accessed from the MAIN MENU
PROTOCOLS screen by pressing the [SPECIAL PROTOCOLS] key. The following
soft key labels are displayed:
EMPTY XDUCERS or
FILL XDUCERS (The soft key label alternates
between these two selections.)
REAGENT RESERVOIR
EMPTY WOC or FILL WOC (The soft key label alternates
between these two selections.)
MAINTEN LOG
CLEAN SHEAR VAL or
RESTORE SHEAR VAL (The soft key label alternates
between these two selections.)
DISABLE ANALYZER or
ENABLE ANALYZER (The soft key label alternates
between these two selections.)
MORE
MAIN
FILL When the [FILL XDUCERS] key is pressed, the transducers are
XDUCERS refilled with reagent.
Press the appropriate EMPTY soft key to empty the reagent reservoir.
Stay on this screen until the "FILL" key appears
After the appropriate FILL soft key is displayed, remove reagent line
from existing container and place in new container.
REAGENT The [REAGENT RESERVOIR] key is used to drain the reagent reservoirs
RESERVOIR located on the Left Side Panel of the Analyzer. When the [REAGENT
RESERVOIR] key is pressed, the following soft key labels are displayed:
EMPTY DILUENT or FILL DILUENT
EMPTY LYSE or FILL LYSE
EMPTY SHEATH or FILL SHEATH
EMPTY DETERGENT or FILL DETERGENT
RETURN
The screen displays the message shown in the preceding figure.
When the [EMPTY DILUENT], [EMPTY DETERGENT] or [EMPTY SHEATH] key
is pressed, the appropriate reagent reservoir is drained. The [EMPTY
LYSE] key is used to drain the WIC/HGB Lyse supply tubing. When the
reservoir (or tubing) is empty, the appropriate [FILL] key is displayed.
When the [FILL DILUENT], [FILL DETERGENT] or [FILL SHEATH] key is
pressed, the appropriate reagent reservoir is refilled. When the
[FILL LYSE] key is pressed, the lyse supply tubing is refilled.
INTERVAL The [INTERVAL SET UP] key is used to configure the maintenance
SET UP schedule.
UPDATE The [UPDATE LOG] key is used to indicate when maintenance was
LOG performed and to add comments to the Maintenance Log.
PRINT & The [PRINT & PURGE] key is used to print the completed log and
PURGE then delete it. When the [PRINT & PURGE] key is pressed, the
following soft key labels are displayed:
CONFIRM
CANCEL
These keys are used to [CONFIRM] or [CANCEL] the Print & Purge
command.
PRINT The [PRINT LOG] key is used to print the Maintenance Log.
LOG
RESTORE When the [RESTORE SHEAR VAL] key is pressed, the syringes refill
SHEAR VAL the Shear Valve and the associated tubing, and the Shear Valve
rotates back to its operational position. When the rotation is
complete, the key label changes to [CLEAN SHEAR VAL].
FLUSH The [FLUSH SHEATH] key is used to flush the WOC Flow Cell with
SHEATH Sheath Reagent.
AUTO The [AUTO CLEAN] key is used to initiate the Auto-Clean Cycle. The
CLEAN Shear Valve, the WOC Mixing Chamber, the WOC Flow Cell, the
von Behrens WIC Transducer, the von Behrens RBC/PLT
Transducer, the HGB Flow Cell and all of the associated fluidics
are automatically cleaned and rinsed during the cycle.
When the [AUTO CLEAN] key is pressed, the screen displays the
message shown in Figure 9.8 in the Daily Maintenance section.
The following soft key labels are displayed:
START
CANCEL
These keys are used to [START] or [CANCEL] the Auto-Clean Cycle.
DAILY The [DAILY SHUTDOWN] key is used to initiate the Daily Shutdown
SHUTDOWN cycle. During the cycle, the fluidics are automatically drained and
rinsed. At the end of the cycle, the Analyzer is placed in STANDBY.
The electronic solenoid valves are automatically opened
periodically while the Analyzer is in STANDBY to prevent the
tubing from becoming pinched.
PREPARE The [PREPARE SHIPPING] key is used to prepare the Analyzer for
SHIPPING shipment or a period of inactivity. The cycle drains all of the
reagents from the system and then rinses the fluidics with
deionized water.
EXTEND The [EXTEND AUTOCLEAN] key is used to initiate the Extended Auto-
AUTO-CLEAN Clean cycle, which is a longer version of the Auto-Clean cycle.
When the [EXTEND AUTOCLEAN] key is pressed, the screen displays
the message shown in Figure 9.17, Special Protocols: Extended
Auto-Clean Screen in the Monthly section within this chapter. The
following soft key labels are displayed:
START
CANCEL
These keys are used to [START] or [CANCEL] the Extended Auto-
Clean cycle.
MORE The [MORE] key is used to return to the first SPECIAL PROTOCOLS
screen.
NOTES
10/16/98 08:32 jg X X X
Comments: Weekly Maintenance
10/23/98 08:33 td X X X X X X X
Comments: Weekly Maintenance
The log displays the following entry fields: <Date>, <Time>, <OpID>,
<SHEAR VALVE>, <AIR FILTR>, <SYNG>, <APERTURES> (<WIC> and
<RBC>), <PUMP TUBING> (<ASPR> and <WOC>), <SL>, <EXT AUTO>,
<AUTO>, <OTHER>, and a line for <Comments>. (Up to 70 characters
may be entered in the <Comments> line.) The log holds 40 entries,
but the screen displays only the 5 most current. Other entries can
be displayed by pressing the Page Up or Page Down keys on the
keyboard.
Each time an entry is made, the current date, time, and operator
ID are automatically entered in the log. When the UPDATE
MAINTENANCE LOG screen (illustrated in Figure 9.7, Update
Maintenance Log Screen) is displayed, the cursor is automatically
positioned in the <Op ID> entry field. If desired, the ID may be
edited. Entries are made by moving the cursor with the arrow keys
on the keyboard to the desired entry field and pressing the Enter
key on the keyboard. An “X” is displayed to indicate the completed
maintenance and the cursor advances to the next entry field.
NOTE: Entries can also be made by moving the cursor to
the desired location, typing an “X”, and pressing the Enter
key on the keyboard.
Enter the maintenance interval (in days) for each of the following:
(enter 0 for no interval)
SHEAR VALVE 7
AIR FILTERS 30
SYRINGES 30
WIC APERTURE 30
RBC APERTURE 90
ASPIRATION PUMP TUBING 90
WOC PUMP TUBING 30
SAMPLE LOADER TRAY AND RACKS 30
EXTENDED AUTO-CLEAN 30
AUTO-CLEAN 7
PRINT RETURN
4. Type the desired interval in days, and press the Enter key on
the keyboard to save the entry and advance the cursor.
5. If desired, press [PRINT] to obtain a printout of the entered
intervals.
6. Press [RETURN] twice to return to the SPECIAL PROTOCOLS
screen.
7. Press [MAIN] to return to the MAIN MENU screen.
11/10/98 08:32 sh X X X
Comments: Weekly Maintenance
11/10/98 08:33 sh X X X X X X X
Comments: Weekly Maintenance
11/10/98 10:30 sh
Comments:
RETURN
NOTES
Auto-Clean
The Auto-Clean Cycle is a fully automated cycle designed to clean
the Shear Valve, the WOC Mixing Chamber, the WOC Flow Cell,
the von Behrens WIC Transducer, the von Behrens RBC/PLT
Transducer, the HGB Flow Cell, the needle in the CS or SL system,
and all the associated fluidics. The forward and reverse action of
the peristaltic pumps is used during this cycle to gently scrub and
remove any fibrin or debris within the system. The Auto-Clean
Cycle takes approximately 11 minutes.
START CANCEL
Materials Required
1. CELL-DYN Enzymatic Cleaner (cleaner should be at room
temperature)
2. Clean test tube or container
3. Lint-free pads
4. Warm water
5. Appropriate personal protective equipment
Procedure
1. Select the Open Sampler Mode.
2. Carefully wipe the outside of the Open Sampler Aspiration
Probe and the bottom of the Wash Block with a pad
dampened with warm water and a few drops of CELL-DYN
Enzymatic Cleaner.
3. From the MAIN MENU screen, press the [SPECIAL PROTOCOLS]
key followed by the [MORE] key to access the Auto-Clean
function.
4. Press the [AUTO CLEAN] key. Instructions for performing the
procedure are given on the screen.
5. Dispense approximately 1.5 mL of Enzymatic Cleaner into a
clean container and hold the container under the Open
Sample Aspiration Probe.
6. Press the [START] key.
NOTE: Do not press the Touch Plate. The Auto-Clean
Cycle is only initiated by the [START] key.
Materials Required
1. CELL-DYN® Enzymatic Cleaner
2. Diluent or deionized water
3. Three empty VACUTAINER® tubes
4. Appropriate personal protective equipment
Procedure
1. Aliquot approximately 2 mL of Enzymatic Cleaner into one
of the VACUTAINER® tubes.
2. Aliquot approximately 2 mL of fresh diluent each into the
other two VACUTAINER® tubes.
3. If necessary, from the Data Station RUN screen, press the
[CHANGE SAMPLER] key to select the Closed Mode.
4. Press the [SPECIMEN TYPE] key followed by the
[BACKGROUND] key.
5. Place the Enzymatic Cleaner tube followed by the two
diluent tubes in a Sample Loader end rack.
6. Position the rack in the Sample Loader tray and install the
Sample Loader Safety Cover.
CAUTION: The Sample Loader will not operate unless the
Safety Cover is in place.
Materials Required
1. CELL-DYN® Enzymatic Cleaner
2. Diluent or deionized water
3. Three empty VACUTAINER® tubes
4. Appropriate personal protective equipment
Procedure
1. Aliquot approximately 2 mL of Enzymatic Cleaner into one
of the VACUTAINER® tubes.
2. Aliquot approximately 2 mL of fresh diluent each into the
other two VACUTAINER® tubes.
3. If necessary, from the Data Station RUN screen, press the
[CHANGE SAMPLER] key to select the Closed Mode.
4. Press the [SPECIMEN TYPE] key followed by the [BACKGROUND]
key.
5. Run the Enzymatic Cleaner.
6. Run the diluent tubes.
7. Run at least five background counts before running controls
or patient samples. If the counts are unacceptable,
troubleshoot accordingly.
Shear Valve
Rear Section
Center Section
Front Section
Tubing Loop
Mounting Guide
Retaining Screw
Rim Notch
Materials Required
1. Deionized water
2. Lint-free pads
3. Appropriate personal protective equipment
Procedure
1. Remove the Left Front Cover to gain access to the Shear
Valve.
NOTE: It is necessary to also remove the Tower Cover on
the SL model to access the Shear Valve.
12. Align the lock notch of the rear section with the back panel
of the Shear Valve Assembly. Carefully slide the section back
as far as it will go. Avoid crimping any of the attached tubing.
13. Remove the center section from the deionized water, and
wipe the surfaces with a lint-free pad dampened in deionized
water. Do not dry.
14. View each surface under reflective light to confirm that it is
clean, and free of lint and fingerprints.
15. Align the center section so that the Rim Notch in the outer
edge faces to the right.
CAUTION: Be certain the Rim Notch faces to the right.
(See Figure 9.9, Shear Valve for correct center section
orientation.) Erroneous results will be obtained if
specimens are analyzed when the center section is
installed backwards.
16. Carefully slide the center section onto the Mounting Guide
and push it back until it touches the rear section.
17. Align the lock notch of the front section with the Mounting
Guide. Carefully slide it back until it touches the center
section.
18. Firmly hold the three valve sections in place and replace the
Shear Valve Retaining Screw. Turn the screw clockwise until
it stops.
19. Press the [RESTORE SHEAR VAL] key. The valve automatically
rotates several times. The instrument is returned to the
READY state when the rotation is finished.
20. Visually inspect the Shear Valve to ensure that the Rim
Notch of the center Shear Valve section faces to the right.
(Refer to Figure 9.9, Shear Valve for correct center section
orientation.)
21. Replace the Left Front Cover.
22. Press the [MAIN] key to return to the RUN screen.
23. Run at least five background counts before running controls
or patient samples. If the counts are unacceptable,
troubleshoot accordingly as directed in Chapter 10:
Troubleshooting.
Pump Rollers
Metal Brackets
Collar
Tubing
Pump
Pump Shoe
Wheel
Figure 9.10: Sample Aspiration Peristaltic Pump
Materials Required
1. Sample Aspiration Peristaltic Pump Tubing.
NOTE: The Sample Aspiration Pump Tubing has a smaller
diameter and is identified by the orange collar on each
end.
Procedure
1. From the SPECIAL PROTOCOLS screen, press the [DISABLE
ANALYZER] key.
2. Remove the Left and Right front covers to gain access to the
Peristaltic Pumps.
3. Locate the Sample Aspiration Pump to the left of the Shear
Valve.
4. Hold the Pump Shoe away from the pump wheel and remove
the tubing from under the pump wheel by lifting the collars
out of the metal brackets that hold them. Pull the tubing
completely out from under the pump wheel. (Refer to Figure
9.10)
5. Disconnect the tubing at the plastic connector.
6. Connect the new tubing to the plastic connector.
7. Place the collars on the ends of the pump tubing into the
metal brackets as shown in Figure 9.10. Hold the Pump Shoe
open and insert the tubing back under the pump rollers.
Make sure the tubing is positioned in the center of the
rollers. When the tubing is centered, release the Pump shoe.
8. Replace the Front Covers.
9. Press the [ENABLE ANALYZER] key.
10. Press the [MAIN] key to return to the MAIN MENU screen.
11. Run at least five background counts before running controls
or patient samples. If the background counts are
unacceptable, troubleshoot accordingly.
Materials Required
1. Container (large enough to hold a rack) filled with a mild
detergent solution made with warm (not hot) water
2. Clean, warm water for rinse
3. Lint-free pads
4. Appropriate personal protective equipment
Procedure
1. Remove the racks from the Sample Loader tray.
2. Wash the racks in the detergent solution. Do not allow them
to soak in the solution, as the labels will come off.
NOTE: When cleaning the racks, do not use an automated
washing system that operates at elevated tempertures as this
may damage the racks.
3. Rinse the racks with warm water and dry thoroughly with
lint-free pads or towels.
4. Wipe the stainless steel tray area with a lint-free pad
moistened with water. Dry the tray with a lint-free pad or
towel.
5. Wipe the stainless steel plate behind the vent/aspirate and
mixing stations with a lint-free pad moistened with water.
Dry the plate with a lint-free pad.
6. Clean the mixing heads with a lint-free pad moistened with
water. Dry the heads with a lint-free pad.
7. Wash the Safety Cover with the detergent solution, rinse,
and dry it.
Reagent Syringes
The Reagent Syringes need to be cleaned on a regular basis to prevent
reagent residue buildup, which may cause leakage or improper
functioning. Syringes should be cleaned one at a time to ensure that
each syringe is replaced in the correct position. Replace each syringe
after it is cleaned and then remove the next one to be cleaned. The
Syringe Assembly is depicted in Figure 9.11.
The 10-mL Syringe should be cleaned as required; the 0.5mL and
2.5 mL syringe should be cleaned monthly.
Syringe Assembly
WOC Metering
Syringe
WOC Sheath
Syringe
V-Block Holder
Pedestal Assembly
Flange
Materials Required
1. A large container filled with approximately 500 mL of
deionized water
2. Lint-free pads (or other lint-free pads)
3. Deionized water
4. Small container of appropriate reagent to refill the clean
syringes
5. Appropriate personal protective equipment
Procedure
1. From the MAIN MENU screen, press the [SPECIAL PROTOCOLS]
key followed by the [DISABLE ANALYZER] key.
