Revision Status

Document Control Revision Section(s) Pages Revised,

Numbers Date Revised Added or Deleted
LN08H56-01A/ May 2006 9140559A Initial release; all sections
LN08H56-02 Revision and Status Log new.
9212934A (TEXT)
9159955A (CD ROM)
9140540AForeword
9140541A
Master Table of Contents
9140542A
List of Figures
9140543AList of Tables
9140544ASystem
Documentation
9140545A
Use or Function
9140546A
Installation Procedures and
Special Requirements
9140547A
Principles of Operation
9140548A
Performance Characteristics
and Specifications
9140549A
Operating Instructions
9140550A
Calibration Procedures
9140551A
Operational Precautions and
Limitations
9140552A
Hazards
9140553A
Service and Maintenance

CELL-DYN RubyTM System Operators Manual i

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 Document Control Revision Section(s) Pages Revised,
Numbers Date Revised Added or Deleted
9140554A
Troubleshooting and
Diagnostics
9140555A
Quality Control
9140556A
Reticulocyte Package
9140561AAppendices
9140562AIndex
LN08H56-03A/ August 9140559B
LN08H56-02B 2006 Revision and Status Log
9212934B (TEXT)
9159955B (CD ROM)
9140540BForeword
9140541B
Master Table of Contents
9140542B
List of Figures
9140545B
Use or Function
9140549B
Operating Instructions
9140552B
Hazards
9140553B
Service and Maintenance
9140561BAppendices

ii CELL-DYN RubyTM System Operators Manual

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 Revision Log

Instructions: Use this log to provide a permanent record to verify that revised chapter(s) and/or page(s) have
been added to your paper 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 the revised section(s) in the manual.
2. Record the revision date, also found in the footer, in the second column.
3. Record the current CELL-DYN Ruby 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
Revision Software Date
Control Incorporated
Date Version Incorporated
Number by

CELL-DYN RubyTM System Operators Manual iii

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 NOTES

iv CELL-DYN RubyTM System Operators Manual

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 Foreword

Congratulations on becoming the operator of a CELL-DYN Ruby. Your System,

which includes state-of-the-art technology, is designed to function consistently and
dependably from day to day.
The CELL-DYN Ruby is backed by dedicated professionals who excel in
engineering, medical technology, training, and service. As part of the customer
training program, we will teach you to operate, maintain, and troubleshoot your
System.
Abbott Laboratories is dedicated to manufacturing the highest quality, most
reliable instrumentation available. We look forward to serving your needs in any
way possible.

Customer Service
If you need information or help in diagnosing a problem, technical assistance is
available by telephone. In the USA, this service is available by calling Abbott
Diagnostics Customer Service 24 hours a day, seven days a week.
United States: 1-877-4ABBOTT (1-877-422-2688)
Canada: 1-800-387-8378
Outside of USA and Canada: Contact your Country Service and Support
Representative.
For correspondence, the address in the USA is:
Abbott Diagnostics Division
Customer Service
200 Abbott Park Road
Abbott Park, IL 60064, USA

Proprietary Statement
The CELL-DYN Ruby software programs and system documentation are protected
by copyright (2006). All rights are reserved.
The software and manual were developed solely for use with the CELL-DYN Ruby
and for in vitro diagnostic applications as specified in the operating instructions.
The information and related graphics published herein (the Information) are the
sole property of Abbott Laboratories. Permission to use the Information is granted,
provided that:
the copyright notice appears on all copies;
use of the Information is for operation of Abbott products by Abbott trained
personnel or informational use only;
the information is not modified in any way; and
no graphics are used separate from accompanying text.

CELL-DYN RubyTM System Operators Manual i

9140540BAugust 2006
 Each person assumes full responsibility and all risks arising from use of the
Information. The Information is presented as is and may include technical
inaccuracies or typographical errors. Abbott Laboratories reserves the right to
make additions, deletions, or modifications to the Information at any time without
any prior notification.

Patent Statement
The CELL-DYN Ruby is covered by one or more of the following USA Patents:
5,017,497; 5,378,633; 5,510,267; 5,733,784. Additional patents may be pending.

Disclaimers
All samples (printouts, graphics, displays, screens, etc.) are for information and
illustration purposes only and shall not be used for clinical or maintenance
evaluations. Data shown in sample printouts and screens do not reflect actual
patient names or test results. Labels depicted in the manual may appear different
from actual product labels.
Abbott Laboratories makes no representations or warranties about the accuracy and
reliability of the information contained in or printed from the CELL-DYN Ruby
Operators Manual CD-ROM.
The information was developed to be used by Abbott Laboratories trained
personnel, by other persons knowledgeable or experienced with the operation and
service of the product identified, or under the direct supervision and with
cooperation from Abbott Laboratories technical sales or service representatives.
In no event shall Abbott Laboratories or its affiliates be liable for any damages or
losses incurred in connection with or arising from the use of the information on this
media by persons not fully trained by Abbott Laboratories. This limitation shall not
apply to those persons knowledgeable or experienced with the operation and
service of the product identified, or under the direct supervision and with
cooperation from Abbott Laboratories technical sales or service representatives.
No confidential relationship shall be established in the event that any user of the
Information should make any oral, written or electronic response to Abbott
Laboratories (such as feedback, questions, comments, suggestions, ideas, etc.).
Such response and any information submitted therewith shall be considered non-
confidential, and Abbott shall be free to reproduce, publish, or otherwise use such
information for any purposes whatsoever including, without limitation, the
research, development, manufacture, service, use, or sale of products incorporating
such information. The sender of any information to Abbott is fully responsible for
its content, including its truthfulness and accuracy and its non-infringement of any
other persons proprietary rights.
Abbott Laboratories is not engaged in rendering medical advice or services.
Updates to the information may be provided in either paper or electronic format.
Always refer to the latest documents for the most current information.

ii CELL-DYN RubyTM System Operators Manual

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 List numbers are unique identifiers that are used when ordering products. The list
number and quantity provided in Appendix A: Parts and Accessories are intended
for guidance only and are subject to change. Contact your Abbott representative for
the most current information regarding list numbers.
All operating instructions must be followed. In no event shall Abbott be
responsible for failures, errors, or other liabilities resulting from customers non-
compliance with the procedures and precautions outlined herein.
The CELL-DYN Ruby is a Class I Laser Product per IEC 60825-1 (1993). Use of
controls or adjustments or performances of procedures other than those specified
may result in hazardous radiation exposure.

CELL-DYN RubyTM System Operators Manual iii

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Warranty Statement for USA Customers Only
Abbott Laboratories warrants the CELL-DYN Ruby Analyzer, sold by Abbott
Sales Representatives, to be free of defects in workmanship and materials during
normal use by the original purchaser. This warranty shall continue for a period of
one (1) year, commencing twenty-one (21) days from the date of shipment to the
original purchaser or until title is transferred from the original purchaser,
whichever occurs first (the Warranty Period).
If any defects occur during the Warranty Period, contact your Abbott Customer
Support Center immediately and be prepared to furnish pertinent details
concerning the defect, the model number, and the serial number.
Abbotts Warranty coverage limits are as follows:
1. Abbott Customer Service: 24 hours per day, 7 days per week phone support
in the United States.
2. Field Service Representative support: 8:30 A.M. to 5:00 P.M. Monday
through Friday (excluding all Abbott-observed holidays).
3. Any on-site service performed at other times and all service required to
correct defects or malfunctions not covered by this Warranty (as noted in the
paragraph below) will be billed at Abbotts labor rates then in effect.
This Warranty does not cover defects or malfunctions which:
1. Are not reported to Abbott during the Warranty Period and within one week
of occurrence.
2. Result from chemical decomposition or corrosion.
3. Are caused primarily by customer or third party abuse, misuse, or negligence,
or by failure to comply with any requirement or instruction contained in the
applicable Abbott Operations Manual.
4. Result from maintenance, repair, or modification performed without Abbotts
authorization.
Abbotts liability for all matters arising from the supply, installation, use, repair,
and maintenance of the Instrument, whether arising under this Warranty or
otherwise, shall be limited solely to the repair or (at Abbotts sole discretion)
replacement of the Instrument or of components thereof. In no event shall Abbott
be liable for injuries sustained by third parties, incidental or consequential
damages, or lost profits. Replaced parts shall become the property of Abbott
Laboratories.
THE FOREGOING IS THE SOLE WARRANTY MADE BY ABBOTT
LABORATORIES REGARDING THE INSTRUMENT; AND ABBOTT
SPECIFICALLY DISCLAIMS ALL OTHER WARRANTIES, EXPRESSED
OR IMPLIED, INCLUDING THE IMPLIED WARRANTIES OF
MERCHANTABILITY AND OF FITNESS FOR A PARTICULAR
PURPOSE.
The CELL-DYN Ruby is manufactured by Abbott Diagnostics Division, Abbott
Laboratories, Abbott Park, IL 60064, USA. Please direct all inquiries concerning
information in this manual to the foregoing address.

iv CELL-DYN RubyTM System Operators Manual

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Regulatory and Safety Agency Approvals
In Vitro Diagnostic Directive 98/79/EC
Legal Manufacturer Abbott Laboratories
Abbott Park, IL 60064, USA
Authorized Representative ABBOTT
Max-Planck-Ring 2
65205 Wiesbaden
Germany

Trademark Statements
CELL-DYN Sapphire, CELL-DYN Ruby, eQC, and MAPSS are trademarks of
Abbott Laboratories.
CELL-DYN and CELL-DYN HemCal are registered trademarks of Abbott
Laboratories.
Becton Dickinson, Greiner, Levey-Jennings, Microsoft, Microsoft Windows,
Sarstedt, Terumo, and Westgard are not trademarks of Abbott.

CELL-DYN RubyTM System Operators Manual v

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Symbols
The symbols listed below are used in labeling for the CELL-DYN Ruby, including that on the instrument,
reagents, calibrator, controls, and in this manual.

Instrument/Power related
Symbol Definition/Use Symbol Definition/Use

Alternating Current
AC INPUT PRESS 1 Pressure 1
Input

APPLICATION SOFTWARE Application Software PRESS 2 Pressure 2

BUSY Busy PRESS 3 Pressure 3

FAULT Fault READY Ready

FILTER 1/2 Filter 1 or 2 RESERVOIR Reservoir

FREQUENCY Frequency REV Revision

HGB HGB Flow Cell Serial Number

SN
FLOW CELL

LINE VOLTAGE Line Voltage SET-UP DISK Set-Up Disk

MAX POWER Maximum Power SHEAR VALVE Shear Valve

MIXING Mixing Chamber Stand By

CHAMBER

MODEL Model Number TRAP Trap

OFF VAC 1/2 Vacuum 1 or 2
ON VENT Vent

OPERATING SYSTEM Operating System WASTE Waste

PERISTALTIC PUMP Peristaltic Pump WASTE SENSOR Waste Sensor

POWER Power

vi CELL-DYN RubyTM System Operators Manual

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Reagent related

CN-FREE HGB/NOC LYSE Cyanide-Free Hemoglobin/Nuclear Optical Count Lyse Reagent

DILUENT Diluent Reagent

DILUENT/SHEATH Diluent/Sheath Reagent

ENZYMATIC CLEANER CONCENTRATE Enzymatic Cleaner Concentrate

Expiration Date

HGB Hemoglobin

HGB LYSE Hemoglobin Lyse

LOT Lot Number

RBC Red Blood Cell

SHEATH Sheath Reagent

8oC
Storage Temperature (Example shows Store at 28C)
2oC

WBC White Blood Cell

WBC LYSE WBC Lyse Reagent

CELL-DYN RubyTM System Operators Manual vii

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Calibrator/Control related

ASSAY VALUE Assay Value

CAL Calibrator

CALIBRATOR Calibrator

CONTROL Control

CONTROL ASSAY DISK Control Assay Disk

CONTROL I/II/III or L/N/H Control, Level I, II, or III or Level L, N, or H

CONTROL L|N|H Control, Tri-Level

MEAN RANGE Mean Range

MEAN VALUE Mean Value

PARAMETER Parameter

RETIC CONTROL Reticulocyte Control

SYSTEM System

WB CAL Whole Blood Calibrator

WB CONTROL Whole Blood Control

WB CONTROL TRI-LEVEL Whole Blood Control, Tri-Level

WB CONTROL L|N|H Whole Blood Control, Low, Normal, or High Level

N/H

viii CELL-DYN RubyTM System Operators Manual

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Miscellaneous

EC REP Authorized Representative

Caution

Consult Instructions for Use

Date of Manufacture

IVD In Vitro Diagnostic Medical Device

Legal Manufacturer

REF List Number

Separate collection for electrical and electronic equipment waste per

Directive 2002/96/EC in the European Union

Manufacturer

ETL Certificate

CELL-DYN RubyTM System Operators Manual ix

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Instrument Labeling
The following labels are affixed to the CELL-DYN Ruby.

Analyzer Rear Panel

CLASS 1 LASER PRODUCT/
Lasergert der Klasse 1/
Produit laser de classe 1/Lser de
clase 1/Prodotto laser di classe 1/
Produto laser da classe 1/Klasse 1-
laserprodukt/Klass 1 laserprodukt/
1 PN 9230702C
Figure 1: Class 1 Laser Product Label

The following U.S. Patents are relevant to the CELL-DYN Ruby or its
components. There are other such patents and patent applications in the
United States and worldwide.
5,017,497 5,378,633 5,510,267 5,733,784

PN: 9231334A

Figure 2:
9221334A.indd 1 CELL-DYN Ruby US Patent Label 6/24/2005 9:16:12 AM

ABBOTT LABORATORIES
Abbott Park, IL 60064 USA

ABBOTT
Max-Planck-Ring 2
65205 Wiesbaden
Germany
+49-6122-580 PN 9230751

Figure 3: CE Mark and Legal Manufacturer

Figure 4: ETL Certification Label

x CELL-DYN RubyTM System Operators Manual

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Analyzer Right Flow Panel

ABBOTT DIAGNOSTICS DIVISION

Abbott Laboratories
Abbott Park IL, 60064, USA
THIS PRODUCT COMPLIES WITH FDA
PERFORMANCE STANDARDS FOR LASER
PRODUCTS EXCEPT FOR DEVIATIONS
PURSUANT TO LASER NOTICE NO. 50,
DATED JULY 26, 2001.
DATE OF MANUFACTURE

MODEL

SN

REF REV

PN 9230308 REV J

Figure 5: Analyzer Serial Number Label

Analyzer Left Flow Panel

Figure 6: CELL-DYN Ruby Service Technical Service Bulletin Record Label

CAUTION Class 3B laser light when open. Avoid

exposure to beam.
VORSICHT Bei offener Abdeckung Laserstrahlung der
Klasse 3B. Nicht direkt in den Laserstrahl blicken.
ATTENTION Rayon laser de classe 3B si ouvert. Eviter
toute exposition au faisceau laser.
PRECAUCIN: Haz de lser de clase 3B. Evite la
exposicin al lser cuando el analizador est abierto.
ATTENZIONE: fascio laser di classe 3B se aperto. Evitare
lesposizione al raggio.
ATENO Quando aberto, emite luz laser da classe
3B. Evitar a exposio ao raio laser.
VIGTIGT: Klasse 3B-laserlys ved bning. Undg
eksponering for strlen.
VIKTIGT: Klass 3B laserljus nr luckan r ppen. Undvik
exponering f r strlen.
3
.
.
UPOZORNN: Po oteven krytu nebezpe ozen
laserem tdy 3B. Vyvarujte se kontaktu s paprskem.
PN 9230701F

Figure 7: Laser Warning Label

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Analyzer Front and Rear

PN 9231477A

Figure 8: Biohazard

xii CELL-DYN RubyTM System Operators Manual

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 Master Table of Contents

Master Table of Contents

Foreword . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i

Customer Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i
Proprietary Statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i
Patent Statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ii
Disclaimers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ii
Warranty Statement for USA Customers Only. . . . . . . . . . . . . . . . . . iv
Regulatory and Safety Agency Approvals . . . . . . . . . . . . . . . . . . . . . . v
Trademark Statements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . v
Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vi
Instrument Labeling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . x
Analyzer Rear Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . x
Analyzer Right Flow Panel. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xi
Analyzer Left Flow Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xi
Analyzer Front and Rear. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xii

System Documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Organization of the online HTML Operators Manual. . . . . . . . . . . . . 2
Conventions for the online HTML Operators Manual . . . . . . . . . . . . 5
Access to the online HTML Operators Manual from
the system software. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Printed documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Access to the PDF Operators Manual from
a stand-alone computer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Use or Function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1

Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
Specimen Processing Sequence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5
Specimen Loading and Presentation. . . . . . . . . . . . . . . . . . . . . . 1-5
Specimen Identification and Test Selection . . . . . . . . . . . . . . . . . . . 1-5
Test Selections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6
System Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7
Analyzer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7
Analyzer Front . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8
Analyzer Right Side . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-10
Analyzer Left Side . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-11
Analyzer Sample Processing Area . . . . . . . . . . . . . . . . . . . . . . . . . 1-11

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Master Table of Contents

Analyzer Flow Panels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-14

Analyzer Internal Assemblies. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-17
Analyzer Rear . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-18
Data Module Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-21
Flat Panel Display with Touch Screen . . . . . . . . . . . . . . . . . . . . . . 1-23
Keyboard. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-24
Mouse Input Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-26
Hand-Held Bar Code Reader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-27
Printers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-28
System Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-29
Analyzer Operating Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-29
Data Station Operating Software . . . . . . . . . . . . . . . . . . . . . . . . . . 1-29
Screen Navigation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-30
Screen Layout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-30
Title Bar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-31
Menu Bar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-31
Tool Bar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-33
Status Bar and System Messages Region . . . . . . . . . . . . . . . . . 1-36
NOTE Region (Next Open Tube Entry) . . . . . . . . . . . . . . . . . . 1-38
Function Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-40
CELL-DYN Ruby Reagents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-41
CELL-DYN Diluent/Sheath . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-41
CELL-DYN CN-Free HGB/NOC Lyse . . . . . . . . . . . . . . . . . . . . . 1-41
CELL-DYN WBC Lyse . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-42
CELL-DYN Reticulocyte Reagent . . . . . . . . . . . . . . . . . . . . . . . . . 1-42
Controls, Calibrator, and Standard Reference Particles . . . . . . . . . . . . . . . 1-43
Controls. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-43
Calibrators. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-43
Standard Reference Particles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-43

Installation Procedures and Special Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1

Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Site Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Clearance Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Power Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Waste Disposal Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4
Unpacking and Inspection Guidelines . . . . . . . . . . . . . . . . . . . . . . . 2-4
System Connection and Start Up Guidelines . . . . . . . . . . . . . . . . . . 2-5
System Relocation and Shipping Guidelines . . . . . . . . . . . . . . . . . . 2-5
System Customization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7
Setup Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7
Patient Sample Setup... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9

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 Master Table of Contents

Patient Sample Setup, Limits Tab View. . . . . . . . . . . . . . . . . . 2-10

Demographics Tab View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11
Customize Limit Sets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11
Demographic Tab View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-20
Units Sets Selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-22
Units Format Selections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-22
Customize Run View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-23
Chartable Page . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-24
Lab Page . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-26
Graphs Page . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-28
Customize Data View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-29
Datalog, QC View, and Groups View . . . . . . . . . . . . . . . . . . . 2-29
Customize Moving Average View . . . . . . . . . . . . . . . . . . . . . . . 2-31
Customize Printed Report. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-32
Customize Report Header . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-33
Auto Print Chartable Page Report . . . . . . . . . . . . . . . . . . . . . . 2-34
Other Printed Report Options . . . . . . . . . . . . . . . . . . . . . . . . . . 2-35
QCID Setup. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-36
Moving Average Acceptance Setup... . . . . . . . . . . . . . . . . . . . . . . 2-36
Administrative Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-36
Operators. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-37
User Interface Preferences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-49
Tool Tip Display Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-50
QCID Daily Cleanup Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-50
Date/Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-51
Instrument ID Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-53
Bar Code Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-55
Orders Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-57
Automatic Order Cleanup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-57
No Bar Code Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-58
LIS Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-60
LIS Configuration Tab View . . . . . . . . . . . . . . . . . . . . . . . . . . 2-63
LIS Tests Tab View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-63
QC Download ID File Setup. . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-64
Flag Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-65

Principles of Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1

Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
Sample Aspiration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
Sample Analysis Cycle Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
Sample Aspiration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
Sample Segments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
RBC/PLT Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3

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Hemoglobin Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4

WBC Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4
Results Displayed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6
Instrument Flushed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6
Instrument Rinsed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6
Flow Cytometry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7
Introduction to Flow Cytometry . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7
Detection with the Optical Bench. . . . . . . . . . . . . . . . . . . . . . . . 3-8
Optical Flow Cell . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9
WBC Measurement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10
WBC Reagent . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-11
WBC Differential . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-11
Mononuclear-Polymorphonuclear Separation . . . . . . . . . . . . . 3-12
Neutrophil-Eosinophil Separation . . . . . . . . . . . . . . . . . . . . . . 3-13
Mononuclear Separation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-14
Other Scatterplots . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-15
Nuclear Optical Count (NOC) . . . . . . . . . . . . . . . . . . . . . . . . . 3-15
Resistant RBC. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-16
WBC Histograms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-17
NWBC-LYM-MONO Histogram. . . . . . . . . . . . . . . . . . . . . . . 3-17
MONO-POLY Histogram. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-17
NOC Histogram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-17
WBC Parameters. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-18
WBC Flagging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-19
RBC/PLT Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-19
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-19
RBC Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-20
RBC Count . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-20
MCV . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-20
HCT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-20
MCH . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-21
MCHC. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-21
RDW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-21
RBC Flagging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-21
Platelet Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-21
PLT Count. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-22
MPV . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-22
PCT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-22
PDW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-22
Platelet Flagging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-22
Hemoglobin Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-23
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-23

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HGB Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-23

HGB Flagging. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-23
Lab Page . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-24
Operational Messages and Data Flagging . . . . . . . . . . . . . . . . . . . . . . . . . 3-27
Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-27
Instrument Fault and Status Conditions . . . . . . . . . . . . . . . . . . . . . 3-27
Cell Populations and Flagging . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-28
Fragile WBC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-28
Lyse-Resistant RBC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-28
Parameter Flagging Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-29
Dispersional Data Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-32
Suspect Parameter Flags . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-32
WBC Descriptors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-32
Data Flagging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-33
Interpretive Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-39
References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-41

Performance Characteristics and Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1

Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
Physical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
Power Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
Environmental Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
Operating Environment Requirements . . . . . . . . . . . . . . . . . . . . 4-4
Clearance Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
Waste Disposal Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
Operating Noise Level and Heat Output. . . . . . . . . . . . . . . . . . . 4-4
Transport and Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
Operational Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5
Maximum Throughput (Closed Mode). . . . . . . . . . . . . . . . . . . . 4-5
Maximum Throughput (Open Mode) . . . . . . . . . . . . . . . . . . . . . 4-5
Nominal Aspiration Volume. . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5
Recommended Anticoagulants . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5
Specimen Tube Dimensions (Closed Mode) . . . . . . . . . . . . . . . 4-5
Recommended Specimen Collection Tubes (Closed Mode) . . . 4-6
Recommended Volume Requirements in Specimen
Collection Tube. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6
Bar Code Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7
Specification for Bar Code Symbols, Bar Code Labels,
and their Placement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7
Performance Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11
Background . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11
Carryover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11

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CBC Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-12

Imprecision (Reproducibility). . . . . . . . . . . . . . . . . . . . . . . . . . 4-13
Analytical Measurement Range (AMR) . . . . . . . . . . . . . . . . . . 4-14
Comparability (Correlation) . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-15
References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-17

Operating Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1

Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
System Priming, Interruption, and Standby . . . . . . . . . . . . . . . . . . . . . . . . . 5-3
System Priming, Interruption, and Standby . . . . . . . . . . . . . . . . . . . 5-3
Power On and Power Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3
System Priming. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-8
Interruption Procedures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-9
Procedural Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-9
Standby . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-10
The To Standby Task Button . . . . . . . . . . . . . . . . . . . . . . . . . . 5-10
Setup Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-11
Setup Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-11
Specimen Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-13
Specimen Analysis Tasks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-13
Preparing to Run Specimens. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-14
Preparing to Run Specimens. . . . . . . . . . . . . . . . . . . . . . . . . . . 5-14
Operator ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-15
Signing On and Off. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-15
Running Background Counts . . . . . . . . . . . . . . . . . . . . . . . . . . 5-15
Preparing and Handling Specimens . . . . . . . . . . . . . . . . . . . . . . . . 5-16
Anticoagulant . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-16
Specimen Stability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-16
Specimen Collection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-17
Interfering Substances. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-17
Specimen Mixing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-17
Running Specimens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-17
Specimen Identification Methods . . . . . . . . . . . . . . . . . . . . . . . 5-18
Introduction to the Orders View . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-19
Default Patient Test Selection Processing Conditions . . . . . . . 5-20
Pending Orders (Match Specimen ID or Match Rxx Tyy). . . . 5-21
Pending Order Entries from the LIS . . . . . . . . . . . . . . . . . . . . . 5-21
Processing with the Orders View . . . . . . . . . . . . . . . . . . . . . . . 5-21
Create Manual Orders. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-23
Printing a Pending Orders Log . . . . . . . . . . . . . . . . . . . . . . . . . 5-25
Orders Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-25
Open Mode Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-27
Closed Mode Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-28

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Post-Analysis Processing Datalog View . . . . . . . . . . . . . . . . . . . . . . . . . 5-29

Alerts and Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-29
Out of Range . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-29
System Messages and Fault Conditions . . . . . . . . . . . . . . . . . . 5-29
Run View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-30
Chartable Page . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-31
Lab Page . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-31
Graphs Page . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-32
Datalog View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-32
Backing up and Restoring System Data . . . . . . . . . . . . . . . . . . 5-36
Advanced Data Management Groups View . . . . . . . . . . . . . . . . . . . . . . 5-39
Creating Orders From the Group View . . . . . . . . . . . . . . . . . . . . . 5-40
Deleting Records From the Group View . . . . . . . . . . . . . . . . . . . . 5-40

Calibration Procedures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1

Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
When to Calibrate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3
Calibration Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5
General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5
Auto-Calibration Wizard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5
Manual Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5
Calibration Materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-6
Calibrating with Commercial Calibrator . . . . . . . . . . . . . . . . . . 6-6
Calibrating with Assayed Whole Blood . . . . . . . . . . . . . . . . . . . 6-6
Recommendations and Requirements for
Whole Blood Specimens. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-7
Recommendations for Reference Methodologies. . . . . . . . . . . . 6-7
Requirements for Obtaining Whole Blood Reference Values . . 6-8
Pre-Calibration Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-11
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-11
Pre-Calibration Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-11
Pre-Calibration Checklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-12
CELL-DYN Ruby Pre-Calibration Procedures Checklist . . . . . . . 6-13
Calibration Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-15
Calibration Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-17
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-17
Last Auto-Calibration Data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-17
Quick Precision Check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-18
Calibration Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-20
Auto-Calibration Wizard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-22
Manual Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-22
Calibration Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-25
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-25

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Auto-Calibration Method . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-25

Auto-Calibration Wizard - Open . . . . . . . . . . . . . . . . . . . . . . . . . . 6-26
Using Commercial Calibrator. . . . . . . . . . . . . . . . . . . . . . . . . . 6-26
Running the Open/Closed Mode Bias Check . . . . . . . . . . . . . . . . . 6-42
Whole Blood Auto-Calibration Wizard - Open Mode . . . . . . . . . . 6-45
Using Whole Blood . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-45
Running the Open/Closed Mode Bias Check . . . . . . . . . . . . . . . . . 6-61
Manual Calibration Method . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-65
Manual Calibration Dialog Box . . . . . . . . . . . . . . . . . . . . . . . . 6-65
Manual Calibration Primary Mode - Open . . . . . . . . . . . . . . . . 6-66
Post-Calibration Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-71
Backing Up Calibration Factors . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-71
General Concepts and Guidelines. . . . . . . . . . . . . . . . . . . . . . . 6-71
Backup Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-71
Manual Calibration Worksheets . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-74
Worksheet 1 Open Mode Calibration - New Factors . . . . . 6-75
Worksheet 2 Open Mode Factor % Difference . . . . . . . . . . 6-76
Worksheet 3 Open Mode Calibration Range Criteria . . . . . 6-77
Worksheet 4 Calibration Verification . . . . . . . . . . . . . . . . . 6-78
References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-79

Operational Precautions and Limitations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1

Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
General Requirements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2
Precautions and Requirements for System Operation . . . . . . . . . . . 7-3
Precautions Before Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3
Precautions During Operation . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4
Requirements for Handling Specimens . . . . . . . . . . . . . . . . . . . . . . 7-6
Interfering Substances and Conditions . . . . . . . . . . . . . . . . . . . . . . . 7-8
Limitations of Result Interpretation . . . . . . . . . . . . . . . . . . . . . . . . . 7-8
Reference . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-9

Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
Operator Responsibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2
Laser Caution Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3
Hazard Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5
Biological and Chemical Hazards. . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5
Biological Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5
Chemical Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-7
Spill Clean-Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-7
Waste Handling and Disposal. . . . . . . . . . . . . . . . . . . . . . . . . . . 8-7
Decontamination Procedure Requirements . . . . . . . . . . . . . . . . 8-8

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Electrical Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-8

Mechanical Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-9
Physical Hazards. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-11
References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-13

Service and Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1

Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1
Recommended Service and Maintenance Schedule . . . . . . . . . . . . . . . . . . . 9-3
Service and Maintenance Software. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-5
Maintenance View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-6
Scheduled Maintenance Tasks . . . . . . . . . . . . . . . . . . . . . . . . . . 9-6
As-Needed Maintenance Tasks . . . . . . . . . . . . . . . . . . . . . . . . . 9-7
Special Protocols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-7
Maintenance Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-8
System View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-9
Calibration Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-9
Event Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-10
Set Point Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-11
Reagents View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-12
Current Reagents. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-12
Reagent Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-13
Scheduled Maintenance Procedures . . . . . . . . . . . . . . . . . . . . . . . . 9-15
As-Needed Maintenance Procedures . . . . . . . . . . . . . . . . . . . . . . . 9-31
Special Protocols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-50
Nonscheduled Maintenance Procedures . . . . . . . . . . . . . . . . . . . . . 9-65
Decontamination Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-65
Printer Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-66
Reagent Container Replacement. . . . . . . . . . . . . . . . . . . . . . . . . . . 9-66
Replace Tubing in Normally Closed (NC) Valves . . . . . . . . . . 9-67
Unclogging Open Mode Probe . . . . . . . . . . . . . . . . . . . . . . . . . 9-71
Vacuum Accumulator 1 and 2 Rinsing Procedure . . . . . . . . . . 9-74
CELL DYN Ruby Maintenance Log . . . . . . . . . . . . . . . . . . . . . . . 9-75
References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-77

Troubleshooting and Diagnostics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1

Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1
Introduction to Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-2
Problem Categories. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-2
Observable Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-2
System Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-3
Troubleshooting Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-5
Troubleshooting Tips and Techniques . . . . . . . . . . . . . . . . . . . 10-5
List of System Messages. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-10
System Information Message (SIM) Tables . . . . . . . . . . . . . . . . . 10-16

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Quality Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-1

Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-1
When to Run QC. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-2
QC Methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-3
Control Material . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-3
Quality Control Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-5
Guidelines for Running Controls . . . . . . . . . . . . . . . . . . . . . . . . . . 11-5
Control Material Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-5
Assay Verification Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-6
Establishing the Mean. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-7
Quality Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-9
QC View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-9
Program Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-10
QCID Files . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-10
Quality Control Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-13
Using QC View. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-14
Main QC View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-14
Scrolling Through the QC View. . . . . . . . . . . . . . . . . . . . . . . 11-15
View QC Spec . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-18
QCID L-J Plots . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-20
QCID Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-21
Download QCID Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-23
View QC Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-24
Moving Average View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-30
Quality Control Software Setup . . . . . . . . . . . . . . . . . . . . . . . . . . 11-31
QCID File Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-31
QC Download ID Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-48
Moving Average Acceptance Setup . . . . . . . . . . . . . . . . . . . . 11-49
Performing a QC Run . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-52
Rejecting/Accepting Specimens . . . . . . . . . . . . . . . . . . . . . . . 11-53
Edit QC Specimens. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-53
Evaluating and Investigating Commercial and Patient Control Results. . 11-57
Analyzing QCID File Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-59
Levey-Jennings Graphs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-59
Westgard Rule Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-60
Westgard Rules for the CELL-DYN Ruby. . . . . . . . . . . . . . . . . . 11-60
Rule Violations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-61
Moving Average Programs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-63
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-63
How Moving Average Programs Work . . . . . . . . . . . . . . . . . . . . 11-63
Principles of Moving Average Analysis. . . . . . . . . . . . . . . . . . . . 11-64
Guidelines for Setting Up X-B Moving Average
Program Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-64

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Establishing the Target Value. . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-65

Guidelines for Interpreting X-B Moving Average
Program Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-66
Guidelines for Setting Up and Interpreting Other Moving
Average Programs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-67
Moving Average Program Operation . . . . . . . . . . . . . . . . . . . . . . 11-69
Data Collection Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-69
Investigating Moving Average Data Problems. . . . . . . . . . . . . . . 11-70
Investigating One Batch Out. . . . . . . . . . . . . . . . . . . . . . . . . . 11-70
Investigating Two Batches Out. . . . . . . . . . . . . . . . . . . . . . . . 11-70
Printing Moving Average Programs Information . . . . . . . . . . . . . 11-70
Customizing Moving Average Programs . . . . . . . . . . . . . . . . . . . 11-71
References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-73

Reticulocyte Package . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-1

Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-1
Principles of Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-2
Setup Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-7
RETIC Test Selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-9
Enabling Reticulocyte Processing . . . . . . . . . . . . . . . . . . . . . . . . 12-10
Disable Reticulocyte Processing. . . . . . . . . . . . . . . . . . . . . . . . . . 12-10
Routine Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-11
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-11
Reticulocyte Specimens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-11
Specimen Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-12
Interfering Substances. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-14
Specimen Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-15
Running Specimens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-15
Quality Control Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-21
Control Material . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-22
Mixing and Handling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-23
Maintenance and Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-25
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-25
General Guidelines for Reticulocyte Troubleshooting . . . . . . 12-25
Operational Messages and Data Flagging . . . . . . . . . . . . . . . . . . 12-26
Dispersional Data Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-26
References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-29

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Appendix A . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1
Appendix A. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1

Appendix B . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-1
Appendix B Reference. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-1

Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Index-1

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List of Figures

Foreword
Figure 1: Class 1 Laser Product Label . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . x
Figure 2: CELL-DYN Ruby US Patent Label . . . . . . . . . . . . . . . . . . . . . . . . . . . x
Figure 3: CE Mark and Legal Manufacturer . . . . . . . . . . . . . . . . . . . . . . . . . . . . x
Figure 4: ETL Certification Label . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . x
Figure 5: Analyzer Serial Number Label . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xi
Figure 6: CELL-DYN Ruby Service Technical Service Bulletin
Record Label . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xi
Figure 7: Laser Warning Label. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xi
Figure 8: Biohazard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xii

Use or Function
Figure 1.1 CELL-DYN Ruby. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
Figure 1.2 Analyzer Right Side . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-10
Figure 1.3 Analyzer Left Side . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-11
Figure 1.4 Sample Loader Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-11
Figure 1.5 Flow Panel Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-14
Figure 1.6 Optical Bench . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-17
Figure 1.7 Analyzer Rear . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-18
Figure 1.8 Hardware Component Cable and Connection Overview -
Rear View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-21
Figure 1.9 Data Module Computer Component Connections - Rear View . . . 1-22
Figure 1.10 Flat Panel Display (Right Side) . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-23
Figure 1.11 Flat Panel Display (Back Side) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-23
Figure 1.12 Example of Standard English Keyboard. . . . . . . . . . . . . . . . . . . . . 1-24
Figure 1.13 Using the Mouse Input Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-26
Figure 1.14 Hand-Held Bar Code Reader Connection. . . . . . . . . . . . . . . . . . . . 1-27
Figure 1.15 Screen Layout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-30
Figure 1.16 Title Bar Example . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-31
Figure 1.17 Menu Bar Example . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-31
Figure 1.18 Tool Bar Buttons. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-33
Figure 1.19 Status Bar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-36
Figure 1.20 System Messages Region Example . . . . . . . . . . . . . . . . . . . . . . . . 1-37
Figure 1.21 NOTE Region . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-38
Figure 1.22 NOTE Detailed (More Spec Info Window) . . . . . . . . . . . . . . . . . . 1-39
Figure 1.23 QCID Lookup Window. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-39
Figure 1.24 Function Key Examples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-40

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Installation Procedures and Special Requirements

Figure 2.1 User Interface Preferences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-49

Principles of Operation
Figure 3.1 Optical Bench . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7
Figure 3.2 Optical Flow Cell . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9
Figure 3.3 WBC Light Scatter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10
Figure 3.4 Mononuclear-Polymorphonuclear Scatter . . . . . . . . . . . . . . . . . . . 3-12
Figure 3.5 Neutrophil-Eosinophil Scatter . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-13
Figure 3.6 Mononuclear Scatter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-14
Figure 3.7 WBC Histograms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-17
Figure 3.8 WBC Data and Scatterplots . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-18
Figure 3.9 RBC Data and Histogram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-20
Figure 3.10 PLT Data and Histogram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-22
Figure 3.11 Lab Page . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-24

Performance Characteristics and Specifications

Figure 4.1 Bar Code Symbol Dimensions & Label Requirements . . . . . . . . . . 4-7
Figure 4.2 Bar Code Label Placement Requirements . . . . . . . . . . . . . . . . . . . . 4-9
Figure 4.3 Tube with Correctly Positioned Bar Code Label in a
Sample Loader Rack . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-9

Operating Instructions
Figure 5.1 Power Switch Locations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3
Figure 5.2 Datalog Function Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-33

Hazards
Figure 8.1 Class 1 Laser Product Label . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3
Figure 8.2 Laser Warning Label . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3
Figure 8.3 CELL-DYN Ruby System Laser Caution Labeling . . . . . . . . . . . . . 8-4

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List of Tables

Use or Function
Table 1.1 Status Indicator LEDs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9
Table 1.2 Reagent Inlet Connectors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-19
Table 1.3 Keyboard Keys and Their Functions on the CELL-DYN Ruby. . . 1-25
Table 1.4 Mouse Actions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-26
Table 1.5 Printing Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-28
Table 1.6 Menu Bar Commands . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-31
Table 1.7 Tool Bar Button Navigation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-33
Table 1.8 Status Bar Function Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-38
Table 1.9 Tab Descriptions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-40

Installation Procedures and Special Requirements

Table 2.1 Customizable Menu Items . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7
Table 2.2 Limit Set Default Descriptions . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-12
Table 2.3 To Change the User Field . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-21
Table 2.4 To Select the Default Patient Test Selection . . . . . . . . . . . . . . . . . 2-21
Table 2.5 Procedure to Change the Unit Sets Selection . . . . . . . . . . . . . . . . . 2-22
Table 2.6 Procedure to Customize Parameter Set - Chartable Page . . . . . . . . 2-24
Table 2.7 Customize the Run View - Lab Page . . . . . . . . . . . . . . . . . . . . . . . 2-26
Table 2.8 Procedure to Customize the Run View - Graphs Page . . . . . . . . . . 2-28
Table 2.9 Procedure to Customize Tab Titles and Column Headings
in Data View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-30
Table 2.10 Procedure to Add/Delete Tab Pages in Data View. . . . . . . . . . . . . 2-31
Table 2.11 To Customize the Printed Report Header . . . . . . . . . . . . . . . . . . . . 2-33
Table 2.12 Procedure to Auto Print Chartable Page Report . . . . . . . . . . . . . . . 2-34
Table 2.13 Procedure to Print Using Other Printed Report Options. . . . . . . . . 2-35
Table 2.14 Operator ID and Access Levels . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-37
Table 2.15 Procedure to Add an Operator . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-39
Table 2.16 Add Operator Dialog Box. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-40
Table 2.17 Procedure to Remove an Operator . . . . . . . . . . . . . . . . . . . . . . . . . 2-41
Table 2.18 Procedure to Edit Operator Information . . . . . . . . . . . . . . . . . . . . . 2-42
Table 2.19 Edit Operator Dialog Box . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-43
Table 2.20 Procedure for Editing Permission Access Rights
for Laboratory Levels I and II . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-45
Table 2.21 Procedure for Setting Up Second Sign Ons . . . . . . . . . . . . . . . . . . 2-47
Table 2.22 Changing the Tool Tip Display Time . . . . . . . . . . . . . . . . . . . . . . . 2-50
Table 2.23 Procedure to Set Up Bar Code Including Symbology Setups . . . . 2-55
Table 2.24 Procedure to Change Automatic Order Cleanup . . . . . . . . . . . . . . 2-58

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Table 2.25 Procedure to Change Use Rack and Tube Matching . . . . . . . . . . . 2-59
Table 2.26 Setting Up Auto-Transmission and Manual Transmission. . . . . . . 2-61
Table 2.27 Flag Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-65

Principles of Operation
Table 3.1 5-Part Differential . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-25
Table 3.2 5-Part Differential Plus Additional Parameters . . . . . . . . . . . . . . . 3-25
Table 3.3 Parameter Flagging Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-29
Table 3.4 Parameters Marked With an Asterisk (*) . . . . . . . . . . . . . . . . . . . . 3-30
Table 3.5 Parameters with Suppressed Results. . . . . . . . . . . . . . . . . . . . . . . . 3-31
Table 3.6 Patient Specimen Type + CBC Test Selection . . . . . . . . . . . . . . . . 3-34
Table 3.7 Patient Specimen Type + CBC+RRBC Test Selection . . . . . . . . . 3-37
Table 3.8 Patient Specimen Type + CBC+NOC Test Selection. . . . . . . . . . . 3-38

Performance Characteristics and Specifications

Table 4.1 CELL-DYN Ruby Physical Specifications. . . . . . . . . . . . . . . . . . . . 4-3
Table 4.2 CELL-DYN Ruby Power Specifications . . . . . . . . . . . . . . . . . . . . . 4-3
Table 4.3 CELL-DYN Ruby Fuse Specifications. . . . . . . . . . . . . . . . . . . . . . . 4-3
Table 4.4 Clearance Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
Table 4.5 Clearance Requirements for Service Access . . . . . . . . . . . . . . . . . . 4-4
Table 4.6 Recommended Collection Tube Dimensions for use
in Closed mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5
Table 4.7 Recommended Specimen Collection Tubes for use in Closed Mode 4-6
Table 4.8 Characteristics of the Bar Code Symbologies Supported by the
CELL-DYN Ruby . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-8
Table 4.9 Background Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11
Table 4.10 Carryover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-12
Table 4.11 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-12
Table 4.12 Fresh Blood Imprecision. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-13
Table 4.13 Analytical Measurement Range . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-14
Table 4.14 Comparability (Correlation) of CBC and Differential to
CELL-DYN Sapphire . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-15
Table 4.15 Comparability (Correlation) of WBC Differential to Microscopy . 4-16

Operating Instructions
Table 5.1 Procedure to Power-up the Instrument When the System
Main Power Switch is in ON Position . . . . . . . . . . . . . . . . . . . . . . 5-4
Table 5.2 Procedure to Power-up the Instrument When the System
Main Power Switch is in OFF Position . . . . . . . . . . . . . . . . . . . . . 5-5
Table 5.3 Procedure to Power Off and Reboot the System . . . . . . . . . . . . . . . 5-6
Table 5.4 Procedure to Power-Down the Instrument and Power Off
the System Main Power Switch . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-7
Table 5.5 Sample Loader Interruption . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-9

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Table 5.6 Procedure to Manually Place the System in Standby State . . . . . . 5-10
Table 5.7 Specimen Analysis Tasks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-13
Table 5.8 Required Procedures for Specimen Analysis . . . . . . . . . . . . . . . . . 5-14
Table 5.9 Processing With Default Patient Test Selection . . . . . . . . . . . . . . . 5-20
Table 5.10 Procedure to Edit Pending Orders . . . . . . . . . . . . . . . . . . . . . . . . . 5-26
Table 5.11 Procedure to Delete Pending Order Entries . . . . . . . . . . . . . . . . . . 5-26
Table 5.12 Open Mode Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-27
Table 5.13 Closed Mode Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-28
Table 5.14 Datalog Specimen Type Icons . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-33
Table 5.15 Datalog Function Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-34

Calibration Procedures
Table 6.1 Auto-Calibration Wizard Reference Value and Assay Value Entry
Range . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-8
Table 6.2 Buttons Last Auto-Calibration Data... . . . . . . . . . . . . . . . . . . . . 6-18
Table 6.3 Fields Quick Precision Check... Dialog Box . . . . . . . . . . . . . . . 6-19
Table 6.4 Buttons Quick Precision Check... Dialog Box. . . . . . . . . . . . . . 6-19
Table 6.5 Fields Calibration Log View . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-21
Table 6.6 Buttons Calibration Log Dialog View . . . . . . . . . . . . . . . . . . . . 6-21
Table 6.7 Fields Manual Calibration... Dialog Box. . . . . . . . . . . . . . . . . . 6-23
Table 6.8 Buttons Manual Calibration... Dialog Box . . . . . . . . . . . . . . . . 6-23
Table 6.9 Buttons Welcome to the CELL-DYN Auto Calibration Wizard 6-27
Table 6.10 Buttons Pre-Calibration Maintenance Check Status Dialog Box6-27
Table 6.11 Buttons Pre-Calibration Reagent/Waste Dialog Box. . . . . . . . . 6-28
Table 6.12 Buttons Pre-Calibration Precision Check Status Dialog Box . . 6-29
Table 6.13 Buttons Pre-Calibration Background Check Status Dialog Box 6-32
Table 6.14 Buttons Calibration Setup Dialog Box . . . . . . . . . . . . . . . . . . . 6-33
Table 6.15 Fields Calibration Setup - Reference Values for Calibration . . 6-35
Table 6.16 Buttons Calibration Setup - Reference Values
for Calibration Dialog Box . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-35
Table 6.17 Buttons Auto-Calibration Data View Dialog Box. . . . . . . . . . . 6-38
Table 6.18 Fields Post-Calibration New Factors Dialog Box . . . . . . . . . . . 6-39
Table 6.19 Buttons Post-Calibration New Factors Dialog Box . . . . . . . . . . 6-39
Table 6.20 When to Select Apply New Factor for Acceptance . . . . . . . . . . . . 6-40
Table 6.21 Buttons Welcome to the CELL-DYN Auto-Calibration
Wizard Dialog Box . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-46
Table 6.22 Buttons Pre-Calibration Maintenance Check Status Dialog Box6-47
Table 6.23 Buttons Pre-Calibration Reagent/Waste Dialog Box. . . . . . . . . 6-48
Table 6.24 Buttons Pre-Calibration Precision Check Status Dialog Box . . 6-49
Table 6.25 Buttons Pre-Calibration Background Check Status Dialog Box 6-52
Table 6.26 Buttons Calibration Setup Dialog Box . . . . . . . . . . . . . . . . . . . 6-53
Table 6.27 Buttons Calibration Setup - Reference Values for Whole Blood
Dialog Box . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-54

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Table 6.28 Buttons Auto-Calibration Data View Dialog Box. . . . . . . . . . . 6-56

Table 6.29 Fields Post-Calibration New Factors Dialog Box . . . . . . . . . . . 6-58
Table 6.30 Buttons Post-Calibration New Factors Dialog Box. . . . . . . . . . 6-58
Table 6.31 When to Select Apply New Factor for Acceptance . . . . . . . . . . . . 6-59

Operational Precautions and Limitations

Table 7.1 Recommended Collection Tube Dimensions for Use
in Closed Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-6

Hazards
Table 8.1 Safety Icons and Descriptions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2
Table 8.2 Hazard Symbol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5

Service and Maintenance

Table 9.1 Scheduled Service and Maintenance Procedures . . . . . . . . . . . . . . . 9-4
Table 9.2 As-Needed Service and Maintenance Procedures . . . . . . . . . . . . . . 9-4
Table 9.3 Nonscheduled Service and Maintenance Procedures . . . . . . . . . . . . 9-4
Table 9.4 Special Protocols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-7

Quality Control
Table 11.1 Screen Navigation Bar and Buttons . . . . . . . . . . . . . . . . . . . . . . . 11-16
Table 11.2 QC View Function Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-17
Table 11.3 Function Keys View QC Spec . . . . . . . . . . . . . . . . . . . . . . . . . 11-18
Table 11.4 Function Keys QCID File Levey-Jennings View . . . . . . . . . . 11-20
Table 11.5 Function Keys QCID Data Dialog Box . . . . . . . . . . . . . . . . . . 11-21
Table 11.6 Field QC Download Dialog Box . . . . . . . . . . . . . . . . . . . . . . . 11-24
Table 11.7 Buttons QC Download Dialog Box . . . . . . . . . . . . . . . . . . . . . 11-24
Table 11.8 Fields QCID Setup: View, Control Data Dialog Box . . . . . . . 11-25
Table 11.9 Fields QCID Setup: View, QC Limits Dialog Box . . . . . . . . . 11-26
Table 11.10 Fields QCID Setup: View, Westgard Dialog Box . . . . . . . . . . 11-27
Table 11.11 Buttons QCID Setup: View, Control Data Dialog Box . . . . . . 11-27
Table 11.12 Function Keys QC Moving Average View . . . . . . . . . . . . . . . 11-30
Table 11.13 Field QCID Setup: View Dialog Box . . . . . . . . . . . . . . . . . . . 11-32
Table 11.14 Buttons QCID Setup: View Dialog Box . . . . . . . . . . . . . . . . . 11-32
Table 11.15 Field QCID Setup: Basics Dialog Box . . . . . . . . . . . . . . . . . . 11-32
Table 11.16 Buttons QCID Setup: Basics Dialog Box . . . . . . . . . . . . . . . . 11-33
Table 11.17 Field QCID Setup: Create New, Control Data Dialog Box. . . 11-34
Table 11.18 Buttons QCID Setup: Create New, Control Data Dialog Box. 11-35
Table 11.19 Field QCID Setup: Create New, QC Limits Dialog Box. . . . . 11-36
Table 11.20 Buttons QCID Setup: Create New, QC Limits Dialog Box . . 11-36
Table 11.21 Field Means and Limits [+/-] Update Details Dialog Box . . . 11-37
Table 11.22 Buttons Update Details Dialog Box. . . . . . . . . . . . . . . . . . . . . 11-37
Table 11.23 Field QCID Setup: Create New, Westgard Dialog Box . . . . . 11-40

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Table 11.24 Buttons QCID Setup: Create New, Westgard Dialog Box . . . 11-41
Table 11.25 Field QCID Setup: View Dialog Box . . . . . . . . . . . . . . . . . . . 11-42
Table 11.26 Buttons QCID Setup: View Dialog Box . . . . . . . . . . . . . . . . . 11-42
Table 11.27 Field QCID Setup: Basics Dialog Box . . . . . . . . . . . . . . . . . . 11-42
Table 11.28 Buttons QCID Setup: Basics Dialog Box . . . . . . . . . . . . . . . . 11-43
Table 11.29 Field Dialog Box . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-44
Table 11.30 Field QCID Setup: Create New, QC Limits Dialog Box. . . . . 11-45
Table 11.31 Field Means and Limits [+/-] Update Details Dialog Box. . . . 11-45
Table 11.32 Buttons Update Details Dialog Box. . . . . . . . . . . . . . . . . . . . . 11-46
Table 11.33 Field QCID Setup: Create New, Westgard Dialog Box . . . . . 11-47
Table 11.34 Buttons QCID Setup: Create New, Westgard Dialog Box . . . 11-47
Table 11.35 Field QC Download ID File Setup Dialog Box. . . . . . . . . . . . 11-48
Table 11.36 Buttons QC Download ID File Setup Dialog Box. . . . . . . . . . 11-49
Table 11.37 Field Moving Average Acceptance Setup Dialog Box . . . . . . 11-50
Table 11.38 Buttons Moving Average Acceptance Setup Dialog Box . . . . 11-50
Table 11.39 Field Customized Moving Average View Dialog Box . . . . . . 11-51
Table 11.40 Buttons Customize Moving Average View Dialog Box . . . . . 11-52
Table 11.41 Troubleshooting X-B RBC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-66
Table 11.42 X-B WBC ValuesDefault . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-68

Reticulocyte Package
Table 12.1 Known or Potential Interferents . . . . . . . . . . . . . . . . . . . . . . . . . . 12-14
Table 12.2 Instrument Alert Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-26
Table 12.3 Data Invalidating Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-27

Parts and Accessories

Table A.1 CELL-DYN Ruby Hardware List Numbers . . . . . . . . . . . . . . . . . . . A-1
Table A.2 CELL-DYN Ruby Accessories Kit (List Number 09H04-01) . . . . . A-2
Table A.3 CELL-DYN Ruby Optional Accessories . . . . . . . . . . . . . . . . . . . . . A-3
Table A.4 CELL-DYN Ruby Support Documentation List Numbers. . . . . . . . A-4
Table A.5 CELL-DYN Calibrator and Controls for use on CELL-DYN Ruby A-4
Table A.6 CELL-DYN Reagents for use on CELL-DYN Ruby . . . . . . . . . . . . A-5

CELL-DYN RubyTM System Operators Manual List of Tables-5

9140543AMay 2006
 List of Tables

NOTES

List of Tables-6 CELL-DYN RubyTM System Operators Manual

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 System Documentation

Introduction
Documentation for the CELL-DYN Ruby consists of the CELL-DYN Ruby
Operators Manual, available in both online HTML version and printed versions.
Also available on the install CD in Portable Document Format (PDF).
The Operators Manual contains instructions for using and maintaining the
CELL-DYN Ruby. It provides information that ranges from step-by-step operating
instructions to a list of parts and accessories.
The online HTML Operators Manual is designed to be the fastest, easiest, and
most user-friendly resource for your informational needs. The online HTML
Operators Manual (CELL-DYN Ruby Operators Manual) contains the same
content as the printed operators manual, which includes complete instructions for
using and maintaining the CELL-DYN Ruby. You can access the online HTML
Operators Manual from the software on the CELL-DYN Ruby data station.
The first and most important step toward learning to use this manual is to become
familiar with its organization. To assist you, System Documentation topics include:
Online HTML documentation
Printed documentation
Online PDF documentation
Online HTML documentation
Online HTML documentation topics include:
Organization of the online HTML Operators Manual
Conventions for the online HTML Operators Manual
Access to the online HTML Operators Manual from the system software
Access to the online PDF Operators Manual for a stand-alone computer

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Organization of the online HTML Operators Manual
NOTE: Due to inconsistent nature of printing in HTML documents, we
recommend that you use the PDF version of the manual for printing.

The online HTML CELL-DYN Ruby Operators Manual is organized as follows:

Table 1: Online Operators Manual Organization

Revision Status and Refer to this section for the Revision Status and History of the
Log CELL-DYN Ruby Operators Manual.

Foreword Refer to this section for important information such as:

Customer Service Contact Information
Proprietary and Patent Statements
Disclaimers
Warranty details
Trademark statements
Key to symbols and instrument labeling

Master Table of Refer to the Table of Contents for a list of all:

Contents Sections
Subsections
List of Figures
List of Tables

System Refer to this section for:

Documentation Information on content organization
Organization of the online HTML Operators Manual
Conventions for the online HTML Operators Manual
Access to the online HTML Operators Manual from the system software
Access to the online PDF Operators Manual for a stand-alone computer

Section 1 Use or Refer to this section for a brief description of the CELL-DYN Ruby, such as:
Function Intended use
Specimen processing sequence
Main hardware components
Basic features of the system software
Reagents, Controls, Calibrator, and Standard Reference Particles

Section 2 Installation Refer to this section for:

Procedures and Information on site requirements for installation
Special Requirements System installation and start-up guidelines
System software customization and procedural guidelines
System relocation and shipping guidelines

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Table 1: Online Operators Manual Organization (Continued)

Section 3 Principles Refer to this section for an explanation of:

of Operation Scientific and technical principles
Types of system measurements
Data analysis and parameter reporting conventions
System Initiated Messages (SIMs) and Data Flags

Section 4 Refer to this section for details such as:

Performance Dimensions of the instrument
Characteristics and Power requirements
Specifications Environmental specifications
Operational specifications
Bar Code specifications
Performance specifications and performance characteristics

Section 5 Operating Use this section to learn how to perform:

Instructions Various tasks related to routine system operation
System customization
Background counts
Basic and advanced patient data management including reviewing,
printing, and transmitting to Laboratory Information Systems

Section 6 Calibration Use this section to learn:

Procedures When to calibrate
Pre-Calibration procedures
Calibration procedures
Post-Calibration procedures

Section 7 Operational Refer to this section to understand the precautions, limitations, and
Precautions and requirements associated with:
Limitations System operation
Handling consumables
Handling specimens
Identifying substances and conditions
Interpreting results

Section 8 Hazards Refer to this section for important hazard and safety information, such as:
Safety icons, laser caution labels, and hazard symbols
Biological, chemical, electrical, mechanical, and physical hazards

Section 9 Service and Refer to this section for:

Maintenance Descriptions of all maintenance procedures
Recommended schedules for service and maintenance
Instructions for performing scheduled and as-needed maintenance
procedures
Step-by-step instructions for replacing components

CELL-DYN RubyTM System Operators Manual 3

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Table 1: Online Operators Manual Organization (Continued)

Section 10 Refer to this section for:

Troubleshooting and Troubleshooting basics and procedures
Diagnostics Information on probable causes and corrective actions for observed
problems, System Initiated Messages (SIMs), and Data-Related problems

Section 11 Quality Refer to this section for:

Control Internal and external quality control programs
Principles and procedures for running quality control using commercial
control material and whole blood patient controls
Procedures to customize system quality control files
Quality control data management

Section 12 This section is a self-contained module that describes how the Reticulocyte
Reticulocyte Package Package software enables the operator of the CELL-DYN Ruby System to
analyze a whole blood specimen for reticulocytes.

Appendix A Refer to this section for information that may be helpful when ordering
products:
List Numbers
Unique Identifiers

Appendix B Refer to this section for information on potential causes of spurious results.

Index Use this alphabetical listing of subject matter to link to specific information in
the operators manual about the system.

4 CELL-DYN RubyTM System Operators Manual

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Conventions for the online HTML Operators Manual
Conventions are a set of defined standards and are used to convey meaning in an
expected manner. The conventions used in the online HTML Operators Manual
are intended to facilitate finding, reading, understanding, and using the available
information.
Table 2: Online HTML Operators Manual Text Conventions

Description Use Examples

Blue, boldface, italic, underlined Indicates hyper-text links to Section 7: Operational Precau-
related information tions and Limitations

Courier font Text entries type admin

Sans serif font, boldface, all capital Window name DATA LOG window
letters

Sans serif font, boldface, initial capital Window area, Menus and Data Set Fields area Setup
letters menu items menu
Sans serif font, boldface, initial capital Screen message or other [Waste Full] text
letters, enclosed in brackets screen display

Sans serif font, boldface, initial capital Data entry field <Operator ID> field
letters, enclosed in angle brackets

Sans serif font, initial capital letters Status or state Standby status
Initialized status
Ready state

Serif font, boldface, all capital letters, Note, Caution, Warning NOTE: text
followed by colon and tab before text

Serif font, boldface, initial capital letters Screen buttons Data Log button
Serif font, all capital letters ON, OFF set to ON
set to OFF
Serif font, initial capital letters only when Keyboard keys Function keys (F1) key
appropriate arrow keys
arrow key
Enter key
ESC key
Page Up key
pound (#) key
asterisk (*) key

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Table 3: Online HTML Operators Manual Graphic Conventions

Description Use Examples

Signal words Highlight information that is relevant to the NOTE:
current subject matter. CAUTION:
WARNING:
Numerical references on illustrations, Indicate the area described in the table 1
photographs and reports that follows or in a sidebar embedded in
the Figure.

Access to the online HTML Operators Manual from the system

software
From the Menu Bar, select the Help menu. From the Help menu, select Operators
Manual. If the manual has not yet been installed you will see a message box with
the message: Operators manual has not been installed.

6 CELL-DYN RubyTM System Operators Manual

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Table 4: Online HTML Operators Manual Search Navigation

Actions Steps Reference

Using the 1. Select the Contents tab on the
table of navigation pane to provide a visual table
contents of contents of the operators manual
(See graphic to the right).
2. Select the box icons and page icons to
1
view subsections.
2
NOTE: The box icons expand and
collapse corresponding
subsections as they are selected.
3. Click on the desired topic to select that
topic. The topic page displays in the
topic pane (right side of window).

Scrolling 1. Select the Contents tab on the

through the navigation pane (see graphic to the
content right), and then select a topic title. The
topic content displays in the topic pane.
2. Drag the scroll bar on the right side of
11
the topical pane to display subsequent
content within the section. 1A 2
3. Repeat step 2 as often as desired.

Paging 1. Select the Contents tab on the

between navigation pane and select a topic title.
sections The desired topic then displays in the 1
topic pane. 2
2. Select a left or right section arrow
(located in the upper right-hand corner of
the topic pane) to move between
sections of the manual (see graphic to
the right).
NOTE: Section arrows are also
visible at the bottom of the topic
pane when viewing the end of a
section.

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Table 4: Online HTML Operators Manual Search Navigation (Continued)

Actions Steps Reference

Using the 1. Select the Index tab on the navigation
index pane (see graphic to the right). 1
2. Type in a keyword to find all references
to the keyword within the manual. Or, 2
click on any topic in the Index.
The topic content displays in the topic pane.

Using the 1. Select the Search button (see graphic to

Search the right). 1
button 2. Type a keyword (or phrase) in the field
indicated and select List Topics 2
3. Review the topics displayed in the
results pane and double-click on a topic
for further review. This topic is then
displayed in the topic pane.
4. To search for new content, type another
keyword (or phrase) in the field indicated
and select List Topics.

8 CELL-DYN RubyTM System Operators Manual

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Printed documentation
The printed version of the CELL-DYN Ruby Operators Manual contains complete
instructions for using and maintaining the CELL-DYN Ruby system. You will find
it a valuable aid and an essential reference as you learn to use the system.
Printed documentation topics include:
Organization of the printed operators manual
Conventions for the printed documentation

Organization of the printed operators manual

The printed CELL-DYN Ruby Operators Manual provides the following tools to
help you access desired information:

Tabs
Primary tabs mark the start of each section. Subtabs mark the start of subsections
within certain sections.

Tables of Contents
The Master Table of Contents at the beginning of the manual lists each section and
its subsections. Section tables of contents are located immediately behind primary
tabs in all major sections.
The printed CELL-DYN Ruby Operators Manual is organized as follows:
Table 5: Online Operators Manual Organization

Revision Status and Refer to this section for the Revision Status and History of the
Log CELL-DYN Ruby Operators Manual.

Foreword Refer to this section for important information such as:

Customer Service Contact Information
Proprietary and Patent Statements
Disclaimers
Warranty details
Trademark statements
Key to symbols and instrument labeling

Master Table of Refer to the Table of Contents for a list of all:

Contents Sections
Subsections
List of Figures
List of Tables

System Refer to this section for:

Documentation Information on content organization
Organization of the online HTML Operators Manual
Conventions for the online HTML Operators Manual
Access to the online HTML Operators Manual from the system software
Access to the online PDF Operators Manual for a stand-alone computer

CELL-DYN RubyTM System Operators Manual 9

9140544AMay 2006
Table 5: Online Operators Manual Organization (Continued)

Section 1 Use or Refer to this section for a brief description of the CELL-DYN Ruby, such as:
Function Intended use
Specimen processing sequence
Main hardware components
Basic features of the system software
Reagents, Controls, Calibrator, and Standard Reference Particles

Section 2 Installation Refer to this section for:

Procedures and Information on site requirements for installation
Special Requirements System installation and start-up guidelines
System software customization and procedural guidelines
System relocation and shipping guidelines

Section 3 Principles Refer to this section for an explanation of:

of Operation Scientific and technical principles
Types of system measurements
Data analysis and parameter reporting conventions
System Initiated Messages (SIMs) and Data Flags

Section 4 Refer to this section for details such as:

Performance Dimensions of the instrument
Characteristics and Power requirements
Specifications Environmental specifications
Operational specifications
Bar Code specifications
Performance specifications and performance characteristics

Section 5 Operating Use this section to learn how to perform:

Instructions Various tasks related to routine system operation
System customization
Background counts
Basic and advanced patient data management including reviewing,
printing, and transmitting to Laboratory Information Systems

Section 6 Calibration Use this section to learn:

Procedures When to calibrate
Pre-Calibration procedures
Calibration procedures
Post-Calibration procedures

Section 7 Operational Refer to this section to understand the precautions, limitations, and
Precautions and requirements associated with:
Limitations System operation
Handling consumables
Handling specimens
Identifying substances and conditions
Interpreting results

10 CELL-DYN RubyTM System Operators Manual

9140544AMay 2006
Table 5: Online Operators Manual Organization (Continued)

Section 8 Hazards Refer to this section for important hazard and safety information, such as:
Safety icons, laser caution labels, and hazard symbols
Biological, chemical, electrical, mechanical, and physical hazards

Section 9 Service and Refer to this section for:

Maintenance Descriptions of all maintenance procedures
Recommended schedules for service and maintenance
Instructions for performing scheduled and as-needed maintenance
procedures
Step-by-step instructions for replacing components

Section 10 Refer to this section for:

Troubleshooting and Troubleshooting basics and procedures
Diagnostics Information on probable causes and corrective actions for observed
problems, System Initiated Messages (SIMs), and Data-Related problems

Section 11 Quality Refer to this section for:

Control Internal and external quality control programs
Principles and procedures for running quality control using commercial
control material and whole blood patient controls
Procedures to customize system quality control files
Quality control data management

Section 12 This section is a self-contained module that describes how the Reticulocyte
Reticulocyte Package Package software enables the operator of the CELL-DYN Ruby System to
analyze a whole blood specimen for reticulocytes.

Appendix A Refer to this section for information that may be helpful when ordering
products:
List Numbers
Unique Identifiers

Appendix B Refer to this section for information on potential causes of spurious results.

Index Use this alphabetical listing of subject matter to link to specific information in
the operators manual about the system.

CELL-DYN RubyTM System Operators Manual 11

9140544AMay 2006
 Conventions for the printed operators manual
Conventions are a set of defined standards and are used to convey meaning in an
expected manner. The conventions used in the printed operators manual are
intended to facilitate finding, reading, understanding, and using the available
information.
Table 6: Printed Operators Manual Text Conventions

Description Use Examples

Boldface, italic Indicates related reference Section 7: Operational Precau-
section that provides information tions and Limitations
to the topic or procedure

Courier font Text entries type admin

Sans serif font, boldface, all Window name DATA LOG window
capital letters

Sans serif font, boldface, initial Window area, Menus and menu Data Set Fields area Setup
capital letters items menu
Sans serif font, boldface, initial Screen message or other screen [Waste Full] text
capital letters, enclosed in display
brackets

Sans serif font, boldface, initial Data entry field <Operator ID> field
capital letters, enclosed in angle
brackets

Sans serif font, initial capital Status or state Standby status

letters Initialized status
Ready state
Serif font, boldface, all capital Note, Caution, Warning NOTE: text
letters, followed by colon and tab
before text

Serif font, boldface, initial capital Screen buttons Data Log button
letters

Serif font, all capital letters ON, OFF set to ON set to OFF
Serif font, initial capital letters only Keyboard keys Function keys (F1) key
when appropriate arrow keys
arrow key
Enter key
ESC key
Page Up key
pound (#) key
asterisk (*) key
Signal words Highlight information that is NOTE:
relevant to the current subject CAUTION:
matter. WARNING:

12 CELL-DYN RubyTM System Operators Manual

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Table 6: Printed Operators Manual Text Conventions (Continued)

Numerical references on Indicate the area described in the 1

illustrations, photographs and table that follows or in a sidebar
reports embedded in the Figure.

CELL-DYN RubyTM System Operators Manual 13

9140544AMay 2006
Access to the PDF Operators Manual from a stand-alone computer
NOTE: Due to inconsistent nature of printing in HTML documents, we
recommend that you use the PDF version of the manual for printing.

To access the PDF operators manual from a stand-alone computer:

NOTE: Adobe Acrobat Reader must be installed in order to open the PDF
operators manual on a stand-alone computer.

1. Insert the CELL-DYN Ruby Operators Manual CD-ROM into the CD-ROM
drive of a stand-alone computer.
2. Click Start, select Run..., type D: (where D: represents the location of your
systems CD-ROM drive), select the OK button and wait for the drive
window contents to display.
NOTE: If you are unable to access the CD-ROM drive, contact your
laboratory computer specialist to troubleshoot your stand-alone computer.
3. Double click on the CELL-DYN.txt file to verify the compatibility between
the CELL-DYN Ruby Online PDF Operators Manual CD-ROM contents
and your laboratorys current CELL-DYN Ruby System software version in
use.
4. Double click on the CDROM_List_Number_Page folder to access and
review the media disclaimer.
5. Double click on the Operators_Manual_Full folder to access the
CELL-DYN Ruby Online PDF Operators Manual complete text.
NOTE: The Operators_Manual_Update folder may either be empty or
contain the individual section(s) that had been updated in the
Operators_Manual_Full folder. This update folder can be used to print the
updated pages and add them to your existing printed version operators
manual.
6. Use any of the optional Acrobat Reader search features to navigate through
the PDF operators manual. See Table 5 below for navigation options.
7. Upon completion, remove the CD-ROM from the CD-ROM drive.

14 CELL-DYN RubyTM System Operators Manual

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Table 7: PDF Operators Manual Search Navigation

Actions Steps Reference

Using the 1. Select the Bookmarks tab on the
table of navigation pane to provide a visual table
contents of contents of the operators manual
(See the graphic to the right).
1 2
2. Select the + symbols next to the book
icons to view subsections. 3
NOTE: You can select the
symbol to collapse the list. 4
3. Use the scroll bar to the right of the
navigation pane to view additional content.
4. Click on the icon to the left of the topic to
select that topic.
The topic page displays in the topic
pane (right side of window).
Paging 1. Select the Bookmarks tab on the
through navigation pane (see graphic to the
the content right), and then select a topic title. 4 2
The topic content displays in the 1
topic pane.
2. Select the Next Page button on the
toolbar to display the next page of the
manual.
3. Repeat step 2 as often as desired.
4. Select the Previous Page button to 4 2
display the previous page of the manual
(optional).
NOTE: You can also use the scroll
bar to the right of the topic pane to
page through the content.
Using the 1. Select the Table of Contents or Index tab
index on the navigation pane (see graphic to
the right).
2. Click on any topic in the Master Table of 1
Contents or Index. 2
The topic content displays in the
topic pane.
Using the 1. Select the Find button (see graphic to
Find the right).
button

CELL-DYN RubyTM System Operators Manual 15

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Table 7: PDF Operators Manual Search Navigation (Continued)

2. Type a word or phrase in the Find What:

field and select Find (see graphic to the
right).
The topic content is highlighted
and displays in the topic pane. The
Text Not Found window will display
if no occurrences were found.
NOTE: You can refine your
searches by checking the Match
Whole Word Only, Match Case and
Find Backwards selections. Type
any combination of letters (a-z) and
numbers (0-9).
3. Select the Find Again button (see
graphic to the right) to find the next
occurrence of the word or phrase in the
manual.
NOTE: The Find Again button will
continue to search to the end of the
manual and display a warning
message. Choose OK to continue
searching from the beginning of the
manual or select the Cancel to end
the search.
4. Select the Cancel button to cancel the
search (optional).
5. Type another word or phrase in the Find
What field and select Find (optional).
Using the 1. Select the Bookmarks tab on the
Glossary navigation pane, and then select the
Glossary title (see graphic to the right).
The alphabetized list of terms and
definitions displays in the topic
pane.
2. Use the scroll bar to the right of the topic
pane, as required, to display the desired
word and definition.
1 2

16 CELL-DYN RubyTM System Operators Manual

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 Section 1 Use or
Function

Section 1 Use or Function

Overview

The CELL-DYN Ruby System is a multi-parameter automated hematology

analyzer designed for in vitro diagnostic use in clinical laboratories. The
instruments utilization of the MAPSS (Multi-Angle Polarized Scatter Separation)
technology, laser flow cytometry, coupled with state of the art software, provides
you with the latest in automation available from Abbott Hematology.
Other features on the CELL-DYN Ruby include a Microsoft Windows Operating
System, USB connectivity on the data module to allow the interface of a wide
variety of printer types, and a standard hand-held bar code reader to help expedite
patient specimen identification.
.

Figure 1.1 CELL-DYN Ruby

Section 1: Use or Function presents a brief description of the CELL-DYN Ruby.

This description includes the following:
Intended Use
Specimen Processing Sequence
Main Hardware Components
Basic Features of the System Software
Reagents, Controls, Calibrator, and Standard Reference Particles
The scientific basis of the CELL-DYN Ruby methodology is presented in
Section 3: Principles of Operation.

CELL-DYN RubyTM System Operators Manual 1-1

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Use or Function
Overview Section 1

Intended Use
The CELL-DYN Ruby System is a multi-parameter, automated hematology
analyzer intended for in vitro diagnostic use in the clinical laboratories.