2. Remove the front covers to gain access to the Syringe Assembly.
3. Lift the syringe out of the snap-in bracket. Note the liquid level in
the syringe so that it can be refilled after cleaning to approximately
this same level. (For example, a piece of tape may be attached to
the syringe barrel to note the position of the plunger tip.)
4. Grasp the metal Luer Lock fitting at the tip of the syringe
that attaches it to the tubing. Carefully turn the syringe
clockwise to release it from the fitting. Use lint-free pads to
absorb excess reagent.
5. Dispense the reagent into a sink or an appropriate waste
container.
6. Aspirate deionized water into the syringe until it is full. Continue
to pull on the plunger until it is removed from the barrel.
NOTE: Do not push or pull on the plunger when the
syringe is dry, as it may damage the plunger. Avoid
touching the plunger because oil from the fingers may
cause it to move erratically.
10. Insert the syringe tip into the Luer Lok® fitting and turn the
syringe counterclockwise until the fitting is finger-tight. Be
careful to not overtighten the fitting or crimp the associated
tubing.
11. Insert the syringe into the bracket and the end of the plunger
into its slot in the pedestal assembly. Position the horizontal
flange on the back of the syringe into the slot at the base of
the bracket.
12. When the syringe has been reinstalled, press the [ENABLE
ANALYZER] key.
13. Press the [MAIN] key to return to the MAIN MENU screen.
14. Run several background counts and observe the action of
each syringe during the cycle. The plunger should move
smoothly up and down and the syringe should not leak.
15. Replace the front covers after the operation of the syringes
has been verified.
16. Run at least five background counts before running controls
or patient samples. If the background counts are
unacceptable, troubleshoot accordingly.
Air Inlet
Filters
Normally
Closed
Valves
Materials Required
1. Running water
2. Lint-free pads
3. Small vacuum cleaner (optional)
4. Appropriate personal protective equipment
Procedure
1. Remove the Front Covers to gain access to the filter holders
on the Left Side Panel. (See the preceding figure.)
2. Grasp the upper filter and slide the holder forward to remove
it. The lower filter is removed the same way.
Pump Rollers
Materials Required
1. WOC Transfer Peristaltic Pump Tubing.
NOTE: The WOC Transfer Pump Tubing has a larger
diameter than the Sample Aspiration Pump Tubing (orange
collar) and is identified by the clear collar on each end.
Procedure
1. From the SPECIAL PROTOCOLS screen, press the [DISABLE
ANALYZER] key.
2. Remove the upper front cover to gain access to the Peristaltic
Pumps.
3. Locate the WOC Transfer Peristaltic Pump to the far left of
the Flow Panel.
4. Hold the Pump Shoe away from the pump wheel and remove
the tubing from under the pump wheel by lifting the collars
out of the metal brackets that hold them. Pull the tubing
completely out from under the pump wheel. (Refer to Figure
9.13)
5. Disconnect the tubing at the plastic connector.
6. Connect the new tubing to the plastic connector.
7. Place the collars on the ends of the pump tubing into the
metal brackets as shown in Figure 9.13. Hold the Pump Shoe
open and insert the tubing back under the pump rollers.
Make sure the tubing is positioned in the center of the
rollers. When the tubing is centered, release the Pump shoe.
8. Replace the Upper Front Cover.
9. Press the [ENABLE ANALYZER] key.
10. Press the [MAIN] key to return to the MAIN MENU screen.
11. Check that the background counts are acceptable before
running controls or patient samples. If the background
counts are unacceptable, troubleshoot accordingly.
Extended Auto-Clean
The Extended Auto-Clean Cycle is a fully automated cycle
designed to clean the Shear Valve, the WOC Mixing Chamber,
the WOC Flow Cell, the von Behrens WIC Transducer, the von
Behrens RBC/PLT Transducer, the HGB Flow Cell, the needle in the
CS or SL version, and all the associated fluidics. The forward and
reverse action of the Peristaltic Pumps is used during this cycle to
gently scrub and remove any fibrin or debris within the system.
The Extended Auto-Clean cycle takes approximately 2.5 hours to
complete. During this time, the instrument is not available to
process samples or manipulate data. (When the process is
complete, the instrument is automatically put in the STANDBY
state.) The cycle may be canceled after 38 minutes by pressing the
[CANCEL] key, which is displayed at this time.
IMPORTANT: It is not possible to exit the SPECIAL PROTOCOLS
screen when the Extended Auto-Clean cycle is in progress. The
screen may be exited only after the [CANCEL] key (displayed after
38 minutes) is pressed or when the cycle is complete.
The Extended Auto-Clean process takes 2.5 hours to complete. During this time, the system is unavailable for processing
samples or manipulating data. When the Extended Auto-Clean process is complete, the instrument will go into STANDBY.
It is important to begin with a sufficient reagent supply and a half empty waste container in order to successfully complete the
Extended Auto-Clean process.
After 38 minutes a CANCEL key is displayed. Press this key to cancel the Extended Auto-Clean process and return to the
operating mode.
START CANCEL
Procedure
1. Select the Open Sampler Mode.
2. Carefully wipe the outside of the Open Sample Aspiration
Probe and the bottom of the Wash Block with a lint-free pad
dampened with warm water and a few drops of CELL-DYN
Enzymatic Cleaner. Wipe any dried reagent or blood off the
bottom of the Wash Block.
3. Press the [SPECIAL PROTOCOLS] key followed by the [MORE]
key to access the Extended Auto-Clean function.
4. Press the [EXTEND AUTOCLEAN] key. Instructions for
performing the procedure are given on the screen.
5. Dispense approximately 1.5 mL of Enzymatic Cleaner into a
clean container and hold the container under the Open
Sample Aspiration Probe.
6. Press the [START] key.
NOTE: Do not press the Touch Plate. The Extended Auto-
Clean cycle is initiated only by the [START] key.
7. Continue to hold the container under the probe until a beep
is heard. Remove the container and discard the remaining
Enzymatic Cleaner.
NOTE: The complete procedure takes 2½ hours but may
be terminated after 38 minutes by pressing the [CANCEL]
key. If the [CANCEL] key is pressed, a rinse cycle is initiated
that prepares the instrument for sample processing.
Proceed to Step 8.
8. When the rinse cycle finishes, carefully wipe the outside of
the Open Sampler Aspiration Probe and the bottom of the
Wash Block with a lint-free pad dampened in warm water to
remove any traces of enzymatic cleaner.
9. If necessary, use a dry, lint-free pad to remove any water that
remains on the Probe or the Wash Block.
10. Press [MAIN] to return to the MAIN MENU screen.
NOTE: At the end of the 2½ hours, the instrument
automatically goes into the STANDBY state. Press the [RUN] key
to bring the Analyzer out of STANDBY and prepare it for
sample processing. Run at least five background counts before
running controls or patient samples. If the backgrounds
counts are unacceptable, troubleshoot accordingly.
9-36 CELL-DYN® 3700 System Operator’s Manual
9140320E — September 2004
Maintenance
Chapter 9 As Required
As Required
Materials Required
1. A large container filled with approximately 500 mL of
deionized water
2. Lint-free pads
3. Deionized water
4. Small container of diluent to refill the clean syringe
5. Appropriate personal protective equipment
Procedure
1. From the MAIN MENU screen, press the [SPECIAL PROTOCOLS]
key followed by the [DISABLE ANALYZER] key.
2. Remove the front covers to gain access to the Syringe
Assembly.
3. Grasp the plastic Luer-Lok fitting at the tip of the syringe
that attaches it to the tubing. Carefully turn the luer nut
on the syringe counterclockwise to release it from the fitting.
Use lint-free pads to absorb excess reagent.
4. Grasp the Syringe barrel below the Luer-Lok with one hand.
With the other hand, grasp the syringe plunger below the
metal band. Pull straight out to remove the syringe from the
snap-in bracket.
5. Note the liquid level in the syringe so that it can be refilled after
cleaning to approximately this same level. (For example, a piece
of tape may be attached to the syringe barrel to note the
position of the plunger tip.)
Aperture Plates
The WIC Aperture Plate and the RBC/PLT Aperture Plate are
automatically cleaned during the Auto-Clean cycle. (The WIC
Aperture Plate is also cleaned at the end of every count cycle by the
Aperture Cleaning Circuit.) However, it may also be necessary to
remove them occasionally for cleaning. Refer to the instrument
logbook to find the latest baseline count time(s) obtained from a
diluent sample with an acceptable background count. Use the
baseline count time(s) to determine the frequency of cleaning
needed.
Counting Chamber
Mixing Chamber
Aperture Plate
Release Lever
(Closed Position)
Materials Required
1. Cleaning solutions:
Either of the following solutions may be used to clean the
Aperture Plate. Because they will deteriorate over time, each
solution should be prepared fresh just before use.
a. Mix 20 drops of Enzymatic Cleaner and 20 mL of warm
water in a container that is large enough to hold the
Aperture Plate.
b. Make a 25% bleach solution (1.25% sodium
hypochlorite) by adding 5 mL of bleach to 15 mL of
deionized water in a container that is large enough to
hold the Aperture Plate.
2. Aperture brush from the Accessory Kit
3. Squirt bottle of deionized water
4. Lint-free pads
5. Sonic cleaner (optional)
6. Appropriate personal protective equipment
Procedure
1. Remove the Front Covers to gain access to the von Behrens
WIC or RBC/PLT Transducer Assembly.
2. Confirm that the Analyzer is in the READY state.
3. From the MAIN MENU screen, press the [SPECIAL PROTOCOLS]
key followed by the [EMPTY XDUCERS] Key. This will drain the
liquid from both the Transducer Assemblies.
NOTE: DO NOT attempt to remove the Aperture Plates
without first emptying the Transducer Assemblies.
Counting Chamber
Mixing Chamber
Aperture Plate
Counting Chamber
Figure 9.17: The von Behrens WIC Transducer, HGB Flow Cell, and
Solenoid 13
Materials Required
1. Cleaning Solution:
Make a 25% bleach solution (1.25% sodium hypochlorite)
by adding 5 mL of bleach to 15 mL of deionized water.
2. 15-mL syringe with a piece of tubing attached
3. Appropriate personal protective equipment
Procedure
1. Remove the front covers to gain access to the von Behrens
WIC Transducer and HGB Flow Cell Assembly.
2. Be sure that the Analyzer is in the READY state.
3. Manually open Solenoid 13 to completely drain all the liquid
from the von Behrens WIC Transducer and HGB Flow Cell.
(If necessary, refer to the preceding figure to locate
Solenoid 13.)
4. Close Solenoid 13.
5. Press the [SPECIAL PROTOCOLS] key followed by the [DISABLE
ANALYZER] key to disable the Analyzer.
6. Disconnect the clear TYGON® tubing from the fitting on the
top right of the von Behrens WIC Transducer Mixing
Chamber. (See the preceding figure.)
7. Fill the syringe with the cleaning solution and connect it to
the fitting on the top of the von Behrens WIC Transducer
Mixing Chamber. Dispense the cleaning solution into the
transducer until it is approximately half full.
8. Remove the syringe and reconnect the TYGON® tubing.
9. Manually open Solenoid 13 and allow approximately half of
the bleach solution to drain into the HGB Flow Cell.
10. Manually close Solenoid 13 to hold the bleach solution in
the Flow Cell.
11. Allow the bleach solution to remain in the transducer and
Flow Cell for 5 minutes.
12. When the time has elapsed, manually open Solenoid 13 to
drain the bleach solution from the transducer and Flow Cell.
13. Press [ENABLE ANALYZER] followed by [MAIN] to return to the
MAIN MENU screen.
14. Rinse the bleach solution out of the system by running a
minimum of five background counts. Check the TYGON®
tubing on the top of the von Behrens WIC Transducer
Mixing Chamber during the cycles to be sure it is properly
attached and does not leak.
15. Verify that the background counts are acceptable before
running controls or patient specimens. If the background
counts are unacceptable, troubleshoot accordingly.
16. Replace the Front Covers.
Aspiration Probe
Tubing Connection
Open Sample
Aspiration Probe
Materials Required
1. Wire stylet, gauge #23 (not provided)
2. Empty VACUTAINER tube
3. CELL-DYN Enzymatic cleaner
4. Appropriate personal protective equipment
Procedure
WARNING: Potential Biohazard. The probe is sharp and
potentially contaminated with infectious materials. Avoid
any contact with the tip of the probe.
Procedure
1. From the MAIN MENU screen, press the [SPECIAL PROTOCOLS] key.
2. From the SPECIAL PROTOCOLS screen, press the [DISABLE
ANALYZER] key.
3. Turn OFF the Sample Loader.
NOTE: The ON/OFF toggle switch is located on the left
end panel of the Sample Loader unit.
Shear Valve
Inlet Tubing
"Y" Fitting
Solenoid 95
Solenoid 96
Closed Mode
Valve Fitting
TEFLON® Tubing
for Drainage
Container
for Drainage
Materials Required
1. 10-mL syringe filled with cleaning solution:
Make a 25% bleach solution (1.25% sodium
hypochlorite) by adding 5 mL of bleach to 15 mL of
deionized water.
2. Tubing, two sizes to be used as a temporary drain line:
• TEFLON, 12"–18", small diameter
• Silicon, 2"–12", same diameter as pinch valve tubing
3. Paper towels/gauze
4. Appropriate personal protective equipment
Procedure
1. From the MAIN MENU screen, select in the following order:
[DIAGNOSTICS], [MORE], [SOLENOID OPERATION], then [STEP
SOLENOID].
2. Place absorbent paper towels/gauze below the probe area to
catch any potential spills.
3. Place a container underneath the Open Probe to recover the
flushing solution.
4. Disconnect the Shear Valve Inlet Tubing from the front
section of the Shear Valve.
5. Flush the Open Mode tubing.
a. On the keyboard, type 95. Press Enter. Solenoid 95 (Open
Mode) will open.
b. Inject the cleaning solution through the tubing and into
the container underneath the probe. A “push/pull”
motion may be used to facilitate cleaning action.
6. Flush the Closed Mode tubing.
a. Refill the syringe with the cleaning solution and
reconnect to the Shear Valve Inlet Tubing.
b. Disconnect the Closed Mode Aspiration Tubing from the
Closed Mode Valve Fitting. Attach a piece of TEFLON®
tubing to the tubing in the Closed Mode Valve. Place the
other end of the tubing into a container for drainage.
c. On the keyboard, press the Up arrow key. Solenoid 95
will close; Solenoid 96 (Closed Mode) will open.
d. Using the syringe, inject the cleaning solution through
the tubing and into the container. A “push/pull” motion
may be used to facilitate cleaning action.
7. Remove syringe and reattach the Shear Valve Inlet Tubing.
8. Remove the TEFLON® drainage tubing from the Closed
Mode Valve Fitting.
9. Reinstall the Closed Mode Aspiration Tubing to the tubing
going through the Closed Mode Valve — the tubing on the
valve’s right side.
10. From the screen, select [DIAGNOSTICS], then [INITIALIZATION].
11. After Initialization is complete, press [MAIN] to return to the
MAIN MENU screen.
12. Run five background counts. Check that the background
counts are acceptable before running controls or patient
samples. If the background counts are unacceptable,
troubleshoot accordingly.
NOTES
Special Procedures
Release Levers
Tube Retainer
Materials Required
1. An empty VACUTAINER® tube
2. Appropriate personal protective equipment
Procedure
1. Squeeze the Release Levers on the sides of the Tube Retainer
between the thumb and forefinger to loosen the Tube
Retainer, and slide the clamp up.
2. Insert the VACUTAINER® tube upside down into the Cap
Piercer Well.
3. Slide the clamp down to hold the tube snugly in place.
4. Release the Release Levers when the Tube Retainer has been
properly positioned.