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Section 1 Use or Function

Indications for Use

The CELL-DYN Ruby System is designed to analyze EDTA-anticoagulated blood
and report the following hematological parameters:

White Blood Cell Parameters

WBC: White Blood Cell concentration
NEU: Neutrophil absolute concentration
%N: Neutrophil percentage of WBC
LYM: Lymphocyte absolute concentration
%L: Lymphocyte percentage of WBC
MONO: Monocyte absolute concentration
%M: Monocyte percentage of WBC
EOS: Eosinophil absolute concentration
%E: Eosinophil percentage of WBC
BASO: Basophil absolute concentration
%B: Basophil percentage of WBC

Platelet Parameters
PLTPlatelet concentration
MPVMean Platelet Volume

Red Blood Cell Parameters

RBCRed Blood Cell concentration
HCTHematocrit
MCVMean Cell Volume
RDWRed Cell Distribution Width
%RReticulocyte Percent
RETCReticulocyte absolute concentration

Hemoglobin Parameters
HGBHemoglobin concentration
MCHMean Cell Hemoglobin
MCHCMean Cell Hemoglobin Concentration

CELL-DYN RubyTM System Operators Manual 1-3

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Use or Function
Overview Section 1

NOTES

1-4 CELL-DYN RubyTM System Operators Manual

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Section 1 Use or Function

Specimen Processing Sequence

This subsection describes how the hardware, reagents, and software components of
the CELL-DYN Ruby interact to create the Specimen Processing Sequence. This
sequence is as follows:
Specimen Loading and Presentation
Specimen Identification and Test Selection

Specimen Loading and Presentation

The CELL-DYN Ruby provides two ways to introduce a specimen to the Analyzer.

Closed Mode
Sampling is performed by using the sample loader module which is attached to the
front of the analyzer. The sample loader module enables the operator to load up to
50 closed-tube samples at one setting, minimizing contact with patient specimens.
Sample loader components read the rack number and tube position bar codes, mix
the blood, and move the tubes through the Sample Processing area. These
components are described later in this section.
Sample loader barcode also reads the tube specimen barcode ID, if present.

Open Tube Mode

The Analyzer aspirates the specimen from an open collection tube presented by the
Operator. Open Tube Mode sampling supports the Reticulocyte parameters. See
Section 12: Reticulocyte Package for details.

Specimen Identification and Test Selection

Each specimen is identified by a unique time- and date-stamped sequence number
and can be identified by a specimen identification number. The test selections can
be made automatically or manually. Detailed information about specimen
identification and test selection is included in Section 5: Operating Instructions,
Subsection: Specimen Identification Methods.
In the Closed Mode, test selections created electronically from a Laboratory
Information System (LIS), or entered manually using the Create Order function
key in the Orders view, along with the bar code label, identify the specimen. The
CELL-DYN Ruby software uses the bar code labels and the Pending Orders log in
the Orders view to identify the specimen and tests requested. If there is no order in
the Pending Orders log, the system runs a default test selection which was
configured in Setup from the menu bar.

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Use or Function
Specimen Processing Sequence Section 1

In the Open Tube Mode, a specimen ID is manually entered, or the bar code label
is scanned in to the Next Open Tube Entry (NOTE) region. The
CELL-DYN Ruby software searches for a matching specimen ID in the Pending
Orders log of the Orders view. When a match is found, the software updates the
test selection in the NOTE region. See Section 5: Operating Instructions for
details about the Orders view and Pending Orders log.
NOTE: The system alerts the operator if a RETIC test selection is found when it
is not in the RETIC test mode. The system also alerts the operator if a
non-RETIC test selection is found and the system is in the RETIC
processing mode.
In Open Tube Mode, the Hand-Held Bar Code Reader can be used to identify the
specimen; or, the operator can visually identify the specimen, enter the patient
information, and select the test in the Next Open Tube Entry (NOTE) region. If
the Specimen ID entered into the Specimen ID field in the NOTE region exists in
the Pending Orders log, the specimen demographics will be placed into the
NOTE (detailed) view.
Specimen identification, patient information, and test selection results appear in
several places:
Datalog
Run View
After sample aspiration, the patient information can be edited in the Datalog view
by selecting the sample record in the Datalog and the F4Edit function key. The
function keys opens the Edit Demographic Information dialog box. Edits are
automatically recorded to the System Event Log.
See also Section 5: Operating Instructions, Subsection: Post-Analysis
Processing Datalog View and Section 9: Service and Maintenance,
Subsection: Event Log.

Test Selections
The CELL-DYN Ruby test selections are described in the following table:

Test Selection Printed

Test Selection Description
or Displayed

CBC Complete Blood Count

CBC + NOC Complete Blood Count with Nuclear Optical Count

CBC + RRBC Complete Blood Count with Resistant RBC

RETIC Reticulocyte

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System Components

The CELL-DYN Ruby System consists of these major modules: the Analyzer, the
Data Module (computer), and the flat panel Display. The Analyzer and the Data
Module are housed in a single chassis. The Display is a standalone module.
The Analyzer contains the hardware to mix, present, aspirate, dilute, and analyze
each specimen.
The Data Module contains the components for analyzing, storing, and reporting
specimen results.
The flat panel Display includes touch screen capability to enhance user interface
interaction.

Analyzer
The Analyzer does the following:
Identifies specimen
Mixes and presents each specimen for aspiration
Aspirates and dilutes the blood sample
Transports and analyzes the sample dilutions
Rinses fluidic components in preparation for the next sample dilutions
The following are key parts of the Analyzer:
Analyzer Front
Covers
Status Indicator Lights
Open Tube Mode Touch Plate
Open Tube Mode Aspiration Probe (Open Mode Probe)
Analyzer Right Side
CD-ROM or DVD Drive
Floppy Disk Drive
Data Station Power Button
Intake Fan and Filter
Analyzer Left Side
Intake Fan and Filter

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Analyzer Sample Processing

Sample Loader
Mixing Assembly
Sample Processing Area
Analyzer Flow Panels
Left Flow Panel
Right Flow Panel
Analyzer Internal Assemblies
Optical Bench Assembly
Analyzer Rear
Main Power Switch
Main Power Connector
Exhaust Fans
Reagent Inlet Connectors
Waste Sensor Jack
Waste Outlet Connector
Data Module (Computer) Cable and Port Connectors

Analyzer Front
Covers
A set of front covers encloses and protects the Analyzer mechanisms and flow
panel. These covers are designed to be opened for inspection and maintenance
procedures. The covers should always be in place during System operation. The
covers for the Analyzer are as follows:
Left Flow Panel Cover
Right Flow Panel Cover
Processor Cover

Left Flow Panel Cover

The Left Flow Panel Cover on the front of the Analyzer provides access to the Left
Flow Panel. The cover is held in place by hinges (located on the inside left edge of
the cover) and magnetic fasteners (located on the inside top edge of the cover). The
cover opens from the center with finger grips located at the lower right of the cover.

Right Flow Panel Cover

The Right Flow Panel Cover on the front of the Analyzer provides access to the
Right Flow Panel. The cover is held in place by hinges (located on the inside right
edge of the cover) and magnetic fasteners (located on the inside top edge of the
cover). The cover opens from the center with finger grips located at the lower left
of the cover.
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Processor Cover
The Processor Cover is located in the middle of the front of the Analyzer and fits
over the Sample Processing Module, Mixing Assembly, and Shear Valve
Assembly. The Processor Cover is not intended to be removed by the operator
during routine operation. The Processor Cover is used to restrict access to the
Sample Processing Module on the sample loader during operation. A sensor detects
if the cover is removed during operation and will stop the loader and generate a
fault message. The operator must re-install the cover and clear the fault in order to
resume operation. The cover must be in place during initialization or else a fault
message is generated.

Status Indicator Light

Status Indicator Light Emitting Diodes (LEDs) are located on the front of the
Analyzer. The LEDs inform the operator of the current operating status of the
CELL-DYN Ruby. The following table lists the LEDs, their color, and an
explanation of their status indications.
Table 1.1 Status Indicator LEDs

LED Color Status Indication

READY Green The Analyzer is ready to run specimens.

BUSY Yellow The Analyzer is busy.

FAULT Amber The Analyzer is not ready to run specimens.

Open Tube Mode Touch Plate

The Open Tube Mode Touch Plate is a spring-loaded touch plate located in the
center frame of the Sample Loader. The Touch Plate is used to start the run cycle
for the Open Tube mode only. Pressing the Touch Plate starts the aspiration for the
selected run cycle.

Open Tube Mode Aspiration Probe (Open Mode Probe)

The Open Tube Mode Aspiration Probe is used to aspirate the specimen from an
opened collection tube. During open sampling, the wash block moves down to the
end of the probe and returns to its up position at the conclusion of the specimen run.
When Select Closed is selected, the Wash Block moves down to the end of the
probe and remains down until the Select Open is again selected.

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System Components Section 1

Analyzer Right Side

1 CD-ROM or DVD
Drive 1
4
2 Floppy Drive
3 Data Station Power 3
Button 5
2
4 Main Power Switch
(Rear Panel)
5 Intake Fan

Figure 1.2 Analyzer Right Side

CD-ROM or DVD Drive

The CD-ROM or DVD Drive allows the installation of software and the online
operators manual, provides backup and restoration of laboratory setup data, and
database record storage to CD-R media.

Floppy Disk Drive

The Floppy Disk Drive accepts high-density (1.44 megabyte), 3-inch diskettes to
transfer quality control assay information to the Analyzer and download quality
control numerical result files for participants in the CELL-DYN eQC Program.

Data Station Power Button

The System Data Station Power Button turns on both the Data Module (computer)
and Analyzer Systems.

Intake Fan
The Intake Fan provides air flow through the Analyzer chassis.

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Analyzer Left Side

Intake Fan
The Intake Fan provides air flow through the Analyzer chassis.

1 Intake Fan

Figure 1.3 Analyzer Left Side

Analyzer Sample Processing Area

Sample Loader Components
The major components of the Sample Loader are depicted in the following figure.

1 Open Tube Mode

Aspiration Probe (with
Wash Block)
2 Open Tube Mode
Touch Plate
3 Y-Valve Assembly
3
4 Mixhead Assembly
5 Tube Sensor
Assembly 1 9
6 Bar Code Reader
7 Tube Spinner
Assembly 8
8 Closed Mode Needle
(with Wash Block)
9 Specimen Rack(s)
10 Sample Loader Load 10
7
Side
11 Sample Loader
11
Unload Side 5 2
6
4

Figure 1.4 Sample Loader Components

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Open Tube Mode Aspiration Probe (with Wash block)

The Open Tube Mode Aspiration Probe (Open Mode Probe) is utilized to aspirate
the patient specimen while in the open sampling mode. Vacuum is applied to the
aspiration probe to draw in the sample for analysis. A Wash Block is used to clean
the outside of the probe by moving up/down and rinsing with Diluent/Sheath
Reagent. The wash block covers the probe tip throughout the run cycle to rinse the
probe and sample line and retracts prior to the instrument returning to Ready
status. Waste is removed through the use of a vacuum source and is deposited into
a waste chamber.

Open Tube Mode Touch Plate

The Touch Plate is utilized during open tube sampling and is pressed to activate an
open mode run cycle.

Y-Valve Assembly
The Y-Valve Assembly has a three-way valve with motor that switches between the
Open Mode Probe and the Closed Mode Needle for aspirating patient specimens.

Mixhead Assembly
The Mixhead Assembly consists of a double-tube holder directly attached to a
stepper motor. As the rack advances, the tube holder descends and grabs the tube.
The tube holder rotates 15 times in an inward motion of approximately 135
degrees. The double-tube configuration of the tube holder allows each tube to be
held and mixed twice in succession before it passes to the tube spinner assembly.
An air cylinder controls the up/down movement of the Mixhead Assembly.

Tube Sensor Assembly

The Tube Sensor Assembly senses the presence of a specimen tube at each
Mixhead Assembly mixing station.

Bar Code Reader

The Bar Code Reader is an LED type that can accommodate Code 39, Code 128,
CODABAR, Interleaved 2 of 5, and ISBT formats. The Bar Code Reader is located
on the center frame section of the Sample Loader. It reads the bar code on the tube
when the tube is at the aspiration station. The Bar Code Reader is also utilized to
read the bar code labels on sample racks to ensure proper rack movement and for
positive patient identification.

Tube Spinner Assembly

The Tube Spinner Assembly consists of a tube holder, motor, and belt. These
components are attached to the Closed Mode Needle drive mechanism, and they
move up and down in tandem with the needle. As the Tube Spinner Assembly and
needle descend together, the spinning tube holder centers and rotates the specimen
tube, allowing the Bar Code Reader to read the bar code on the sample tube. After
the bar code is read, the needle penetrates the rubber stopper and aspirates the
sample.

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Closed Mode Needle (Vent Needle with Wash Block)

The Closed Mode Needle is used to aspirate the patient specimen from a closed
collection tube and is used while in the Closed Mode. The needle consists of two
ports; one port for sample aspiration and the other for closed tube venting. During
operation, the needle pierces the collection tube stopper, vents the tube, aspirates
patient specimen and retracts for rinsing at the end of each cycle. Needle rinsing is
performed by the wash block that utilizes Diluent/Sheath Reagent. Waste is
removed through the use of a vacuum source and is deposited into a waste chamber.

Specimen Rack(s)
Each Sample Loader Specimen Rack is able to accommodate up to 10 tubes.
Specimen racks are labeled with rack number and tube position, using a 2-digit bar
code label.

Sample Loader Load Side

The Load Side accommodates from one to five racks with specimen tubes for
sample processing through the Sample Loader. Once all specimen racks have been
processed, a message alerts the user that the load side is empty.

Sample Loader Unload Side

The Unload Side receives one to five racks with specimen tubes after they have
been processed. Once four racks are received after processing, a message alerts the
user that the unload side is nearly full. When five racks enter the unload side, a
message alerts the user that the unload side is full.

Sample Processing Module

The Sample Processing Module is attached to the Sample Loader and contains
components used for Closed Mode tube sampling. The Processor Cover previously
described is used to restrict user access to the Sample Processing Module area
during operation.
The Sample Processing Module consists of the following components:
Closed Mode Needle (Aspiration/Vent)
Wash Block
Tube Spinner Assembly
Mixhead Assembly
Y-Valve Assembly

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System Components Section 1

Analyzer Flow Panels

Right and Left Flow Panels
The major components of the Right and Left Flow Panels are depicted in
Figure 1.5. A brief description of Flow Panel components follows.

1 Vent Chamber 11
2 Sample Transfer 6
Peristaltic Pump 9 10
7
3 Waste Chambers CAUTION Class 3B laser light when open. Avoid
exposure to beam.
VORSICHT Bei offener Abdeckung Laserstrahlung der
Klasse 3B. Nicht direkt in den Laserstrahl blicken.
ATTENTION Rayon laser de classe 3B si ouvert. Eviter
toute exposition au faisceau laser.
PRECAUCIN: Haz de lser de clase 3B. Evite la
exposicin al lser cuando el analizador est abierto.
ATTENZIONE: fascio laser di classe 3B se aperto. Evitare
lesposizione al raggio.
ATENO Quando aberto, emite luz laser da classe
3B. Evitar a exposio ao raio laser.
VIGTIGT: Klasse 3B-laserlys ved bning. Undg
eksponering for strlen.

4 WBC Mixing
VIKTIGT: Klass 3B laserljus nr luckan r ppen. Undvik
exponering f r strlen.
3
.
.
UPOZORNN: Po oteven krytu nebezpe ozen
laserem tdy 3B. Vyvarujte se kontaktu s paprskem.

19
PN 9230701F

Chamber/WOC 5
Heater 20
5 RBC/PLT Mixing 8
Chamber 2
6 HGB Flow Cell/Mixing 4
Assembly
7 Shear Valve Assembly 18
8 Normally Closed
Valves 1
9 Diluent Reservoir 12
10 Sheath Reservoir 3
11 Normally Closed
Valves 13 14 15 16 17
12 Diluent/Sheath Filter
13 Sample Injection
Syringe
14 HGB Lyse Syringe
15 WBC Lyse Syringe
16 Diluent/Sheath
Syringe
17 Waste Chambers
18 WBC Lyse Reservoir
19 HGB Heater Assembly
20 Solenoid Valves
(example)

Figure 1.5 Flow Panel Components

Vent Chamber
The Vent Chamber allows various components such as the WBC, RBC and HGB
Mixing Chambers to equalize to atmospheric pressure for effective function.

Sample Transfer Peristaltic Pump

The Sample Transfer Peristaltic Pump is composed of a rotor and a pump tube
holder. It is used to transfer the WBC dilution, RBC/PLT dilution, and HGB/NOC
dilution to the Optical Flow Cell from their respective mixing chambers.

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Waste Chambers
The Waste Chambers collect the liquid waste from the Analyzer flow panel.

WBC Mixing Chamber/WOC Heater

The combination of a WOC heater and mixing chamber allows the WBC Lyse
Reagent to be controlled at room temperature prior to being delivered to the mixing
chamber. Pressurized air (bubble mix) is use to mix the sample and reagent being
delivered to the mixing chamber. The dilution is then delivered to the Optical Flow
Cell for processing.

RBC/PLT Mixing Chamber

The RBC/PLT Mixing Chamber utilizes pressurized air (bubble mix) to mix the
sample and reagent being delivered to the mixing chamber. The dilution is then
delivered to the Optical Flow Cell for processing.

HGB Flow Cell and Mixing Chamber

The HGB Flow Cell Assembly is integrated with a mixing chamber and contains
the following components:
A fully enclosed (light-tight) mixing chamber with optical windows and
electronics
An LED Light Source
A Photodetector for measuring the light transmitted

HGB Heater Assembly

The HGB Heater Assembly pre-heats the diluent for HGB and HGB/NOC Lyse
prior to dispensing into the HGB Mixing Chamber. The reagent is heated above
room temperature to ensure a consistent reaction temperature for HGB.

Shear Valve Assembly

The three-piece ceramic Shear Valve isolates a precise volume of sample by means
of a shearing action as the front and rear sections of the valve rotate. The aspirated
sample is isolated in three separate volume segments one for the WBC dilution,
one for the HGB dilution and one for the RBC/PLT dilution. Sensors located before
and after the shear valve control sample being aspirated into the probe and being
transferred into the shear valve. In both Open and Closed modes an ultrasonic
sensor checks the segment movement as it is being aspirated. Additionally, in the
Closed mode, an additional optical sensor checks the segment as it exits the shear
valve.

Normally Closed Valves

The Normally Closed Valves remain closed even after the power to the instrument
is turned off to prevent the backflow of reagents into critical areas.

Diluent Reservoir
The Diluent Reservoir maintains a Diluent/Sheath Reagent supply for cleaning
and sample dilution.

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System Components Section 1

Sheath Reservoir
The Sheath Reservoir maintains a Diluent/Sheath Reagent supply, separate from
that of the Diluent Reservoir, for hydrodynamic focusing of the sample cell stream
through the Flow Cell.

Diluent/Sheath Filter
The Diluent/Sheath Filter is placed in-line between the Sheath Reservoir and
Optical Flow Cell, as well as the Sample Injection Syringe, to eliminate micro
bubbles.

Syringe Assembly
There are two syringe driver assemblies, each containing two syringes. Each
syringe is operated by its own stepper motor. The function of each syringe is
described below:
Sample Injection Syringe injects a specific volume of the diluted sample
into the Optical Flow Cell for RBC/PLT, WBC (WOC), and WBC (NOC)
measurements.
HGB Lyse Syringe delivers a specific volume of HGB Lyse to the HGB
Mixing Chamber/Flow Cell to further dilute the HGB segment prior to
measurement.
WBC Lyse Syringe delivers a specific volume of WBC Lyse to transport
the WBC segment from the Shear Valve to the WBC Mixing Chamber,
dilutes the segment prior to measurement and a specific volume of WBC
Lyse is delivered to rinse the WBC Mixing Chamber.
NOTE: The WBC Lyse Syringe does not deliver the rinsing solution. The
rinsing solution is delivered by pressure from the WBC Lyse
reservoir.
Diluent/Sheath Syringe (1) delivers a specific volume of Diluent/Sheath
to transport the RBC segment from the Shear Valve to the RBC/PLT Mixing
Chamber and to dilute the segment prior to measurement, and (2) delivers a
specific volume of diluent to transport the HGB segment from the Shear
Valve to the HGB Mixing Chamber and to dilute the segment prior to
measurement.

Solenoid Valves
The Solenoid Valves are used throughout the entire instrument, but particularly on
the Front Flow Panel. They are used to control air and liquid movement during
instrument operation.

WBC Lyse Reservoir

The WBC Lyse Reservoir maintains a WBC Lyse Reagent supply that is used to
dilute the sample that is presented to the Optical Flow Cell Assembly. The reagent
is also used to flush and clean the WBC Mixing Chamber prior to the next run
cycle.

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Analyzer Internal Assemblies

Optical Bench Assembly
Description and illustrations of the Optical Bench Assembly are provided for
information purposes only. Access to this area is restricted to authorized Abbott
Service and Support Personnel only.

Laser Optics Assembly

The laser tube, a Helium-Neon gas laser, projects a beam that is shaped and
focused onto the Optical Flow Cell Assembly for detection and measurement
of blood cells.
A series of optical mirrors and lenses are used to shape and focus the beam
onto the Optical Flow Cell Assembly.
The Forward Angle Light Scatter Detectors are used to capture scattered light
in the 0 and 10 forward angles for count and measurement purposes.
The Orthogonal Light Scatter Detectors are used to capture scattered light in
the 90 and 90 Depolarized angles for measurement purposes. Compiled
orthogonal and forward light scattered data is used to generate WBC count/
differential, RBC/PLT counts including MCV, NOC counts and Reticulocyte
results.

1 Optical Flow Cell 2

Assembly 5
2 Laser Tube
3 Laser Beam Shaping
Components (e.g.
Mirrors, Lenses and
Slits)
4 Forward Angle
(0 and 10) Light
Scatter Detectors
5 Orthogonal
(90 and 90D) Light
Scatter Detectors

4
3 1
Figure 1.6 Optical Bench

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System Components Section 1

Optical Flow Cell Assembly

The Optical Flow Cell Assembly contains the fluidics and hardware needed
to hydrodynamically focus the RBC/PLT, WBC, and NOC sample streams in
the path of the laser beam for analysis. The primary components of this
assembly are:
Sample Feed Nozzle a specially designed tube used to deliver the diluted
sample into the sheath stream
Sample Flow Cell an optically clear quartz chamber with a central square
opening of a specific size, which flares out into a cone at the bottom of the
flow cell

Analyzer Rear
1 Main Power Switch
2 Main Power
1
Connector 10
3 Exhaust Fans
4 WBC Lyse Reagent
Inlet Connector
5 Diluent/Sheath
8 7 6 5 4
Reagent Inlet 9
Connector
3
6 HGB Lyse Reagent
Inlet Connector
7 Waste Outlet
Connector
8 Waste Sensor Jack 2
9 Data Module
(Computer)
10 CPU Exhaust Fan

Figure 1.7 Analyzer Rear

Main Power Switch

The Main Power Switch is labeled POWER . Refer to the previous figure for
location.

Main Power Connector

The Main Power Connector connects the Analyzer to an external power source.

Exhaust Fans
The Exhaust Fans provide air flow through the analyzer chassis.

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Reagent Inlet Connectors

These connectors attach the tubing from the reagent containers to the Analyzer.
The container end of each piece of tubing has a cap, sinker, and label. The
following color-coded connectors are located on the Analyzer:
WBC Lyse Reagent Inlet Connector
Diluent/Sheath Reagent Inlet Connector
Hemoglobin Reagent Inlet Connector
Table 1.2 Reagent Inlet Connectors

Label Reference Reagent Inlet Connector Connector Color

WBC LYSE WBC Lyse Reagent Purple

Inlet Connector

DILUENT/SHEATH Diluent/Sheath Reagent Red

Inlet Connector

HGB Hemoglobin Reagent Inlet Blue

Connector

WBC Lyse Reagent Inlet Connector

The WBC Lyse Reagent Inlet Connector (color-coded purple) attaches the WBC
Lyse Reagent inlet tubing to the Analyzer.

Diluent/Sheath Reagent Inlet Connector

The Diluent/Sheath Reagent Inlet Connector (color-coded red) attaches the
Diluent/Sheath Reagent inlet tubing to the Analyzer.

Hemoglobin Reagent Inlet Connector

The Hemoglobin Reagent Inlet Connector (color-coded blue) attaches the
Hemoglobin Reagent inlet tubing to the Analyzer.

Ground Connector
See Waste Sensor Jack.

Waste Outlet Connector

The Analyzer Waste Outlet Connector, labeled WASTE OUTLET , attaches the
Analyzer waste tubing to the Analyzer. The Analyzer waste tubing evacuates the
liquid waste from the Analyzer to an external waste container or drain. See
previous figure.

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System Components Section 1

Waste Sensor Jack

The Waste Sensor Jack, labeled WASTE SENSOR , accepts the Waste Sensor Plug
that connects the Waste Sensor Electrodes to the electrical Waste Sensor in the
Analyzer. A disconnected Waste Sensor Plug will be interpreted by the System as
an external Waste Full message and the Ready state is inhibited until the situation
is corrected. The ground shield on the cable should be attached to the Ground
Connector on the rear panel. If waste is routed directly to a drain rather than to a
waste container, a dummy plug (supplied in the Accessory Kit) must be inserted
into the Waste Sensor Jack.

Data Module (Computer) - Cable and Port Connectors

See the following Subsection: Data Module Components for a description of the
components of the Data Module and associated cable and port connections used
with the CELL-DYN Ruby.

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Data Module Components

The major hardware component cable and port connections are depicted within this
section. A description of each component's function follows.

1
4 5
7 2 3 6
5
8 1
3
2 4

1 Printer 4 Flat Panel Display 6 Analyzer Power Cord

2 Mouse 5 Touch Screen Interface to Data 7 Printer Power Cord
3 Hand-Held Bar Code Reader Module 8 Monitor Power Cord
or Keyboard

Figure 1.8 Hardware Component Cable and Connection Overview - Rear View

Data Module Computer

High-speed Microprocessor 2.0GHz or faster
RAM: 512MB or larger
Hard Disk 5.1GB or larger
1 parallel port
1 serial port
4 USB Ports
Video and Sound card

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System Components Section 1

1 HSSL (2)
2 Printer LPT1 (Parallel
Port Not Used) 1
3 LIS (Serial Port
COM1) 2 3
4 Flat Panel Display
5 Keyboard/Hand-Held
8 9 10 11
Bar Code Reader
6 USB (2) Touch Screen
& Printer
7 RJ-45 Network
(Reserved) 4 5 6 7
8 USB (2) Mouse and
Spare
9 Line Out (For Display
1
Speaker)
10 Line In (Not Used)
11 MIC (Microphone
Not Used)

Figure 1.9 Data Module Computer Component Connections - Rear View

HSSL (High Speed Serial Link) Connectors

The High Speed Serial Link transfers data between the Analyzer and the Data
Module. The HSSL Connector on the Data Module connects to the HSSL
Connector on the back panel of the Analyzer rear panel.

Graphics Printer (Parallel) Connector (Not Used)

This connector allows printers with parallel connections to interface to the system.

LIS (Laboratory Information System) Connector

LIS serial port is used to connect the Laboratory Information System to the Data
Module.

Flat Panel Display Connector

The Flat Panel Display Connector allows connection of the Flat Panel Display to
the Data Module Computer.

PC Keyboard/Hand-Held Bar Code Reader Connector

This port allows connection of a standard PC Keyboard. It can also accommodate
the hand-held bar code reader by using a specialized connector (included with the
unit) to attach to the PC Keyboard connection.

Universal Serial Bus (USB) Port(s)

These ports allow connection of the mouse, touch screen and USB compatible
printers.

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RJ-45 Network Connector

This port allows System Interface to Laboratory Network Systems.

Line Out Connector

This connector allows connection of the Flat Panel Display speakers to the Data
Module Computer.

Flat Panel Display with Touch Screen

The 17-inch Flat Panel Display provides a high-resolution graphical interface with
an additional feature of touch screen capability for navigation through the
CELL-DYN Ruby application software. The Display switches automatically
between 100 and 240 volts.
The following are on the right hand side of the Flat Panel Display (see attached
figure):

User Controls

Figure 1.10 Flat Panel Display (Right Side)

Adjustment Buttons control the Display

ON/OFF Switch powers up and powers down the Display
The following are on the rear of the Flat Panel Display (see attached figure):
Connections on Underside
CONNECTIONS ON UNDERSIDE

POWER

Power Display USB

Cable Cable Touchscreen
Cable

Figure 1.11 Flat Panel Display (Back Side)

Power Cable connects the Display to an external power source

NOTE: Use a cable that is approved for this application.

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System Components Section 1

Display Cable connects the Display to the Data Module Computer

USB Touch Screen Cable connects the Display to the Data Module
Computer

Keyboard
The standard computer keyboard provides complete input functionality. It contains
a complete set of alphanumeric keys that can be used for data entry. The keyboard
connects to the rear panel of the computer. Certain keys have special uses
dependent on the area or dialog screen that is active. The following figure depicts
an example of an abbreviated standard keyboard used with the CELL-DYN Ruby.
The following table lists these keys and their functions.

Figure 1.12 Example of Standard English Keyboard

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Table 1.3 Keyboard Keys and Their Functions on the CELL-DYN Ruby

Press: To:

Numeric keys (above Enter data in fields.

keyboard letter keys)

Numeric keypad keys Enter data in fields.

(calculator arrangement
of keys at right of
keyboard)

Enter Accept data typed in a specific field and move cursor to next field (windows with
text entry fields).

[~] Tilde character associated with Quality Control bar code IDs.

Tab Move cursor to beginning of next field (left to right, top to bottom).

Shift + Tab Move cursor to previous field (right to left, bottom to top).

Shift + Left Mouse Click Highlight a range of selected records in a log view.

Ctrl + Left Mouse Click Highlight selected individual records in a log view.

Insert Toggle between inserting and overwriting text.

Backspace Remove characters to left of cursor.

Delete Remove characters to right of cursor.

Print Scrn Print the displayed screen view.

Num Lock Activate the numeric keypad area on the keyboard used to type numbers.

Esc Reset unresponsive mouse actions when attempting to select buttons or text.

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System Components Section 1

Mouse Input Device

A mouse input device is provided with the CELL-DYN Ruby System. The mouse
can move the cursor to select buttons and text, and turn options ON and OFF. The
following table describes how to use the mouse.

Mouse

Figure 1.13 Using the Mouse Input Device

Table 1.4 Mouse Actions

Task Mouse Action

Move cursor Move mouse on flat surface to change cursor

position on screen.

Select buttons or text 1. Position cursor on button or text.

2. Click (quickly press and release) left mouse
button.

Open drop down menu in 1. Position cursor in a view.

a view 2. Click (quickly press and release) right mouse
button.

NOTE: When dialog boxes used for text entry are opened, the mouse can be used
to move the text cursor to the left most area of the desired field by clicking
in it before attempting to type any characters.

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Hand-Held Bar Code Reader

The Hand-Held Bar Code Reader uses an LED light and can read and interpret any
bar code that meets the specifications described in Section 4: Performance
Characteristics and Specifications, Subsection: Bar Code Specifications.
The hand-held reader can be used to rapidly input the Quality Control specimen bar
code identification number into the NEXT OPEN TUBE ENTRY (NOTE) region
and enter reagent lot numbers and expiration dates into the New Reagent Entry
dialog box.
The Hand-Held Bar Code Reader must also be set up to indicate whether a check
character is used with the different supported bar code symbologies. This
customization is done within the unit itself, not from the CELL-DYN Ruby
software. For complete instructions, see the Hand-Held Bar Code Reader Users
Guide.
NOTE: The Hand-Held Bar Code Reader is connected in series to the keyboard
(see the following figure) and must be properly installed and programmed
before being used with the CELL-DYN Ruby. See the Hand-Held Bar
Code Reader Users Guide for complete information.
NOTE: Do not leave the Caps Lock key on the keyboard when using the
Hand-Held Bar Code Reader.

1 Keyboard
2 Hand-Held Bar Code
Reader

1 2

Figure 1.14 Hand-Held Bar Code Reader Connection.

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System Components Section 1

Printers
Printers available for use with the CELL-DYN Ruby include a standard color
printer (parallel or USB connector) or an optional color laser printer (USB
connector).
Results can be automatically printed at the completion of each run cycle or can be
printed on demand by the operator. Graphics reports are printed in color.
Complete information about printer capabilities and requirements can be found in
the printer manufacturers printer manuals. Descriptions of printer components,
safety precautions, running self-test printouts, types of replacement toner and
cartridges, and instructions on changing cartridges and loading paper are included
in the printer manual. Do not use printer cables longer than 10 feet (three meters).
Instructions for customizing the printout format and report headings are included
in Section 2: Installation Procedures and Special Requirements, Subsection:
Customize Printed Report.
CAUTION: Use of a non-Abbott-recommended printer must be validated
by your laboratory for use as it may lead to erroneous printer functionality.
Contact your Country Service and Support Center for information on printer
compatibility. Refer to Appendix A: Parts and Accessories for component
List Numbers.

The CELL-DYN Ruby software automatically controls and adjusts most print
conditions, including page width and color. It is recommended to select File, Print
Preview from the menu bar prior to selecting the F1 Print from the views. The
System will notify the operator if the layout of the view displayed spreads over one
page.
NOTE: Based on the printer manufacturer's color mapping software, you may
experience variations within the spectrum of color specified to print by
the CELL-DYN Ruby software.
Table 1.5 Printing Options

Graphics Printing

Printer Port USB Parallel

Connection Type

Report Forms Single copy Single copy

Paper Feed Single sheet Single sheet

Paper Size US letter, A4 US letter, A4

Ink Color Color

Header Up to four lines Up to four lines

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Section 1 Use or Function

System Software

The CELL-DYN Ruby contains the following sets of software:

Analyzer Operating Software
Data Station Operating Software

Analyzer Operating Software

The Analyzer Operating Software (AOS) controls the fluidic and mechanical
operation of the Analyzer, monitors System functioning, and provides the
framework for the flow sequences. The AOS is downloaded from the Data Module
to the Analyzer each time the System Computer is initialized.

Data Station Operating Software

The Data Station Operating Software (DSOS) supports the operator interface,
communicates with the AOS to initiate tasks and obtain measurement results, and
manages the processing, storage, and output of measurement results.
CELL-DYN Ruby software performs a confirmation of numerical entries in data
entry fields. This confirmation is performed as the operator enters text in fields or
when the OK button is selected in the active dialog box. The software matches the
entered date and time with established format, and checks that integers and
decimals entered are within specified ranges and that there are no invalid
characters. A message bulletin line of text will display at the bottom of the dialog
box indicating the field or fields where the invalid entry occurred. Examples
include:
Specimen ID name must include between 3 and 20 non-space characters
Westgard Rules are disabled until limits represent 2 or 3 standard deviations
No records found by the specified match criteria

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Use or Function
System Software Section 1

Screen Navigation
Screen Layout
These are the main sections as shown in Figure 1.15.

SYSTEM
MESSAGES
REGION

REGION

Figure 1.15 Screen Layout

The main sections are:

Title Bar
Menu Bar
Tool Bar
Status Bar and System Messages Region
NOTE Region
View
Function Keys

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Title Bar

Figure 1.16 Title Bar Example

The purpose of the Title bar is to identify the main view being displayed. The Title
bar also displays the CELL-DYN Rubys last run datalog sequence number and the
current date and time.

Menu Bar

Figure 1.17 Menu Bar Example

The Menu bar contains the menu command items available in CELL-DYN Ruby
software. To display the CELL-DYN Ruby menu commands, open each menu item
on the Menu bar using a single mouse click. Scroll down the menu list using the
mouse cursor and single click on the command item to open the menu command
dialog box.
NOTE: Options may be greyed out (inactive) based on user access level or
analyzer status.
Table 1.6 Menu Bar Commands

Menu Bar Item Menu Commands

File

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System Software Section 1

Table 1.6 Menu Bar Commands

Setup

Calibration

Diagnostics

Help

Sign Off

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Tool Bar

Figure 1.18 Tool Bar Buttons

The Tool Bar Buttons control the display of the Main View and the associated
Function Keys. To change the Main View, single mouse click on each tool bar
button. The identity of the main view is displayed in the Title bar of the screen
layout. Refer to Figure 1.15 Screen Layout.
Table 1.7 Tool Bar Button Navigation

Display Change and

Tool Bar Buttons
Main View Description Displayed Function Keys Associated Function
and Icons
Keys

Run View Displays F1-Print None

Specimen view of last run
sequence number

Orders Displays F1-Print None

Pending Orders
F3-Find/Filter

F4-Edit

F6-Create Order

Datalog Displays F1-Print None

System Data Log
F2-Transmit

F3-Find/Filter

F4-Edit

F7-View Specimen F6-Create Order

F7-Previous Specimen

F8-Next Specimen

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Use or Function
System Software Section 1

Table 1.7 Tool Bar Button Navigation (Continued)

QC View Displays F1-Print None

QC Log
F2-Transmit

F3-Find/Filter

F4-Edit

F5-Moving Average F8-Closed Batch Data

F8-Levey Jennings

F7-View QC Spec F7-Previous Specimen

F8-Next Specimen

F8-QCID L-J Plot F5-Download QCID

Data

F6-View QC Setup

F8-QCID Data

F5-Reject/Accept

F6-View QC Setup

F7-View QC Spec

F6-QCID Data

F7-Previous
Specimen

F8-Next
Specimen

Groups Displays F1-Print None

FWBC Group
NRBC/RRBC Group F2-Transmit
Exceptions
F3-Find/Filter
Not Transmitted Group
F4-Edit

F5-Delete All

F6-Create Order

F7-View Specimen F7-Previous Specimen

F8-Next Specimen

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Table 1.7 Tool Bar Button Navigation (Continued)

Reagents Displays F1-Print None

Current Reagent Status,
Reagent Log F3-Find/Filter

F4-Edit

F6-New Entry

Maintenance Displays F1-Print None

Scheduled, As-Needed,
Special Protocols, F3-Find/Filter
Maintenance Log
F4-Edit

System Displays Event F1-Print None

Log, Calibration Log, Set
Point Log F3-Find/Filter

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Use or Function
System Software Section 1

Status Bar and System Messages Region

The Status bar consists of four function keys and three distinct regions:
Analyzer Status
QC Status
System Messages
Status Bar Function Keys

Figure 1.19 Status Bar

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Analyzer Status Region

Provides the System status for:
Analyzer Operating States
Standby, Initialized, Priming, Ready, Maintenance
System Sampling Mode
Open or Closed
System Status Bulletin Messaging
Aspirating
Remove Specimen
Dispensing
Counting
Rinsing

QC Status Region
Provides on-line Quality Control monitoring status for:
Westgard Rule Alert IN/OUT Status
Moving Average Program IN/OUT Status

System Messages
Displays up to seven system messages at a time, generated from System events
such as warnings, conditions, and failures. When the mouse pointer is paused over
any System message containing an ellipsis () in the System Messages region, a
pop-up tool tip display appears containing the complete system message text
description. See also Section 10: Troubleshooting and Diagnostics,
Subsection: System Messages. See also Section 2: Installation Procedures and
Special Requirements, Subsection: User Interface Preferences for more
information on increasing or decreasing the display delay time for the pop-up tool
tips.

Figure 1.20 System Messages Region Example

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System Software Section 1

Status Bar Function Keys

Table 1.8 Status Bar Function Keys

Displayed Function Key Provides Access to:

F9 Printer Status Open the Printer Status window

F10 LIS Open the LIS Setup window

F11 Mode Status Select Open or Closed

F12 Loader Control Select Start or Stop Loader

NOTE Region (Next Open Tube Entry)

The Next Open Tube Entry region displays the operator entered Specimen ID or
(QCID), Specimen Type, and Test Selection for the next specimen to be sampled
in the Open Tube Mode. Next Open Tube Entry demographic details can be added
for patient specimens by selecting the More Spec Info button. For Backgrounds,
QC and SRP specimen types, comments can be added by selecting the More Spec
Info button. Select the QCID icon to open the QCID Lookup window which
displays the list of QCID files.
NOTE: When using this icon, the list of QCID files associated with the
reticulocyte parameters can only be displayed when the System is ready
to run the Open Mode Reticulocyte Method, RETIC test selection.

Figure 1.21 NOTE Region

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Figure 1.22 NOTE Detailed (More Spec Info Window)

Figure 1.23 QCID Lookup Window

View
Depending on the view, the navigation possibilities will change. When there is
more than one page of information that can be displayed within a view, the operator
can touch or click on the tab to bring that page into the main view. See also
Section 2: Installation Procedures and Special Requirements,
Subsection: System Customization for details on customizing views.

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System Software Section 1

Table 1.9 Tab Descriptions

Tool Bar Buttons Main View

Tab Descriptions
and Icons Description

Run View Displays

Specimen view of last
run sequence number

Orders Displays
Pending Orders

Datalog Displays
System Data Log

QC View Displays
QC Log

Groups Displays
FWBC Group,
NRBC/RRBC Group,
Not Transmitted
Group

Reagents Displays
Current Reagent
Status, Reagent Log

Maintenance
Displays Scheduled,
As-Needed, Special
Protocols,
Maintenance Log

System Displays
Event Log, Calibration
Log, Set Point Log

Function Keys

Figure 1.24 Function Key Examples

The function keys can be selected by either touching the screen function key
button, pressing the associated F1 thru F12 function keys on the keyboard, or
clicking on each function key button. Available function keys appear, disappear,
and can change functions depending on the view displayed.

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CELL-DYN Ruby Reagents

CELL-DYN Ruby reagents are formulated for use on the CELL-DYN Ruby in
order to provide optimal system performance. Use of reagents other than those
specified in this manual is not recommended as system performance can be
affected. Each CELL-DYN Ruby is tested at the factory using the specified
reagents and all performance claims are generated using these reagents.
The reagents used with the CELL-DYN Ruby are:
CELL-DYN Diluent/Sheath Reagent
CELL-DYN CN-Free HGB/NOC Lyse Reagent
CELL-DYN WBC Lyse Reagent
CELL-DYN Reticulocyte Reagent
Reagents must be stored at room temperature to ensure optimal performance. All
reagents should be protected from direct sunlight, extreme heat, and freezing
during shipment and storage. Temperatures below 32 F (0C) may cause reagent
layering that changes the tonicity and conductivity of the reagents.
CAUTION: If any reagent has been frozen, it must not be used.

The reagent inlet tubes have a cap attached that minimizes evaporation and
contamination during use. However, reagent quality may deteriorate with time.
Therefore, use all reagents within the dating period indicated on the label. For list
numbers of reagents, refer to Appendix A: Parts and Accessories, Table A.6.

CELL-DYN Diluent/Sheath
CELL-DYN Diluent/Sheath has the following major functions:
Maintain the stable diluted cell volume of each red cell and platelet during
the count and sizing portion of the measurement cycle
Serve as a sheath fluid for the hydrodynamic focusing process
Serve as a rinsing agent for the fluidics system

CELL-DYN CN-Free HGB/NOC Lyse

CELL-DYN CN-Free HGB/NOC Lyse is cyanide-free and has the following major
functions:
Rapidly lyse the red blood cells and minimize the resultant cellular debris
Strip the white cell cytoplasm leaving the nuclear membrane intact so the
white cell nuclei can be enumerated

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Use or Function
CELL-DYN Ruby Reagents Section 1

Convert hemoglobin to a stable chromagen complex that is measurable at

555 nm.

CELL-DYN WBC Lyse

CELL-DYN WBC Lyse has the following major functions:
Act as the diluent for the WBC
Osmotically lyse the red cells
Maintain the right scattering properties of the WBC for the duration of the
measurement period
Provide sufficient wetting action to prevent accumulation of air bubbles in
the WBC flow system
Serve as a rinsing agent for the WBC Mixing Chamber
Act as a diluent for Reticulocytes

CELL-DYN Reticulocyte Reagent

CELL-DYN Reticulocyte Reagent is formulated specifically to provide optimal
system performance for the CELL-DYN Ruby Reticulocyte procedure. Use of
reagents other than those specified in this manual is not recommended because
instrument performance can be affected. Each CELL-DYN Ruby System is
checked at the factory using the specified reagents and all performance claims were
generated using these reagents.
Reagent must be stored in the dark at room temperature. All reagents should be
protected from direct sunlight, extreme heat, and freezing during storage.
CAUTION: If any reagent has been frozen, it must not be used.

Reagent tubes have been capped to minimize evaporation. However, reagent

quality may deteriorate with time. Therefore, use all reagents within the dating
period indicated on the label.
See Section 12: Reticulocyte Package for Reticulocyte procedure details.

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Controls, Calibrator, and Standard Reference Particles

Controls, Calibrator, and Standard Reference Particles (SRPs) are reference

materials used to test, set, and monitor CELL-DYN Ruby performance.

Controls
Day-to-day verification of System calibration is performed using CELL-DYN
Control products. The frequency of quality control runs should be determined by
each laboratory. This may be specified by the regulatory agencies governing the
laboratory. CELL-DYN 22 Control, CELL-DYN 29 Plus Control (with Retic), and
CELL-DYN Retic Plus Control can be used to monitor the CBC, differential, and
reticulocyte parameters. Quality Control is discussed in detail in Section 11:
Quality Control. For list numbers of control products, refer to Appendix A: Parts
and Accessories.

Calibrators
Calibration of the directly measured parameters can be performed using
CELL-DYN calibrator products. Calibration is discussed in detail in
Section 6: Calibration Procedures.
For list numbers of calibrator products, see Appendix A: Parts and Accessories.

Standard Reference Particles

Standard Reference Particles (SRPs) are standardized materials intended for use by
field service and support representatives to verify and/or set electronic gain and
optical alignment. These reference materials are not intended for use by operators.

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Use or Function
Controls, Calibrator, and Standard Reference Particles Section 1

NOTES

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 Section 2 Installation Procedures and Special Requirements

Section 2 Installation Procedures and Special Requirements

Overview

This section provides information about installation and customization of the

CELL-DYN Ruby. The beginning of this section provides the following
requirements and guidelines for installing the System:
Site requirements
Guidelines for unpacking and inspection, connection and start-up, and
relocation
NOTE: An authorized Abbott representative should install the
CELL-DYN Ruby. Installation of the CELL-DYN Ruby by an
unauthorized or untrained person could result in damage to the
System. Do not attempt to install the System without an authorized
Abbott representative present or the warranty could be voided.
The remainder of this section provides the procedures for customizing various
functions and features. These customization options include the following:
Setting up the operating conditions (for example, units displayed and the
default patient test selection)
Configuring data view displays and customizing printed reports
NOTE: Basic setup for Quality Control ID (QCID) Files is covered in
Section 11: Quality Control.

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Installation Procedures and Special Requirements
Overview Section 2

NOTES

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Section 2 Installation Procedures and Special Requirements

Installation

This subsection provides the following requirements and guidelines for

installation:
Site Requirements
Unpacking and Inspection Guidelines
System Connection and Start-Up Guidelines
System Relocation and Shipping Guidelines

Site Requirements
Site requirements for installation cover the following topics:
Clearance Requirements
Power Requirements
Waste Disposal Requirements
Refer to Section 4: Performance Characteristics and Specifications for site
requirement details on physical, power, and environmental specifications.
Refer to Section 7: Operational Precautions and Limitations for general
requirements and precautions for System operation.

Clearance Requirements
To ensure proper service access and ventilation, provide the CELL-DYN Ruby
with the Clearance Requirements specified in Section 4: Performance
Characteristics and Specifications, Table 4.4 and 4.5.
CAUTION: Do not position the CELL-DYN Ruby so that it is difficult to
operate the main power switch, located on the rear right of the Analyzer.

Power Requirements
The following are the power requirements:
A constant, non-fluctuating power source. Use of an AC line with dimmer
switches can cause electrical current fluctuations that could affect proper
functioning of the System, and therefore is not recommended.
Three outlets grounded to the same grounding wire. Separate grounding can
result in voltage differences that can create internal interference in the
system.
NOTE: For complete power specifications, refer to
Section 4: Performance Characteristics and Specifications.

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Installation Section 2

Waste Disposal Requirements

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

Observe the following requirements for waste routing and disposal:

Users are responsible for disposing of waste according to local, state, and
federal regulations.
If a waste container is used, it must be labeled as biohazardous waste.
If a waste container is used, verify that the Waste Sensor Plug (attached to the
Waste Container Caps electrode wires) is properly inserted into the
connector labeled Waste Sensor on the rear panel of the Analyzer.
If a drain is used, it must be suitable for waste that could present a biological
or chemical hazard.
WARNING: Potential Biohazard. The waste is under pressure. Be sure
that the Waste Outlet Tube is placed securely in the drain. To prevent a
possible hazard, ensure that all System components are located away from
potential waste overflow.

If a drain is used, insert the Dummy Plug provided in the Accessory Kit into
the Waste Sensor connector. Otherwise, the System will generate an incorrect
System Information Message, indicating Waste Full, and the System will
halt.

Unpacking and Inspection Guidelines

An Abbott representative uncrates, inspects, and moves the CELL-DYN Ruby to
the designated location in the laboratory.
The following reagents are required for installation:
CELL-DYN Diluent/Sheath Reagent
CELL-DYN WBC Lyse Reagent
CELL-DYN CN-Free HGB/NOC Lyse Reagent
Refer to Appendix A: Parts and Accessories for the list of calibrators and controls
available for installation.
All materials must be inspected upon receipt, and refrigerated if indicated. Refer to
the material manufacturers specific documentation (such as package insert and
labels) that are associated with these materials. If any reagents, calibrators, or
controls are missing, leaking, or damaged, contact your Country Service and
Support Center.

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System Connection and Start Up Guidelines

An authorized Abbott representative will perform all System setup, including
installation of the Analyzer, flat panel display, printer, and reagents, and ensure that
the System is operating within the manufacturers specifications. This person or
another Abbott representative will assist the customer in customizing the System.
If the CELL-DYN Ruby is ever moved, or if power, tubing, or cables are ever
disconnected for any reason, verify that the Analyzer, flat panel display, printer,
and all tubing and cables are properly reconnected. For illustrations of connectors
and cable locations for each module, refer to Section 1: Use or Function,
Figure 1.8 and 1.9.

System Relocation and Shipping Guidelines

If the CELL-DYN Ruby must be relocated or shipped, contact your Country
Service and Support Center for directions for repackaging. The instrument must be
properly decontaminated before it is shipped, relocated, or serviced. For
procedures to decontaminate the System and prepare it for shipping, refer to
Section 9: Service and Maintenance, Subsection: Decontamination Procedures.

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Installation Procedures and Special Requirements
Installation Section 2

NOTES

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Section 2 Installation Procedures and Special Requirements

System Customization

The CELL-DYN Ruby provides a high degree of flexibility in customization. This

subsection covers the various operating conditions and features that can be
customized, and provides procedures for customization. Once customization is
completed, frequent changes in settings should not be necessary.
System Customization is carried out through the Setup menu bar item.
Procedures for backing up and restoring the System customization and database is
also described in this section.
Customization and setup of Quality Control ID (QCID) Files is detailed in
Section 11: Quality Control.

Setup Menu
The Setup menu provides various menu options for customizing System operating
conditions.
The following table lists the Setup menu selections and summarizes the associated
features that are customizable.
Table 2.1 Customizable Menu Items

Setup Selection Features That Can Be Customized

Limit Set Name

Lower and upper limits for each parameter
Patient Sample Setup... Limits reset to factory defaults
Demographics label for User Field 1 and User Field 2
Default Patient Test Selection

Units format selections

Units Sets Selection
Units format reset to factory defaults

Chartable Page (up to 8 different parameter sets):

Parameter Set Name
Graphs and Parameters
Lab Page:
Customize Run View
Graphs and Parameters
Graphs Page:
Graphs
All Run Views reset to factory defaults

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System Customization Section 2

Table 2.1 Customizable Menu Items (Continued)

Datalog, QC View, and Groups View:

Tab Title
Tab view column headings (Add/Remove)
Customize Data View Add Tab Page and Delete Tab Page
All Data Views reset to factory defaults
NOTE: Customization setup done in Datalog view will be
applied to the Groups view.

Moving Average View:

Tab view column heading (add/remove)
Customize Moving Average View Tab view reset to factory defaults
See Section 11: Quality Control, Subsection:
Customize Moving Average View.

Customize Report Header

Auto Print Chartable Page Report
Other Printed Report Options:
Customize Printed Report Graphs
Manual Differential Grids
Interpretive Report
Limits Report

Control Data for Commercial and Whole Blood

QC Limits:
Update Means and Limits
Standard Deviations
QCID Setup
Retrieve from file
Westgard Rule Setup
See Section 11: Quality Control, Subsection: QCID File
Setup.

Monitor Moving Average On/Off

Moving Average Groups:
Lower and Upper Limits
Target Values
Moving Average Acceptance Setup Action Limits
Tab view reset to factory defaults
Number of Batches to display in view
See Section 11: Quality Control, Subsection: Moving
Average Acceptance Setup.

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Table 2.1 Customizable Menu Items (Continued)

Operator Accounts
Add, Remove, Edit
Administrative Operator ID, Password, Access level
Operators
Setup Permission Access Rights for:
Laboratory I and II Levels
Second Sign On for all access levels

Tool Tip Display Time

QCID Daily Cleanup
User Interface
Date Format
Preferences
Time Format
Set Date/Time and Time Zone

Instrument ID Setup Analyzer Name

Bar Code Setup Check digit setup for all symbologies enable/disable

Automatic Orders Cleanup

Orders Setup
Use rack and tube matching enable/disable

Auto Transmission
Manual Transmission
LIS Setup
LIS Configuration
LIS Tests

QC Download ID File Set- See Section 11: Quality Control, Subsection: QC

up Download ID Setup.

Flag Settings ATYPDEP: Off, Medium, High

Patient Sample Setup...

Patient Sample Setup dialog box makes it possible to:
Customize Limit Sets
Change the demographic label for User Field 1 and User Field 2
Setup the Default Patient Test Selection

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System Customization Section 2

Patient Sample Setup, Limits Tab View

Setup > Patient Sample Setup >

Limits tab

Limit Set: numbers 1 through

3; additional numbers created

Limit Set Name: Default,

Universal Male, Universal
Female, etc.

Default button returns ALL

Limit Sets to factory-set default

Print button print __________ Cancel button

<<Prev button - returns to previous page OK button confirms changes

Next>> button: Bold white text indicates button is active

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Demographics Tab View

Customize Limit Sets

Patient Limit Sets contain specified
numerical lower and upper limits for
each parameter. The Limits tab view is
used to enter upper and lower flagging
limits for groups of patient samples. (For
example, limits may be entered for adult
males, adult females, neonates, etc.) The
System uses the selected Limit Set to
determine whether a result is in
violation. Results displayed in yellow-
orange are below the limit, results
displayed in purple are above the limit,
and the flagged result is underlined on
the printed report.
Limit Set 1, 2, and 3 contain upper and
lower limits pre-set at the factory. If
these Limit sets are changed, the
operator can return to the factory-set
limits selecting the Default button.
The limit of available Limit Sets beyond Limit Set 3 are based on your laboratorys
setup using the following Subsection: Automatic Patient Limit Set Creation.
NOTE: Selecting the Default button deletes all Limits Sets created or customized
to the factory defaults.

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System Customization Section 2

Table 2.2 Limit Set Default Descriptions

Limit Set
Description Comment
Number

1 No age Assigned to any Patient without both an

No sex age and a sex designation or whose age
(Default) and sex (if input) cannot be assigned by
the system to a specific Limit Set.

2 Universal Male Assigned to any Patient with a designated

sex as male without an age or whose age
(if input) cannot be assigned by the system
to a specific Limit Set.

3 Universal Female Assigned to any Patient with a designated

sex as female without an age or whose age
(if input) cannot be assigned by the system
to a specific Limit Set.

Dispersional Data Alerts

It is suggested that one Patient Limit Set be used to enter instrument-specific
laboratory action limits. If the Print Interpretive Report option is enabled in Setup,
Customize Printed Report, the Interpretive messages, such as leukocytosis,
anemia, thrombocytopenia, etc., will be displayed when a result falls outside the
appropriate limit. A result that falls outside a laboratory action limit can also
indicate the need for the operator to follow a laboratory protocol, such as repeating
the specimen, notifying the physician or performing a smear review. In cases where
a cellular abnormality is present that alters cellular morphology to the point that the
cells do not fit the criteria used by the instrument to generate a flag, dispersional
data alerts may be the only flag(s) that will alert the operator to a potentially
erroneous result.

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Automatic Patient Limit Set Creation

1. Select Setup from the menu bar, and Patient Sample Setup... from the pull-
down menu. The Patient Sample Setup dialog box opens.

2. Select the Next>> button until a message box opens and displays the
message: No Auto Limit Sets; Create new one?

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System Customization Section 2

3. Select Yes to create a new Limit Sets. (Selecting No closes the message box.)
The Patient Sample Setup dialog box now displays:

Field Entry Description

Limit Set: 4 The first three Limit Sets are default

settings, #4 is the first Limit Set that
can be customized

Limit Set M(0,0-199,0) Default name uses M=male and

Name: F=female. Default age range is 0-199
years for easy identification

Sex: Male Automatic defaults as the sex to

customize first

Age Range: From 0,0 To X,X = years, weeks therefore

199,0 M(0,0-199,0) is 0 years, 0 weeks to
199 years, 0 weeks

the next available Limit Set Male with settings of age 0 to 199 years.

Newly created Limit Set #4

Limit Set Name is a descriptive name

Sex selection is automatic for first

created

Age Range fields

used to enter age
parameters

Once a Male limit set with an upper age range of 199 years has been created,
selecting the NEXT >> button automatically creates a Female limit set with
age range 0.0 to 199.0.
As the Male or Female related age ranges are updated, the system software
automatically calculates and creates the next Male or Female limit set age
range to 199 years.

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Additionally, when Limit Sets are altered, the software notifies the operator
that executing the change updates the Limit Set field in Pending Order entries
to AUTO. This causes the system to search for the appropriate Limit Set
based on sex and age range.

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System Customization Section 2

Example of Limit Set Customization and Procedures

The following steps describe the default settings and how to create new Limit
Sets.
1. Select Setup from the menu bar, and Patient Sample Setup... from the pull-
down menu. The Patient Sample Setup dialog box opens.

Field Description

Limit 1 (Use the pull-down

Set menu to view the
other Limit Sets
and their
respective data.)

Limit Default
Set NOTE: Sex not
Name defined, no
field listed in
dialog box

The default age range is from 0

to 199 years and the sex is not
defined.
Default

0 days 199 years

2. Click the Next>> button to view the next Limit Sets and the respective data.

Field Description

Limit 2
Set

Limit Universal Male

Set
Name

Sex Male; New field, Sex,

added to dialog box

Universal Male

0 days 199 years

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3. Click the Next>> button to view the next Limit Sets and the respective data.

Field Description

Limit 3
Set

Limit Universal Female

Set
Name

Sex Female

Universal Female

0 days 199 years

4. Click Next>> and the Create New dialog box opens.

5. Select Yes and then the M(0,0 -199,0) Limit Set Name opens.

Field Description

Limit 4
Set

Limit M(0,0 -199,0) (A male

Set from age 0 to 199
Name years.)

Sex Male

Age From (0 Years) (0

Range: Weeks) To (199
Years) (0 Weeks)

M(0,0-199,0)

0 days 199 years

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System Customization Section 2

6. Setup a New Limit Set for a neonate male from age 0 week to 1 week by
entering the following data.

Field Enter this data:

Limit 4 automatically Enter the age range here...

Set entered

Limit M(0,0 -0,1) (A male

Set from 0 weeks to 1
Name week)

Sex Male

Age From (0 Years) (0

Range: Weeks) To (0 Years)
(1 Weeks) and the System
automatically calculates the
Limit Set Name Field
M(0,0-0,1)

0 days - 1 week 199 years

NOTE: The system automatically

creates the next limit set
using this age range and
naming it in the Limit Set
Name field.

M(0,1-199,0)

1 week 199 years

7. Select the Next >> button and the next limit set is automatically calculated to
display the following data.

Field Description:

Limit 5 System
Set automatically
calculates and enters
the new Limit Set.

Limit M(0,1 -199,0) (A male

Set from age 1 week to
Name 199 years.)

Sex Male

Age From (0 Years) (1

Range: Weeks) To (199
Years) (0 Weeks)

M(0,1-199,0)

1 week 199 years

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8. Select the Next >> button and the Patient Sample Setup displays the
following information.

Field Description

Limit 6 automatically
Set entered

Limit F(0,0 -199,0) (A

Set female from age 0 to
Name 199 years.)

Sex Female

Age From (0 Years) (0

Range: Weeks) To (199
Years) (0 Weeks)

F (0,0-199,0)

0 days 199 years

9. Enter the following information to create a Limit Set for a neonate female
from age 0 week to 1 week old.

Field Enter this data:

Limit 6 automatically
Set entered

Limit From (0 Years) (0

Set Weeks) To (0 Years) Enter the age range here...
Name (1 Weeks)

Sex Female

Age F(0,0 -0,1) (A female

Range: from 0 weeks to 1
week) and the System
automatically calculates the
F (0,0-0,1) Limit Set Name field

0 days - 1 week 199 years

NOTE: The system auto

creates the next limit
set with this age range.

F(0,1-199,0)

1 week 199 years

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System Customization Section 2

10. Select the Next >> button and next limit set is automatically calculated to
display:

Field Description

Limit 7 automatically
Set entered

Limit F(0,1 -199,0) (A

Set female from age 1
Name week to 199 years.)

Sex Female

Age From (0 Years) (1

Range: Weeks) To (199
Years) (0 Weeks)

F (0,1-199,0)

1 week 199 years

11. Select the OK button to save the customization.

12. Using the Print button, print out each Limit Set, verify the lower and upper
limits entered, and review that the customization of sex and age range meets
the laboratorys expectations.

Demographic Tab View

To Change Demographic the User Field 1 & 2 Label

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Table 2.3 To Change the User Field

Task Step Result/Comment

Change User Field 1. Select Setup from the menu bar, and
Label Patient Sample Setup from the
pull-down menu to open the Patient
Sample Setup dialog box.
2. Click on Demographics tab.
3. Type the text to update the label
name.
4. Select the OK button to save the
changes.

Default Patient Test Selection

Refer to Section 5: Operating Instructions, Subsection: Default Patient Test
Selection Processing Conditions for details of this setting.
Table 2.4 To Select the Default Patient Test Selection

Task Step Result/Comment

Choose Default 1. Select Setup from the menu bar, and

Patient Test Selection Patient Sample Setup from the
pull-down menu to open the Patient
Sample Setup dialog box.
2. Click on Demographics tab.
3. From the drop down list, select the
default processing test selection.
4. Select the OK button to save the
changes.

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System Customization Section 2

Units Sets Selection

The units selected are displayed and printed along with the numerical results in
various views. You can select one reporting system to apply to all parameters, or,
you can mix and match the type of units for individual parameters.
NOTE: The CELL-DYN Ruby software transmits all numerical results in USA
units of measure. Refer to the document CELL-DYN Ruby Laboratory
Information System Interface Specification, an orderable item listed in
Appendix A: Parts and Accessories.

Units Format Selections

Table 2.5 Procedure to Change the Unit Sets Selection

Tasks Steps Result/Comments

Accessing the Units 1. Select Setup and Units Sets

Sets Selection dialog Selection from the menu bar. The
box Units Sets Selection dialog box
opens.

Select one reporting 1. Select the parameter units using one

unit of the following methods:
Choose a category USA, SI, SI
Mod, Set 1 or Set 2 by selecting
the button at the top of the column.
Choose a parameter unit one
per row by clicking the radio
button directly to the left of the unit.
2. Select OK which saves any changes
and closes the dialog box.
Cancel button closes the dialog box
without retaining any changes.

Reset to factory 1. Select the Default which resets the

defaults report units to the USA default
settings
2. Select OK.

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Customize Run View

Customize Run Data

Chartable Page
Graphs tab
Parameters tab

Customize Run Data

Lab Page
Graphs tab
Parameters tab

Customize Run Data

Graphs Page
Graphs tab

Using the button resets all the Run View Parameter Set settings to the factory defaults.

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System Customization Section 2

Sections:
Chartable Page
Lab Page
Graphs Page
NOTE: The Default button resets all the Run View parameter set setting to
factory defaults no matter which view you are in.

Chartable Page

Parameter Set Name

There are eight customizable parameter set views.
Table 2.6 Procedure to Customize Parameter Set - Chartable Page

Task Steps Result/Comment

Access the 1. Select Run View from the tool bar.

Customize Run View 2. Select Setup and Customize Run
Chartable Page View View from the menu bar. The
Customize Run View dialog box
opens.
3. Select the Chartable page from the
Select Page pull-down menu and the
Chartable page opens. The other
pages are Lab or Graphs.
4. Select the Parameter Set using the
pull-down menu in the Parameter Set
field.
5. Enter a Parameter Set Name in the
Parameter Set Name field.

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Table 2.6 Procedure to Customize Parameter Set - Chartable Page (Continued)

Task Steps Result/Comment

Customize Graphs 1. Select the Graphs tab view.

and Parameters for 2. In the Available Graphs area, select
the Parameter Set the Measurement Type from the pull-
down menu: RBC, WBC, NOC.
3. To change which plots or histograms
are visible in the Run View:
a. To add plots or histograms to the
Selected Graphs column:
1. Select the item from the
Available Graphs.
2. Select the arrow pointing right
and the selected item moves to
the Selected Graphs column
and will display in the Run
View.
b. To remove items from the
Selected Graphs column so they
do not display in the Run View:
1. Select the item in the Selected
Graphs column.
2. Select the arrow point to the left
and the selected items returns
to the appropriate field.
4. The Graphs Layout region depicts
how the selected graphs will display in
the Run View.
5. Select the Parameters tab and the
Parameters view opens.
6. Select the checkbox of parameters to
display on the Run View.
7. Click OK to confirm all the changes.
NOTE: Clicking OK at an earlier stage
confirms the changes to that
point and closes the dialog box.
Only Click OK when all changes
are completed.

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System Customization Section 2

Lab Page
This page is for laboratory use only.

Graphs and Parameters

Table 2.7 Customize the Run View - Lab Page

Task Steps Result/Comment

Customize Run View 1. Select Run View from the tool bar.
Lab Page View 2. Select Setup and Customize Run
View from the menu bar. The
Customize Run View dialog box
opens.
3. Select the Lab page from the Select
Page pull-down menu and the Lab
page opens.
4. In the Available Graphs area, select
the Measurement Type from the pull-
down menu: RBC, WBC, NOC.
5. To change which plots or histograms
are visible in the Run View:
a. To add plots or histograms to the
Selected Graphs column:
1. Select the item from the
Available Graphs.
2. Select the arrow pointing right
and the selected item moves to
the Selected Graphs column
and will display in the Run
View.
b. To remove items from the selected
Graphs column so they do not
display in the Run View:
1. Select the item in the Selected
Graphs column.
2. Select the arrow point to the left
and the selected items returns
to the appropriate field.
6. The Graphs Layout region depicts
how the selected graphs will be
displayed in the Run View.

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Table 2.7 Customize the Run View - Lab Page (Continued)

Task Steps Result/Comment

7. Select the Parameters tab and the

Parameters view opens.
8. Select the checkbox of parameters to
display on the Run View.
9. Click OK to confirm all the changes.
NOTE: Clicking OK at an earlier stage
confirms the changes to that
point and closes the dialog box.
Only Click OK when all changes
are completed.

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System Customization Section 2

Graphs Page

Graphs
Table 2.8 Procedure to Customize the Run View - Graphs Page

Task Steps Result/Comment

Access the 1. Select Run View from the tool bar.

Customize Run View 2. Select Setup and Customize Run
Graphs Page View View from the menu bar. The
Customize Run View dialog box
opens.
3. Select the Graphs page from the
Select Page pull-down menu and the
Graphs page opens.
4. In the Available Graphs, select the
Measurement Type from the pull-
down menu: RBC, WBC, NOC.
5. To change which plots or histograms
are visible in the Run View:
a. To add plots or histograms to the
Selected Graphs column:
1. Select the item from the
Available Graphs region.
2. Select the arrow pointing right
and the selected item moves to
the Selected Graphs column
and will display in the Run
View.
b. To remove items from the
Selected Graphs column so they
do not display in the Run View:
1. Select the item in the Selected
Graphs column.
2. Select the arrow point to the left
and the selected items returns
to the appropriate field.
6. The Graphs Layout region depicts
how the selected graphs will be
displayed in the Run View.
7. Click OK to confirm all the changes.
NOTE: Clicking OK at an earlier stage
confirms the changes to that
point and closes the dialog box.
Only Click OK when all changes
are completed.

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Customize Data View

Datalog, QC View, and Groups View
Allows customization of:
Tab Page Titles
Tab page column headings (Add/Remove)
Add Tab Page and Delete Tab Page
All Data Views reset to factory defaults
Customize Data View:
Is only active when the screen is in Datalog view or QC View.
Customization made in the Datalog view is applied to the Groups view.
Customize one data view tab page at a time.
NOTE: Using the Default button resets the tab page in the view to factory
default, thereby eliminating any customizations to the individual
tab pages.

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System Customization Section 2

Table 2.9 Procedure to Customize Tab Titles and Column Headings in Data View

Task Steps Result/Comment

Access the 1. Select Datalog or QC View from the

Customize Data View tool bar menu.
dialog box 2. Select Setup and Customize Data
View from the menu bar. The
Customize Data View dialog box
opens.
3. To change the name of the Tab Page:
a. From the page field, select the tab
page name from the pull-down
menu
b. Type in the new name
c. Select the OK button to accept the
changes.
4. To change the tab page column
headings:
a. From the page field, select the tab
page name from the pull-down
menu.
b. To remove a parameter from
Selected Columns:
1. Select the heading in the
column entitled Selected
Columns.
2. Select the arrow pointing to the
left and the item moves to the
left into the column entitled
Available Columns.
c. To add a heading to Selected
Columns:
1. Highlight the item being added
to the tab page from Available
Columns.
2. Select the arrow pointing to the
right and the item moves to the
right into the column entitled
Selected Columns.
d. Select OK. The changes are
implemented and the dialog box
closes.

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Table 2.10 Procedure to Add/Delete Tab Pages in Data View

Task Steps Result/Comment

Access the 1. Select Datalog or QC View from the

Customize Data View tool bar menu.
dialog box 2. Select Setup and Customize Data
View from the menu bar. The
Customize Data View dialog box
opens.
3. To add or delete a tab page:
a. To remove a tab page from the
view:
1. Select the tab page name from
the pull-down menu at the Page
field.
2. Select the Del Page button and
the tab page is deleted from the
view.
3. Select OK. The changes are
implemented and the dialog
box closes.
b. To add a new tab page to the view:
1. Click on Add Page and an
entry entitled New Page is
added to the items listed in the
pull-down menu.
2. Name the new tab page and
add the column heading to the
selected columns.
3. Select OK. The changes are
implemented and the dialog
box closes.

Customize Moving Average View

Moving Average View:
Tab view column heading (add/remove)
Tab view reset to factory defaults
See Section 11: Quality Control, Subsection: Customize Moving Average View.

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System Customization Section 2

Customize Printed Report

Customize Report Header

Auto Print Chartable Page Report
Other Printed Report Options:
Graphs
Manual Differential Grids
Interpretive Report
Limits Report

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Customize Report Header

Table 2.11 To Customize the Printed Report Header

Tasks Steps Result/Comments

Access the 1. Select Setup and Customize

Customize Printed Printed Reports from the menu bar.
Report dialog box The Customize Printed Report
dialog box opens.

2. Select the Include Software

Version, Current Date/Time, and
Analyzer Name/Serial No.
checkbox.
3. Type in a four line Report Header or
any other information to appear in the
Report Header area.
4. Select OK the settings are
preserved and the dialog box closes.

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System Customization Section 2

Auto Print Chartable Page Report

Table 2.12 Procedure to Auto Print Chartable Page Report

Task Step Comment/Result

Accessing the 1. Select Customize Printed Report...

Customize Printed from Setup on the menu bar and the
Report dialog box Customize Printed Report dialog
box opens.

Selecting Auto Print 1. Select one of the following options

Options from the Auto Print Chartable Page
Report:
None
All Specimens
Alerted Specimens only
2. Select one of the following buttons:
Click OK to accept the selections
and close the dialog box
Click Cancel to close the dialog
box without saving any of the
selections.

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Other Printed Report Options

Table 2.13 Procedure to Print Using Other Printed Report Options

Task Step Comment/Result

Accessing the 1. Select Customize Printed Report...

Customize Printed from Setup on the menu bar and the
Report dialog box Customize Printed Report dialog
box opens.

Selecting Other 2. Select one of the following options for

Printed Report each of the items Graphs, Manual
Options Differential Grid, Interpretive Report,
and Limits Report from the Other
Printed Report Options:
None
All Specimens
Alerted Specimens Only

Saving and/or 3. Select one of the following buttons:

Closing the Click OK to accept the selections
Selections and close the dialog box
Click Cancel to close the dialog
box without saving any of the
selections

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System Customization Section 2

QCID Setup
Control Data for Commercial and Whole Blood
QC Limits:
Update Means and Limits
Standard Deviations
Retrieve from file
Westgard Rule Setup
See Section 11: Quality Control, Subsection: QCID File Setup.

Moving Average Acceptance Setup...

Moving Average Groups:
Lower and Upper Limits
Target Values
Action Limits
Tab view reset to factory defaults
Number of Batches to display in view
See Section 11: Quality Control, Subsection: Moving Average Acceptance Setup.