5. Check the height adjustment with several VACUTAINER®
tubes to be certain that it is correct.
Materials Required
1. Container with approximately 500 mL of deionized water.
2. If the instrument will be shipped, the following are also needed:
• Shear Valve Dummy Center Section (this is stored in the
disk storage container located on the Analyzer Flow Panel
to the right of the WOC Flow Cell Access Cover)
• Four plastic bags to hold the reagent inlet and waste
outlet tubes
3. Appropriate personal protective equipment
Procedure
1. From the MAIN MENU screen, press the [SPECIAL PROTOCOLS]
key followed by the [MORE] key followed by the [PREPARE
SHIPPING] key.
2. Place the reagent lines in the container of deionized water
and then press the [START] key. The flow system will be
automatically rinsed. (This process takes about 10 minutes.)
NOTE: The message CLEAN FOR SHIPPING IS IN
PROGRESS is displayed during the rinsing process.
Introduction
NOTES
Diagnostics Menu
Several keys listed are described as “For Service Use Only.” The
data these keys provide are meaningful only to trained Field
Service Representatives and are not useful to the operator. If
certain keys are pressed inadvertently, the system may have to be
initialized.
There are five primary screens in the DIAGNOSTICS MENU. For ease
of explanation, the keys are discussed screen by screen.
FAULT EXECUTION CNT RATE CLEAR RAW DATA MORE PRINT MAIN
REPORT TIMES SUMMARY FAULTS SUMMARY
MOTOR PWR HOME EXERCISE SHEAR VAL SHEAR VAL PRINT DIAG-
CHECKING MOTORS MOTOR TIME DISPENSE NOSTICS
SHEAR VAL
ASPIRATE
WOC 1 WOC 2 CALC SCATTER SMOOTHING EXTENDED PRINT DIAG- STOP TRANSMIT DIAG-
DATA DATA CV GRAPHS ON/OFF WOC COUNT NOSTICS TRANSMISS MESSAGE NOSTICS
WOC 1 WOC 2
HISTOGRAM HISTOGRAM
FAULT EXECUTION CNT RATE CLEAR RAW DATA MORE PRINT MAIN
REPORT TIMES SUMMARY FAULTS SUMMARY
DIAG- The first DIAGNOSTICS MENU screen (see the preceding figure) and
NOSTICS the following soft key labels are displayed when the [DIAGNOSTICS]
key is pressed:
FAULT REPORT
EXECUTION TIMES
CNT RATE SUMMARY
CLEAR FAULTS
RAW DATA SUMMARY
MORE
PRINT
MAIN
Detergent empty
Detergent Empty
FAULT EXECUTION CNT RATE CLEAR RAW DATA MORE PRINT MAIN
REPORT TIMES SUMMARY FAULTS SUMMARY
FAULT EXECUTION CNT RATE CLEAR RAW DATA MORE PRINT MAIN
REPORT TIMES SUMMARY FAULTS SUMMARY
No fault pending
FAULT EXECUTION CNT RATE CLEAR RAW DATA MORE PRINT MAIN
REPORT TIMES SUMMARY FAULTS SUMMARY
CNT RATE When the [CNT RATE SUMMARY] key is pressed, the following soft
SUMMARY key labels (see the preceding figure) are displayed:
WOC CNT RATE or
WOC CNT GRAPH*
Count rate data from the last cycle is displayed in a tabular format.
The total count, time segments, and rate per second are displayed
for multiple data points from that cycle. (See the preceding
figure.) When the [CNT GRAPH] key for a particular parameter is
pressed, the rate-per-second data is displayed as a graph. (See the
following figure.) The kinetic data and graph are useful when
troubleshooting problems related to these parameters.
864.7
756.6
648.5
540.4
432.4
324.3
216.2
108.1
0.5 1.0 1.5 2.0 2.5 3.0 3.5 4.0 4.5 5.0 5.5 6.0 6.5 7.0 7.5
CLEAR When the [CLEAR FAULTS] key is pressed, the Analyzer returns to
FAULTS the Ready state if the corrective action taken resolved the
problem. If the corrective action did not correct the problem, the
fault status does not change.
List Mode WOC: 4350 RBC: 23598 PLT: 2682 WIC: 2956
Raw Count WOC: 4206 RBC: 31166 PLT: 2741 WIC: 3038 WIC Bubble: 94
RBC Times Upper: 3.53 Count: 6.23 Avg: 6.22 Timeout: 6.41
WIC Times Upper: 1.53 Count: 4.69 Avg: 4.69 Timeout: 4.89
FAULT EXECUTION CNT RATE CLEAR RAW DATA MORE PRINT MAIN
REPORT TIMES SUMMARY FAULTS SUMMARY
RAW DATA When the [RAW DATA SUMMARY] key is pressed, detailed
SUMMARY information pertaining to the last cycle run is displayed. An
example of the RAW DATA SUMMARY screen is shown in the
preceding figure. The most useful information for the operator,
the metering times and the HGB Reference and Sample readings, is
highlighted on the screen shown in the preceding figure.
MORE When the [MORE] key is pressed, the second DIAGNOSTICS MENU
screen is displayed. The [MORE] keys on the remaining screens to
be discussed always display the next DIAGNOSTICS MENU screen.
Consequently, they are discussed last in each section.
MAIN The [MAIN] key is used to return to the MAIN MENU screen. The
[MAIN] key appears on each primary DIAGNOSTICS MENU screen and
works the same way on each screen. Consequently, it will not be
discussed again in this section.
MORE When the [MORE] key on the first DIAGNOSTICS MENU screen is
pressed, the second DIAGNOSTICS MENU screen (see the preceding
figure) and the following soft key labels are displayed:
MOTOR OPERATION
SOLENOID OPERATION
PUMP OPERATION
DRAIN ACCUMULAT
INITIALIZATION
MORE
MAIN
This key is for service use only. The system must be initialized
MOTOR
OPERATION after this key is pressed.
SOLENOID This key is for service use only. The system must be initialized
OPERATION after this key is pressed.
PUMP When the [PUMP OPERATION] key is pressed, the following soft key
OPERATION labels (see the preceding figure) are displayed:
VACUUM ON or
VACUUM OFF (The key label alternates between these two
selections.)
PRESSURE ON or
PRESSURE OFF (The key label alternates between these two
selections.)
INHIBIT PUMPS*
VACUUM TEST
PRESSURE TEST
DIAGNOSTICS
* This key is displayed after either key listed above it is pressed.
Vacuum is on
VACUUM When the [VACUUM ON] key is pressed, the key label changes to
ON [VACUUM OFF], the vacuum pump is turned ON, and the screen
VACUUM
OFF
displays the message: Vacuum is on. (See the preceding figure.)
Press the [VACUUM OFF] key to turn the pump OFF.
NOTE: The pump is automatically turned OFF and control
of the pump is returned to the instrument when the screen
is exited.
This key is useful for troubleshooting vacuum problems. If the
pump does not turn ON when the key is pressed, the vacuum
pump may be the cause of the vacuum problem.
NOTE: The system must be initialized after this key is
pressed.
PRESSURE When the [PRESSURE ON] key is pressed, the key label changes to
ON [PRESSURE OFF], the pressure pump is turned ON, and the screen
PRESSURE
OFF
displays the message: Pressure is on. Press the [PRESSURE
OFF] key to turn the pump OFF.
NOTE: The pump is automatically turned OFF and control
of the pump is returned to the instrument when this
screen is exited.
INHIBIT When the [INHIBIT PUMPS] key is pressed, the key label changes to
PUMPS [ENABLE PUMPS], operation of the pumps is inhibited (no vacuum
ENABLE
PUMPS
and pressure are produced), and the screen displays the message:
Pressure and vacuum are inhibited. (See the preceding
figure.) Press the [ENABLE PUMPS] key to enable pump operation.
VACUUM When the [VACUUM TEST] key is pressed, the system releases the
TEST vacuum into the atmosphere and then determines the amount of
time required for it to return to the correct level. The key labels
disappear and the incrementing time is displayed on the screen.
(See the preceding figure.) When the test is complete, the time
stops incrementing and the key labels are displayed.
A vacuum recovery time greater than 5 seconds may indicate a
vacuum problem.
NOTE: The system must be initialized after this key is
pressed.
PRESSURE When the [PRESSURE TEST] key is pressed, the system releases the
TEST pressure into the atmosphere and then monitors the amount of
time required for it to return to the correct level. The key labels
disappear and the incrementing time is displayed on the screen.
When the test is complete, the time stops incrementing and the
key labels are displayed.
A pressure recovery time greater than 4 seconds may indicate a
pressure problem.
NOTE: The system must be initialized after this key is
pressed.
DRAIN When the [DRAIN ACCUMULAT] key is pressed, the internal vacuum
ACCUMULAT accumulators are drained of accumulated fluid. This key is used to
correct the Vacuum Accumulator Wet fault. (See the preceding
figure.)
When the process is completed, the system must be initialized
and primed. A prime cycle and background are automatically run
whenever the [RUN] key is pressed after the system is initialized.
Run an additional five background counts.
INITIAL- When the [INITIALIZATION] key is pressed, the Analyzer is
IZATION initialized. This is necessary when a fatal fault has occurred.
When the Analyzer is initialized, a prime cycle must be run.
NOTE: A prime cycle and background are automatically
run whenever the [RUN] key is pressed after the system is
initialized.
MORE When the [MORE] key is pressed, the third DIAGNOSTICS MENU
screen (see the preceding figure) and the following soft key labels
are displayed:
DIGITAL READINGS
VOLTAGE READINGS
GAIN ADJUSTMNT
MORE
PRINT
MAIN
DIGITAL This key is for service use only.
READINGS
DCM: slf-tst f/DAC:0.00 99mv refrence:0.08 15v/2 pwr sp :7.49 5v pwr sp :5.14
slf-test ramp:9.99 9.901v refrnc:9.86 -15v/2 pwr sp:-7.55
SPM: WOC threshold:0.85 SPM tst f/DAC:0.00 WOC ch 1 peak:0.00 RBC peak :0.00
RBC threshold:0.57 5v supply :5.12 WOC ch 2 peak:0.00 RBC intgrl:0.00
PLT L thrshld:0.53 10v refrence :9.97 WOC ch 3 peak:0.00 PLT peak :0.04
PLT H thrshld:9.97 -10v refrence:-10.0WOC ch 4 peak:0.00
MAM: ch 1 offset :0.20 ch 5 offset :-2.06electrode v/2:0.41 laser ref :0.00
ch 2 offset :0.97 ch 6 offset :-3.00apt crrnt set:-0.05
ch 3 offset :0.64 ch 3-Vdyn/100:6.14 tstpuls H set:-0.05
ch 4 offset :0.27 ch 4-Vdyn/100:5.65 tstpuls L set:-0.00
VPM: press 1 psi :12.0 press 3 psi :4.88 vac 1 in. Hg :11.8 pos rf prs:5.00
press 2 psi :9.01 vac 2 in. Hg :11.7 pos rf prs:-5.07
FCM: HGB output :5.53
WIC: WIC offset v :-3.26WIC H thrshld:7.30 WIC apt cr st:0.00 WIC peak :0.00
WIC elctd v/2:0.66 WIC L thrshld:1.54 WIC test puls:0.00
VOLTAGE When the [VOLTAGE READINGS] key is pressed, the voltage and
READINGS vacuum/pressure value from a test point, measured at the moment
when the key was pressed, is displayed. (See the preceding figure.)
The following additional soft key labels are displayed:
FINISH SELECT*
SELECT*
*These two keys are for service use only.
GAIN This key is for service use only. The system may have to be
ADJUSTMNT initialized after this key is pressed.
MORE When the [MORE] key is pressed, the fourth DIAGNOSTICS MENU
screen (see the preceding figure) and the following soft key labels
are displayed:
WOC DATA
RBC DATA
PLT DATA
WIC DATA
MORE
PRINT
MAIN
These keys are for service use only.
MORE When the [MORE] key is pressed, the fifth and last DIAGNOSTICS
MENU screen (see the preceding figure) and the following soft key
labels are displayed:
AUTO-SAMP This key is used to display the software version currently installed
VERSION in the Sample Loader. The Sample Loader must be ON before the
key is pressed. When the [AUTO-SAMP VERSION] key is pressed, the
screen displays the following message (see the preceding figure):
BAR CODE This key is for service use only and is displayed on the CELL-DYN
ALIGNMENT 3700SL System only.
BAR CODE This key is for service use only and is displayed on the CELL-DYN
VERIFY 3700SL System only.
SERIAL The [SERIAL TEST] key is used to test the functionality of the RS232
TEST port (referred to as the “serial interface connector”) at the rear of
the Data Station. This test is designed to assist in troubleshooting
problems related to interfacing with a Laboratory Information
System (LIS). The loop-back connector must be connected to the
Data Station RS232 port before performing the test.
When the [SERIAL TEST] key is pressed, the following soft key
labels (see the preceding figure) are displayed:
STOP TRANSMISS
TRANSMIT MESSAGE
DIAGNOSTICS
The DIAGNOSTICS MENU screen for Serial Test displays the
following message:
STOP The [STOP TRANSMISS] key is used to abort any transmission that is
TRANSMISS in progress to an LIS.
NOTES
Troubleshooting Guide
Overview
Good troubleshooting skills are learned by using a logical, step-
by-step approach to problem solving. The first step in the process
is understanding normal instrument operation and preventive
maintenance. A good working knowledge of the instrument is
essential for identifying and resolving operational problems.
1. Problem Identification
2. Problem Isolation
3. Corrective Action
Troubleshooting Procedures
The procedures in this section are for troubleshooting purposes
only. A specific procedure should be performed when indicated in
this chapter or at the request of an Abbott Customer Support
Specialist.
Power ON Procedure
IMPORTANT: If the power has been OFF more than five minutes,
the laser must be allowed to warm up for 15 minutes once the
power is turned back ON. Do not process samples during this
warm-up period.
Replacing Reagents
If a reagent (or reagents) is suspected as the cause of a particular
problem, replace the container. However, the Analyzer has
reservoirs that contain a small amount of reagent to maintain the
supply within the system. This supply must be depleted before
installing the new reagent.
Replaceable Components
Procedures are given in this section for those components that
may be replaced by the operator. All other components must be
replaced by an Authorized Service Representative.
WARNING: Potential Biohazard. Components may 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) or equivalent biosafety
procedures.
Fuse Replacement
The CELL-DYN 3700 System has a fuse located above the Power
Cord Connector on the Rear Panel. It should only be replaced
with the following types of fuses:
For 220-volt operation, a 4-amp T (slow-blow) fuse
For 110-volt operation, an 8-amp T (slow-blow) fuse
Replacement fuses are provided in the Accessory Kit.
Materials Required
Flathead screwdriver
Procedure
WARNING: Electrical Shock Hazard. Always turn the
System OFF and disconnect the Power Cord from the
receptacle before checking or changing the fuse.
6. Check that the fuse is fully inserted into the Fuse Holder and
replace the holder.
7. Insert a flathead screwdriver into the Fuse Holder Slot and
push in, turning clockwise to lock it in place.
8. Reconnect the power cord to the receptacle and turn the
Analyzer power switch ON.
Pulley Belt
Blood Sensor A Sample
Aspiration
Vent Tubing
Tubing V
Silicon
Tubing
Sleeve Mounting
Block
Locking
Screw
Vent Reservoir
A Sample
Aspiration
Vent Tubing
Tubing V
Aspiration
Tubing
Silicon Sleeve
Materials Required
1. Sample Loader Vent/Aspiration Needle, L/N 03H99-01
(provided in the Accessory Kit)
2. Enzymatic Cleaner in a VACUTAINER tube
3. Gauze
4. A 2.5-mm Allen wrench
5. Two VACUTAINER tubes approximately half full of Diluent
6. Small needle nose pliers or similar tool.
Procedure
1. Perform the Auto-Clean procedure as directed in Chapter 9:
Maintenance, Subsection: Daily Maintenance Procedures,
Auto-Clean. When the cycle is complete, turn the Sample
Loader power switch OFF.