Administrative Setup

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Operators
Operators
The purpose of the security feature on the CELL-DYN Ruby is to allow laboratory
management to restrict write access to certain functions to specific laboratory
personnel, and to require the use of an operator ID where it is desired.
The following Operator access/permission levels are available in the software.
NOTE: Read access is to view only, and write access is to be able to make/save
changes, or perform functions.
Administrator read/write
Service read/write
Laboratory I customizable
Laboratory II customizable
Guest read only access
NOTE: Only Laboratory I and Laboratory II access/permissions may be changed.
The software can be configured to require password authorization and/or operator
sign-on for the following:
to change key configuration settings
to edit demographics
for calibration
These are the CELL-DYN Ruby software default Operator ID and associated
Access Levels:
Table 2.14 Operator ID and Access Levels

Operator ID Access Level

Admin Administrator

Guest Guest

CSC Service

FSE Service

NOTE: CSC and FSE logins are for use only by Abbott personnel.
An Administrator-level operator can perform the following functions:
Create new Operator accounts having any of the supported access levels,
except for Service level.
Remove Operator accounts, except for Guest, CSC, and FSE Operator IDs.
Require passwords (secure sign-on) for Operator accounts.

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System Customization Section 2

Select which functions may be assigned to the Laboratory I and

Laboratory II access levels.
Access a list of all Operator accounts and their Operator IDs (all those to
whom access has been granted).
Select a group of functions for which a second sign-on is required at the time
of performing the function.
An Administrator-level operator is able to set the following write access/
permissions with Operator accounts having the Laboratory I and
Laboratory II access level, as well as require a second sign-on in order to gain
access to the following:
Patient Sample Setup
Unit Sets Selection
Customize Printed Report
Edit Specimens demographics (after data is acquired)
Bar Code Setup
Instrument ID Setup
LIS Setup
User Interface Preferences
Calibration
QCID Setup
Moving Average Setup
Diagnostics

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Operator Accounts
Table 2.15 Procedure to Add an Operator

Task Step Result/Comment

Access the Operators 1. Select Setup, Administrative Setup

dialog box and Operators... on the pull-down
menu. The Operators dialog box
opens.

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System Customization Section 2

Table 2.15 Procedure to Add an Operator (Continued)

Task Step Result/Comment

Add 2. Click the Add button and the Add

Operator dialog box opens.
3. Enter the information in the fields:
Table 2.16 Add Operator Dialog Box

Operator ID Limited to 6
alphanumeric
characters

Full name Users name, 30

characters
maximum

Description Optional, 50
characters
maximum

Secure sign Select or deselect

on to require operator
password

Password 15 character
maximum

Confirm Must be an exact

Password match

Access level Select level to

determines
privileges

Save 4. Select the Create button and the

information is saved and the fields in
the dialog box are cleared for entry of
another Operator.

Exit 5. When all entries are completed,

select Close and the dialog box
closes.

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Table 2.17 Procedure to Remove an Operator

Task Step Result/Comment

Access the Operators 1. Select Setup, Administrative Setup

dialog box and Operators... on the pull-down
menu. The Operators dialog box
opens.

Remove 2. Highlight the operator ID to remove it

and click the Remove button. The
name is removed from the listing.
NOTE: Operator ID accounts for
Guest, FSE, and CSC cannot
be removed.

Exit 3. When all entries are completed,

select Close and the dialog box
closes.

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System Customization Section 2

Table 2.18 Procedure to Edit Operator Information

Task Step Result/Comment

Access the Operators 1. Select Setup, Administrative Setup

dialog box and Operators... on the pull-down
menu. The Operators dialog box
opens.

Edit/View 2. Highlight the Operator ID and click

the Edit/View button and the View
Operator dialog box opens.

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Table 2.18 Procedure to Edit Operator Information (Continued)

Task Step Result/Comment

3. Edit the following fields:

Table 2.19 Edit Operator Dialog Box

Full name Users name, 30

characters
maximum

Description Optional, 50
characters
maximum

Secure sign Select or deselect

on to require operator
password

Password 15 character
maximum

Confirm Must be an exact

Password match

Access level Select level to

determines
privileges

4. Select the Modify button to save the

changes and the box closes.
5. Select Close to close the Operators
dialog box.

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System Customization Section 2

Permission Access Rights for Laboratory I and II Levels

Laboratory management can utilize this feature to customize the access/
permissions for Laboratory I (e.g. general lab staff) and Laboratory II (e.g. lab
section managers).

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Table 2.20 Procedure for Editing Permission Access Rights for Laboratory Levels I and II

Task Step Comment/Result

Access the 1. Select Setup, Administrative Setup

Operators dialog box and Operators... on the pull-down
menu. The Operators dialog box
opens.

Edit permission 2. Click the Options button and the

access rights Options dialog box opens.

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System Customization Section 2

Table 2.20 Procedure for Editing Permission Access Rights for Laboratory Levels I and II (Continued)

Task Step Comment/Result

3. Select the Laboratory I or

Laboratory II from the drop down
menu and access rights are
displayed.
4. Select the checkboxes as they apply
to your laboratorys setup.

Save 5. Select the Apply button to apply the

settings.
6. Select the OK button to close the
Options dialog box.

Exit 7. Select the Close button to close the

Operators dialog box.

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Second Sign On for All Access Levels

This customization can be set up to automatically display a message dialog box
prompting the Operator to re-enter their password when proceeding into the
following software functions:
Patient Sample Setup
Unit Sets Selection
Customize Printed Report
Edit Specimens
Bar Code Setup
Instrument ID Setup
LIS Setup
User Interface Preferences
Calibration
QC Setup
Moving Average Setup
Diagnostics
Table 2.21 Procedure for Setting Up Second Sign Ons

Task Step Comment/Result

Access the 1. Select Setup, Administrative Setup

Operators dialog box and Operators... on the pull-down
menu. The Operators dialog box
opens.

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System Customization Section 2

Table 2.21 Procedure for Setting Up Second Sign Ons (Continued)

Task Step Comment/Result

Open Second Sign 2. Select the Options button and the

On dialog box. Options dialog box opens.

Setup second sign on 3. Select the Second Sign On tab and

the Second Sign On page opens.
4. Select or deselect the checkboxes as
they apply to your laboratorys set up.
5. When completed, select the Apply
button and then the OK button and
the Options dialog box closes.

Save 6. Select the Apply button to apply the

settings.
7. Select the OK button to close the
Options dialog box.

Exit 8. Select the Close button to close the

Operators dialog box.

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User Interface Preferences

Tool Tip Display Time
QCID Daily Clean-up
Date Format
Set Date/Time and Time Zone

Figure 2.1 User Interface Preferences

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System Customization Section 2

Tool Tip Display Time

Tool Tip Display Time

The operator can use the mouse to point and roll over (for example: System
Messages, dialog box fields, and buttons) to display additional text descriptions
(tool tips) if available. Customization of this setting can be used to increase or
decrease the amount of time the tool tip will display.
Table 2.22 Changing the Tool Tip Display Time

Task Step Result/Comment

Changing the Tool 1. Using the mouse, click, hold, and

Tip Display Time slide the bar to increase or decrease
the display time.
2. Select OK to save the setting.

QCID Daily Cleanup Time

The QCID Daily Cleanup time can be
set for the system to automatically
search for and delete aged QCID files.
See also Section 11: Quality Control,
Subsection: Program Operation,
QCID Files. To set the time for the
QCID Daily Cleanup to run, select the
time using the up and down arrows as
in the QCID Daily Cleanup area of the
User Interface Preferences dialog
box.
NOTE: While the QCID Daily
Cleanup is in process, the
Analyzer is not available to
run samples.

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Date/Time

To Set the Date, Time, and Zone

1. Select Setup, Administrative Setup, and User Interface Preferences...
from the menu bar. The User Interface Preferences... dialog box opens.

2. Select the alarm clock or Set Date/Time and the Date - Time Properties
dialog box opens.

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System Customization Section 2

3. In the Date field, select the month using the pull-down menu, click on the day
in the calendar, and select the year.
4. In the Time field, select the current time by clicking on the clock or using the
up and down arrows, or typing in the correct time.
5. Select Time Zone tab and select the appropriate time zone.
6. Click OK and Apply and the date and time are set.
7. Click OK and the User Interface Preferences dialog box closes.

Choosing a Delimiter
1. Select Setup, Administrative Setup, and User Interface Preferences...
from the menu bar. The User Interface Preference... dialog box opens.

2. In the Date Format field of the dialog box, select one of the radio buttons.
3. In the Date Format field of the dialog box, select the type of delimiter [/]
or a dot from the drop down menu.
4. In the Time Format field of the dialog box, select one of the radio buttons.
5. Click OK and the User Interface Preferences dialog box closes and the new
formats are applied.

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Instrument ID Setup
The Instrument ID Setup contains the Analyzer serial number and makes it possible
to name the Analyzer. Naming the Analyzer is optional.

To complete the Instrument ID Setup:

1. Select Setup from the menu bar and Administrative Setup from the pull-
down menu.

2. Select Instrument ID Setup... and the Instrument ID Setup dialog box

opens. The serial number, installed at the factory, is listed below the field for
the Analyzer name.

123456789

3. Fill in the Analyzer name.

4. Click OK and the Instrument ID Setup dialog box closes.

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5. Select Help and Instrument Information and the Instrument Information

dialog box opens and displays the Analyzer name.

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Bar Code Setup

Table 2.23 Procedure to Set Up Bar Code Including Symbology Setups

Tasks Steps Result/Comments

Accessing the Bar 1. Select Setup, Administrative Setup

Code Setup dialog and Bar Code Setup... from the
box menu bar. The Bar Code Setup
dialog box opens.

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System Customization Section 2

Table 2.23 Procedure to Set Up Bar Code Including Symbology Setups (Continued)

Tasks Steps Result/Comments

Activating the Check 2. Select Include Check Digit for all

Digit function symbologies. The Set Analyzer
button is activated.

Updating Bar Code 3. Select Set Analyzer and the

Settings message bar at the bottom of the
dialog box displays a message:
Barcode settings have been
updated.
4. Select the Close button and the Bar
Code Setup dialog box closes.

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Orders Setup

Automatic Order Cleanup

The Automatic Order Cleanup can be set to automatically delete aged Pending
Orders in the Orders view. This can be set to delete approximately twelve (12) to
forty eight (48) hours after it was created and saved, or downloaded from the
Laboratory Information System (LIS). See also Section 5: Operating Instructions,
Subsection: Introduction to the Orders View.

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System Customization Section 2

Table 2.24 Procedure to Change Automatic Order Cleanup

Task Step Comment/Result

1. Select Setup from the menu bar,

Administrative Setup from the pull-
down menu, and Orders Setup....
The Orders Setup dialog box opens.
2. To change the default setting for
Automatic Order Cleanup, which is
48 hours, enter the new hours in the
field.
3. Select either OK to confirm the
changes or Cancel to keep Orders
Setup without any changes.

No Bar Code Setup

This option is not recommended. If you set up the System to identify pending
orders using rack and tube position matching, specimens run in the Closed Mode
without bar code labels must be carefully monitored to avoid specimen mis-
identification. See also Section 5: Operating Instructions, Subsection:
Introduction to the Orders View.
NOTE: This customization is only available when the Pending Orders log is
empty.

1. Select Setup, Administrative Setup and Orders Setup from the pull-
down menu to open the Orders Setup dialog box.
2. Select the checkbox to use Rack and Tube matching or deselect the checkbox
to turn off Rack and Tube matching.
3. Select OK to save the setting.

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Table 2.25 Procedure to Change Use Rack and Tube Matching

Task Step Comment/Result

1. Select Setup from the menu bar,

Administrative Setup from the pull-
down menu, and Orders Setup....
The Orders Setup dialog box opens.
2. Select or deselect the Use Rack and
Tube Matching checkbox.
IMPORTANT: Selecting the checkbox
disables the use of the
bar code option.
3. Select either OK to confirm the
changes or Cancel to keep Orders
Setup without any changes.

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LIS Setup

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The LIS Setup dialog box provides access to:

Enable LIS connection
Enable Auto-Transmission of specimen results and graphs for specimen
types: Patient and QC
Enable Manual Transmission of specimen results and graphs for specimen
types: Patient, QC, and Other Specimen Types
LIS Configuration Settings
LIS Tests
To enable the connection to a host computer, select the Enable LIS check box at
the top of the window. To disable the connection, uncheck the box.
Table 2.26 Setting Up Auto-Transmission and Manual Transmission

Task Step Result/Comment

Accessing the LIS 1. Select Setup from the menu bar,

Setup dialog box Administrative Setup from the pull-
down menu, and LIS Setup... from
the extended menu.
OR
Select the F10LIS function key.
AND
The LIS Setup dialog box opens.

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Table 2.26 Setting Up Auto-Transmission and Manual Transmission

Task Step Result/Comment

Auto Transmission 2. Make any changes.

and Manual
Transmission tab
views

3. Select Apply to apply the changes.

4. Select OK and dialog box and asking

whether to close.

5. Select Yes and the dialog boxes

close.

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LIS Configuration Tab View

If you are not certain of the correct communication setup between the
CELL-DYN Ruby and the LIS, refer to the document CELL-DYN Ruby
Laboratory Information System Interface Specification, an orderable item listed in
Appendix A: Parts and Accessories, or consult your laboratorys computer staff.
For additional assistance, contact your Country Service and Support Center.

LIS Tests Tab View

The LIS Tests tab view provides access to tests used in troubleshooting the
CELL-DYN Ruby LIS connection.

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System Customization Section 2

QC Download ID File Setup

The QC Download ID File Setup information is used to enter Laboratory
Identification information for QC. This information is necessary for participants in
the CELL-DYN Interlaboratory QC Program. Laboratory Identification must be
entered before QC data can be transferred to the floppy disk. See Section 11:
Quality Control, Subsection: QC Download ID Setup.

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Flag Settings
This customization is used to enable ATYPDEP flagging sensitivity or disable the
ATYPDEP flag. See Section 3: Principles of Operation, Subsection: Data
Flagging.

Table 2.27 Flag Settings

Task Steps Result/Comment

Accessing the Flag Select Setup from the menu bar,

Setting dialog box Administrative Setup from the pull-
down menu, and Flag Settings... from
the extended menu.
The Flag Setting dialog box opens.

ATYPDEP 1. Turn on ATYPDEP flagging sensitivity ATYPDEP:

by selecting either Medium or High O for Off
radio button. M for Medium
2. Turn off the ATYPDEP flagging by H for High
selecting the Off radio button. This setting is displayed and printed in
3. Select either OK to confirm the the demographics region on the Lab
selections or Cancel to disregard the Page view and is for lab use only.
changes.

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NOTES

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 Section 3 Principles of Operation

Section 3 Principles of Operation

Overview

The principles the CELL-DYN Ruby uses to measure, count and calculate the
hematological parameters are discussed in Sample Analysis Cycle Overview and
Introduction to Flow Cytometry within this section. Subsequent sections discuss
the measurement process for WBC, RBC, PLT, and HGB. The last subsection,
Operational Messages and Data Flagging, discusses the flags generated by the
instrument due to measured parameters outside predefined limits, sample
abnormality, interference in the measurement process, or detection of an abnormal
subpopulation. Quality Control methodology is discussed in Section 11: Quality
Control. Reticulocytes and Reticulocyte flagging are discussed in
Section 12: Reticulocyte Package.
The two independent measurement channels used in the CELL-DYN Ruby are:
The Optical channel for determining the WBC, NOC, and RBC/PLT data
The Hemoglobin channel for determining the HGB
During each instrument cycle, the sample is aspirated, diluted, and mixed before
each parameter is measured.

Sample Aspiration
There are two modes of sample aspiration on the CELL-DYN Ruby:
The Open Mode is used to aspirate the sample from a collection tube that has
been opened and is held under the open mode probe.
The Closed Mode is used to mix and then aspirate the blood directly from a
closed collection tube by piercing the tube stopper.
Refer to Section 4: Performance Characteristics and Specifications,
Subsection: Operational Specifications for Open and Closed mode aspiration
volumes.
Once the mode of aspiration is selected, the whole blood sample is aspirated to the
Shear Valve by vacuum/pressure action. An ultrasonic sensor, located upstream of
the Shear Valve, checks the integrity of the sample stream before it enters the Shear
Valve. An ultrasonic sensor and LED sensor, located downstream of the Shear
Valve, checks the sample stream to ensure the proper amount of sample has been
transferred through the Shear Valve.

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Principles of Operation
Overview Section 3

NOTES

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Section 3 Principles of Operation

Sample Analysis Cycle Overview

NOTE: Sample and reagent volumes given in this section are stated as the
nominal values. Slight differences between instruments may cause these
volumes to vary. These differences are compensated for by factory-set
internal dilution factors.

Sample Aspiration
A sample is aspirated either in Open Mode or Closed Mode and transferred to the
Shear Valve.

Sample Segments
The Shear Valve rotates in order to separate three volumes of the aspirated sample.
The three volumes are:
20 L for the WBC dilution
1.67 L for the RBC/PLT dilution
12 L for the HGB dilution

RBC/PLT Analysis
1. The Diluent/Sheath Syringe dispenses 2.79 mL of diluent through the Shear
Valve where the 1.67 L RBC/PLT volume is transferred to the RBC Mixing
Chamber.
2. The segment and diluent are then routed to the RBC/PLT Mixing Chamber
where the dilution is mixed. The final dilution is 1:1675.
3. The Sample Transfer Pump transfers the RBC/PLT dilution from the RBC/
PLT Mixing Chamber to the Optical Flow Cell Sample Feed Nozzle.
4. Diluent/Sheath reagent, under constant pressure in the Sheath Reservoir, is
directed into the Optical Flow Cell.
5. Sequentially, the Sample Metering Syringe injects 24 L of the RBC/PLT
dilution into the flow cell at a pressure (and speed) lower than that of the
diluent/sheath reagent.
6. The higher speed of the sheath, which surrounds the RBC/PLT dilution, and
the special geometry of the flow cell combine to focus the RBC/PLT dilution
stream so that individual cells can be counted.
7. A laser beam is focused on the flow cell. As the sample stream intersects the
laser beam, the light scattered is measured at 0, 10, and 90 for red blood
cells, and at 0 and 10 for platelets.

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Sample Analysis Cycle Overview Section 3

Hemoglobin Analysis
1. The Diluent/Sheath Syringe injects 1.7 mL of diluent through the Shear
Valve where the 12 L HGB volume is transferred to the HGB Flow Cell.
2. The HGB Lyse Syringe dispenses 0.9 mL of HGB Lyse into the line after the
diluent has transferred the HGB volume to the HGB Flow Cell. The entry
point for the HGB Lyse is between the Shear Valve and the HGB Flow Cell.
3. The segment, lyse, and diluent are routed to the HGB Flow Cell where the
dilution is mixed. The final dilution is 1:218.
4. A low-energy LED attached to the HGB Flow Cell measures the absorbance
of light at 555 nm. The absorbance is proportional to the HGB concentration
of the sample.

WBC Analysis
WBC are analyzed optically as follows:
1. The WBC Lyse Syringe dispenses 0.973 mL of WBC Lyse reagent through
the shear valve where the 20 L WBC volume is transferred to the WBC
Mixing Chamber/WOC Heater.
2. The segment and reagent are then routed to the WBC Mixing Chamber/WOC
Heater where the dilution is mixed. The final dilution is 1:50. The diluted
sample remains in the mixing chamber for 14 seconds for the lysing of the
red blood cells.
3. The Sample Transfer Pump transfers the WBC dilution from the WBC
Mixing Chamber/WOC Heater to the Optical Flow Cell Sample Feed Nozzle.
4. Diluent/Sheath reagent, under constant pressure in the Sheath Reservoir, is
directed into the Optical Flow Cell.
5. Sequentially, the Sample Metering Syringe injects 46.5 L of the WBC
dilution into the flow cell at a pressure (and speed) lower than that of the
diluent/sheath reagent.
6. The higher speed of the sheath, which surrounds the WBC dilution, and the
special geometry of the flow cell combine to focus the WBC dilution stream
so that individual cells can be counted.
7. A laser beam is focused on the flow cell. As the sample stream intersects the
laser beam, the light scattered by the cells is measured at four different
detectors located in the forward (0 and 10) and side (90 and 90D) angles.

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Fragile WBC and Resistant RBC

When running patient samples in the CBC test selection, the operator may suspect
the presence of fragile WBC when the FWBC flag is displayed or may suspect the
presence of resistant RBC when the RRBC and NRBC flags are displayed.
In the case of samples containing fragile WBC or resistant RBC, alternate test
selections are used to measure white blood cells. The results of these test selections
are referred to as the Nuclear Optical Count (NOC). The NOC measurement is
derived from the HGB dilution as described below. Refer to Subsection: Nuclear
Optical Count (NOC) and Resistant RBC later in this section for additional
information.
The CBC+NOC test selection is available for fragile WBC and the CBC+RRBC
test selection is available for resistant RBC. Refer to Section 5: Operating
Instructions, Subsection: General Concepts for Reorder Entries from the Datalog
and Group Views.
When the CBC+NOC test is selected, both NOC and WOC are reported in the
Datalog. The NOC value is reported as WBC in the Datalog and on the Run View.
When the CBC+RRBC test is selected, both NOC and WOC are reported in the
Datalog. Either NOC or WOC is reported as WBC (based on algorithmic decision-
making) in the Datalog and on the Run View.
NOTE: When a Quality Control ID (QCID) is run using the CBC+NOC test
section both NOC and WOC are reported in the Datalog. Either NOC or
WOC is reported as WBC (based on algorithmic decision-making) on the
Run View.
The analysis for CBC+NOC and CBC+RRBC is performed as follows:
1. After the HGB sample is measured (refer to Subsection: Hemoglobin
Analysis earlier in this section), the Sample Transfer Pump transfers the
diluted solution from the HGB Flow Cell to the Optical Flow Cell Sample
Feed Nozzle.
2. Diluent/Sheath reagent, under constant pressure in the Sheath Reservoir, is
directed into the Optical Flow Cell.
3. Sequentially, the Sample Metering Syringe injects 140 L of the HGB
dilution into the flow cell.
4. The higher speed of the sheath which surrounds the HGB dilution, and the
special geometry of the flow cell, focus the HGB dilution stream so that
individual cells can be counted.
5. A laser beam is focused on the flow cell. As the sample stream intersects the
laser beam, the light scattered by the cells is measured by the 0 degree
detector. The nuclei of the lysed cells are counted as the NOC result.
6. The WBC Analysis in the CBC+NOC test selection occurs as described in
Subsection: WBC Analysis earlier in this section.
7. The WBC Analysis in the CBC+RRBC test selection occurs as described in
WBC Analysis above except that the diluted WBC segment is lysed in the
WBC Mixing Chamber/WOC Heater for an additional 15 seconds.

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Sample Analysis Cycle Overview Section 3

Results Displayed
All data is transmitted to the Data Module Computer for analysis. Results are
computed for all parameters and are displayed on the Run View. Results are also
stored in a log format called the Datalog.

Instrument Flushed
1. The remaining sample segment from the aspiration process is flushed to
Waste Chamber #2.
2. The remaining segments in the WBC and RBC/PLT Mixing Chambers are
flushed to Waste Chamber #3.
3. The segments sent to the Optical Flow Cell are flushed to Waste Chamber #1.

Instrument Rinsed
1. The Open Mode Probe is rinsed internally and externally with Diluent/
Sheath.
2. The Closed Mode needle is rinsed internally and externally with Diluent/
Sheath.
3. The WBC Mixing Chamber/WOC Heater is rinsed with WBC Lyse.
4. The RBC/PLT Mixing Chamber is rinsed with Diluent/Sheath.
5. The Optical Flow Cell and Sample Line tubing are rinsed with Diluent/
Sheath.
6. The HGB Flow Cell is rinsed with Diluent/Sheath.

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Section 3 Principles of Operation

Flow Cytometry

Introduction to Flow Cytometry

The CELL-DYN Ruby uses flow cytometric techniques to analyze the RBC/PLT,
WBC, and NOC populations. This section gives a brief introduction to the
principles of flow cytometry1.
Flow cytometry is a process in which individual cells or other biological particles
in a single file produced by a fluid stream are passed through a beam of light. A
sensor or sensors measure, by the loss or scattering of light, the physical or
chemical characteristics of the cells or particles2.
Flow cytometry enables the rapid screening of large numbers of cells and provides
quantitative cell analysis at the single-cell level. The basic components of a flow
cytometer include:
A sample collector and transporter
A flow system to focus the sample flow stream
A light source and focusing optics
Light collectors, signal detectors, and polarizers
Data collection and storage
Data display and analysis

1 Orthogonal (90 and 2

90D) Scatter Light 1
Detectors
2 Laser Tube
3 Forward Angle (0 and
10) Light Detectors
4 Optical Flow Cell
5 Laser Cover

3
5 4
Figure 3.1 Optical Bench

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Principles of Operation
Flow Cytometry Section 3

Detection with the Optical Bench

The optical bench assembly contains the components that make up the flow
cytometer. It is depicted in the previous figure. The main purpose of the optical
bench is to detect the light scattered by the cells as they pass through the flow cell.
The detection process is discussed in this section.
The light source is a vertically polarized 10 mW helium-neon laser with a
wavelength of 632.8 nm. The laser beam passes through a cylindrical lens which
changes the shape from a circle to an ellipse. The beam is then directed through a
125 m slit which blocks the weaker outer edges. This process yields a uniformly
intense beam approximately 80 m wide that allows the cell stream to wander
slightly in the flow cell and still be exposed to the same light intensity. An imaging
lens centers the focused laser beam onto the quartz flow cell.
The Sample Transfer Syringe injects different sample dilutions into the sheath
stream in the Optical Flow Cell. The sample is hydrodynamically focused into a
small stream approximately 30 m in diameter. This focused stream aligns the
diluted cells in single file as they pass through the light beam, which allows them
to be detected one at a time in the sensing region of the detectors.
Since the average diameter of the cells are smaller than the focused laser beam, the
cells do not scatter much laser light. If the remaining unscattered light were
allowed to reach the 0 and 10 (forward) detectors, it would saturate the
electronics. Therefore, an obscuration bar blocks 0 1 of the forward unscattered
light beam. The forward angles of scatter are directed to a perforated mirror. The
0 (1 3) light scatter passes through the mirror to the 0 silicon photodiode
detector. The 10 (7 10 or narrow angle) light scatter is deflected off the mirror
to the 10 silicon photodiode detector.
The orthogonal scatter is directed through a 700 m slit which blocks the scatter
from the walls of the flow cell. A beam splitter then separates the orthogonal light
scatter into two portions. One portion of the light is directed to the 90 Photo
Multiplier Tube (PMT). The remaining light is directed through a horizontal
polarizer. Only light that has changed polarization (depolarized) can pass through
the polarizer to the 90D PMT. (PMTs are used because relatively little light is
scattered at this angle.)
The light signals collected by each detector are converted into electrical signals or
pulses. The pulses are digitized based on intensity and sorted into 256 channels for
each angle of light measured.
If a pulse falls above the hardware threshold in the 0 and 10 detectors, the cell
counter counts the pulse and stores it for further evaluation. Pulses that fall below
this threshold are not included in the count.
The information from each detector is collected in list mode. This format stores the
channel information from each of the four dimensions. The data is then used to
determine the WOC differential and RBC, PLT, and NOC counts.

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Section 3 Principles of Operation

1 Sample Feed Nozzle

2 Sheath Stream
5
3 Sample Stream
4 Focused Laser Beam
5 Various Angles of
Scattered Light
4
3

Figure 3.2 Optical Flow Cell

Optical Flow Cell

In a flow cytometer, the cell suspension is transferred from the mixing chamber
through a sample tube into a special flow chamber with a small opening at the tip. The
suspension is then injected into a stream of fast-moving, cell-free liquid (sheath
fluid). Since the two liquids travel at different rates of speed, they do not
intermingle. The special geometry of the flow cell and the flow rate of the sheath
fluid forces the cells into single file. This process is known as hydrodynamic
focusing. (Refer to Figure 3.2 for a drawing of the Optical Flow Cell.)
As the cells enter the view volume (specific viewing area), they intersect with the
laser beam. The different types of cells scatter the laser light at different angles,
yielding information about cell size, internal structure, granularity and surface
morphology. The optical signals the cells generate are detected and converted to
electrical impulses which are then stored and analyzed by the computer.
Flow cytometers generally measure two angles of scatter. Forward angle light
scatter is a measure of cell size. Side angle (orthogonal) light scatter is a measure
of cell surface and internal structure but is primarily a measurement of internal
granularity. Combining the information from the two scatter measurements
provides more accurate discrimination between cell populations than either single
measurement. (See Figure 3.3 for an example of the light scatter measured by the
CELL-DYN Ruby.)

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Flow Cytometry Section 3

WBC Measurement
Overview
The Optical Channel is used for the determination of WBC data. During sample
aspiration, 20 L of sample is segmented in the Shear Valve for WBC
measurement. The WBC Syringe dispenses 0.973 mL of WBC lyse to the Shear
Valve. The sample and lyse are then transferred to the WBC Mixing Chamber/
WOC Heater where the dilution is mixed, resulting in a 1:50 dilution ratio.
The Sample Transfer Pump transfers the WBC dilution from the mixing chamber
to the sample feed nozzle in the Optical Flow Cell. At the same time, sheath
reagent, under constant pressure in the Sheath Reservoir, is transferred to the sheath
feed nozzle in the Optical Flow Cell and injected into the cell. At the same time,
the Sample Metering Syringe injects 46.5 L of the WBC dilution into a sheath
stream. The sample stream is then hydrodynamically focused to align the cells in
single file as they pass through the Optical Flow Cell, which is an optically clear
quartz chamber. A vertically polarized Helium Neon Laser is the light source.
The instrument measures:
Both types of forward angle light scatter (1 to 3, referred to as 0, and 7 to
11, referred to as 10 or narrow angle)
Both types of orthogonal (side) light scatter (70 to 110, referred to as 90,
and 70 to 110 depolarized, referred to as 90D).
This is referred to as MAPSS (for Multi-Angle Polarized Scatter Separation)
technology. Various combinations of these four measurements are used to classify
the WBC subpopulations and provide morphological flagging.

1 Focused Laser Beam

2 0 Scatter 1
3 10 Scatter
4 90 Scatter 2 4
5 90D Scatter

3 5

Figure 3.3 WBC Light Scatter

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The previous figure illustrates the measurement of light scattered during the WBC
optical measurement process.
The WBC count is determined by enumerating the number of occurrences above a
hardware threshold in the 0 channel. The information from all four measurements
is used to differentiate the WBC into five subpopulations:
Neutrophils
Lymphocytes
Monocytes
Eosinophils
Basophils
The WBC data is presented graphically as scatterplots or histograms.

WBC Reagent
The WBC reagent used with the CELL-DYN Ruby instrument is the CELL-DYN
WBC Lyse. It is an integral part of the WBC analysis. White blood cells diluted in
the reagent maintain cellular integrity close to their native state. The structure of
the basophils changes slightly due to the hygroscopic nature of the basophilic
granules.
The RBC are also altered by the reagent. The osmotic pressure of the RBC is higher
than that of the reagent. Therefore, the hemoglobin in the RBC diffuses out of the
cell and water from the reagent diffuses into the cell. The cell membrane remains
intact but the RBC now has the same refractive index as the sheath, thereby
rendering it invisible to the laser.

WBC Differential
The light scatter information is graphically presented in the form of scatterplots.
(The data can also be presented in histograms.) Each cell analyzed is represented
by a dot on the scatterplot. The dots are plotted at a point determined by the
intersection of the channel information designated on the X and Y axes. For
example, if a cell falls in channel 50 on the X axis and channel 50 on the Y axis, it
is plotted at the intersecting point of the two channels.
The scatter information may be plotted in various combinations to yield different
information. The CELL-DYN Ruby uses the scatterplots to differentiate the WBC
into five subpopulations:
Neutrophils
Eosinophils
Lymphocytes
Basophils
Monocytes

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Flow Cytometry Section 3

Mononuclear Polymorphonuclear Mononuclear Polymorphonuclear

Separation Identification
90 Lobularity

90 Lobularity

10 Complexity 10 Complexity

Figure 3.4 Mononuclear-Polymorphonuclear Scatter

Mononuclear-Polymorphonuclear Separation
The scatter information is plotted with the 90 scatter on the Y axis and the 10
scatter on the X axis. (The 90/10 scatterplot is shown in the previous 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.

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Section 3 Principles of Operation

Neutrophil Eosinophil Neutrophil Eosinophil

Separation Identification
90 Depolarized Granularity

90 Depolarized Granularity
90 Lobularity 90 Lobularity

Figure 3.5 Neutrophil-Eosinophil Scatter

Neutrophil-Eosinophil Separation
The scatter information is plotted with the 90D scatter on the Y axis and the 90
scatter on the X axis. (The 90D/90 scatterplot is shown in the previous 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 90D light. The eosinophils scatter more 90D
light than any of the other cells because of the unique nature of granules they
contain. This property of the eosinophils is used to positively identify them and
thus clearly differentiate them from the neutrophil population.

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Principles of Operation
Flow Cytometry Section 3

Mononuclear Mononuclear
Separation Identification
0 Size

0 Size

10 Complexity 10 Complexity
Figure 3.6 Mononuclear Scatter

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 previous 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 WBC Lyse reagent. Consequently, the degranulated
basophils becomes a less complex cell that falls into the mononuclear cluster.
The lymphocytes fall in the lowest large cluster. (The small population of cells
below the lymphocytes contains particles that are unlikely to be WBC.) The
basophils fall in the cluster above and slightly to the right of the lymphocytes. The
monocytes fall in the cluster above the lymphocytes and basophils. The instrument
uses dynamic thresholds to determine the best separation between the three main
populations. Each cell is then classified as a LYMPH, a MONO or a BASO.

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Finally, the instrument evaluates the area below the lymphocyte cluster but above
the hardware threshold (channel 23). Any particles that fall in this area are
separated from the lymphocytes by a dynamic threshold. The following cell types
may be present in this region:
NRBC
Unlysed RBC
Giant PLT
PLT clumps
All particles in this region are excluded from the WBC count and the Differential.

Other Scatterplots
90/0
The scatter information is plotted with the 90 scatter on the Y axis and the 0
scatter on the X axis.
90D/0
The scatter information is plotted with the 90D scatter on the Y axis and the 0
scatter on the X axis.
90D/10
The scatter information is plotted with the 90D scatter on the Y axis and the 10
scatter on the X axis.
All scatterplots may be displayed and printed at operator request.

Nuclear Optical Count (NOC)

Samples containing fragile WBC are difficult to measure accurately because of the
rapid breakdown of cells during the measurement process. To obtain an accurate
WBC count, an alternate method using the HGB segment (instead of the WBC
segment) is used to measure samples containing fragile WBC.
The HGB sample segment, after being measured in the HGB Flow Cell, is
transferred to the Optical Flow Cell instead of being sent to a waste chamber as in
the CBC test selection. While in the HGB Flow Cell, the HGB reagent lyses the
cytoplasmic membrane of the white blood cells but allows the nuclear membrane
to remain intact. This results in a greater stability of the white cells in the sample.
The HGB segment is lysed for approximately 15 seconds before it is sent to the
Optical Flow Cell.
As the HGB segment passes through the Optical Flow Cell, the nuclei of the cells
are counted. The results of this measurement are stored in the Datalog as NOC.

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Flow Cytometry Section 3

Resistant RBC
When a specimen containing resistant RBC is run in the CBC test selection, the
lytic agent in the WBC lyse reagent may be insufficient to lyse the resistant cells
in the time allotted for the WBC count. Consequently, unlysed RBC can be
erroneously included in the WBC count resulting in a falsely elevated value. When
this occurs, a significant amount of cellular debris will be present in the region
below the WBC dynamic threshold on the 0/10 scatterplot.
When these types of specimens are rerun in the CBC+RRBC test selection, the
diluted WBC sample is held in the mixing chamber 15 seconds longer than in the
routine patient mode. This additional lysing time is used to break down (lyse) the
resistant RBC cells and prevent them from interfering with the WBC count and
differential.
NOTE: A higher incidence of false positive band flags may be evident on
specimens run under the Resistant RBC test selection.

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WBC Histograms

Figure 3.7 WBC Histograms

The CELL-DYN Ruby can present the WBC scatter information as two
histograms: NWBC-LYM-MONO (N-L-M) and Mono-Poly (M-P). The NOC
(Nuclear Optical Count) data can also be presented as a histogram. (Refer to the
previous figure.) These histograms may be displayed and printed at the operators
request.

NWBC-LYM-MONO Histogram
The scatter information is plotted in a histogram format with the relative number
of cells on the Y axis and the NWBC, Lymphocyte and Monocyte size distribution
data on the X axis.

MONO-POLY Histogram
The scatter information is plotted in a histogram format with the relative number
of cells on the Y axis and the mononuclear and polymorphonuclear size
distribution data on the X axis.

NOC Histogram
The NOC data is plotted in a histogram format with the relative number of nuclei
on the Y axis and the size distribution data on the X axis.

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Flow Cytometry Section 3

WBC Parameters

Figure 3.8 WBC Data and Scatterplots

The WBC data is generally displayed as depicted in Figure 3.8. All numeric and
graphic data are automatically displayed in the Run View Chartable, Lab, and
Graphics tabs in the format selected in Customizing Run View. See
Section 2: Installation Procedures and Special Requirements,
Subsection: Customize Run View. After the WBC scatter information has been
plotted and the cells have been classified into the five subpopulations, the
algorithms then determine the WBC and the percent of cells in each subpopulation.
Once the WBC count is determined, the absolute number of cells in each
subpopulation is calculated by multiplying that WBC count by the percentage. The
results are expressed as follows:
WBC # x 10e3/L
NEU # x 10e3/L and %
LYM # x 10e3/L and %
MONO # x 10e3/L and %
EOS # x 10e3/L and %
BASO # x 10e3/L and %
The decimal point moves to display up to three decimal places for the absolute
number and percent.

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The WBC subpopulations are further identified by the following colors:

Neutrophils yellow
Lymphocytes blue
Monocytes purple
Eosinophils green
Basophils white
NOTE: The basophils are displayed as white dots but appear as black dots on
color printouts.
The WBC scatter information is usually displayed in two scatterplots as shown in
the previous figure.
SIZE/COMPLEXITY The size (0 scatter) information is plotted on the
Y axis and the complexity (10 scatter) information
is plotted on the X axis.
GRANLRTY/LOBULARITY The granularity (90D scatter) information is plotted
on the Y axis and the lobularity (90 scatter)
information is plotted on the X axis.

WBC Flagging
Refer to the Operational Messages and Data Flagging subsection of this section
for WBC flagging information.

RBC/PLT Measurement
Overview
The Optical Channel is used for the determination of RBC and PLT data. During
sample aspiration, 1.67 L of sample is segmented in the Shear Valve for RBC/PLT
measurement.
The Diluent/Sheath Syringe dispenses 2.79 mL of diluent to the Shear Valve. The
sample and diluent are then transferred to the RBC/PLT Mixing Chamber where
the dilution is mixed, resulting in a 1:1675 dilution ratio.
The Sample Transfer Pump transfers the RBC/PLT dilution from the mixing
chamber to the sheath feed nozzle in the Optical Flow Cell. The Sample Metering
Syringe injects 24 L of RBC/PLT dilution into the sheath stream. The sample
stream is then hydrodynamically focused to align the cells in single file as they pass
through the Optical Flow Cell, which is an optically clear quartz chamber. A
vertically polarized Helium Neon Laser is the light source.
There are 256 size channels for each of the parameters, each RBC size channel
being equivalent to 1 fL and each PLT size channel being equivalent to 0.137 fL.
The RBC parameters are calculated using 0, 10, and 90 sensor data, while the
PLT parameters are calculated using 0 and 10 sensor data.

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Flow Cytometry Section 3

RBC Parameters

Figure 3.9 RBC Data and Histogram

All numeric and frequency size distribution data are automatically displayed on the
Run View in the format selected. The size distribution data for the red cells is
displayed graphically as a histogram using 0 data. The size distribution data is
plotted on the X axis. The relative number of cells is normalized and plotted on the
Y axis. The RBC data are shown in the previous figure.

RBC Count
The Red Blood Cell Count is directly measured, and is expressed as follows:
RBC = # x 10e6/L
Counts below 1.0 x 10e6/L are displayed to three decimal places. The RBC count
is corrected for coincidence and WBC interference.

MCV
The Mean Cell Volume is the average volume of the individual red blood cells.
The MCV is derived from the RBC size distribution data on the 0, 10, and 90
histograms, and is expressed in femtoliters.

HCT
The Hematocrit is the ratio of red blood cells to plasma and is expressed as a
percentage of the whole blood volume. The HCT is calculated from the red blood
cell count and the mean cell volume as follows:
HCT = (RBC x MCV)/10

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MCH
The Mean Corpuscular Hemoglobin is the average amount of hemoglobin
contained in the red blood cell expressed in picograms. The MCH is calculated
from the RBC and the HGB as follows:
MCH = (HGB/RBC) x 10

MCHC
The Mean Corpuscular Hemoglobin Concentration is the ratio of the weight of
hemoglobin to the volume of the average red blood cell expressed in grams per
deciliter. MCHC is calculated from the HGB and the HCT as follows:
MCHC = (HGB/HCT) x 100

RDW
Red Cell Distribution Width is a measure of the heterogeneity of the RBC
population. The CELL-DYN Ruby reports a relative RDW equivalent to a CV in
grams per deciliter. The RDW is derived from the RBC histogram using the 20th
and 80th percentiles.

RBC Flagging
Refer to Subsection: Operational Messages and Data Flagging for RBC Flagging
information.

Platelet Parameters
Events counted in the RBC/PLT dilution between floating thresholds are included
in the platelet (PLT) data, which is collected using the 0 and 10 sensors. The
lower threshold floats between 1 and 3 fL and the upper threshold floats between
15 and 35 fL. If there are not enough data to determine the PLT count, the lower
and upper thresholds are set at 2 and 35 fL respectively. Once the thresholds have
been determined, the PLT count is derived from the 10 data.
Data can be displayed in two formats. Data can be displayed as a scatterplot (0/
10) including the RBC. Data can also be displayed as one of the following three
histograms:
PLT only using 10 data
PLT and RBC using 0 data
PLT and RBC using 10 data
PLT data are shown as a histogram of the 10 data in the following figure.
Events counted in the region below the lower threshold are usually either optical
noise or small particulate matter. Events counted in the region above the upper
threshold are counted as RBC. If interference with either threshold region exceeds
a predetermined limit, the PLT parameters are flagged accordingly. The flags are
discussed in the last section of this section.

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Flow Cytometry Section 3

PLT Count
The PLT count is expressed as thousands per microliter (10e3/L).

Figure 3.10 PLT Data and Histogram

MPV
The Mean Platelet Volume is derived from the PLT histogram after the PLT count
has been determined. The MPV is expressed in femtoliters.

PCT
The Plateletcrit is the product of PLT and MPV and is analogous to the hematocrit.
It is expressed in percent and is calculated as follows:
PCT = (PLT x MPV)/10

PDW
Platelet Distribution Width is a measure of the heterogeneity of the PLT
population. It is expressed as the geometric standard deviation.
NOTE: Clinical significance has not been established for PCT and PDW.
Therefore, they are not reportable in the US.

Platelet Flagging
Refer to Subsection: Operational Messages and Data Flagging for PLT flagging
information.

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Hemoglobin Measurement
Overview
The HGB channel is used for the colorimetric determination of hemoglobin.
During sample aspiration, 12 L of sample is segmented in the Shear Valve for
HGB measurement.
The Diluent/Sheath Syringe dispenses 1.7 mL of Diluent/Sheath to the Shear
Valve, transferring the HGB segment to the HGB Mixing Chamber. The HGB Lyse
Syringe then dispenses 0.9 mL of HGB Lyse into the mixing chamber. The mixture
is mixed, resulting in a 1:218 dilution ratio. The HGB lyse reagent lyses the red
blood cells, converting the hemoglobin that is released by a cyanide-free chemical
process. When the lysing action is completed, a low-energy LED in the HGB Flow
Cell, attached to the mixing chamber, measures the amount of absorbance which is
proportional to the HGB concentration. Five separate HGB readings are made on
the sample. The lowest and highest are eliminated and the remaining three are
averaged to give the final HGB sample reading. After the hemoglobin readings
have been made, the HGB Flow Cell is rinsed with diluent/sheath.
A reference value is then obtained using the diluent/sheath in the HGB Flow Cell.
A zero or blank reading is obtained on the diluent to provide a reference to which
the sample signal is compared. Five separate blank readings are made on the
diluent. The lowest and highest are eliminated and the remaining three are
averaged to give the final HGB reference reading.
A LED with a wavelength of 555 nm is the light source. A photodetector measures
the light that is transmitted.
The sample and reference readings are compared to determine the HGB
concentration of the sample. The HGB result is expressed in grams of hemoglobin
per deciliter of whole blood. Up to two decimal places may be displayed for
hemoglobin results less than 10.0 g/dL.

HGB Parameters
The Hemoglobin is directly measured and is expressed in grams of hemoglobin per
deciliter of whole blood.

HGB Flagging
Refer to Subsection: Operational Messages and Data Flagging for HGB flagging
information.

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Flow Cytometry Section 3

Lab Page
The Run View Lab Page is provided to assist the laboratory staff in data review and
validation (refer to the following figure). This screen is for laboratory use only. The
lab page displays the 5-Part Differential plus additional parameters. The Run View
Chartable Page displays only the 5-Part Differential (refer to the figure in the WBC
Scatterplots subsection). The difference between the two formats is shown in the
following tables.
NOTE: The parameters MON and LYM have an e after the label, indicating that
the values are estimated. MONe represents monos minus blasts. LYMe
represents reported lymphs minus variant lymphs.

Figure 3.11 Lab Page

All numeric and graphic data are automatically displayed in the Run View Lab tab
in the format selection in Customize Run View. See Section 2: Installation
Procedures and Special Requirements, Subsection: Customize Run View.
The 5-Part Differential separates WBC into 5 components: Neutrophils,
Lymphocytes, Monocytes, Eosinophils, and Basophils. The additional parameters
further separate the Neutrophils, Lymphocytes, and Monocytes into their
constituent components. Eosinophils and Basophils are the same in both tables.

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Table 3.1 5-Part Differential

Parameter Results (10e3/L)

WBC 7.23

1 NEU 4.65

2 LYM 1.67

3 MONO .639

4 EOS .228

5 BASO .045

Table 3.2 5-Part Differential Plus Additional

Parameters

Parameter Results (10e3/L)

WBC 7.23

NEU

1a SEG 4.40

1b BAND .208

1c IG .038

MONO

3a BLST .001

3b MONe .638

4 EOS .228

5 BASO .045

LYM

2a LYMe 1.64

2b VARL .030

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Flow Cytometry Section 3

NOTES

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Operational Messages and Data Flagging

Introduction
Operational messages and data flags appear on the Run View, screen, on printed
reports and can be transmitted to a laboratory computer system. The
CELL-DYN Ruby monitors instrument conditions and data criteria that may affect
the displayed results and these messages and flags are used to alert the operator.
Instructions for interpreting all flags, and numeric, scatter and histogram data
should be incorporated into the laboratorys procedure and used to determine the
need for further action and/or review of results. Messages are divided into the
following categories:
System Messages:
Fault Conditions
Status Conditions
Parameter Flagging Messages:
Dispersional Data Alerts
Suspect Parameter Flags
Suspect Population Flags
Interpretive Messages
Detailed descriptions of the messages in each of the categories are given in this
section.

Instrument Fault and Status Conditions

The Instrument Fault and Status conditions are discussed in Section 10:
Troubleshooting and Diagnostics, Subsection: System Messages. These
messages are displayed when the instrument detects an inappropriate condition
during specimen processing. When necessary, data is suppressed. When any of
these messages are displayed, refer to the System Messages for assistance. Follow
the instructions given and take the appropriate corrective action. When the problem
is corrected, repeat the specimen.

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Operational Messages and Data Flagging Section 3

Cell Populations and Flagging

Fragile WBC
Typically, fragile WBC are abnormal lymphocytes that are present in chronic
lymphocytic leukemia (CLL) and are the smudge cells that appear when the
blood smear is made.
When processing samples in the CBC test selection, if fragile WBC are present the
WBC (WOC) count may be abnormally low due to the gradual destruction of the
cytoplasmic membrane of these fragile cells by the lysing agents during the run
cycle.
When the FWBC flag displays, repeat the specimen using the CBC+NOC test
selection. This selection uses the HGB sample dilution containing intact WBC
nuclei. This Nuclear Optical Count (NOC) provides a more accurate WBC count
when fragile WBC are present.

Lyse-Resistant RBC
Lyse-resistant RBC are red blood cells which contain abnormalities or whose
membranes have been altered, making them more resistant to the lysing process.
When running samples in the CBC test selection, the hypo-osmotic lysing ability
of the WBC Lyse reagent is usually insufficient to lyse any lyse-resistant RBC, if
present, in the time allotted for the WBC count. Consequently, the unlysed RBC
may be erroneously included in the WBC count, resulting in a falsely elevated
count.
In normal patient samples, lyse-resistant RBC are either absent or their number is
negligible. In patient samples with a significant number of lyse-resistant RBC,
usually there is also a significant amount of cellular debris interference present in
the region below the dynamic WOC threshold on the 0 / 10 scatterplot.
When cellular debris interference is suspected and other conditions are met, the
RRBC/NRBC (Resistant RBC/Nucleated RBC) flag is displayed, alerting the user
to run the specimen in the CBC+RRBC test selection. The WBC lyse time is
extended, allowing for a complete lysing of the lyse-resistant RBC to obtain an
accurate WBC count.
For samples suspected of containing NRBC or resistant RBC, or those whose
smear review indicates the presence of NRBC (e.g., sickle cells or target cells may
indicate that NRBC are also present), run the sample(s) in the CBC+RRBC test
selection to verify the WBC count.

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Parameter Flagging Messages

Table 3.3 summarizes all of the parameter flagging messages by parameter and
category.
Table 3.3 Parameter Flagging Messages

Suspect Suspect Interpretive

Parameter Dispersional Data Alerts
Parameter Flags Population Flags Messages

Result displays in yellow if WBC NWBC Leukopenia

below lower limit FWBC Leukocytosis
Result displays in purple if NRBC
above upper limit RRBC
WBC Result underlined on graphics
printout when limits exceeded
Result marked with asterisk (*)
if further result validation is
required. (See Table 3.4)

DFLT (NLMEB) BAND Neutropenia

Differential DFLT (NE) IG Neutrophilia
NEU DFLT (LM) BLAST Lymphopenia
LYM
Same as WBC DFLT (B) VAR LYM Lymphocytosis
MONO
EOS DFLT (LB) Monocytosis
BASO Eosinophilia
Basophilia

RBC MORPH Anemia

Polycythemia
RBC Microcytic RBC
HGB
Same as WBC Macrocytic RBC
MCV
RDW Hypochromic
Hyperchromic
Anisocytosis

LRI The MPV value Thrombocytopenia

PLT URI may be suppressed Thrombocytosis
Same as WBC (not displayed
MPV LURI Microcytic PLT
or printed).
Macrocytic PLT

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Operational Messages and Data Flagging Section 3

The following summarizes all of the parameters marked with an asterisk (*)
requiring further result validation.
NOTE: This applies to Patient, Quality Control ID (QCID) whole blood, and
Calibrator whole blood Specimen Types.
Table 3.4 Parameters Marked With an Asterisk (*)

Suspect Parameters marked with an asterisk (*) Parameters marked with an

Parameter Flag on Chartable Page asterisk (*) on Lab Page

WBC WBC, NEU, MONO, EOS, BASO, LYM WBC, SEG, BAND, IG, BLST, MONe,
EOS, BASO, LYMe, VARL

DFLT (NLMEB) NEU, MONO, EOS, BASO, LYM, %N, SEG, BAND, IG, BLST, MONe, EOS,
%M, %E,%B, %L BASO, LYMe, VARL, %S, %BD, %IG,
%BLST, %Me, %E, %B, %Le, %VL

DFLT (NE) NEU, EOS, %N, %E SEG, BAND, IG, EOS, %S, %BD, %IG,
%E

DFLT (LM) MONO, LYM, %M, %L BLST, MONe, LYMe, VARL, %BLST,
%Me, %Le, %VL

DFLT (B) BASO, %B BASO, %B

DFLT (LB) BASO, LYM, %B, %L BASO, LYMe, VARL, %B, %Le, %VL

MCHC RBC, HGB, HCT, MCV, MCH, MCHC RBC, HGB, HCT, MCV, MCH, MCHC

LRI PLT, MPV PLT, MPV, PCT, PDW

URI PLT, MPV PLT, MPV, PCT, PDW

LURI PLT, MPV PLT, MPV, PCT, PDW

CBC + NOC or CBC +RRBC Test Selection invalidates additional parameters with an MCHC Suspect
Parameter Flag.

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Table 3.4 Parameters Marked With an Asterisk (*) (Continued)

Instrument and
Parameters marked with an asterisk (*) Parameters marked with an
Data Invalidating
on Chartable Page asterisk (*) on Lab Page
Alerts

Sampling error All Parameters All Parameters

Incomplete
Aspiration

WOC Heater Error WBC (If WOC is chosen), NEU, MONO, WBC (If WOC is chosen) WOC, SEG,
EOS, BASO, LYM, %N, %M, %E, %B, %L, BAND, IG, BLST, MONe, EOS, BASO,
%R, RETC LYMe, VARL, %S, %BD, %IG, %BLST,
%Me, %EO, %B, %Le, %VL, %R, RETC

HGB Heater Error HGB, MCH, MCHC HGB, MCH, MCHC

Reticulocyte
Instrument and Parameters marked with an asterisk (*) Parameters marked with an
Data Invalidating on Chartable Page asterisk (*) on Lab Page
Alerts

Fragile RBC %R, RETC %R, RETC

Too Few Events %R, RETC %R, RETC

ERL %R, RETC %R, RETC

Flow Error %R, RETC %R, RETC

Table 3.5 Parameters with Suppressed Results

Parameters with suppressed results on Parameters with suppressed results

System Errors
Chartable Page on Lab Page

WOC Flow Error WBC (If WOC is chosen), NEU, MONO, WBC (If WOC is chosen), SEG, and IG,
EOS, BASO, LYM, %N, %M, %E, %B, %L BLST, MONe, EOS BASO, LYMe,
VARL, %N,%M, %E, %B, %L

RBC Flow Error RBC, MCH, HCT, MCHC, PLT, MPV RBC, MCH, HCT, MCHC, PLT, MPV,
PCT, PDW

NOC Flow Error WBC (If NOC is chosen), NEU, MONO, WBC (If NOC is chosen), NOC, SEG,
EOS, BASO, LYM, %N, %M, %E, %B, %L BAND, IG, BLST, MONe, EOS, BASO,
LYMe, VARL, %N, %M, %E, %B, %L

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Operational Messages and Data Flagging Section 3

Dispersional Data Alerts

These alerts are triggered by the numeric limits entered into the Patient Sample
Setup Limit Sets (see Section 2: Installation Procedures and Special
Requirements, Subsection: Patient Sample Setup...) or taken from the
instruments preset linearity limits. If results for a parameter exceed these limits,
they are flagged on the screen and on the report. Dispersional alerts are displayed
or printed as follows:
Screen display: Result below lower limit shown in yellow
Result above upper limit shown in purple
Linearity Exceeded: Result displayed as >>>>
NOTE: When the WBC result exceeds the linearity (>>>>) the HGB result is
displayed as <<<< to indicate possible interference with the HGB due to
the elevated WBC result.
Graphic Report: Results outside limits are underlined
Specimens with results that exceed the linearity should be diluted with Diluent/
Sheath according to the laboratorys procedure and repeated. (Be sure to correct the
results for the dilution factor used.)
NOTE: MCV and MPV are unaffected by dilution and do not require correction.

Suspect Parameter Flags

These flags are generated after the instrument evaluates the measured data for a
particular parameter or group of parameters. The result may be suspect due to
interfering substances or the inability of the instrument to measure a particular
parameter due to a sample abnormality.

Introduction to WBC Flagging

These are the WBC parameter flags: WBC, DFLT (NLMEB), DFLT (NE), DFLT
(LM), DFLT (B), and DFLT (LB). The following WBC population flags may be
displayed: NWBC, FWBC, NRBC, RRBC, BAND, IG, BLAST, VAR LYM. If any
of the WBC population or parameter flags is displayed, the message SUSPECT is
displayed to the right of the Limits field on the Run View. This message also
appears on printouts.

WBC Descriptors
The WBC Descriptors (WOC and NOC) are included on the display screen and
printout to provide additional information about the reported WBC value. If there
is a clinically significant difference between the two results in the CBC+RRBC test
selection, the instrument will select the appropriate result and display a descriptor
in parentheses next to the WBC value.
NOTE: In the CBC+NOC test selection, the NOC value is always selected.

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Data Flagging
This section presents the different data descriptors/flagging that can be displayed
when patient specimens are run in the:
CBC test selection
CBC+RRBC test selection
CBC+NOC test selection

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Operational Messages and Data Flagging Section 3

Table 3.6 Patient Specimen Type + CBC Test Selection

Patient Specimen Type + CBC Test Selection

Descriptor/
Cause Suggested Action
Flag

NWBC When cellular debris interference is high A. Review smear for platelet clumps, giant
and there is no declining WOC kinetic rate. platelets or low levels of NRBC and follow your
laboratorys review criteria.
B. If no other suspect parameter flags are present,
the WBC and differential may be reported.

WBC Cellular debris interference is high and a A. Repeat in CBC+RRBC test selection.
NRBC/RRBC declining WOC kinetic rate is detected. B. If flag persists, review a smear for presence of
NRBC and verify Lymph value. Confirm WBC
count by alternate method.

WBC 1. Cellular debris interference is low but a A. Repeat in CBC+NOC test selection. NOC
VAR LYMPH declining WOC kinetic rate is detected. result will be reported as WBC result.
FWBC 2. Cellular debris interference is low and B. Review smear to confirm lymph count and
DFLT (NLMEB) there is no declining WOC kinetic rate, but presence of fragile WBC.
WOC>4.1 x 10e3/L and LYM%>80%.

DFLT(NLMEB)* One or more of the following conditions are A. If the DFLT (NLMEB) flag is accompanied with
true: the FWBC flag, repeat in CBC+NOC test
1. Fragile cells may be present. (When the selection.
FWBC flag is triggered, DFLT (NLMEB) flag B. Review scatterplot for clear separation of cell
is always set.) cluster.
2. An abnormally low number of cells C. Review a stained smear to verify the
available to calculate differential. differential values.
3. The mono-poly cut has too much
interference.
NOTE: These are the different DFLT flags:
(NLMEB), (NE), (LM), (B), and
(LB).
(N=Neutrophils, L=Lymphocytes,
M=Monocytes, E=Eosinophils,
B=Basophils)

DFLT (NE)* The letters in parentheses indicate which A. Review scatterplot for clear separation of cell
or DFLT (LM)* WBC subpopulation or group of cluster.
or DFLT (B)* subpopulations is suspect. The DFLT flag B. Review a stained smear to verify the
or DFLT (LB)* may be due to the presence of abnormal differential values.
cell clusters so the instrument cannot
reliably discriminate among WBC
subpopulations. Thus, a default threshold is
selected.

MCHC MCHC <24 g/dL or 40 >g/dL Verify that the specimen was properly mixed by
following your laboratorys protocol for flagged
RBC indices.

* These flags are also triggered in the CBC+NOC and CBC+RRBC test selections when there is no significant
difference between WOC and NOC.

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Table 3.6 Patient Specimen Type + CBC Test Selection (Continued)

Patient Specimen Type + CBC Test Selection

Descriptor/
Cause Suggested Action
Flag

BAND* The BAND flag is triggered if any of the Review a stained smear for the presence of
following conditions are met: bands and follow your laboratorys review
1. The CV of the neutrophil cluster on the 0 criteria.
axis exceeds expected criteria. NOTE: When bands are present, they are
2. %BAND > 12.5% of the total WBC count. included in the total neutrophil count.
3. The ratio of suspected bands to mature
neutrophils is >50%.

IG* The IG flag is triggered if the following Review a stained smear for the presence of
condition is met: immature granulocytes and follow your
%IG 3% of the total WBC count laboratorys review criteria.
NOTE: When IGs are present, they are included
in the total neutrophil count.

BLAST* The BLAST flag is triggered if any of the Review a stained smear for the presence of
following conditions are met: blasts and follow your laboratorys review criteria.
1. %Blast > 1% of the total WBC count NOTE: When blasts are present, they are
included in the monocyte count.

VAR LYM* 1. When the FWBC flag is triggered, Review a stained smear for the presence of
VAR LYM flag is always set. variant lymphocytes and follow your laboratorys
2. Any of the following attributes fail to meet review criteria.
expected criteria: NOTE: When variant lymphocytes are present,
a. Position of the lymphocyte cluster on the they are included in the lymphocyte
scatter plot. count.
b. Ratio between lymphocytes and other NOTE: This flag may be displayed singly or in
WBC subpopulations combination with the blast flag. If the flag
c. Lymphocyte count (absolute or %) is displayed with the blast flag, it is
displayed as VLYM/BLAST.

RBC MORPH* One or more of the following parameters 1. Review a stained smear for abnormal RBC or
exceeds expected limits: PLT morphology and follow your laboratory's
MCH < 25pg or >34pg review criteria.
MCHC < 29g/dL or >37g/dL 2. If NRBC or RRBCs are suspected to be
RDW >18.5% present, run the specimen in the CBC+RRBC test
selection.

* These flags are also triggered in the CBC+NOC and CBC+RRBC test selections when there is no significant
difference between WOC and NOC.

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Operational Messages and Data Flagging Section 3

Table 3.6 Patient Specimen Type + CBC Test Selection (Continued)

Patient Specimen Type + CBC Test Selection

Descriptor/
Cause Suggested Action
Flag

LRI* 1. Interference in the lower threshold region A. Repeat the specimen. If the flag persists,
(2fL3fL) > 25% of PLT count. review a smear and verify the platelet count.
2. Too much interference between noise B. If the flag persists on subsequent samples,
region and PLT population. check the platelet background count. If the
3. Too much noise in the 0-low threshold background count exceeds the specification,
region. troubleshoot accordingly.
NOTE: LRI may be caused by:
Debris
Contaminated reagent
Microbubbles
Dirty Diluent/Sheath filter

URI* 1. Interference in the upper threshold region A. Review MCV, platelet histogram and
(1535fL) > 25% of PLT peak. scatterplot.
2. PLT aggregate count (PLT clumps) B. If the scatterplot shows overlap in the RBC or
> 15% of PLT count. platelet populations or a population is present
URI may be cause by: above the platelet scatter, review a smear to
Microcytic RBC determine the cause and confirm the platelet
Schistocytes count.
Giant Platelets
Sickle Cells
Platelet Clumps

LURI* Interference is present in both the upper Same actions as for LRI and URI
and lower regions of the PLT histogram.

NO MPV* MPV < 3.5 fL Repeat the specimen. If the MPV data is
PLT has an abnormal distribution suppressed, review the smear for abnormal
platelet morphology and platelet aggregates and
follow your laboratorys review criteria. Verify the
platelet count.

ATYPDEP* Atypical depolarization events detected in Review a stained blood film to detect a possible
the lobularity (90), granularity (90 morphologic correlate (situation), and follow your
depolarizing) scatter data with cross check laboratory's review criteria.
done using size (0) and complexity (10)
scatter data. See also Section 2: Installation Procedures and
Special Requirements, Subsection: Flag
Settings.

* These flags are also triggered in the CBC+NOC and CBC+RRBC test selection when there is no significant
difference between WOC and NOC.

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Table 3.7 Patient Specimen Type + CBC+RRBC Test Selection

Patient Specimen Type + CBC+RRBC Test Selection

Descriptor/Flag Cause Suggested Action

(NOC) WOC > NOC in the Resistant RBC cycle A. Review a stained smear to determine the
WBC (NOC is selected as WBC count.) cause of the interference such as (NRBC) and
RRBC/NRBC NOTE: Higher WOC is due to unlysed confirm the lymphocyte result.
DFLT (NLMEB) RRBCs, such as target cells and B. If NRBCs are present, quantify them
sickle cells. Lymphocyte count is according to your laboratorys procedure. If
corrected by adding the correction of the WBC is required, correct the
difference between WOC and NOC value and use the resultant number to
NOC to the lymphocyte count. confirm the WOC result. If no other Suspect
Parameter flags are present, the corrected
NOC (or confirmed WOC) value is reportable.
C. If lytic-resistant RBCs are present, follow
your laboratorys procedure for reporting the
results.

(WOC) NOC > WOC and high stroma A. Review a stained smear to determine the
WBC interference in the Resistant RBC cycle cause of the interference (NRBC and/or
RRBC/NRBC (WOC is selected as WBC count.) unlysed RRBCs).
B. If NRBCs are present, quantify them
according to your laboratorys procedure. If
correction of the WBC is required, correct the
NOC value and use the resultant number to
confirm the WOC result. If no other Suspect
Parameter flags are present, the corrected
NOC (or confirmed WOC) value is reportable.

(WOC) NOC >WOC, low stroma interference, A. Review a stained smear for the presence of
WBC and %L<60% in the Resistant RBC cycle NRBCs.
NRBC (WOC is selected as WBC count.) B. If NRBCs are present, quantify them
according to your laboratorys procedure. If
correction of the WBC is required, correct the
NOC value and use the resultant number to
confirm the WOC result. If no other Suspect
Parameter flags are present, the corrected
NOC (or confirmed WOC) value is reportable.

(NOC) NOC>WOC, low stroma interference, Review a stained smear and follow your
WBC and %L>60% in the Resistant RBC laboratorys procedure to confirm the
FWBC cycle. lymphocyte count, the reported WBC and the
VAR LYM (NOC is selected as WBC count.) presence of fragile WBCs.
DFLT (NLMEB) NOTE: Lymphocyte count is corrected
by adding the difference
between WOC and NOC to the
lymphocyte count.

NOTE: See Table 3.6 for additional flags that may trigger with this test selection when there is no significant
difference between WOC and NOC.

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Operational Messages and Data Flagging Section 3

Table 3.8 Patient Specimen Type + CBC+NOC Test Selection

Patient Specimen Type + CBC+NOC Test Selection

Descriptor/Flag Cause Suggested Action

(NOC) In the CBC+NOC test selection, the Review smear to confirm Lymph count and
FWBC FWBC and VAR LYM flags are always presence of fragile WBC.
DFLT (NLMEB) displayed along with the DFLT (NLMEB)
flag.
VAR LYM
(NOC is selected as WBC Count.)

NOTE: See Table 3.6 for additional flags that may trigger with this test selection when there is no significant
difference between WOC and NOC.

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Interpretive Messages
Interpretive messages appear only on the graphics report and are generated when the
numeric limits entered in the Patient Limit Sets are exceeded. See
Section 2: Installation Procedures and Special Requirements,
Subsection: Patient Sample Setup.... These messages are printed only when the
Interpretive Report option is selected on the Setup, Customize Printed Report dialog
box. The Interpretive messages are summarized below.
WBC Messages
Message Cause
Leukopenia result exceeds the lower limit for WBC
Leukocytosis result exceeds the upper limit for WBC
Neutropenia result exceeds the lower limit for Neutrophil absolute
number
Neutrophilia result exceeds the upper limit for Neutrophil absolute
number
Lymphopenia result exceeds the lower limit for Lymphocyte
absolute number
Lymphocytosis result exceeds the upper limit for Lymphocyte
absolute number
Monocytosis result exceeds the upper limit for Monocyte absolute
number
Eosinophilia result exceeds the upper limit for Eosinophil absolute
number
Basophilia result exceeds the upper limit for Basophil absolute number

RBC Messages
Message Cause
Anemia result exceeds the lower limit for RBC
Polycythemia result exceeds the upper limit for RBC
Microcytic RBC result exceeds the lower limit for MCV
Macrocytic RBC result exceeds the upper limit for MCV
Hypochromic result exceeds the lower limit for MCHC
Hyperchromic result exceeds the upper limit for MCHC
Anisocytosis result exceeds the upper limit for RDW

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Operational Messages and Data Flagging Section 3

PLT Messages
Message Cause
Thrombocytopenia result exceeds the lower limit for PLT
Thrombocytosis result exceeds the upper limit for PLT
Microcytic PLT result exceeds the lower limit for MPV
Macrocytic PLT result exceeds the upper limit for MPV

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Section 3 Principles of Operation

References

1. Clinical Applications of Flow Cytometry, ASCP National Meeting, Spring

1990.
2. Shapiro, Howard, Practical Flow Cytometry, 1984.

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Principles of Operation
References Section 3

NOTES

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 Section 4 Performance Characteristics and Specifications

Section 4 Performance Characteristics and Specifications

Overview

This section presents the various specifications and performance characteristics of

the CELL-DYN Ruby. In particular, the following are discussed:
Specifications
Physical Specifications
Power Specifications
Environmental Specifications
Operational Specifications
Bar Code Specifications
Performance Specifications
This section does not describe the limitations of the System. For this information,
refer to Section 7: Operational Precautions and Limitations.

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Performance Characteristics and Specifications
Overview Section 4

NOTES

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Section 4 Performance Characteristics and Specifications

Specifications

Physical Specifications
Physical specifications for the CELL-DYN Ruby are provided in the following
table.
Table 4.1 CELL-DYN Ruby Physical Specifications

Module Height Width Depth Weight

Analyzer 49.9 cm 86.4 cm 76.8 cm 105.2 kg

(19.25 in.) (34.0 in.) (30.25 in.) (232.0 lbs.)

Printers Refer to the printer manufacturers specifications.

Power Specifications
The power specifications for the CELL-DYN Ruby are described in the following
tables. Refer to the power specifications applicable in your country.
Table 4.2 CELL-DYN Ruby Power Specifications

Module Voltage Frequency Max Current BTU/Hr

Analyzer 100 - 240 VAC 47/63 Hz 5.0 - 2.2 amps 550 watts

Display 100 - 240 VAC 50/60 Hz 1.5 amps 50 watts

Printer For power specifications for printers, refer to the operators manual for your printer or
other documentation received with your printer.

Table 4.3 CELL-DYN Ruby Fuse Specifications

Module Fuse Rating

Analyzer Internal fuses only. Not operator replaceable.

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Performance Characteristics and Specifications
Specifications Section 4

Environmental Specifications
Environmental specifications include the operating environment required by the
CELL-DYN Ruby, the clearance and waste disposal requirements, and the noise
level and heat output that can be expected during normal operation.

Operating Environment Requirements

Temperature: 15C30C (59F86F)
Relative Humidity: < 80%
(non-condensing)
Indoor Use

Clearance Requirements
To ensure proper service access and ventilation, provide the CELL-DYN Ruby
with the clearances shown in the following table.
Table 4.4 Clearance Requirements

Unit Above Behind Left Right

Analyzer 15.2 cm 15.2 cm 15.2 cm 15.2 cm

(6 in.) (6 in.) (6 in.) (6 in.)

Table 4.5 Clearance Requirements for Service Access

Unit Above Behind Left Right

Analyzer 30.5 cm 15.2 cm 40.6 cm 40.6 cm

(12 in.) (6 in.) (16 in.) (16 in.)

Waste Disposal Requirements

All waste produced by the CELL-DYN Ruby must be disposed of according to
local, state, and federal regulations governing the treatment and disposal of
medical waste. Label all waste containers as biohazardous waste.

Operating Noise Level and Heat Output

The CELL-DYN Ruby produces a certain amount of noise and heat as a normal
part of operation. The following levels of noise and heat can be expected:
Noise Level: Idle Mode < 60 db
Running Mode < 65 db
Heat Output: 0.6 kW maximum (2000 BTU)

Transport and Storage

There are no specific environmental conditions for transport or storage.

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Section 4 Performance Characteristics and Specifications

Operational Specifications
Maximum Throughput (Closed Mode)
CBC: 68 specimens/hr

Maximum Throughput (Open Mode)

CBC: 76 specimens/hr

Nominal Aspiration Volume

Closed Mode: < 230 L
Open Mode: < 150 L

Recommended Anticoagulants
All performance claims given in this manual were generated using specimens
collected in K2EDTA. Results may be affected by the use of other anticoagulants.

Specimen Tube Dimensions (Closed Mode)

Table 4.6 Recommended Collection Tube Dimensions for use in Closed mode

Collection Tube Dimensions Rack

11.5-13 mm diameter x 65-75 mm long Refer to Appendix : Appendix A -

CELL-DYN Ruby Parts and
Accessories for rack information.

When all specimens are run with this test selection

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Specifications Section 4

Recommended Specimen Collection Tubes (Closed Mode)

CAUTION: The tubes listed in the following table are only listed to
address physical compatibility and are not recommended based on analytic
performance.

Table 4.7 Recommended Specimen Collection Tubes for use in Closed Mode

Specified Tube Maximum Tube Specified Tube Specified Tube

Brand
Dimensions Draw Volume Closure Type

Becton Dickinson 13 mm diameter x 5.0 mL Conventional or Glass

Vacutainer 75 mm long Hemogard or
Plastic

Greiner 13 mm diameter x 4.0 mL None Plastic

Vacuette 75 mm long

Sarstedt 13 mm diameter x 2.6 mL None Plastic

S-Monovette 65 mm long
or
11.5 mm diameter x 2.7 mL
66 mm long

Terumo 13 mm diameter x 5.0 mL None Glass or Plastic or

Venoject 75 mm long PET
Venosafe

Recommended Volume Requirements in Specimen Collection Tube

Closed Mode:
Minimum Specimen Volume > 1.2 mL
NOTE: Follow the collection tube manufacturers recommendation for minimum
volume in specimen tubes.
Open Mode:
Minimum Specimen Volume > 0.5 mL (500L)
NOTE: 0.18 mL (180 L) - In Micro-Specimen Collection Tubes
(Non-vacuum)
NOTE: Follow the collection tube manufacturers recommendation for minimum
volume in specimen tubes.