2. Remove all racks from the tray.
3. Place some gauze under the Vent/Aspiration Needle to catch
any liquid.
9. Disconnect the “A” tubing from the needle. Slide the silicon
tubing sleeve onto the aspiration tubing before
disconnecting it. (See the preceding figure.) Disconnect the
“V” tubing from the Vent/Aspiration Needle.
10. Use the Allen wrench to remove the locking screw on the
mounting bracket. (See Figure 10.22, Sample Loader Vent/
Aspiration Needle Assembly.)
11. Using the needle nose pliers, grip the holding clip on the
mounting block and carefully pull it forward until it clears
the block.
12. Remove the needle by pulling it up through the Wash Block
and the mounting block.
WARNING: Potential Biohazard. The needles are sharp and
are potentially contaminated with infectious materials.
Handle with extreme care.
13. Insert the new needle through the mounting bracket and
down through the Wash Block until the wide collar at the
top of the needle is flush with the top of the mounting
bracket.
NOTE: Be sure that the vent section (slanted) is facing the
analyzer.
14. Slide the holding clip back onto the mounting block and
push in until it is snug against the block.
15. Using the Allen wrench, replace and tighten the locking
screw in the mounting bracket.
16. Reconnect the vent tubing and the aspiration tubing.
NOTE: When connected, the aspiration tubing must be
placed at least 1/4 inch over the top of the needle to cover
it. The silicon tubing sleeve must slide over this
connection for a proper seal.
18. Replace the tower cover and check all tubing to ensure it is
not pinched or crimped.
19. Reinstall all Sample Loader Racks. Prepare the first rack to
run two diluent tubes. Install Safety Cover.
20. Enable the Analyzer by pressing the [ENABLE ANALYZER] key
on the SPECIAL PROTOCOLS screen.
21. Turn the Sample Loader power switch ON.
22. Run the two diluent tubes and verify proper needle
movement. Check to be sure the background count is
acceptable on the last cycle.
NOTE: If the background count is unacceptable, clean the
aspiration needle as directed in Chapter 9: Maintenance,
Subsection: Daily Maintenance Procedures and repeat the
background count. If any problems are encountered, call
Abbott Diagnostics Customer Service for assistance
(at 1-877-4ABBOTT in the US).
Apertures
It may be necessary to replace the WIC Aperture Plate and/or the
RBC/PLT Aperture Plate if no other solution to a related problem
is found.
WIC apertures are identified by “WBC” etched on the Aperture
Plate. RBC/PLT apertures are identified by “R/P” etched on the
Aperture Plate.
Procedure
1. Remove the old Aperture Plate as directed in the aperture
cleaning procedure described in Chapter 9: Maintenance,
Subsection: As required, Aperture Plates.
2. Confirm that the replacement Aperture Plate is the correct one.
3. Clean the new Aperture Plate and install it as directed in the
aperture cleaning procedure described in Chapter 9:
Maintenance, Subsection: As Required, and follow the
remaining steps in that procedure.
CAUTION: Changing the Aperture Plate may alter the
instrument calibration. Therefore, confirm the calibration
by running commercial controls before processing
samples. If necessary, recalibrate the instrument as
directed in Chapter 6: Calibration.
4. Repeat the samples that were running when the problem was
detected to determine if it has been resolved. If the problem
is not resolved, call Abbott Diagnostics Customer Service for
assistance (at 1-877-4ABBOTT in the US).
Syringes
It may be necessary to replace a syringe to correct a problem, for
example, if a syringe is cracked or broken.
Procedure
1. Remove the syringe in question as directed in the
appropriate syringe cleaning procedure described in
Chapter 9: Maintenance and set it aside.
2. Remove the screw from the base of the plunger on the old
syringe. Install the screw on the base of the new syringe
before installing the syringe on the instrument.
3. Install the new syringe as directed in the appropriate syringe
cleaning procedure and follow the remaining steps in that
procedure.
4. Repeat the samples that were in process when the problem was
detected to determine if it has been resolved. If the problem
is not resolved, call Abbott Diagnostics Customer Service for
assistance (at 1-877-4ABBOTT in the US).
List of Symptoms
Troubleshooting Background Counts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-39
Platelet background out of specification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-40
WOC background out of specification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-41
WIC background out of specification. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-42
RBC background out of specification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-43
Hemoglobin background out of specification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-44
Multiple background counts out of specification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-45
Troubleshooting Incomplete Aspiration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-46
Sampling Error — Incomplete Aspiration: Open Mode. . . . . . . . . . . . . . . . . . . . . . . . . . . .10-47
Sampling Error — Incomplete Aspiration: Closed Mode (Cap Piercer System) . . . . . . . . 10-48
Sampling Error — Incomplete Aspiration: Closed Mode (Sample Loader System) . . . . . . .10-49
Troubleshooting Clog and Flow Error Messages for RBC/PLT and WIC . . . . . . . . . . . . . . . . . . . . 10-50
RBC/PLT clog or flow errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-51
WIC clog or flow errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-52
Troubleshooting WOC Flow Errors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-53
WOC flow errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-54
Troubleshooting Imprecise or Inaccurate Data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-55
RBC/MCV/PLT data are imprecise or inaccurate. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-56
WOC data are imprecise or inaccurate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-58
WIC data are imprecise or inaccurate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-59
Hemoglobin data are imprecise or inaccurate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-60
>>>> appear in place of the result for WBC, RBC, HGB, or PLT . . . . . . . . . . . . . . . . . . . . .10-61
Observable Fault Conditions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-62
Analyzer or Data Station will not power ON . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-62
No screen display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-62
The MAIN MENU screen is not displayed after initialization . . . . . . . . . . . . . . . . . . . . . 10-63
The word FAULT on the Analyzer Status Indicator Panel is illuminated in red . . . . . . . . 10-63
Instrument will not stop cycling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-64
The Data Station keyboards, membrane (including soft keys) and external,
are not operational . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-64
The Sample Loader does not power ON . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-65
The Sample Loader beeps and the Start key is not illuminated . . . . . . . . . . . . . . . . . . . . 10-65
Shear Valve problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-65
Troubleshooting Clog and Flow Error Messages for RBC/PLT and WIC
The following list contains some general guidelines for
troubleshooting RBC/PLT and WIC clog and flow errors.
Start
Detector
(Count
Meniscus Initiated)
Count
Time
Stop
Detector
(Count
Completed)
• Print the RUN screen to record the metering times. The upper
metering time and the count time are both important in
troubleshooting clogs or flow errors.
• The metering times are automatically stored in the Data Log.
Configure the Data Log to display and print the appropriate
upper metering time and count time. (If necessary, refer to
the directions given in Chapter 5: Operating Instructions.)
Platelet clumps falsely decrease the Check the specimen for clots and/or the
platelet count stained blood smear for platelet clumps.
Recollect the specimen using proper
technique.
Rerun the specimen.
Electrical interference If Analyzer covers have been removed,
replace them and reconnect the ground
wires.
Perform an electrical background count.
Clean the Fan Filters (as directed in
Chapter 9).
Check for any equipment near the
CELL-DYN 3700 System that may be
causing electrical interference.
Contaminated Reagent Empty the RBC/PLT Diluent Reservoir.
Replace the reagent with a new box of
reagent.
NOTE: To prevent contamination, place
the Reagent tubing on a clean surface.
Dirty RBC/PLT Aperture Plate Clean the RBC/PLT Aperture Plate (as
directed in Chapter 9).
The RBC/PLT Diluent Syringe contains Clean the RBC/PLT Diluent Syringe (as
salt crystals directed in Chapter 9).
Certain red blood cells (for example, Rerun specimen under [RESISTANT RBC].
hypochromic RBC or RBC containing large
amounts of HGB S, C, or F) may not be
completely lysed by the Sheath Reagent and
cause interference with the WOC count.
Laser light is not on Check MAM 1, 2, 3, and 4 Offset readings
on the VOLTAGE READING SUMMARY screen
in the DIAGNOSTICS MENU.
If the readings are 0.0, the laser or laser
power supply has malfunctioned.
Free plasma HGB from in vivo hemolysis Determine the plasma HGB and calculate
the corrected HGB concentration:
Corrected HGB = Whole Blood HGB -
[Plasma HGB x (1-HCT)] and Recalculate
the MCH and MCHC.
>>>> appear in place of the result for WBC, RBC, HGB or PLT
NOTE: When the WOC or WIC result is replaced with >>>>, the HGB result is
suppressed. <<<< displays to indicate that the HGB is affected by the elevated WOC or
WIC value.
Cause of Inaccurate Result Corrective Action
Data exceed linear range for that For RBC or HGB: Dilute a 0.5-mL aliquot
parameter of well-mixed whole blood with 0.5 mL of
diluent (1:2 ratio). Close the container
and invert it 10 to 15 times to mix. Run
the specimen as usual. Multiply the RBC
or HGB result by 2 to obtain a reportable
value.
No screen display.
Probable Cause Corrective Action
1. Monitor power switch is turned OFF. 1. Turn the monitor power switch ON.
2. Data Station power switch is turned 2. Turn the power switch ON.
OFF.
3. Brightness control is turned down. 3. Adjust the brightness control on the
Data Station until the image is visible.
4. Defective Data Station or other 4. Call Abbott Diagnostics Customer
component. Service for assistance
(at 1-877-4ABBOTT in the US).
The word Fault on the Analyzer Status Indicator Panel is illuminated in red.
Probable Cause Corrective Action
1. The Analyzer has detected a fault 1. From the first DIAGNOSTICS MENU
situation and has inhibited operation. screen, press [FAULT REPORT]. Print a
copy of the report and perform the
indicated corrective action. When the
action is completed, initialize the
Analyzer by pressing the
[INITIALIZATION] key on the second
DIAGNOSTICS MENU screen.
2. If the fault report does not indicate a
message or action, document the
situation and initialize the Analyzer by
pressing the [INITIALIZATION] key on the
second DIAGNOSTICS MENU screen.
The Data Station keyboard and the soft keys are not operational.
Probable Cause Corrective Action
1. The computer is performing a function 1. No action required. Refer to the screen
that inhibits the keys. for the current Status Box message.
2. There is an incomplete operator entry. 2. Complete the operator entry or press
the Esc key on the keyboard.
3. A data transmission to the printer or 3. No action required. Refer to the screen
laboratory computer is in progress. for the current Status Box message.
4. Keyboard entry is not possible on the 4. No action required. Refer to the screen
displayed screen. for the current Status Box message.
5. Data Station computer, keyboard and/ 5. Initialize the Analyzer by pressing the
or circuitry malfunction. [INITIALIZATION] key on the second
DIAGNOSTICS MENU screen. If necessary,
call Abbott Diagnostics Customer
Service for assistance
(at 1-877-4ABBOTT in the US).
The Sample Loader beeps and the Start key is not illuminated.
Probable Cause Corrective Action
1. The cable that connects the Sample 1. Check that each end of the cable is
Loader to the Analyzer is loose or securely connected. If necessary,
disconnected. remove the cable and reconnect it.
Press the INT key on the Sample Loader
operation keyboard to initialize the
Sample Loader.
2. Circuitry malfunction. 2. Call Abbott Diagnostics Customer
Service for assistance
(at 1-877-4ABBOTT in the US).
Status Conditions
Auto-Sampler Busy
This message is displayed in the Bulletin Line.
Explanation/Action
An action was requested during Sample Loader operation and the Sample Loader
cannot perform it.
Press the Sample Loader PAUSE key before requesting the desired action.
Auto-Sampler Initializing
This message is displayed in the Bulletin Line.
Explanation/Action
The Sample Loader hardware initialization cycle is in progress.
Wait for the cycle to be completed.
Auto-Sampler Off
This message is displayed in the Bulletin Line.
Explanation/Action
Power to the Sample Loader is turned OFF.
Turn ON the Power Switch and wait for the initialization cycle to be completed.
Auto-Sampler Pause
This message is displayed in the Bulletin Line.
Explanation/Action
The Sample Loader PAUSE key was pressed during operation and therefore, operation is
suspended.
Press the Sample Loader START key to initiate processing.
Auto-Sampler Ready
This message is displayed in the Bulletin Line.
Explanation/Action
The Sample Loader initialization cycle is complete and samples may be processed.
Press the Sample Loader START key to initiate processing.
Bar Code flag not allowed to change unless Work List is purged
This message is displayed in the Bulletin Line.
Explanation/Action
The [BAR CODE ON] or [BAR CODE OFF] key was pressed and there is an existing Work List.
Delete all samples from the Work List before turning the bar code ON or OFF.
Clearing Apertures
This message is displayed in the Status Box
Explanation/Action
The [CLEAR APERTURES] key was pressed or the instrument automatically performed the
Clear Apertures function in response to a clog or flow problem.
Wait until the READY message is displayed in the Status Box and repeat the sample.
Clearing Fault
This message is displayed in the Status Box
Explanation/Action
The [CLEAR FAULT] key was pressed after an operator correctable fault was detected.
Resume operation when READY is displayed in the Status Box and the word READY on
the Status Indicator Panel is illuminated in green.
Entering Standby
This message is displayed in the Status Box
Explanation/Action
The instrument has been idle for four hours and therefore is automatically performing
a cleaning cycle before entering the STANDBY state. (The [DAILY SHUTDOWN] key also
initiates this message.)
When the cycle is complete, press [PRIME] or [RUN] to initiate the priming cycle and return
the instrument to the READY state. Resume operation when the cycle is complete.
Extended Count
This message is displayed in the Status Box
Explanation/Action
A low value has been detected for the WBC and/or PLT count. The Analyzer is
automatically extending the cycle to count more cells. The Extended Count message is
displayed while running a specimen in the Auxiliary Mode.
Resume processing when the READY message is displayed in the Status Box.
Initialized
This message is displayed in the Status Box
Explanation/Action
The Analyzer hardware initialization is complete.
Press [PRIME] or [RUN] to initiate the priming cycle and return the instrument to the
READY state. Resume operation when the cycle is complete.
No entry found
This message is displayed in the Bulletin Line.
Explanation/Action
The number (Sequence Number or specimen ID number) entered on the DATA LOG
SEARCH screen is not present in the Data Log.
Check that the entry was correct. If appropriate, enter the correct number.
Ready
This message is displayed in the Status Box
Explanation/Action
The Analyzer is ready to process samples.
Samples Completed
This message is displayed in the Bulletin Line.
Explanation/Action
The Sample Loader has completed processing samples in the End Rack and has stopped
automatically.
Standby
This message is displayed in the Status Box
Explanation/Action
The instrument has entered the STANDBY state.
Press [PRIME] or [RUN] to initiate the priming cycle and return the instrument to the
READY state. Resume operation when the cycle is complete.
Unpinching Valves
This message is displayed in the Status Box
Explanation/Action
The Analyzer was idle for a predetermined time period and therefore the valves are
being exercised to be sure that tubing is not pinched shut.
Resume processing when the READY message is displayed in the Status Box.
Auto-Sampler/Data fault
This message is displayed in the Bulletin Line.
Probable Cause Corrective Action
1. Four sequential clog or flow messages 1. Follow the instructions given in
occurred during Sample Loader Symptom Identification and
operation. Resolution within this chapter for
troubleshooting clog, flow, or
incomplete aspiration messages.
2. Four sequential incomplete aspiration
messages occurred during Sample
Loader operation.