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Section 4 Performance Characteristics and Specifications

Bar Code Specifications

Specification for Bar Code Symbols, Bar Code Labels, and their Placement
Bar code symbols, labels, and their placement must meet the following
specifications to be used with the CELL-DYN Ruby System.

Symbology:
Code 39
Interleaved 2 of 5
Codabar
Code 128
All CELL-DYN Ruby-compatible symbologies have Character Self-
Checking.

Symbol Dimensions:
Length of the Bar Code Symbol (see the following figure):
Maximum Bar Code Symbol Length: 41mm (1.6 in.)
Minimum length of Quiet Zone at each end: 5mm (0.2 in.)
NOTE: A maximum Bar Code Label length of 51mm (2.0 in.) includes
the required minimum Quiet Zone of 5mm (0.2 in.) at each end
of the symbol.
Height of the Bar Code Symbol (see the following figure):
Minimum Bar Code Symbol Height: 12.7mm (0.5 in.)

Figure 4.1 Bar Code Symbol Dimensions & Label Requirements

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Specifications Section 4

Bar Code Label:

Label Orientation: Place the label with the bars perpendicular to the axis of
the tube. See Figure 4.2.
Label Size:
Maximum label length: 51mm (2.0 in.)
Maximum label width: 31.8mm (1.25 in.)

Print Quality of Measurement:

Minimum printer resolution: 200dpi (dots per inch)
Reflective contrast between bars and label background: >70%
Density: Low or Medium
Symbol Grade: Minimum of C as defined by ANSI X3. 182-1990

Module Dimension (Narrow Element Dimension):

The width of the narrowest element in a bar code: 0.25mm (0.01 in.)

Data Content:
Bar Code Symbology Characters
CAUTION: DO NOT use the following characters for Specimen
Identification: ~, | , \ , ^ , and &. These characters will cause the Specimen
ID to be truncated at the point where the character is located within the ID.
This action will result in an erroneous Specimen ID for the downloaded
Pending Order entry or for the record received by the LIS, without any error
notification.

Table 4.8 Characteristics of the Bar Code Symbologies Supported by the CELL-DYN Ruby

Bar Code Symbology Name Elements per Character Characters*

Code 39 Each character has 9 elements: Alphanumeric characters:

5 bars and 4 spaces A-Z, 0-9, <space>, $ - . / + %

Interleaved 2 of 5 Each character (2 digits) has 10 Numeric characters:

elements: 5 bars and 5 spaces 0-9

Codabar Each character has 7 elements: Numeric characters:

4 bars and 3 spaces 0-9 , and $ - . / + :

Code 128 Each character has 6 elements: All 128 ASCII characters and all 128
3 bars and 3 spaces extended ASCII characters
* Do not use these character for specimen identification: ~, | , \ , ^ , and &.

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Bar Code Label Placement:

A Bar Code Symbol including Quiet Zone should be placed at least 8mm
(0.31 in.) from the bottom of the tube and within the following label
placement zone on a specimen tube to be sensed by the tube sensor(s) and to
be read by the Bar Code Reader in the Closed Mode, see the following two
figures.

Figure 4.2 Bar Code Label Placement Requirements

59

2 3 4 5 6

Figure 4.3 Tube with Correctly Positioned Bar Code Label in a Sample Loader
Rack

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Specifications Section 4

CAUTION: To prevent potential bar code reading errors or a sample

identification that can be mistaken for another Sample ID:

Use the bar code symbology Code 128 specified by the Clinical and
Laboratory Standards Institute CLSI1.
Verify that laboratory generated bar code labels and label placement follow
the specifications listed in this section.
Good Laboratory practice mandates that each specimen is labeled with
information traceable to one patient only. Therefore, it is recommended that
only one bar code label is used on each tube for correct specimen
identification.

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Section 4 Performance Characteristics and Specifications

Performance Specifications
The following performance specifications apply to systems that have been installed
and maintained according to the guidelines in this manual and are operated with the
recommended reagents and supplies. Specifications listed apply to all modes and
test selections. System performance is expected to meet or exceed the
specifications listed.

Background
Background concentrations represent apparent sample-related constituents that
actually originate from blood-free reagents and/or electronic noise. The
background concentrations are used to confirm the Systems baseline performance,
where no actual sample is aspirated. The following table lists acceptable
background concentration limits that must be met before using the instrument.
Table 4.9 Background Limits

Parameter Background Concentration Limits

WBC (WOC and NOC) < 0.10 x 103/L

RBC < 0.02 x 106/L

HGB < 0.10 g/dL

PLT < 5.00 x 103/L

RETC < 100 counts

Results are expressed in traditional US Units.

Carryover
Carryover is defined by CLSI EP10-A22 as the discrete amount of analyte carried
by the measuring system from one sample reaction into subsequent sample
reactions, thereby erroneously affecting the apparent amounts in subsequent
samples. It is expressed as either a percent or an absolute effect of one sample
upon succeeding analysis. For hematology instruments, carryover generally causes
a positive bias on the results for the succeeding sample.

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Specifications Section 4

CBC Parameters
The specific parameters tested for carryover were WBC (WOC and NOC), RBC,
HGB and PLT. Whole blood specimens with high target values were processed in
triplicate, followed by three aspirations of whole blood specimens with low target
values. Carryover is calculated and expressed as a percentage using the following
formula per the ICSH3:

% Carryover = ( High Target Value - Low Target Value )

Low Target Value - Low Target Value
1
3
X 100 3
3

Table 4.10 Carryover

Target Values
Parameter % Carryover
(USA)

Low Value High Value

WBC 0.05 x 103/L 128 x 103/L < 1%

(WOC and NOC)

RBC 0.01 x 106/L 7.98 x 106/L < 1%

HGB 0.01 x g/dL 24g/dL < 1%

PLT 0.28 x 103/L 1458 x 103/L < 1%

Manipulation of fresh whole blood was needed to generate the pathologically elevated
or depressed concentrations shown in this Table. Results are expressed in traditional
USA units.

As a matter of convenience, many laboratories compare a normal value specimen

followed by an aspiration of air to calculate background.
Reticulocyte % measurement carryover, as shown in Table 4.11 is calculated using
actual Listmode counts, rather than using the Reticulocyte percent. It is calculated
using the following formula:

Background1 - Background3
% Carryover = X 100
Retic Listmode3 - Background Count3
Reticulocyte carryover is determined on fresh blood samples with RBC in the
range of 4.0-6.0 M/L. Retic Background count is reported on the Retic Run
Results Screen, while Retic Listmode can be found in DIAGNOSTICS---> RETIC
RAW DATA.
Table 4.11

Parameter Specimen Range % Carryover

RETIC % 0.9 - 1.6% < 1%

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Imprecision (Reproducibility)
Imprecision is the standard deviation (SD) or coefficient of variation (%CV) of
analytic results in a set of replicate measurements. Fresh whole blood specimens
used to verify imprecision specifications should have mean values that fall within
the range tested in the following table and should not display any Suspect
Parameter flags for the measurand (parameter) studied.
The following data were derived from multiple fresh normal blood imprecision
runs (n=31 replicates/run) performed on 3 analyzers in various test selections and
modes during the Abbott Hematology medical-clinical validation study.
Table 4.12 Fresh Blood Imprecision

Observed % CV Upper Confidence LimitsC

Parameter Ranges TestedA
RangeB
95 % 97.5 % 99 %

WBC (WOC) 4.4 9.5 X 103/L 1.2 2.7 2.4 2.5 2.7

WBC (NOC) 4.4 9.4 X 103/L 1.2 - 3.1 2.8 3.0 3.3

RBC 4.52 5.72 X 106/L 0.6 1.8 1.8 1.9 2.1

HGB 13.4 16.9 g/dL 0.3 1.8 1.4 1.5 1.7

HCT 40.1 - 51.6 % 0.6 1.9 1.8 1.9 2.1

MCV 82.5 97.3 fL 0.2 0.8 0.8 0.8 0.9

RDW 10.6 13.2 % 0.8 1.6 1.5 1.6 1.7

PLT 168 371 X 103/L 1.7 3.9 3.8 4.0 4.3

MPV 5.4 9.9 fL 2.4 7.1 6.2 6.6 7.1

RETC 1.2 1.8 % 8.1 12.3 13.9D 15.0D 16.5D

NEU 46.1 69.1 % 0.7 1.7 1.8 1.9 2.0

LYM 22.3 42.6 % 1.7 3.4 3.3 3.5 3.7

MONO 4.5 9.4 % 4.3 12.0 11.0D 11.9D 13.1D

EOS 0.6 7.0 % 5.0 20.1 21.2D 23.2D 25.8D

BAS0 0.5 1.6 % 10.1 23.1 23.3D 24.8D 26.7D

Expected Failure Frequency For Statistical Reasons Alone: 1 in 20 1 in 40 1 in 100

A Results are expressed in traditional US units. These ranges do not represent globally applicable reference intervals, but re-
flect normal ambulatory adults in the validation study. Each laboratory should establish/verify its own reference intervals.
B These are the minimum and maximum imprecision values observed for up to 39 imprecision runs with n=31 replicates.
C Each column represents the maximum imprecision (%CV) expected for this entire data set. The frequency statements at the
bottom of each column represent how often a higher %CV is expected for statistical reasons alone.
D Higher values than the other measurands are expected because of lower numbers of reticulocytes, monocytes, eosinophils,
and basophils in normal blood. This table format is used to simplify comparisons of achieved %CV for all measurands on
an analyzer undergoing evaluation.

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Performance Characteristics and Specifications
Specifications Section 4

Laboratories should confirm this imprecision performance, using fresh whole

blood specimens within the ranges shown above. Specimens with values outside
these ranges may have higher or lower %CV, in part based on binomial
distributions and Poisson statistics that govern particle counting. If a laboratory
uses a different number of replicates than n=31, a statistical comparability test must
be performed for different sample sizes, such as the chi-squared method described
in CLSI EP5-A2.

Analytical Measurement Range (AMR)

This represents the range over which the system will yield accurate results. The
analytical measurement range (AMR) specifications in the following table were
determined by analyzing dilutions and concentrations of fresh human whole blood,
supplemented with commercial material. Only samples without invalidating or
suspect flags for the parameter studied were used. The stated limits were
determined by regression analysis using a statistical process method evaluation
based on CLSI EP6-A.
Table 4.13 Analytical Measurement Range

Paramter Display Range AMR UnitsA

WBC 0.00 246. 0.02 246.8 X 103/L

RBC 0.00 7.16 0.00 7.16 X 106/L

HGB 0.00 19.9 0.0 19.9 g/dL

HCT 0.00 99.5 13.0 60.0 %

MCV 0.00 139 58 139 fL

RDW 0.00 29.8 10.0 29.8 %

PLT 0.00 1903 11 1903 X 103/L

MPV 0.00 17.2 4.3 17.2 fL

RETC 0.00 23.0 0.2 22.9 %

A Results are expressed in traditional U.S. units

In order to extend the MCV lower limit beyond that encountered in the Abbott
medical-clinical studies, various animal bloods were compared to a reference
MCV derived from a centrifugal microhematocrit and a CELL-DYN Sapphire
reference RBC concentration, with the following expanded range:
MCV: 38.3 63.5 fL
Patient specimen values beyond the upper limit of the AMR should be established
by dilution and re-assay, while specimen values beyond the lower limit of the AMR
(as applicable) should be established by alternate methods in accordance with
laboratory policy.

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Section 4 Performance Characteristics and Specifications

Comparability (Correlation)
Results from five CELL-DYN Ruby systems were compared with five
CELL-DYN Sapphire hematology analyzers for principal comparability purposes.
Additional comparisons of the WBC differential were made to microscopy. These
results represent typical performance achieved during Abbotts medical-clinical
validation studies. The results in individual laboratories may vary from these data.
Table 4.14 Comparability (Correlation) of CBC and Differential to CELL-DYN Sapphire

Parameter Range TestedA Replicates r-valueB Slope Y - Intercept

WBC 0.02 212 X 103/L 2,635 0.998 1.03 -0.05

RBC 1.47 7.84 X 106/L 2,668 0.995 0.99 +0.04

HGB 4.5 23.8 g/dL 2,735 0.997 1.01 -0.10

HCT 29.6 60.0 % 2,306 0.988 1.00 +0.40

MCV 71 118 fL 2,665 0.965 0.96 +4.74

RDW 10 30 % 2,688 0.942 0.97 +0.46

PLT 23 1993 X 103/L 2,453 0.996 0.98 +6.39

MPV 4 17 fL 2,441 0.823 1.28 -2.01

RETC 0.2 4.9 % 605 0.822 0.69 +0.37

NEU 18 97 % 2,273 0.995 0.99 +1.01

LYM 1 75 % 2,273 0.992 0.98 -0.12

MONO 0 30 % 2,273 0.930 0.93 +0.66

EOS 0 12 % 2,273 0.969 1.02 -0.18

BASO 05% 2,273 0.624 0.81 +0.46

A Results are expressed in traditional US units. These values do not represent the analytical measurement range, which is
provided in another table.
B Correlation coefficient, established by Passing-Bablok regression analysis, except for BASO, which was analyzed by
orthogonal regression analysis.

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Performance Characteristics and Specifications
Specifications Section 4

Table 4.15 Comparability (Correlation) of WBC Differential to Microscopy

Parameter Range TestedA Replicates r-valueB Slope Y - Intercept

NEU 7 95% 113 0.983 0.97 -1.98

LYM 1 72% 113 0.921 0.95 +0.94

MONO 3 69% 113 0.711 1.10 +1.93

EOS 0 20% 113 0.952 1.04 +0.01

BASO 0 10% 113 0.146 0.18 +1.22

A Results are expressed in traditional US units. These values do not represent the analytical measurement range, which is
provided in another table.
B Correlation coefficient, established by Passing-Bablok regression analysis, except for BASO, which was analyzed by
orthogonal regression analysis.

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Section 4 Performance Characteristics and Specifications

References

1. Clinical and Laboratory Standards Institute/NCCLS. Evaluation of the Linearity

of Quantitative Measurement Procedures; a Statistical Approach; Approved
Guideline. CLSI/NCCLS document EP6-A [ISBN 1-56238-498-8] Clinical and
Laboratory Standards Institute/NCCLS, 940 West Valley Road, Suite 1400,
Wayne, PA, 2003.
2. Clinical and Laboratory Standards Institute/NCCLS. Evaluation of Precision
Performance of Quantitative Measurement Methods; Approved Guideline
Second Edition. CLSI/NCCLS document EP5-A2 [ISBN 1-56238-542-9]
Clinical and Laboratory Standards Institute/NCCLS, 940 West Valley Road,
Suite 1400, Wayne, PA, 2004.

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Performance Characteristics and Specifications
References Section 4

NOTES

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 Section 5 Operating Instructions

Section 5 Operating Instructions

Overview

The CELL-DYN Ruby System accommodates many laboratory environments and

workflow. Before attempting to operate the system, you should be familiar with the
hardware components of your system and the fundamental principles of the
software user interface. See Section 1: Use or Function.
This section presents the information necessary to perform the day-to-day
operation of the CELL-DYN Ruby. Operating instructions topics include:
System Priming, Interruption, and Standby
Describes how to prime, interrupt, standby, power on, and power off the
system.
Setup Guidelines
Tasks to configure your system.
Specimen Analysis
Provides descriptions of specimen analysis tasks, Orders Management for
specimen processing, and how to initiate processing runs in the Open and
Closed Modes.
Post Analysis Processing
Provides descriptions of the stored results and instructions on how to find,
view, transmit, and print results.
Advanced Data Management
Describes working in the Groups View.
Quality Control ID (QCID) File Setup, control material processing in the
Open Mode, control results analysis and file data management, Westgard
rules, Levey-Jennings graphs, and QC views are described in detail in
Section 11: Quality Control.

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Operating Instructions
Overview Section 5

NOTES

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 Operating Instructions
Section 5 System Priming, Interruption, and Standby

System Priming, Interruption, and Standby

System Priming, Interruption, and Standby

Power On and Power Off
1 CD-ROM or DVD
Drive 1
4
2 Floppy Drive
3 Data Station Power 3
Button 5
2
4 Main Power Switch
(Rear Panel)
5 Intake Fan

Figure 5.1 Power Switch Locations

Power ON Procedure
Leave the System main power switch, located on the back of the Analyzer, ON at
all times. The instrument is designed to maintain itself when it is idle. If the
instrument is idle for four hours, an automatic To Standby cycle is initiated. The
instrument is placed in the Analyzer Status, Standby state at the end of the
automatic cycle.
With the System main power switch in the ON position, the Data Module Power
button (spring-loaded momentary type) is used to power the Analyzer and Display
ON.
The Application Programs shutdown menu option should be used to turn the
Analyzer OFF.
The Display and Printer have their own power switches and should be left ON as
long as the main power switch to the System is ON. Power to the Display and
printer should be turned OFF when the System main power switch is turned OFF,
when a malfunction is suspected, or requested to by an authorized Abbott
representative.
Refer to the printer manufacturers operating instructions for complete instructions
on printer operation.
CAUTION: If the power has been OFF more than five minutes, let the
laser warm up for 15 minutes once the power is turned back ON. Do not
process samples during this warm-up period.

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Operating Instructions
System Priming, Interruption, and Standby Section 5

Power On with Main Power Switch in ON Position

Table 5.1 Procedure to Power-up the Instrument When the System Main Power Switch is in ON Position

Task Step Result/Comment

Power-up 1. Press and hold (4 seconds), then CAUTION: If the power has been
release the Data Module power OFF more than five minutes, the
switch (right side). laser must be allowed to warm up
2. When the Analyzer Status indicates for 15 minutes once the power is
Uninitialized state, press F12 Init turned back ON. Do not process
to initialize the system. samples during this warm-up
period.
3. When the Analyzer Status indicates
Initialized state, press F12 Prime
to prime the system and run an Auto
Background.
NOTE: Verify background count results
are within acceptable limits prior
to running controls or patient
specimens.

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 Operating Instructions
Section 5 System Priming, Interruption, and Standby

Power On with Main Power Switch in OFF Position

:

Table 5.2 Procedure to Power-up the Instrument When the System Main Power Switch is in OFF Position

Task Step Result/Comment

Pre-Power Up Tasks 1. Verify that: CAUTION: If the power has been

a. All components are properly OFF more than five minutes, the
installed (syringes, tubing in the laser must be allowed to warm up
normally closed valves, Shear for 15 minutes once the power is
Valve, etc.). turned back ON. Do not process
samples during this warm-up
b. All reagents are properly installed.
period.
c. All necessary cables and power
cords are properly connected.
d. The Analyzer covers are properly
installed, including the Processor
Cover.
e. If a problem caused the main
power switch to be turned OFF,
verify that the problem has been
corrected.

Turn on the System 2. Turn the System main power switch

and peripherals (rear panel) to the ON position
followed by:
a. Display
b. Printer
c. Data Module power switch (right
side), press and hold for 4
seconds, then release the Data
Module power switch (right side).

Initialize 3. When the Analyzer Status indicates

Uninitialized state, press F12 Init
to initialize the system.

Prime and check 4. When the Analyzer Status indicates

background counts Initialized state, press F12 Prime
to prime the system and run an Auto
Background.
NOTE: Verify background count results
are within acceptable limits prior
to running controls or patient
specimens.

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Operating Instructions
System Priming, Interruption, and Standby Section 5

Power OFF Procedure

It is not necessary to turn the System main power switch OFF under normal
operating conditions. The System main power switch (rear panel) should be turned
OFF when a malfunction is suspected, when instructed or requested to do so by an
Abbott representative, when the system will be moved, or when the system will be
inactive for an extended period of time (greater than 2 weeks). If the system will
be inactive for a longer period of time see the special protocol Section 9: Service
and Maintenance, Subsection: 7009 Prepare for Shipping protocol.
NOTE: In the event of an emergency, turn the System main power switch OFF as
quickly as possible.
Table 5.3 Procedure to Power Off and Reboot the System

Task Step Result/Comment

Power off 1. With the System main power 1 If analyzer state is READY, shutdown will put
and reboot switch ON, select File, then analyzer in standby mode before turning it OFF,
Shutdownfrom the menu bar. otherwise, analyzer will be turned off without
2. Select OK to initiate shutdown. standby.
3. Wait 5-10 seconds after the 2 Analyzer and Data Module are OFF.
display turns black, press and
hold (4 seconds), then release
the Data Module power button
(right side) to reboot the system.
4. When the Analyzer Status
indicates Uninitialized state,
press F12 Init to initialize the
system.
5. When the Analyzer Status
indicates Initialized state, press
F12 Prime to prime the system
and run an Auto Background.
NOTE: Verify background count
results are within
acceptable limits prior to
running controls or patient
specimens.

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 Operating Instructions
Section 5 System Priming, Interruption, and Standby

Power Down and Power Off Main Power Switch

Table 5.4 Procedure to Power-Down the Instrument and Power Off the System Main Power Switch

Task Step Result/Comment

Power off the main 1. With the System main power switch Refer to Section 9: Service and
power switch ON, perform Auto-Clean procedure. Maintenance, Subsection: Scheduled
2. When the Auto-Clean cycle is Maintenance Procedures.
finished, select To Standby from the
Maintenance, Special Protocols
view.
3. When the Analyzer Status indicates
Standby state, select System
Shutdown from the Maintenance,
Special Protocols view.
4. Wait 5-10 seconds after the display
turns black, then turn the System
main power switch OFF (rear panel)
followed by:
a. Display
b. Printer

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Operating Instructions
System Priming, Interruption, and Standby Section 5

System Priming
The Analyzer must be primed for specimen analysis. If the CELL-DYN Ruby
Analyzer Status indicates Standby state, the System can be primed in two ways:
F12 Prime
Select the F12 Prime function key to activate prime cycle
and run an AutoBackground.
NOTE: Verify background count results are within
acceptable limits prior to running controls or patient specimens.
Prime task button
Select Prime task button
from the Maintenance,
Special Protocols tab
view to activate prime
cycle and run an AutoBackground.
NOTE: Verify background count results are within acceptable limits prior
to running controls or patient specimens

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 Operating Instructions
Section 5 System Priming, Interruption, and Standby

Interruption Procedures
Sample Loader processing can be interrupted using the following procedures in the
following table. If the Sample Loader halts automatically in response to a System
Information Message, refer to Section 10: Troubleshooting and Diagnostics,
Subsection: System Messages.

Procedural Guidelines
Starting, interrupting and re-starting the loader without changing to Open mode
generates the Sample Loader Resume or Reset dialog box that provides the option
to resume rack processing if the rack was not moved, or to reset the rack to the load
position and begin again.
Starting, interrupting, changing to Open mode and then back to Closed mode, and
re-starting the loader generates the Sample Loader Reset dialog box that prompts
the operator to reset the rack to the load position and begin again.
Table 5.5 Sample Loader Interruption

Task Step

Interrupt loader and 1. Select F12 Stop Loader function key.

restart loader 2. Select F12 Start Loader function key.
3. If rack under the Processor Cover is not being
removed, select the Resume Loader button in
the Sample Loader Resume or Reset dialog
box to resume loader processing.
If rack under the Processor Cover is being
removed, remove any completed tubes from
the racks, reset the rack to the load position,
select the Reset Loader button in the Sample
Loader Resume or Reset dialog box to
restart loader processing.

Interrupt loader, 1. Select F12 Stop Loader function key.

change modes, and 2. Select F11 Select Open function key to
then re-start loader change modes and process as necessary.
3. Select F11 Select Closed function key to
change modes.
4. Press the F12-Start Loader function key.
5. Select the Reset Loader button in the Sample
Loader Reset dialog box to begin loader
processing.

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Operating Instructions
System Priming, Interruption, and Standby Section 5

Standby
The To Standby Task Button
The System enters the Standby state automatically or on demand. When the
System goes into the Standby state, the following events are automatically
performed:
Fluidics are rinsed and drained
Pinch valves are opened
Laser power is reduced as needed
Vacuum and pressure are vented
Internal timer is set
After four hours of inactivity, the System automatically goes into Standby state.
Once in Standby, the System exercises pinch valves every four hours to unpinch
tubing.
Table 5.6 Procedure to Manually Place the System in Standby State

Task Step Result/Comment

To Standby 1. From the Maintenance view select

the Special Protocols tab view.
2. Select the To Standby task button.

The System enters Standby and

records the activity in the System Event
Log with date, time, and operator ID.

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 Operating Instructions
Section 5 Setup Guidelines

Setup Guidelines

Setup Guidelines
The following table summarizes the tasks involved to configure your System to
your laboratorys requirements. See Section 2: Installation Procedures and
Special Requirements, Subsection: System Customization for more details.

Task For Information, See:

Date/Time Section 2: Installation Procedures and Special

Requirements, Subsection: User Interface
Preferences.
Units Selection Section 2: Installation Procedures and Special
Requirements, Subsection: Units Sets Selection.
Bar Code Setup Section 2: Installation Procedures and Special
Requirements, Subsection: Bar Code Setup.
Orders Setup Section 2: Installation Procedures and Special
Requirements, Subsection: Orders Setup.
LIS Setup Section 2: Installation Procedures and Special
Requirements, Subsection: LIS Setup.
Patient Limits Section 2: Installation Procedures and Special
Requirements, Subsection: Patient Sample Setup....
Default Patient Test Section 2: Installation Procedures and Special
Selection Requirements, Subsection: Patient Sample Setup....
Reagents Section 9: Service and Maintenance, Subsection:
Reagents View.
QCID Setup Section 11: Quality Control, Subsection: QCID File
Setup.
Customize Run View Section 2: Installation Procedures and Special
Requirements, Subsection: Customize Run View.
Customize Data View Section 2: Installation Procedures and Special
Requirements, Subsection: Customize Data View.
Customize Printed Section 2: Installation Procedures and Special
Report Requirements, Subsection: Customize Printed
Report.

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Operating Instructions
Setup Guidelines Section 5

NOTES

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 Operating Instructions
Section 5 Specimen Analysis

Specimen Analysis

The CELL-DYN Ruby offers highly automated specimen analysis. The following
list highlights important features of the specimen analysis process:
Specimens in closed tubes can be processed in the Closed mode, or can be
uncapped and processed in Open Tube mode.
The System obtains specimen processing instructions from the default patient
test selection setup in Patient Sample Setup, Demographics dialog box or,
if there are Pending Orders in the Orders view.
The System obtains instructions from matched entry fields based on
matching orders by bar code ID or not using a bar code ID (match by rack
and tube position).
Processing and Demographics data for each Pending Order entry can be
added manually or downloaded from a Laboratory Information System
(LIS).

Specimen Analysis Tasks

The following table summarizes the tasks involved in specimen analysis and
provides references to other subsections for detailed information.
NOTE: Review the procedures described in Subsection: Preparing to Run
Specimens within this section before analyzing specimens.
Table 5.7 Specimen Analysis Tasks

Task For Information, See:

Verify or Change Default Patient Subsection: Default Patient Test

Test Selection Processing Condition Selection Processing Conditions
within this section.

Create Pending Orders Subsection: Create Manual Orders

within this section.

Enter Specimen Demographics Subsection: Create Manual Orders

Information within this section.

Routine System Startup Subsection: Preparing to Run

Specimens within this section.

Run Specimen in Open or Closed Subsection: Running Specimens

Mode within this section.

Review Results Subsection: Post-Analysis

Processing Datalog View within this
section.

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Operating Instructions
Specimen Analysis Section 5

Table 5.7 Specimen Analysis Tasks (Continued)

Task For Information, See:

Reorder Tests Subsection: Advanced Data

Management Groups View within this
section.

Preparing to Run Specimens

Preparing to Run Specimens
This subsection describes the procedures that are completed in preparation for
specimen analysis. The procedure for running background counts is also described.
Because the exact steps followed can vary depending on the organization of a
laboratory, always follow your laboratorys procedures along with these general
guidelines.

Routine System Startup

The following table provides references to other sections and subsections for use if
detailed information is needed.
Table 5.8 Required Procedures for Specimen Analysis

Task Comment

Prime the Analyzer. See Subsection: System Priming, Interruption, and Standby
within this section.
NOTE: Ensure that background counts are within acceptable limits
before running controls and patient specimens.

Enter, check, or change operator ID. See Subsection: Operator ID within this section.

Check waste container level, if Empty waste (as needed).

applicable.

Check reagent levels in Reagents Replace reagent(s) as needed. See Section 9: Service and
view. Maintenance, Subsection: Reagents View and Reagent
Container Replacement.

Check for any maintenance due in Perform any required maintenance indicated. See Section 9:
Maintenance view. Service and Maintenance, Subsection: Maintenance View.

Check QC Status region. Review specific QCID Files and moving average programs as
needed. See Section 11: Quality Control, Subsection:
Evaluating and Investigating Commercial and Patient Control
Results.

Verify Background Counts. See Subsection: Running Background Counts within this
section.

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 Operating Instructions
Section 5 Specimen Analysis

Table 5.8 Required Procedures for Specimen Analysis (Continued)

Prepare, run, and verify controls. Handle controls as directed on the manufacturers assay sheet. See
Section 11: Quality Control, Subsection: Performing a QC Run.

Verify specimen acceptability for See Subsection: Preparing and Handling Specimens within this
processing (ID, volume, temperature). section.

Prepare and run Specimens. See Subsection: Running Specimens within this section.

Operator ID
Signing On and Off
The operator should perform Operator Sign On to update the Operator ID (OPID)
before running specimens.

The Operator ID is displayed on all screens and printed on the graphics report. It is
also retained in the Datalog, QC View, Reagent Log, Maintenance Log, Calibration
Log and the System Event Log. The operator sign on and sign off area is located in
the upper right-hand area of the view. The Operator ID is selected from the drop-
down Menu.

Running Background Counts

Background counts, which are reported in the Datalog, QC View, and the Run
View, are results obtained by performing a QCID Background (normal CBC).
Background counts can be used to confirm that the Systems baseline performance
meets stated performance criteria. For more information on performance criteria,
refer to Section 4: Performance Characteristics and Specifications.
The QCID RETC_Background counts are not part of the QCID Background count
and must be performed separately. AutoBackground counts are performed
automatically by the System after certain routine functions such as Prime and are
reported in the Datalog and Run View.
See Section 10: Troubleshooting and Diagnostics, Subsection: Troubleshooting
Tips and Techniques for information on troubleshooting background counts.

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Operating Instructions
Specimen Analysis Section 5

Although the System automatically runs a background count at the end of Prime,
additional Background counts and RETC_Background counts can be run on
demand as follows:
1. In the Next Open Tube Entry region, select the Background from the
Specimen ID or QCID drop down menu.
NOTE: To check the RETC_Background count, verify the Analyzer Status
indicates Ready state, select Retic from the Test Selection menu
to change to Reticulocyte mode. Select RETC_Background from
the Specimen ID or QCID drop down menu.
2. Press the Touch Plate to start the background counting cycle.
3. Ensure that background counts are within acceptable limits before running
controls and patient specimens.
Background counts may be run in Closed mode according to operator preferences.
1. Place a Background QCID barcode label on an empty Vacutainer tube.
2. Put the tube in a Sample Loader rack and place the rack in the load side of the
Sample Loader.
3. Select F12 Start Loader.
4. When processing is complete, verify that background counts are within
acceptable limits before running controls and patient specimens.
NOTE: Background QCID bar code labels are available as an optional accessory.
Refer to Appendix A: Parts and Accessories.

Preparing and Handling Specimens

WARNING: Potential Biohazard. Consider all specimens, reagents,
controls, calibrators, etc., that contain human blood or serum as potentially
infectious. Wear lab coats, protective eye wear, and gloves, and follow
biosafety practices as specified in the OSHA Bloodborne Pathogen Rule
(29 CFR Part 1910.1030) or other equivalent biosafety procedures.

Anticoagulant
See Section 4: Performance Characteristics and Specifications, Subsection:
Operational Specifications for information on recommended anticoagulants.

Specimen Stability
Any refrigerated specimens should be brought to room temperature before
processing. If specimens are to be run within eight hours after collection, storage
at room temperature is recommended. If specimens are to be run more than eight
hours after collection, storage at temperatures between 2 and 8 C is
recommended.
Stability studies show that, when specimens are stored at room temperature before
mixing and processing, results for the WBC, RBC, HGB, MCV and PLT are stable
(5.4%) for up to 24 hours after collection. An increase in false-positive Suspect
Population Flags may be seen on samples processed more than 4 hours after
collection time.

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 Operating Instructions
Section 5 Specimen Analysis

The stability of capillary samples may vary depending on the collection device
manufacturer. Refer to the collection tube manufacturers package insert for
stability claims.

Specimen Collection
All specimens should be collected using proper technique and following the tube
manufacturers recommendation.
NOTE: For additional information on collecting venous and capillary samples,
refer to CLSI Standards, H3-A51 and H4-A52.
See Section 4: Performance Characteristics and Specifications, Subsection:
Operational Specifications for information on recommended volume
requirements in specimen collection tubes.

Interfering Substances
It is important to note that there are commonly occurring interfering substances that
can affect the results reported by hematology analyzers. See Section 7:
Operational Precautions and Limitations, Subsection: Interfering Substances
and Conditions.

Specimen Mixing
Proper mixing of specimens prior to sample aspiration is essential for obtaining
accurate results on the CELL-DYN Ruby System. For control or calibrator mixing
instructions, refer to the manufacturers product insert. Specimens stored at
refrigerator temperatures must be brought to room temperature prior to mixing.
Specimens to be run in the Open Mode must be well mixed on a mechanical mixer
or hand mixed by inversion per your laboratorys protocol. Immediately prior to
sample aspiration, mix again by inverting the tube a minimum of 10 times.
For specimens collected in micro-collection devices, refer to the collection tube
manufacturers insert for proper mixing and handling.
The Sample Loader automatically mixes the specimen before aspiration.

Running Specimens
Specimens may be analyzed whenever the Analyzer Status indicates Ready state.
For Open Mode only, when specimens have not been run for one hour or more, a
background should be run immediately prior to running a patient specimen.
Refer to Subsection: Specimen Mixing for proper mixing of specimens prior to
sample aspiration.
NOTE: The Quick Precision Check dialog box should not be opened when
running patient samples. The Quick Precision Check takes precedence
over patient specimen processing conditions and will result in samples
being labeled and processed as calibration samples. For more
information, refer to Subsection: Processing with the Orders View.

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Specimen Analysis Section 5

Specimen Identification Methods

The System supports the use of a bar-coded Specimen ID on the specimen tube to
provide positive specimen identification. Positive specimen identification ensures
that results reported for a specimen tube are associated with the patient from which
the specimen was drawn. In Closed mode, the bar code on the tube is read by a bar
code reader in the Analyzer at the point of aspiration. In Open Tube mode, the bar
code on the tube is read by the Hand-Held Bar Code Reader. In both cases, the
Specimen ID from the tube is contained in the results record and is displayed next
to the results in the Datalog.
WARNING: DO NOT use any Specimen ID for a hematology specimen
that contains any of the following characters: ~, |, \, ^, and &.
These characters will create an error message.

In Closed mode, specimens can also be identified by rack and tube position
numbers. If bar code labels are not used on specimen tubes, specimen identification
is by rack and tube position numbers only, offering a physical location for the tube,
which must subsequently be positively identified and verified by the laboratory
before reporting specimen results.
In addition to positively identifying specimen results, using bar code labels on
specimen tubes ensures that the processing requested for the specimen via
Specimen ID-based Orders is actually performed on the specimen. Pending Order
entries can also be based on the rack and tube position numbers, again offering a
physical location for the tube, which must subsequently be positively identified and
verified by the laboratory before reporting results. When running controls in
Closed mode, Abbott Q Label bar codes on control tubes use processing directions
from and direct results to specific Quality Control ID (QCID) files.

Specimen ID Requirements
The specimen identification number, or the text entered in the Specimen ID field, is
used to identify the specimens run on the Analyzer. It is validated and:
must contain at least three and not more than twenty characters.
must not contain blanks.
must not be in the form of a rack number and tube position format Rxx Tyy
(xx=0099,yy=0010).
must not contain LIS message delimiters, which will cause the Specimen ID
to be truncated at the point where the character is located within the ID.
must not contain the text Invalid_ID or No_ID.
CAUTION: In the event that the specimen is aspirated in the Open Tube
Mode and the Specimen ID is not entered in the Next Open Tube Entry
region, the record in the Datalog view displays as No_ID and is not
transmitted to the laboratory information system until it is edited using F4
Edit. If the record is printed, the Specimen ID field prints as No_ID until
it is edited in the Edit Demographic Information dialog box.

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 Operating Instructions
Section 5 Specimen Analysis

Introduction to the Orders View

The Orders view is operationally involved in Sample Processing in both the Open
and Closed Tube Modes. Processing and Specimen Demographic orders are
manually added to the CELL-DYN Ruby as Pending Orders, or automatically
added via the Laboratory Information System (LIS). The System matches either the
bar code label specimen ID, with entries contained in the Orders view, for
processing instructions. The system will not download orders when the system has
Rack and Tube matching ON.
The Orders button is selected from the tool bar to display the Pending Orders. The
Orders view displays the Pending Orders in a log format as a tabular list. Scroll bars
are provided to allow the display of additional records. The Orders view can store
up to 3,000 entries and will alert the operator when an attempt is made to save
additional entries into a full Orders view. The CELL-DYN Ruby software is
configured to automatically remove a Pending Order entry that was never used for
specimen processing from the Orders view approximately twelve (12) to forty
eight (48) hours after it was created and saved, or downloaded from the Laboratory
Information System (LIS).
F1 - Print function key can be used to print the summary report of Pending Orders.
WARNING: It is recommended that your laboratory set up a laboratory
procedure to require any unprocessed Pending Orders be viewed and
cleared at the end of each shift or day. Use of this procedure will maintain
an up-to-date Orders view and reduce the opportunity for any unprocessed
Specimen IDs, left in the Orders view for an extended time, to be matched
with a different patient with the same Specimen ID.

Orders view customization consists of:

Setting up the Default Patient Test Selection
Setting up a default match criteria (matching by bar code ID or rack and tube
position) when Pending Orders are manually created.
NOTE: The software only allows the operator to elect to change the default
match criteria that appears in the Create New Order Entry dialog
box when the Pending Orders view is empty.
For information on Orders Setup, refer to Section 2: Installation Procedures and
Special Requirements, Subsection: Patient Sample Setup... and Orders Setup.

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Specimen Analysis Section 5

Default Patient Test Selection Processing Conditions

The CELL-DYN Ruby System is set up to automatically process and analyze
specimens in the Closed mode according to a Default Patient Test Selection if there
is no Pending Order and the bar code ID is not a QCID. The laboratory can
customize a Default Patient Test Selection to perform either one of the following
test selections CBC, CBC+NOC, CBC+RRBC, when the following occurs:
The System is matching by bar code ID and detects a readable bar code label
for the specimen ID for the tube being processed in the Closed mode, and no
matching order is found, the default test selection is performed and the
Specimen ID in the Datalog will be the tube bar code ID.
The System is matching by bar code ID and is unable to detect a readable bar
code label for the specimen ID for the tube being processed in the Closed
mode, the default test selection is performed and the Specimen ID in the
Datalog will be documented as Invalid_ID or No_ID based on tube bar code
validation.
The System is matching by rack and tube and detects a readable bar code
label for the specimen ID which is not a QCID label for the tube being
processed in the Closed mode, the default test selection is performed and the
Specimen ID in the Datalog will be documented as Rxx Tyy position based
on tube bar code validation.
The System is matching by rack and tube and is unable to find a matching
order for the rack and tube being processed in the Closed Mode, the
Specimen ID in the Datalog will be documented as Rxx Tyy position based
on tube bar code validation.
Table 5.9 Processing With Default Patient Test Selection

Task Steps Result/Comment

Identify specimens Label tubes with bar code labels. Refer to Section 4: Performance
Characteristics and Specifications,
Subsection: Bar Code Specifications.

Check or change Check Patient Sample Setup Refer to Section 2: Installation

Default Patient Test Demographics dialog box Procedures and Special
Selection Requirements, Subsection: Patient
Sample Setup... Default Patient Test
Selection

Load tubes Place tubes in racks. Loading order is important if using Rack
and Tube matching.

Analyze specimens Select F11- Select Closed, F12 Start Begins specimen processing.
Loader.

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 Operating Instructions
Section 5 Specimen Analysis

Pending Orders (Match Specimen ID or Match Rxx Tyy)

Processing and Specimen Demographics are added to the CELL-DYN Ruby as
Pending Orders manually, or automatically, via the Laboratory Information System
(LIS).
Pending Orders originating from the LIS are created to match the bar code label
specimen ID with the pending order specimen ID as the match field. These entries
contain a non-blank Specimen ID value, do not contain a rack and tube position
value, and cannot be QCIDs.
Manually entered Pending Orders must match the Orders Setup and either match:
the bar code label specimen ID with the pending order specimen ID
the rack and tube (Rxx Tyy) position with the Rack ID and Tube ID fields in
the New Order Entry dialog box.
If the match field is match by bar code label specimen ID, the operator must verify
or enter the Specimen ID field in the New Order Entry dialog box and is not
allowed to enter a Rack ID or Tube ID value in the New Order Entry dialog box.
If the match field is match by rack and tube (Rxx Tyy) position, the operator must
enter a Rack ID and Tube ID value and also enter a Specimen ID in the New Order
Entry dialog box. These entries contain a non-blank specimen ID value and cannot
be a Quality Control ID (QCID).
See also Section 2: Installation Procedures and Special Requirements,
Subsection: Orders Setup, to customize by rack and tube matching.

Pending Order Entries from the LIS

The CELL-DYN Ruby allows Pending Orders to be downloaded from an
interfaced Laboratory Information System (LIS). A special program must be
written using the CELL-DYN Ruby LIS Interface Specification as a guide. This
document is an optional information accessory with the System. For ordering
information, refer to Appendix A: Parts and Accessories.
NOTE: The information from the LIS must contain specimen ID numbers
corresponding to the bar code labels on the tubes. The System will not
accept Pending Orders from an LIS to match by rack and tube position.

Processing with the Orders View

The Orders view is used to display the Pending Orders log and also to access F6 -
Create Order that opens the New Order Entry dialog box. To display Pending
Orders, select Orders from the tool bar.
Manual Pending Order entries for control and calibrator specimens are not
required. When control specimens with QCID bar code labels, or Q-labels, are run
in the Closed mode and match a QCID setup, the System recognizes the QCID and
processes the specimen according to the QCID setup, which takes precedence over
processing using Pending Orders. When calibrator specimens are run using
software wizards such as the Auto-Calibration Wizard or Quick Precision Check,
the specimens are processed according to the wizard taking precedence over
processing using the Pending Orders.

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Specimen Analysis Section 5

Pending Orders in Closed Mode

In the Closed mode, the System attempts to match the specimen ID or the rack and
tube (Rxx Tyy) position with a Pending Order Entry for processing instructions.
The CELL-DYN Ruby software is shipped with default settings to match, based on
the specimen ID. When a match is found, the System uses the processing
instructions defined from the Pending Order entry. Once a specimen with a
matched Pending Order entry is processed, the entry is automatically deleted from
the Orders view and results are placed in the Datalog. Specimen tubes with
readable bar code labels will cause the System to search the Pending Orders for an
entry with a match field of match Specimen ID. Specimen tubes without a bar code
label will cause the System to use the default patient test selection and the specimen
ID in the Datalog will indicate No_ID.
If Orders Setup is set to use rack and tube matching, Specimen tubes with or
without a bar code label causes the System to search Pending Orders for an entry
using a match field of match Rxx Tyy. Specimen tubes with a bar code label will
have an additional validation against the specimen ID in the pending order. If the
rack and tube position matches the order, but the tube bar code read does not match
the Specimen ID in the order, the specimen is processed using the Default Patient
Test Selection, and the rack and tube position will be used in the Specimen ID field
in the Datalog; however, a system message will be generated indicating there was
a specimen ID mismatch.

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Section 5 Specimen Analysis

Pending Orders in Open Mode

In the Next Open Tube Entry (NOTE) region, as the operator enters the specimen
ID in the Specimen ID field, the System attempts to match the Specimen ID with a
Pending Orders Entry for processing and specimen demographics. Once a
specimen with a matched Pending Order entry is processed, the entry is
automatically deleted from the Orders view and results are placed in the Datalog.
Because the Open mode does not use rack and tube position processing, there is no
search of the Pending Orders if the Orders Setup is set to match by rack and tube
there will be no matches found when entering the specimen ID in the NOTE region.
NOTE: The Reticulocyte test selection can only be run in the Open Mode. A
system message will alert the operator when it has identified a specimen
ID match within the Pending Orders but the test selection for the
Specimen ID in the Pending Orders does not match the current test
selection in the NOTE region. For example, the test selection is CBC but
the pending order is for a Retic test selection. The Pending Order
specimen demographics will also be used to fill in the NOTE detailed
dialog box. See also Section 12: Reticulocyte Package.

Create Manual Orders

The Pending Orders log will not accept a mixture of processing orders to match by
both specimen ID and match by rack and tube. Matching by rack and tube
(Rxx Tyy) is customized in the Orders Setup dialog box and can only be enabled/
disabled if the Pending Orders log is empty. Rack and tube orders are only created
manually.
NOTE: If matching by rack and tube is selected, RETIC is not available as a test
selection for New Order Entry since Retic can only be run in the Open
Mode.

New Order Entry Dialog Box

The Orders View and F6 - Create Order button are used to create Pending Order
entries.

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Operating Instructions
Specimen Analysis Section 5

General Concepts for New Order Entry Creation

Select the Orders view from the tool bar.
Use F6 - Create Order to open the New Order Entry dialog box.
Enter the demographic information.
Select OK to save the entry.
Select the F6 - Create Order to continue making entries.
Once the entry is created and saved, it is displayed in log format in the
Orders view.

General Concepts for Reorder Entries from the Datalog and Group
Views
The System allows the operator to create orders for patient records from the
Datalog or Group views.

Datalog View

Select the Datalog view from the tool bar.

Highlight the Datalog record and select F7 View Specimen.
The F6 - Create Order function key is only available for patient specimen
types.
Select F6 - Create Order to open the Reorder Entry dialog box. The Test
Selection field will default to display the Datalog record test selection.
NOTE: Matching by rack and tube is available if it is customized in the
Orders Setup dialog box.
Verify specimen demographic information.
Select OK to save the entry.
Once the entry is created and saved, it is displayed in log format in the
Orders view.

Groups View

Select the Groups view from the tool bar.

Select the FWBC or NRBC/RRBC or exceptions tab view.
Use the mouse do one of the following:
Mouse click to highlight a record
Ctrl key + mouse to point and click to select various records to create
reorders
Shift key + mouse to point and click to select a range of records to create
reorders
Select F6 - Create Order to open the Reorder Entry dialog box. The Test
Selection field will default to display the recommended reorder test selection
based on the Group tab view.

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 Operating Instructions
Section 5 Specimen Analysis

Once a sample is ordered or deleted from either FWBC?RRBC or Except Groups,

it is removed from all three groups.
FWBC: recommended reorder test selection is CBC+NOC
NRBC/RRBC: recommended reorder test selection is CBC+RRBC
NOTE: The F6 Create Order function key is not available in the Groups
view if matching by rack and tube is enabled in the Orders Setup
dialog box.
For one reorder at a time, select OK to save the entry.
For a selection or range of reorders at one time, select the Yes button to
proceed with creating reorders for the selected specimens with the
recommended reorder test selection.
NOTE: Duplicate specimen orders are not accepted into the Orders view.

Printing a Pending Orders Log

To print a report of all the records in the Pending Orders log, select the Orders view
and select F1 Print. The report shows the number of records in the Orders view
and includes the displayed column header information for: Record number (Rec#),
Specimen ID (Spec ID), Rack and Tube position (RRTT), Test Selection, Patient
ID (Pat ID), Patient Name (Pat Name), Sex, DOB, Doctor, Parameter Set (Param),
Limit Set (Limits), Entry Date and Time (Entry D/T), and Draw Date and Time
(Draw D/T).
NOTE: The following displayed column header information: User Field 1, User
Field 2, and Comment demographic fields do not print on the Pending
Orders report.

Orders Management
Entries in the current Orders view can be edited or deleted before the specimens are
processed. The CELL-DYN Ruby software can be customized to automatically
remove a Pending Order that was never used for specimen processing from the
Orders view approximately twelve (12) to forty eight (48) hours after it was created
and saved or downloaded from the Laboratory Information System (LIS). Use the
following procedures. See Section 2: Installation Procedures and Special
Requirements, Subsection: Orders Setup to customize automatic selection.
WARNING: It is recommended that your laboratory set up a laboratory
procedure to require any unprocessed Pending Orders be viewed and
cleared at the end of each shift or day. Use of this procedure will maintain
an up-to-date Orders view and reduce the opportunity for any unprocessed
Specimen IDs, left in the Pending Orders for an extended time, to be
matched with a different patient with the same Specimen ID.

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Specimen Analysis Section 5

Table 5.10 Procedure to Edit Pending Orders

Task Step Comment

Open Orders View Select Orders from the tool bar. Displays Pending Orders tab view.

Specify record to edit 1. Scroll through Pending Orders to Highlights record to be edited.
bring entry into view.
2. Highlight entry from Pending Orders
Log.

Open Edit Order Select F4 - Edit. Displays Edit Order Entry dialog box in a
Entry dialog box form for editing.

Change processing Use buttons and resulting menus to Changes processing selection.
information change processing selection.

Change 1. Select field. Edits processing or demographic

demographics 2. Type new information. information.
3. Repeat step 1-2 for additional fields. NOTE: The Hand-Held Bar Code
Reader is an optional means of
entering the specimen ID.

Save edited Select OK button. Saves the edited Pending Order.

information

View and edit Repeat procedure, starting from Task: Selects additional Pending Order for
additional records Specify record to edit, above. editing.

Table 5.11 Procedure to Delete Pending Order Entries

Task Steps Result/Comment

Open Orders View Select Orders from the tool bar. Displays Pending Orders tab view.

Delete Selection 1. Highlight the selection or selections. Deletes the highlighted entry.
2. Using the mouse, keep the cursor
over one of the highlighted
selections, right click and the drop
down menu opens.
3. Select Delete Selection menu item.
4. Select Yes button in the Message
dialog box to confirm deletion.

Delete All 1. Using the mouse, right click Deletes all entries in the Pending Orders
anywhere in the view, and the drop log.
down menu opens.
2. Select Delete All menu items.
3. Select Yes button in Message dialog
box to confirm deletion.

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 Operating Instructions
Section 5 Specimen Analysis

Open Mode Analysis

Table 5.12 Open Mode Analysis

Task Step Result/Comment

Preparation Verify the Analyzer Status indicates Select F11 Select Open to
the Ready state and is in the Open switch from Closed mode.
mode.

Enter Specimen ID in the Next 1. Wand or enter the specimen ID in If the specimen is a quality
Open Tube Entry (NOTE) the Specimen ID QCID field. control specimen the specimen
region 2. Select the test selection from the type and test selection will be
drop down menu. automatically selected based
3. Select More Spec Info button to on the QCID setup.
verify, add, or change specimen If the specimen has a
demograhic information in the matching pending order, the
Next Open Tube Entry (Detailed) test selection will be
dialog box. automatically selected
based on the order.

Mix Specimen Tube With the stopper still in the tube, Gently rock or invert the tube a
gently mix the sample. minimum of 5 times to thoroughly
mix the sample.

Aspirate Specimen 1. Open the sample tube and place it NOTE: Do not let the probe touch
under the Open Mode Probe. the bottom of the tube. It
Raise the tube until the end of the may affect aspiration and
probe is deeply immersed in the produce erroneous
sample. results.
2. Press the Touch Plate to activate The wash block moves down the
aspiration. probe and cleans it. When the
cycle is finished the wash block
3. Remove the tube when the beep
moves back up the probe.
sounds and replace the cap.

Review Results When the cycle is finished, the results Analyzer Status indicates Ready
post to the Datalog and are displayed state.
in the Run View.

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Specimen Analysis Section 5

Closed Mode Analysis

:

Table 5.13 Closed Mode Analysis

Task Step Result/Comment

Preparation Verify the Analyzer Status indicates Select F11 Select Closed to switch
Ready state and is in the Closed from Open mode.
mode.

Mix Specimens and Load Mix the specimens and place them Refer to Subsection: Specimen
Racks in the Sample Loader racks. Mixing.

Place Racks in the Loader Place the racks in the Sample The Sample Loader does not operate
Loader to the right of the Processor if the Processor Cover is not in place.
Cover with the rack bar code labels
facing the Operator.

Start Loader Select F12 Start Loader. The Sample Loader automatically
processes all the specimens
according to QCID setup, Pending
Orders, or Default Patient Test
Selection.
Processing stops when either of the
following occurs:
The F12 Stop Loader function
key is selected
The last rack has moved
completely to the unload side of the
Sample Loader.

Review Results The results are posted to the The Run View refreshes as each new
Datalog and are displayed in the sample result is available.
Run View.

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Section 5 Post-Analysis Processing Datalog View

Post-Analysis Processing Datalog View

After the System processes specimens, the CELL-DYN Ruby software

automatically stores the run result data (along with any entered ID and
demographics) in the Datalog for review and validation. This section describes the
Datalog and how to search and find, view, transmit, and print results.
Alerts and Indicators
Run View
Datalog View
Refer to Subsection: Advanced Data Management Groups View for flagging
indications and the Groups View.

Alerts and Indicators

This subsection describes information displayed on the screen as the samples are
analyzed and/or when reports are printed. This subsection does not discuss how to
interpret parameter flags, which are displayed after the sample is run. Refer to
Section 3: Principles of Operation, Subsection: Operational Messages and Data
Flagging.

Out of Range
Results that fall outside the range of the selected limit set are displayed in color.
Yellow indicates that the result exceeded the lower limit and purple indicates
that the result exceeded the upper limit. These results are underlined on the
graphic printouts.
Results that exceed a parameters linear range are indicated by >>>> in place
of the result.
Results that have been determined to require laboratory validation are
indicated by an asterisk [*] next to the result.
Results that do not have sufficient data to calculate values are represented
by -------.

System Messages and Fault Conditions

System Information Message dialog boxes appear in the view when a fault
condition is detected that requires Operator intervention. See Section 10:
Troubleshooting and Diagnostics, Subsection: System Messages for details on
System Messages and System Information Messages.

Flow Errors
If an RBC Flow Error occurs, results are suppressed for the RBC/PLT parameters
and the RBC flow error message is displayed in the System Message region.
Scatterplots are not suppressed. They are not analyzed.

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Post-Analysis Processing Datalog View Section 5

If a WOC Flow Error occurs, results are suppressed for the WBC and Differential
and the WOC flow error message is displayed in the System Message region.
Scatterplots are not suppressed. The list mode data is not analyzed.
If a NOC Flow Error occurs, results are suppressed for the WBC and Differential
and the NOC flow error message is displayed in the System Message region. The
Loader will halt for three consecutive Flow errors.

Sampling Errors
The message Sampling error incomplete aspiration is displayed in the System
Message region if insufficient sample was detected during aspiration. SAMPLING
ERR is printed on the graphics report to the right of the PLT.

3 Consecutive Short Samples

If the Sample Loader is being used and the Instrument detects three consecutive
incomplete aspirations, the Sample Loader halts at the end of the cycle and
3 Consecutive Short Samples is displayed in the System Message region.

Heater Errors
If a WOC Heater Error occurs, results invalidated for the WBC and Differential
parameters are marked with an asterisk (*). The WOC heater error message is
displayed in the System Message region.
If a HGB Heater Error occurs, results invalidated for the HGB, MCH, and MCHC
parameters are marked with an asterisk (*). The HGB heater error message is
displayed in the System Message region. The Loader will halt for three consecutive
Heater Errors.

Run View
For customization of the Run view see Section 2: Installation Procedures and
Special Requirements, Subsection: Customize Run View.

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Section 5 Post-Analysis Processing Datalog View

Chartable Page

Lab Page

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Operating Instructions
Post-Analysis Processing Datalog View Section 5

Graphs Page

Datalog View

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Section 5 Post-Analysis Processing Datalog View

The Datalog stores all data and demographic information in a log format for the last
10,000 cycles run on the CELL-DYN Ruby. The record information is stored
chronologically by sequence number. Scattergrams and histograms are stored for
all 10,000 records.
NOTE: When the log is full, subsequent entries cause the oldest entry to be
deleted and the remaining entries to move up one line, so that the current
records are added to the bottom of the list.
See Section 2: Installation Procedures and Special Requirements, Subsection:
Customize Data View and Customize Printed Report for details on
customizing the display and printouts of the datalog.

Figure 5.2 Datalog Function Keys

Table 5.14 Datalog Specimen Type Icons

Specimen Type Icons

Patient

QC-Commercial

QC-Wholeblood

QC-Background

Auto-Background

SRP-LATEX

AutoCalibration - Calibrator

AutoCalibration-WholeBlood

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Post-Analysis Processing Datalog View Section 5

Table 5.15 Datalog Function Keys

Function key ... What it does ... Comments

Prints the selected record or a range

F1Print
of records

F2Transmit Transmit Data

Opens the Find/Filter dialog box

which has two tabs Find/Filter
and Advanced Find/Filter. Both are
used to locate a particular record by
entering information.
Find locates the earliest matching
entry, displays the number of
matches, and adds a Find Next key
to move to the next matching entry.
Filter closes the dialog box and
F3Find/Filter displays a new screen with all the
matching entries; exit the filtered
entries by selecting the Unfilter
function key.

NOTE: When searching for a name

that contains an apostrophe
(), enter two apostrophes in
the Namefield to return
search results.

Opens the Edit Demographic Any change made to the Specimen ID,
Information dialog box and saved by selecting OK and closing
the Edit Demographic Information
dialog box changes the format of the
F4Edit listing from black to red.

A red sequence number indicates a

flagged item.

Opens the Reorder Entry dialog box Completing the Reorder Entry
information and selecting OK sends the
F6Create Order Reorder Entry information to the
NOTE: Becomes Pending Orders queue in Orders.
available after F7View
Specimen in the Datalog
view is selected.

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Table 5.15 Datalog Function Keys (Continued)

Function key ... What it does ... Comments

Opens the Chartable, Lab, and

Graphs tabs, and:
Expands the existing Datalog
function keys:
F1Print
F2Transmit
F7View Specimen F3Find/Filter
F4Edit
By adding three function keys:
F6Create Order
F7Previous Specimen
F8Next Specimen.

F7Previous Changes the current view to reflect Appears as a function key when F7
Specimen the data in the previous entry in the View Specimen in the Datalog view
NOTE: Becomes Datalog list. has been selected.
available after F7View
Specimen in the Datalog
view is selected.

F8Next Specimen Changes the current view to reflect Appears as a function key when F7
NOTE: Becomes the data in the next entry in the View Specimen in the Datalog view
available after F7View Datalog list. has been selected.
Specimen in the Datalog
view is selected.

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Post-Analysis Processing Datalog View Section 5

Backing up and Restoring System Data

A user may wish to back up the system data on a regular basis in order to be able
to restore if there is a hard disk failure. It is not necessary to restore on a regular
basis. Once the Datalog is full (10,000 runs) the backup process will take up to 30
minutes and will require two 700MB CDs. The restore process will take about 12
minutes for the full datalog case. Only an operator with Admin rights can perform
backup and restore procedures.
NOTE: The restore process will shut down the Analyzer as well as the Data
Station.

Procedure: Backup of System Data

NOTE: A user with admin rights must be logged on to perform this procedure.
1. Verify the Analyzer is in the Ready state.
2. From the menu bar, select File, Backup . The Backup dialog box opens.

3. In the Backup to CD field, select both checkboxes.

4. Insert a CD in the CD/DVD ROM drive.
5. Wait until the green light on the CD/DVD ROM drive no longer flashes.
6. In the Backup to CD field, select the Start Backup button.
7. The dialog box will flash messages telling you of the progress. A progress
bar will fill up the indented rectangle.

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 Operating Instructions
Section 5 Post-Analysis Processing Datalog View

8. Once the first CD is written, a message will appear:

Label the disk Disk 1. Please insert a Blank CD media in the CD drive and
press OK.
Remove the first CD (Disk 1), insert a second CD and select OK.
9. Once the second CD is written to, the dialog will close and the CD/DVD
ROM Drive will eject the CD. Label the second CD Disk 2.

Procedure: Restoring System Data

NOTE: A user with admin rights must be logged on to perform this procedure.
1. Verify the Analyzer is in the Ready state.
2. Put Disk 1 in the CD/DVD ROM drive.
3. From the menu bar, select File, Restore . The Restore dialog box opens.
The flashing red text will identify the source of the install disk.

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Operating Instructions
Post-Analysis Processing Datalog View Section 5

4. In the Restore from CD field, select all the setups you want to restore. If the
selected setups did not exist in the backup, you will be notified by a message
box identifying the setup. Select OK if this is expected.
5. In the Restore from CD field, select the Start Restore button.
6. After the first disk is uncompressed, the system will ask you for a second
disk. Put Disk 2 in the CD/DVD ROM drive and continue.
7. After all files are uncompressed a message box appears:
Application will close to complete the restore. Restart the application to
continue.
8. Select Yes. The application will close and the Disk will eject. The system will
reboot and restart. While restarting you will see the message: Please Wait-
Restore in progress.
NOTE: For the procedure to backup calibration factors following calibration,
refer to Section 6: Calibration Procedures, Subsection: Post-
Calibration Procedures.
IMPORTANT: The RESTORE procedure will restore the settings (e.g., patient
limit sets) that were in effect at the time of the last backup. If any
changes to settings were made subsequent to the last backup,
settings should be verified and adjusted if necessary.

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 Operating Instructions
Section 5 Advanced Data Management Groups View

Advanced Data Management Groups View

The purpose of Groups view is to allow users to have filtered views of the Datalog
to support reflex test orders and transmission of records to the LIS.
Three groups of Datalog records found in the Groups view are formed based on the
following criteria:
FWBC Group: all records with specimen type Patient and CBC test selection
with the FWBC Suspect Population flag and the WBC Suspect Parameter
flag.
NRBC/RRBC Group: all records with specimen type Patient and CBC test
selection with the NRBC and/or RRBC Suspect Population flags and the
WBC Suspect Parameter flag.
Exceptions Group: all records with Specimen Type Patient that contain
alerted (Suspect Population, Suspect Parameter, Limit Violation or System
Flags) sample results.
Not Transmitted Group: all records that were selected for transmission to
the host computer, but were not transmitted.

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Operating Instructions
Advanced Data Management Groups View Section 5

Creating Orders From the Group View

When an order is requested for a single record in the FWBC Group, the test
selection that is initially displayed is CBC+NOC. If multiple records are selected
for order creation from the FWBC tab view, a message is generated to confirm that
the test selection to be used is as follows: -FWBC group: CBC + NOC.
When an order is requested for a single record in the NRBC/RRBC Group, the test
selection that is initially displayed is CBC+RRBC. If multiple records are selected
for order creation from the NRBC/RRBC tab view, a software message is generated
to confirm that the test selection to be used is as follows: -NRBC/RRBC group:
CBC + RRBC.
When an order is requested for a record in the Exceptions Group, the original test
selection is displayed.
NOTE: If the Orders Setup is configured to match on rack and tube position,
orders cannot be created from the FWBC, NRBC/RRBC, or Exceptions
Group.
Once an order from the Groups view is created from a record or group of records,
the record(s) for the sample(s) is removed from the Group view and is placed in the
Orders view.
Once a record in the Not Transmitted tab view is transmitted, the record for that
sample is removed from the group.

Deleting Records From the Group View

Records can be manually deleted from the Groups view using the following
procedures.

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 Operating Instructions
Section 5 Advanced Data Management Groups View

To delete a record or several records:

1. Using the mouse, select the tab view and highlight the record(s) you want to
delete.
2. Using the mouse, right click in the Groups view and select Delete Selection
from the drop down menu.
3. Select the Yes button to confirm.
To delete all records:
1. Select F5 - Delete All
2. Select the Yes button to confirm.

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Operating Instructions
Advanced Data Management Groups View Section 5

NOTES

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 Section 6 Calibration Procedures

Section 6 Calibration Procedures

Overview

Calibration is a procedure that confirms the accuracy of the CELL-DYN Ruby.

Calibration also assists in conforming to guidelines established by the regulatory
agencies that govern your laboratory.
The CELL-DYN Ruby is calibrated at the factory before shipment. During System
installation, an Abbott representative assists the operator in verifying factory
calibration.
The CELL-DYN Ruby is designed to remain stable, without frequent calibration,
when it is operated and maintained according to the recommendations in this
manual.
The following parameters reported by the CELL-DYN Ruby can be calibrated:
WOC, NOC, RBC, HGB, MCV, PLT, and MPV.
Calibration can be performed using either commercial calibrator or assayed whole
blood.
This discussion of calibration distinguishes between specimens and samples. They
are defined as:
Specimen a tube of commercial calibrator material or assayed whole
blood that is presented to the Analyzer for sampling
Sample the material that is aspirated from the specimen tube,
diluted, and analyzed
This section provides information about the following topics:
When to Calibrate
Calibration Guidelines
Pre-Calibration Procedures
Calibration Menu
Calibration Procedures
Post-Calibration Procedures

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Calibration Procedures
Overview Section 6

NOTES

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Section 6 Calibration Procedures

When to Calibrate

Scheduled calibration of the CELL-DYN Ruby must conform to the guidelines

established by regulatory accreditation agencies.
Confirm calibration on a regular basis according to your laboratorys standards and
protocols for maintaining good laboratory practice. Built-in Quality Control
programs on the CELL-DYN Ruby are designed to provide continual monitoring
and confirmation of instrument calibration. The laboratory should make the
decision to recalibrate based on the performance of the CELL-DYN Ruby System
in these Quality Control programs. For details on Quality Control programs, refer
to Section 11: Quality Control.
Calibration of the CELL-DYN Ruby may need to be verified in the following
instances:
When there is a complete change of reagents, i.e., change in type of reagent
from same vendor, or change to a different vendor.
When indicated by quality control data.
After major maintenance and service procedures.
At least every six months.
As directed by the regulatory agencies governing your laboratory.
One common method of calibration verification involves processing a commercial
calibrator and comparing instrument results to those published by the
manufacturer. When calibration verification criteria are exceeded, the instrument
must be recalibrated.
Always consider calibration as the last step in a troubleshooting sequence.
Frequent unnecessary calibration can mask an underlying problem with instrument
performance.
NOTE: If there are any questions about when to calibrate, contact your Country
Service and Support Center.

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Calibration Procedures
When to Calibrate Section 6

NOTES

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Section 6 Calibration Procedures

Calibration Guidelines

General Information
The CELL-DYN Ruby System has two modes of operation:
Open
Closed
The System software applies the mode and parameter-specific calibration factor to
the data obtained when the specimens are run.
Two methods of calibration are available on the CELL-DYN Ruby System:
Auto-Calibration Wizard
Manual Calibration

Auto-Calibration Wizard
The Auto-Calibration Wizard simplifies the generation of new calibration factors
by:
Qualifying specimen results run in the primary mode of operation
Calculating the new calibration factors for activation by the operator
Copying these new calibration factors for activation from one mode to the
other.
NOTE: The primary mode of operation (e.g., Open) should be calibrated
using the Auto-Calibration Wizard followed by an Open/Closed
Mode Bias Check using normal, fresh whole blood specimens.

Manual Calibration
The Manual Calibration process is available for the operator to manually calculate
and enter new calibration factors.

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Calibration Procedures
Calibration Guidelines Section 6

Calibration Materials
The CELL-DYN Ruby System requires commercial calibrator material or assayed
whole blood for calibration.

Calibrating with Commercial Calibrator

Commercial calibrator is a blood-based material with assayed reference values.
The values must be traceable to a national or international reference preparation or
method for hematology.
When using a calibrator, follow the instructions provided on the calibrator package
insert, for proper storage, handling, and mixing.
Abbott calibrator is for use in Open Mode only.
Abbott recommends cycling the calibrator a minimum of 6 and a maximum of 10
consecutive runs when using the Auto-Calibration Wizard.
For the Manual Calibration method, cycle the calibrator for a minimum of 6
consecutive runs. Additional samples and/or repetitions of the specimens may be
used to achieve calibration accuracy beyond Clinical and Laboratory Standards
Institute (CLSI) recommendations.
For list numbers of calibrators refer to Appendix A: Parts and Accessories.

Calibrating with Assayed Whole Blood

Assayed whole blood is blood that has been analyzed and assigned values using a
reliably calibrated instrument or reference methodology.
Calibration using assayed whole blood is an alternative to calibration using
commercial calibrator. Whole blood specimens must meet certain requirements to
be suitable for use in calibration.
Abbott recommends cycling a single whole blood specimen a minimum of 6 and a
maximum of 10 consecutive runs, or cycle each of five whole blood specimens
twice for a total of at least 10 runs, when using the Auto-Calibration Wizard in
either Open or Closed Mode.
For the Manual Calibration method, cycle each of five whole blood specimens
twice for a total of at least ten runs. Use additional specimens and/or repetitions
of the specimens to achieve calibration accuracy beyond CLSI recommendations.
This subsection includes the following:
Recommendations and Requirements for Whole Blood Specimens
Recommendations for Reference Methodologies
Requirements for Obtaining Whole Blood Reference Values
CAUTION: Use commercial calibrator to calibrate the MPV parameter.
Do not use assayed whole blood.

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Section 6 Calibration Procedures

Recommendations and Requirements for Whole Blood Specimens

The following are recommendations and requirements for whole blood specimens
used in calibration.
The ICSH recommends that specimens used for calibration be less than four
hours old following venous sampling1.
The determination of reference values for whole blood and the analysis of
whole blood specimens of the CELL-DYN Ruby must be completed within
two hours of each other.
All specimen reference results must be within your laboratorys normal
range.
All cellular morphology must be normal. Specimens with interfering
substances or conditions must also be excluded. Refer to Section 7:
Operational Precautions and Limitations for a list of interfering substances
and conditions.
All specimens must be properly collected in tubes containing EDTA
anticoagulant. Follow tube manufacturers recommendations for fill volume
specifications.

Recommendations for Reference Methodologies

Reference methodologies used in assaying whole blood for calibration must
conform to the following ICSH recommendation for the parameters listed:
WBC, RBC, and PLT
HGB
MCV

WBC, RBC, and PLT

Determine reference values for white blood cells, red blood cells, and platelets
using:
Multiple counts from a certified hemocytometer, a counter that meters a
fixed, calibrated, sample volume
Reliably calibrated hematology analyzer.

HGB
Determine reference values for hemoglobin using either:
The reference cyanmethemoglobin method
A reliably calibrated hemoglobinometer or hematology analyzer.
Do not attempt to calibrate the CELL-DYN Ruby directly with a hemoglobin
standard designed for the calibration of specific reference cyanmethemoglobin
methods. The CELL-DYN Ruby uses a cyanide-free method that is not designed
to analyze these standards.

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Calibration Procedures
Calibration Guidelines Section 6

MCV
Determine reference values for the mean cell volume by:
Calculation from reference microhematocrit and RBC measurements
Multiple analyses on a reliably calibrated hematology analyzer.
Determine reference microhematocrit values by multiple analyses using the CLSI
method for Packed Cell Volume (PCV)2. Use only plain (non-anticoagulated)
capillary tubes for use with EDTA anticoagulated whole blood. Be certain to verify
the proper operation of the microhematocrit centrifuge and the timer as
recommended by CLSI.

Requirements for Obtaining Whole Blood Reference Values

The following table provides the numerical range of values that can be entered in
the Reference Value or Assay Value field in the Auto-Calibration Wizard
Setup. Reference values should be entered based on your laboratorys patient units
setup. Reference values outside these limits cannot be entered. You must use
Manual Calibration to calibrate any parameter with an assigned value that exceeds
the Auto-Calibration Wizard reference value or assay value entry range.
For more information on units setup, see Section 2: Installation Procedures and
Special Requirements, Subsection: Units Sets Selection.
Table 6.1 Auto-Calibration Wizard Reference Value and Assay Value Entry Range

Auto-Calibration Reference Value or Assay Value

Entry Range
Parameter
SI USA

WBC > 1.99 < 25.0 x 109/L > 1.99 < 25.0 x 103/L

RBC > 2.00 < 6.50 x 1012/L > 2.00 < 6.50 x 103/L

HGB > 70.0 < 150.0 g/L > 7.00 g/L <15.0 g/dL

MCV > 70.0 < 130.0 fL > 70.0 < 130.0 fL

PLT > 50.0 < 600 x 109/L > 50.0 < 600 x 103/L

MPV > 4.99 < 15.0 fL > 4.99 < 15.0 fL

CAUTION: Use commercial calibrator to calibrate the MPV parameter.

Do not use assayed whole blood.

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Section 6 Calibration Procedures

Obtaining Whole Blood Reference Values from a Reference Analyzer

Follow the procedures below to determine the reference values that will be used to
calibrate the instrument using whole blood.
1. Go to a reference hematology instrument (or use appropriate hematology
methods) with 5 specimens of normal, whole blood. Run each specimen at
least twice for a minimum of 10 replicates on the reference instrument.
NOTE: Because the same specimens will be used to first obtain reference
values on a reference instrument, then to calibrate the primary and
check bias on the secondary mode, it is important to begin with a
sufficient amount of each sample.
2. If a mean value for each parameter based on at least 10 runs is not
automatically calculated by the reference hematology instrument or
hematology methods, use a calculator to determine the cumulative Reference
Value Mean for each parameter.
For example:
The cumulative Reference WOC Mean is 7.15 when the WOC results from
each run are as follows:
Sample 1 = 9.2, 9.1
Sample 2 = 4.5, 4.6
Sample 3 = 6.1, 5.9
Sample 4 = 7.0, 7.3
Sample 5 = 8.9, 8.9
The cumulative mean of 7.15 equals the sum of the values (71.5) divided by
the 10 runs.
You may use the following worksheet to record the values obtained from
running samples on a reference instrument. Make copies of the blank
worksheet as necessary.
NOTE: Enter the WBC mean as the reference value for both the WOC and
NOC.

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Calibration Procedures
Calibration Guidelines Section 6

Whole Blood Calibration Reference Values Worksheet

Date: _____________ Operator:_____________ Reference Instrument: __________________

WBC WBC
Specimen ID Run # RBC HGB MCV PLT
(WOC) (NOC)

Sum of Values

Cumulative Mean

NOTE: The WBC value obtained on the Reference Instrument should be used for calibrating both the WOC
and NOC parameters on the CELL-DYN Ruby System.

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Section 6 Calibration Procedures

Pre-Calibration Procedures

Overview
The Pre-Calibration Procedures in this subsection verify proper instrument
performance to ensure a successful calibration.
The Auto-Calibration Wizard prompts the operator to verify:
Pre-Calibration Maintenance Check Status
Pre-Calibration Reagent and Waste Check
Pre-Calibration Precision Check Status
NOTE: Verify that both the primary and secondary mode Quick Precision
Checks were completed and passed within 24 hours of beginning
the Auto-Calibration Wizard.
Pre-Calibration Background Check Status
For Manual Calibration, complete the steps in this section just prior to beginning
the calibration procedure. A pre-calibration checklist is available for the operator
to complete. See Subsection: Pre-Calibration Checklist.
If problems are detected during these checks, DO NOT ATTEMPT TO
CALIBRATE THE INSTRUMENT. If necessary, call your local Country Service
and Support Center for assistance. After the problems have been resolved, repeat
the Pre-Calibration Procedures to verify proper performance.
NOTE: Complete instrument calibration, including the pre-calibration
procedures, without interruption.

Pre-Calibration Guidelines
Perform the scheduled maintenance as directed in Section 9: Service and
Maintenance before calibrating the instrument. Instrument cleanliness is
essential for accurate calibration. Perform additional maintenance according
to laboratory requirements.
Use only recommended CELL-DYN reagents.
Verify the precision for the Open and Closed Modes using the Calibration,
Quick Precision Check menu bar item, prior to calibration as directed in
Subsection: Pre-Calibration Checklist.
Select and process all whole blood specimens according to the requirements
in Subsection: Recommendations and Requirements for Whole Blood
Specimens.

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Calibration Procedures
Pre-Calibration Procedures Section 6

The whole blood specimen volume should be at least 15 mL to accomplish

the following:
Obtain reference values on a reference instrument prior to calibration.
Run precision checks prior to calibration.
Calibrate the primary mode of operation.
NOTE: If one whole blood specimen is used in the Auto-Calibration
Wizard, it is important that a representative specimen be selected to
calibrate the instrument. A specimen containing abnormalities may
adversely affect calibration. If sufficient sample is not available,
use a different sample for precision check.
Be certain that all specimens used are brought to room temperature and
mixed well before aspiration.
Be certain that the operator performing the calibration has read and
understands the information contained in the package insert for the calibrator.
Be certain that the operator performing the calibration has read and
understands the calibration procedure(s) and the appropriate overviews
described in this manual.
Confirm that reagent containers are at least one third full. Replace them as
necessary. See Section 9: Service and Maintenance, Subsection: Reagent
Container Replacement.
Confirm that the waste container is no more than half full. If necessary,
empty it as described in Section 8: Hazards, Subsection: Waste Handling
and Disposal.
Confirm that background counts are within limits. A background count
should be run immediately prior to running any calibration specimens.
Confirm your Operator ID sign on.

Pre-Calibration Checklist
Follow the procedures outlined in the Pre-Calibration Procedures Checklist to
ensure the instrument is ready for calibration. Use the Calibration Notes to note any
problems encountered. Make copies of both lists as needed.
NOTE: For Manual Calibration, always complete the Pre-Calibration procedures
before beginning any calibration. For the Auto-Calibration Wizard, use
this checklist as a guide.

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Section 6 Calibration Procedures

CELL-DYN Ruby Pre-Calibration Procedures Checklist

Instrument Serial Number & Software Version: ____________ Date: _________________________
Operator: ______________________

1. _______ Perform all required maintenance.

2. _______ Verify that all reagent containers are at least 1/3 full and the waste container is less than 1/2 full.
3. _______ Verify that the reagents have not reached the expiration date.
Diluent/Sheath: Lot #____________ Exp. date _______
HGB Lyse: Lot #____________ Exp. date _______
WBC Lyse: Lot #____________ Exp. date _______
4. _______ If applicable, verify that the calibrator has not reached the expiration date.
Lot #____________ Exp. date _______
5. _______ After the maintenance has been completed, verify that the background counts are within the
acceptable limits. Record the background counts below or attach a printout to this document.
WOC < 0.10 ________
NOC < 0.10 ________
RBC < 0.02 ________
HGB < 0.10 ________
PLT < 5.0 ________

6. _______ Verify the Analyzer Status is Ready State and in the Open Mode. Verify the Open Mode
precision as follows:
Obtain a normal whole blood specimen.
Select Calibration, Quick Precision Check from the menu bar, ensure the <Sampler
Mode> field indicates Open in the dialog box, and select New Precision Check button.
Enter the Specimen ID in the dialog box and run the specimen 10 times.
When the runs have been completed, select the Print button and write the %CV in the
appropriate spaces below and attach a file printout to this document.
PARAMETER %CVLIMIT %CV
WOC < 2.4% ________
NOC < 2.8% ________
RBC < 1.8% ________
HGB < 1.4% ________
MCV < 0.8% ________
PLT < 3.8% ________

7. _______ If the CV% for all parameters pass and fall within the limits, go to step 8 to verify Closed Mode
precision. If a parameters %CV exceeds the limit, select New Precision Check... button and
repeat step 6. If the over-limit condition persists, see Section 10: Troubleshooting and
Diagnostics, Subsection: Troubleshooting Imprecise or Inaccurate Data.

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Calibration Procedures
Pre-Calibration Procedures Section 6

8. _______ Verify the Analyzer Status is Ready State and in the Closed Mode. Verify the Closed Mode
precision as follows using the same specimen as in the Open Mode.
Aliquot the specimen into 10 5-mL empty specimen tubes containing no anticoagulant
(each tube requires a minimum volume of 1.5 mL of sample).
Select Calibration, Quick Precision Check from the menu bar, ensure the <Sampler
Mode> field indicates Closed in the dialog box, and select New Precision Check button.
Place the tubes in a rack, place the rack in the loading position, and select F12 - Start
Loader.
When the runs have been completed, select the Print button and write the %CV in the
appropriate spaces below and attach a file printout to this document
PARAMETER %CV LIMIT %CV
WOC < 2.4% ________
NOC < 2.8% ________
RBC < 1.8% ________
HGB < 1.4% ________
MCV < 0.8% ________
PLT < 3.8% ________
9. _______ If the %CV for all parameters pass and fall within the limits, go to step 10. If a parameters %CV
exceeds the limit, select New Precision Check... button and repeat step 8. If the over-limit
condition persists, see Section 10: Troubleshooting and Diagnostics, Subsection:
Troubleshooting Imprecise or Inaccurate Data.
10. _______ If any problems are detected during the procedures outlined above, document them on the
following form. Make copies of this form as necessary.
11. _______ Continue with Subsection: Calibration Procedures.

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Section 6 Calibration Procedures

Calibration Notes
_________________________________________________________________________________

_________________________________________________________________________________

_________________________________________________________________________________

_________________________________________________________________________________

_________________________________________________________________________________

_________________________________________________________________________________

_________________________________________________________________________________

_________________________________________________________________________________

_________________________________________________________________________________

_________________________________________________________________________________

_________________________________________________________________________________

_________________________________________________________________________________

_________________________________________________________________________________

_________________________________________________________________________________

_________________________________________________________________________________

_________________________________________________________________________________

_________________________________________________________________________________

_________________________________________________________________________________

_________________________________________________________________________________

_________________________________________________________________________________

_________________________________________________________________________________

_________________________________________________________________________________

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Calibration Procedures
Pre-Calibration Procedures Section 6

NOTES

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Section 6 Calibration Procedures

Calibration Menu

Overview
This subsection gives an overview of Calibration menu items:

Access the Calibration menu from the pull-down Menu Bar by dragging down on
Calibration. The Calibration menu displays the selections.

Last Auto-Calibration Data

Select Calibration and Last Auto-Calibration Data... on the pull-down menu
and the Last Calibration: Sample Runs Summary dialog box opens, displaying
data from the last calibration. Select either Sample Mode, Open or Closed, to view
the data, which includes the run date, the run time, and the method.

This area is
blank if there
is no previous
data

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Calibration Procedures
Calibration Menu Section 6

Table 6.2 Buttons Last Auto-Calibration Data...

Field Description

Close Closes the dialog box

Quick Precision Check

Select Calibration and Quick Precision Check... on the pull-down menu and the
Quick Precision Check... dialog box opens in the mode displayed in the Analyzer
Status region, or, if there is historical data available, it is displayed indicating date,
time, and the sampler mode it was run in.

Sampler Mode: Open or Closed

Run results

Data analysis
of run results

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Section 6 Calibration Procedures

Table 6.3 Fields Quick Precision Check... Dialog Box

Field Description

A precision check was Date and time of last performed check

performed on

Open or Closed
NOTE: This field is automatically filled with the
current Analyzer Status mode when
Calibration, Quick Precision Check... is
selected from the menu bar or historical
information based on last performed
precision check
Sampler Mode

Specimen ID Enter the Specimen ID for the Specimen being run

Table 6.4 Buttons Quick Precision Check... Dialog Box

Buttons Description

Print Prints the Quick Precision Check... data

New Precision Check Clears the data to begin a new precision check

Saves the precision check data only if 10 samples

Done
were run

Cancel Exits the wizard

NOTE: Parameter status may display as FAILED in the Quick Precision Check
dialog box if any of the following occur:
The CV% for the parameter exceeds the CV% Ref
The run result for a parameter
is suppressed
displays as >>>>>
is flagged as invalid (marked with an asterisk)

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Calibration Procedures
Calibration Menu Section 6

Calibration Log
The Calibration Log is accessed either through the Calibration pull-down menu
on the menu bar or by selecting System from the tool bar.
The log displays up to 32 line entries in the view up to 3000 records. Once 3000
records have been reached, the oldest record is deleted each time a new record is
added. Additional log entries are accessed by using the arrows on the right-hand
side of the view.

Navigation
arrows

Horizontal scroll bar

The Calibration Log has 17 columns. All columns may not be visible on the screen
at the same time. Use the horizontal scroll bar located at the bottom of the view to
access the unseen portion of the view. The Calibration Log displays the mode and
parameter-specific calibration factors for the CELL-DYN Ruby System
calibratable parameters. The Calibration Log also has the following columns:

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Section 6 Calibration Procedures

Table 6.5 Fields Calibration Log View

Field Description

Rec# Record number

DATE Date the calibration occurred

Time Time the calibration occurred

M Mode: Open or Closed

Maint Maintenance: Incomplete or Done

Prec Precision Check: Incomplete, Fail or Pass

Bkgd Background Count: Fail or Pass

OPID ID of operator performing calibration

Method of calibration factory, calibrator, whole blood, or

Method
manual

Comment Operator-entered comments at calibration

Table 6.6 Buttons Calibration Log Dialog View

Buttons Description

Displays the Print dialog box while in the Calibration

Log view, providing the following print options:
Record range:
All
F1 Print Selection
Start Rec# End#
Number of copies
NOTE: Select File and Print Preview to verify
Landscape orientation is selected.

Opens the Advanced Find/Filter Dialog box. Used to

F3 Find/Filter
locate a particular record by entering information.

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Calibration Procedures
Calibration Menu Section 6

Auto-Calibration Wizard
The Auto-Calibration Wizard program provides a calibration wizard that prepares
the CELL-DYN Ruby System for calibration, calculates new calibration factors,
and copies those new calibration factors from one mode to the other.
The Auto-Calibration Wizard... is accessed from Calibration on the menu bar
and Auto-Calibration Wizard... on the pull-down menu.
When specimens are run, the Auto-Calibration Wizard:
Accepts up to ten consecutive specimen runs for either calibrator or fresh
whole blood specimens.
Compares sample results against internal precision and reference checks,
highlighting results that fail.
Calculates the new calibration factors (Mean Factors) and Factor % Diff
values.
Compares the Factor % Diff values to ranges in an internal table to determine
which parameters require calibration.
Highlights Factor % Diff values for parameters which require calibration or
which are over-limit.

Manual Calibration
Select Calibration from the menu bar and Manual Calibration... on the pull-
down menu and the Manual Calibration... dialog box opens.

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NOTE: This example of the Dilution Factor page

visible, is only available to users with administrative
privileges.

There are two tabs:

Calibration Factor
Dilution Factor
The Calibration Factor displays the current mode and parameter specific
calibration factors. See also Subsection: Manual Calibration Method.
The Dilution Factor displays the current mode and parameter specific Dilution
Factors, and is for use only by Abbott personnel. Users with administrative level
access are able to view the Dilution Factor page.
.

Table 6.7 Fields Manual Calibration... Dialog Box

Field Description

Comment Operator entered comment or remarks

Table 6.8 Buttons Manual Calibration... Dialog Box

Buttons Description

OK Saves any changes or comments

Cancel Cancels the dialog box

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Calibration Menu Section 6

Four worksheets are provided to assist in manual calculation and determination of

new calibration factors for the CELL-DYN Ruby System. Three worksheets are
designed for the Open Mode procedure and one for confirmation. Refer to
Subsection: Manual Calibration Worksheets.
Worksheet 1 Open Mode Calibration New Factors
Worksheet 2 Open Mode Factor % Difference
Worksheet 3 Open Mode Calibration Range Criteria
Worksheet 4 Calibration Verification

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Calibration Procedures

Overview
Before initiating calibration, complete the Pre-Calibration Procedures described
previously in this section.
The CELL-DYN Ruby System software applies the mode and parameter specific
calibration factor to the data obtained when the specimens are run. The
CELL-DYN Ruby provides the operator the option to initiate the Auto-Calibration
Wizard and Manual Calibration using Commercial Calibrator material or Assayed
Whole Blood specimens.
The Auto-Calibration Wizard method simplifies the generation of new calibration
factors for Commercial Calibrator or Assayed Whole Blood specimens. The
Manual Calibration method allows the operator to manually calculate and enter
new calibration factors generated from Commercial Calibrators or Assayed Whole
Blood Specimens.
NOTE: If a System Initiated Message (SIM) displays during the Auto-Calibration
Wizard or Manual Calibration method, refer to Section 10:
Troubleshooting and Diagnostics for the corrective action to perform
before running the next sample.

Auto-Calibration Method
Auto-Calibration is a multi-step process that involves:
Selecting Open or Closed mode for calibration
NOTE: Commercial Calibrator is for Open Mode use only.
Pre-Calibration Maintenance Check Status
Pre-Calibration Reagent and Waste Check
Pre-Calibration Precision Check Status
NOTE: It is recommended that the operator verify that both the primary
and secondary mode Quick Precision Checks have been completed
before beginning the Auto-Calibration Wizard.
Pre-Calibration Background Check Status
Selecting Calibration Setup Specimen Type
Entering Reference Values or Assay Values for Calibrator
Auto-Calibration Data View: Running calibrator specimens
Accepting or Rejecting calibrator runs
Reviewing and Activating Post Calibration New Factors
Auto-Calibration Wizard Open/Closed Mode Bias Check

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Calibration Procedures Section 6

Running Mode to Mode Specimens in Primary Mode (6-10 normal whole

blood specimens)
Running Mode to Mode Specimens in Secondary Mode
Accepting or Rejecting Bias Check Runs
Reviewing and Activating Post Mode Check Factors (if required)
Printing Auto-Calibration Summary report
Run Controls to confirm calibration

Auto-Calibration Wizard - Open

Using Commercial Calibrator
When using a calibrator, follow the instructions provided on the calibrator package
insert for proper storage, handling, and mixing.
Abbott recommends cycling the calibrator a minimum of 6 and a maximum of 10
consecutive runs when using the Auto-Calibration Wizard in Open Mode.

Beginning Auto-Calibration
1. Verify the System is in Open Mode. If the System is in Closed Mode select
the F11Select Open function key to change from Closed to Open Mode.
2. Select Calibration and Auto-Calibration Wizard... from the pull-down
menu. The Auto-Calibration Wizard... dialog box opens.

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NOTE: The Sample Mode field displays the current Analyzer Status
mode when the dialog box opens.
Table 6.9 Buttons Welcome to the CELL-DYN Auto Calibration Wizard

Buttons Description
Next> Advances to the next dialog box
Cancel Opens dialog box:
Cancel Auto-Calibration Wizard?
No, returns to the wizard
Yes, cancels the wizard
3. Select Next> and the Pre-Calibration Maintenance Check Status dialog
box opens. Read the information in the dialog box and follow the directions.

Table 6.10 Buttons Pre-Calibration Maintenance Check Status Dialog Box

Buttons Description

Perform Cancels the Wizard and displays the Maintenance,

Maintenance Scheduled tab view

<Back Returns to the previous screen

Advances to the next screen if maintenance is current

NOTE: When Maintenance Procedures are incomplete, the
information bar immediately above the Perform
Next>
Maintenance button displays a message:
Incomplete maintenance performed. Please enter a
comment to continue calibration.

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Calibration Procedures Section 6

Table 6.10 Buttons Pre-Calibration Maintenance Check Status Dialog Box

Buttons Description

Opens dialog box:

Cancel Auto-Calibration Wizard?
Cancel
No, returns to the wizard
Yes, cancels the wizard

4. Click Next> and the Pre-Calibration Reagent/Waste dialog box opens.

Read the information in the dialog box and follow the directions.

Table 6.11 Buttons Pre-Calibration Reagent/Waste Dialog Box

Buttons Description

Cancels the wizard and displays the Reagents, Current

Change Reagent
Reagents tabs view

<Back Returns to the previous screen

Next> Advances to the next screen

Opens dialog box:

Cancel Auto-Calibration Wizard?
Cancel
No, returns to the wizard
Yes, cancels the wizard

Finish Completes an operation

5. Click Next> and the Pre-Calibration Precision Check Status dialog box
opens. Review the information in the dialog box.

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The date, time, and results of the most recent Quick Precision Check are
displayed, if available, in the Pre-Calibration Precision Check Status
dialog box.
Example: The last precision check was performed on the date listed

Table 6.12 Buttons Pre-Calibration Precision Check Status Dialog Box

Buttons Description

Opens a dialog box to exit the wizard and opens the

New Precision Check
Quick Precision Check... dialog box

<Back Returns to the previous screen

Advances to the next screen if a precision check was

performed within the last 24 hours and the status of
each parameter is PASS
NOTE: When Precision Check fails, the information
Next>
bar immediately above the New Precision
Check button displays a message:
Failed Precision Check. Please enter a
comment to continue calibration.

Opens dialog box:

Cancel Auto-Calibration Wizard?
Cancel
No, returns to the wizard
Yes, cancels the wizard

Finish Completes an operation

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Calibration Procedures Section 6

Verify that the results of the last precision check are not greater than 24 hours
old and the Status column lists PASS, indicating parameters are calibrated,
before advancing to the next screen. See the dialog box below.
NOTE: If any of the following occurred, select the New Precision Check
button to exit the wizard and open the Quick Precision Check...
dialog box.
The A precision check was performed on field is blank,
indicating no precision check was performed
Any parameter status results indicate FAILED
The precision check is more than 24 hours old
Example: Field is empty - no date listed, no precision check performed

6. Click Next> and the Pre-Calibration Background Check Status dialog box
opens and starts the Auto Background cycle.

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A flashing blue/black message appears in the view: Pre-Calibration

Running Auto Background... and the message bar displays a message in
yellow: Wait.
In the Analyzer Status section, the State field turns yellow and the names of
the processes scroll across the bottom of the status bar area as each occurs:

Color State Scroll Bar

AutoBkg Aspirating
AutoBkg Removing Specimen
AutoBkg Dispensing
AutoBkg Counting
AutoBkg Rinsing
message scrolling area
AutoBkg Rinsing
Ready

The green light and the word Ready appear in the State field when the Pre-
Calibration Background Check is completed.
The Pre-Calibration Background Check Status dialog box reveals a new
view.

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Calibration Procedures Section 6

a. Read the information in the dialog box.

b. Verify that the Result column indicates PASS background counts are
within parameters before advancing to the next screen.
NOTE: If any parameter has a FAILED result, select Rerun
Background before advancing to the next step.
Table 6.13 Buttons Pre-Calibration Background Check Status Dialog Box

Buttons Description

Returns to the Pre-Calibration Background Check

Rerun Background Status dialog box and flashes message:
Pre-Calibration - Running Auto Background...

<Back Returns to the previous screen

Advances to the next screen if all parameter results list

Next>
PASS

Opens dialog box:

Cancel Auto-Calibration Wizard?
Cancel
No, returns to the wizard
Yes, cancels the wizard

Finish Completes an operation

7. Click Next> and the Calibration Setup dialog box opens. Read the
information in the dialog box and follow the directions. Verify that the
Calibrator radio button is selected.

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Table 6.14 Buttons Calibration Setup Dialog Box

Buttons Description

<Back Returns to the previous screen

Next> Advances to the next screen
Cancel Opens dialog box:
Cancel Auto-Calibration Wizard?
No, returns to the wizard
Yes, cancels the wizard
Finish Completes an operation

Inputting Calibrator Information

1. Click Next> and the Calibration Setup - Reference Values for Calibrator
dialog box opens. Read the information in the dialog box and follow the
directions.

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Calibration Procedures Section 6

2. Using the calibrator assay sheet, input the information:

a. Find a parameter.
b. Select the same parameter on the screen.
c. Enter that parameters value on the screen. When entering assay values:
Check the parameter to make sure the parameter listed for the
Calibrator on the assay sheet matches the CELL-DYN Ruby.
Carefully check the assay values as the order in which they are listed
on the assay sheet may be different from the order on the screen.
NOTE: Use the Manual Calibration method to calibrate any parameter
with an assigned value that exceeds the assay value entry range.
Select a box in the Parameter column. The cursor positions itself in
the corresponding Value column.
NOTE: Scrolling over a check
Assay Values:
box in the Parameter
column displays the
numerical range limit
for each parameter.

After entering the last value, press the Enter key to save the entered
values.
Use the calibrator's vial label to enter the information shown in the
following table.

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.

Table 6.15 Fields Calibration Setup - Reference Values for Calibration

Fields Description

Specimen ID Enter the Calibrator Lot Number

(Calibrator ID)

Lot Number Enter the Calibrator Lot Number

Expiration Date Enter the expiration date

Number of Runs for Enter the number of runs

Calibration NOTE: When using commercial calibrator, Abbott
recommends a minimum of 6 runs in
Open Mode.

Table 6.16 Buttons Calibration Setup - Reference Values for Calibration Dialog
Box

Buttons Description

<Back Returns to the previous screen

Next > Advances to the next screen

Opens dialog box:

Cancel Auto-Calibration Wizard?
Cancel
No, returns to the wizard
Yes, cancels the wizard

Finish Completes an operation

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Calibration Procedures Section 6

3. Click Next> and the Auto-Calibration Data View dialog box opens. The
Run# field displays the number of runs made over the number of runs
selected in the Calibration Setup - Reference Values for Calibrator
screen:
Accepted Run # X/x the accepted runs which increase each time a run
is completed.
Number of runs, Run # x/X set in the previous screen, Calibration
Setup - Reference Values for Calibrator.

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Running the Calibrator

1. Read and follow the directions in the Auto-Calibration Data View dialog
box before running the specimens.

a. Follow the instructions provided in the calibrator package insert for

proper handling and mixing procedure of the specimens.
b. Remove the cap from the vial.
c. Position the vial around the Open Mode probe keeping the tip of the
Open Mode probe from resting on the bottom of the tube.
d. Press the touch plate to activate aspiration of the specimen.
e. Remove the vial at the sound of the beep, before the wash block moves
down the Open Mode probe.
In the Analyzer Status section, the State field turns yellow and the
names of the processes scroll across the bottom of the status bar area as
each occurs:
.

Color State Scroll Bar

Ready
Counting Aspirating
Counting Removing Specimen
Counting Dispensing
Counting Counting
Counting Rinsing
Cleaning Rinsing
Ready

The data appears in the dialog box during the Counting-Rinsing process.
The green light and the word Ready appear in the State field when the
run is completed.

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When the run is ended, the Auto-Calibration Data View reflects the
information.
f. Continue running specimens until the total number of runs are complete.
This is an example of Auto-Calibration Data View when the accepted
number of runs match the number of runs selected in the Calibration
Setup - Reference Values for Calibrator dialog box.

2. Review the calibrator run data. If the number of accepted runs equals the
number of selected runs, the Next> button is available. Select the Next>
button to advance to the next dialog box.
To reject a run:
a. Deselect or clear a check box. The Run# x/x reflects each change made.
In the previous example, if two boxes were deselected, then the runs
would be listed as 4/6. Two new specimens would need to be run to
replace the two deselected runs.
b. Run the missing number of specimens and review the calibrator run data.
Table 6.17 Buttons Auto-Calibration Data View Dialog Box

Buttons Description
<Back Returns to the previous screen
Advances to the next screen when the number of accepted runs
Next>
equals the number of selected runs.
Opens dialog box:
Cancel Auto-Calibration Wizard?
Cancel
No, returns to the wizard
Yes, cancels the wizard
Finish Completes an operation

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Review New Factors to Apply

1. Click Next> and the Post-Calibration New Factors dialog box opens.
Review the information in the dialog box

Table 6.18 Fields Post-Calibration New Factors Dialog Box

Field Description

Cal. Recommended Displays Yes or No

Apply New Factor Applies the new factor to the next screen

Table 6.19 Buttons Post-Calibration New Factors Dialog Box

Buttons Description

<Back Returns to the previous screen

Next> Applies new factors and advances to the next screen

Opens dialog box:

Cancel Auto-Calibration Wizard?
Cancel
No, returns to the wizard
Yes, cancels the wizard

Finish Completes an operation

The dialog box provides an explanation of the information in the Cal

Recommended column.
Refer to Table 6.20 for guidance on when to select Apply New Factor for
acceptance.

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Calibration Procedures Section 6

Table 6.20 When to Select Apply New Factor for Acceptance

And the parameter(s) ... the check Operator Action:

If <Cal box <Apply
Recommended> New Factor>
message is: display/status
is:

% Diff is within the Selectable Apply New Factor by selecting the check
calibration range: box.
WOC >1.5% but <10% Continue with wizard.
NOC >1.5% but <10%
YES
RBC >1.0% but <10%
(green)
HGB >1.0% but <10%
MCV >1.0% but <10%
MPV >1.0% but <10%
PLT >3.0% but <15%

% Diff is greater than the Selectable Apply New Factor ONLY if the reason for
calibration range: the large % Diff is understood.
WOC >10% Continue with wizard.
NOC >10%
YES RBC >10%
(blue)
HGB >10%
MCV >10%
MPV >10%
PLT >15%

% Diff is less than the Selectable The parameter current Cal Factor is OK as
calibration range: is. It is not required to select the Apply
WOC <1.5% New Factor check box.
NOC <1.5% Continue with wizard.
NO
RBC <1.0%
(green)
HGB <1.0%
MCV <1.0%
MPV <1.0%
PLT <3.0%

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Table 6.20 When to Select Apply New Factor for Acceptance (Continued)

Calibration factor value Not DO NOT CALIBRATE.

exceeds allowable range: selectable If the parameter New Factor falls
WOC 0.7001.300 outside the software allowable factor
NOC 0.7001.300 range:
RBC 0.8001.200 Select the < Back button twice.
HGB 0.7001.300 Verify the Reference Values or Assay
MCV 0.7001.300 Values entered are acceptable.
NO PLT 0.7001.300 If the entered values are OK, select the
(red) Cancel button to exit the wizard.
Rerun auto-calibration with new calibrator
specimen(s).
If the entered values are Not OK
Correct the value or values.
Select the Next > button twice.
Review the updated <Cal
Recommended> message.

2. To complete Auto-Calibration with the currently Calculated Factors, select

Finish>.
or
To continue with Open/Closed Mode Bias Check, select Next>
The following dialog box opens:

Select <YES> to continue. The Open/Closed Mode Bias Start dialog box opens.

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Calibration Procedures Section 6

Running the Open/Closed Mode Bias Check

You will need 6-10 fresh, normal whole blood specimens to perform the Open/
Closed Mode Bias Check
1. Review the information in the Open/Closed Mode Bias Start dialog box.
The Primary mode is based upon the initial sampling mode for Auto-
Calibration.

Buttons Description

<Back Goes to previous page

Next > Advances to the next screen

Opens dialog box:

Cancel Auto-Calibration Wizard?
Cancel
No: returns to Wizard
Yes: cancels the Wizard

Finish Returns to selected view

2. Select Next >. The Open/Closed Mode Bias Runs dialog box opens.
a. Read the information in the dialog box and follow the directions before
running the bias check specimens.
NOTE: Enter the specimen ID for Open Mode samples in the NOTE
region.

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3. Run the Bias Check specimens:

a. Run 6 10 normal whole blood specimens in the Open Mode
b. Select F11 to change to the Closed Mode.
c. Run the same whole blood specimens in the Closed Mode.
d. To reject a run, deselect or clear the checkbox next to the run to be
rejected.
4. Select Next > to continue. The Open/Closed Mode Bias Results dialog box
opens.

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Calibration Procedures Section 6

5. Review the Open/Closed Mode Bias results.

a. If the Open/Closed bias for a parameter is within tolerance range, the
parameter row will be shaded, and the Cal Rec and Apply columns will
be blank.
b. If the Open/Closed bias for a parameter exceeds the tolerance range, the
Cal Rec column will display Yes or No, and the Apply column will
contain a checkbox.
The dialog box provides an explanation of the information in the Cal Rec
column.
6. Select the checkbox(es) in the Apply column apply the New Factor(s).
7. Select Finish > to accept the new secondary mode factors. The Auto-
Calibration dialog box opens and indicates Auto-Calibration completed
Successfully!

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8. Click Print to print out and review the calibration summary report.

9. Click Close and the Auto Calibration Wizard closes.

10. Continue with Subsection: Post-Calibration Procedures.

Whole Blood Auto-Calibration Wizard - Open Mode

Using Whole Blood
When using whole blood, it is important to mix the specimen well by inverting the
tube at least ten times just prior to aspiration. Do not shake the specimen.
Abbott recommends cycling a single whole blood specimen a minimum of 6 and a
maximum of 10 consecutive runs or cycle each of five whole blood specimens
twice for a total of at least ten times when using the Auto-Calibration Wizard in
Open Mode. See Subsection: Obtaining Whole Blood Reference Values from a
Reference Analyzer before beginning the procedure to auto-calibrate using whole
blood.

Beginning Auto-Calibration Using Whole Blood

1. Verify the System is in Open Mode. If the System is in Closed Mode select
the F11Select Open function key to change from Closed to Open Mode.

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2. Select Calibration and Auto-Calibration Wizard... from the pull-down

menu. The Auto-Calibration Wizard... dialog box opens.

NOTE: The Sample Mode field displays the current Analyzer

Status mode when the dialog box opens.
Table 6.21 Buttons Welcome to the CELL-DYN Auto-Calibration Wizard Dialog
Box

Buttons Description

Next> Advances to the next dialog box

Opens dialog box:

Cancel Auto-Calibration Wizard?
Cancel
No, returns to the wizard
Yes, cancels the wizard

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3. Select Next> and the Pre-Calibration Maintenance Check Status dialog

box opens. Read the information in the dialog box and follow the directions.

Table 6.22 Buttons Pre-Calibration Maintenance Check Status Dialog Box

Buttons Description

Perform Cancels the Wizard and displays the Maintenance,

Maintenance Scheduled tab view

<Back Returns to the previous screen

Advances to the next screen if maintenance is current

NOTE: When Maintenance Procedures are incomplete,
the information bar immediately above the
Next> Perform Maintenance button displays a
message:
Incomplete maintenance performed. Please enter
a comment to continue calibration.

Opens dialog box:

Cancel Auto-Calibration Wizard?
Cancel
No, returns to the wizard
Yes, cancels the wizard

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4. Click Next> and the Pre-Calibration Reagent/Waste dialog box opens.

Read the information in the dialog box and follow the directions.

Table 6.23 Buttons Pre-Calibration Reagent/Waste Dialog Box

Buttons Description

Cancels the wizard and displays the Reagents, Current

Change Reagent
Reagents tabs view

<Back Returns to the previous screen

Next> Advances to the next screen

Opens dialog box:

Cancel Auto-Calibration Wizard?
Cancel
No, returns to the wizard
Yes, cancels the wizard

Finish Completes an operation

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5. Click Next> and the Pre-Calibration Precision Check Status dialog box
opens. Review the information in the dialog box.
The date, time, and results of the most recent Quick Precision Check are
displayed, if available, in the Pre-Calibration Precision Check Status
dialog box.
Example: The last precision check was performed on the date listed

Table 6.24 Buttons Pre-Calibration Precision Check Status Dialog Box

Buttons Description

Opens a dialog box to exit the wizard and opens the

New Precision Check
Quick Precision Check... dialog box

<Back Returns to the previous screen

Advances to the next screen if a precision check was

performed within the last 24 hours and the status of
each parameter is PASS
NOTE: When Precision Check fails, the information
Next>
bar immediately above the New Precision
Check button displays a message:
Failed Precision Check. Please enter a
comment to continue calibration.

Opens dialog box:

Cancel Auto-Calibration Wizard?
Cancel
No, returns to the wizard
Yes, cancels the wizard

Finish Completes an operation

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Verify that the results of the last precision check are not greater than 24 hours
old and the Status column lists PASS, indicating parameters are calibrated,
before advancing to the next screen.
NOTE: If any of the following occurred, select the New Precision Check...
button to exit the wizard and open the Quick Precision Check
dialog box.
The A precision check was performed on field is blank,
indicating no precision check was performed
Any parameter status results indicate FAILED
The precision check is more than 24 hours old
Example: Field is empty - no date listed, no precision check performed

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6. Click Next> and the Pre-Calibration Background Check Status dialog box
opens and starts the Auto Background cycle

A flashing blue/black message appears in the view: Pre-Calibration

Running Auto Background... and the message bar displays a message in
yellow: Wait.
In the Analyzer Status section, the State field turns yellow and the names of
the processes scroll across the bottom of the status bar area as each occurs:
1

Color State Scroll Bar

AutoBkg Aspirating
AutoBkg Removing Specimen
AutoBkg Dispensing
AutoBkg Counting
AutoBkg Rinsing
message scrolling area
AutoBkg Rinsing
Ready

The green light and the word Ready appear in the State field when the Pre-
Calibration Background Check is completed.

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The Pre-Calibration Background Check Status dialog box reveals a new

view.

a. Read the information in the dialog box.

b. Verify that the Result column indicates PASS background counts are
within parameters before advancing to the next screen.
NOTE: If any parameter has a FAILED result, select Rerun
Background before advancing to the next step.
Table 6.25 Buttons Pre-Calibration Background Check Status Dialog Box

Buttons Description

Returns to the Pre-Calibration Background Check

Rerun Background Status dialog box and flashes message:
Pre-Calibration - Running Auto Background...

<Back Returns to the previous screen

Advances to the next screen if all parameter results

Next>
list PASS

Opens dialog box:

Cancel Auto-Calibration Wizard?
Cancel
No, returns to the wizard
Yes, cancels the wizard

Finish Completes an operation

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7. Click Next> and the Calibration Setup dialog box opens. Read the
information in the dialog box and follow the directions. Verify that the Whole
Blood radio button is selected.

Table 6.26 Buttons Calibration Setup Dialog Box

Buttons Description

<Back Returns to the previous screen

Next> Advances to the next screen

Opens dialog box:

Cancel Auto-Calibration Wizard?
Cancel
No, returns to the wizard
Yes, cancels the wizard

Finish Completes an operation

Inputting Whole Blood Information

1. Select Next> and Calibration Setup - Reference Values for Whole Blood
dialog box opens. Read the information in the dialog box and this step and
follow the directions.

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Table 6.27 Buttons Calibration Setup - Reference Values for Whole Blood
Dialog Box

Buttons Description

<Back Returns to the previous screen

Next> Advances to next screen

Opens dialog box:

Cancel Auto-Calibration Wizard?
Cancel
No, returns to the wizard
Yes, cancels the wizard

Finish Completes an operation

2. Using the Whole Blood Calibration Reference Values Worksheet, input the
information:
a. Enter Reference Values
1) Find a parameter, cumulative mean value on the worksheet.
2) Select the same parameter on the screen.
3) Enter that parameters value on the screen. When entering reference
values:
Select a box in the Parameter column. The cursor positions
itself in the corresponding Value column.
After entering the last value, press the Enter key to save the
entered values.

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NOTE: Scrolling over a check box in Assay Values:

the Parameter column displays
the numerical range limit for
each parameter.

b. Enter Specimens Used for Reference and Calibration

1) Enter Confirm Factor/Comments the specimen ID in the field just
above the Add button.

Specimen ID entered here . . .

Click Add . . .

Specimen ID appears in the Specimen ID field

2)
Click Add and the information is entered into the Specimen ID
field. Repeat steps 1 and 2 for each Specimen ID being run.
c. Using the Whole Blood Calibration Reference Values Worksheet, verify
the number of runs per specimen for calibration.

d. Enter source of Reference Values

1) Enter the Reference Instrument from the worksheet.

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Running the Whole Blood Specimens

1. Click Next> and Auto-Calibration Data View dialog box opens.
Number of runs completed / total number of runs to be made

Reference
Values entered
in the
Calibration
Setup dialog
box

Table 6.28 Buttons Auto-Calibration Data View Dialog Box

Buttons Description

<Back Returns to the previous screen

Button isnt operative when counts are running but is after

Next>
a count is through running

Opens dialog box:

Cancel Auto-Calibration Wizard?
Cancel
No, returns to the wizard
Yes, cancels the wizard

Finish Completes an operation

The reference values entered in the prior step appear in the Auto-Calibration
Data View.
The Run# field displays the number of:
Run# X/xCompleted and/or selected runs
Number of runs Run# x/X set in the previous screen, Calibration
Setup - Reference Values for Whole Blood.
Read and follow the directions in the Auto Calibration Data View dialog
box to run the specimens.

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2. Using the Whole Blood Calibration Reference Values Worksheet as a guide:

a. Go to the NOTE region.
b. At the Specimen ID or QCID field pull-down
menu, select the Specimen ID to be run.
c. Verify the specimen ID on the tube label
matches the specimen ID field in the NOTE
region.
3. Aspirate the specimen:
a. Properly mix and remove the cap from the
tube.
b. Position the vial around the Open Mode probe keeping the tip of the
Open Mode probe from resting on the bottom of the tube.
c. Press the touch plate to activate aspiration of the specimen.
d. Remove the vial, at the sound of the beep, before the wash block moves
down the Open Mode probe.
Each sample goes through the following process:
In the Analyzer Status section, the State field turns yellow and the
names of the processes scroll across the bottom of the status bar area as
each occurs:
.

Color State Scroll Bar

Ready
Counting Aspirating
Counting Removing Specimen
Counting Dispensing
Counting Counting
Counting Rinsing
Cleaning Rinsing
Ready

The data appears in the chart during the Counting-Rinsing process.

The green light and Ready appear in the State field when each run is
completed
e. Run the specimen the assigned number of runs. When all calibration
specimens have been run, select the Next> button to advance to the next
dialog box.

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Review New Factors to Apply

1. Click Next> and the Post-Calibration New Factors dialog box opens.
Review the information in the dialog box.

The dialog box provides an explanation of the information in the Cal

Recommended column. Refer to Table 6.31 for guidance on when to select Apply
New Factor for acceptance.
Table 6.29 Fields Post-Calibration New Factors Dialog Box

Field Description

Cal. Recommended Displays Yes or No

Apply New Factor Applies the new factor to the next screen

Table 6.30 Buttons Post-Calibration New Factors Dialog Box

Buttons Description

<Back Returns to the previous screen

Applies new factors and advances to the next

Next>
screen

Opens dialog box:

Cancel Auto-Calibration Wizard?
Cancel
No, returns to the wizard
Yes, cancels the wizard

Finish Completes Auto-Calibration without BIAS check

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Table 6.31 When to Select Apply New Factor for Acceptance

And the parameter(s) ... the check Operator Action:

If <Cal box <Apply
Recommended> New Factor>
message is: display/status
is:

% Diff is within the Selectable Apply New Factor by selecting the check
calibration range: box.
WOC >1.5% but <10% Continue with wizard.
YES NOC >1.5% but <10%
(green) RBC >1.0% but <10%
HGB >1.0% but <10%
MCV >1.0% but <10%
PLT >3.0% but <15%

% Diff is greater than the Selectable Apply New Factor ONLY if the reason for
calibration range: the large % Diff is understood.
WOC >10% Continue with Wizard.
YES NOC >10%
(blue) RBC >10%
HGB >10%
MCV >10%
PLT >15%

% Diff is less than the Selectable The parameter current Cal Factor is OK as
calibration range: is, it is not required to select the Apply New
WOC <1.5% Factor check box Continue with wizard.
NO NOC <1.5%
(green) RBC <1.0%
HGB <1.0%
MCV <1.0%
PLT <3.0%

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Table 6.31 When to Select Apply New Factor for Acceptance (Continued)

Calibration factor value Not DO NOT CALIBRATE.

exceeds allowable range: selectable If the parameter New Factor falls
WOC 0.7001.300 outside the software allowable factor
NOC 0.7001.300 range:
RBC 0.8001.200 Select the < Back button twice.
HGB 0.7001.300 Verify the Reference Values or Assay
MCV 0.7001.300 Values entered are acceptable.
NO PLT 0.7001.300 If the entered values are OK, select the
(red) Cancel button to exit the wizard.
Rerun auto-calibration with new calibrator
specimen(s).
If the entered values are Not OK:
Correct the value or values.
Select the Next > button twice.
Review the updated <Cal
Recommended> message.

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Running the Open/Closed Mode Bias Check

You will need 6-10 fresh, normal whole blood specimens to perform the Open/
Closed Mode Bias Check
1. Review the information in the Open/Closed Mode Bias Start dialog box.
The Primary mode is based upon the initial sampling mode for Auto-
Calibration.

Buttons Description

<Back Goes to previous page

Next > Advances to the next screen

Opens dialog box:

Cancel Auto-Calibration Wizard?
Cancel
No: returns to Wizard
Yes: cancels the Wizard

Finish Returns to selected view

2. Select Next >. The Open/Closed Mode Bias Runs dialog box opens.
a. Read the information in the dialog box and follow the directions before
running the bias check specimens.
NOTE: Enter the specimen ID for Open Mode samples in the NOTE
region.

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3. Run the Bias Check specimens:

a. Run 6 10 normal whole blood specimens in the Open Mode
b. Select F11 to change to the Closed Mode.
c. Run the same whole blood specimens in the Closed Mode.
d. To reject a run, deselect or clear the checkbox next to the run to be
rejected.
4. Select Next > to continue. The Open/Closed Mode Bias Results dialog box
opens.

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5. Review the Open/Closed Mode Bias results.

a. If the Open/Closed bias for a parameter is within tolerance range, the
parameter row will be shaded, and the Cal Rec and Apply columns will
be blank.
b. If the Open/Closed bias for a parameter exceeds the tolerance range, the
Cal Rec column will display Yes or No, and the Apply column will
contain a checkbox.
The dialog box provides an explanation of the information in the Cal Rec
column.
6. Select the checkbox(es) in the Apply column apply the New Factor(s).
7. Select Finish > to accept the new secondary mode factors. The Auto-
Calibration dialog box opens and indicates Auto-Calibration completed
Successfully!

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Calibration Procedures Section 6

8. Click Print to print out and review the calibration summary report.

9. Click Close and the Auto Calibration Wizard closes.

10. Continue with Subsection: Post-Calibration Procedures.

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Manual Calibration Method

The Manual Calibration method can be used to enter a predetermined factor to
adjust calibration when a consistent bias exists between the CELL-DYN Ruby
System and a comparison analyzer. Either Commercial Calibrator or Assayed
Whole Blood can be used for calibration.
When using Assayed Whole Blood begin with a sufficient amount of sample
15 mL each is recommended the same sample is used to obtain reference values
on a reference instrument and to calibrate in the Open and verify the Closed Modes.
A set of worksheets is provided in Manual Calibration Worksheets at the end of
this section to assist in the manual calibration process.
NOTE: Always complete Pre-Calibration procedures before beginning any
calibration.

Manual Calibration Dialog Box

When Manual Calibration is selected from the Calibration menu bar, the
Manual Calibration... dialog box is displayed with two tab views: Calibration
Factor and Dilution Factor. New calibration factors can be manually entered on the
Calibration Factor tab view.

NOTE: This example of the Dilution Factor page

visible, is only available to users with administrative
privileges.

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Manual Calibration Primary Mode - Open

Using Commercial Calibrator or Whole Blood

Use the following procedures to manually calibrate the instrument in the Open
Mode:
Determining New Calibration Factors
Determining Which Parameters Need Calibration
Entering New Calibration Factors

Determining New Calibration Factors

1. Verify the System is in Open Mode. If the System is in Closed Mode select
the F11Select Open function key to change from Closed to Open Mode.
2. Select Calibration from the menu bar and Manual Calibration from the
pull-down menu to open the Manual Calibration dialog box. The
Calibration Factor tab, which is the default tab, opens and displays the
current calibration factors.
3. Select the Print Scrn key on the keyboard to obtain a printout of the factors.
4. Select Calibration from the menu bar and Quick Precision Check from
the pull-down menu and the Quick Precision Check dialog box opens.
5. Use commercial calibrator or assayed whole blood, following directions set
forth in this step.
Commercial Calibrator
a. Follow the mixing instructions found in the package insert.
b. Enter the Calibrator Lot Number in the <Specimen ID> field and run the
calibrator a minimum of 6 times.
c. Select the Print button to obtain a printout of the mean values to be used
with Worksheet 1 Open Mode Calibration - New Factors.
Assayed Whole Blood
a. Obtain the same five specimens used to obtain the reference values.
b. Mix well by gently inverting the tube a minimum of ten times. Do not
shake the specimen.
c. Run each specimen twice, entering the Specimen ID in the Specimen ID
field as each is being run.
d. Select the Print button to obtain a printout of the mean values to be used
with Worksheet 1 Open Mode Calibration - New Factors.
6. Using Worksheet 1 Open Mode Calibration - New Factors, provided in
Manual Calibration Worksheets, determine the New Calibration Factor for
each parameter using either commercial calibrator or assayed whole blood.

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For Commercial Calibrator

Using the values on the assay sheet and the CELL-DYN mean values
determined in step 5 above, enter the information in columns 1 and 2
respectively of Worksheet 1 Open Mode Calibration - New Factors,
Open Mode Calibration New Factors, provided in Manual Calibration
Worksheets at the end of this section.
For Assayed Whole Blood
Using the Reference Mean Values determined in Obtaining Whole Blood
Reference Values from a Reference Analyzer described earlier (refer to the
Whole Blood Calibration Reference Values Worksheet) and the CELL-DYN
mean values determined in step 4 above, enter the information in columns 1
and 2 respectively of Worksheet 1, Open Mode Calibration New Factors,
provided in Manual Calibration Worksheets at the end of this section.
7. Using the printout obtained in Step 3 above, enter the Open Calibration
Factors to column 3 of Worksheet 1.
Follow the instructions on Worksheet 1 to calculate the new Open Mode
Calibration Factor for each parameter and enter the information in column
4 of the worksheet.
The method for determining the new factors is:
a. Calibrator Calibration

Assay Value
--------------------------------------------- Current Open Mode = New Open Mode
CELL-DYN Mean Calibration Factor Calibration Factor

b. Whole Blood Calibration

Reference Mean - Current Open Mode = New Open Mode
--------------------------------------------
CELL-DYN Mean Calibration Factor Calibration Factor

For example, if the Reference Mean Value for WOC is 6.6, the CELL-DYN
Mean for WOC is 7.1, and the current Open Mode Calibration Factor for
WOC is 0.98, then:
(6.6 / 7.1) 0.981 = 0.912
and 0.912 is your New Open Mode Calibration Factor for WOC.

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Calibration Procedures Section 6

Determining Which Parameters Need Calibration

To determine which parameters require calibration in the Open Mode, follow the
procedure below using Worksheet 2 Open Mode Factor % Difference and
Worksheet 3 Open Mode Calibration Range Criteria provided in Manual
Calibration Worksheets at the end of this section.
1. Transfer the values from column 4 of Worksheet 1 to the New Open Mode
Factor column 1 of Worksheet 2, Open Mode Factor % Difference.
2. Transfer the values for the Current Open Mode Cal factor from column 3 of
Worksheet 1 and enter these values in columns 2 and 3 of Worksheet 2.
3. Follow the instructions on this worksheet to determine the Factor % Diff for
each parameter.
4. Transfer the Factor % Diff values from column 5 (calculated in Worksheet 2)
to column 1 of Worksheet 3, Open Mode Calibration Range Criteria.
5. For each parameter, if the Factor % Diff is equal to or less than the value in
the Lower Limit column, then CALIBRATION IS NOT REQUIRED for that
parameter because the value is within range.
6. For each parameter, if the Factor % Diff falls between the upper and lower
calibration range, shown in the Calibration Range column, then
CALIBRATION IS REQUIRED.
7. For each parameter, if the Factor % Diff is greater than the value in the
Upper Limit column, there may be a computation error or an instrument
problem. In this case, do the following:
a. Recheck all numbers and calculations on Worksheets 1 and 2.
b. Determine if any component on the instrument was changed. This could
affect calibration. Such components include the Shear Valve, Optical
Flow Cell, Hemoglobin Flow Cell, or one of the syringes.
c. If a component was changed, then treat the result as if it fell within the
calibration range (even though it is greater than the upper limit).
CALIBRATION IS REQUIRED for that parameter.
d. If no component was changed and your calculations are correct, DO
NOT CALIBRATE. Confirm that all Pre-Calibration procedures were
completed and contact your local Country Service representative for
assistance.

Entering New Calibration Factors

Based on the results from Worksheet 3 column 5 and using Worksheet 2 column 1:
For parameter(s) that calibration is required:
1. Select Calibration, Manual Calibration from the menu bar to display the
current calibration factors.
2. Using Worksheet 2 column 1, enter the New Open Mode Factor(s) for the
associated parameter(s) that calibration is required (Worksheet 3 column 5)
in the Open Factor column, Manual Calibration, Calibration Factor tab view.
3. For the parameter(s) updated, copy the Open Factor to the Closed Factor
column to match the Open Factor column, then select the OK button.

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4. Select the System view, Calibration Log tab, and use the F1 Print to
obtain a copy of the Calibration Log.
5. Proceed to Subsection: Post-Calibration Procedures.

If none of the parameters requires calibration:

1. Select Calibration, Manual Calibration from the menu bar to display the
current calibration factors.
2. Enter text in the Comment field, Manual Calibration, Calibration Factor tab
view, indicating no factors require change, then select the OK button.
3. Select the System view, Calibration Log tab, and use the F1 Print to
obtain a copy of the Calibration Log.
4. Proceed to Subsection: Post-Calibration Procedures.

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NOTES

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Post-Calibration Procedures

Confirm calibration by running at least two levels of controls. CELL-DYN Ruby

results should now be within your laboratorys established acceptance range.
(Refer to Section 11: Quality Control for instructions on running controls.) If
control results are not within the acceptable range, troubleshoot accordingly. If
necessary, contact your local Country Service and Support Center for assistance.
Refer to Section 11: Quality Control, Subsection: Guidelines for Running
Controls for information on day-to-day verification of System calibration.

Backing Up Calibration Factors

It is recommended that the calibration factors be printed and saved on backup
media whenever calibration is changed. Each laboratory should establish its own
procedures for determining when to restore the information.

General Concepts and Guidelines

The CELL-DYN Ruby is shipped with an Analyzer Settings media that
contains set points, related Analyzer configuration information, and the
Analyzer serial number.
NOTE: Each backup process requires new media to copy the current
information to. See Section 1: Use or Function, Subsection: Data
Module Computer for details on the type of backup media to use.
Properly label the media and store it in a safe location.
All setup information, including the calibration factors, is backed up from the
hard drive to the media. Individual settings or categories of information
cannot be backed up selectively.

Backup Procedure
The following is the procedure for backing up calibration factors and analyzer
setpoints.
NOTE: Before beginning the backup procedure, printing hard copies of the
Manual Calibration, calibration factors and the Calibration Log is
recommended.

Procedure: Backing Up Calibration Factors

NOTE: A user with admin rights must be logged on to perform this procedure.
1. Verify the Analyzer is in the Ready state.
2. From the menu bar, select File, Backup . The Backup dialog box opens.

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Post-Calibration Procedures Section 6

3. Place a labeled floppy disk in the disk drive.

4. In the Backup to floppy field, select the Start Backup button. The dialog
box will indicate the status.
5. When backup is complete, the message: Backup Completed successfully
displays.
6. Remove the floppy disk from the disk drive and store it in a safe location.

Procedure: Restoring Calibration Factors

NOTE: A user with admin rights must be logged on to perform this procedure.
1. Verify the Analyzer is in the Ready state.
2. Insert the floppy disk containing calibration factors into the floppy drive.
3. From the menu bar, select File, Restore . The Restore dialog box opens.

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4. In the Restore from floppy field, select the Start Restore button.
5. After all files are restored a message box appears:
Application will close to complete the restore. Restart the application to
continue.
6. Remove the floppy and select Yes. The application will close. The system
will reboot and restart.
NOTE: For the procedure to backup/restore System Data including the Data Log,
refer to Section 5: Operating Instructions, Subsection: Post-Analysis
Processing Datalog View.

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Post-Calibration Procedures Section 6

Manual Calibration Worksheets

Four worksheets are provided to assist in the calculation of calibration factors for
the CELL-DYN Ruby System. Three worksheets are designed for the Open Mode
procedure and one worksheet for calibration verification.
Worksheet 1 Open Mode Calibration New Factors
Worksheet 2 Open Mode Factor % Difference
Worksheet 3 Open Mode Calibration Range Criteria
Worksheet 4 Calibration Verification
Make copies of these worksheets as necessary.

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Worksheet 1 Open Mode Calibration - New Factors

Instrument:________________________ Date: ________________ Operator:____________

Calculate All Factors To Three Decimal Places

(1) (3) (4)

(2)
Assay Value Current New (5)
/ Open Mode x =
or Open Mode Open Mode Range
Mean
Ref Mean Cal Factor Cal Factor

WOC / x = 0.7001.300

NOC / x = 0.7001.300

RBC / x = 0.8001.200

HGB / x = 0.7001.300

MCV / x = 0.7001.300

PLT / x = 0.7001.300

1. In column 1, enter the calibrator assay values or the whole blood reference means that were used in the
calibration process. Use the same WBC Reference Value for WOC and NOC.
2. In column 2, enter the mean values calculated in the Quick Precision Check... dialog.
3. In column 3, enter the current Open Factor calibration factors from the Manual Calibration... dialog print
screen.
4. For each parameter, divide the value in column 1 by the value in column 2 and multiply the result by the
value in column 3.
5. The value calculated in step 4 is the new calibration factor. Write this value in column 4.
6. Compare the new calibration factor in column 4 with the range shown in column 5. If the new factor falls
within the range, go to Worksheet 2. If the new factor falls outside the range, check all calculations. If
necessary, run the samples again into a new Quick Precision Check dialog and perform new calculations.

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Worksheet 2 Open Mode Factor % Difference

Instrument:________________________ Date: ________________ Operator:____________

Calculate All Factors To Three Decimal Places

(1) (2) (3) (4) (5)

New Open Current Open / Current Open Factor
Mode Factor Mode Factor Mode Factor x 100 = % Diff

WOC / x 100 =

NOC / x 100 =

RBC / x 100 =

HGB / x 100 =

MCV / x 100 =

PLT / x 100 =

1. In column 1, enter the new factor calculated in column 4 of Worksheet 1.

2. In columns 2 and 3, enter the current Open Factor calibration factors from the Manual Calibration...
dialog print screen.
3. Subtract the current factor in column 2 from the new factor in column 1, divide the result by the current
factor in column 3, multiply the result by 100 and enter the result in column 5.

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Worksheet 3 Open Mode Calibration Range Criteria

Instrument:________________________ Date: ________________ Operator:____________

(1) (2) (3) (4) (5)

Factor Lower Limit Calibration Range Upper Limit
% Diff Cal Not Required Cal Required Do Not Cal Cal? Y/N

WOC <1.5% >1.5% but <10% >10%

NOC <1.5% >1.5% but <10% >10%

RBC <1.0% >1.0% but <10% >10%

HGB <1.0% >1.0% but <10% >10%

MCV <1.0% >1.0% but <10% >10%

PLT <3.0% >3.0% but <15% >15%

1. In column 1, enter the new Factor % Diff from column 5 of Worksheet 2 (disregard the sign).
2. If the new Factor % Diff exceeds the limit in column 4, DO NOT CALIBRATE. Confirm that all Pre-
Calibration procedures were completed, review Determining Which Parameters Need Calibration and
contact your local Country Service and Support Center for assistance.

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Post-Calibration Procedures Section 6

Worksheet 4 Calibration Verification

Instrument Serial Number Software Version:____________Date: ________________Operator ID ______________

Part 1 Primary Mode:

Using: Commercial Calibrator Sampling Mode: Open Mode Results within tolerance: Pass
Whole Blood Closed Mode Fail
Sample # WOC NOC RBC HGB MCV PLT

Mean Value of Runs

Reference or Assay Value

Difference (absolute value)

Tolerance Limits *
* For Calibrator, use the pre-established tolerance limits found on the Calibrator Assay sheet. The Calibration value is for Open Mode use only. For Whole
Blood, each laboratory should establish tolerance limits according to its protocol.

Part 2 Secondary Mode:

Using: Commercial Calibrator Sampling Mode: Open Mode Results within tolerance: Pass
Whole Blood Closed Mode Fail
Sample # WOC NOC RBC HGB MCV PLT

Mean Value of Runs

Reference or Assay Value

Difference (absolute value)

Tolerance Limits *
* For Calibrator, use the pre-established tolerance limits found on the Calibrator Assay sheet. The Calibration value is for Open Mode use only. For Whole
Blood, each laboratory should establish tolerance limits according to its protocol.

1. Enter the mean value from the Quick Precision Check... for commercial calibrator or whole blood runs.
2. Enter the reference values or assay values used to calibrate those parameters.
3. Calculate and enter the Difference (absolute value) between the Mean and Reference or Assay Value.
4. Enter the Tolerance Limits and compare the Difference with the Tolerance Limits.
5. If the Difference is within the limit, continue to complete calibration verification by running at least two
levels of Quality Control specimens and verify to be within acceptable limits prior to reporting patient
results.
6. If the Difference is outside the limits, recheck all numbers and calculations and contact your local Country
Service and Support Center for assistance.

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References

1. International Committee for Standardization in Haematology (ICSH).

Protocol for Evaluation of Automated Blood Cell Counters. Clinical and
Laboratory Hematology 1984; 6:69-84.
2. Clinical and Laboratory Standards Institute (CLSI). Procedure for
Determining Packed Cell Volume by the Microhematocrit Method; Approved
Standard - Third Edition. CLSI Document H7-A3
[ISBN 1-56238-413-9]. CLSI, 940 West Valley Road, Suite 1400, Wayne,
Pennsylvania 19087-1898 USA, 2000.

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References Section 6

NOTES

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 Section 7 Operational Precautions and Limitations

Section 7 Operational Precautions and Limitations

Overview

The CELL-DYN Ruby is designed for in vitro diagnostic use only.

This section addresses operational requirements, precautions, and limitations to
ensure operator safety and accurate test results. Failure to follow these
requirements or take these precautions may cause damage to the system, impact
system performance or adversely affect results, or present a hazard to the operator.
Operational precautions and limitations topics include:
General requirements
Lists the requirements for system environment, maintenance, and
troubleshooting to ensure proper system performance.
Precautions and requirements for system operation
Lists the precautions you should take and the requirements you should follow
before and during system operation.
Requirements for handling consumables
Lists the requirements for storing and using consumables such as reagents,
calibrators, and controls.
Requirements for handling specimens
Lists the requirements for collecting, preparing, and storing specimens.
Interfering Substances and Conditions
Limitations of result interpretation
Discusses the other factors you should consider when interpreting patient test
results.

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Overview Section 7

General Requirements
You MUST follow these general CELL-DYN Ruby System requirements to help
ensure proper system performance:
Contact your Abbott representative to install your CELL-DYN Ruby System.
The CELL-DYN Ruby instrument employs a Microsoft Windows Operating
System. Any software added to the system other than specified by Abbott
Laboratories may interfere with the correct function of the analyzer and is not
recommended.
Do not save any files to the Data Station hard drive, as it may affect
instrument performance.
Ensure the system is out of direct sunlight, heat and drafts, and away from
any heat-generating device. Exposure to heat and drafts can interfere with the
ability of the system to maintain an operating temperature that is within the
acceptable range.
Place the CELL-DYN Ruby Analyzer on a hard, level surface. Maintain the
required space on all sides of the system. For more information about space
requirements, see Section 4: Performance Characteristics and
Specifications, Subsection: Clearance Requirements. This clearance is
essential for:
Adequate ventilation and cooling of electrical components
Easy access for maintenance
Easy access for disconnecting the power cord when required
Place the CELL-DYN Ruby Analyzer away from centrifuges, hand-held
mobile radios, x-ray equipment, cell phones, and copiers.
NOTE: The CELL-DYN Ruby has been evaluated to EN 55011 and
EN 61000 for electromagnetic emissions and immunity,
respectively.

Do not use devices that transmit radio frequency in the same room as the
instrument.
Leave the system power on continuously unless instructed otherwise in a
maintenance or troubleshooting procedure, or unless an emergency situation
occurs.
Ensure Analyzer waste line is connected to the appropriate Analyzer outlet
and is routed to a suitable waste container or drain.
If an external waste container is used, ensure that the top of the external waste
container is placed below the bottom of the Analyzer.
WARNING: Potential Biohazard. If the System is allowed to go into
Standby after performing the Auto-Clean procedure and the instrument is
connected to an external waste container, verify that the waste container is
at least two-thirds empty prior to running the Auto-Clean procedure.

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Section 7 Operational Precautions and Limitations

If a drain is used for waste, ensure that the Waste Outlet Tube is secured in
the drain hole. Ensure that System components are located away from
potential waste overflow.
Perform maintenance procedures as recommended in Section 9: Service and
Maintenance.
Do not attempt any maintenance or repairs that are not specified in
documentation provided by Abbott Laboratories. An Abbott-authorized
representative must perform all major service work or the warranty could be
voided.
CELL-DYN Ruby components are designed specifically for use with the
CELL-DYN Ruby. Substitution of unauthorized components may adversely
affect the performance of the system.

Precautions and Requirements for System Operation

You MUST take these precautions and follow these requirements when operating
the CELL-DYN Ruby System. Failure to do so may cause damage to the system
and may adversely affect test results.

Precautions Before Operation

Before you begin operating the system, you should:
Read this manual thoroughly to understand the full functionality of the
system and associated hazards.
Read the sections of the reagent manufacturers documentation (such as a
package insert) specific to:
Warnings and precautions
Safety precautions
Handling precautions

Requirements Before Operation

Before you begin operating the system:
DO NOT run open tubes in the Closed Mode.
DO NOT change Calibration or Dilution Factors, or any values in the
Setpoint Entry dialog box unless specifically requested to do so by an
authorized Abbott representative.
Ensure that Auto Background and background counts are within acceptable
limits before running controls and patient specimens.
Specimens run in the Open Mode must be premixed according to your
laboratorys procedure. Specimens collected in micro-collection tubes should
be premixed according to the collection device manufacturers
recommendations.

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Operational Precautions and Limitations
Overview Section 7

WARNING: DO NOT use any Specimen ID for a hematology specimen

that contains any of the following characters: ~, |, \, ^, and &.
These characters will cause the Specimen ID to be truncated at the point
where the character is located within the ID. This action will result in an
erroneous Specimen ID for the downloaded Pending Orders entry or for the
record received by the LIS, without any error notification.

Precautions During Operation

While operating the system, take the following precautions:
Keep all instrument covers in place unless instructed otherwise in a
maintenance or troubleshooting procedure.
Do not disconnect any electrical connection while the power is on.
Respond to system initiated messages relating to waste levels during
processing. Dispose of all liquid waste according to local, state, and federal
regulations.
WARNING: Potential Biohazard. If the System is allowed to go into
Standby after performing the Auto-Clean procedure and the instrument is
connected to an external waste container, verify that the waste container is
at least two-thirds empty prior to running the Auto-Clean procedure to
prevent an overflow of waste.

Do not select any menu bar options unless specifically requested to do so in

this manual or by an authorized Abbott representative.
Do not select any Diagnostic menu bar options unless specifically requested
to do so in this manual or by an authorized Abbott representative.

Requirements for Handling Consumables

You MUST follow these requirements when handling consumables to help ensure
your safety and accurate assay results. See the reagent (such as a package insert,
product label, or Material Safety Data Sheet (MSDS) for detailed information. For
a description of the hazard symbols, see Section 8: Hazards.

Requirements for Storage

Follow these requirements for storing reagents, calibrators, and controls:
Store reagents, calibrators, and controls according to directions in the
manufacturers documentation (such as a package insert or label
recommendation).
Protect reagents from extreme heat and freezing during storage.
Temperatures below 0 C (32 F) can cause layering, which changes the
tonicity and conductivity of the reagent. Do not use reagents that have been
frozen.
Contact your Abbott Country Service and Support Center if you receive
reagents, calibrators, or controls that are in a condition contrary to the
products documentation (such as a package insert or label recommendation),
or that are damaged.

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Section 7 Operational Precautions and Limitations

Requirements for Use

Follow these requirements for using reagents, calibrators, and controls:
Do not substitute. Substitution of materials may affect CELL-DYN Ruby
System performance, results, safety, and equipment life.
Keep the tops of the reagent containers lower than the bottom of the
Analyzer.
Keep reagents away from direct sunlight and protect them from evaporation.
Use the reagent container cap attached to each inlet tube. The cap will
minimize evaporation and contamination.
Use caution when handling reagents, calibrators, and controls to prevent
contamination and operator exposure.
Refer to the manufacturers documentation for reagent, calibrator, and
control temperature requirements and handing instructions prior to using the
product on the CELL-DYN Ruby.
Wear clean gloves to avoid contamination and operator exposure when
removing and replacing the reagent inlet lines in uncapped reagent
containers.
Never add reagent from one container to that in another.
Do not smoke, eat, drink, apply cosmetics, or handle contact lenses in areas
where specimens, reagents, calibrators, and controls are handled.
Do not use reagents, calibrators, and controls beyond their expiration dates.
Do not mix reagents, calibrators, and controls within a lot or between lots.
Verify the lot number and expiration date of the Reticulocyte Reagent
according to the manufacturers documentation (such as package insert)
before Open Mode use on the CELL-DYN Ruby.

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Operational Precautions and Limitations
Overview Section 7

Requirements for Handling Specimens

Consider all clinical specimens, reagents, calibrators, and controls that contain
human-sourced materials as potentially infectious. Consider all system surfaces or
components that have come in contact with human-sourced materials as potentially
infectious. Refer to Section 8: Hazards, for additional information.
WARNING: Potential Biohazard. Identifies an activity or area where
you may be exposed to potentially infectious material.

Collect all specimens according to your laboratorys procedures, following the

recommendations of the collection tube manufacturer. Follow all usual precautions
while collecting blood by venipuncture or capillary puncture to avoid clotting
and/or specimen hemolysis.

Requirements for Preparation and Storage

Follow these requirements for preparing and storing specimens:
The following specimen collection tube dimensions are recommended for
use in the Closed mode:
Table 7.1 Recommended Collection Tube Dimensions for Use in Closed Mode

Collection Tube Dimensions Rack

11.5-13 mm diameter x 65-75 mm long Refer to Appendix A -

CELL-DYN Ruby Parts
and Accessories for
rack information.
NOTE: To ensure satisfactory operation, no other specimen tube dimensions are
recommended for use in the Closed Mode. All other dimensions should
be run in the Open Mode. Refer to Section 4: Performance
Characteristics and Specifications, Subsection: Recommended
Specimen Collection Tubes (Closed Mode).

All performance claims given in this manual were generated using specimens
collected in K2EDTA. Results may be affected by the use of other
anticoagulants. Each laboratory should develop protocols for handling
specimens collected in anticoagulants other than K2EDTA.
In the Closed mode, ensure that the specimen volume is at least 1.2 mL in
standard collection tubes. Refer to Section 4: Performance Characteristics
and Specifications, Subsection: Recommended Specimen Collection Tubes
(Closed Mode).
In the Open mode, ensure that the specimen volume is at least 0.5 mL (500L)
in standard collection tubes, and 0.18 mL (180L) in micro-collection tubes.
Refer to Section 4: Performance Characteristics and Specifications,
Subsection: Recommended Volume Requirements in Specimen Collection
Tube.

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Section 7 Operational Precautions and Limitations

Use fresh, whole blood specimens to achieve the most reliable result data.
The International Committee for Standardization in Haematology (ICSH)
defines a fresh blood specimen as one processed within four hours after
collection1.
Specimen stability after collection of venous whole blood:
Specimens run within eight hours of collection:
Room Temperature storage is recommended
Specimens run more than eight hours after collection:
Refrigerated (2 8 C) storage is recommended
Any refrigerator-stored specimens should be brought to room temperature
before mixing and processing.
Stability studies show that when specimens stored at room temperature
before mixing and processing, average results for the WBC, RBC, HGB,
MCV and PLT are stable (5.4%) for up to 24 hours after collection. An
increase in false-positive Suspect Population Flags may be seen on
samples processed more than 4 hours after collection time.
For information on specimen stability for specimens collected using
micro-collection devices, refer to the collection tube manufacturers
package insert.

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Operational Precautions and Limitations
Overview Section 7

Interfering Substances and Conditions

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 Ruby has been designed to detect and flag many of these substances,
it may not always be possible to do so. The following indicates some of the
substances that may interfere with each of the listed parameters.
WBC: Fragile WBC, neutrophil aggregates, lytic-resistant RBC, NRBC, PLT
clumps, cryofibrinogen, cryoglobulin, paraproteins
RBC: Elevated WBC count, increased numbers of giant PLT, autoagglutination, in
vitro hemolysis
HGB: Elevated WBC count, increased plasma substances (triglycerides, bilirubin,
in vivo hemolysis), lytic-resistant RBC
MCV: Elevated WBC count, hyperglycemia, in vitro hemolysis, increased
numbers of giant PLT
PLT: WBC fragments, in vitro hemolysis, microcytic RBC, cryofibrinogen,
cryoglobulins, PLT clumping, increased numbers of giant PLT
NOTE: This list is neither all-inclusive or non-exclusive. All potential interferents
have not been formally tested by Abbott. It is important to note that there
are commonly-occurring interfering substances that can affect the results
reported by hematology analyzers. See Appendix B: Potential Causes of
Spurious Results for a list of potential causes of spurious results with
automated hematology analyzers.

For a detailed description of the flags that are generated, refer to Section 3:
Principles of Operation, Subsection: Operational Messages and Data Flagging.

Limitations of Result Interpretation

The CELL-DYN Ruby has been validated for its intended use. However, error can
occur due to potential operator errors and CELL-DYN Ruby System technology
limitations. Results obtained on the CELL-DYN Ruby MUST be used with other
clinical data, for example, symptoms, other test results, patient history, clinical
impressions, information available from clinical evaluation, and other diagnostic
procedures. All data MUST be considered for patient care management. If the
results are inconsistent with clinical evidence, additional testing is suggested to
confirm the result.

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Section 7 Operational Precautions and Limitations

Reference

1. International Committee for Standardization in Haematology (ICSH).

Protocol for Evaluation of Automated Blood Cell Counters. Clinical and
Laboratory Hematology 1984; 6:69-84.

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Operational Precautions and Limitations
Reference Section 7

NOTES

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 Section 8 Hazards

Section 8 Hazards

Overview

This section provides information on potential hazards to personnel and potential

damage to the laboratory environment.
Hazard and safety topics include:
Safety icons
Provides an illustration of each safety icon and sample text associated with
the icon.
Laser caution labels
Provides an illustration of the caution labels found on the system.
Hazard symbols
Provides an illustration of each hazard symbol and a description along with
its standard abbreviation.
Biological and chemical hazards
Provides an overview of the biological and chemical hazards you may be
exposed to and the precautions you should take to minimize exposure to these
hazards.
Electrical hazards
Provides an overview of precautions you should take to avoid personal injury
or damage to the system from its electrical components.
Mechanical hazards
Provides an overview of the precautions you should take to avoid personal
injury or damage to the system from its mechanical components.
Physical hazards
Provides an overview of the precautions you should take to avoid physical
injury when operating or moving the system.