Initialization Failed
This message is displayed at the bottom of the screen. (MAIN MENU is not displayed.)
Probable Cause Corrective Action
1. The Data Station was unable to 1. Initialize the Analyzer by following the
initialize. The CELL-DYN software does instructions in Power OFF Procedure
not display the MAIN MENU screen. and Power ON Procedure in
Troubleshooting Procedures within this
chapter. If the Data Station does not
initialize, press the Print Screen key on
the computer keyboard to document
any screen messages and call Abbott
Diagnostics Customer Service for
assistance (at 1-877-4ABBOTT in the
US).
Mixing Error
This message is displayed in the Bulletin Line.
MIX ERROR is displayed on the RUN screen to the right of the MCH result.
“MIXING ERR” is printed on the graphics report. A mixing error is always accompa-
nied by a sampling error; therefore, “SAMPLING ERR” is printed on all reports.
Probable Cause Corrective Action
1. The Sample Loader mixing head(s) 1. Check to be sure that the sample tube
detected resistance when attempting to can spin freely in the Sample Loader
mix a sample. Therefore, no sample rack. If necessary, remove excess labels
was aspirated and results appear to be a or obstructions. Repeat the sample.
background count.
2. One or both mixer motors is binding 2. Call Abbott Diagnostics Customer
and generating resistance. Service for assistance
(at 1-877-4ABBOTT in the US).
Uninitialized
This message is displayed in the Status Box.
Probable Cause Corrective Action
1. Data Station has power but the 1. Ensure that the Analyzer power cord is
Analyzer is not responding. connected to the Analyzer and that the
cord is connected to the power outlet.
Initialize the Analyzer by pressing the
[INITIALIZATION] key on the second
DIAGNOSTICS MENU screen.
2. Communication malfunction between 2. Check the cable that connects the
the Analyzer and Data Station. Analyzer to the Data Station. If
necessary, secure the connections.
Initialize the Analyzer by pressing the
[INITIALIZATION] key on the second
DIAGNOSTICS MENU screen.
Overview
NOTES
Routine Operation
Graphics Printer
The CELL-DYN 3700 software automatically controls and adjusts
most print conditions, including page width. If printing is not
what you expect, refer to the printer manual for guidance in
making adjustments. If you have additional questions or
experience any problems, call Abbott Diagnostics Customer
Service for assistance.
Ticket Printer
For detailed information about loading continuous-feed tickets or
paper and changing the ribbon in the Ticket Printer, refer to the
manuals that accompany the printer. In particular, note the
important safety instructions. This section gives information
about ticket printing and instructions for loading individual pre-
printed tickets in the Ticket Printer.
Printing Tickets
To print tickets, the printer cable must be connected to the Ticket
Printer connector on the back of the Data Station. (See Figure 2.5
for the location of these connectors.) Refer to Chapter 5:
Operating Instructions, Subsection: Set Up Instructions for
instructions for customizing either type of printout.
9. Position the ticket so that the lower red line on the paper
shield (located between the print head and the paper) is
positioned where the first line of printing should occur.
NOTE: When the Top of Form is set, the position is
retained in the printer memory until it is reset.
10. Press the Sel key to select the printer. The printer is now
ready to print.
Cleaning
Every six months (or after about 300 hours of operation) turn the
printer OFF and use a clean, dry cloth to dust the area around the
carriage shaft and platen. Be sure to remove any loose particles of
paper. Do not use solvents or strong detergents on the cabinet.
Troubleshooting
Refer to the printer manuals for a list of the most common printer
problems and how to solve them. If the problem is not resolved,
contact the Abbott Diagnostics Customer Service Center for
assistance.
NOTES
Overview
When the START key on the Sample Loader is pressed, the tube
racks advance to move each tube through the three processing
stations located in the base of the tower:
Tower Station 2:
Station 3: Mixing Station 1:
Vent/Aspiration Pre-Mixing
Needle
Front
Figure 12.2: Rack Movement - Top View
CELL-DYN Q Labels
Special bar code labels are available to identify QC specimens.
These “Q” labels (numbers Q1 – Q20) automatically select QC
files 1 to 20 and, therefore, should be used to process only QC
specimens.
Exposed
Bar Bottom
Clear Coded
Tape Label
High
IMPROPERLY LABELED TUBES Collar
16.5 mm Dia.
Width Limit for Flap
Multiple
Labels
Edges
Peeled
Loose
Tail
The bar code label should be placed on the tube just below the
stopper, with the bars perpendicular to the length of the tube, so
that the entire bar code can be viewed through the slot in the rack
as the tube rotates. See the preceding figure for proper placement.
Tower Unit
Safety Cover
Operation Keyboard
Power ON/OFF
Switch
Tube Racks
Main Module
Main Module
The Main Module contains:
• Power ON/OFF Switch
• Operation Keyboard
• Safety Cover
• Tray to hold the Tube Racks
Manual
Operation
Keys
Primary
Keys
Primary Keys
The red and yellow Primary Keys on the Sample Loader are:
Tower Unit
The Tower Unit illustrated in the following figure contains the
following:
• Two Mixing Heads
• Vent/Aspiration Needle and Vent/Aspiration Needle Wash
Block
• Tube Detector
• Vial Positioning Mechanism (referred to as the Plunger)
• Bar Code Reader Window
NOTE: A detailed functional description of all
components is given in Operating Principles, Functional
Description within this chapter.
Blood Sensor
Station 2:
Mixing Head 2
(Mixing)
Station 3: Station 1:
Needle Mixing Head 1
(Vent/Aspiration) (Pre-Mixing)
NOTES
Operating Principles
Functional Description
The Sample Loader is attached to the Analyzer as shown in
Figure 12.1, Analyzer with Sample Loader.
Three stations located at the base of the Sample Loader Tower are
used to pre-mix, mix, and vent/aspirate each specimen tube. (See
Figure 12.6, Tower Stations.) The mixing process is performed by
counter-rotation of the tubes at the first two stations. A Mixing
Head extends to pre-mix the specimen at Station 1 for
approximately 30 seconds. A second Mixing Head extends to mix
the specimen for approximately 30 seconds more at Station 2. (The
first tube in a series skips Station 1 and is advanced to Station 2 for
complete mixing for approximately 60 seconds.) A Mixing Monitor
checks to ensure that both mixers are operating properly. If the
tube cannot spin properly, a MIX ERROR is displayed. The Vent/
Aspiration Needle then extends to puncture the tube stopper, vent
the tube, and aspirate the mixed specimen at Station 3.
Ten Tube Racks must be in place for Sample Loader operation. The
End Rack is marked with black dots on top and a black mark on the
left end of the rack. (See the following figure.) The End Rack is used
to indicate the last rack of a specific run. The Sample Loader
automatically stops after the last tube in the End Rack is processed.
When the Sample Loader sensors detect the End Rack, the Sample
Loader emits audible beeps for three seconds to alert the operator.
The message SAMPLES COMPLETED appears in the Data Station
Bulletin Line. If continuous processing is desired, an unmarked
rack should be substituted for the End Rack.
Tube
Rack
The tube racks are identified by a bar code label which must be in
place between the first and second tube position. (See the
preceding figure.)
The Tube Rack Bar Code Label identifies each rack by number and
is read by the Bar Code Reader. Each individual tube position has
a unique bar code. The system tracks the rack number and tube
position for each specimen placed in the rack.
The operator must pay careful attention to the rack number and
tube position of each sample being processed, particularly when
not using bar code labels and when using the Work List. For a
complete explanation of the Work List, see Chapter 5: Operating
Instructions.
Function Sequence
The following sequence is a basic description of the events that
occur from the time that the Sample Loader power is turned ON
through the complete processing cycle. During the cycle, the
position of the Tube Racks is monitored by four reflective sensors
in the corners of the Sample Loader tray. Another sensor detects
the non-reflective black mark on the End Rack.
1. Each time the Sample Loader is switched ON, it completes an
Initialization cycle.
2. When the Sample Loader is initialized and ready, the START
key on the Sample Loader Keyboard flashes and the message
AUTO SAMPLER READY appears in the Data Station Bulletin
Line.
3. When the START key is pressed, the Sample Loader begins
moving the right rear rack under the tower. As the rack
advances, the sensor at the Pre-Mixing Station searches for a
tube. When the sensor detects a tube, the rack advances it to
the Mixing Station. The second tube in the rack is positioned
at the Pre-Mixing Station.
4. The Mixing Head moves down until the height sensor senses
the tube at the Mixing Station. Mixing begins at the same
time that the bar code label is read. If no bar code label is
present, the sample is identified by rack number and tube
position or by a Work List entry. (For instructions on using
the Work List, refer to Chapter 5: Operating Instructions.)
5. The first specimen is then mixed by counter-rotation for
approximately 60 seconds. When approximately 30 seconds
have elapsed, the second tube begins mixing. The total
mixing time for each sample is approximately 60 seconds.
NOTE: Tubes must be able to spin freely while in the tube
racks. Tubes with excessive numbers of labels or with label
flaps sticking out will not spin properly and may cause the
Sample Loader to stop. (Refer to Figure 12.3, Tube Labeling
Requirements.) The Bulletin Line will display the
following message: SAMPLING ERROR — INCOMPLETE
ASPIRATION. The RUN screen will display the MIXING
ERROR and SAMPLING ERROR messages.
Directions for routine operation with the Sample Loader are given
in Chapter 5: Operating Instructions.
Operating Tips
NOTES
Maintenance
Maintenance procedures for the Sample Loader should be
performed as directed in Chapter 9: Maintenance. These
procedures consist of cleaning the Safety Cover, the Vent/
Aspiration Needle, the Tray, and the Tube Racks. If the Vent/
Aspiration Needle requires replacement, refer to Chapter 10:
Troubleshooting, Subsection: Troubleshooting Guide.
Set Up
For detailed instructions on how to set up the Sample Loader, refer
to Chapter 2: Installation.
Troubleshooting
If a Sample Loader fault, error, or other problem is detected, an
alert message is displayed on the Bulletin Line of the screen. For a
list of messages, descriptions of possible problems, and
recommended actions, refer to Chapter 10: Troubleshooting.
NOTES
Introduction
Principles of Operation
Performance Characteristics
Operating Instructions (including a description of the
soft keys)
Calibration
Quality Control
Adding New Animal Types (including instructions for
configuring additional species)
Turning the Vet Package OFF
NOTES
Principles of Operation
Once the file is copied to the Animal Type Set Up Table, it may be
accessed by pressing the [ANIMAL TYPE] key displayed on the RUN
screen. When the key is pressed, the settings for that species are
transferred to the Analyzer. (It takes approximately 10 seconds
for the transfer to occur.) When the Status Box displays the
READY message, samples may be processed. Samples from other
species may be processed by again pressing the [ANIMAL TYPE] key
and selecting the desired animal.
Performance Characteristics
Introduction
Instrument performance specifications are included in Chapter 4:
System Specifications. The Performance Characteristics included
in this section illustrate instrument performance for the species
indicated.
Precision
Precision results are derived from paired difference analysis of a
minimum of 100 data pairs from normal animal samples. The
results are stated as a coefficient of variation (CV).
Accuracy
Accuracy is expressed as a correlation coefficient based on a
minimum of 50 pairs of samples. The data are correlated to a
reference methodology. Dog and cat hemogram parameters are
compared to a Coulter® S+IV and differential parameters are
compared to a manual 100-cell differential. Rat and mouse
hemogram parameters are compared to Contraves AL820® and
differential parameters are compared to a manual 100-cell
differential.
Linearity
Linearity was evaluated by testing specimens with high values for
the parameters indicated in the table. The highest values tested
and correlated to a Coulter® S+IV or Contraves AL820® are listed
in the following table.
Table 13.3: Linearity
Carryover
Carryover is determined by running samples with high
concentrations of WBCs, RBCs, HGB, and PLTs. Each sample is
run in triplicate followed by three background cycles. The
percent carryover is calculated using the following formula:
Background1 – Background3
% Carryover = x 100
Sample3 – Background3
Table 13.4: Carryover
Parameter Carryover
Dog Cat Rat1 Mouse1
WBC < 1% < 1% < 1% < 1%
RBC < 1% < 1% < 1% < 1%
HGB < 1% < 1% < 1% < 1%
PLT < 3.5% < 3.5% < 3.5% < 3.5%
Flagging
The following Suspect Population Flags, and Suspect Parameter
Flags are active in the Vet Package software:
WBC
DFLT (NLMEB)
NWBC
FWBC
NRBC
RRBC
PLTR
Descriptors:
WIC
WOC
The interpretive messages described in Chapter 3: Principles of
Operation, Subsection: Operational Messages and Data Flagging are
also active in the Vet Package.
Samples may be flagged by entering up to four sets of limits for
each animal type. Limits may be normal range, panic values, etc.
Values that fall outside these limits are displayed and printed as
they are for human samples. When a result exceeds the
maximum value that the system can display, >>>> (over-range)
are displayed and printed in place of the result.
Operating Instructions
Procedure:
Turn Vet Package ON
1. From the MAIN MENU screen, press the [SET UP] key followed
by the [OPERATION SET UP MENU] key to display the
OPERATION SET UP MENU screen.
2. From the OPERATION SET UP MENU screen, press the [TURN ON
VET PKG] key to enable the Vet Package software.
NOTE: The key label changes to [TURN VET PKG OFF] when
the Vet Package is selected.
3. Press the [RETURN] key followed by the [SET UP] key to return
to the SET UP MENU screen.
The [ANIMAL SET UP] key is now displayed.
ANIMAL The [ANIMAL SET UP] key is displayed on the SET UP MENU screen
SET UP (see the preceding figure) when the Vet Package is ON. When the
[ANIMAL SET UP] key is pressed, the ANIMAL TYPE SET UP screen (see
the following figure) and the following soft key labels are
displayed:
ADD NEW ANIMAL
DELETE ANIMAL
VIEW ANIMAL
ANIMAL LIMITS
BROWSE CATALOG
RETURN
CAT
DEFAULT
DOG
MOUSE
RAT
ADD NEW The [ADD NEW ANIMAL] key is used to add a new animal type to the
ANIMAL Animal Type Set Up Table. This key is discussed and directions for
adding new animals are given in the Adding New Animal Types
section of this chapter.
DELETE The [DELETE ANIMAL] key is used to delete the file indicated by the
ANIMAL cursor position from the Animal Type Set Up Table. The
following soft key labels are displayed when the [DELETE ANIMAL]
key is pressed:
CONFIRM DELETION
CANCEL DELETION
These keys are used to confirm or cancel the Delete Animal
command.
DEFAULT SET UP
Gains: WBC 0D 1408
WBC 10D 1267
WBC 90D 1401
WBC 90DEP 1465 Current HGB 1680
RBC 1817 RBC 2930
PLT 2147 WIC 3000
WIC 3307
PRINT RETURN
VIEW The [VIEW ANIMAL] key displays the configuration file for the
ANIMAL animal type indicated by the cursor position on the ANIMAL TYPE
SET UP screen. The VIEW ANIMAL TYPE SET UP screen is shown in
the preceding figure.
ANIMAL The [ANIMAL LIMITS] key is used to enter upper and lower flagging
LIMITS limits for each animal in the Animal Type Set Up Table. Four
different sets of limits may be entered for each animal type. The
animal type is displayed on the upper left corner of each Limit
Set. The following soft key labels are displayed (see the preceding
figure) when the [ANIMAL LIMITS] key is pressed:
LIMIT SET 1*
LIMIT SET 2
LIMIT SET 3
LIMIT SET 4
PRINT
RETURN
*The key label for the Limit Set displayed on the screen is not shown.
12. Press the appropriate soft key to select another Limit Set and
repeat steps 8–11 to enter the desired limits.