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Hazards
Overview Section 8

Operator Responsibility
You are responsible for using the CELL-DYN Ruby System only as designed.
Operators must be trained before being allowed to operate the system. Failure to
follow safe-use instructions could cause personal injury, damage to the system, or
could adversely affect results. See also Section 7: Operational Precautions and
Limitations.

Safety Icons
Safety icons in this manual and on the CELL-DYN Ruby identify potentially
dangerous conditions. You MUST recognize the icons and understand the type and
degree of potential hazard they represent.
The following icons may be used with text or in lieu of text. If text accompanies
the icons, it describes the nature of the hazard and is labeled with WARNING or
CAUTION.
WARNING: is defined as a physical, mechanical, or procedural condition that
could result in moderate to serious personal injury.

CAUTION: is defined as a condition that could result in minor injury or interfere

with proper functioning of the system.

Table 8.1 Safety Icons and Descriptions

Icon Hazard Description

WARNING: Potential Biohazard Identifies an activity or area where operators may be
exposed to potentially infectious material.
WARNING: Electrical Shock Indicates the possibility of electrical shock if
Hazard procedural or engineering controls are not observed.
CAUTION: Class 3B laser light Warns against direct viewing of the beam or
when open. Avoid exposure to beam. reflections from the beam.
CAUTION: Identifies an activity that may present a safety related
hazard, and advises you to consult the associated
caution or warning instructions provided.

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Section 8 Hazards

Laser Caution Labels

Laser caution labels must not be removed and are to be kept legible. If label(s)
become illegible, notify your Country Service and Support Representative. The
following labels shown consist of black lettering against a yellow background and
are affixed to the CELL-DYN Ruby. See Figure 8.3 for an illustration depicting
laser label placement.

CLASS 1 LASER PRODUCT/

Lasergert der Klasse 1/
Produit laser de classe 1/Lser de
clase 1/Prodotto laser di classe 1/
Produto laser da classe 1/Klasse 1-
laserprodukt/Klass 1 laserprodukt/
1 PN 9230702C

Figure 8.1 Class 1 Laser Product Label

The label is affixed on the rear panel of the instrument.

CAUTION Class 3B laser light when open. Avoid

exposure to beam.
VORSICHT Bei offener Abdeckung Laserstrahlung der
Klasse 3B. Nicht direkt in den Laserstrahl blicken.
ATTENTION Rayon laser de classe 3B si ouvert. Eviter
toute exposition au faisceau laser.
PRECAUCIN: Haz de lser de clase 3B. Evite la
exposicin al lser cuando el analizador est abierto.
ATTENZIONE: fascio laser di classe 3B se aperto. Evitare
lesposizione al raggio.
ATENO Quando aberto, emite luz laser da classe
3B. Evitar a exposio ao raio laser.
VIGTIGT: Klasse 3B-laserlys ved bning. Undg
eksponering for strlen.
VIKTIGT: Klass 3B laserljus nr luckan r ppen. Undvik
exponering f r strlen.
3
.
.
UPOZORNN: Po oteven krytu nebezpe ozen
laserem tdy 3B. Vyvarujte se kontaktu s paprskem.
PN 9230701F

Figure 8.2 Laser Warning Label

The label is affixed to the upper left front flow panel and inside the Analyzer on top
of the optics protective cover of the optics bench assembly.

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Overview Section 8

CAUTION Class 3B laser light when open. Avoid

exposure to beam.
VORSICHT Bei offener Abdeckung Laserstrahlung der
Klasse 3B. Nicht direkt in den Laserstrahl blicken.
ATTENTION Rayon laser de classe 3B si ouvert. Eviter
toute exposition au faisceau laser.
PRECAUCIN: Haz de lser de clase 3B. Evite la
exposicin al lser cuando el analizador est abierto.
ATTENZIONE: fascio laser di classe 3B se aperto. Evitare
lesposizione al raggio.
ATENO Quando aberto, emite luz laser da classe
3B. Evitar a exposio ao raio laser.
VIGTIGT: Klasse 3B-laserlys ved bning. Undg
eksponering for strlen.
VIKTIGT: Klass 3B laserljus nr luckan r ppen. Undvik
exponering f r strlen.
3
.
.
UPOZORNN: Po oteven krytu nebezpe ozen
laserem tdy 3B. Vyvarujte se kontaktu s paprskem.
PN 9230701F

Figure 8.3 CELL-DYN Ruby System Laser Caution Labeling

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Section 8 Hazards

Hazard Symbols
CELL-DYN Ruby product labeling may include the following hazard symbol. The
symbol conveys properties of the chemical or chemical mixture, and notifies you
that you should take precautions when working with the material.

Table 8.2 Hazard Symbol

Hazard Symbol Description (with Standard Abbreviation)

This symbol indicates that some of the component(s) in the product has Harmful (Xn) or
Irritant (Xi) properties.

Biological and Chemical Hazards

You may be exposed to biological materials and hazardous chemicals while using
the CELL-DYN Ruby. The following information is presented to help you
minimize the likelihood and degree of impact of any such exposure.
Biological and chemical hazard topics include:
Biological hazards
Chemical hazards
Spill clean-up
Waste handling and disposal
Decontamination procedure requirements

Biological Hazards
The following activities may involve the presence of biological materials:
Handling patient specimens, reagents, calibrators, and controls
Cleaning spills
Handling and disposing of waste
Moving the system
Performing maintenance procedures
Performing decontamination procedures
Performing component replacement procedures
WARNING: Potential Biohazard. Identifies an activity or area where
you may be exposed to potentially infectious material.

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Overview Section 8

Precautions
You should consider all clinical samples, reagents, calibrators, and controls that
contain human-sourced material as potentially infectious. You should consider all
system surfaces or components that have come in contact with human-sourced
material potentially infectious. No known test method can offer complete
assurance that products derived from human-sourced material will not transmit
infection. Therefore, all products derived from human-sourced materials and
system components exposed to human-sourced materials should be considered
potentially infectious.
It is recommended that you handle all potentially infectious materials in
accordance with the Standard on Bloodborne Pathogens1. You should use
Biosafety Level 22 or appropriate biosafety practices3,4 for materials that contain or
are suspected of containing infectious agents. Precautions include, but are not
limited to, the following:
Wear gloves, lab coats, and protective eye wear when handling human-
sourced material or contaminated system components.
Do not pipette by mouth.
Do not eat, drink, smoke, apply cosmetics, or handle contact lenses when
handling human-sourced material or contaminated system components.
Clean spills of potentially infectious materials and contaminated system
components with an appropriate disinfectant, such as 0.5% sodium
hypochlorite, refer to Section 9: Service and Maintenance, Subsection:
Decontamination Procedures.
Decontaminate and dispose of all specimens, reagents, calibrators, controls,
and other potentially contaminated materials in accordance with local, state,
and federal regulations.
If you are exposed to biohazardous or potentially infectious materials, you should
seek medical attention immediately and take steps to cleanse the affected area.

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Section 8 Hazards

Chemical Hazards
You may be exposed to hazardous chemicals when handling reagents, calibrators,
and controls.
Your exposure to hazardous chemicals is minimized by following instructions
provided in the manufacturers documentation (such as the product insert), on
product labels, and on product-specific Material Safety Data Sheets (MSDS).
Precautions
In general, observe the following precautions when handling chemicals:
Consult MSDS for safe-use instructions and precautions.
Avoid contact with skin and eyes. If contact with material is anticipated, wear
impervious gloves, protective eye wear and clothing.
Maintain good housekeeping. Do not eat, drink, or store food and beverages
in areas where chemicals are used.
Seek medical attention if irritation or signs of toxicity occur after exposure.
Hazard symbols that appear on CELL-DYN Ruby product labeling are
accompanied by risk (R) and safety (S) numbers and represent risk and safety
phrases defined by European Community Directives. The risk and safety phrases
describe precautions you should use when working with a particular chemical or
chemical mixture.

Spill Clean-Up
Clean spills in accordance with established biosafety practices. In general, use
these safe work practices for cleaning spills:
1. Wear appropriate personal protective equipment.
2. Absorb the spill with absorbent material.
3. Wipe the spill area with detergent cleaning solution.
4. Wipe the area clean with an appropriate disinfectant such as 0.5% sodium
hypochlorite, refer to Section 9: Service and Maintenance, Subsection:
Decontamination Procedures. Allow at least 10 minutes of contact time
before wiping the area.
5. Dispose of spilled and contaminated material in accordance with local, state,
and federal regulations.

Waste Handling and Disposal

Dispose of all waste materials in accordance with local, state, and federal
regulations.
It is the responsibility of each facility to label all waste containers and to
characterize its waste stream to ensure the waste is disposed in accordance with the
appropriate waste disposal regulations.

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Overview Section 8

Decontamination Procedure Requirements

The CELL-DYN Ruby must be decontaminated before shipment or relocation.
Always wear appropriate personal protective equipment while performing
decontamination activities. Refer to Section 9: Service and Maintenance,
Subsection: Decontamination Procedures for procedures that describe
preparation for shipment and decontamination.

Electrical Hazards
The CELL-DYN Ruby does not pose uncommon electrical hazards to operators if
it is installed and operated without alteration, and is connected to a power source
that meets required specifications. See Section 4: Performance Characteristics
and Specifications, Subsection: Power Specifications.
The electrical circuit spacing of the CELL-DYN Ruby is based on pollution degree
(2) and altitude [up to 2000 M (6500 ft)] as per IEC 61010-15. Pollution degree 2
is defined as an environment where normally only non-conductive pollution
occurs. Occasionally, however, a temporary conductivity caused by condensation
must be expected.

Electrical Safety
WARNING: Indicates the possibility of electrical shock if procedural or
engineering controls are not observed.

Basic electrical hazard awareness is essential to the safe operation of any system.
Only qualified personnel should perform electrical servicing. If the instrument is
used or modified in a manner not specified by the manufacturer, the protection
provided by the instrument may be impaired.
Elements of electrical safety include, but are not limited to, the following:
Inspect electrical cabling into and on the CELL-DYN Ruby for signs of wear
and damage.
Use only approved power cords and electrical accessories, such as those
supplied with the system, to protect against electric shock.
Use a properly grounded electrical outlet of correct voltage- and current-
handling capability.
Do not disconnect any electrical connection or service any electrical or
internal components while the power is on.
Keep liquids away from all electrical or communication component
connectors.
Do not touch with wet hands any switches or outlets.
Keep the floor under and around the CELL-DYN Ruby dry and clean.
Clean spilled fluids immediately.

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Section 8 Hazards

Mechanical Hazards
The CELL-DYN Ruby is an automated system that operates under computer
control. As with most automated equipment, there is potential for injury and bodily
harm from moving mechanical components whenever the system is in operation.
The CELL-DYN Ruby minimizes mechanical hazards by providing protective
covers, protection guards, and encoding the software with safety features to protect
against accidental contact with mechanical and moving components.
The CELL-DYN Ruby requires accurate placement of all samples, reagents,
calibrators, and controls on the system. It is very important that reagent tubes,
patient specimens, calibrators, and controls are accurately placed in the sample
loader racks or presented to the system, as described in Physical Hazards, before
initiating any operation. It is NEVER acceptable to attempt to reach into the
processing area when the system is in operating mode. Should operator
intervention be necessary during a run, interrupt the run according to instructions
defined in Section 5: Operating Instructions, Subsection: Interruption
Procedures.

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Hazards
Overview Section 8

During operation of the CELL-DYN Ruby, the operator is potentially exposed to the following:

Moving Mechanical Components:

Sample Loader
Wash Block Open Mode Probe
Syringe Drive Assemblies
Peristaltic Transfer Pumps
Shear Valve Assembly
Y-Valve Assembly
Fan

Mechanical Components:
Tube Spinner Assembly
Wash Block - Closed Mode Needle
Mixhead Assembly
Basic elements of mechanical safety include:
Never bypass or override a safety device.
Keep all protective covers in place.
Never allow any part of the body to enter the region of movement of any
mechanical component when the system is operating.
Never perform manual tasks on the surface of the system.
Open or remove covers only as directed during scheduled and as-needed
maintenance, and component troubleshooting and consumable removal and
replacement procedures described in Section 9: Service and Maintenance
and Section 10: Troubleshooting and Diagnostics. If covers are opened
when access is not indicated, the mechanical components do not stop
moving.
Wear powder-free gloves when operating the instrument and when
performing maintenance or service procedures.
Use caution when loading racks on to the sample loader. Do not run open
tubes in the Closed Mode.
Use caution when performing maintenance, cleaning, or consumable
removal and replacement procedures, always using protective equipment
when specified.
Do not wear long hair loose or articles of clothing or accessories that could
catch on the system.
Keep pockets free of items that could fall into the system.
In the event of a system malfunction or an unexpected sequence of
movements, operator reflex actions could occur and cause injury.

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Section 8 Hazards

Physical Hazards
Safe practices should be observed to avoid physical injury in the following
situations:

Aspiration Probes (Open Mode Probes) and

Vent Needles (Closed Mode Needles)
WARNING: Potential Biohazard. Aspiration probes and vent needles
are potentially contaminated with infectious material. Vent needle tips are
sharp; avoid contact with needle tips. Avoid contact with the tips of probes.

Dispose of aspiration probes and vent needles in an appropriately labeled,

puncture-resistant, and leakproof container before treatment and disposal.

Exposure to Laser Light

The CELL-DYN Ruby is a Class 1 (Class l) Laser Product per IEC 60825-16;
however, it contains a Class 3 B laser.
CAUTION: Class 3 B Laser Light when open. Avoid exposure to beam.

CAUTION: Use of controls or adjustments or performance of procedures

other than those specified herein may result in hazardous laser light
exposure.

During normal operation, the Optics bench assembly resides inside an inner
protective cover. The inner protective cover is to remain in place to prevent laser
light exposure from the Optics bench. The inner protective cover is to be removed
only during servicing by a qualified Abbott Service Representative. The
Helium-Neon laser power up to 10 mW continuous wave at 632.8 nm is a beam
with a 1 mR divergence, could be accessible in the interior of the optics bench. Do
not look directly into the laser beam or any reflections of the beam from a mirror-
like surface. This amount of energy, with insignificant attenuation over distance, is
sufficient to cause eye damage.

Heavy Objects
CAUTION: Identifies an activity where you may be required to lift or
move a heavy object. Use proper lifting techniques.

The CELL-DYN Ruby Reagent containers are heavy when full. Use proper lifting
techniques to reduce the risk of injury when handling the containers.
The CELL-DYN Ruby is heavy. Ensure that you have adequate help before
attempting to move the system.

Tripping Hazard
The CELL-DYN Ruby is equipped with power cords and various computer
connectors. To avoid a tripping hazard, ensure that cords in high traffic areas are
properly stowed.

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Overview Section 8

NOTES

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Section 8 Hazards

References

1. US Department of Labor, Occupational Safety and Health Administration, 29

CFR Part 1910.1030, Occupational Exposure to Bloodborne Pathogens.
2. US Department of Health and Human Services. Biosafety in Microbiological
and Biomedical Laboratories, Fourth Edition. Washington, DC: US
Government Printing Office, May 1999.
3. World Health Organization. Laboratory Biosafety Manual. Geneva: World
Health Organization, 1993.
4. Clinical and Laboratory Standards Institute. Protection of Laboratory
Workers from Occupationally Acquired Infections; Approved Guideline
Second Edition. CLSI document M29-A2 (ISBN 1-56238-453-8). CLSI, 940
West Valley Road, Suite 1400, Wayne, PA 19087-1898, 2001.
5. IEC 61010-1, International Electrotechnical Commission World
Standards for Electrical and Electronic Engineering, 61010: Safety
Requirements for Electrical Equipment for Measurement, Control, and
Laboratory Use, 61010-1 (2001) Part 1: General Requirements.
6. IEC 60825-1, International Electrotechnical Commission World
Standards for Electrical and Electronic Engineering, 60825: Safety of
Laser Products, 60825-1 (1993) Part 1: Equipment Classification,
Requirements, and Users Guide.

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Hazards
References Section 8

NOTES

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 Section 9 Service and Maintenance

Section 9 Service and Maintenance

Overview

The CELL-DYN Ruby is designed to require minimal routine maintenance.

However, it is important to regularly perform the recommended maintenance
procedures to ensure instrument precision, accuracy, and reliability. Performing
these maintenance procedures will do the following:
Maximize data reliability
Minimize downtime
Aid in problem prevention and troubleshooting
Preventive maintenance of equipment under warranty will be performed by a
trained Abbott representative. Customers with questions concerning maintenance
can call the local Country Service and Support Center.
This section of the manual provides:
A schedule of recommended service and maintenance procedures
A description of the service and maintenance software windows
Step-by-step instructions for performing service and maintenance procedures
For information on parts and accessories, refer to Appendix B: Potential Causes
of Spurious Results. Refer to Section 1: Use or Function for additional
illustrations of instrument components.

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Overview Section 9

NOTES

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Section 9 Service and Maintenance

Recommended Service and Maintenance Schedule

Perform the scheduled procedures at the intervals recommended in the following

tables; perform the as-needed procedures as indicated by laboratory needs. For
instructions on performing the procedures, refer to Subsection: Scheduled
Maintenance Procedures, As-Needed Maintenance Procedures within this
section.
WARNING: Potential Biohazard. Consider all specimens, reagents,
calibrators and controls or other materials that contain or contacted human-
sourced material as potentially infectious. Wear lab coats, protective
eyewear and gloves. Follow biosafety practices as specified in the OSHA
Bloodborne Pathogen Rule (29 CFR Part 1910.1030) or other equivalent
biosafety practices.

NOTE: After performing most service and maintenance procedures, it is

important to verify instrument performance by running and verifying
control recovery.

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Recommended Service and Maintenance Schedule Section 9

Table 9.1 Scheduled Service and Maintenance Procedures

Daily Procedure Weekly Procedure Monthly Procedures

6001 Auto-Clean 6002 Clean Loader 6003 Inspect Syringes

Components 6005 Replace Transfer Pump
Tubing
6006 Clean Shear Valve
6007 Replace Dil/Sheath Filter
6008 Extended Auto-Clean
It is recommended that this scheduled maintenance activity be performed on a weekly basis if your laboratory is running the Reticulocyte
assay.

Table 9.2 As-Needed Service and Maintenance Procedures

As-Needed Procedures

6055 Clean Fan Filter

6051 Clean Bar Code Reader

Window

6052 Clean or Replace Open

Mode Probe

6053 Clean or Replace Closed

Mode Needle

6054 Clean or Replace

Syringe

Table 9.3 Nonscheduled Service and Maintenance Procedures

Nonscheduled Procedures

Decontamination Procedures

Printer Cleaning

Reagent Container
Replacement

Replace Tubing in Normally

Closed (NC) Valves

Unclogging Open Mode Probe

Vacuum Accumulator 1 and 2

Rinsing Procedure

NOTE: The list of Nonscheduled maintenance tasks that the operator may perform are not based on time,
cycles, or scheduled intervals managed by the System software. See also Subsection: Nonscheduled
Maintenance Procedures.

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Section 9 Service and Maintenance

Service and Maintenance Software

The following views for performing and recording service and maintenance
procedures are available on the CELL-DYN Ruby:
Maintenance view
Scheduled
As-Needed
Special Protocols
Maintenance Log
System view
Calibration Log
Event Log
Set-Point Log
Reagents view
Current Reagents
Reagent Log

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Service and Maintenance Software Section 9

Maintenance View
The CELL-DYN Ruby System software provides a user-friendly interface for
performing and tracking your maintenance activities. The Maintenance view
provides access to procedure tasks that are scheduled to be performed based on a
time interval or cycle count criteria or as-needed. Once you select a task button and
initiate a procedure, dialog box instructions will guide you through its completion
including an on-line Help button that links specifically to the detailed procedure
instructions contained in this operators manual. Some procedures have a video
button that links to a video clip that demonstrates the procedure. Each dialog box
instruction also contains an <Enter Comment> field for the operator to document
any remarks during the activity. Performance and comments entered for a
scheduled or as-needed procedure are tracked in the Maintenance log.
NOTE: Refer to previous Table 9.3 for the list of Nonscheduled maintenance
tasks that the operator may perform that are not based on time, cycles, or
scheduled intervals managed by the System software. See also
Subsection: Nonscheduled Maintenance Procedures.
The Maintenance view provides access to tabs:
Scheduled maintenance tasks
As-Needed maintenance tasks
Special Protocols
Maintenance Log

Scheduled Maintenance Tasks

The Scheduled tab of the Maintenance view displays the scheduled maintenance
task buttons and also shows the:
Current Cycle Count: the cumulative total of instrument processing runs for
which a Datalog entry was created.
Setup Interval: time and cycle interval the task is scheduled to be
performed.
NOTE: For scheduled maintenance Setup Interval customization
procedures, see Section 2: Installation Procedures and Special
Requirements, Subsection: System Customization.
Last Performed: date, cycle count, and operator ID when the task was last
completed.
Maintenance Due: date and cycles left before the maintenance procedure is
past due. Maintenance Due tasks will be highlighted in orange when the date
and cycles left are past due.
Refer to previous Table 9.1 for the list of Scheduled maintenance tasks.

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As-Needed Maintenance Tasks

The As-Needed tab of the Maintenance view displays the as-needed maintenance
task buttons and also shows the:
Current Cycle Count: the cumulative total of instrument processing runs for
which a Datalog entry was created.
Last Performed: date, cycle count, and operator ID when the task was last
completed.
Refer to previous Table 9.2 for the list of As-Needed maintenance tasks.

Special Protocols
The Special Protocols tab of the Maintenance view allows the operator to activate
important activities including Initialize Analyzer, Prime, and To Standby. Once you
select a Special Protocol task button and initiate a procedure, dialog box
instructions will guide you through its completion, including an on-line Help
button that links specifically to the detailed procedure instructions contained in this
operators manual. Each dialog box instruction also contains an <Enter
Comment> field for the operator to document any remarks during the activity.
Performance and comments entered for a Special Protocol activity are tracked in
the System Event log. The following table lists the Special Protocols that can be
activated in this view:
Table 9.4 Special Protocols

Button Result

7000 To Standby Analyzer is placed in Standby State. When standby is complete, System
Shutdown can be executed.

7001 Initialize Analyzer Analyzer is placed in Initialized State. When initialization is complete, the
Analyzer can then be Primed.
NOTE: During Analyzer power on, this same activity can be activated by
selecting the F12 Init button.
NOTE: This activity can be performed only in the Open Mode.

7002 Disable/Enable Analyzer is placed in Maintenance State and returned to the current state
Analyzer prior to disabling.

7003 Prime Activates System prime, runs Auto Background, and brings
Analyzer to Ready State.
NOTE: This activity can be performed only in the Open Mode.
NOTE: During Analyzer power on, this same activity can be activated by
selecting the F12 Prime button. Ensure that background counts
are within acceptable limits before running controls and patient
specimens.

7004 Empty/Fill Optical Activates the draining and filling of diluent/sheath reagent in the Optical
Flow Cell Flow Cell.
NOTE: This activity can be performed only in the Open Mode.

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Service and Maintenance Software Section 9

Table 9.4 Special Protocols

7005 System Shutdown Powers off the data module and instrument without first entering Standby.
NOTE: This same activity can also be activated by selecting File, then
Shutdown from the menu bar.

7006 Drain Accumulator Activates draining of the internal vacuum accumulators and places the
Analyzer in Uninitialized State. When the protocol is complete the system
must be Initialized and Primed.
NOTE: Ensure that background counts are within acceptable limits before
running controls and patient specimens.

7007 Empty/Fill Reagent Activates the drain and filling of either the WBC Lyse reservoir, HGB Lyse
Reservoir line tubing, or the Diluent/Sheath reservoirs, and places the Analyzer in
Ready State.

7008 Flush Closed Needle Activates automatic flushing of the closed mode needle.
NOTE: This activity can be performed only in the Closed Mode.

7009 Prepare for Shipping Prepares Analyzer for shipment, prolonged periods of non-use, and powers
off the System, or can be executed if instrument contamination is
suspected.

Maintenance Log
The Maintenance Log tab of the Maintenance view displays a record of all
scheduled and as-needed maintenance activities performed on the instrument, up
to 10,000 entries. Once 10,000 entries have been reached, the oldest record is
deleted when a new record is added.
The Maintenance Log displays:
Rec #: maintenance log record number
Maintenance Task: name of the scheduled or as-needed maintenance task
Type: Scheduled (Daily, weekly, Monthly) or As-Needed
Date Completed: date maintenance activity was performed
Cycle Count: instrument cycle count when the task was completed
OPID: operator ID when the task was completed
Comments: operator entered comment remarks when the activity was
performed.
NOTE: The comment field is not editable and is for print and display purposes
only.

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F1 Print
F1 Print can be selected to display the Print dialog box while in the
Maintenance Log view.
These print options can be selected:
Record range: (1) All (2) Selection and (3) Start Rec# End#.
Number of copies
NOTE: When the F1 Print button is selected, if the layout of this view exceeds
the printer page orientation setup (Portrait) under File, Print Setup, the
system software will notify you to adjust the layout before the system can
print. If the printer page orientation setup is already set to Landscape and
the software still notifies you to adjust the layout, unless the log you are
trying to print is customizable, you can only utilize the Print Scrn button
from the keyboard to obtain a printout of what is displayed.

F3 Find/Filter
F3 Find/Filter can be selected to display the Find/Filter dialog box that allows
you to search and sort the information contained in the log. Refer to Section 5:
Operating Instructions, Table 5.15 for more details on its use.

System View
The System view contains a set of logs that automatically store a chronological
history of system processes or functions that can be used to track the systems
performance.
The System view provides access to tabs:
Calibration Log
Event Log
Set Point Log

Calibration Log
The Calibration Log tab of the System view is a data repository containing the
chronological history of the changes made to the Calibration Factors. This
Calibration Log also contains the history of changes made to the Dilution Factors,
which are intended for use by Abbott field service and support representatives and
are not directly intended for use by the operator.
Refer to Section 6: Calibration Procedures for a description of the Calibration
Log.

F1 Print
F1 Print can be selected to display the Print dialog box while in the Calibration
Log view.
These print options can be selected:
Record range: (1) All (2) Selection and (3) Start Rec# End#.
Number of copies

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Service and Maintenance Software Section 9

F3 Find/Filter
F3 Find/Filter can be selected to display the Find/Filter dialog box that allows
you to search and sort the information contained in the log. Refer to Section 5:
Operating Instructions, Table 5.15 for more details on its use.

Event Log
The Event Log tab in the System view is a data repository containing the history
of the system's processes, functions, and faults in chronological order, along with
the date and time of each occurrence, up to 10,000 records. Once 10,000 records
have been reached, the oldest record is deleted when a new record is added. Each
Event Log record can be selected (by double-clicking) to display the Event
Properties dialog box that allows the operator to add or edit remarks in the
<Comment> field and to view the before and after details of Edit/Change event
types.
The Event Log displays:
Rec#: event log record number.
Event Type:

Event Type Icons

Information

Warning

OCF (Operator Correctable Fault)

SL Fault (Sample Loader)

Fatal Fault

Edit/Change

Date_Time: date and time the event occurred on the system.

SIM#: system initiated message number.
NOTE: For the complete list of SIM numbers see Section 10:
Troubleshooting and Diagnostics, Subsection: List of System
Messages.
Message: text string associated with the system event that occurred.
OPID: operator ID when the system event occurred.
Comment: operator entered comment remarks.

F1 Print
F1 Print can be selected to display the Print dialog box while in the Event Log
view.

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These print options can be selected:

Record range: (1) All (2) Selection and (3) Start Rec# End#.
Number of copies

F3 Find/Filter
F3 Find/Filter can be selected to display the Find/Filter dialog box that allows
you to search and sort the information contained in the log.
Refer to Section 5: Operating Instructions, Table 5.15 for more details on its use.

Set Point Log

The Set Point Log tab in the System view is a data repository containing the
chronological history of changes to many of the instrument diagnostics settings
(e.g. gain settings, thresholds, pressure/vacuum settings) and related
configurations. The Set Point Log is intended for use by Abbott field service and
support representatives and is not directly intended for use by operators.

F1 Print
NOTE: The Set Point Log can only be printed using the Print Scrn button from
the keyboard to obtain a printout of what is displayed. While F1 Print
can be selected in the Set Point Log view, the software will continue to
notify you to adjust the layout before the system can print this log because
the number of columns exceeds the printer page orientation of both
Portrait and Landscape printing.

F3 Find/Filter
F3 Find/Filter can be selected to display the Find/Filter dialog box that allows
you to search and sort the information contained in the log. Refer to Section 5:
Operating Instructions, Table 5.15 for more details on its use.

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Service and Maintenance Software Section 9

Reagents View
The CELL-DYN Ruby System software provides a user-friendly interface for
viewing System reagent volume status, creating a new reagent entry, and tracking
the history of reagent usage on the instrument.
The Reagents view provides access to tabs:
Current Reagents
Reagent Log

Current Reagents
The Current Reagents tab of the Reagents view displays a graphical
representation of the percentage of reagent remaining for each reagent installed on
the system. Whenever the System or operator performs any function that uses
reagent, such as maintenance, calibration, and specimen processing, the amount of
reagent used will be mathematically subtracted from percentage of reagent
remaining and will update the graphical display. The System software provides an
early warning message based on this calculation when each reagent used on the
system has less than ten percent left.
NOTE: If replacing reagents on the System before a reagent empty message is
generated, it is important for the operator to create an associated New
Reagent Entry for the reagent replaced to maintain an up to date Current
Reagents view volume status.
The Current Reagents view also displays for each reagent used on the System:
Lot Number: lot number of the reagent container.
List Number: reagent product number.
Package Size: reagent container configuration volume.
Expiration Date: reagent expiration date (YYYY/MM/DD).
Open Date: date the container was placed on the System.
Comment: operator entered comment remarks.

F1 Print
NOTE: The Current Reagents view can only be printed using the Print Scrn
button from the keyboard to obtain a printout of what is displayed. While
F1 Print can be selected to display the Print dialog box while in the
Current Reagents view, when the OK button is selected, no printout will
be generated.

F6 New Entry
F6 New Entry can be selected to display the New Reagent Entry dialog box that
allows you to document new reagent replacement.
Refer to Subsection: Nonscheduled Maintenance Procedures, Reagent
Container Replacement for more details on its use.

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Reagent Log
The Reagent Log tab of the Reagents view is used by the operator to track the
history of reagent usage by the instrument.
The Reagent Log displays:
Rec #: reagent log record number
Reagent: name of the reagent
% Left: calculated percentage of reagent available in the current container.
Size: reagent container configuration volume.
List Number: reagent product number.
Lot Number: lot number of the reagent container.
Exp Date: reagent expiration date. (YYYY/MM/DD)
Open Date: date the container was placed on the System.
OPID: operator ID when the new reagent entry was created.
Comment: operator entered comment remarks when the new reagent entry
was created.
NOTE: The comment field can be edited by either double-clicking on the record
or selecting F4 Edit to display the Edit Reagent Entry dialog box.
The Reagent Log can store up to 10,000 records. After 10,000 records have been
reached, the oldest record is deleted when a new record is added.

F1 Print
F1 Print can be selected to display the Print dialog box while in the Reagent
Log view.
These print options can be selected:
Record range: (1) All (2) Selection and (3) Start Rec# End#.
Number of copies

F3 Find/Filter
F3 Find/Filter can be selected to display the Find/Filter dialog box that allows
you to search and sort the information contained in the log.
Refer to Section 5: Operating Instructions, Table 5.15 for more details on its use.

F4 Edit
F4 Edit can be selected to display the Edit Reagent Entry dialog box for the
record selected and allows you to make changes to:
Lot Number: lot number of the reagent container.
Expiration Date: reagent expiration date.
Open Date: date the container was placed on the System.

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Service and Maintenance Software Section 9

% Remaining: calculated percentage of reagent available in the current

container.
Comment: operator entered comment remarks
NOTE: Edits or changes made using the Edit Reagent Entry dialog box
are not included in the System Event Type Edit/Change and
therefore are not saved to the System Event Log. It is important for
the operator to verify that the record selected or highlighted to edit
in the Edit Reagent Entry dialog box is the current reagent on the
System.

F6 New Entry
F6 New Entry can be selected to display the New Reagent Entry dialog box that
allows you to document reagent replacement.
Refer to Subsection: Nonscheduled Maintenance Procedures, Reagent
Container Replacement for more details on its use.

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Scheduled Maintenance Procedures

The following list of scheduled maintenance procedures are described in this
subsection:
6001 Auto-Clean
6002 Clean Loader Components
6003 Inspect Syringes
6005 Replace Transfer Pump Tubing
6006 Clean Shear Valve
6007 Replace Dil/Sheath Filter
6008 Extended Auto-Clean
WARNING: Potential Biohazard. Wear lab coats, protective eyewear,
and gloves and follow biosafety practices as specified in the OSHA
Bloodborne Pathogen Rule (29 CFR 1910.1030) or other equivalent
biosafety procedures.

6001 Auto-Clean
Perform this scheduled daily maintenance procedure to:
Clean the Shear Valve and associated fluidic system.
CAUTION: This activity presents a chemical-related hazard. Refer to
Section 8: Hazards, Subsection: Chemical Hazards.

The Auto-Clean Cycle is a fully automated cycle designed to clean the Shear
Valve, RBC/PLT Mixing Chamber, the WBC Mixing Chamber, the Optical Flow
Cell, the HGB Flow Cell, Open Mode Probe, the Closed Mode Needle, and all the
associated fluidics. The forward and reverse action of the peristaltic pump is used
during this cycle to gently scrub and remove any fibrin or debris within the system.
NOTE: The Auto-Clean cycle should be run prior to performing any maintenance
procedure. This ensures that all waste is purged from the fluid pathways.

The Analyzer Status must be in the Ready State and in the Open Mode.
Prerequisite
Maintenance view, Scheduled tab.

Estimated time required 15 Minutes

CELL-DYN Enzymatic Cleaner

Tools/materials required
Empty Tube

Replacement parts NA

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Action Steps Reference

Preparation in 6001 - Auto-Clean 1. Select Auto-Clean task button. NOTE: Selecting the Cancel
dialog box. button in this dialog box
2. Aliquot 2 mL Enzymatic
will not log the task.
Cleaner into empty tube.

Aspirate Enzymatic Cleaner and 1. Hold the tube up until the tip of When Auto-Clean cycle is
Begin Auto-Clean cycle the open probe touches the complete, three background
bottom of the tube and select counts are automatically run, logs
the Auto-Clean button. the activity to the Maintenance
NOTE: Do not remove the tube Log and closes the 6001 - Auto-
until you hear an audible Clean dialog box.
beep. Aspiration will take
30 seconds.
2. (Optional) Enter comments in
the <Enter Comment:> field.
NOTE: Comments are
automatically saved to the
Maintenance log view
when Auto-Clean cycle is
complete.

Verify Background Results 1. Ensure background results are See Section 4: Performance
within acceptable limits before Characteristics and Specifica-
running controls or patient tions, Subsection: Performance
specimens. Specifications.

6002 Clean Loader Components

Perform this scheduled weekly maintenance procedure to manually:
Clean the Sample Loader Tray
Clean the Sample Loader Racks
Clean the Tube Grippers
Clean the Tube Spinner
WARNING: Potential Biohazard. The loader track and racks may have
contacted potentially infectious materials. This is an activity or area where
you may be exposed to potentially infectious material. Refer to Section 8:
Hazards, Subsection: Biological Hazards.

CAUTION: This activity presents a chemical-related hazard. Refer to

Section 8: Hazards, Subsection: Chemical Hazards.

Blood spills in the Sample Loader track or racks should be cleaned up immediately
to allow proper movement of the racks. Weekly cleaning is recommended when the
Sample Loader is used, but more frequent cleaning may be indicated by the
laboratory workload.

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The Analyzer Status must be in the Ready State and in the Open or
Prerequisite
Closed Mode. Maintenance view, Scheduled tab.

Lint-free pads or absorbent towel

Cotton swabs
Tools/materials required
Cleaning Solution (0.5% sodium hypochlorite)
DI Water

Replacement parts NA

Action Steps Reference

Preparation in 6002 - Clean 1. Select Clean Loader NOTE: Selecting the Cancel
Loader Components dialog box Components task button. button in this dialog box
will not log the task.
2. Select Disable Analyzer
button. Disables Analyzer for cleaning.
3. When Analyzer Status
indicates Maintenance State
remove the Processor Cover.

Clean Sample Loader Tray 1. Wipe off Sample Loader tray NOTE: See Decontamination
surfaces with cleaning solution. Procedures for the
formula used to prepare
this solution.

Clean Sample Loader Racks 1. Wipe or rinse racks using NOTE: Do not soak racks.
cleaning solution followed by Soaking may impact rack
DI water rinse. Dry racks. bar code label adhesion
and fade the bar code
imprint over time.

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Action Steps Reference

Clean Tube Grippers and Tube 1. Loosen Mixhead thumbscrew

Spinner counter clockwise to unlock
and release the Mixhead Cam.
2. Lift and rotate the Mixhead 90
towards you.
3. Wipe out gripper surfaces
using the DI water and cotton
swabs.
4. Rotate the Mixhead 90 back
down to home position.
5. Prepare to lock the Mixhead
Cam by re-aligning it with the
thumbscrew.
6. Turn the thumbscrew
clockwise to lock the Mixhead
Cam in place.
NOTE: Verify that the Mixhead
cannot rotate towards
you. If it does, repeat
steps 5 6.
7. Wipe the tube spinner surfaces
using the cleaning solution and
cotton swabs.
8. Replace the Processor Cover.

Maintenance Activity Completion 1. Select Enable Analyzer Enables the Analyzer to Ready
button. State, logs the activity to the
2. (Optional) Enter comments in Maintenance Log and closes the
the <Enter Comment:> field. 6002 - Clean Loader
3. Select Log Task Complete Components dialog box.
button to indicate the task has
been performed.
NOTE: Selecting the Cancel
button in this dialog box
will not log the task.

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6003 Inspect Syringes

Perform this scheduled monthly maintenance procedure to manually:
Inspect the four syringes.
WARNING: Potential Biohazard. This is an activity or area where you
may be exposed to potentially infectious material. See Section 8: Hazards,
Subsection: Biological Hazards.

CAUTION: This activity presents a chemical-related hazard. See

Section 8: Hazards, Subsection: Chemical Hazards.

The Analyzer Status must be in the Ready State and in the Open or
Prerequisite
Closed Mode. Maintenance view, Scheduled tab.

Tools/materials required NA

Replacement parts NA

Action Steps Reference

Preparation in 6003 Inspect 1. Select Inspect Syringes task NOTE: Selecting the Cancel
Syringes dialog box. button. button in this dialog box will not log
2. Open the Right Front Cover. the task.

Inspect Syringes 1. Visually inspect syringes.

NOTE: For any syringe requiring
cleaning or replacement,
complete this inspection
activity first and then
proceed to Maintenance
view, As-Needed tab and
select the Clean or
Replace Syringe task.
2. Close the Right Front Cover.

Maintenance Activity Completion 1. (Optional) Enter comments in Enables the Analyzer to Ready
the <Enter Comment:> field. State, logs the activity to the
2. Select Log Task Complete Maintenance Log and closes the
button to indicate the task has 6003 Inspect Syringes dialog
been performed. box.
NOTE: Selecting the Cancel
button in this dialog box
will not log the task.

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Service and Maintenance Software Section 9

6005 Replace Transfer Pump Tubing

Perform this scheduled monthly maintenance procedure to manually:
Replace the Transfer Pump Tubing
WARNING: Potential Biohazard. This is an activity or area where you
may be exposed to potentially infectious material. See Section 8: Hazards,
Subsection: Biological Hazards.

CAUTION: This activity presents a chemical-related hazard. See

Section 8: Hazards, Subsection: Chemical Hazards.

Constant pressure on the tubing under the Peristaltic Pump Wheel tends to flatten
the tubing, thereby inhibiting the flow of liquid past the pump. Use this procedure
to replace the Transfer Pump Tubing.

The Analyzer Status must be in the Ready State and in the Open Mode.
Prerequisite
Maintenance view, Scheduled tab.

Tools/materials required Lint-free pads or absorbent towel

Replacement parts Transfer pump tubing set

Action Steps Reference

Preparation in 6005 1. Select Replace NOTE: Selecting the Cancel button in this dialog box
Replace Transfer Pump Tubing will not log the task.
Transfer Pump task button.
Tubing dialog box. 2. Select Disable Disables Analyzer for tubing replacement.
Analyzer button.
3. Open the Left Front
Cover.

Remove Transfer 1. When Analyzer Status

1 Tubing
Peristaltic Pump indicates Maintenance
Tubing State, remove the tubing 2 Collar
completely out from 3 Pump Shoe
under the pump wheel 4 Pump Wheel 2
by holding the Pump 5 Pump Rollers 4
Shoe away from the
pump wheel and
removing the tubing 1 5
from under the wheel by
lifting the collars out of
the metal brackets. 2 3
2. Disconnect the tubing at
the plastic connectors
over a lint-free pad.

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Action Steps Reference

Replace Transfer 1. Connect the new tubing

1 Tubing
Peristaltic Pump to the plastic
Tubing connectors. 2 Collar
2. Place the collars on the 3 Pump Shoe
ends of the pump tubing 4 Pump Wheel 2
into the metal brackets. 5 Pump 4
3. Place the tubing under Rollers
the pump wheel by
holding the Pump Shoe
1 5
open, guiding the tubing
back under the pump
rollers. 2 3
NOTE: Ensure the tubing
is positioned in the
center of the
rollers.
4. Release the Pump Shoe
when the tubing is
centered under the
pump rollers.
5. Close the Left Front
Cover.

Maintenance 1. Select Enable Enables the Analyzer to Ready State, logs the activity to
Activity Completion Analyzer button. the Maintenance Log and closes the 6005 Replace
2. (Optional) Enter Transfer Pump Tubing dialog box.
comments in the <Enter
Comment:> field.
3. Select Log Task
Complete button to
indicate the task has
been performed.
NOTE: Selecting the
Cancel button in
this dialog box will
not log the task.

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Service and Maintenance
Service and Maintenance Software Section 9

Action Steps Reference

Verification 1. Select the Datalog

view.
2. Run at least three
background counts to
rinse the system.
3. Verify that the
background counts are
within acceptable limits
before running controls
or patient specimens.
NOTE: If the counts are
unacceptable,
troubleshoot
accordingly (refer
to Section 10:
Troubleshooting
and Diagnostics,
Subsection:
Troubleshooting
Tips and
Techniques.)
4. Open the Left Front
Cover and verify the
component replaced is
not leaking.
5. Close the Left Front
Cover.

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Section 9 Service and Maintenance

6006 Clean Shear Valve

Perform this scheduled monthly maintenance procedure to manually:
Clean the Shear Valve
WARNING: Potential Biohazard. This is an activity or area where you
may be exposed to potentially infectious material. See Section 8: Hazards,
Subsection: Biological Hazards.

CAUTION: This activity presents a chemical-related hazard. See

Section 8: Hazards, Subsection: Chemical Hazards.

Cleaning of the Shear Valve ensures optimum performance. Any reagent or blood
residue may cause the valve to leak or function improperly.
NOTE: The center section is not connected by tubing and must be handled
carefully, as it will break if it is dropped. Care should be taken to avoid
chipping, scratching or otherwise damaging any of the sections. Do not
disconnect any of the tubing connected to the front and rear sections.

The Analyzer Status must be in the Ready State and in the Open Mode.
Prerequisite
Maintenance view, Scheduled tab.

Lint-free pads or absorbent towel

Tools/materials required
100 mL plastic container of DI Water

Replacement parts NA

Action Steps Reference

Preparation in 1. Select the Clean Shear Valve NOTE: Selecting the Cancel button in this dialog box
6006 Clean task button. will not log the task.
Shear Valve 2. Select Clean Shear Valve Disables Analyzer and unlocks the shear
window. button. valve for cleaning.
3. Remove the Processor Cover.

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Service and Maintenance
Service and Maintenance Software Section 9

Action Steps Reference

Remove the 1. When Analyzer Status

1 Back Section
Shear Valve for indicates Maintenance State, 1
cleaning place a lint-free pad on the 2 Center
Section
2
shelf under the Shear Valve. 3
2. Turn the Shear Valve 3 Front Section
Retaining Screw 4 Retaining
counterclockwise until it can Screw
be removed. 5 Rim Notch 7 5
3. Pull the front section forward 6 Lock Notch
until it is free of the mounting 7 Mounting Arm 6 4
arm and place on the lint-free
pad.
NOTE: Keep tubing attached.
4. Pull the ceramic center
section forward until it is free
of the mounting arm and place
into container of DI water for
the remainder of the cleaning
procedure.
CAUTION: Do not use
bleach. Use of Bleach will
damage the ceramic
center section.
5. Pull the rear section forward
until it is free from the
mounting arm and wipe the
inner surface using a lint-free
pad dampened with DI water.
Do Not Dry.
6. Wipe the mounting arm using
a lint-free pad dampened with
DI Water followed by a dry lint-
free pad.
NOTE: Hold the rear section by
the edges to avoid
fingerprints on the inner
surface.

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Section 9 Service and Maintenance

Action Steps Reference

Replace Shear 1. Align the lock notch of the rear

1 Back Section
Valve section with the mounting 1
guide and slide the section 2 Center
Section
2
back onto the mounting arm 3
as far as it will go. 3 Front Section
NOTE: Be careful not to crimp 4 Retaining
any of the attached Screw
tubing. 5 Rim Notch 7 5
2. Remove the ceramic center 6 Lock Notch
section from the container of 7 Mounting Arm 6 4
DI Water and verify that it is
clean and free of lint and
fingerprints. Do Not Dry.
3. With the rim notch facing
down, align the lock notch of
the center section with the
mounting guide and gently
slide the section back flush
against the rear section on the
mounting arm.
CAUTION: Results
may be affected if the
center section is installed
backwards. Be certain
the rim notch faces down.
4. Wipe the inner surface of the
front section using a lint-free
pad dampened with DI water.
Do Not Dry.
5. Align the lock notch of the
front section with the
mounting guide and slide the
section back flush against
center section on the
mounting arm.
6. Hold the three sections
together and replace the
Shear Valve Retaining Screw,
turning the screw clockwise
until it stops.
7. Using a lint-free pad
dampened with DI Water,
wipe off the shelf below the
shear valve and remove any
pads that may have been left
on the instrument.
8. Replace the Processor Cover.

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Service and Maintenance
Service and Maintenance Software Section 9

Action Steps Reference

Maintenance 1. Select Restore Shear Valve Enables the Analyzer to Ready State, logs the activity
Activity button. to the Maintenance Log and closes the 6006 Clean
Completion 2. (Optional) Enter comments in Shear Valve dialog box.
the <Enter Comment:> field.
3. Select Log Task Complete
button to indicate the task has
been performed.
NOTE: Selecting the Cancel
button in this dialog box
will not log the task.

Verification 1. Select the Datalog view.

2. Run at least five background
counts to rinse the system.
3. Verify that the background
counts are within acceptable
limits before running controls
or patient specimens.
NOTE: If the counts are
unacceptable,
troubleshoot accordingly
(refer to Section 10:
Troubleshooting and
Diagnostics,
Subsection:
Troubleshooting Tips
and Techniques.)
4. Remove the Processor Cover
and verify that the component
cleaned is not leaking.
5. Replace the Processor Cover.

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Section 9 Service and Maintenance

6007 Replace Dil/Sheath Filter

Perform this scheduled monthly maintenance procedure to manually:
Replace the Diluent/Sheath Filter
WARNING: Potential Biohazard. This is an activity or area where you
may be exposed to potentially infectious material. See Section 8: Hazards,
Subsection: Biological Hazards.

CAUTION: This activity presents a chemical-related hazard. See

Section 8: Hazards, Subsection: Chemical Hazards.

The Diluent/Sheath Filter is located on the left front flow panel to the left of waste
chamber #3. Replace the filter once a month, or whenever contamination is
suspected. A sign of contamination is usually manifested by high platelet
background, poorly defined PLT-RBC (0/10) scatterplot, excessive WBC
flagging, or erroneous 5-part differential results. Refer to Section 10:
Troubleshooting and Diagnostics, Subsection: Troubleshooting Tips and
Techniques for more details.

The Analyzer Status must be in the Ready State and in the Open Mode.
Prerequisite
Maintenance view, Scheduled tab.

Tools/materials required Lint-free pads or absorbent towel

Replacement parts Diluent/Sheath Filter

Action Steps Reference

Preparation in 6007 1. Select Replace Dil/ NOTE: Selecting the Cancel button in this dialog
Replace Dil/Sheath Sheath Filter task box will not log the task. Disables Analyzer
Filter dialog box. button. for Diluent/Sheath Filter replacement.
2. Select Close Filter
Valve button.
3. Open the Left Front
Cover.

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Service and Maintenance
Service and Maintenance Software Section 9

Action Steps Reference

Remove Diluent/Sheath 1. When Analyzer Status

Filter and replace with indicates Maintenance
new filter. State, locate the
Diluent/Sheath Filter on
the front left flow panel.
2. Disconnect the luer slip
inlet from the Diluent/
Sheath Filter over the
lint-free pad.
3. Connect the luer slip
inlet to the top of the
new Diluent/Sheath
Filter and remove the
old filter from its spring
clip.
4. Disconnect the silicon
tubing from the bottom
of the used Diluent/
Sheath Filter and
connect it to the bottom
of the new Diluent/
Sheath Filter.
5. Insert the new Diluent/
Sheath Filter into the
spring clip.
6. Close the Left Front
Cover.

Maintenance Activity 1. Select Open Filter Enables the Analyzer to Ready State, logs the
Completion Valve button. activity to the Maintenance Log and closes the
2. (Optional) Enter 6007 Replace Dil/Sheath Filter dialog box.
comments in the <Enter
Comment:> field.
3. Select Log Task
Complete button to
indicate the task has
been performed.
NOTE: Selecting the
Cancel button in
this dialog box will
not log the task.

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Section 9 Service and Maintenance

Action Steps Reference

Verification 1. Select the Datalog

view.
2. Run at least five to ten
background counts to
rinse the system.
3. Verify that the
background counts are
within acceptable limits
before running controls
or patient specimens.
NOTE: If the counts are
unacceptable,
troubleshoot
accordingly (refer
to Section 10:
Troubleshooting
and Diagnostics,
Subsection:
Troubleshooting
Tips and
Techniques.)
4. Open the Left Front
Cover and verify that
the component replaced
is not leaking.
5. Close the Left Front
Cover.

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Service and Maintenance
Service and Maintenance Software Section 9

6008 Extended Auto-Clean

Perform this scheduled monthly maintenance procedure to:
Clean the Shear Valve and associated fluidic system.
CELL-DYN Ruby Systems running the Reticulocyte test should increase the
scheduled frequency from monthly to weekly.
NOTE: This activity takes approximately 2.5 hours to complete and cannot be
interrupted or cancelled once Extended Auto-Clean button in the 6008 -
Extended Auto-Clean dialog box is selected. During this time, the
instrument is not available to process specimens. The system is
automatically placed in Standby State when completed.
CAUTION: This activity presents a chemical-related hazard. See
Section 8: Hazards, Subsection: Chemical Hazards.

The Analyzer Status must be in the Ready State and in the Open Mode.
Prerequisite
Maintenance view, Scheduled tab.

Estimated time required 2.5 hours

CELL-DYN Enzymatic Cleaner

Tools/materials required
Empty Tube

Replacement parts NA

Action Steps Reference

Preparation in 6007 Extended 1. Select Extended Auto-Clean NOTE: Selecting the Cancel
Auto-Clean dialog box. task button. button in this dialog box
will not log the task.
2. Aliquot 2 mL Enzymatic
Cleaner into empty tube.

Aspirate Enzymatic Cleaner and 1. Hold the tube up until the tip of When Auto-Clean cycle is
Begin Auto-Clean cycle the open probe touches the complete, the system goes into
bottom of the tube and select Standby State.
the Extended Auto-Clean NOTE: See Subsection: 7003
button. Prime for the procedure
NOTE: Do not remove the tube to start the system from
until you hear an audible the Standby State.
beep. Aspiration will take
30 seconds.
2. (Optional) Enter comments in
the <Enter Comment:> field.
NOTE: Comments are
automatically saved to the
Maintenance log view
when Extended Auto-
Clean cycle is complete.

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Section 9 Service and Maintenance

As-Needed Maintenance Procedures

As-Needed maintenance procedures are performed to prevent or eliminate a
problem. These procedures can also be performed in the course of troubleshooting
(See Section 10: Troubleshooting and Diagnostics) or in response to direction
from your Country Service and Support Center.
The following As-Needed Maintenance Procedures are in this subsection:
6055 Clean Fan Filter
6051 Clean Bar Code Reader Window
6052 Clean or Replace Open Mode Probe
6053 Clean or Replace Closed Mode Needle
6054 Clean or Replace Syringe
WARNING: Potential Biohazard. Wear lab coats, protective eyewear,
and gloves and follow biosafety practices as specified in the OSHA
Bloodborne Pathogen Rule (29 CFR 1910.1030) or equivalent biosafety
procedures.

6051 Clean Bar Code Reader Window

Perform this as-needed maintenance procedure to manually:
Clean the Bar Code Reader Window
WARNING: Potential Biohazard. This is an activity or area where you
may be exposed to potentially infectious material. See Section 8: Hazards,
Subsection: Biological Hazards.

CAUTION: This activity presents a chemical-related hazard. See

Section 8: Hazards, Subsection: Chemical Hazards.

The Analyzer Status must be in the Ready State and in the Open or
Prerequisite
Closed Mode. Maintenance view, As-Needed tab.

3 - Applicator swabs (non-sterile)

Tools/materials required Microscope lens tissue
Cleaning Solution: Isopropyl Alcohol, lens cleaner, or DI Water

Replacement parts NA

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Service and Maintenance
Service and Maintenance Software Section 9

Action Steps Reference

Preparation in 6051 Clean Bar 1. Select Clean Bar Code NOTE: Selecting the Cancel
Code Reader Window dialog Reader Window task button. button in this dialog box
box. will not log the task.
2. Select Disable Analyzer
Disables Analyzer for
button.
cleaning.
3. Remove the Processor Cover.

Clean Bar Coder Reader Window 1. When Analyzer Status

indicates Maintenance State,
wrap a lens tissue around each
swab.
2. Moisten one of the wrapped
swabs in cleaning solution.
3. Locate the Bar Code Reader
Window and wipe the window.
4. Using one of the dry wrapped
swabs, wipe the window dry.
NOTE: Use the second dry swab
if necessary.

Verification 1. Visually inspect the window to

ensure that blood, debris and
smudges have been removed.
2. Replace the Processor Cover.

Maintenance Activity Completion 1. Select Enable Analyzer Enables the Analyzer to Ready
button. State, logs the activity to the
2. (Optional) Enter comments in Maintenance Log and closes the
the <Enter Comment:> field. 6051 Clean Bar Code Reader
3. Select Log Task Complete Window dialog box.
button to indicate the task has
been performed.
NOTE: Selecting the Cancel
button in this dialog box
will not log the task.

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Section 9 Service and Maintenance

6052 Clean or Replace Open Mode Probe

Perform this as-needed maintenance procedure to manually:
Remove and replace the Open Mode Probe
WARNING: Potential Biohazard. This is an activity or area where you
may be exposed to potentially infectious material. See Section 8: Hazards,
Subsection: Biological Hazards.

The Analyzer Status must be in the Ready State and in the Open Mode.
Prerequisite
Maintenance view, As-Needed tab.

Lint-free pads or absorbent toweling

Tools/materials required 7/64 Allen wrench
Small needle-nose pliers or similar tool

Replacement parts See Appendix A: Parts and Accessories for list number.

Action Steps Reference

Preparation in 6052 1. Select Clean or Replace NOTE: Selecting the Cancel button in this
Clean or Replace Open Open Mode Probe task dialog box will not log the task.
Mode Probe dialog box. button. Disables Analyzer for Open Mode
Probe replacement.
2. Select Disable Analyzer
button.

Remove Open Mode Probe 1. When Analyzer Status

1 Retainer 1 2 3
indicates Maintenance
State, remove the 2 Probe
Processor Cover and Bracket Arm
locate the tubing attached 3 Bracket
to the top of the Open Support Arm
Mode Probe. 4 Wash Block
2. Place absorbent towel
under the Open Mode
4
Probe.
3. Hold the probe firmly and
use the pliers to carefully
work the tubing up and off
the top of the probe.
4. Using the Allen wrench,
remove the two hex nuts
holding the Probe Bracket
Arm to the Bracket
Support Arm on the Probe
Assembly Frame.
5. Pull the probe up and out
of the Wash Block.

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Service and Maintenance
Service and Maintenance Software Section 9

Action Steps Reference

Replace Open Mode Probe 1. Insert the new probe into

1 Retainer 1 2 3
the Wash Block.
2 Probe
2. Place the Probe Bracket
Bracket Arm
Arm on top of the Bracket
Support Arm. Align the 3 Bracket
holes in the bracket arm to Support Arm
the holes in the Probe 4 Wash Block
Assembly Frame. Insert
and tighten the two hex
4
nuts using the Allen
wrench.
3. Hold the probe firmly and
reattach the Open Mode
tubing using pliers to
carefully work the tubing
back onto the top of the
probe.
NOTE: Wetting the top
portion of the probe
will allow the tubing
to slide more easily.
4. Verify that the Open Mode
tubing is firmly seated on
the probe, remove the
absorbent towel, and
replace the Processor
Cover.

Maintenance Activity 1. Select Enable Analyzer Enables the Analyzer to Ready State, logs the
Completion button. activity to the Maintenance Log and closes
2. (Optional) Enter the 6052 Clean or Replace Open Mode
comments in the <Enter Probe dialog box.
Comment:> field.
3. Select Log Task
Complete button to
indicate the task has been
performed.
NOTE: Selecting the Cancel
button in this dialog
box will not log the
task.

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Section 9 Service and Maintenance

Action Steps Reference

Verification 1. Select the Datalog view.

2. Run at least three
background counts to
rinse the system.
3. Verify that the background
counts are within
acceptable limits before
running controls or patient
specimens.
NOTE: If the counts are
unacceptable,
troubleshoot
accordingly (refer to
Section 10:
Troubleshooting
and Diagnostics,
Subsection:
Troubleshooting
Tips and
Techniques.)
4. Remove the Processor
Cover and verify that the
component cleaned or
replaced is not leaking.
5. Replace the Processor
Cover.

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Service and Maintenance
Service and Maintenance Software Section 9

6053 Clean or Replace Closed Mode Needle

Perform this as-needed maintenance procedure to manually:
Clean or replace the Closed Mode Needle
WARNING: Potential Biohazard. The closed mode vent needle is sharp
and potentially contaminated with infectious materials. Exercise caution
when handling the needle and performing this procedure. See
Section 8: Hazards, Subsection: Biological Hazards.

If the Closed Mode Needle becomes bent or becomes clogged (and performing the
special protocol Flush Closed Needle does not remove the blockage), the needle
should be replaced.
NOTE: The needle consists of two separate needles joined together, one for
venting and one for aspiration.

The Analyzer Status must be in the Ready State and in the Open Mode.
Prerequisite
Maintenance view, As-Needed tab.

Lint-free pads or absorbent toweling

Tools/materials required
Small needle-nose pliers or similar tool

Replacement parts See Appendix A: Parts and Accessories for list number.

Action Steps Reference

Preparation in 6053 1. Select Clean or Replace NOTE: Selecting the Cancel button in this dialog
Clean or Replace Closed Mode Needle box will not log the task. Disables
Closed Mode Needle task button. Analyzer for Closed Mode Needle
dialog box. replacement.
2. Select Disable Analyzer
button.
3. Remove the Processor
Cover.

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Section 9 Service and Maintenance

Action Steps Reference

Remove Closed Mode 1. When Analyzer Status

1 Holding Clip
Needle indicates Maintenance 9 1
State, locate the Closed 2 Aspiration
Tubing 2
Mode Needle.
NOTE: The vent needle is 3 Vent Tubing 3
the shorter side of 4 Needle Top
the closed mode 5 Vent Needle 4
8
needle and faces (shorter)
the instrument. The 6 Aspiration
tubing attached to Needle
the opening at the (longer)
top of the vent 7 Wash Block
needle leads to a
8 Needle 6
vent chamber,
Mounting 5
while the tubing 7
Assembly
attached to the
opening at the top 9 Thumb Screw
of the aspiration (with spring)
needle leads to the
Y valve located
between the Shear
Valve and the Open
Mode Probe.
2. Hold the needle firmly
and use the pliers to
carefully work the tubing
up and off both ends of
the needle.
3. Loosen the Thumb
Screw at the top of the
Needle Mounting
Assembly and remove
the clip holding the
needle to the assembly.
4. Carefully pull the top of
the needle forward until
the flange clears the slot
in the bracket. Lift the
needle up and out of the
Wash Block.

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Service and Maintenance
Service and Maintenance Software Section 9

Action Steps Reference

Replace Closed Mode 1. Place the new needle

1 Holding Clip
Needle into the Wash Block, 9 1
making sure the vent 2 Aspiration
Tubing 2
needle (shorter side)
faces the instrument, 3 Vent Tubing 3
and place the flange into 4 Needle Top
its slot in the top bracket. 5 Vent Needle 4
8
2. Reinstall the clip over the (shorter)
top of the needle and 6 Aspiration
tighten the Thumb Needle
Screw. (longer)
3. Hold the needle firmly 7 Wash Block
and attach the vent 8 Needle 6
tubing to the vent side Mounting 5
and the aspiration tubing Assembly 7
to the aspiration side.
9 Thumb Screw
NOTE: Wetting the top (with spring)
portion of the probe
will allow the tubing
to slide more easily.
4. Verify that the tubing is
attached correctly and
replace the Processor
Cover.

Maintenance Activity 1. Select Enable Analyzer Enables the Analyzer to Ready State, logs the
Completion button. activity to the Maintenance Log and closes the
2. (Optional) Enter 6053 Clean or Replace Closed Mode Needle
comments in the <Enter dialog box.
Comment:> field.
3. Select Log Task
Complete button to
indicate the task has
been performed.
NOTE: Selecting the
Cancel button in
this dialog box will
not log the task.

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Section 9 Service and Maintenance

Action Steps Reference

Verification 1. Select the Datalog view.

2. Run at least three
background counts to
rinse the system.
3. Verify that the
background counts are
within acceptable limits
before running controls
or patient specimens.
NOTE: If the counts are
unacceptable,
troubleshoot
accordingly (refer
to Section 10:
Troubleshooting
and Diagnostics,
Subsection:
Troubleshooting
Tips and
Techniques.)
4. Remove the Processor
Cover and verify that the
component cleaned or
replaced is not leaking.
5. Replace the Processor
Cover.

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Service and Maintenance
Service and Maintenance Software Section 9

6054 Clean or Replace Syringe

Perform this as-needed maintenance procedure to manually clean, remove, and/or
replace the:
Sample Injection Syringe
HGB Lyse Syringe
WBC Lyse Syringe
Diluent/Sheath Syringe
WARNING: Potential Biohazard. This is an activity or area where you
may be exposed to potentially infectious material. See Section 8: Hazards,
Subsection: Biological Hazards.

CAUTION: This activity presents a chemical-related hazard. Section 8:

Hazards, Subsection: Chemical Hazards.

Syringes on the CELL-DYN Ruby System should be cleaned only as necessary one
at a time to ensure that each syringe is replaced in the correct position. Replace
each syringe after it is cleaned and then remove the next one to be cleaned.

The Analyzer Status must be in the Ready State and in the Open Mode.
Prerequisite Maintenance view, As-Needed tab.
NOTE: Only remove and replace one syringe at a time.

Lint-free pads or absorbent toweling

500mL container
Tools/materials required
DI Water
Small container of each reagent to refill the clean syringe(s)

Sample Injection Syringe

Replacement parts HGB Lyse and WBC Lyse Syringe
Diluent/Sheath Syringe

Action Steps Reference

Preparation in 6054 1. Select Clean or NOTE: Selecting the Cancel button in this dialog box
Clean or Replace Replace Syringe task will not log the task. Disables Analyzer for
Syringe dialog box. button. Syringe replacement.
2. Select Disable
Analyzer button.
3. Open the Right Front
Cover, lift and remove
the Right Front Railing.

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Section 9 Service and Maintenance

Action Steps Reference

Remove and Clean 1. When Analyzer Status

1 Tube Fitting
Syringe: indicates Maintenance
State, locate the 2 Luer Lock 1
Diluent/Sheath
Diluent/Sheath Syringe 3 Holding Block
Syringe 2
on the front right flow 4 Diluent/Sheath
panel and note that the Syringe 3
plastic barrel of this 5 Double Collar 4
syringe has four
vertical edges, two of
which fit into vertical
grooves on the syringe 5
mounting bracket, and
a horizontal circular
plastic flange which
also fits into a
horizontal groove on
the syringe mounting
bracket.
2. Grasp the syringe
barrel below the Luer
Lock with one hand.
With the other hand,
grasp the syringe
plunger below the
metal band. Gently and
carefully, pull and twist
one side of the syringe
to release it from the
snap-in mounting
bracket.
3. Carefully turn the Luer
Lock on the syringe
clockwise to release
the fitting, using an
absorbent towel to
catch any excess
reagent.
4. Note the liquid level of
reagent in the syringe
so that it can be refilled
after cleaning to the
same approximate
level.

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Service and Maintenance Software Section 9

Action Steps Reference

(Continued from WARNING: Point the tip of the syringe away

previous page) from eyes.
5. Slowly dispense the
reagent into
appropriate waste
container or sink.
NOTE: Do not pull the
plunger out of the
barrel. Do not
push or pull on
the plunger when
the syringe is dry,
as it may damage
the plunger.
6. Immerse the tip of the
syringe in the container
of DI Water and
aspirate the water into
the syringe until it is
full. Dispense the water
into appropriate waste
container or sink.
Repeat this step 5
times.
7. Refill the syringe with
Diluent/Sheath reagent
to the level noted in
Step 4.

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Section 9 Service and Maintenance

Action Steps Reference

Replace Syringe: 1. Place the fitting back

1 Tube Fitting
Diluent/Sheath into the Luer Lock on
the top of the syringe 2 Luer Lock 1
Syringe
and turn the lock 3 Holding Block
2
counterclockwise until 4 Diluent/Sheath
the fitting is finger tight. Syringe 3
2. Insert the double collar 5 Double Collar 4
on the plunger into the
syringe drive fork and
line up the horizontal
circular flange on the 5
barrel with the slot on
the syringe mounting
bracket.
3. Insert one of the
vertical edges on the
barrel into a vertical
side groove on the
syringe mounting
bracket and carefully
twist the barrel until the
other side snaps into
place.
4. Verify that the syringe
is firmly in place.

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Service and Maintenance
Service and Maintenance Software Section 9

Action Steps Reference

Remove and Clean 1. Verify Analyzer Status These three syringes snap into their mounting
Syringe: indicates Maintenance brackets.
Sample Injection State, locate the
Syringe, or HGB Lyse Sample Injection 1 Sample Injection
Syringe, or WBC Lyse Syringe, or HGB Lyse Syringe
Syringe, or WBC Lyse
5
Syringe 2 HGB Lyse Syringe
Syringe on the front 3 WBC Lyse Syringe
right flow panel.
4 Diluent/Sheath
NOTE: Only remove and Syringe
replace one
5 Mounting Brackets
syringe at a time.
2. Place one finger
behind the upper
portion of the barrel 1 2 3 4
and one finger behind
the lower portion of the
plunger. Gently pull
forward until the
syringe barrel snaps
free from the syringe
mounting bracket and
the double collar
attached to the bottom
of the plunger clears
the syringe drive fork
on the syringe drive
assembly.
NOTE: The flattened
edges of the glass 1 Flattened Edge
flange at the 2
2 Tube Fitting
bottom of the
syringe barrel 3 Sample Injection
align with the Syringe 3
bottom edge of 4 Double Collar
the syringe 5 Base 1
mounting bracket. 4
3. Using one hand to 5
grasp the fitting at the
top of the syringe and
an absorbent towel to
catch any excess
reagent, carefully turn
the syringe
counterclockwise to
release it from the
fitting.

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Action Steps Reference

(Continued from
previous page)
4. Note the liquid level of
reagent in the syringe
so that it can be refilled
after cleaning to the
same approximate
level.
5. Slowly dispense the WARNING: Point tip away from eyes.
reagent into
appropriate waste
container or sink.
NOTE: Do not pull the
plunger out of the
barrel. Do not
push or pull on
the plunger when
the syringe is dry,
as it may damage
the plunger.
6. Immerse the tip of the
syringe in the container
of DI Water and
aspirate the water into
the syringe until it is
full. Dispense the water
into appropriate waste
container or sink.
Repeat this step 5
times.
7. Refill the syringe with
appropriate reagent to
the level noted in Step
4.
NOTE: Sample Injection
Syringe is filled
with Diluent/
Sheath reagent.

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Service and Maintenance Software Section 9

Action Steps Reference

Replace Syringe: 1. Place the fitting into the

1 Sample Injection
Sample Injection top of the syringe and
Syringe
Syringe, or HGB Lyse turn the syringe 5
clockwise until the 2 HGB Lyse Syringe
Syringe, or WBC Lyse
Syringe fitting is finger tight. 3 WBC Lyse Syringe
2. Insert the double collar 4 Diluent/Sheath
on the plunger into the Syringe
syringe drive fork and 5 Mounting Brackets
line up the flattened
edges of the glass
flange at the bottom of 1 2 3 4
the syringe barrel with
the bottom edge of the
syringe mounting
bracket.
3. Snap the syringe into
the syringe mounting
bracket.
4. Verify that the syringe
is vertical and firmly in
place.
5. Replace the Right
Front Railing and close
the Right Front Cover.

Maintenance Activity 1. Select Enable Enables the Analyzer to Ready State, logs the activity
Completion Analyzer button. to the Maintenance Log and closes the 6054 Clean
2. (Optional) Enter or Replace Syringe dialog box.
comments (e.g.
indicate each syringe)
in the <Enter
Comment:> field.
3. Select Log Task
Complete button to
indicate the task has
been performed.
NOTE: Selecting the
Cancel button in
this dialog box will
not log the task.

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Action Steps Reference

Verification 1. Select the Datalog

view.
2. Run at least three
background counts to
rinse the system.
3. Verify that the
background counts are
within acceptable limits
before running controls
or patient specimens.
NOTE: If the counts are
unacceptable,
troubleshoot
accordingly (refer
to Section 10:
Troubleshooting
and Diagnostics,
Subsection:
Troubleshooting
Tips and
Techniques.)
4. Open the Right Front
Cover and visually
inspect that the
syringes are not
leaking.
5. Close the Right Front
Cover.

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Service and Maintenance Software Section 9

6055 Clean Fan Filter

Perform this as-needed maintenance procedure to manually:
Clean the Fan Filters on side panels.
The air filters are located on the side panels of the Analyzer. The filters require
periodic removal and cleaning to maintain a constant, unrestricted air flow.
NOTE: More frequent cleaning may be required whenever the instrument is
located in a particularly dusty or warm area.

The Analyzer Status can be in the Standby or Ready State and in either
Prerequisite
the Open or Closed Mode. Maintenance view, As-Needed tab.

Lint-free pads or absorbent toweling

Tools/materials required
Running Water

Replacement parts Fan Filter

Action Steps Reference

Preparation in 6055 1. Select Clean Fan NOTE: Selecting the Cancel button in this dialog box will
Clean Fan Filter Filter task button. not log the task. Disables Analyzer for cleaning.
dialog box. 2. Select Disable
Analyzer button.

Remove Fan Filter 1. When Analyzer (Optional) The Fan Filter may be cleaned using a vacuum
Frame and Clean Status indicates cleaner once it is removed from the fan filter frame.
Fan Filter Maintenance State,
snap off the plastic 1 Left and right Fan
Fan Filter Frame Filters
from the left or right
side panel.
2. Remove the Fan 1
Filter from the Fan
Filter Frame and
rinse under running 1 CD-ROM or DVD 5 3
water. Drive 4
2 Floppy Drive 2
3. Blot the Fan Filter
dry. 3 Data Station Power 1
4. Reinsert the Fan Button
Filter into the Fan 4 Main Power Switch
Filter Frame and (Rear Panel)
snap the frame back 5 Intake Fan
in place on the side
panel. 1 Intake Fan

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Action Steps Reference

Maintenance 1. Select Enable Enables the Analyzer to Ready State, logs the activity to
Activity Completion Analyzer button. the Maintenance Log and closes the 6055 Clean Fan
2. (Optional) Enter Filter dialog box.
comments in the
<Enter Comment:>
field.
3. Select Log Task
Complete button to
indicate the task has
been performed.
NOTE: Selecting the
Cancel button
in this dialog
box will not log
the task.

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Service and Maintenance Software Section 9

Special Protocols
The following Special Protocol procedures are in this subsection:
7000 To Standby
7001 Initialize Analyzer
7002 Disable/Enable Analyzer
7003 Prime
7004 Empty/Fill Optical Flow Cell
7005 System Shutdown
7006 Drain Accumulator
7007 Empty/Fill Reagent Reservoir
7008 Flush Closed Needle
7009 Prepare for Shipping
WARNING: Potential Biohazard. Wear lab coats, protective eyewear,
and gloves and follow biosafety practices as specified in the OSHA
Bloodborne Pathogen Rule (29 CFR 1910.1030) or other equivalent
biosafety procedures.

7000 To Standby
This automated special protocol is available for the operator to place the Analyzer
in the Standby State prior to executing System Shutdown that powers off the
system.
NOTE: When the instrument has been idle for four hours, it will automatically
enter the Standby State.
This protocol rinses and drains fluidics, reduces laser power, and opens pinch
valves. The solenoid valves are automatically opened periodically to prevent the
tubing from becoming pinched if the Analyzer is left in this state. When the
protocol is complete, the operator may proceed to System Shutdown special
protocol to power off the System.

Action Steps Reference

Place Analyzer in 1. Select Maintenance view. NOTE: Selecting the Cancel button in
Standby State this dialog box will not log the
2. Select Special Protocols tab.
task.
3. Select To Standby task button to open
the To Standby dialog box.
Enables the Analyzer to Standby State,
4. (Optional) Enter comments in the
logs the activity to the Event Log and
<Enter Comment:> field.
closes the 7000 To Standby dialog box.
5. Select To Standby button.

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Action Steps Reference

Bring the Analyzer 1. Select F12 Prime. Enables the Analyzer to Ready State.
out of Standby 2. Select the Datalog view.
State 3. Verify that the background results are
within acceptable limits before running
controls or patient specimens.
NOTE: If the results are unacceptable,
troubleshoot accordingly (refer to
Section 10: Troubleshooting
and Diagnostics, Subsection:
Troubleshooting Tips and
Techniques.)

7001 Initialize Analyzer

This automated special protocol is utilized to bring the Analyzer from an
Uninitialized State to an Initialized State during Analyzer power on, certain
maintenance tasks, and corrective action for various Analyzer fault conditions.
NOTE: During Analyzer power on, this same activity can be activated by
selecting the F12 Init button.
The execution of this special protocol establishes communication between the
Analyzer and Data Module. When initialization is complete, the Analyzer can then
be primed.

Action Steps Reference

Initialize the 1. Select Maintenance view. NOTE: Selecting the Cancel button in
Analyzer to the this dialog box will not log the
2. Select Special Protocols tab.
Ready State task.
3. Select Initialize Analyzer task button to
open the Initialize Analyzer dialog box.
4. (Optional) Enter comments in the <Enter
Comment:> field.
5. Select Initialize Analyzer button.
6. Select F12 Prime. Enables the Analyzer to Initialized State,
7. Select the Datalog view. logs the activity to the Event Log and
8. Verify that the background results are closes the 7001 Initialize Analyzer
within acceptable limits before running dialog box.
controls or patient specimens. Enables the Analyzer to Ready State.
NOTE: If the results are unacceptable,
troubleshoot accordingly (refer to
Section 10: Troubleshooting and
Diagnostics, Subsection:
Troubleshooting Tips and
Techniques.)

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Action Steps Reference

(Optional) 1.Select F12 Init. NOTE: The F12 Init function key will
Initialize the only display when available.
2.Select F12 Prime.
Analyzer to the Enables the Analyzer to
3.Select the Datalog view. Initialized State. Enables the
Ready State
4.Verify that the background results are Analyzer to Ready State.
using the
within acceptable limits before running
function key
controls or patient specimens.
NOTE: If the results are unacceptable,
troubleshoot accordingly (refer to
Section 10: Troubleshooting and
Diagnostics, Subsection:
Troubleshooting Tips and
Techniques.)

7002 Disable/Enable Analyzer

This automated special protocol is utilized to prevent the Analyzer from cycling
while nonscheduled maintenance procedures are performed.

Action Steps Reference

Disable Analyzer 1. Select Maintenance view. NOTE: Selecting the Cancel button in
this dialog box will not log the
2. Select Special Protocols tab.
task.
3. Select Disable/Enable Analyzer task
button to open the Disable/Enable
Analyzer dialog box. Places Analyzer in Maintenance State
4. Select Disable Analyzer button. for maintenance task.

Enable Analyzer 1. Select Enable Analyzer button.

2. Enter comments (e.g. Flushed Open
Probe) in the <Enter Comment:> field.
3. Select Log Task Complete button to Enables the Analyzer to the current state,
indicate the task has been performed. logs the activity to the Event Log and
NOTE: Selecting the Cancel button in this closes the 7002 Disable/Enable
dialog box will not log the task. Analyzer dialog box.

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7003 Prime
This automated special protocol is available for the operator to activate a System
prime, execute an auto background, and place the Analyzer in Ready State during
Analyzer power on, certain maintenance tasks, and corrective action for various
Analyzer fault conditions.
NOTE: During Analyzer power on, this same activity can be activated by
selecting the F12 Prime button.

Action Steps Reference

Prime the 1. Select Maintenance view. NOTE: Selecting the Cancel button in
Analyzer this dialog box will not log the
2. Select Special Protocols tab.
task.
3. Select Prime button to open the Prime
dialog box.
4. (Optional) Enter comments in the
<Enter Comment:> field.
5. Select Prime button.
6. Select the Datalog view. Enables the Analyzer to Ready State,
logs the activity to the Event Log and
7. Verify that the background results are
closes the 7003 Prime dialog box.
within acceptable limits before running
controls or patient specimens.
NOTE: If the results are unacceptable,
troubleshoot accordingly (refer to
Section 10: Troubleshooting
and Diagnostics, Subsection:
Troubleshooting Tips and
Techniques.)

(Optional) Prime 1. Select F12 Prime. NOTE: The F12 Prime function key will
the Analyzer using only display when available.
2. Select the Datalog view.
the function key Enables the Analyzer to Ready State.
3. Verify that the background results are
within acceptable limits before running
controls or patient specimens.
NOTE: If the results are unacceptable,
troubleshoot accordingly (refer to
Section 10: Troubleshooting
and Diagnostics, Subsection:
Troubleshooting Tips and
Techniques.)

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7004 Empty/Fill Optical Flow Cell

This automated special protocol is available for the operator to activate during
corrective action for various Analyzer fault conditions.
NOTE: The System must be in the Open Mode to execute this activity.

Action Steps Reference

Preparation Analyzer Status must be in Open Mode.

Empty Optical 1. Select Maintenance view. NOTE: Selecting the Cancel button in
Flow Cell this dialog box will not log the
2. Select Special Protocols tab.
task.
3. Select Empty/Fill Optical Flow Cell
task button to open the Empty/Fill
Optical Flow Cell dialog box. Analyzer Status indicates Maintenance
4. Select Empty Flow Cell button. State.

Fill Optical Flow 1. Select Fill Flow Cell button.

Cell 2. Enter comments (e.g. Empty/Fill Flow
Cell") in the <Enter Comment:> field.
3. Select Log Task Complete button to Enables the Analyzer to current state,
indicate the task has been performed. logs the activity to the Event Log and
4. Run a whole blood before QC or Patient closes the 7004 Empty/Fill Optical
testing. Flow Cell dialog box.
NOTE: Selecting the Cancel button in this
dialog box will not log the task.

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7005 System Shutdown

This automated special protocol is utilized to effectively power off the data module
and instrument and is also executed during certain maintenance tasks and
corrective action for various Analyzer fault conditions.
NOTE: Selecting File, then Shutdown from the menu bar can also access this
same activity.

Action Steps Reference

System Shutdown 1. Select Maintenance view. NOTE: Selecting the Cancel button in
this dialog box will not log the
2. Select Special Protocols tab.
task.
3. Select System Shutdown button to
open the System Shutdown dialog
box.
4. (Optional) Enter comments in the
<Enter Comment:> field. Opens dialog box to OK or Cancel
5. Select System Shutdown button. initiation of shutdown.
6. Select OK to initiate shutdown.
NOTE: The application and operating
system software will shutdown, the Logs the activity to the Event Log and
display will turn to black, and closes the 7005 System Shutdown
instrument power will turn off. dialog box.

System Shutdown 1. Select File from the menu bar.

using the menu 2. Select Shutdown Opens dialog box to OK or Cancel
bar. 3. Select OK to initiate shutdown. initiation of shutdown.
NOTE: The application and operating
system software will shutdown, the
display will turn to black, and
instrument power will turn off.

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Service and Maintenance Software Section 9

7006 Drain Accumulator

This automated special protocol is available for the operator to activate and drain
the internal vacuum accumulators during corrective action for various Analyzer
fault conditions and place the Analyzer in an Uninitialized State.
NOTE: If the fault condition corrective action requests this protocol to be
executed multiple times, the Drain Accumulator task button can be
selected when the Analyzer Status indicates Initialized.

Action Steps Reference

Drain Accumulator 1. Select Maintenance view. NOTE: Selecting the Cancel button in
this dialog box will not log the
2. Select Special Protocols tab.
task.
3. Select Drain Accumulator task button
to open the Drain Accumulator dialog
box.
4. (Optional) Enter comments in the
<Enter Comment:> field. Analyzer Status indicates Uninitialized
State, logs the activity to the Event Log
5. Select Drain Accumulator button.
and closes the 7006 Drain
Accumulator dialog box.

Bring Analyzer to 1. Select F12 Init. Enables the Analyzer to Initialized State.
Ready State using NOTE: F12 Init is not always displayed
the function key. and available.
2. (Optional) Repeat action Drain
Accumulator.
3. Select F12 Prime. Enables the Analyzer to Ready State.
4. Select the Datalog view.
5. Verify that the background results are
within acceptable limits before running
controls or patient specimens.
NOTE: If the results are unacceptable,
troubleshoot accordingly (refer to
Section 10: Troubleshooting
and Diagnostics, Subsection:
Troubleshooting Tips and
Techniques.)

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7007 Empty/Fill Reagent Reservoir

This automated special protocol is available for the operator to activate the draining
and filling of either the WBC Lyse reservoir, HGB Lyse line tubing, or the Diluent/
Sheath reservoirs during corrective action for various Analyzer fault conditions,
and place the Analyzer in the Ready State.
NOTE 1: This protocol must be repeated three times in order to empty and fill the
WBC Lyse reservoir, HGB Lyse line tubing, and the Diluent/Sheath
reservoirs.
NOTE 2: The analyzer must be in the READY state and in the Open Mode.

Action Steps Reference

Empty Reagent 1. Remove reagent lines from reagent NOTE: Selecting the Cancel button in
Reservoir/Line containers. this dialog box will not log the
2. Select Maintenance view. task.
3. Select Special Protocols tab.
4. Select Empty/Fill Reagent Reservoir
task button to open the Empty/Fill
Reagent Reservoir dialog box.
5. Select either:
Empty WBC Lyse button Analyzer Status indicates Maintenance
Empty HGB Lyse button
State.
Empty Dil/Sheath button

Fill Reagent 1. Place reagent line back to reagent box

Reservoir/Line or to new reagent container.
2. Depending on which button was
selected to empty, select Fill <WBC
Lyse, HGB Lyse, or Dil/Sheath>
button.
3. (Optional) Enter comments in the Enables the Analyzer to Ready State,
<Enter Comment:> field. logs the activity to the Event Log and
4. Select Log Task Complete button to closes the 7007 Empty/Fill Reagent
indicate the task has been performed. Reservoir dialog box.
5. Run a whole blood before QC or Patient
testing.
NOTE: Selecting the Cancel button in this
dialog box will not log the task.

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Service and Maintenance Software Section 9

7008 Flush Closed Needle

This automated special protocol is available for the operator to activate when a
blockage is suspected.
NOTE: The System must be in the Closed Mode to execute this activity.

Action Steps Reference

Preparation Analyzer Status must be in Ready State,

Closed Mode.

Flush Closed 1. Select Maintenance view. NOTE: Selecting the Cancel button in
Needle 2. Select Special Protocols tab. this dialog box will not log the task.
3. Select Flush Closed Needle task
button to open the Flush Closed
Needle dialog box. Enables the Analyzer to Ready State,
4. (Optional) Enter comments in the logs the activity to the Event Log and
<Enter Comment:> field. closes the 7008 Flush Closed Needle
5. Select Flush Closed Needle button. dialog box.
6. Run a whole blood before QC or Patient
testing.

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7009 Prepare for Shipping

This automated special protocol is available to the operator for preparing the
Analyzer for shipment, prolonged periods of non-use including power off, or if
instrument contamination is suspected.
WARNING: Potential Biohazard. Consider all materials that have
contacted human sourced material as potentially infectious.

NOTE: The complete activity requires this automated protocol to be executed

three times: first using 0.5% sodium hypocholorite, second using DI
water, and third using air. The first and second time, this cycle drains and
rinses the fluidics system, releases vacuum and pressure, and places
Analyzer in Uninitialized State. When the cycle is finished the third time,
the Data Module and Analyzer will power off. It is important to review
the entire procedure before executing this special protocol.
NOTE: When starting the system after 2 weeks or more of inactivity, or if
instrument contamination is suspected, it is necessary to perform 6007
Replace Dil/Sheath Filter before priming the System.

Action Steps Reference

Preparation 3 Large beakers or NOTE: See Decontamination Procedures for the formula
containers used to prepare this solution.
Cleaning solution
(0.5% sodium
hypochlorite) 600 mL
DI water 300 mL
200 mL of nonabrasive
detergent solution
Four Plastic Bags
Shear valve dummy
center section

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Service and Maintenance Software Section 9

Action Steps Reference

Prepare for 1. Remove the WBC NOTE: Selecting the Cancel button in this dialog box will not
Shipping with Lyse, HGB Lyse, and log the task.
0.5% sodium Diluent/Sheath reagent
hypochlorite lines from their reagent
containers and place
the lines in the
container with 300 mL
of cleaning solution.
2. Select Maintenance
view.
3. Select Special
Protocols tab.
4. Select Prepare for
Shipping task button
to open the Prepare
for Shipping dialog
box.
5. Select Prepare For Analyzer Status indicates Maintenance State.
Shipping button.
6. When the Analyzer
Status indicates
Uninitialized State,
select F12 Init.
7. Continue with next
action.

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Action Steps Reference

Prepare for 1. When the Analyzer

Shipping with Status indicates
DI water Initialized State, place
the lines in the
container with 300 mL
of DI water.
2. Select Maintenance
view.
3. Select Special
Protocols tab.
4. Select Prepare for
Shipping task button
to open the Prepare
for Shipping dialog
box.
5. Select Prepare For Analyzer Status indicates Maintenance State.
Shipping button.
6. When the Analyzer
Status indicates
Uninitialized State,
select F12 Init.
7. Continue with next
action.

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Service and Maintenance Software Section 9

Action Steps Reference

Prepare for 1. When the Analyzer

Shipping with Status indicates
Air and Power Initialized State, place
Off the lines in a clean
empty container.
2. Select Maintenance
view.
3. Select Special
Protocols tab.
4. Select Prepare for
Shipping task button
to open the Prepare
for Shipping dialog
box.
5. Select Prepare For Analyzer Status indicates Maintenance State.
Shipping And Power
Off button.
NOTE: At the end of this
cycle, the
application and
operating system
software will
shutdown, the
display will turn to
black, and
instrument power
will turn off.
6. If this special protocol
is being executed for
preparing for shipment
or prolonged periods of
non-use, skip this step
and proceed to the
next action.
7. If this special protocol
is being executed
because of suspected
contamination, install
new reagent line tubing
and place into new
reagent containers,
install a new dil/sheath
filter, and then proceed
to power ON the data
station. STOP here, do
not continue to next
action.

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Action Steps Reference

Remove 1. Turn the Main power

Tubing From switch to OFF on the
Rear Panel Rear Panel.
2. Remove all reagent
lines, Waste Tubing
line, and the Waste
Sensor line from the
Rear Panel.
3. Empty the Waste
Tubing line and rinse
with disinfectant.
4. Place each length of
tubing in a separate
plastic bag and close
the bag. (Keep the
Waste line and Waste
Sensor line together.)
5. Place in Accessory Kit.

Remove 1. Remove the Analyzer

Power Cord power cord from the
outlet receptacle and
remove its connector
on the rear of the
Analyzer.
2. Place in Accessory Kit.

Disconnect 1. Disconnect all the

Data Module cable connections on
Cable the rear of the Data
Connections Module.
2. Place the HSSL cable
in the Accessory Kit.

Wipe down of 1. Wipe down instrument

instrument surfaces with non-
exterior. abrasive detergent
solution.
2. Then, wipe down
instrument with 0.5%
sodium hypochlorite
solution.
3. Then, wipe down
instrument with tap
water.

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Service and Maintenance Software Section 9

Action Steps Reference

Remove 1. Open the Left and

Tubing from Right Front Covers and
NC Valves and locate the six Normally
Transfer Pump Closed Valves.
2. Carefully remove the
tubing from all the NC
Valves.
NOTE: Do not detach the
tubing.
3. Carefully remove the
tubing from the
Transfer Pump.
NOTE: Do not detach the
tubing. Transfer Pump
4. Close the Left and
Right Front Covers.

Prepare Shear 1. Remove the Processor

1 Back Section
Valve Cover. 1
2 Center
2. Remove and perform
Section
2
6006 Clean Shear 3
Valve. 3 Front Section
3. Blot ceramics dry. 4 Retaining
Wrap the ceramic Screw
center section carefully 5 Rim Notch 7 5
for protection and 6 Lock Notch
place in the Accessory 7 Mounting Arm 6 4
kit.
4. Obtain the Shear Valve
Dummy Center section
from the Accessory Kit
and reassemble the
Shear Valve on the
instrument using the
dummy center section.
5. Replace the Processor
Cover.

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Nonscheduled Maintenance Procedures

The following list of nonscheduled maintenance procedures described in this
subsection are tasks that the operator may perform that are not based on time,
cycles, or scheduled intervals managed by the System software.
Decontamination Procedures
Printer Cleaning
Reagent Container Replacement
Replace Tubing in Normally Closed (NC) Valves
Unclogging Open Mode Probe
Vacuum Accumulator 1 and 2 Rinsing Procedure
WARNING: Potential Biohazard. Wear lab coats, protective eyewear,
and gloves and follow biosafety practices as specified in the OSHA
Bloodborne Pathogen Rule (29 CFR 1910.1030) or other equivalent
biosafety procedures.

Decontamination Procedures
The OSHA Bloodborne Pathogen Rule (29 CFR Part 1910.1030) requires
decontamination of laboratory equipment prior to servicing or shipment:
Flush the instrument by performing the 6001 Auto-Clean cycle. This cycle
flushes all of the fluid pathways with reagents to purge any waste from the fluid
pathways. The Open Mode Probe and the Closed Needle 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.
If the instrument is to be shipped, it must be decontaminated prior to
shipment by performing the 7009 Prepare for Shipping special protocol.
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

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Add 9.5 parts deionized water to 1 part bleach to obtain a 0.5% sodium
hypochlorite solution, or 9.5 mL of deionized water to 1.0 mL of bleach (5.25%
sodium hypochlorite) to obtain 10.5 mL of a 0.5% solution of sodium hypochlorite.

Printer Cleaning
Printers must be turned off before cleaning. Do not dust inside the printer with
paper towels or tissues. Do not use solvents or strong detergents on the cabinets.
Printers should be cleaned as necessary to maintain good operating condition (at
least every six months or approximately every 300 hours of operation). For more
detailed maintenance instructions, refer to the printer manufacturers manual.

Reagent Container Replacement

CAUTION: This activity presents a chemical-related hazard. See
Section 8: Hazards, Subsection: Chemical Hazards.

The CELL-DYN Ruby System utilizes liquid level sensing hardware to detect
when a reagent container is empty and requires replacement, as indicated by a
WBC Lyse Empty, HGB Lyse Empty, or Dil/Sheath Empty System Initiated
Message. See also Section 10: Troubleshooting and Diagnostics;
Subsection: List of System Messages.
The operator must first install a new container of reagent before selecting the Clear
Fault button in the SIM dialog box. A New Reagent Entry dialog box will open
that allows the operator to select which reagent is being replaced and record the
following:
Lot Number
Expiration Date
Open Date
Comment
It is recommended to run at least five background counts to rinse the system and
verify that the background counts are within acceptable limits before running
controls or patient specimens.
NOTE: If the counts are unacceptable, troubleshoot accordingly (refer to
Section 10: Troubleshooting and Diagnostics,
Subsection: Troubleshooting Tips and Techniques.)
CAUTION: Do not pour the remaining contents of the old reagent
container into the new reagent container. This mixing could contaminate the
new reagent.

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Reagent contamination could be suspected if a group of parameters measured using

the same reagent are consistently errant. If reagent replacement is required as a
result of data-related troubleshooting, select F6 - New Entry in the Reagents view
to open the New Reagent Entry dialog box. Select which reagent is being replaced
and complete the remaining dialog fields. Run at least five background counts to
rinse the system and verify that the background counts are within acceptable limits
before running controls or patient specimens.
NOTE: If the counts are unacceptable, troubleshoot accordingly (refer to
Section 10: Troubleshooting and Diagnostics,
Subsection: Troubleshooting Tips and Techniques.)

Replace Tubing in Normally Closed (NC) Valves

Perform this nonscheduled maintenance procedure to manually:
Replace tubing in Normally Closed Valves
WARNING: Potential Biohazard. This is an activity or area where you
may be exposed to potentially infectious material. See Section 8: Hazards,
Subsection: Biological Hazards.

This activity presents a chemical-related hazard. See Section 8: Hazards,

Subsection: Chemical Hazards.
Tubing in the Normally Closed Valves should be replaced when it shows signs of
indentation or flattening and is impeding the flow of fluid through the tubing.

The Analyzer must be Shutdown. Status must be in the Ready State and
Prerequisite
in the Open Mode. Maintenance view, Special Protocols tab.

Valve Tubing (12)

Tools/materials required
Hemostats (2)

Replacement parts NA

Action Steps Reference

Preparation in 1. Select System NOTE: Selecting the Cancel button in this dialog box will not
7005 Shutdown task button. log the task. Prepares the Data Module for shutdown
System and powers off the System.
2. Select System
Shutdown Shutdown button, the
dialog box. select OK.

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Service and Maintenance Software Section 9

Action Steps Reference

Replace 1. When display is black,

Tubing in remove the Processor
Normally Cover, open the Left
Closed (NC) and Right Front Covers
Valves and locate all six NC
valves.
2. Use hemostats to
clamp the tubing above
and below the normally
closed valve tubing
connectors to prevent
leakage when the
normally closed valve
tubing is replaced.
NOTE: Remove and
replace NC valve 1 Tubing
tubing one valve 2 Slot 4
at a time. 3 Valve 2
3. Pull the tubing from the 4 Connectors
connectors on either
side and then insert the 3
new tubing into both 1
connectors making
sure the tubing is
pushed all the way into
the connectors.
4
4. Reinsert the tubing into
the slot on the valve,
working the tubing
back and forth until it is
completely inserted
into the valve and
resting on the bottom
of the slot.
5. Remove the
hemostats.
6. When all valve tubing
has been replaced,
close the Left and
Right Front Covers,
and replace the
Processor Cover.

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Action Steps Reference

Power ON 1. Press and hold the

1 CD-ROM or DVD
Data Station power 5 3
Drive
button for 4 seconds to 4
restart the System. 2 Floppy Drive 2
2. When Analyzer Status 3 Data Station 1
indicates Uninitialized Power Button
State, select F11-Init. 4 Main Power
3. When Analyzer Status Switch (Rear
indicates Initialized Panel)
State, select F11 5 Intake Fan
Prime.
Enables the Analyzer to Ready State.

Log 1. Select System view,

Maintenance Event Log tab.
Activity 2. Using the mouse,
Completion highlight and double- Opens the Event Properties dialog box.
click on the record #
associated with the
System Shutdown
event. Enter text (e.g.
Replaced NC
tubings.) in the
<Comment:> field and
select the OK button. Logs the comment to the Event Log record and closes the
Event Properties dialog box.

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Service and Maintenance Software Section 9

Action Steps Reference

Verification 1. Select the Datalog

view.
2. Run at least three
background counts to
rinse the system.
3. Verify that the
background counts are
within acceptable limits
before running controls
or patient specimens.
NOTE: If the counts are
unacceptable,
troubleshoot
accordingly (refer
to Section 10:
Troubleshooting
and
Diagnostics,
Subsection:
Troubleshooting
Tips and
Techniques.)
4. Remove the Processor
Cover, open the Left
and Right Front Covers
and verify the
components are not
leaking.
5. Replace the Processor
Cover and close the
Left and Right Front
Covers.

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Unclogging Open Mode Probe

Perform this nonscheduled maintenance procedure to manually:
Flush the interior of the Open Mode Probe
WARNING: Potential Biohazard. This is an activity or area where you
may be exposed to potentially infectious material. See Section 8: Hazards,
Subsection: Biological Hazards.

CAUTION: This activity presents a chemical-related hazard. See

Section 8: Hazards, Subsection: Chemical Hazards.

The Open Sample Aspiration Probe is thoroughly cleaned whenever the Auto-
Clean cycle is performed. The probe may be cleaned manually using this procedure
if a blockage is suspected.

The Analyzer Status must be in the Ready State and in the Open Mode.
Prerequisite
Maintenance view, Special Protocols tab.

Lint-free pads or absorbent toweling

Syringe (10 cc or larger) with at least 3 of 1/32 (internal diameter)
silicone tubing attached to the tip
Tools/materials required Small needle-nose pliers or similar tool
Small beaker or container
DI Water
Cleaning solution (0.5% sodium hypochlorite)

Replacement parts NA

Action Steps Reference

Preparation in 7002 1. Select Disable/Enable NOTE: Selecting the Cancel button in this dialog box
Disable/Enable Analyzer task button. will not log the task. Disables Analyzer for
Analyzer dialog cleaning.
2. Select Disable
box. Analyzer button.
3. Fill the syringe with NOTE: See Decontamination Procedures for the
Cleaning Solution. formula used to prepare this solution.

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Service and Maintenance Software Section 9

Action Steps Reference

Flush Open Mode 1. When Analyzer Status

1 Probe Tubing 1 2
Probe indicates Maintenance
State remove the 2 Probe Top
Processor Cover and 3 Wash Block
locate the tubing
attached to the top of
the Open Mode Probe.
2. Place small beaker
under the probe to
3
catch the rinse liquid.
3. Hold the probe firmly
and use the pliers to
carefully work the
tubing up and off the top
of the probe.
4. Attach the tubing
connected to the
syringe with Cleaning
Solution onto the top of
the probe and gently
inject the solution to
flush the probe.
5. Fill the same syringe
with DI water and flush
again from the top of
the probe. Repeat this
step three times.
NOTE: Empty the small
beaker as
necessary.
6. Hold the probe firmly
and reattach the Open
Mode tubing using
pliers to carefully work
the tubing back onto the
top of the probe.
NOTE: Wetting the top
portion of the
probe will allow
the tubing to slide
more easily.
7. Verify that the Open
Mode tubing is firmly
seated on the probe,
remove the small
beaker, and replace the
Processor Cover.

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Action Steps Reference

Maintenance 1. Select Enable

Activity Completion Analyzer button.
2. Enter comments (e.g.
Flushed Open Probe)
in the <Enter
Comment:> field.
3. Select Log Task Enables the Analyzer to Ready State, logs the activity
Complete button to to the Event Log, closes the 7002 Disable/Enable
indicate the task has Analyzer dialog box.
been performed.
NOTE: Selecting the
Cancel button in
this dialog box will
not log the task.

Verification 1. Select the Datalog

view.
2. Run at least three
background counts to
rinse the system.
3. Verify that the
background counts are
within acceptable limits
before running controls
or patient specimens.
NOTE: If the counts are
unacceptable,
troubleshoot
accordingly (refer
to Section 10:
Troubleshooting
and Diagnostics,
Subsection:
Troubleshooting
Tips and
Techniques.)
4. Remove the Processor
Cover and verify the
component is not
leaking.
5. Replace the Processor
Cover.

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Service and Maintenance Software Section 9

Vacuum Accumulator 1 and 2 Rinsing Procedure

Perform this nonscheduled maintenance procedure to manually:
Rinse Vacuum Accumulators 1 and 2 with DI Water.

Action Steps Reference

Prerequisite 1. Be sure that instrument is in the

Initialized or Ready state.

Materials Required Clean 500 mL Beaker or Container

DI Water
12 inches of S3 Silicon Tubing

Preparation 1. Open Left Access (Front) Cover.

2. Remove the Left Panel from the
rear rail of the Autoloader.

Induce DI Water into 1. Locate VAC 1 and VAC 2

Vacuum Accumulators 1 accumulator drain lines. [1]
and 2 2. Measure and add 250 mL of DI
Water into a clean 500 mL beaker
or container.
CAUTION: Do not place more than
stated amount of DI water in
container.
1. Remove silicon portion of VAC1
drain line (along with plug) and
attach the 12 inch portion of S3
silicon tubing. [2]
2. Insert the end of the S3 silicon
tubing into the DI Water container
and allow the vacuum to aspirate
all of the liquid.
3. Remove the 12 inch piece of
silicon tubing and re-install the
original tubing along with plug.
4. Repeat Step 1 through Step 5 for
the VAC 2 drain line.

Drain Rinse Liquid with 1. From the Maintenance view,

Drain Accumulator Select
Protocol Special Protocols
Drain Accumulator
Drain Accumulator (from pop
up window).
2. Select Init (F12) to initialize the
system.

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Section 9
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CELL-DYN RubyTM System Operators Manual

Maintenance Log

Day of the Month

Year ______ Month ______
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
Run Auto-Clean
Daily

Clean Loader Components

Weekly

Inspect Syringes
Clean Shear Valve
Replace Dil/Sheath Filter
Monthly
Replace Transfer Pump Tubing
Extended Auto-Clean

Clean Fan Filter

Clean Bar Code Reader Window
Clean Open Mode Probe
Clean Closed Mode Needle
Clean Sample Injection Syringe
Clean WBC Lyse Syringe
As-Needed Clean HGB Lyse Syringe
Procedures Replace Open Mode Probe
Replace WBC Lyse Syringe
Replace Closed Mode Needle
Replace Sample Injection Syringe

Service and Maintenance Software

Replace HGB Lyse Syringe

Service and Maintenance

Replace Diluent/Sheath Syringe

Decontamination Procedures
Printer Cleaning
Reagent Container Replacement
Non-
Replace Tubing in Normally
Scheduled
Closed (NC) Valves
Procedures
Unclogging Open Mode Probe
9-75

Calibration

It is recommended that this scheduled maintenance activity be performed on a weekly basis if your laboratory is running the Reticulocyte assay.
Service and Maintenance
Service and Maintenance Software Section 9

NOTES

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References

1. US Department of Labor, Occupational Safety and Health Administration, 29

CFR Part 1910.1030, Occupational Exposure to Bloodborne Pathogens.
2. World Health Organization. Laboratory Biosafety Manual. Geneva: World
Health Organization, 1993.
3. Clinical and Laboratory Standards Institute. Protection of Laboratory
Workers from Occupationally Acquired Infections; Approved Guideline
Second Edition. CLSI document M29-A2 (ISBN 1-56238-453-8). CLSI, 940
West Valley Road, Suite 1400, Wayne, PA 19087-1898, 2001.

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Service and Maintenance
References Section 9

NOTES

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 Section 10 Troubleshooting and Diagnostics

Section 10 Troubleshooting and Diagnostics

Overview

This section provides the CELL-DYN Ruby operator with instructions for
identifying, troubleshooting and correcting instrument problems. The
Troubleshooting Guide is intended as a referral guide for customer troubleshooting
and optimal instrument operation and contains the following:
Introduction to Troubleshooting
Problem Categories
Troubleshooting Procedures
List of System Messages
System Information Message Tables
The CELL-DYN Ruby continuously monitors the status of the system and displays
pertinent information in the Analyzer Status region. If a problem is detected, a
system message will display in the System Messages region.
NOTE: Generally, conditions that are instrument- or reagent-related will occur on
all samples, including controls. Therefore, if a problem is detected or
suspected, it is important to confirm instrument performance by re-
running controls.
WARNING: Potential Biohazard. Follow established biosafety practices
when performing maintenance, service or troubleshooting procedures.
Refer to Section 8: Hazards for additional information

If assistance is needed for any technical or operational problems, call your local
Country Service and Support Center.
When calling for assistance, be ready to provide the following information:
Instrument model and serial number
Software version
Problem description
Lot numbers and expiration dates of reagents, calibrator and controls
currently in use
Maintenance procedures recently performed
Troubleshooting steps taken
Any data gathered in the course of troubleshooting

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Overview Section 10

Introduction to Troubleshooting
Understanding normal instrument operation is essential for identifying and
resolving operational problems. Effective troubleshooting requires a logical, step-
by-step approach to problem solving. Logical troubleshooting can be divided into
three steps as follows:
1. Problem Identificationrequires the Operator to investigate not only what
is wrong but also to note what is right. The investigation should identify the
problem area and eliminate areas that are working correctly. Once this step is
done, move to the next step.
2. Problem Isolationfurther classifies an instrument problem. These
problems are generally divided into three categories:
Measurement related to sample analysis
Software related
Hardware component related
Typically, hardware and software problems are Operator-correctable with
technical assistance. Measurement problems are generally Operator-
correctable and are further subdivided into problems related to sample
handling, maintenance, or calibration.
3. Corrective Actioninvolves taking appropriate steps to correct the
problem. If the Operator can correct the problem, with or without technical
assistance, normal operation can quickly resume.

Problem Categories
Problems encountered when running the CELL-DYN Ruby can be classified into
three categories:
Observable problems
Problems that generate System Messages:
System Event Types
System Information Messages (SIMs)
Data-related problems

Observable Problems
Observable problems are easily noticed by the operator during routine operation or
maintenance. Examples of observable problems are salt deposits on the syringe
plunger or a flickering display.

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Section 10 Troubleshooting and Diagnostics

System Messages
Problems or system events that generate System Messages are detected by the
System and lead to the display of message text in the System Messages region. The
System software determines which System Messages will be historically
documented to the System Event Log. Refer to Subsection: List of System
Messages for the complete list of System Messages and SIM numbers. See also
Section 9: Service and Maintenance, Subsection: Event Log.
The System Messages region will display up to seven messages at one time, with
the most recent appearing at the top of the region. When a system message appears
in the System Messages region, the operator can point and roll the mouse cursor
over the message line to display the full system message description information:
Date and Time that the event occurred
Sequence Number that the event occurred
Type of system event:
Information
Warning
Operator-Correctable Fault
Sample Loader Fault
Fatal Fault
Description of the event

System Event Types

The following table contains the categories of event types that can display in the
System Messages region.

Event Type ICON Message Example

Information Samples completed

Warning QC Rule alert

OCF (Operator Correctable Fault) WBC Lyse Empty

SL Fault (Sample Loader) Rack bar code read failure

Fatal Fault Analyzer failed to prime

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Information and Warning messages displayed in the System Messages region are
provided for informational purposes only and, based on their level of importance
for troubleshooting purposes, are documented to the System Event Log. They do
not have a System Information Message (SIM) dialog box associated with them.
Operator Correctable Fault (OCF), SL Fault, and Fatal Fault messages have an
associated SIM dialog box. Refer to Subsection: List of System Messages for the
complete list of System Messages and SIM numbers. See also Section 9: Service
and Maintenance, Subsection: Event Log.

System Information Messages (SIMs)

The System Information Message (SIM) dialog box will display when the System
detects certain conditions that are inconsistent with normal functioning. The SIM
dialog box indicates: a brief description of the event, an error code and the most
likely or least time consuming corrective action for the problem. If this corrective
action does not resolve the problem, refer to the Subsection: System Information
Message (SIM) Tables for additional instructions.
A SIM dialog box will have either one or a combination of two buttons (Clear
Fault or Save). The Clear Fault button will remove the SIM dialog box from the
view and the System Messages region. The Save button will remove the SIM
dialog box from the view but save the message in the System Messages region. The
operator can point and roll the mouse cursor over the message line to display the
full system message description information or point and click on the message line
to re-open the SIM dialog box. Saving messages that contain a Clear Fault button
causes the System to remain in an OCF or SL Fault State until the situation is
actually corrected and the SIM is cleared.
If a System action is required in order to clear a fault condition, then a Clear Fault
button is displayed in the SIM dialog box. The operator must select the Clear Fault
button to initiate the System action. In some cases, the operator is required to take
action (for example, emptying waste) before selecting the Clear Fault button. In
such cases, the operator action will be displayed in the corrective action field of the
SIM dialog box.
NOTE: If the System must perform an action to resolve the problem, the Analyzer
Status will indicate a current state when the action has been completed. If
the Analyzer Status indicates Ready State, sample processing can be
resumed. If the System or operator action does not clear the fault, samples
cannot be processed. Refer to Subsection: System Information Message
(SIM) Tables for additional instructions and if further action does not
clear the fault, you must contact your Country Service and Support Center
to resolve the problem.

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If the Analyzer Status indicates Fatal Fault State, only the Save button is available
in SIM dialog box. It is important for the operator to review the recommended
corrective action described in the SIM dialog box before selecting the Save button
to remove the SIM dialog box from the view but save the message in the System
Messages region. The operator can point and roll the mouse cursor over the
message line to display the full system message description information or point
and click on the message line to re-open the SIM dialog box. Saving messages that
only contain a Save button causes the System to remain in a Fatal Fault State until
the situation is actually corrected.

Data-Related Problems
Data-related problems are noticed by the operator during review and analysis of
result data. This category includes problems that cause elevated backgrounds,
imprecision, or trends or shifts in control data.
NOTE: If the controls are out of range or if the instrument appears to be
inaccurate, follow your laboratorys protocols to determine whether
calibration is required. If necessary, refer to Section 6: Calibration
Procedures for details.

Troubleshooting Procedures
The procedures in this section are for troubleshooting purposes only. A specific
procedure should be performed under one of the following conditions:
1. To correct a problem described in this section.
2. At the request of an Abbott Customer Service Specialist.
WARNING: Potential Biohazard. Follow established biosafety practices
when performing maintenance, service or troubleshooting procedures.
Refer to Section 8: Hazards for additional information.

Troubleshooting Tips and Techniques

Effective troubleshooting is possible only when the problem is clearly recognized
and the probable cause is isolated. This is always facilitated by obtaining sufficient
information and data pertaining to the specific problem. Carefully observe the
situation. Document the steps that have been taken and record all results. The
following section is designed to guide the operator through a logical series of steps
to obtain information regarding the nature of the problem. If it is necessary to call
for technical assistance, this information should be made available to the Country
Service and Support Center.

Troubleshooting the Background Count

1. Determine which parameter(s) exceed the background count specifications:
WBC, RBC, PLT, HGB, NOC.*
* Background counts for NOC are available on the Datalog and QC View,
Diff tab.
2. Check the Datalog to determine when the problem first occurred.

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Overview Section 10

3. Check the Reagent Log, Maintenance Log and, if applicable, service reports
to see if the problem occurred immediately after a specific action. For
example, did the problem occur immediately after the reagent was changed?
4. Check the Background count in the open and closed modes to see if the
problem is common to both modes. To do this in closed mode, you must have
a sample tube filled with Diluent/Sheath to aspirate for a background count.
5. Note the lot number of the reagent. Is it a new lot?
6. Configure the Run View to display the appropriate graphic for the
parameter(s) for which the background exceeds the specifications:

Parameter Appropriate Graphic

WBC WBC Histogram/Scatterplots
RBC RBC and PLT Histograms/Scatterplots
PLT RBC and PLT Histograms/Scatterplots
HGB WBC, RBC and PLT Histograms
NOC NOC Histogram
Obtain several printouts of this information by running multiple background
cycles.
NOTE: Instructions for customizing the Run View, see Section 2:
Installation Procedures and Special Requirements, Subsection:
System Customization.
7. Configure the Datalog to display values for WBC, RBC, PLT, HGB, and
NOC. Obtain printouts of the Data Log, including the sequence numbers of
the background cycles.
NOTE: Instructions for customizing the Datalog, see Section 2:
Installation Procedures and Special Requirements, Subsection:
System Customization.

Troubleshooting Reagent Problems

If a reagent (or reagents) is suspected as the cause of a particular problem, replace
it. However, the Analyzer has reservoirs that contain a small amount of reagent to
maintain the supply within the system. This supply must be depleted before
installing the new reagent.
NOTE: There is no reservoir for the HGB Lyse reagent. The amount of HGB Lyse
contained in the lyse supply tubing is sufficient to maintain the systems
supply. The HGB Lyse tubing is drained and filled by pressing the
appropriate reagent key displayed on the Special Protocol Empty/Fill
Reagent Reservoir dialog box described below.
To ensure that the new reagent is actually in the system, proceed as follows:
1. From Maintenance view, Special Protocols tab, select the Empty/Fill
Reagent Reservoir task button.
2. From the Empty/Fill Reagent Reservoir dialog box, select button for the
desired reagent and follow the instructions given on the screen.

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3. Wipe the reagent line with a lint-free wipe before placing it in the new
container. Place the line in the container and secure the cap.
4. Select the button to refill the reservoir.
5. Run five Background counts before assessing the results.
NOTE: Verify background count results are within acceptable limits prior
to running controls or patient specimens.

Troubleshooting the Sampling error-incomplete aspiration

Message
1. Check to see if the problem occurs in both the Open and Closed Modes of
operation. If the problem is confined to one mode only, the other may be
eliminated as the cause of the problem.
2. Determine whether the problem is a true incomplete aspiration. Run a sample
and verify that blood is visible in the sample tubing above the appropriate
probe or needle.
3. Verify that blood is pulled through the Shear Valve. Blood should be visible
in the lines (approximately one inch) on both sides of the Shear Valve before
it rotates.

Troubleshooting a Flow Error Message

1. The flow error messages indicate a problem with the kinetic rate of the WBC,
RBC/PLT, or NOC measurements. The kinetic information is available
immediately after the run cycle is finished in the Count Rate Summary file.
2. Select Run View, then select Diagnostics, Diagnostics Views from the menu
bar to add the Diagnostics Views tab to the Run View.
3. Using the mouse, click open the Count Rate Summary file to access the
count rate data and graph views for WOC, RBC/PLT, or NOC.
4. Click on the view you wish to print and select F1 Print.
5. Configure the Run View to display the WBC Size/Complexity scatter and the
WBC N-L-M histogram. Obtain several printouts. This information can help
to determine if the flow is erratic or just momentarily interrupted.
NOTE: Instructions for customizing the Datalog, see Section 2:
Installation Procedures and Special Requirements, Subsection:
System Customization.

Troubleshooting Imprecise or Inaccurate Data

1. Obtain a normal blood sample. Select Calibration, Quick Precision Check
from the menu bar to open the Quick Precision Check dialog box.
2. Enter the Specimen ID and run a minimum of ten Open Mode runs, then press
the Print button.
3. Select the New Precision Check button to clear the dialog box and run a
minimum of ten closed mode runs, then press the Print button.
4. Review the information to determine if the problem is mode or measurement
related.
5. Obtain printouts of related data as indicated in the following steps.

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6. WBC:
Configure the Run View to display the following and select F1 Print. (This
requires two printouts per sample.)
Printout 1:
WBC: Size-Cmp (010)
WBC: Grn-Lob (90D90)
WBC: 900 deg Scatter
WBC: N-L-M histogram
WBC: M-P histogram
RBC: 9010 deg Scatter
Printout 2:
NOC: NOC histogram
NOTE: Instructions for customizing the Datalog, see Section 2:
Installation Procedures and Special Requirements, Subsection:
System Customization.
Obtain printouts of the Count Rate Summary view, WOC Count Rate
Data, and WOC Count Rate Graphs view for several samples. See
previous procedure: Troubleshooting a Flow Error Message.
Select the Raw Data Summary view, then select F1 Print immediately
after the problem sample is run from the Diagnostics View tab.
If there is a flagging problem or a problem with an abnormal sample, obtain
a printout of a normal sample for comparison.
Configure the Datalog to display and print WBC and NOC values. Print the
results for the last 100 cycles.
NOTE: Instructions for customizing the Datalog, see Section 2:
Installation Procedures and Special Requirements, Subsection:
System Customization.
7. RBC, HGB, MCV and PLT:
Configure the Run View to display the following and select F1 Print of
problem samples.
RBC 010 deg Scatter
RBC 9010 deg Scatter
RBC RBC Volume
RBC RBC/PLT 0 Histogram
RBC RBC/PLT 10 Histogram
RBC PLT Histogram
Select the Raw Data Summary view, then select F1 Print immediately
after the problem sample is run from the Diagnostics View tab.

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Select QC View, F5 - Moving Average, F1 Print to obtain a printout of

the X-B tab view. Select the RBC tab view and scroll to view the Hemoglobin
Sample Mean HbS Mn and the Hemoglobin Reference Mean HbR Mn
columns, press the Print Scrn key on the keyboard to obtain a printout.
Check the Hemoglobin Reference and verify that its values are within 2050
250.
Check the hemoglobin Flow Cell if the reference value is <1800.
If the Hemoglobin Reference Value is >2300, call your local Country Service
and Support Center.
8. NOC:
Obtain the same information given in step 6.
Obtain printouts of the Count Rate Summary view, NOC Count Rate
Data, and NOC Count Rate Graphs view for several samples. See previous
procedure: Troubleshooting a Flow Error Message.

Troubleshooting Imprecise or Inaccurate Data

Probable Cause Corrective Action

1. Improper Sample Mixing 1. Verify all samples are well-mixed prior to analysis.
(Refer to Section 5: Operating Instructions,
Subsection: Routine System Startup.)

2. Dirty Syringe(s) 1. Inspect/Clean syringe as directed is

Section 9: Service and Maintenance,
Subsection: Scheduled Maintenance
Procedures.

3. Leaking Syringe(s) 1. Inspect syringe for evidence of leaks.

2. Verify syringe connectors are secure.
3. Remove/Clean/Replace syringe as directed in
Section 9: Service and Maintenance,
Subsection: Scheduled Maintenance
Procedures.

4. Dirty Shear Valve 1. Clean shear valve as directed in

Section 9: Service and Maintenance,
Subsection: Scheduled Maintenance
Procedures.

5. Worn Sample Transfer Pump Tubing 1. Inspect/Replace sample transfer pump tubing as
directed in Section 9: Service and
Maintenance, Subsection: Scheduled
Maintenance Procedures.

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List of System Messages

The following table lists the System Messages and SIMs that can be displayed in
the System Messages Region on the CELL-DYN Ruby.

SIM ID Numbers Message Text Event Type Saved to Event Log

N/A Initialization succeeded Information Yes (not displayed in

System Messages region)

N/A Initialization Start: sw ver Information Yes (not displayed in

xxxx System Messages region)

N/A Prime finished auto bkg Information Yes (not displayed in

to follow System Messages region)

N/A Starting Auto Background Information Yes (not displayed in

System Messages region)

N/A Admin password was Information Yes (not displayed in

reset System Messages region)

N/A Cant change to/from retic Warning No

in current state

N/A Specimen ID name must Warning No

include between 3 and 20
non-space characters

0102 3 Consecutive Flow Errors Warning Yes

0103 Sampling error Warning Yes

incomplete aspiration

0104 Processor Tower cover SL Fault Yes

open

0118 RETIC Test Selection, but Warning No

not in RETIC mode

0119 Non-RETIC Test Selection, Warning No

but in RETIC mode

0120 QC Rule Alert in QCID Warning Yes

XXXXX for Seq YYYY

0121 No tube present Information Yes

0122 Samples completed Information Yes

0123 3 Consecutive Short Warning Yes

Samples

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SIM ID Numbers Message Text Event Type Saved to Event Log

0124 WOC flow error Warning No

0125 NOC flow error Warning No

0126 RBC flow error Warning No

0127 Retic flow error Warning No

0128 Retic bar code read in Warning Yes

closed mode

0129 Bar code xx mismatch for Warning Yes

order Rxx Tyy

0130 Rxx Tyy order and QCID Warning Yes

mismatch

0131 Processor Tower Cover Operator Correctable Yes

Open Fault

0643 WBC Lyse Empty OCF Yes

0644 HGB Lyse Empty OCF Yes

0645 Dil/Sheath Empty OCF Yes

0646 Waste Full OCF Yes

0647 WBC Lyse reagent left < Warning Yes

10% (x%)

0648 HGB Lyse reagent left < Warning Yes

10% (x%)

0649 Dil/Sheath reagent left < Warning Yes

10% (x%)

0840 Vacuum Accumulator #1 Fatal Fault Yes

Wet

0841 Vacuum Accumulator #2 Fatal Fault Yes

Wet

0842 Shear valve position fault Fatal Fault Yes

0843 RBC diluent syringe Fatal Fault Yes

overpressure

1093 Mix head failed to SL Fault Yes

complete downward
rotation

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SIM ID Numbers Message Text Event Type Saved to Event Log

1094 Mix head failed to SL Fault Yes

complete upward rotation

1095 Mix head not at top SL Fault Yes

position

1096 Mix head stuck at top SL Fault Yes

position

1097 Tube stuck in position 3 SL Fault Yes

1098 Tube stuck in position 4 SL Fault Yes

1099 Invalid tube height SL Fault Yes

1100 Tube dropped during SL Fault Yes

mixing

1101 Mix zone rack position SL Fault Yes

error

1102 Unexpected tube in SL Fault Yes

position 4 after rack
advance

1103 Tube lost moving from SL Fault Yes

position 3 to position 4

1104 Mix zone must be cleared SL Fault Yes

for reset

1105 Excessive cycling SL Fault Yes

1106 Unload area full Information Yes

1107 Unload area hardware SL Fault Yes

malfunction

1108 Closed mode needle stuck SL Fault Yes

at home position

1109 Closed mode needle SL Fault Yes

unable to reach home
position

1110 Unload area nearly full Information Yes

1111 Load zone empty Information Yes

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SIM ID Numbers Message Text Event Type Saved to Event Log

1257 Shear valve position Fatal Fault Yes

sensor fault

1631 WOC heater temperature Warning Yes

out of range

1632 HGB heater temperature Warning Yes

out of range

1633 Three consecutive WOC Warning Yes

heater errors

1634 Three consecutive HGB Warning Yes

heater errors

2072 Analyzer initialization Fatal Fault Yes

failed

2073 Error opening A32MAIN.S Fatal Fault Yes

2074 Error opening Fsq <name Fatal Fault Yes

of Fsq>

2075 Unable to open HSSL Fatal Fault Yes

driver

2076 HSSL Error Fatal Fault Yes

2077 Flow script timeout <name Fatal Fault Yes

of fsq>

2078 Invalid Parameter in Fsq Fatal Fault Yes

<name of fsq>

2079 Invalid Macro in Fsq Fatal Fault Yes

<name of fsq>

2080 HSSL bad command or Fatal Fault Yes

command sent at
inappropriate time

2081 HSSL bad command or Warning Yes

command sent at
inappropriate time

2082 Message ack timeout on Fatal Fault Yes

Analyzer

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SIM ID Numbers Message Text Event Type Saved to Event Log

2083 Analyzer monitor (bios) Fatal Fault Yes

received illegal command

2084 Runtime error in Analyzer Fatal Fault Yes

Module

2085 DMA controller error during Fatal Fault Yes

list mode acquisition

2086 DMA controller setup error Fatal Fault Yes

2088 Bad checksum in non- Fatal Fault Yes

volatile RAM

2089 Incorrect FSQ command Fatal Fault Yes

on Analyzer

2090 Sample handler command Fatal Fault Yes

negatively acknowledged

2091 Flow sequence timeout on Fatal Fault Yes

Analyzer

2092 Retransmission error on Fatal Fault Yes

Analyzer

2093 <Tower or Loader> Fatal Fault Yes

transmission failure

2094 <Tower or Loader> Fatal Fault Yes

communication failure

2095 <Tower or Loader> direct Fatal Fault Yes

command parameter error

2096 <Tower or Loader> motor SL Fault Yes

command timing error

2097 <Tower or Loader> invalid Fatal Fault Yes

direct command

2098 <Tower or Loader> invalid Fatal Fault Yes

processing command

2099 Analyzer failed to prime Fatal Fault Yes

2100 HSSL timeout Fatal Fault Yes

2237 Rack bar code read failure SL Fault Yes

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SIM ID Numbers Message Text Event Type Saved to Event Log

2238 Tube position bar code SL Fault Yes

read failure

2442 Unable to open Warning Yes

communication

2443 LIS transmit Err: Warning Yes

invalid specid

2444 LIS transmit Err: Warning Yes

already on LIS queue

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System Information Message (SIM) Tables

The following tables give the number, message, probable cause(s), and corrective
action(s) for System Information Messages (SIMs).

0102 3 Consecutive Flow Errors

Event Type: Warning
The Analyzer Status region indicates Ready.
NOTE: The Loader halts.

Probable Cause(s) Corrective Action(s)

Three consecutive flow error messages (of the 1. Three consecutive flow errors of the same type
same type) occurred during Loader operation. will cause the Loader to halt. Refer to
Subsection: Troubleshooting a Flow Error
Message.
2. If unable to resolve this problem, contact
Abbott Customer Service.

0103 Sampling error incomplete aspiration

Event Type: Warning
The Analyzer Status region indicates current state.
NOTE: This message does not halt the Loader.
SAMPLING ERROR is displayed to the right of the PLT result in the Run View.
SAMPLING ERROR is printed on all reports. Results may look like background counts.

Probable Cause(s) Corrective Action(s)

The sensor system did not detect a sufficient 1. Check the specimen tube to be sure it contains a
amount of sample at the expected time sufficient quantity of sample. Verify that the
following aspiration. specimen contains no clots.
2. Clean the Open Mode Probe or the Closed
Mode Needle as directed in Section 9: Service
and Maintenance, Subsection: 6052 Clean
or Replace Open Mode Probe or 6053 Clean
or Replace Closed Mode Needle to remove any
obstructions.
3. Clean the Shear Valve as directed in Section 9:
Service and Maintenance, Subsection: 6006
Clean Shear Valve.
4. If unable to resolve this problem, contact
Abbott Customer Service.

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0104 Processor Tower cover open

Event Type: SL Fault
The Analyzer Status region indicates Loader Fault.
NOTE: The Loader halts.
The circuit formed when the Processor cover in place has been broken.

Probable Cause(s) Corrective Action(s)

The System in Closed Mode and the 1. Reinstall or reset the Processor cover. Make
Processor Tower Cover has been removed or sure the cover is held in position by the magnets
is not seated properly. on the instrument frame.
2. Reset the racks. Reset the Loader by pressing
the following keys in order: Clear Fault, Start
Loader, Reset Loader.
A failure of the sensor or related electronics If unable to resolve this problem, contact Abbott
has occurred. Customer Service.

0118 RETIC Test Selection, but not in RETIC Mode

Event Type: Warning
The Analyzer Status region indicates current state.
NOTE: This message does not halt the Loader.
The software has identified a Specimen ID match within the Pending Orders during Specimen ID entry in the
Next Open Tube Entry region; however, the test selection for the Specimen ID in the Pending Orders does not
match the current test selection in the Next Open Tube Entry region.

Probable Cause(s) Corrective Action(s)

Specimen ID in the Pending Orders does not 1. Update the Test Selection in the Next Open
match the current test selection in the Next Tube Entry region to match the test selection in
Open Tube Entry region. the Pending Orders and process the specimen.
NOTE: When this action is complete, the
matched Pending Order will be removed.
2. (Optional) Process the specimen but do not
update the Test Selection in the Next Open
Entry region to match the test selection in the
Pending Orders.
NOTE: When this action is complete, the
demographic information for the Specimen ID
is transferred to the Next Open Tube Entry
(Detailed) window; however, the Specimen ID
record remains in Pending Orders.

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0119 Non-RETIC Test Selection, but in RETIC mode

Event Type: Warning
The Analyzer Status region indicates current state.
NOTE: This message does not halt the Loader.
The software has identified a Specimen ID match within the Pending Orders during Specimen ID entry in the
Next Open Tube Entry region; however, the test selection for the Specimen ID in the Pending Orders does not
match the current test selection in the Next Open Tube Entry region.

Probable Cause(s) Corrective Action(s)

Specimen ID in the Pending Orders does not 1. Update the Test Selection in the Next Open
match the current test selection in the Next Tube Entry region to match the test selection in
Open Tube Entry region. the Pending Orders and process the specimen.
NOTE: When this action is complete, the
matched Pending Order will be removed.
2. (Optional) Process the specimen but Do Not
update the Test Selection in the Next Open
Entry region to match the test selection in the
Pending Orders.
NOTE: When this action is complete, the
demographic information for the Specimen ID
is transferred to the Next Open Tube Entry
(Detailed) window; however, the Specimen ID
record remains in Pending Orders.

0120 QC Rule Alert in QCID XXXXX for Seq YYYY

Event Type: Warning
The Analyzer Status region indicates current state.
The QC Status region Rule Alert: indicates Yes.
NOTE: This message does not halt the Loader.
One or more of the Westgard Rules has been violated.

Probable Cause(s) Corrective Action(s)

The data in the QCID file has violated one or Review the data in the QCID file and take
more of the enabled Westgard Rules selected appropriate action.
during set up of the QCID file.

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0121 No tube present

Event Type: Information
The Analyzer Status region indicates current state.
NOTE: The Loader halts.

Probable Cause(s) Corrective Action(s)

The tube being processed is not tall enough. 1. Verify recommended collection tube
dimensions for use in closed mode. See
Section 7: Operational Precautions and
Limitations for recommended collection tube
dimensions for use in Loader Mode.
2. Reset the Racks.
3. Reset the Loader by pressing the following
keys in order; Clear Fault, Start Loader, Reset
Loader.
A failure of the sensor or related electronics If unable to resolve this problem, contact Abbott
has occurred. Customer Service.

0122 Samples completed

Event Type: Information
The Analyzer Status region indicates current state.
NOTE: The Loader halts.
The last rack in the load zone has been processed. No corrective action is necessary. When you wish to run
additional samples in the Loader, load racks and press the Start Loader key.

0123 3 Consecutive Short Samples

Event Type: Warning
The Analyzer Status region indicates READY.
NOTE: The Loader halts.

Probable Cause(s) Corrective Action(s)

Three consecutive 0103 Sampling error 1. Three consecutive 0103 Sampling error
incomplete aspiration messages occurred incomplete aspiration messages will cause the
during Loader operation. Loader to halt. Refer to Subsection:
Troubleshooting the Sampling error-
incomplete aspiration Message.
2. If unable to resolve this problem, contact
Abbott Customer Service.

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0124 WOC flow error

Event Type: Warning
The Analyzer Status region indicates current state.
NOTE: This message does not halt the Loader.
WOC FLOW ERROR is displayed to the right of the EOS result in the Run View.
WOC FLOW ERROR is printed on all reports. The invalid numerical results for WBC and Differential are
marked with an asterisk [*]. Review all results marked with an asterisk. Follow your laboratorys procedures.

Probable Cause(s) Corrective Action(s)

An increasing WOC count rate was detected Rerun the specimen.

in the optical flow cell during the WOC
measurement.
Optical flow cell is dirty or contains bubbles. 1. Select Maintenance, Special Protocols tab.
a. Perform Empty/Fill Optical Flow Cell.
2. Select Scheduled tab.
a. Perform Auto-Clean and/or Extended
Auto-Clean.
Sample dilution delivery problem. 1. Select Maintenance, Scheduled tab.
a. Perform Replace Transfer Pump Tubing.
2. Clean Sample Injection Syringe, check for
leakage, and replace as necessary.
Dil/Sheath flow (partially) obstructed. 1. Select Maintenance, Scheduled tab.
a. Perform Replace Dil/Sheath Filter.

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0125 NOC flow error

Event Type: Warning
The Analyzer Status region indicates current state.
NOTE: This message does not halt the Loader.
NOC FLOW ERROR is displayed under the BASO result in the Run view.
NOC FLOW ERROR is printed on all reports. The invalid numerical results for WBC and Differential are
marked with an asterisk [*]. Review all results marked with an asterisk. Follow your laboratorys procedures.

Probable Cause(s) Corrective Action(s)

An increasing NOC count rate was detected Rerun the specimen.

in the optical flow cell during the NOC
measurement.
Optical flow cell is dirty or contains bubbles. 1. Select Maintenance, Special Protocols tab.
a. Perform Empty/Fill Optical Flow Cell.
2. Select Scheduled tab.
a. Perform Auto-Clean and/or Extended
Auto-Clean.
Sample dilution delivery problem. 1. Select Maintenance, Scheduled tab.
a. Perform Replace Transfer Pump Tubing.
2. Clean Sample Injection Syringe, check for
leakage, and replace as necessary.
Dil/Sheath flow (partially) obstructed. 1. Select Maintenance, Scheduled tab.
a. Perform Replace Dil/Sheath Filter.

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0126 RBC flow error

Event Type: Warning
The Analyzer Status region indicates current state.
NOTE: This message does not halt the Loader.
RBC FLOW ERROR is displayed to the right of the RDW result in the Run view.
RBC FLOW ERROR is printed on all reports. The invalid numerical results for RBC, PLT, and related
parameters are marked with an asterisk [*]. Review all results marked with an asterisk. Follow your
laboratorys procedures.

Probable Cause(s) Corrective Action(s)

An increasing RBC count rate was detected in Rerun the specimen.

the optical flow cell during the RBC
measurement.
Optical flow cell is dirty or contains bubbles. 1. Select Maintenance, Special Protocols tab.
a. Perform Empty/Fill Optical Flow Cell.
2. Select Scheduled tab.
a. Perform Auto-Clean and/or Extended
Auto-Clean.
Sample dilution delivery problem. 1. Select Maintenance, Scheduled tab.
a. Perform Replace Transfer Pump Tubing.
2. Clean Sample Injection Syringe, check for
leakage, and replace as necessary.
Dil/Sheath flow (partially) obstructed. 1. Select Maintenance, Scheduled tab.
a. Perform Replace Dil/Sheath Filter.

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0127 Retic Flow error

Event Type: Warning
The Analyzer Status region indicates current state.
FLOW ERROR is displayed under ALERTS in the Run view.
FLOW ERROR is printed on all reports. The invalid numerical results for %R and RETC parameters are
marked with an asterisk [*]. Review all results marked with an asterisk. Follow your laboratorys procedures.

Probable Cause(s) Corrective Action(s)

An increasing Retic Count rate was detected Rerun the Reticulocyte specimen.
in the optical flow cell during the Retic
measurement.
An air bubble. Run a background count to cycle air through the
system and rerun the Reticulocyte specimen.
If problem occurs repeatedly, refer to Subsection:
Troubleshooting a Flow Error Message

0128 Retic bar code read in closed mode

Event Type: Warning
The Analyzer Status region indicates current state.
NOTE: This message does not halt the Loader.
When this message appears, the System has detected a tube labeled with a reticulocyte QCID or a reticulocyte
Specimen ID bar code label during Closed Mode processing. The System will run the default patient test
selection and the <Spec ID> field will be replaced with the <Rxx Tyy> (rack and tube) position.
NOTE: The CELL-DYN Ruby Reticulocyte assay is run in the Open Mode only. See Section 12: Reticulocyte
Package for more information on running reticulocyte specimens.

Probable Cause(s) Corrective Action(s)

A reticulocyte QCID or a reticulocyte No corrective action is necessary.

Specimen ID bar code label was read during Rerun the specimen in the Open Mode using the
Closed Mode processing. RETIC test selection.
See also Section 12: Reticulocyte Package.

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0129 Bar code xx mismatch for order Rxx Tyy

Event Type: Warning
The Analyzer Status region indicates current state.
NOTE: This message does not halt the Loader.
When this message appears, the Orders Setup dialog box has been configured to use rack and tube matching
and the System has detected that the bar code label specimen ID on the tube is different from the specimen ID
in the rack and tube order. The System will process the specimen using the Default Patient Test Selection and
the Spec ID field in the Datalog will be replaced with the specimen rack and tube position information.

0130 Rxx Tyy order and QCID mismatch

Event Type: Warning
The Analyzer Status region indicates current state.
NOTE: This message does not halt the Loader.
When this message appears, the Orders Setup dialog box has been configured to use rack and tube matching
and the System has detected that the bar code label specimen ID on the tube matches a QCID file and does not
match the specimen ID in the rack and tube order. The System will run the QCID test selection with results
placed into the QCID file. The rack and tube order from the Pending Orders log is not deleted.

0131 Processor Tower Cover Open

Event Type: Operator Correctable Fault
The Analyzer Status region indicates OCF.
NOTE: After the current sample completes, no more samples can be run.

Probable Cause(s) Corrective Action(s)

1. The operator requests system 1. Reinstall or reset the processor cover.

initialization and the processor 2. Press Clear Fault to close the SIM dialog box.
cover has been removed or is not
seated properly.
2. The system is processing an open
mode aspiration and the processor
cover has been removed or is not
seated properly.

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0643 WBC Lyse Empty

Event Type: OCF (Operator Correctable Fault)
The Analyzer Status region indicates Op Correc. Fault.
NOTE: The Loader halts.

Probable Cause(s) Corrective Action(s)

Container is empty. 1. Install a new container of reagent.

2. Press Clear Fault.
NOTE: Do not pour any remaining reagent
into the new container.
3. Enter new reagent information.
4. Run 5 or more background counts and review
results. Background results must be within
acceptable limits before running controls or
patient specimens.
5. Run a whole blood before QC or Patient testing.
Reagent inlet tubing is crimped or Inspect the whole length of the inlet tubing to ensure
obstructed. it is not crimped and/or remove any obstruction.
Reagent line is not on the bottom of the Ensure that the line is properly inserted in the
container. container and the sinker is on the bottom of the
container.
An incorrect reagent or a nonconductive 1. Check the label on the reagent container to be
liquid is connected to the inlet tube. sure the correct reagent is installed.
2. Trace the line to the inlet connector and ensure
that it is connected to the correct one.
3. Check the connection to be sure it is secure and
then press Clear Fault.
Appropriate syringe not mounted properly. Check proper mounting of syringes.
The Luer fitting connection on the top of the Verify the Luer connection on the top of syringes is
appropriate syringe is loose. secure.
The tubing in solenoid valve is pinched or not 1. Check tubing in N/C valve 23 (WBC Lyse) is
fully inserted. not pinched or obstructed; replace as necessary.
2. Verify tubings are fully inserted in solenoids 23,
25 (WBC Lyse).
Circuitry malfunction. Contact Abbott Customer Service.

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0644 HGB Lyse Empty

Event Type: OCF (Operator Correctable Fault)
The Analyzer Status region indicates Op Correc. Fault.
NOTE: The Loader halts.

Probable Cause(s) Corrective Action(s)

Container is empty. 1. Install a new container of reagent.

2. Press Clear Fault.
NOTE: Do not pour any remaining reagent
into the new container.
3. Enter new reagent information.
4. Run 5 or more background counts and review
results. Background results must be within
acceptable limits before running controls or
patient specimens.
5. Run a whole blood before QC or Patient testing.
Reagent inlet tubing is crimped or Inspect the whole length of the inlet tubing to ensure
obstructed. it is not crimped and/or remove any obstruction.
Reagent line is not on the bottom of the Ensure that the line is properly inserted in the
container. container and the sinker is on the bottom of the
container.
An incorrect reagent or a nonconductive 1. Check the label on the reagent container to be
liquid is connected to the inlet tube. sure the correct reagent is installed.
2. Trace the line to the inlet connector and ensure
that it is connected to the correct one.
3. Check the connection to be sure it is secure and
then press Clear Fault.
Appropriate syringe not mounted properly. Check proper mounting of syringes.
The Luer fitting connection on the top of Verify the Luer connection on the top of syringes is
the appropriate syringe is loose. secure.
The tubing in solenoid valve is pinched or 1. Check tubing in N/C valve 28 (HGB Lyse) is
not fully inserted. not pinched or obstructed; replace as necessary.
2. Verify tubings are fully inserted in solenoids 28,
24 (HGB Lyse).
Circuitry malfunction. Contact Abbott Customer Service.

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0645 Dil/Sheath Empty

Event Type: OCF (Operator Correctable Fault)
The Analyzer Status region indicates Op Correc. Fault.
NOTE: The Loader halts.

Probable Cause(s) Corrective Action(s)

Container is empty. 1. Install a new container of reagent.

2. Press Clear Fault.
NOTE: Do not pour any remaining reagent
into the new container.
3. Enter new reagent information.
4. Run 5 or more background counts and review
results. Background results must be within
acceptable limits before running controls or
patient specimens.
5. Run a whole blood before QC or Patient testing.
Reagent inlet tubing is crimped or Inspect the whole length of the inlet tubing to ensure
obstructed. it is not crimped and/or remove any obstruction.
Reagent line is not on the bottom of the Ensure that the line is properly inserted in the
container. container and the sinker is on the bottom of the
container.
An incorrect reagent or a nonconductive 1. Check the label on the reagent container to be
liquid is connected to the inlet tube. sure the correct reagent is installed.
2. Trace the line to the inlet connector and ensure
that it is connected to the correct one.
3. Check the connection to be sure it is secure and
then press Clear Fault.
Appropriate syringe not mounted properly. Check proper mounting of syringes.
The Luer fitting connection on the top of Verify the Luer connection on the top of syringes is
the appropriate syringe is loose. secure.
Circuitry malfunction. Contact Abbott Customer Service.

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0646 Waste Full

Event Type: OCF (Operator Correctable Fault)
The Analyzer Status region indicates Op Correc. Fault.
NOTE: The Loader halts.

Probable Cause(s) Corrective Action(s)

External waste container full. WARNING: Potential Biohazard.

Identifies an activity or area where you may
be exposed to potentially infectious material.

Empty the waste container and/or replace it. Press

Clear Fault to resume operation.
NOTE: Make sure the Analyzer rinse process has
been completed before removing the waste
tube.
Waste sensor connector is loose or Reconnect the waste sensor connector and then
disconnected. press Clear Fault.
Shorted wire(s) or electrode(s) on the waste Visually inspect wires and electrodes and call for
cap. technical assistance.
Circuitry malfunction. If the message appears repeatedly, contact Abbott
Customer Service.

0647 WBC Lyse reagent left < 10% (x%)

Event Type: Warning
The Analyzer Status region indicates current state.
NOTE: This message does not halt the Loader.
The amount of WBC Lyse reagent in the container is less than 10%. The message displays the actual percentage
of reagent left in the parentheses (x%). No corrective action is necessary. SIM 0643 WBC Lyse Empty message
will alert the operator when reagent container replacement is required.

0648 HGB Lyse reagent left < 10% (x%)

Event Type: Warning
The Analyzer Status region indicates current state.
NOTE: This message does not halt the Loader.
The amount of HGB Lyse reagent in the container is less than 10%. The message displays the actual percentage
of reagent left in the parentheses (x%). No corrective action is necessary. SIM 0644 HGB Lyse Empty message
will alert the operator when reagent container replacement is required.

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0649 Dil/Sheath reagent left < 10% (x%)

Event Type: Warning
The Analyzer Status region indicates current state.
NOTE: This message does not halt the Loader.
The amount of Diluent/Sheath reagent in the container is less than 10%. The message displays the actual
percentage of reagent left in the parentheses (x%). No corrective action is necessary. SIM 0645 Dil/Sheath
Empty message will alert the operator when reagent container replacement is required.

0840 Vacuum Accumulator #1 Wet

Event Type: Fatal Fault
The Analyzer Status region indicates Fatal Fault.
NOTE: The Loader halts.

Probable Cause(s) Corrective Action(s)

Liquid is detected in Vacuum Accumulator 1. Review the following recommended corrective

#1. action.
2. Press the Save button to close the SIM dialog
box.
3. Select Maintenance, Special Protocols tab.
a. Perform Drain Accumulators procedure.
b. Perform Initialize Analyzer.
c. Perform Vacuum Accumulator 1 and 2
Rinsing Procedure. Refer to Section 9:
Service and Maintenance, Subsection:
Nonscheduled Maintenance Procedures.
d. Perform Prime.
NOTE: Verify background count results
are within acceptable limits prior to running
controls or patient specimens.

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0841 Vacuum Accumulator #2 Wet

Event Type: Fatal Fault
The Analyzer Status region indicates Fatal Fault.
NOTE: The Loader halts.

Probable Cause(s) Corrective Action(s)

Liquid is detected in Vacuum Accumulator 1. Review the following recommended corrective

#2. action.
2. Press the Save button to close the SIM dialog
box.
3. Select Maintenance then Special Protocols
tab.
a. Perform Drain Accumulators procedure
two times.
b. Perform Initialize Analyzer.
c. Perform Vacuum Accumulator 1 and 2
Rinsing Procedure. Refer to Section 9:
Service and Maintenance, Subsection:
Nonscheduled Maintenance Procedures.
d. Perform Prime.
NOTE: Verify background count results
are within acceptable limits prior to running
controls or patient specimens.

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0842 Shear valve position fault

Event Type: Fatal Fault
The Analyzer Status region indicates Fatal Fault.
NOTE: The Loader halts.

Probable Cause(s) Corrective Action(s)

The Shear Valve did not rotate properly or in 1. Review the following recommended corrective
the allotted time. action.
2. Press the Save button to close the SIM dialog
box.
3. If using the Loader, reset the racks before
proceeding to the next step.
4. Select Maintenance then Scheduled tab.
a. Perform Clean Shear Valve.
5. Select Special Protocols tab.
a. Perform Initialize Analyzer.
b. Perform Prime.
NOTE: Verify background count results
are within acceptable limits prior to running
controls or patient specimens.
6. If the message appears again, reboot the system.
a. Select File, then Shutdown
b. Select OK to initiate Shutdown.
c. Wait 5-10 seconds after the display turns
black, then press the Data Station power
button to reboot the system.
NOTE: See Section 5: Operating
Instructions, Subsection: Power On and
Power Off.
Sensor or cable malfunction. If the problem occurs repeatedly, contact Abbott
Customer Service.