13. Press the [RETURN] key to return to the ANIMAL TYPE SET UP
screen.
14. Repeat this procedure to enter limits for a different species.
CAT
DEFAULT
DOG
MOUSE
RAT
BROWSE The [BROWSE CATALOG] key is used to view the Animal Catalog.
CATALOG The Animal Catalog stores the files for up to 60 different animal
types. Information for the animal types currently supported by
existing data is stored in the catalog. To run samples from a
specific animal, the file must be moved from the catalog to the
Animal Type Set Up Table. When the [BROWSE CATALOG] key is
pressed, the ANIMAL TYPE CATALOG screen and the following soft
key labels are displayed (see the preceding figure):
VIEW SET UP
EXPECTED RANGES
ADD TO SET UP
RETURN
CATALOG CONTENTS
Ready Dec 01 1998 14:39
ANIMAL TYPE SET UP Operator ID 757
Sequence # 3404
CAT SET UP
Gains: WBC 0D 1948
WBC 10D 1397
WBC 90D 2866
WBC 90DEP 2998 Current HGB 1680
RBC 3388 RBC 2930
PLT 2258 WIC 3000
WIC 3307
PRINT RETURN
VIEW When the [VIEW SET UP] key is pressed, the CATALOG CONTENTS,
SET UP ANIMAL TYPE SET UP screen (see the preceding figure) for the
animal type indicated by the cursor position and the following
soft key labels are displayed:
PRINT
RETURN
NOTE: The file cannot be modified from this screen, only
displayed and printed.
PRINT The [PRINT] key is used to print a copy of the displayed settings.
RETURN The [RETURN] key is used to return to the ANIMAL TYPE CATALOG
screen.
PRINT RETURN
ADD TO The [ADD TO SET UP] key is used to move the configuration file
SET UP indicated by the cursor position from the Animal Catalog to the
Animal Type Set Up Table.
3. Press the [ADD TO SET UP] key to move the file to the Animal
Type Set Up Table.
NOTE: If the selected file has already been moved to the
Animal Type Set Up Table, the Bulletin Line will display
the message: Animal type was added to set up
already. The file with the same name must be deleted
from the Animal Type Set Up Table before the selected file
can be added.
RETURN The [RETURN] key is used to return to the ANIMAL TYPE SET UP
screen. The [RETURN] key on the ANIMAL TYPE SET UP screen is
used to return to the SET UP MENU screen.
NOTES
Routine Operation
RUN
Next ID CAT/10533/03 Auto Dec 01 1998 09:44
Ready
Animal: CAT Operator ID 732
Sex(M/F):M DOB:01/09/92 Report for CAT/10552/02 Sequence # 1702
Dr FELINE, DVM XB RBC:1/OUT2 XB WBC WL:OFF Open Sampler
Param: 1 Limits: 1
9
WBC 7.24 K/uL 0
NEU 4.75 65.6 %N S
LYM 1.63 22.5 %L I d
Z e
MONO .566 7.82 %M
E g
EOS .168 2.33 %E
BASO .129 1.79 %B
WCT:4.33
RBC 4.18 M/uL COMPLEXITY 10 deg
HGB 13.1 g/dL
HCT 37.4 %
MCV 89.5 fL
MCH 31.4 pg
MCHC 35.1 g/dL
RDW 14.9 %
Run Screen
The RUN screen for animals differs slightly from the RUN screen
for humans. The preceding figure shows the RUN screen for
animals. On this screen, the <PATIENT> field is replaced by the
<ANIMAL> field. The selected animal type is automatically
displayed in this field.
The [SPECIMEN TYPE] key is replaced by the [ANIMAL TYPE] key.
However, the [SPECIMEN TYPE] key is available from the ANIMAL
TYPE SELECTION screen.
NOTE: Animal type and specimen type are two
independent characteristics of the sample. For example,
Dog QC, Cat Background, etc.
CAT
DEFAULT
DOG
MOUSE
RAT
ANIMAL When the [ANIMAL TYPE] key on the RUN screen is pressed, the
TYPE ANIMAL TYPE SELECTION screen (see the preceding figure) and the
following soft key labels are displayed:
SELECT ANIMAL
SPECIMEN TYPE
RETURN
RUN
Animal: DOG Ready Dec 01 1998 10:20
Type BACKGROUND Report for BACKGROUND Operator ID 757
Param Set: 1 Sequence # 4166
WL:OFF Open Sampler
WBC 0.12 K/uL
G
NEU %N R
LYM %L S A
MONO %M I N
Z L
EOS %E E R
BASO %B T
Y
WCT:4.57
RBC .001 M/uL
HGB 009 g/dL COMPLEXITY LOBULARITY
HCT %
MCV fL
MCH pg
MCHC g/dL
RDW %
When the Vet Package is ON, the screens differ in that the
selected animal type is always displayed in the upper left corner
of each of the specimen type RUN screens. See the preceding
figure for an example of a BACKGROUND screen for a dog.
Sample Analysis
Veterinary samples may be run in the Open Mode or the Closed
Mode (SL or CS) on the CELL-DYN 3700 System. Once the animal
type is selected, these samples are processed in the same manner
as human samples. Daily Start Up Procedures and Quality
Control checks should be performed before processing samples.
For instructions for these procedures, refer to Chapter 5:
Operating Instructions, Subsections: Daily Start Up Procedure, Daily
Quality Control Procedures, and Sample Analysis.
Patient
QC Specimen
Background
Electrical Background
Latex
Resistant RBC (in the Open Mode only)
1. From the MAIN MENU screen, press the [RUN] key followed by
the [ANIMAL TYPE] key.
2. Use the arrow keys on the keyboard to move the cursor to
the desired animal and press the [SELECT ANIMAL] key.
The Status Box briefly displays the message Setting
gains and returns to the Ready message.
3. When the Ready message is displayed, press the [SPECIMEN
TYPE] key.
4. Press the soft key for the desired specimen type and then
press the [RETURN] to display the RUN screen for the selected
specimen type.
5. Run the sample in the selected mode of operation.
6. To run a different species, press the [ANIMAL TYPE] key.
7. Move the cursor to the desired animal and press the [SELECT
ANIMAL] key.
8. Press the [RETURN] key to display the RUN screen for the
selected animal type.
9. Run the sample in the selected mode of operation (Open or
Closed).
10. Repeat this procedure to run samples from a different
species.
Data Log
All veterinary samples are entered in the Data Log in the order in
which they are processed. All samples run with the Vet Package
ON are stored with the Data Log code V to indicate veterinary
samples.
Calibration
Calibration factors for MCV and MPV may differ from those for
the default animal type. These calibration factors may also differ
among the species. If a calibration factor is not entered in the
configuration file for these parameters, the factors for the default
animal type will be used. If calibration factors are entered for
these parameters, they will be linked to the factors for the default
animal type. Whenever the default factors are changed, these
factors will be automatically updated.
When the calibration factors for MCV and MPV have been
computed, they are entered manually from the ENTER
CALIBRATION FACTOR screen (see the following figure) in the
Calibration menu as directed on the following pages.
Parameter Factor
MCV 0.486
MPV 0.974
RESTORE RETURN
FACTORS
Pre-Calibration Procedures
Be certain to complete the procedures outlined in the
Pre-Calibration Procedures section of Chapter 6 before beginning
the calibration procedure. Human blood should be used to verify
specifications.
Quality Control
NOTES
RETURN
1. From the MAIN MENU screen, press [SET UP] key followed by
the [ANIMAL SETUP] key.
2. Press the [ADD NEW ANIMAL] key to display the ADD NEW
ANIMAL TYPE screen shown in the preceding figure.
3. Type in the name of the new species to be added.
The screen displays the following message:
Do you wish to copy this animal from an
existing animal?
If you do not wish to copy this animal from an existing
animal, type N and press the Enter key on the keyboard to
save the entry and advance the cursor. The default settings
will be used to create the new configuration file.
RUN
Next ID ----------- Auto Ready Dec 01 1998 10:20
Animal: HORSE Report for BACKGROUND Operator ID 757
Sex(M/F):-M DOB:--/--/-- Sequence # 4166
Dr --------------------- XB RBC: XB WBC: WL:OFF Open Sampler
Param: 1 Limits: 1
G
WBC K/uL R
NEU %N S A
I N
LYM %L
Z L
MONO %M E R
EOS %E T
BASO %B Y
RUN
Next ID ----------- Auto Ready Dec 01 1998 10:20
Animal: HORSE Report for BACKGROUND Operator ID 757
Sex(M/F):-M DOB:--/--/-- Sequence # 4166
Dr --------------------- XB RBC: XB WBC: WL:OFF Open Sampler
Param: 1 Limits: 1
G
R
WBC K/uL S A
NEU %N I N
LYM %L Z L
MONO %M E R
EOS %E T
BASO %B Y
0
0
S Target
I Box
Z
E
Neutrophil
Population
Lymphocyte
Population
10 COMPLEXITY
0
SET RETURN
ANALYZER
296 B 4
Figure 13.18: Set Point Entry Screen
M
S E
I 2
Z
o
as
E
B
3
1
L
Legend:
N = Neutrophil
4 L = Lymphocyte
M = Monocyte
E = Eosinophil
COMPLEXITY Baso = Basophil
Sum
N
Average
Variance
Sum
N
Average
Variance
Variance
Limit ±5% ±5% ±5% ±5% ±5% ±5%
Mice
Since only small amounts of specimen are available, make a
dilution with diluent in order to have enough specimen for
processing.
Goats, Sheeps, Llamas, and Other Mammals with Red Blood Counts over 10,000
Since the linearity of impedance counts may be questionable for
species with extremely high RBC counts, the RBC count may be
underestimated unless a dilution is made. For example, a 1:2
dilution with diluent may yield more accurate RBC counts and
RBC indices.
NOTES
NOTES
References
NOTES
Reticulocyte Package
Overview
Chapter Contents
Flowchart Conventions
Menus are shown as square-cornered rectangles in the flowcharts,
and soft keys are shown as round-cornered rectangles:
MAIN MENU
Ready
MAIN MENU
Ready
Flowcharts
The Reticulocyte Package master menu flowchart on the following
page was designed to help guide the operator quickly and easily
through the menu levels and soft key functions used in the
Reticulocyte Package. A segment of this flowchart is included at
the beginning of each submenu description to guide the operator
through the levels and functions of each submenu and back again
to the MAIN MENU. The master menu flowchart can be used as a
pull-out guide.
NOTES
RETIC QC LOG
RETIC PT RETIC QC OPERATION RETIC RETIC Ready
LIMITS SET UP SET UP UNITS MAIN
USA SI SI MOD SET 1 SET 2 SELECT RETURN VIEW RETIC RETIC RETIC
UNITS UNITS UNITS UNITS UNITS UNITS QC LOG QC LIMITS SET UP QC MAIN
TURN OFF BAR CODE COMPUTER RETURN RETIC DATA LOG TOGGLE PRINT RETURN
RETIC PKG SET UP SET UP Ready ON/OFF
LIMIT LIMIT LIMIT LIMIT PRINT RETURN CONFIRM CANCEL CONFIRM CANCEL
SET 1 SET 2 SET 3 SET 4 NEXT PREVIOUS PRINT RETURN DELETION DELETION
*
10 10
* DISPLAYED WHEN MORE THAN 30 RESULTS ARE IN THE FILE.
Overview
Reticulocyte Package
14-5
Reticulocyte Package
Overview Chapter 14
NOTES
Principles of Operation
To turn on the RETIC PKG you must enter the operator ID and the
instrument must be in Open mode. To turn on the VET PKG you must
exit the RETIC PKG.
MAIN MENU
Ready
MAIN MENU
Ready
The upper left-hand corner of the RETIC MAIN menu screen shows
the current revision of the instrument system. The upper right-
hand corner shows the current date and time, the current operator
ID, and the Reticulocyte Sequence Number. The information in
the upper right-hand corner is displayed on every screen during
operation of the Reticulocyte Package.
The Status Box is displayed in the top center of the screen. This
box appears on every screen to show the following information:
The following soft key labels are displayed on the RETIC MAIN
menu screen:
RETIC SET UP
RETIC RUN
RETIC DATA LOG
DATA LOG
RETIC QC LOG
RETIC DIAGNOSTC
RETIC SP PROTOCOLS
RETIC MAIN
Ready
RETIC SET UP
Ready
MEANS/ RANGE
LIMITS ENTRY
The following soft keys are displayed on the RETIC SET UP menu
screen:
RETIC PT LIMITS
RETIC QC SET UP
OPERATION SET UP
RETIC UNITS
RETIC MAIN
These soft keys are described in this section as they appear from
left to right on the screen.
RETIC PT
The [RETIC PT LIMITS] key is used to display the RETIC PATIENT
LIMITS LIMITS screen (see the following figure). The following soft key
labels are displayed on the RETIC PATIENT LIMITS screen:
LIMIT SET 1*
LIMIT SET 2
LIMIT SET 3
LIMIT SET 4
PRINT
RETURN
*The soft key label for whichever limit set is displayed on the
screen is not shown.
LIMIT SET 1
The [RETIC PT LIMITS] key is used to enter upper and lower flagging
limits for groups of patient samples. (For example, limits may be
entered for adult males, adult females, neonates, etc.)
Four sets of limits may be entered. Whenever a result falls outside
an entered limit, the result is displayed in color on the screen to
alert the operator. Results displayed in yellow are below the limit
and results displayed in purple are above the limit. The flagged
result is underlined on the graphics report and in the Reticulocyte
Data Log when printed. Patient results that exceed the linearity
specifications will be suppressed and chevrons (>>>>) will be
displayed and printed.
2. Use the arrow keys on the keyboard to move the cursor to the
desired limit entry field and type the desired number. Press
the Enter key on the keyboard to save the entry.
3. Repeat step 2 until all desired entries have been made.
4. If desired, press the [PRINT] key to obtain a printout of the
Limit Set being displayed.
NOTE: Retaining a hard copy of each Limit Set is
recommended, as the screens do not display names or
categories for the Limit Sets.
5. Press the appropriate soft key to select another Limit Set and
repeat steps 2– 4 to enter the desired limits.
6. Press the [RETURN] key to return to the RETIC SET UP menu.
1. FILE 1 0
2. FILE 2 0
3. FILE 3 0
4. FILE 4 0
5. FILE 5 0
6. FILE 6 0
The [RETIC QC SET UP] key is used to display the QC files and the
RETIC QC
SET UP RETIC QC SET UP screen (see the preceding figure). The following
soft key labels are displayed on the RETIC QC SET UP screen:
RETIC QC LIMITS
RETIC SET UP QC
RETURN
This section discusses the procedures that are used to set up the
Reticulocyte QC files. The keys are discussed in the order in which
they are used to set up the QC files. Use the arrow keys on the
keyboard to move the cursor to the desired QC file shown on the
RETIC QC SET UP screen, then type in the desired alphanumeric file
name. (Up to 12 characters may be entered.) Press the Enter key on
the keyboard to save the entry and advance the cursor to the next
QC file. Use the arrow keys to move the cursor back into the
selected file. Then press the [RETIC QC LIMITS] key or the [RETIC SET
UP QC] key to continue to set up the QC file.
RETIC QC
The [RETIC QC LIMITS] key is used to display the RETIC QC RANGE
LIMITS ENTRY screen or the RETIC QC MEANS/LIMITS screen, and the
following soft key labels:
MEANS/LIMITS or
RANGE ENTRY (This key label alternates between
these two selections.)
PRINT
RETURN
RETIC % 4 6
RETIC% 5 1
MEANS/
If Means/Limits Entry is selected by pressing the [MEANS/LIMITS]
LIMITS key, the current means and limits for the selected file are displayed
as shown in Figure 14.8, Retic QC Means/Limits Screen.
RETIC
The [TOGGLE ON/OFF] key is used to configure the QC file. The file
SET UP QC can be used for commercial controls. The lot number and
expiration date may be entered into the appropriate areas on the
RETIC SET UP QC screen (see the following figure) and saved by
pressing the Enter key on the keyboard. The following soft key
labels are displayed on the RETIC SET UP QC screen:
TOGGLE ON/OFF
PRINT
RETURN
TOGGLE
The Westgard Rule selections can be toggled ON or OFF using the
ON/OFF [TOGGLE ON/OFF] key.
OPERATION
The [OPERATION SET UP] key on the RETIC SET UP menu is used to
SET UP display the OPERATION SET UP MENU screen. The OPERATION SET UP
MENU screen in the Reticulocyte Package displays the following
soft keys:
The [TURN OFF RETIC PKG] key is discussed earlier in this chapter
(in Retic Menu Options, Turning the Reticulocyte Package ON
and OFF). The [BAR CODE SET UP] and [COMPUTER SET UP] keys are
described in Chapter 5: Operating Instructions.
RETIC % % % % % %
RETIC ABS K/uL G/L 10e9/L 10e3/uL 10e4/uL
RBC M/uL T/L 10e12/L 10e6/uL 10e4/uL
RETIC
The [RETIC UNITS] key on the the RETIC SET UP screen is used to
UNITS display the RETIC UNITS SELECTION screen (see the preceding
figure). The RETIC UNITS SELECTION screen shows the report units
for the indicated parameters. Units may be selected for each
parameter individually, or a set of units may be selected by
pressing the appropriate soft key. The following soft key labels are
displayed on the RETIC UNITS SELECTION screen:
USA UNITS
SI UNITS
SI MOD UNITS
SET 1 UNITS
SET 2 UNITS
SELECT UNITS
RETURN
RETIC MAIN
Ready
RETIC
The [RETIC DATA LOG] key on the RETIC MAIN menu screen is used
DATA LOG to display the RETIC DATA LOG screen. The Reticulocyte Data Log
stores all data (Reticulocyte percentage, RBC value, Reticulocyte
Absolute Number, IRF, and Reticulocyte Flags) and all patient
demographic information in a log format for each of the most
current 2,000 Reticulocyte cycles run on the CELL-DYN 3700
System. The record information is stored chronologically by
Reticulocyte Sequence Number. Each Reticulocyte Sequence
Number will have an "R" prefix (R0 to R1999). This will
distinguish the Reticulocyte Sequence Numbers from the
Standard Hematology Data Log sequence numbers. Scatterplots
and histograms are stored for all 2,000 records. The RBC value
will be identified on the RETIC DISPLAY SPECIMEN screen to show
whether it was obtained from the Standard Hematology Data Log
or entered by the operator. This section discusses the RETIC DATA
LOG screen first, then it discusses how to review data from the
Reticulocyte Data Log.
The current date, time, and operator ID and the last Reticulocyte
Sequence Number that was used are displayed in the upper right-
hand corner of the RETIC DATA LOG screen.
The RETIC DATA LOG screen contains the following soft keys:
EDIT
The [EDIT ID] key on the RETIC DATA LOG screen is used to edit only
ID the Specimen ID. When the [EDIT ID] key is pressed, the cursor
moves into the <SPECIMEN ID> field and all soft key labels are
blank. Each edit is saved by pressing the Enter key on the
keyboard.
NOTE: The [EDIT ID] key is displayed only when the cursor is
positioned next to a Reticulocyte Patient Record. It is not
displayed for Reticulocyte Background or Reticulocyte QC
records.
When using the Edit Specimen ID feature in the Data Log, set up a
laboratory procedure to verify any Specimen ID that has been
manually edited in the Data Log by showing the content of the
Specimen ID before and after editing.
Such verification could be:
Printouts of the Data Log summary reports that show the edited
ID. These printouts should be signed, dated and saved to ensure
tracking of any changes to specimen identification within your
laboratory.
OR
Re-running any specimen unintentionally identified with a Rack
and Tube Number, via Open or Closed Mode, to confirm that the
correct Specimen ID is applied.
The current date, time, and operator ID and the last Reticulocyte
Sequence Number that was used are displayed in the upper right-
hand corner.
RETIC% 0.91 %
RBC 4.00 M/uL
RETIC ABS 36.00K/uL
IRF 0.10
DISPLAY
The [DISPLAY SPECIMEN] key is used to display the results for the
SPECIMEN record indicated by the cursor position. The following soft keys
are displayed on the RETIC DISPLAY SPECIMEN screen:
PREVIOUS
The [PREVIOUS SPECIMEN] key is used to display the results for the
SPECIMEN Reticulocyte Sequence Number preceding the one currently
displayed without returning to the main RETIC DATA LOG screen.
NEXT
The [NEXT SPECIMEN] key is used to display the results for the
SPECIMEN Reticulocyte Sequence Number following the one currently
displayed without returning to the RETIC DATA LOG screen.
EDIT
The [EDIT SPECIMEN] key is used to edit patient demographic
SPECIMEN information for the selected record. It may also be used to edit and
display the results with a Parameter Set or Patient Limit Set
different from the one currently displayed. The following soft key
labels are displayed when the [EDIT SPECIMEN] key is pressed:
CONFIRM
CANCEL
These keys are used to [CONFIRM] or [CANCEL] the edits. The
bulletin line displays the message PRESS CONFIRM TO SAVE
CHANGES OR CANCEL TO CANCEL CHANGES. When the
[CONFIRM] key is pressed, the edited record is displayed.
TRANSMIT
The [TRANSMIT SPECIMEN] key is used to transmit the displayed
SPECIMEN report to a Laboratory Information System or on-line computer.
PRINT
The [PRINT REPORT] key is used to print a graphics report for the
REPORT displayed report.
COLOR
PRINT
NOTE: The ticket printer is not supported in the
Reticulocyte mode.
The [COLOR PRINT] key will be displayed if the Color Print option is
turned on in the Standard Hematology Mode.
RETURN
The [RETURN] key is used to return to the RETIC DATA LOG screen.
FIND
The [FIND SPECIMEN] key is used to locate a particular record by
SPECIMEN entering the Reticulocyte Sequence Number, the Reticulocyte
Specimen ID, or the patient’s name for the desired record. When
the [FIND SPECIMEN] key is pressed, the RETIC DATA LOG SEARCH
screen is displayed. (See the preceding figure.) The Reticulocyte
Specimen ID, the Reticulocyte Sequence Number, or the patient’s
name may be entered in the appropriate area. The cursor will be
flashing in the Reticulocyte Specimen ID area, but it can be
moved to the other areas by using the arrow keys on the keyboard.
If the requested reticulocyte record is available, the page of the
RETIC DATA LOG that contains that record will be displayed on the
screen. The cursor will be flashing next to the Reticulocyte
Sequence Number that was requested. The reticulocyte record can
be displayed by pressing the [DISPLAY SPECIMEN] key. If the record
is not found in the Reticulocyte Data Log, the bulletin line
displays the message NO ENTRY FOUND.
TRANSMIT
When the [TRANSMIT DATA] key is pressed, the screen prompts the
DATA operator to enter the starting and ending Reticulocyte Sequence
Numbers (from the lowest to the highest) for the desired
transmission. Records may be transmitted to a Laboratory
Information System or on-line computer singly or in batches as
designated by the Reticulocyte Sequence Number(s).
PRINT
The [PRINT DATA LOG] key is used to print the Reticulocyte Data
DATA LOG Log. When the [PRINT DATA LOG] key is pressed, the screen prompts
the operator to enter the starting and ending Reticulocyte
Sequence Numbers (from the lowest to the highest) for the
desired printout. (See the following figure.)
Figure 14.15: Reticulocyte Data Log Screen Showing the Starting Reticulocyte
Sequence Number Field
Displaying a Record
A copy of the RETIC RUN RESULT screen can be displayed for the
most current 2,000 records in the Reticulocyte Data Log. A record
is displayed by positioning the cursor at the record you desire in
the Reticulocyte Data Log listing and pressing the [DISPLAY
SPECIMEN] key. The Status Box indicates RETIC DISPLAY SPECIMEN
on results displayed (or printed) from the Reticulocyte Data Log
record. (See following figure.)
RETIC% 0.91 %
RBC 4.00 M/uL
RETIC ABS 36 K/uL
IRF 0.09
RETIC MAIN
Ready
RETIC QC LOG
Ready
PRINT RETURN
1. FILE 1 0
2. FILE 2 0
3. FILE 3 0
4. FILE 4 0
5. FILE 5 0
6. FILE 6 0
The [RETIC QC LOG] key on the RETIC MAIN menu screen is used to
RETIC
QC LOG display the RETIC QC LOG screen. The Reticulocyte Package on the
CELL-DYN 3700 System offers six QC Logs with statistical and
graphical analysis of the data. The statistical analysis includes the
mean, standard deviation, and coefficient of variation. The results
in each QC Log can be displayed as a Levey-Jennings chart.
Westgard Rules can be applied to each QC Log. The rule options
can be used independently or in combination, at the operator’s
discretion.
NOTE: The [RETIC QC LIMITS] key and the [RETIC SET UP QC]
key are used to set up the QC files.
The following soft keys are displayed on the RETIC QC LOG screen:
VIEW QC LOG (Move the cursor with the arrow keys
on the keyboard to the QC file
desired, then press this soft key.)
RETIC QC LIMITS
RETIC SET UP QC
RETIC MAIN
RTC% IRF
N: 2 2
FILE MEAN 1.40 0.61
Std Dev: 0.03 0.01
CV% 2.1 1.1
Auto-Sampler Pause
VIEW
The [VIEW QC LOG] key is used to display the QC Log indicated by the
QC LOG position of the cursor. Each QC Log display includes the following
information (see the preceding figure):
1. The lot number and expiration date are displayed in the upper
left corner. The file name, the number of runs currently in
the file, and the file capacity are also in the upper left corner.
(For example, 35/120 indicates that the file contains 35 runs
out of a possible 120.) The page number of the display and
the total number of pages in the file are also displayed in the
upper left corner.
2. The current date, time, and operator ID and the last
Reticulocyte Sequence Number to be used are all displayed
in the upper right-hand corner.
3. The remainder of the screen displays the file information and the
data. The Upper and Lower Limits and Target Mean entered are
displayed immediately above each parameter name. The
Reticulocyte Sequence Number for each result is displayed to
the left of the data. The date, time, and operator ID when the
reticulocyte sample was run are displayed to the right of the data.
These soft keys are discussed in the order in which they appear on
the screen from left to right.
PURGE
The [PURGE QC LOG] key is used to delete the contents of a
QC LOG designated file in the QC Log. When the [PURGE QC LOG] key is
pressed, the following soft key labels are displayed:
CONFIRM PURGE
CANCEL PURGE
These soft keys are used to confirm or cancel the [PURGE QC LOG]
command. When the [CONFIRM PURGE] key is pressed, all the
results are deleted from the designated file (the data are no longer
displayed nor stored in the file). When the [CANCEL PURGE] key is
pressed, the results are not deleted.
RETIC %: - - - - - - IRF: - - - - - -
1.35 0.77
.850 0.62
.350 0.47
LEVEY-
The [LEVEY-JENNINGS] key is used to display the Levey-Jennings
JENNINGS graphs of the data in the QC Log. (See the preceding figure.) Up to
30 data points can be displayed on the screen at one time. If there
are more than 30 data points in the QC Log, the [PREVIOUS 10] and
[NEXT 10] keys can be used to scroll through the graphs. The
following soft key labels are displayed when the [LEVEY-JENNINGS]
key is pressed:
PREVIOUS 10 (This key is not displayed when the first
10 data points are displayed.)
NEXT 10 (This key is not displayed when the last
10 data points are displayed.)
PRINT
RETURN
RTC IRF
N: 2 2
FILE MEAN 1.40 0.61
Std Dev: 0.03 0.01
CV%: 2.1 1.1
Auto-Sampler Pause
REJECT
The [REJECT SPECIMEN] key is used to exclude the results for the
SPECIMEN specimen indicated by the cursor position. When the soft key is
ACCEPT pressed, the key label changes to [ACCEPT SPECIMEN], an “R” is
SPECIMEN
displayed in the column immediately left of the results, and the
statistics are recalculated excluding those results. (See the
preceding figure.) The data are still displayed and stored in the
file, but they are excluded from the statistical calculations.
When the [ACCEPT SPECIMEN] key is pressed, the “R” is deleted and
the statistics are recalculated including those results.
DELETE
The [DELETE SPECIMEN] key is used to delete the results for the
SPECIMEN specimen indicated by the cursor position. When the [DELETE
SPECIMEN] key is pressed, the following soft key labels are
displayed:
CONFIRM DELETION
CANCEL DELETION
These soft keys are used to confirm or cancel the Delete Specimen
command. When the [CONFIRM DELETION] key is pressed, the
results are deleted from the file (the data are no longer displayed
nor stored in the file) and the statistics are recalculated excluding
those results.
MOVE
The [MOVE SPECIMEN] key is used to move the QC result indicated
SPECIMEN by the cursor position to another QC file. When the [MOVE
SPECIMEN] key is pressed, the RETIC QC LOG screen is displayed,
allowing the desired file to be selected. When the [MOVE TO FILE]
key is pressed, the result is moved to the indicated file.
RETURN
Return Soft Key
The [RETURN] key is used to return to the RETIC QC LOG screen.
RETIC MAIN
Ready
RETIC DIAGNOSTICS
Ready
FAULT REPORT
RETIC CNT RATE SUMM
CLEAR FAULT
RAW DATA SUMMARY
INITIALIZATION
RETIC MAIN
These soft keys are discussed in the order in which they appear on
the screen from left to right.
When the [RETIC CNT RATE SUMM] key is pressed, the following soft
RETIC CNT
RATE SUMM key labels are displayed:
The data displayed on the screen are the kinetic data for the
Reticulocyte specimen from the last run, displayed in a tabular
format. (See the preceding figure.) The total count, data
acquisition intervals, and rate per second are displayed.
When the [RETIC CNT GRAPH] key is pressed, the rate per second
RETIC CNT
GRAPH data are displayed as a graph. (See the following figure.) The
RETIC kinetic data and graph information are useful when
CNT RATE troubleshooting problems with the reticulocyte parameter. A
printout of the Reticulocyte Count Rate Summary may be
obtained by pressing the [PRINT] key when the desired format is
displayed on the screen.
10479.2
9169.3
7859.4
6549.5
5239.6
3929.7
2691.8
1309.9
0 0.5 1.0 1.5 2.0 2.5 3.0 3.5 4.0 4.5 5.0 5.5 6.0 6.5 7.0 7.5
RETIC CNT GRAPH
PRINT RETURN
RETIC MAIN
Ready
When the [FILL WOC] key is pressed, the flow cell is refilled with
reagent. When the flow cell is filled, the soft key label changes
back to [EMPTY WOC].
When the [RESTORE SHEAR VLV] key is pressed, the syringes refill
the shear valve and the associated tubings and the shear valve
rotates back to its operational position. When the rotation is
complete, the soft key label changes back to [CLEAN SHEAR VLV].
Routine Operation
Overview
This section contains information and procedures that are
recommended for the routine operation of the Reticulocyte
Package for the CELL-DYN 3700 System. This section contains the
following subsections:
• Retic Run Menu Flowchart
• Retic Run Menu
• Reticulocyte Specimens
• Specimen Requirements
• Running Specimens
• Background
• Quality Control
• Patient
• Interfering Substances
• Specimen Preparation
For instructions on turning the Reticulocyte Package ON and OFF,
refer to Retic Menu Options, Turning Reticulocyte Package On
and OFF within this chapter.
RETIC MAIN
Ready
RETIC RUN
Ready
ENTER DATA
1. FILE 1 0
2. FILE 2 0
3. FILE 3 0
4. FILE 4 0
5. FILE 5 0
6. FILE 6 0
RETIC The [RETIC RUN] key on the RETIC MAIN menu screen is used to
RUN display the RETIC RUN screen. (See the preceding figure.) This
screen allows the operator to decide which type of Reticulocyte
specimen will be analyzed. The upper right-hand corner of the
screen contains the current time and date, the operator ID, and the
next Reticulocyte Sequence Number.
The following soft keys are displayed on the RETIC RUN screen:
CLEAR FAULT (This key label appears whenever a
system fault occurs.)
PATIENT SPECIMEN
QC SPECIMEN
BACKGROUND
RETIC MAIN
These soft keys will be discussed as they appear on the RETIC RUN
screen from left to right.
CANCEL
PATIENT ID : C01804
Patient: _ _ _ _ _ _ _ _ _ _ _ _ _ _
Dr. _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
CANCEL
CANCEL
PATIENT ID : 123456
CANCEL
RETIC% 0.91 %
RBC 4.00 M/uL
RETIC ABS 36 K/uL
IRF 0.10
NEXT COLOR
RETIC PRINT
Figure 14.31: The Reticulocyte Run Result Screen for a Patient Specimen
Top Center
The Status Box is displayed in the top center of the RETIC RUN
RESULT screen. This box appears on every screen to show the
following information:·
• The menu in use (such as RETIC RUN RESULT).
• The status of the Analyzer (such as Ready, Not ready,
and FAULT messages).
• Status and instructive messages. During the Reticulocyte
Run cycle these are:
Aspirating
Remove Specimen
Dispensing
Rinsing
Processing Data
Ready
Center
The center section of the RETIC RUN RESULT screen displays the
results. The list of the parameters and results is displayed on the
left side. The information on RBC value entry is also displayed on
the left side. The scatterplot and the histograms are displayed on
the right. The red blood cells are shown in red, the reticulocytes
are shown in blue, the nucleated cells are shown in white (black
on the color printout), the immature Reticulocytes are shown in
cyan (light blue), and coincidence passage events are shown in
green and the noise is shown in yellow. Any alert messages will
appear in the lower left-hand corner of the screen.
The following soft key labels are displayed on the RETIC RUN
RESULT screen:
NEXT RETIC (This soft key label appears when the
Reticulocyte specimen run has been
completed.)
PRINT REPORT
RETURN (This key is used to return to the RETIC
RUN screen.)
IRF
QC When the [QC SPECIMEN] key on the RETIC RUN screen is pressed, the
SPECIMEN QC file where the cursor is positioned is opened and the RETIC RUN
RESULT screen for QC specimens is displayed. (See the preceding
figure.) Results from the QC run option are stored in the selected
reticulocyte QC file and in the Reticulocyte Data Log.
BACK- When the [BACKGROUND] key on the RETIC RUN screen is pressed,
GROUND the RETIC RUN RESULT screen for background counts is displayed.
(See the preceding figure.) Results from this run option are
identified by the designation BACKGROUND on the RETIC RUN
RESULT screen and in the Retic Data Log.
Reticulocyte Specimens
Overview
This subsection discusses routine operation of the Reticulocyte
Package. Guidelines and procedures are provided for running
background counts, quality control, and patient specimens. The
Reticulocyte Package is only available for use in the Open Sampler
Mode.
For background counts, a tube of reticulocyte reagent is run
without an aliquot of whole blood, to check for particulate
material in the reagent and system.
Control material should be properly warmed and mixed according
to the manufacturer’s recommendations. Patient reticulocyte
controls should be handled according to the laboratory’s protocol.
Quality control checks (which verify Reticulocyte Package
performance) should be performed on each shift that reticulocyte
samples are run.
Each reticulocyte sample is run by starting from the RETIC RUN
screen. The operator selects the type of Reticulocyte specimen to
be run (Patient, QC, or Background) and proceeds through the
screen(s) displayed for that specimen type. When the reticulocyte
sample is completed, the [NEXT RETIC] key is displayed. When the
[NEXT RETIC] key is pressed, the operator can then select the
specimen type for the next specimen. Specific instructions for
each specimen type are given in this section of this chapter.
CAUTION: When using the reticulocyte reagent, avoid
contact with skin and clothing. This reagent contains New
Methylene Blue, which will stain skin, clothing, and many
other surfaces.
Specimen Requirements
• Do not run hemolyzed specimens, as they may result in
inaccurate reticulocyte values.
• Specimens may be run up to 8 hours after collection time
without refrigeration.
NOTE: Studies have shown that reticulocytes continue to
mature at room temperature. Increased flagging can occur
when using specimens more than 8 hours old.
Interfering Substances
The CELL-DYN 3700 Reticulocyte method is a nucleic acid
staining method. Therefore, other substances that contain nucleic
acids could potentially be enumerated by the instrument as
reticulocytes. If these interfering substances are present in
sufficient numbers, they may interfere with the dynamic
thresholds used to obtain the CELL-DYN 3700 reticulocyte count.
Consequently, these specimens should be flagged by the
instrument. Refer to Troubleshooting, Instrument Alert
Conditions within this chapter for a complete description of the
Reticulocyte flags.
The information in the following table, based on CLSI/NCCLS
Document H44-A21 indicates substances that are known or
potential interferents. The CELL-DYN 3700 Reticulocyte
procedure is designed to minimize some common interferents,
including high WBC counts and NRBCs.
Running Specimens
This section contains information and procedures recommended
for routine operation of the Reticulocyte Package. Proper start-up
procedures should be performed prior to processing patient
specimens. These include the background counts and daily quality
control checks described in the following sections.
Background Counts
The reticulocyte background count must be included in the daily
start-up procedures to check for particulate matter in the
reticulocyte reagent and the CELL-DYN 3700 System. The
background count is determined from the total counts that occur
in the reticulocyte scatter area on the 10°/90° scatterplot.
Quality Control
Quality control checks should be performed daily according to
the laboratory’s protocol. Control material should be properly
warmed and prepared according to the manufacturer’s
recommendations. Patient controls should be handled according
to the laboratory’s protocol. For customizing the QC files, see
Chapter 5: Operating Instructions, Subsection: Set Up
Instructions, QC Set Up Menu.
12. When the cycle is completed, the Wash Block moves up the
probe.
NOTE: The word Ready appears in the Status Box. No
message is illuminated on the Analyzer Status Indicator Panel
until the [NEXT RETIC] key is pressed on the RETIC RUN
RESULT screen and the operator has selected the specimen
type for the next specimen to be processed from the RETIC
RUN screen.
13. Repeat steps 8 through 12 for all prepared control specimens.
14. Verify that the control results are acceptable.
NOTE: Out-of-range results are displayed in color. Data
invalidating alerts, such as Fragile RBCs, are not valid when
running commercial controls.
15. If the results are unacceptable, repeat the run. If the results
are still unacceptable, run the other levels of the control
material. If the results are still unacceptable, prepare another
stained dilution of that level of the control material. If the
results on all levels are unacceptable, troubleshoot
accordingly. See Chapter 10: Troubleshooting.
16. When the control results are acceptable, patient samples may
be analyzed.
Patient Specimens
CAUTION: When using the reticulocyte reagent, avoid
contact with skin and clothing. This reagent contains New
Methylene Blue, which will stain skin, clothing, and many
other surfaces.
Specimen Preparation
1. The Reticulocyte Package is available for use only in the
Open Sampler Mode.
2. Use reticulocyte reagent and verify the expiration date. Store
the stock reagent in the dark at room temperature.
3. Label a tube of reticulocyte reagent for each patient.
4. Verify that the whole blood specimen is warmed to room
temperature and well mixed prior to sampling.
5. Pipette 20 µL of the whole blood specimen into each labeled
tube of reticulocyte reagent.
6. Incubate the stained Reticulocyte specimens on the rotator
or in a rack, after fully inverting the stained specimens 5
times. Incubation is performed according to Reagent Package
Insert.
NOTE: The timing stated in the Reagent Package Insert
allows Reticulocyte specimens to be processed for either
STAT requests or grouped and run in batches.
1. Press the [RETIC RUN] key to display the RETIC RUN menu.
Press the [PATIENT SPECIMEN] key to display the RETIC PATIENT
SPECIMEN screen.
2. From the RETIC PATIENT SPECIMEN screen enter the Patient ID
and press the Enter key on the keyboard to start the search
process. The Standard Hematology Data Log for the last
8 hours will be searched for this Patient ID.
3. If the Patient ID is found, the second RETIC PATIENT SPECIMEN
screen is displayed. All the available patient demographic
information, and the RBC value, are shown on the screen.
Proceed to step 4.
If the Patient ID is found but is more than 8 hours old, the third
RETIC PATIENT SPECIMEN screen is displayed and the operator
may enter an RBC value in this screen. Skip to step 5.
NOTES
Control Material
Abbott Diagnostics recommends using the CELL-DYN control
material for performing quality control checks on the CELL-DYN
3700 System. These controls should be run:
• After daily start-up procedures are completed.
• After a reagent lot number change.
• After a service call or component replacement.
• After calibrating the Standard Hematology Mode.
• In accordance with the laboratory’s quality control
protocol.
• According to regulatory requirements.
NOTE: Data invalidating alerts, such as Fragile RBCs, are not
valid when running commercial controls.
Reagent
• Use Reticulocyte Reagent prepared only by Abbott
Diagnostics. Verify the expiration date.
• Store the Reticulocyte Reagent in the dark at room
temperature.
• Use one Reticulocyte Reagent tube for each
CELL-DYN control or patient specimen.
Troubleshooting
Overview
This section provides instructions for identifying,
troubleshooting, and correcting instrument alerts and conditions
in the Reticulocyte Package. All instrument conditions which
adversely affect the Standard Hematology Mode of the CELL-DYN
3700 System will also apply to the Reticulocyte Package. These
instrument conditions may be found in Chapter 10:
Troubleshooting.
This section is divided into the following subsections:
• Operational Messages and Data Flagging
• Dispersional Data Alerts
• Instrument Alert Conditions
• Alert Messages with Suppressed Reticulocyte Results
• Data Invalidating Alerts
• High Background Counts
NOTE: For a list of interfering substances, refer to Routine
Operation, Reticulocyte Specimens, Interfering Substances
within this chapter.
References
NOTES
Bull BS, Hay KL. Are Red Blood Cell Indexes International?
Archives of Pathology and Laboratory Medicine; 109:604–606;
1985.
Overview
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® 3700 System.
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 its software, which interpret and store
bar code data. For the CELL-DYN 3700 System, this is
accomplished by the Data Station and its software.
• The scanning device, which “decodes” the information on
the bar code labels. (The Sample Loader of a CELL-DYN
3700SL System has an integrated reader.)
• The bar code labels, which supply the specimen
identification codes.
• Code 39
Also referred to as code 3 of 9, Code 39 encodes 43 data
characters: 0–9, A–Z, six symbols and spaces. Each character
is represented by nine elements, three of which are wide and
six of which are narrow.
• 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 ten
numeric digits 0–9 and certain special characters. The code is
characterized by four unique start/stop codes and variable
intercharacter spacing.
NOTE: When the check digit is on, only the letter A can
be used as a stop/start character.
• 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.
NOTES
Specifications
Minimum
Quiet Zone Maximum
0.25 inches Label Length
2.0 inches
CELL-DYN Q Labels
Special bar code labels are available to identify QC specimens.
These “Q” labels (numbers Q1–Q20) automatically select QC files
1 to 20, and therefore should be used to process only QC
specimens.
Exposed
Bottom
Tail
Figure A.2: Tube Labeling Requirements
Acknowledgment
NOTES
Overview
Part/List
Number Quantity Description
Table B.1 CELL-DYN 3700 Accessories Kit (List Number 06H88-01) (Continued)
Part/List
Quantity Description
Number
04H91-04 1 set Sample Loader Racks Set of 11 Sample Loader racks pre-
labeled with tube position numbers
and rack number label
08H58-02 1 CELL-DYN® 29 Plus Control (with Retic), half pack 6 x 3.0 mL vials
Appendix C
Source:
• Cornbleet J. Spurious Results from Automated Hematology Cell Counters. Laboratory
Medicine 1983; 14:509-514.
NOTES
Numerics C
10-mL Reagent Syringe 9-37 Calibrating All Parameters 6-43, 6-54, 6-80
Calibrating Individual Parameters 6-44, 6-55,
A 6-81
Abbott Instrument Warranty iii Calibrating the Closed Mode 6-90
Accessing the Maintenance Log 9-8 Calibrating the Open Mode 6-65
Accessing the Shear Valve 9-9 Calibration Backup 6-95
Accuracy 13-6 Calibration Factor Calculation 6-40, 6-50, 6-77,
Acknowledgment A-9 6-90
Adding a New Configuration File 13-34 Calibration Factor Calculations 6-62
Adding New Animal Types 13-33 Calibration Guidelines 6-27
Analyzer Air Filters 9-32 Calibration Log Soft Key 6-18
Analyzer Flow Panel Components Diagram 9-2 Calibration Materials 6-3
Analyzer 1-6 Calibration Menu 6-13
Aperture Plates 9-39 Calibration Menu Flowchart 6-13
As Required 9-37 Calibration Methods 6-3
Auto-Cal Calibration Criteria Worksheet 6-45, Calibration Procedural Summary 6-11
6-57 Calibration Requirements for Auto-Cal 6-35
Auto-Cal Methodology 6-34 Calibration Screen 6-14
Auto-Cal Mode to Mode Calibration 6-71 Calibration 13-27
Auto-Cal Overview 6-33 Calibrator 1-27
Auto-Cal Sample Capacity 6-34 Carryover 13-7
Auto-Cal Using Calibrator 6-37 Cell Populations and Flagging 3-45
Auto-Cal Using Whole Blood 6-47 CELL-DYN 3700 Accessories B-1
Auto-Calibrate Soft Key 6-19 CELL-DYN 3700CS System Specifications 4-3,
Auto-Clean 9-19 4-9
CELL-DYN Bar Code Labels 12-3, A-7
B CELL-DYN Controls 7-27
CELL-DYN Q Labels 12-3, A-7
Bar Code Check Digit Formats A-5
Chemical Hazards 8-4
Bar Code Label Formats A-5
Closed Mode Calibration Confirmation 6-72
Bar Code Label Placement 12-3, A-8,
Closed Sampler Aspiration Needle 9-22
Bar Code Label Specifications A-6
Closed Sampler Tube Retainer Adjustment (CS
Bar Code Labels 12-3
System Only) 9-51
Bar Code Reader Window 9-46
Coincidence Passage Correction 3-27
Bar Code Specifications 4-7
Collecting the Calibration Data 6-38, 6-48, 6-75
Bar Code Types and Characteristics A-3
Combined Specifications for the SL and
Bar Coding Function A-1
CS Systems 4-13
Baso Box Setup 13-46
Completing Manual Calibration 6-66
Bibliography Bibliography-1
Completing Mode to Mode Calibration 6-82,
6-91
Completing Open Mode Calibration 6-44
S U
Safety Agency Approvals iv Unclogging the Open Sample Aspiration Probe
Safety xvi 9-45
Sample Analysis Cycle Overview 3-5 Understanding the Label Code A-2
Sample Analysis Using the CS Model 5-99 Units Selection Soft Key 5-49
Sample Analysis Using the SL Model 5-92 Update Maintenance Log Procedure 9-16
Sample Analysis Using the Work List 5-114 Using The Data Log 5-121
Sample Analysis 5-89 Using The Work List 5-103
Sample Aspiration Peristaltic Pump Tubing 9-26