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0843 RBC diluent syringe overpressure

Event Type: Fatal Fault
The Analyzer Status region indicates Fatal Fault.
NOTE: The Loader halts.
Diluent/Sheath syringe attempted to move up and pressure exceeding the allowed limit was detected in the
Diluent/Sheath line.

Probable Cause(s) Corrective Action(s)

The Shear Valve did not rotate properly or in 1. Review the following recommended corrective
the allotted time and a blockage obstructs the action.
Diluent/Sheath reagent distribution through 2. Press the Save button to close the SIM dialog
the flow system. box.
3. If using the Loader, reset the racks before
proceeding to the next step.
4. Reboot the system.
a. Select File, then Shutdown
b. Select OK to initiate Shutdown.
c. Wait 5-10 seconds after the display turns
black, then press the Data Station power
button to reboot the system.
NOTE: See Section 5: Operating
Instructions, Subsection: Power On and
Power Off.
5. Select Maintenance then Scheduled tab.
a. Perform Clean Shear Valve.
6. Select Special Protocols tab.
a. Perform Initialize Analyzer.
b. Perform Prime.
NOTE: Verify background count results
are within acceptable limits prior to running
controls or patient specimens.
Sensor or cable malfunction. If the problem occurs repeatedly, contact Abbott
Customer Service.

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1093 Mix head failed to complete downward rotation

Event Type: SL Fault
The Analyzer Status region indicates Loader Fault.
NOTE: The Loader halts.
The Mix Head failed to return to its vertical position.

Probable Cause(s) Corrective Action(s)

A mechanical problem is preventing the Mix 1. Remove the Processor Cover.

Head from rotating downward. 2. Check for an obstruction that is preventing the
Mix Head from rotating downward. If an
obstruction is found, remove it.
3. Reinstall the Processor Cover, reset the racks,
and reset the Loader by pressing the following
keys in order: Clear Fault, Start Loader,
Reset Loader.
A failure of the magnetic reed sensor or If the message appears repeatedly, contact Abbott
related electronics has occurred. Customer Service.

1094 Mix head failed to complete upward rotation

Event Type: SL Fault
The Analyzer Status region indicates Loader Fault.
NOTE: The Loader halts.
The Mix Head failed to move from its vertical position.

Probable Cause(s) Corrective Action(s)

A mechanical problem is preventing the Mix 1. Remove the Processor Cover.

Head from rotating upward. 2. Check for an obstruction that is preventing the
Mix Head from rotating upward and, if one is
found, remove it.
3. Reinstall the Processor Cover, reset the racks,
and reset the Loader by pressing the following
keys in order: Clear Fault, Start Loader,
Reset Loader.
A failure of the magnetic reed sensor or If the message appears repeatedly, contact Abbott
related electronics has occurred. Customer Service.

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1095 Mix head not at top position

Event Type: SL Fault
The Analyzer Status region indicates Loader Fault.
NOTE: The Loader halts.
The Mix/Lift Assembly failed to reach its top position.

Probable Cause(s) Corrective Action(s)

A mechanical problem is preventing Mix/Lift 1. Remove the Processor Cover.

Assembly is from moving upward. 2. Check for an obstruction that is preventing the
Mix/Lift Assembly from moving upward and, if
one is found, remove it.
3. Reinstall the Processor Cover, reset the racks,
and reset the Loader by pressing the following
keys in order: Clear Fault, Start Loader,
Reset Loader.
A failure of the optical sensor or related If the message appears repeatedly, contact Abbott
electronics has occurred. Customer Service.

1096 Mix head stuck at top position

Event Type: SL Fault
The Analyzer Status region indicates Loader Fault.
NOTE: The Loader halts.
The Mix/Lift Assembly failed to move from its top position.

Probable Cause(s) Corrective Action(s)

A mechanical problem is preventing the Mix/ 1. Remove the Processor Cover.

Lift Assembly from moving downward. 2. Check for an obstruction that is preventing the
Mix/Lift Assembly from moving downward
and, if one is found, remove it.
3. Reinstall the Processor Cover, reset the racks,
and reset the Loader by pressing the following
keys in order: Clear Fault, Start Loader,
Reset Loader.
A failure of the optical sensor or related If the message appears repeatedly, contact Abbott
electronics has occurred. Customer Service.

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1097 Tube stuck in position 3

Event Type: SL Fault
The Analyzer Status region indicates Loader Fault.
NOTE: The Loader halts.
The sensor for tube position 3 in the mixing zone is sensing the presence of a tube when the tube should be
lifted clear of the rack by the Mix Head.

Probable Cause(s) Corrective Action(s)

The tube in position 3 has liquid on it. 1. Remove the Processor Cover.
2. Dry the tube in position 3 and verify that it is not
leaking.
NOTE: For the location of the tube sensors,
refer to the figure in Section 1: Use or
Function, Subsection: Sample Loader
Components.
3. Reinstall the Processor Cover, reset the racks.
Reset the Loader by pressing the following keys
in order: Clear Fault, Start Loader, Reset
Loader.
The tube in position 3 either has a loose bar 1. If the bar code label is loose, secure it in place.
code label or too many bar code labels. If multiple bar code labels are on the tube,
remove them and carefully apply a single bar
code label.
NOTE: For information concerning proper
application of bar code labels, refer to
Section 4: Performance Characteristics and
Specifications, Subsection: Bar Code Label
Placement:.
2. Reset the racks, and reset the Loader by
pressing the following keys in order: Clear
Fault, Start Loader, Reset Loader.

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1097 Tube stuck in position 3 (Continued)

Event Type: SL Fault
The Analyzer Status region indicates Loader Fault.
NOTE: The Loader halts.
The sensor for tube position 3 in the mixing zone is sensing the presence of a tube when the tube should be
lifted clear of the rack by the Mix Head.

Probable Cause(s) Corrective Action(s)

The Mix Head Tube Grippers are dirty. 1. Remove the Processor Cover.
2. Using a lint-free wipe moistened with a 0.5%
sodium hypochlorite solution, clean the Mix
Head Tube Grippers. Refer to Section 9:
Service and Maintenance, Subsection: 6002
Clean Loader Components. (See the formula
for mixing this solution under Section 9:
Service and Maintenance, Subsection:
Decontamination Procedures.)
3. Repeat Step 2 with deionized water. Dry the
Mix Head thoroughly.
4. Reinstall the Processor Cover, reset the racks,
and reset the Loader by pressing the following
keys in order: Clear Fault, Start Loader,
Reset Loader.
A failure of the sensor or related electronics If the message appears repeatedly, contact Abbott
has occurred. Customer Service.

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1098 Tube stuck in position 4

Event Type: SL Fault
The Analyzer Status region indicates Loader Fault.
NOTE: The Loader halts.
The sensor for tube position 4 in the mix zone is sensing the presence of a tube when the tube should be lifted
clear of the rack.

Probable Cause(s) Corrective Action(s)

The tube in position 4 has liquid on it. 1. Remove the Processor Cover.
2. Dry the tube in position 4 and verify that it is not
leaking.
3. Reinstall the Processor Cover. Reset the racks.
Reset the Loader by pressing the following keys
in order: Clear Fault, Start Loader, Reset
Loader.
The tube in position 4 either has a loose bar 1. If the bar code label is loose, secure it in place.
code label or too many bar code labels. If multiple bar code labels are on the tube,
remove them and carefully apply a single bar
code label.
NOTE: For information concerning proper
application of bar codes, refer to Section 4:
Performance Characteristics and
Specifications, Subsection: Bar Code Label
Placement:
2. Reset the racks, and reset the Loader by
pressing the following keys in order: Clear
Fault, Start Loader, Reset Loader.
The Mix Head Tube Grippers are dirty. 1. Remove the Processor Cover.
2. Using a lint-free wipe moistened with a 0.5%
sodium hypochlorite solution, clean the Mix
Head Tube Grippers. Refer to Section 9:
Service and Maintenance, Subsection: 6002
Clean Loader Components. (See the formula
for mixing this solution under Section 9:
Service and Maintenance, Subsection:
Decontamination Procedures.)
3. Repeat Step 2 with deionized water. Dry the
Mix Head thoroughly.
4. Reinstall the Processor Cover, reset the racks,
and reset the Loader by pressing the following
keys in order: Clear Fault, Start Loader,
Reset Loader.

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1098 Tube stuck in position 4 (Continued)

Probable Cause(s) Corrective Action(s)

The tube position sensor is dirty. 1. Remove the Processor Cover.

2. Using a lint-free wipe moistened with lens
cleaner or deionized water, clean the tube
sensors (the tube position 4 sensor is on the
left). Dry the sensors thoroughly.
NOTE: For the location of the tube sensors,
refer to the figure in Section 1: Use or
Function, Subsection: Sample Loader
Components.
3. Reinstall the Processor Cover, reset the racks,
and reset the Loader by pressing the following
keys in order: Clear Fault, Start Loader,
Reset Loader.
A failure of the sensor or related electronics If the message appears repeatedly, contact Abbott
has occurred. Customer Service.

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1099 Invalid tube height

Event Type: SL Fault
The Analyzer Status region indicates Loader Fault.
NOTE: The Loader halts.
The tube height sensor system indicates that the tube at the Aspiration Station exceeds height specification.

Probable Cause(s) Corrective Action(s)

The instrument cannot accommodate the 1. Verify recommended collection tube

height of the tube. dimensions for use in Closed Mode. Section 7:
Operational Precautions and Limitations,
Subsection: Requirements for Handling
Specimens for recommended collection tube
dimensions for use in Loader Mode.
2. Reset the racks. Reset the Loader by pressing
the following keys in order: Clear Fault, Start
Loader, Reset Loader.
A failure of the sensor or related electronics 1. Reset the racks. Reset the Loader by pressing
has occurred. the following keys in order: Clear Fault, Start
Loader, Reset Loader.
2. If unable to resolve this problem, contact
Abbott Customer Service.
The tube height sensor flag on the aspiration The Guide Shafts are the three vertical bars on the
tower is not moving into position properly aspiration tower.
because the Guide Shafts are obstructed or 1. Remove the Processor Cover.
dirty.
2. Check for an obstruction that is preventing the
tube spinning assembly with tube height sensor
flag from moving up and down properly and, if
one is found, remove it.
3. Using a lint-free wipe moistened with isopropyl
alcohol, clean the Guide Shafts.
4. Reinstall the Processor cover. Reset the racks.
Reset the Loader by pressing the following keys
in order: Clear Fault, Start Loader, Reset
Loader.
The tube height sensor flag is bent or the Contact Abbott Customer Service.
tower sensors, motor, or related electronics
are defective.

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1100 Tube dropped during mixing

Event Type: SL Fault
The Analyzer Status region indicates Loader Fault.
NOTE: The Loader halts.
A tube was sensed as missing from tube position 3 or 4 after the mixing cycle.

Probable Cause(s) Corrective Action(s)

The tube in position 3 or 4 has liquid on it. 1. Remove the Processor Cover.
2. Dry the tubes in position 3 and 4, and verify that
they are not leaking.
3. Reinstall the Processor Cover. Reset the racks.
Reset the Loader by pressing the following keys
in order: Clear Fault, Start Loader, Reset
Loader.
The Mix Head Tube Gripper is dirty. 1. Remove the Processor Cover.
2. Using a lint-free wipe moistened with a 0.5%
sodium hypochlorite solution, clean the Mix
Head Tube Grippers. Refer to Section 9:
Service and Maintenance, Subsection: 6002
Clean Loader Components. (See the formula
for mixing this solution under Section 9:
Service and Maintenance, Subsection:
Decontamination Procedures.)
3. Repeat Step 2 with deionized water. Dry the
Mix Head thoroughly.
4. Reinstall the Processor Cover. Reset the racks.
Reset the Loader by pressing the following keys
in order: Clear Fault, Start Loader, Reset
Loader.
A failure of the sensor system or related 1. Remove the Processor Cover.
electronics has occurred. 2. Using a lint-free wipe moistened with lens
cleaner or deionized water, clean the tube
sensors. Dry the sensors thoroughly.
NOTE: For the location of the tube sensors,
refer to the figure in Section 1: Use or
Function, Subsection: Sample Loader
Components.
3. Reinstall the Processor Cover. Reset the racks.
Reset the Loader by pressing the following keys
in order: Clear Fault, Start Loader, Reset
Loader.

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1100 Tube dropped during mixing

Event Type: SL Fault
The Analyzer Status region indicates Loader Fault.
NOTE: The Loader halts.
A tube was sensed as missing from tube position 3 or 4 after the mixing cycle.

A failure of the bladder or bladder pressure Contact Abbott Customer Service.

system has occurred.

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1101 Mix zone rack position error

Event Type: SL Fault
The Analyzer Status region indicates Loader Fault.
NOTE: The Loader halts.
The rack tube position bar code number read was not the number expected.

Probable Cause(s) Corrective Action(s)

The rack did not advance. 1. Check for an obstruction that is preventing the
rack from advancing and, if one is found,
remove it.
2. Reset the racks. Reset the Loader by pressing
the following keys in order: Clear Fault, Start
Loader, Reset Loader.
The rack and/or Loader Tray are dirty. 1. Select Clear Fault.
2. Reset the racks before proceeding to the next
step.
3. Select Maintenance then Scheduled tab.
a. Perform Clean Loader Components.
4. Reset the Loader by pressing the following keys
in order: Start Loader, Reset Loader.
A failure of the Air Cylinder or a failure in the Contact Abbott Customer Service.
Air Cylinder pressure system has occurred.

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1102 Unexpected tube in position 4 after rack advance

Event Type: SL Fault
The Analyzer Status region indicates Loader Fault.
NOTE: The Loader halts.
A tube was not sensed in tube position 3 before a rack advance, but a tube was sensed in tube position 4 after
a rack advance.

Probable Cause(s) Corrective Action(s)

The rack did not advance. 1. Check for an obstruction that is preventing the
rack from advancing and, if one is found,
remove it.
2. Reset the racks. Reset the Loader by pressing
the following keys in order: Clear Fault, Start
Loader, Reset Loader.
The rack and/or Loader Tray are dirty. 1. Select Clear Fault.
2. Reset the racks before proceeding to the next
step.
3. Select Maintenance then Scheduled tab.
a. Perform Clean Loader Components.
4. Reset the Loader by pressing the following keys
in order: Start Loader, Reset Loader.
A failure of the Air Cylinder or the Air Contact Abbott Customer Service.
Cylinder pressure system has occurred.
Tube sensor in position 3 is dirty. 1. Remove the Processor Cover.
2. Using a lint-free wipe moistened with lens
cleaner or deionized water, clean the tube
sensors. Dry the sensors thoroughly.
NOTE: For the location of the tube sensors,
refer to the figure in Section 1: Use or
Function, Subsection: Sample Loader
Components.
3. Reinstall the Processor Cover, reset the racks,
and reset the Loader by pressing the following
keys in order: Clear Fault, Start Loader,
Reset Loader.
A failure of the sensor system or related Contact Abbott Customer Service.
electronics has occurred.

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1103 Tube lost moving from position 3 to position 4

Event Type: SL Fault
The Analyzer Status region indicates Loader Fault.
NOTE: The Loader halts.
A tube was sensed in tube position 3 before the rack advance, but a tube was not sensed in tube position 4 after
the rack advance.

Probable Cause(s) Corrective Action(s)

The rack did not advance. 1. Check for an obstruction that is preventing the
rack from advancing and, if one is found,
remove it.
2. Reset the racks. Reset the Loader by pressing
the following keys in order: Clear Fault, Start
Loader, Reset Loader.
The rack and/or Loader Tray are dirty. 1. Select Clear Fault.
2. Reset the racks before proceeding to the next
step.
3. Select Maintenance then Scheduled tab.
a. Perform Clean Loader Components.
4. Reset the Loader by pressing the following keys
in order: Start Loader, Reset Loader.
A failure of the Air Cylinder or the Air Contact Abbott Customer Service.
Cylinder pressure system has occurred.
Tube sensor in position 4 is dirty. 1. Remove the Processor Cover.
2. Using a lint-free wipe moistened with lens
cleaner or deionized water, clean the tube
sensors. Dry the sensors thoroughly.
NOTE: For the location of the tube sensors,
refer to the figure in Section 1: Use or
Function, Subsection: Sample Loader
Components.
3. Reinstall the Processor Cover, reset the racks,
and reset the Loader by pressing the following
keys in order: Clear Fault, Start Loader,
Reset Loader.
A failure of the sensor system or related Contact Abbott Customer Service.
electronics has occurred.

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1104 Mix zone must be cleared for reset

Event Type: SL Fault
The Analyzer Status region indicates Loader Fault.
NOTE: The Loader halts.
The sensor system indicates that a tube is present in tube position 4 immediately after the Loader was reset, but
a rack has not yet been pushed into the mix zone.

Probable Cause(s) Corrective Action(s)

A rack remains in the mix zone when the 1. Remove the rack from the mix zone.
Loader is reset. 2. Reset the racks. Reset the Loader by pressing
the following keys in order: Clear Fault, Start
Loader, Reset Loader.
There is an obstruction at tube position 4 that 1. Remove the Processor Cover.
is activating the sensor. 2. Check for an obstruction at tube position 4 that
is activating the sensor and, if one is found,
remove it.
3. Reinstall the Processor Cover. Reset the racks.
Reset the Loader by pressing the following keys
in order: Clear Fault, Start Loader, Reset
Loader.
Tube sensor in position 4 is dirty. 1. Remove the Processor Cover.
2. Using a lint-free wipe moistened with lens
cleaner or deionized water, clean the tube
sensors. Dry the sensors thoroughly.
NOTE: For the location of the tube sensors,
refer to the figure in Section 1: Use or
Function, Subsection: Sample Loader
Components.
3. Reinstall the Processor Cover, reset the racks,
and reset the Loader by pressing the following
keys in order: Clear Fault, Start Loader,
Reset Loader.
A failure of the sensor system or related Contact Abbott Customer Service.
electronics has occurred.

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1105 Excessive cycling

Event Type: SL Fault
The Analyzer Status region indicates Loader Fault.
NOTE: The Loader halts.
Twenty rack advances have occurred without a tube being sensed in the mix zone or twenty-five rack advances
have occurred after the last tube was processed.

Probable Cause(s) Corrective Action(s)

The System is functioning as intended. No corrective action is necessary. When you wish to
run additional samples in the Loader, load tubes in
racks and press the keys in the following order:
Clear Fault, Start Loader, Resume Loader.
The rack advance mechanism is not making 1. Check for an obstruction that is preventing the
contact with the racks. rack arms from extending and holding the racks
against the loader wall so the racks can engage
with the rack advance mechanism. If an
obstruction is found, remove it.
2. Reset the racks and reset the Loader by pressing
the following keys in order: Clear Fault, Start
Loader, Resume Loader.
Both tube sensors are dirty. 1. Remove the Processor Cover.
2. Using a lint-free wipe moistened with lens
cleaner or deionized water, clean the tube
sensors. Dry the sensors thoroughly.
NOTE: For the location of the tube sensors,
refer to the figure in Section 1: Use or
Function, Subsection: Sample Loader
Components.
3. Reinstall the Processor Cover, reset the racks,
and reset the Loader by pressing the following
keys in order: Clear Fault, Start Loader,
Resume Loader.
A failure of the sensor or related electronics, Contact Abbott Customer Service.
or loader mechanisms, has occurred.

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1106 Unload area full

Event Type: Information
The Analyzer Status region indicates current state.
NOTE: The Loader halts.
The unload area contains 5 racks. No corrective action is necessary. When you wish to run additional samples
in the Loader, remove the racks from the unload area and press the Start Loader key.

1107 Unload area hardware malfunction

Event Type: SL Fault
The Analyzer Status region indicates Loader Fault.
NOTE: The Loader halts.
The sensor system is indicating that the unload area is full (contains 5 racks), but is not indicating that it is also
nearly full (contains 4 racks).

Probable Cause(s) Corrective Action(s)

One or more racks did not move properly in 1. Check for an obstruction that is preventing rack
the unload area. movement in the unload area and, if one is
found, remove it.
2. Reset the racks. Reset the Loader by pressing
the following keys in order: Clear Fault, Start
Loader, Reset Loader.
A failure of the sensor system or related If the message appears repeatedly, contact Abbott
electronics has occurred. Customer Service.

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1108 Closed mode needle stuck at home position

Event Type: SL Fault
The Analyzer Status region indicates Loader Fault.
NOTE: The Loader halts.
The home position for the probe is the uppermost position. The sensor indicates that the needle is in the home
position when the System does not expect the probe to be homed.

Probable Cause(s) Corrective Action(s)

A mechanical problem has prevented the 1. Remove the Processor Cover.

closed mode needle from leaving the home 2. Check for an obstruction with the aspiration
position on the aspiration tower. tower that is preventing the closed mode needle
from leaving the home position and, if one is
found, remove it.
3. Reinstall the Processor Cover. Reset the racks.
Reset the Loader by pressing the following keys
in order: Clear Fault, Start Loader, Reset
Loader.
A failure of the sensor or related electronics If the message appears repeatedly, contact Abbott
has occurred. Customer Service.
The tower, motor, or related electronics is Contact Abbott Customer Service.
defective.

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1109 Closed mode needle unable to reach home position

Event Type: SL Fault
The Analyzer Status region indicates Loader Fault.
NOTE: The Loader halts.
The home position for the probe is the uppermost position. The sensor system indicates that the needle is not
in the home position when the system expects the probe to be homed.

Probable Cause(s) Corrective Action(s)

A mechanical problem has prevented the 1. Remove the Processor Cover.

closed mode needle from leaving the home 2. Check for an obstruction with the aspiration
position on the aspiration tower. tower that is preventing the closed mode needle
from leaving the home position and, if one is
found, remove it.
3. Reinstall the Processor Cover. Reset the racks.
Reset the Loader by pressing the following keys
in order: Clear Fault, Start Loader, Reset
Loader.
A failure of the sensor or related electronics If the message appears repeatedly, contact Abbott
has occurred. Customer Service.
The tower, motor, or related electronics is Contact Abbott Customer Service.
defective.

1110 Unload area nearly full

Event Type: Information
The Analyzer Status region indicates current state.
NOTE: This message does not halt the Loader.
The unload area contains 4 racks. No corrective action is necessary. If a rack is being processed and there are
no other faults, the Loader will continue to operate.

1111 Load zone empty

Event Type: Information
The Analyzer Status region indicates current state.
The load zone empty sensor is not sensing the presence of a rack in the load zone.
NOTE: The Loader halts.
No corrective action is necessary. When you wish to run samples in the Loader, load tubes in racks and press
the Start Loader key.

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Overview Section 10

1257 Shear valve position sensor fault

Event Type: Fatal Fault
The Analyzer Status region indicates Fatal Fault.
NOTE: The Loader halts.

Probable Cause(s) Corrective Action(s)

The Shear Valve did not rotate properly or in 1. Review the following recommended corrective
the allotted time. action.
2. Press the Save button to close the SIM dialog
box.
3. If using the Loader, reset the racks before
proceeding to the next step.
4. Select Maintenance then Scheduled tab.
a. Perform Clean Shear Valve.
5. Select Special Protocols tab.
a. Perform Initialize Analyzer.
b. Perform Prime.
NOTE: Verify background count results
are within acceptable limits prior to running
controls or patient specimens.
6. If the message appears again, reboot the system.
a. Select File, then Shutdown
b. Select OK to initiate Shutdown.
c. Wait 5-10 seconds after the display turns
black, then press the Data Station power
button to reboot the system.
NOTE: See Section 5: Operating
Instructions, Subsection: Power On and
Power Off.
Sensor or cable malfunction. If the problem occurs repeatedly, contact Abbott
Customer Service.

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1631 WOC heater temperature out of range

Event Type: Warning
The Analyzer Status region indicates current state.
NOTE: The Loader halts.
System detected reagent heater temperature out of specification range.
WOC HEATER ERROR is displayed to the right of the platelet parameter result region in the Run View.
WOC HEATER ERROR is printed on all reports. The invalid numerical results for WBC and Differential are
marked with an asterisk [*]. Review all results marked with an asterisk. Follow your laboratorys procedures.

Probable Cause(s) Corrective Action(s)

WOC heater temperature is sensed as being 1. If using the Loader, reset the racks before
outside of the manufacturers specified range proceeding to the next step.
due to: 2. Reboot the system.
1. Ambient temperature below or above a. Select File, then Shutdown
manufacturers specified range.
b. Select OK to initiate Shutdown.
2. Heater temperature sensor failure.
c. Wait 5-10 seconds after the display turns
3. Heater is stuck OFF (low temperature black, then press the Data Station power
failure) or ON (high temperature failure). button to reboot the system.
NOTE: See Section 5: Operating
Instructions, Subsection: Power On and
Power Off.
3. If the message appears repeatedly, contact
Abbott Customer Service.

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Overview Section 10

1632 HGB heater temperature out of range

Event Type: Warning
The Analyzer Status region indicates current status.
NOTE: The Loader halts.
System detected reagent heater temperature out of specification range.
HGB HEATER ERROR is displayed to the right of the platelet parameter result region in the Run View.
HGB HEATER ERROR is printed on all reports. The invalid numerical results for WBC (if NOC is chosen),
Differential, HGB, MCH, and MCHC are marked with an asterisk [*]. Review all results marked with an
asterisk. Follow your laboratorys procedures.

Probable Cause(s) Corrective Action(s)

HGB heater temperature is sensed as being 1. If using the Loader, reset the racks before
outside of the manufacturers specified range proceeding to the next step.
due to: 2. Run a background count and review results.
1. Heater temperature sensor failure. Background results must be within acceptable
2. Heater is stuck OFF (low temperature limits before running controls or Patient
failure) or ON (high temperature failure). Specimens.
3. If the message appears again, reboot the system.
a. Select File, then Shutdown
b. Select OK to initiate Shutdown.
c. Wait 5-10 seconds after the display turns
black, then press the Data Station power
button to reboot the system.
NOTE: Section 5: Operating
Instructions, Subsection: Power On and
Power Off.
4. If the message appears repeatedly, contact
Abbott Customer Service.

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1633 Three consecutive WOC Heater Errors

Event Type: Warning
The Analyzer Status region indicates the current state.
NOTE: The Loader halts.

Probable Cause(s) Corrective Action(s)

Three consecutive WOC Heater Error 1. Troubleshoot the WOC heater.

messages occurred during loader operation.

1634 Three consecutive HGB Heater Errors

Event Type: Warning
The Analyzer Status region indicates the current state.
NOTE: The Loader halts.

Probable Cause(s) Corrective Action(s)

Three consecutive HGB Heater Errors 1. Troubleshoot the HGB heater.

occurred during loader operation.

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Overview Section 10

2072 Analyzer initialization failed

Event Type: Fatal Fault
The Analyzer Status region indicates Fatal Fault.

Probable Cause(s) Corrective Action(s)

The instrument software was unable to 1. Review the following recommended corrective
initialize. action.
2. Press the Save button to close the SIM dialog
box.
3. If using the Loader, reset the racks before
proceeding to the next step.
4. Select Maintenance, Special Protocols tab.
a. Perform Initialize Analyzer.
b. Perform Prime.
NOTE: Verify background count results
are within acceptable limits prior to running
controls or patient specimens.
5. If the message appears again, reboot the system.
a. If using the Loader, reset the racks before
proceeding to the next step.
b. Select File, then Shutdown
c. Select OK to initiate Shutdown.
d. Wait 5-10 seconds after the display turns
black, then press the Data Station power
button to reboot the system.
NOTE: See Section 5: Operating
Instructions, Subsection: Power On and
Power Off.
6. If the message appears repeatedly, contact
Abbott Customer Service.

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2073 Error opening A32MAIN.S

Event Type: Fatal Fault
NOTE: The Analyzer Status region indicates Fatal Fault.

Probable Cause(s) Corrective Action(s)

The A32MAIN.S software file is missing 1. Review the following recommended corrective
after software installation or upgrade. action.
2. Press the Save button to close the SIM dialog
box.
3. If using the Loader, reset the racks before
proceeding to the next step.
4. Select Maintenance, Special Protocols tab.
a. Perform Initialize Analyzer.
b. Perform Prime.
NOTE: Verify background count results
are within acceptable limits prior to running
controls or patient specimens.
5. If the message appears again, reboot the system.
a. Select File, then Shutdown
b. Select OK to initiate Shutdown.
c. Wait 5-10 seconds after the display turns
black, then press the Data Station power
button to reboot the system.
NOTE: See Section 5: Operating
Instructions, Subsection: Power On and
Power Off.
6. If the message appears repeatedly, contact
Abbott Customer Service.
A failure in the Analyzer hardware, possibly Contact Abbott Customer Service.
related to the HSSL cable, card, or memory,
has occurred.

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Overview Section 10

2074 Error opening Fsq <name of Fsq>

Event Type: Fatal Fault
The Analyzer Status region indicates Fatal Fault.

Probable Cause(s) Corrective Action(s)

The allotted time for the flow sequence (Fsq) 1. Review the following recommended corrective
downloading was exceeded. action.
2. Press the Save button to close the SIM dialog
box.
3. If using the Loader, reset the racks before
proceeding to the next step.
4. Select Maintenance, Special Protocols tab.
a. Perform Initialize Analyzer.
b. Perform Prime.
NOTE: Verify background count results
are within acceptable limits prior to running
controls or patient specimens.
5. If the message appears again, reboot the system.
a. Select File, then Shutdown
b. Select OK to initiate Shutdown.
c. Wait 5-10 seconds after the display turns
black, then press the Data Station power
button to reboot the system.
NOTE: See Section 5: Operating
Instructions, Subsection: Power On and
Power Off.
6. If the message appears repeatedly, contact
Abbott Customer Service.
Computer hardware component failure or Contact Abbott Customer Service.
malfunction.

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2075 Unable to open HSSL driver

Event Type: Fatal Fault
The Analyzer Status region indicates Fatal Fault.

Probable Cause(s) Corrective Action(s)

Unable to open High Speed Serial Link 1. Review the following recommended corrective
(HSSL) driver action.
2. Press the Save button, to close the SIM dialog
box.
3. Check the HSSL cable connections.
NOTE: For the location of the HSSL ports,
refer to Section 1: Use or Function,
Subsection: Data Module Components.
4. Reboot the system.
a. Select File, then Shutdown
b. Select OK to initiate Shutdown.
c. Wait 5-10 seconds after the display turns
black, then press the Data Station power
button to reboot the system.
NOTE: See Section 5: Operating
Instructions, Subsection: Power On and
Power Off.
5. If the message appears repeatedly, contact
Abbott Customer Service.
Computer hardware component failure or Contact Abbott Customer Service.
malfunction.

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Overview Section 10

2076 HSSL Error

Event Type: Fatal Fault
The Analyzer Status region indicates Fatal Fault.

Probable Cause(s) Corrective Action(s)

Communication between Analyzer and Data 1. Review the following recommended corrective
Module failed. action.
2. Press the Save button to close the SIM dialog
box.
3. Check the HSSL cable connections.
NOTE: For the location of the HSSL ports,
refer to Section 1: Use or Function,
Subsection: Data Module Components.
4. Reboot the system.
a. Select File, then Shutdown
b. Select OK to initiate Shutdown.
c. Wait 5-10 seconds after the display turns
black, then press the Data Station power
button to reboot the system.
NOTE: See Section 5: Operating
Instructions, Subsection: Power On and
Power Off.
5. If the message appears repeatedly, contact
Abbott Customer Service.
Computer hardware component failure or Contact Abbott Customer Service.
malfunction.

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2077 Flow script timeout <name of fsq>

Event Type: Fatal Fault
The Analyzer Status region indicates Fatal Fault.

Probable Cause(s) Corrective Action(s)

Flow script did not execute in expected time. 1. Review the following recommended corrective
action.
2. Press the Save button to close the SIM dialog
box.
3. If using the Loader, reset the racks before
proceeding to the next step.
4. Select Maintenance, Special Protocols tab.
a. Perform Initialize Analyzer.
b. Perform Prime.
NOTE: Verify background count results
are within acceptable limits prior to running
controls or patient specimens.
5. If the message appears again, reboot the system.
a. Select File, then Shutdown
b. Select OK to initiate Shutdown.
c. Wait 5-10 seconds after the display turns
black, then press the Data Station power
button to reboot the system.
6. See Section 5: Operating Instructions,
Subsection: Power On and Power Off.
7. If the message appears repeatedly, contact
Abbott Customer Service.

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Overview Section 10

2078 Invalid Parameter in Fsq <name of fsq>

Event Type: Fatal Fault
The Analyzer Status region indicates Fatal Fault.
Size or structure of parameter (e.g., gain) is invalid.

Probable Cause(s) Corrective Action(s)

A software error has occurred. 1. Review the following recommended corrective

action.
2. Press the Save button to close the SIM dialog
box.
3. If using the Loader, reset the racks before
proceeding to the next step.
4. Select Maintenance, Special Protocols tab.
a. Perform Initialize Analyzer.
b. Perform Prime.
NOTE: Verify background count results
are within acceptable limits prior to running
controls or patient specimens.
5. If the message appears again, reboot the system.
a. Select File, then Shutdown
b. Select OK to initiate Shutdown.
c. Wait 5-10 seconds after the display turns
black, then press the Data Station power
button to reboot the system.
NOTE: See Section 5: Operating
Instructions, Subsection: Power On and
Power Off.
6. If the message appears repeatedly, contact
Abbott Customer Service.

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2079 Invalid Macro in Fsq <name of fsq>

Event Type: Fatal Fault
The Analyzer Status region indicates Fatal Fault.

Probable Cause(s) Corrective Action(s)

A software error has occurred. 1. Review the following recommended corrective

action.
2. Press the Save button to close the SIM dialog
box.
3. If using the Loader, reset the racks before
proceeding to the next step.
4. Select Maintenance, Special Protocols tab.
a. Perform Initialize Analyzer.
b. Perform Prime.
NOTE: Verify background count results
are within acceptable limits prior to running
controls or patient specimens.
5. If the message appears again, reboot the system.
a. Select File, then Shutdown
b. Select OK to initiate Shutdown.
c. Wait 5-10 seconds after the display turns
black, then press the Data Station power
button to reboot the system.
NOTE: See Section 5: Operating
Instructions, Subsection: Power On and
Power Off.
6. If the message appears repeatedly, contact
Abbott Customer Service.

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Overview Section 10

2080 HSSL bad command or command sent at inappropriate time

Event Type: Fatal Fault
The Analyzer Status region indicates Fatal Fault.

Probable Cause(s) Corrective Action(s)

Data Module and Analyzer did not 1. Review the following recommended corrective
communicate properly. action.
2. Press the Save button to close the SIM dialog
box.
3. If using the Loader, reset the racks before
proceeding to the next step.
4. Select Maintenance, Special Protocols tab.
a. Perform Initialize Analyzer.
b. Perform Prime.
NOTE: Verify background count results
are within acceptable limits prior to running
controls or patient specimens.
5. If the message appears again, reboot the system.
a. Select File, then Shutdown
b. Select OK to initiate Shutdown.
c. Wait 5-10 seconds after the display turns
black, then press the Data Station power
button to reboot the system.
NOTE: See Section 5: Operating
Instructions, Subsection: Power On and
Power Off.
6. If the message appears repeatedly, contact
Abbott Customer Service.

2081 HSSL bad command or command sent at inappropriate time

Event Type: Warning
The Analyzer Status region indicates current state.
NOTE: This message does not halt the Loader.
This is a warning that a bad command or a command was sent to the Analyzer at an unexpected time. No
corrective action is necessary.

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2082 Message ack timeout on Analyzer

Event Type: Fatal Fault
The Analyzer Status region indicates Fatal Fault.

Probable Cause(s) Corrective Action(s)

Communication between the Analyzer and 1. Review the following recommended corrective
the Data Module did not occur when action.
expected. 2. Press the Save button to close the SIM dialog
box.
3. Check the HSSL cable connections.
NOTE: For the location of the HSSL ports,
refer to Section 5: Operating Instructions,
Subsection: Power On and Power Off.
4. Reboot the system.
a. Select File, then Shutdown
b. Select OK to initiate Shutdown.
c. Wait 5-10 seconds after the display turns
black, then press the Data Station power
button to reboot the system.
NOTE: See Section 5: Operating
Instructions, Subsection: Power On and
Power Off.
5. If the message appears repeatedly, contact
Abbott Customer Service.

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Overview Section 10

2083 Analyzer monitor (bios) received illegal command

Event Type: Fatal Fault
The Analyzer Status region indicates Fatal Fault.
This message pertains to a software execution monitor on the Analyzer, not the display screen (LCD).

Probable Cause(s) Corrective Action(s)

During the initialization process, the Data 1. Review the following recommended corrective
Module and Analyzer did not communicate action.
properly. 2. Press the Save button to close the SIM dialog
box.
3. If using the Loader, reset the racks before
proceeding to the next step.
4. Select Maintenance, Special Protocols tab.
a. Perform Initialize Analyzer.
b. Perform Prime.
NOTE: Verify background count results
are within acceptable limits prior to running
controls or patient specimens.
5. If the message appears again, reboot the system.
a. Select File, then Shutdown
b. Select OK to initiate Shutdown.
c. Wait 5-10 seconds after the display turns
black, then press the Data Station power
button to reboot the system.
NOTE: See Section 5: Operating
Instructions, Subsection: Power On and
Power Off.
6. If the message appears repeatedly, contact
Abbott Customer Service.

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2084 Runtime error in Analyzer Module

Event Type: Fatal Fault
The Analyzer Status region indicates Fatal Fault.

Probable Cause(s) Corrective Action(s)

An illegal software operation was requested 1. Review the following recommended corrective
by the Analyzer. action.
2. Press the Save button to close the SIM dialog
box.
3. If using the Loader, reset the racks before
proceeding to the next step.
4. Select Maintenance, Special Protocols tab.
a. Perform Initialize Analyzer.
b. Perform Prime.
NOTE: Verify background count results
are within acceptable limits prior to running
controls or patient specimens.
5. If the message appears again, reboot the system.
a. Select File, then Shutdown
b. Select OK to initiate Shutdown.
c. Wait 5-10 seconds after the display turns
black, then press the Data Station power
button to reboot the system.
NOTE: See Section 5: Operating
Instructions, Subsection: Power On and
Power Off.
6. If the message appears repeatedly, contact
Abbott Customer Service.

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Overview Section 10

2085 DMA controller error during list mode acquisition

Event Type: Fatal Fault
The Analyzer Status region indicates Fatal Fault.
A direct memory access (DMA) control problem occurred during data acquisition.

Probable Cause(s) Corrective Action(s)

A failure in the Analyzer hardware has 1. Review the following recommended corrective
occurred. action.
2. Press the Save button to close the SIM dialog
box.
3. If using the Loader, reset the racks before
proceeding to the next step.
4. Select Maintenance, Special Protocols tab.
a. Perform Initialize Analyzer.
b. Perform Prime.
NOTE: Verify background count results
are within acceptable limits prior to running
controls or patient specimens.
5. If the message appears again, reboot the system.
a. Select File, then Shutdown
b. Select OK to initiate Shutdown.
c. Wait 5-10 seconds after the display turns
black, then press the Data Station power
button to reboot the system.
NOTE: See Section 5: Operating
Instructions, Subsection: Power On and
Power Off.
6. If the message appears repeatedly, contact
Abbott Customer Service.

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2086 DMA controller setup error

Event Type: Fatal Fault
The Analyzer Status region indicates Fatal Fault.
A problem occurred during setup of the direct memory access (DMA) controller.

Probable Cause(s) Corrective Action(s)

A failure in the Analyzer hardware has 1. Review the following recommended corrective
occurred. action.
2. Press the Save button to close the SIM dialog
box.
3. If using the Loader, reset the racks before
proceeding to the next step.
4. Select Maintenance, Special Protocols tab.
a. Perform Initialize Analyzer.
b. Perform Prime.
NOTE: Verify background count results
are within acceptable limits prior to running
controls or patient specimens.
5. If the message appears again, reboot the system.
a. Select File, then Shutdown
b. Select OK to initiate Shutdown.
c. Wait 5-10 seconds after the display turns
black, then press the Data Station power
button to reboot the system.
NOTE: See Section 5: Operating
Instructions, Subsection: Power On and
Power Off.
6. If the message appears repeatedly, contact
Abbott Customer Service.

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Overview Section 10

2088 Bad checksum in non-volatile RAM

Event Type: Fatal Fault
The Analyzer Status region indicates Fatal Fault.

Probable Cause(s) Corrective Action(s)

When the system was powered ON, the 1. Review the following recommended corrective
Analyzer did not transmit the correct message action.
to the Data Module. 2. Press the Save button to close the SIM dialog
box.
3. If using the Loader, reset the racks before
proceeding to the next step.
4. Reboot the system.
a. Select File, then Shutdown
b. Select OK to initiate Shutdown.
c. Wait 5-10 seconds after the display turns
black, then press the Data Station power
button to reboot the system.
NOTE: See Section 5: Operating
Instructions, Subsection: Power On and
Power Off.
5. If the message appears repeatedly, contact
Abbott Customer Service.

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2089 Incorrect FSQ command on Analyzer

Event Type: Fatal Fault
The Analyzer Status region indicates Fatal Fault.

Probable Cause(s) Corrective Action(s)

A software error has occurred. 1. Review the following recommended corrective

action.
2. Press the Save button to close the SIM dialog
box.
3. If using the Loader, reset the racks before
proceeding to the next step.
4. Reboot the system.
a. Select File, then Shutdown
b. Select OK to initiate Shutdown.
c. Wait 5-10 seconds after the display turns
black, then press the Data Station power
button to reboot the system.
NOTE: See Section 5: Operating
Instructions, Subsection: Power On and
Power Off.
5. If the message appears repeatedly, contact
Abbott Customer Service.

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Overview Section 10

2090 Sample handler command negatively acknowledged

Event Type: Fatal Fault
The Analyzer Status region indicates Fatal Fault.

Probable Cause(s) Corrective Action(s)

A software error has occurred. 1. Review the following recommended corrective

action.
2. Press the Save button to close the SIM dialog
box.
3. If using the Loader, reset the racks before
proceeding to the next step.
4. Reboot the system.
a. Select File, then Shutdown
b. Select OK to initiate Shutdown.
c. Wait 5-10 seconds after the display turns
black, then press the Data Station power
button to reboot the system.
NOTE: See Section 5: Operating
Instructions, Subsection: Power On and
Power Off.
5. If the message appears repeatedly, contact
Abbott Customer Service.

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2091 Flow sequence timeout on Analyzer

Event Type: Fatal Fault
The Analyzer Status region indicates Fatal Fault.

Probable Cause(s) Corrective Action(s)

A software error has occurred. 1. Review the following recommended corrective

action.
2. Press the Save button to close the SIM dialog
box.
3. If using the Loader, reset the racks before
proceeding to the next step.
4. Reboot the system.
a. Select File, then Shutdown
b. Select OK to initiate Shutdown.
c. Wait 5-10 seconds after the display turns
black, then press the Data Station power
button to reboot the system.
NOTE: See Section 5: Operating
Instructions, Subsection: Power On and
Power Off.
5. If the message appears repeatedly, contact
Abbott Customer Service.

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Overview Section 10

2092 Retransmission error on Analyzer

Event Type: Fatal Fault
The Analyzer Status region indicates Fatal Fault.
Communication from the Data Module to the Analyzer failed.

Probable Cause(s) Corrective Action(s)

A hardware failure or system error has 1. Review the following recommended corrective
occurred. action.
2. Press the Save button to close the SIM dialog
box.
3. Check the Hssl cable connections.
NOTE: For the location of the Hssl ports,
refer to Section 1: Use or Function,
Subsection: Data Module Components.
4. If using the Loader, reset the racks before
proceeding to the next step.
5. Select Maintenance, Special Protocols tab.
a. Perform Initialize Analyzer.
b. Perform Prime.
NOTE: Verify background count results
are within acceptable limits prior to running
controls or patient specimens.
6. If the message appears again, reboot the system.
a. Select File, then Shutdown
b. Select OK to initiate Shutdown.
c. Wait 5-10 seconds after the display turns
black, then press the Data Station power
button to reboot the system.
NOTE: See Section 5: Operating
Instructions, Subsection: Power On and
Power Off.
7. If the message appears repeatedly, contact
Abbott Customer Service.

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2093 <Tower or Loader> transmission failure

Event Type: Fatal Fault
The Analyzer Status region indicates Fatal Fault.
A transmission acknowledgment failure occurred between the Analyzer and the module that controls the tower
and loader.

Probable Cause(s) Corrective Action(s)

A failure of the electronics or communication 1. Review the following recommended corrective

hardware has occurred. action.
2. Press the Save button to close the SIM dialog
box.
3. If using the Loader, reset the racks before
proceeding to the next step.
4. Reboot the system.
a. Select File, then Shutdown
b. Select OK to initiate Shutdown.
c. Wait 5-10 seconds after the display turns
black, then press the Data Station power
button to reboot the system.
NOTE: See Section 5: Operating
Instructions, Subsection: Power On and
Power Off.
NOTE: If the message appears
repeatedly, contact Abbott Customer
Service.

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Overview Section 10

2094 <Tower or Loader> communication failure

Event Type: Fatal Fault
The Analyzer Status region indicates Fatal Fault.
A communication failure occurred between the Analyzer and the module that controls the tower and loader.

Probable Cause(s) Corrective Action(s)

A communication timing or handshake error 1. Review the following recommended corrective

has occurred. action.
2. Press the Save button to close the SIM dialog
box.
3. If using the Loader, reset the racks before
proceeding to the next step.
4. Reboot the system.
a. Select File, then Shutdown
b. Select OK to initiate Shutdown.
c. Wait 5-10 seconds after the display turns
black, then press the Data Station power
button to reboot the system.
NOTE: See Section 5: Operating
Instructions, Subsection: Power On and
Power Off.
5. If the message appears repeatedly, contact
Abbott Customer Service.

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2095 <Tower or Loader> direct command parameter error

Event Type: Fatal Fault
The Analyzer Status region indicates Fatal Fault.
The Analyzer command given to the module that controls the tower and loader is invalid.

Probable Cause(s) Corrective Action(s)

A software error has occurred. 1. Review the following recommended corrective

action.
2. Press the Save button to close the SIM dialog
box.
3. If using the Loader, reset the racks before
proceeding to the next step.
4. Reboot the system.
a. Select File, then Shutdown
b. Select OK to initiate Shutdown.
c. Wait 5-10 seconds after the display turns
black, then press the Data Station power
button to reboot the system.
NOTE: See Section 5: Operating
Instructions, Subsection: Power On and
Power Off.
5. If the message appears repeatedly, contact
Abbott Customer Service.

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Overview Section 10

2096 <Tower or Loader> motor command timing error

Event Type: SL Fault
The Analyzer Status region indicates Loader Fault.
NOTE: The Loader halts.
A motor in the Loader was busy (e.g., in motion) when a command was received and could not respond.

Probable Cause(s) Corrective Action(s)

A mechanical problem in the aspiration tower 1. Remove the Processor Cover.

or Loader has occurred. 2. Check for an obstruction in the aspiration tower
or Loader and remove it.
3. Reinstall the Processor Cover, reset the racks,
and reset the Loader by pressing the following
keys in order: Clear Fault, Start Loader, Reset
Loader.

2097 <Tower or Loader> invalid direct command

Event Type: Fatal Fault
The Analyzer Status region indicates Fatal Fault.
The Analyzer command given to the module that controls the tower and loader is invalid.

Probable Cause(s) Corrective Action(s)

A software error has occurred. 1. Review the following recommended corrective

action.
2. Press the Save button to close the SIM dialog
box.
3. If using the Loader, reset the racks before
proceeding to the next step.
4. Reboot the system.
a. Select File, then Shutdown
b. Select OK to initiate Shutdown.
c. Wait 5-10 seconds after the display turns
black, then press the Data Station power
button to reboot the system.
NOTE: See Section 5: Operating
Instructions, Subsection: Power On and
Power Off.
5. If the message appears repeatedly, contact
Abbott Customer Service.

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2098 <Tower or Loader> invalid process command

Event Type: Fatal Fault
The Analyzer Status region indicates Fatal Fault.
The Analyzer command given to the module that controls the tower and loader is invalid.

Probable Cause(s) Corrective Action(s)

A software error has occurred. 1. Review the following recommended corrective

action.
2. Press the Save button to close the SIM dialog
box.
3. If using the Loader, reset the racks before
proceeding to the next step.
4. Reboot the system.
a. Select File, then Shutdown
b. Select OK to initiate Shutdown.
c. Wait 5-10 seconds after the display turns
black, then press the Data Station power
button to reboot the system.
NOTE: See Section 5: Operating
Instructions, Subsection: Power On and
Power Off.
5. If the message appears repeatedly, contact
Abbott Customer Service.

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Overview Section 10

2099 Analyzer failed to prime

Event Type: Fatal Fault
The Analyzer Status region indicates Fatal Fault.

Probable Cause(s) Corrective Action(s)

A software error has occurred. 1. Review the following recommended corrective

action.
2. Press the Save button to close the SIM dialog
box.
3. If using the Loader, reset the racks before
proceeding to the next step.
4. Select Maintenance, Special Protocols tab.
a. Perform Initialize Analyzer.
b. Perform Prime.
NOTE: Verify background count results
are within acceptable limits prior to running
controls or patient specimens.
5. If the message appears again, reboot the system.
a. Select File, then Shutdown
b. Select OK to initiate Shutdown.
c. Wait 5-10 seconds after the display turns
black, then press the Data Station power
button to reboot the system.
NOTE: See Section 5: Operating
Instructions, Subsection: Power On and
Power Off.
6. If the message appears repeatedly, contact
Abbott Customer Service.

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2100 HSSL timeout

Event Type: Fatal Fault
The Analyzer Status region indicates Fatal Fault.

Probable Cause(s) Corrective Action(s)

Communication timed out between Analyzer 1. Review the following recommended corrective
and Data Module. action.
2. Press the Save button to close the SIM dialog
box.
3. Check the HSSL cable connections.
NOTE: For the location of the HSSL ports,
refer to Section 1: Use or Function,
Subsection: Data Module Components.
4. Reboot the system.
a. Select File, then Shutdown
b. Select OK to initiate Shutdown.
c. Wait 5-10 seconds after the display turns
black, then press the Data Station power
button to reboot the system.
NOTE: See Section 5: Operating
Instructions, Subsection: Power On and
Power Off.
5. If the message appears repeatedly, contact
Abbott Customer Service.

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Overview Section 10

2237 Rack bar code read failure

Event Type: SL Fault
The Analyzer Status region indicates Loader Fault.
NOTE: The Loader halts.
The rack bar code label (the first label on the rack) could not be read. This label has a two-digit rack number.

Probable Cause(s) Corrective Action(s)

The window on the Bar Code Reader is dirty. 1. Review the following recommended corrective
action.
2. Reset the racks before proceeding to the next
step.
3. Press Clear Fault to close the SIM dialog box.
4. Select Maintenance then As-Needed tab.
a. Perform Clean Bar Code Reader.
b. Reset the Loader by pressing the following
keys in order: Start Loader, Reset Loader.
The tube position bar code label is scuffed or 1. Clean or replace the tube position bar code
dirty. label.
2. Reset the racks and reset the Loader by pressing
the following keys in order: Clear Fault, Start
Loader, Reset Loader.
The rack from the mix zone was not removed Reset the racks, then reset the Loader by pressing
and reset before the Reset Loader key was the following keys in order: Clear Fault, Start
pressed. Loader, Reset Loader.
The Bar Code Reader cable has been If the message appears repeatedly, contact Abbott
disconnected, or the Bar Code Reader or Customer Service.
related electronics has failed.

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2238 Tube position bar code read failure

Event Type: SL Fault
The Analyzer Status region indicates Loader Fault.
NOTE: The Loader halts.
A tube position bar code label could not be read.

Probable Cause(s) Corrective Action(s)

The window on the Bar Code Reader is dirty. 1. Review the following recommended corrective
action.
2. Reset the racks before proceeding to the next
step.
3. Press Clear Fault.
4. Select Maintenance then As-Needed tab.
a. Perform Clean Bar Code Reader
Window.
b. Reset the Loader by pressing the following
keys in order: Start Loader, Reset Loader.
The tube position bar code label is scuffed or 1. Clean or replace the tube position bar code
dirty. label.
2. Reset the racks and reset the Loader by pressing
the following keys in order: Clear Fault, Start
Loader, Reset Loader.
The Bar Code Reader cable has been If the message appears repeatedly, contact Abbott
disconnected, or the Bar Code Reader or Customer Service.
related electronics has failed.

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Overview Section 10

2442 Unable to Open Communication

Event Type: Warning
The Analyzer Status region indicates the current state.

Probable Cause(s) Corrective Action(s)

Serial port hardware failure. 1. Check cabling. Check configuration of comm

port.

2443 LIS Transmit Err: Invalid specid

Event Type: Warning
The Analyzer Status region indicates the current state.
Probable Cause(s) Corrective Action(s)

Invalid specimen ID in a record for which a 1. Ensure that specimen ID is valid. See section on
manual transmit was initiated. Valid Specimen ID.

2444 LIS Transmit Err: Already on LIS queue

Event Type: Warning
The Analyzer Status region indicates the current state.

Probable Cause(s) Corrective Action(s)

A record for which a manual transmit was 1. Only one instance of a specimen ID is allowed
initiated is already queued for transmission. on the queue at a time. Check the cause for two
orders with the same specimen ID.

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 Section 11 Quality Control

Section 11 Quality Control

Overview

Quality control on the CELL-DYN Ruby involves monitoring control results,

whole blood patient data, and operator initiated background count data. Quality
Control ID (QCID) files and programs designed especially for the
CELL-DYN Ruby facilitate this monitoring. The System can automatically
evaluate results and display messages for the operator to review data and confirm
results. The quality control programs on the CELL-DYN Ruby help assess
precision and accuracy, identify shifts and trends, and determine the nature and
cause of errors.
The following programs are available for monitoring daily quality control using
commercial and whole blood patient controls:
QCID File Data and Statistics
Westgard Rules
Levey-Jennings Graphs
The following program is available for System performance monitoring during
routine analysis of patient specimens:
Moving Average Programs (including X-B) and associated Levey-Jennings
Graphs
The CELL-DYN Ruby software programs listed above are referred to as internal
quality control programs because they involve instruments and materials within a
laboratory. The System is shipped with default settings for these programs to
enable a laboratory to use them immediately.
Abbott recommends that internal quality control programs be left on and run
initially with the default settings until your laboratory has had a chance to establish
means and ranges based on your facilitys population. Programs can then be
optimized and customized over the next few months. Suggestions for optimization
and customization are provided with the descriptions and procedures for each
program.
External quality control programs use resources available outside a laboratory to
assess System performance. These programs assist in the peer review process that
allows a laboratory to compare its performance with that of other laboratories. For
example, in Germany and the USA, laboratories are required to participate in
proficiency testing. Proficiency testing provides independent validation of a
laboratorys internal QC program.
For more information about external quality control programs, contact your
Country Service and Support Center.

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Overview Section 11

When to Run QC
The frequency of quality control runs should be determined by each laboratory.
This may be specified by the regulatory agencies governing the laboratory. Quality
Control specimens should be run and results confirmed to be within acceptable
limits prior to reporting patient results. Controls should also be run:
After a reagent lot number change
After maintenance, component replacement, or a field service action
After a software change
Following calibration
According to your laboratorys quality control program
According to regulatory requirements

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Section 11 Quality Control

QC Methods

The following programs are for monitoring daily quality control using commercial
and whole blood patient controls:
QCID File Data and Statistics
Westgard Rules
Levey-Jennings Graphs
The following program is available for System performance monitoring during
routine analysis of patient specimens:
Moving Average Programs (including X-B) and associated Levey-Jennings
Graphs

Control Material
Commercial controls contain fixed cells and are assayed by the manufacturer to
determine target ranges. Refer to Appendix A: Parts and Accessories for the list
of available commercial control material that can be used for monitoring the CBC
(including differential) and reticulocyte parameters. MCHC Flag will not trigger
on QC-Commercial Control type.
NOTE: Flags may occur with control materials and should be disregarded.
Whole Blood patient controls are fresh specimens selected from normal patients
and tested by the laboratory to establish target ranges. They are an accurate and
cost-effective means of evaluating the performance of the CELL-DYN Ruby.

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QC Methods Section 11

NOTES

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Section 11 Quality Control

Quality Control Procedures

Guidelines for Running Controls

Day-to-day verification of System calibration is performed using
CELL-DYN Control products, unless the laboratory has an alternative
approach, such as the equivalent quality control system recognized by the US
Centers for Medicare and Medicaid Services. In such cases, Abbott does not
require daily stabilized controls.
Prior to running patient specimens, run controls according to the laboratorys
procedures.
Run controls for each measured parameter in the same manner as patient
specimens.
Verify that control results are within the laboratorys acceptable limits and
review the data for shifts or trends.
If QC results fall outside the laboratorys acceptable limits, see Section 10:
Troubleshooting and Diagnostics or try another tube from the same lot of
control material. If the problem persists, contact your Country Service and
Support Center.
Do not report patient results if QC results fall outside the laboratorys
acceptable limits.
Verify the control file being used is the correct file in which means and limits
are updated.
Print and/or archive the information in each QCID File at intervals specified
in your laboratorys procedures.
For efficiency in running controls in the Closed Mode, Q Label Bar Codes
can be used on the tubes to identify them as controls and direct the results to
the appropriate QCID File. Q Labels are available as optional accessories.
For more information, refer to Appendix A: Parts and Accessories.

Control Material Guidelines

Use the following guidelines for proper handling of control material:
Check the condition of incoming control material. Be sure the tubes are at the
proper temperature and are not leaking. Check for gross hemolysis.
Check the shelf-life and open-tube stability dating. Do not use products
longer than recommended by the manufacturer, or the results may be
compromised.
Always mix and handle commercial control materials according to the
directions given on the package insert. Proper mixing is essential for accurate
results.

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Quality Control
Quality Control Procedures Section 11

Never subject controls to excessive cold, heat, or agitation. Store controls at

recommended temperatures; if storing controls inside a refrigerator, place in
a central location. Do not store control or calibrator material in the
refrigerator door.

Assay Verification Procedure

New control material lots should be analyzed in parallel with current lots prior to
their expiration dates. To accomplish the transition to a new lot of control material,
follow your laboratorys protocol or proceed as follows:
1. Create Low, Normal, and High QCID files for the new lot. Refer to
Subsection: QCID File Setup.
2. Verify the new control lot by running each level of control three times in its
respective file to ensure that the mean of all three runs is within the range
shown on the assay sheet.
3. Run the new controls twice a day for five days.
4. Use the mean of the 10 runs to verify that the new lot yields expected results.
5. Compare the mean to the range specified on the assay sheet. The mean should
fall within the range specified by the manufacturer in the package insert.
6. If the calculated mean falls within the range specified on the assay sheet, use
it in place of the manufacturers stated mean. (For details on updating means,
refer to Subsection: QCID File Setup.)
7. When results for any parameter(s) are flagged (outside of laboratory-defined
limits or reportable range), follow your laboratorys procedure for out-of-
range results.

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Section 11 Quality Control

Establishing the Mean

Three QCID files should be set up for the new lot number for each level of control:
Low, Normal, and High. If desired, the QCID files can then be used to run the
controls for the remainder of the dating period. It is not necessary to create another
file.
The expected ranges published by manufacturers are generally too broad for
effective Quality Control1. Each office or laboratory must establish its own ranges.
These ranges may be determined by evaluating data from a three to six month
period (data from the interlaboratory CELL-DYN eQC Program can be used) for a
particular level of control.
Individual SD (standard deviation) values can be averaged as follows:

(N1 x SD12) + (N2 x SD22) + ... (Ni x SDi2)

Average SD =
(N1 + N2 + ...Ni) - 1
N = number of values in a group
SD = Standard Deviation of the values in that group
i = the last group of values
The resulting long-term instrument standard deviation and the laboratory-
established mean for each lot number can be used to monitor overall instrument
performance.

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Quality Control Procedures Section 11

NOTES

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Section 11 Quality Control

Quality Control

QC View
This section discusses the QC View, which is selected from the tool bar. The QC
View stores all Quality Control ID (QCID) result data and the control
demographic information in a log format on the CELL-DYN Ruby. Their Datalog
view sequence number displays the QC run results chronologically when results
are available for each QCID specimen run. The QC run view that contains the
scatterplot and histogram details can be viewed either by using the mouse to
highlight and double click on the record or by selecting the F7 View QC Spec.
See also Subsection: View QC Spec.
The options used to set up the QCID files are available from Setup, QCID Setup
menu bar where the Operator can edit the lot number and expiration date for the
selected QCID files, enter means and range values for each parameter specified on
screen, and select which Westgard Rules will be applied to Quality Control results.
When reviewing QCID L-J Plots or QCID Data, using F6 View QC Setup can
also access the QCID Setup information dialog box. Parameter results for any
control run that fall outside the entered limits are displayed in color (purple for out-
of- range high and yellow for out-of-range low) and underlined on the printout to
alert the Operator. See also Subsection: QCID File Setup.

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Quality Control Section 11

Program Operation
QCID Files
QC result data and statistics are stored in QCID Files. Three QCID subtypes
available on the CELL-DYN Ruby are:
Commercial
Whole Blood
Background and RETC_Background
NOTE: QC limits and control data information are not customizable for
QCID subtype Background and RETC_Background.
A QCID File is assigned to each level of
commercial control and each whole blood patient
control. There is a maximum of 500 QCID files
that can be set up and created on the System. The

QCID Lookup icon , located in the Next

Open Tube Entry (NOTE) region can be
selected to display the current listing of QC
Specimen IDs (QCID) files set up on the System.
NOTE: When using this icon, the list of QCID files associated with the
reticulocyte parameters can only be displayed when the System is ready
to run the Open Mode Reticulocyte Method, RETIC test selection.
A QCID file can be manually deleted using the Setup, QCID Setup menu bar if
there are no result records in the file. QCID files are automatically deleted when:
There are no sample records for the QCID in the QC View or in the Datalog
view and that QCID setup is more than 1 month old.
The last sample run into the file for a QCID subtype of Commercial control
in the QC View or in the Datalog view is greater than 180 days old.
The last sample run into the file for a QCID subtype of Whole Blood control
in the QC View or in the Datalog view is greater than 90 days old.
The last sample run into the file for a QCID subtype of Background and
RETC_Background in the QC View or in the Datalog view is greater than 90
days old.
QCID file data can also be downloaded to a floppy diskette for use with the
interlaboratory QC monitoring CELL-DYN eQC program that compares
instrument performance between different labs, allowing you to determine the
reliability of your laboratory testing. Refer to Subsection: Download QCID Data.

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Section 11 Quality Control

QCID file summary data currently stored in each file can be displayed and printed.
Each time a QC specimen is run, the number of specimens, mean, coefficient of
variation, and standard deviation for each parameter displayed are calculated and
updated automatically in each file. The Operator can, at any time, elect to reject any
run with flagged (outside entered limits) data from this calculation or move any
specimen run from one QCID file to another QCID file. The CELL-DYN Ruby
software does not allow the Operator to manually delete any runs from a QCID file
or the QC View. Refer to Subsection: Rejecting/Accepting Specimens and
Subsection: Edit QC Specimens.
Westgard Rules status can be applied to the analysis of QCID specimen results with
Westgard Rule warnings viewable in the QCID file summary data on screen and
printed on reports. The Levey-Jennings graphs for QCID file results can be printed.
Refer to Subsection: Analyzing QCID File Results later in this section.

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Quality Control Section 11

NOTES

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Section 11 Quality Control

Quality Control Software

The QC View allows the Operator to perform the following functions:

Display the parameter-specific result data for each QCID specimen record in
the QC View log
Display the QC information data for each QCID specimen record in the QC
View log
Display the run view for each QCID specimen record in the QC View log
Select a QCID specimen record and view the QCID file Levey-Jennings
graphs and data
View the QCID file means and limits
Accept and reject QCID specimen results from the QCID file
Move QCID specimens from one QCID file to another
Display and print Levey-Jennings graphs
Download QCID file data to floppy diskette
Open the QCID Setup dialog box
View and print the Moving Average Programs Levey-Jennings graphs and
closed batch data
A brief description of each view and its function follows.

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Quality Control Software Section 11

Using QC View
Main QC View

Tab Views
The QC View consists of the following 7 tab views:
CBC
DIFF
RBC
PLT
RETC
DIFF ABS
QC Info
The following column headings are
common to all 7 tab views:
Seq# - Datalog sequence
number
Spec ID QCID Specimen ID number
M - Mode: O = Open Mode or C = Closed Mode
Date Run date
Time Run time
OPID - Operator ID at the time the QCID specimen was run

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Section 11 Quality Control

For details on customizing the tab view while in the QC View, see Section 2:
Installation Procedures and Special Requirements, Subsection: Customize Data
View.
The QC Info tab view contains additional column headings:
Spec Type - QC-Commercial, QC-Whole Blood, QC Background, or QC
RETC_Background
Lot Number QCID File commercial control lot number
Exp Date QCID File commercial control expiration date
Org Spec ID QCID File whole blood original specimen ID number
Comment
The text
entered in the
QCID Setup
Control Data
Comments field.

Scrolling Through the QC View

Each screen display (page) contains up to 34 specimens.

Use the screen navigation keys to scroll through the complete list of parameter tab
views for all specimens displayed or use the mouse and click on the tab to display
a different parameter view.

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Quality Control Software Section 11

Table 11.1 Screen Navigation Bar and Buttons

Navigation

Bar Buttons Description

Scrolls to desired page; lists current page

and total number of pages

Moves to the view of the previously

displayed specimen

Moves to the page previously viewed

Moves to the beginning of the log view

Moves to the view of the next specimen

in the display view

Moves to the next page in the display

view

Moves to the end of the log view

Function Keys
When QC View is selected from the tool bar the following function keys are
displayed for all tab views:

F1 F2 F3 F4 F5 F7 F8
Print Transmit Find/Filter Edit Moving Average View QCID
QC Spec L-J Plots

F1Print
F2Transmit
F3Find/Filter

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Section 11 Quality Control

F4Edit
F5Moving Average
F7View QC Spec
F8QC L-J Plots
Table 11.2 QC View Function Keys

Function key ... What it does ... Comments

Prints all records or the selected

F1Print
records in the QC View

This feature is currently not

F2Transmit
available.

Opens the Find/Filter dialog box

which has two tabs
Find/Filter
Advanced Find/Filter
Both are used to locate a record by
F3Find/Filter entering information in the dialog
box fields. Selecting the Find
button displays the QC View
screen. If the record is not found in
the QC View, the Bulletin line
displays the message: NO ENTRY
FOUND.

Opens the QCID Edit dialog box to

change the highlighted QCID
F4Edit
records QCID file specimen ID
number

Displays the System Moving Tabs and Function

Average Programs keys will change in
F5Moving this view. See also
Average Subsection:
Moving Average
Programs.

Displays the Run View for the Tabs and Function

highlighted QCID record keys will change in
F7View QC this view. See also
Spec Subsection:
Moving Average
Programs.

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Quality Control Software Section 11

Table 11.2 QC View Function Keys

Displays the QCID file Levey- Tabs and Function

Jennings view for the highlighted keys will change in
F8QCID L-J
QCID record this view. See also
Plots
Subsection: QCID
L-J Plots.

View QC Spec
Chartable tab Lab tab Graphs tab

Selecting the F7View QC Spec function key from the QC View displays three
tabs Chartable, Lab, Graphs which reveal the specimen information for the
selected record. The following function keys are displayed.
Table 11.3 Function Keys View QC Spec

Function key ... What it does ... Comments

Prints the Run View for the tab

F1Print
selected.

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Table 11.3 Function Keys View QC Spec (Continued)

Function key ... What it does ... Comments

Opens the Find/Filter dialog box

which has two tabs Find/Filter
and Advanced Find/Filter. Both are
used to locate a particular record
Run view by entering information.
When the Find button is selected,
F3Find/Filter and the software finds a match, the
QC View updates and displays the
Run view with the record it found. If
the record is not found in the QC
View, the Bulletin line displays the
message: NO ENTRY FOUND in the
Find/Filter dialog box.

Opens the QCID Edit dialog box to

change the highlighted QCID
F4Edit
records QCID file specimen ID
number

Displays the Run View results for the

F7Previous sequence number preceding the one
Specimen currently displayed without returning
to the main QC View

Displays the Run View results for

F8Next the next specimen in the QCID file
Specimen without returning to the main QC
View

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Quality Control Software Section 11

QCID L-J Plots

When F8QC L-J Plots is selected from QC View to display the QCID file Levey-
Jennings view for the highlighted QCID record, the following function keys are
displayed in all tab views.
Table 11.4 Function Keys QCID File Levey-Jennings View

Function key ... What it does ... Comments

Prints the Levey-Jennings Plot for

F1Print
the QCID file tab view selected

Opens the Download QCID Data See also

F5Download dialog box save QCID file data to Subsection:
QCID Data media. Download QCID
Data

Displays the QCID Setup: View See also

F6View QC
dialog box. Subsection: QCID
Setup
File Setup

Displays the QCID file data view Function keys change

F8QCID Data
for the highlighted QCID record. in this view.

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Section 11 Quality Control

QCID Data

When F8QCID Data is selected from QCID L-J Plot view to display the QCID
file data for the highlighted QCID record, the following function keys are
displayed for all tab views.
Table 11.5 Function Keys QCID Data Dialog Box

Function key ... What it does ... Comments

Prints all records or the selected

F1Print
records in the QCID File Data view.

This feature is currently not

F2Transmit
available.

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Quality Control Software Section 11

Table 11.5 Function Keys QCID Data Dialog Box

Opens the Find/Filter dialog box

which has two tabs Find/Filter
and Advanced Find/Filter. Both are
used to locate a particular record
Run view by entering information.
When the FIND button is selected,
and the software finds a match, the
F3Find/Filter QC View updates and displays the
Run view with the record it found.
If the record is not found in the QCID
File Data view, the Bulletin line
displays the message: No records
found for the specified match
criteria in the Find/Filter dialog
box.

Opens the QCID Edit dialog box to

change the highlighted QCID
F4Edit
records QCID file specimen ID
number.

Rejects or Accepts the highlighted

F5 data; when Reject is selected for an
Reject/Accept item, the F5 function key appears as
F5Accept

Displays the QCID Setup: View See also

F6View QC
dialog box. Subsection: QCID
Setup
File Setup

Displays the Run View for the Tabs and Function

F7View QC
highlighted QCID record. keys will change in
Spec
this view.

Displays the QCID file Levey- Tabs and Function

F8QCID L-J
Jennings view for the highlighted keys will change in
Plots
QCID record. this view.

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Download QCID Data

F5Download QCID Data can be selected from either the QCID L-J Plot or the
QCID Data view to display the Download QCID Data dialog box.

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Table 11.6 Field QC Download Dialog Box

Field Description

QCID Details Lists details of data being downloaded

+ Instructions for downloading data

Table 11.7 Buttons QC Download Dialog Box

Buttons Description

OK Advances to the next step in the downloading process

Cancel Closes the dialog box

View QC Setup
Control Data page

QC Limits page

Westgard page

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F6View QC Setup can be selected from either the QCID L-J Plot or the QCID
Data view to display the QCID Setup: View dialog box. The QCID Setup: View
has three tabs:
Control Data
QC Limits
Westgard
Each dialog box and the qualities specific to the dialog box are explained in each
section. The buttons which are common to each dialog box are explained in QC
Setup Buttons.

Control Data
Control Data page, Control Type: Background

Control Data page,

Control Type: Whole Blood

Control Data page,

Control Type:
Commercial

The Control Data information which is displayed is based on the control type for
the selected QCID file.
Table 11.8 Fields QCID Setup: View, Control Data Dialog Box

Field Description
QCID Select the name using the pull-down menu
Control Data Indicates the type of control: Commercial, Whole Blood,
Information Background
Comments Optional operator entered comments in QCID file Setup

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QC Limits QC Limits page

QC Limits are established by the

laboratory and used to monitor the
system according to laboratory
requirements.

Table 11.9 Fields QCID Setup: View, QC Limits Dialog Box

Field Description

QCID Assigned name

Select QC Limit setting to: N/A, 2SD, or 3SD. 2SD or

Standard Deviations
3SD must be selected to enable Westgard Rules.

Displays the parameter specific means, limits, and units

Limits [+/-]
set up for the selected QCID file

Westgard
A multi-rule system applied to the data in each of the QC Files to detect drift and
imprecision and to detect systematic or random error.

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Table 11.10 Fields QCID Setup: View, Westgard Dialog Box

Field Description

QCID Quality Control ID

Rule Westgard
Description
# Term

1 1 sub 2S Value outside 2SD

2 1 sub 3S Value outside 3SD

3 2 sub 2S Two consecutive values outside the same 2SD

4 R sub 4S The range between two consecutive values is greater

than 4SD

5 2 of 3 sub 2S Two of three consecutive values outside the same 2SD

6 4 sub 1S Four consecutive values outside the same 1SD

7 10x Ten consecutive values on the same side of the mean

QC Setup Buttons
Table 11.11 Buttons QCID Setup: View, Control Data Dialog Box

Buttons Description

Update Opens the Update Details dialog box when editing or

Mean/Limits [+/-] creating a QCID file

Prints the control data information, QC Limit, and

Print
Westgard Rules for the selected QCID file

Opens the QCID Setup: Basics dialog box to edit a

QCID file.

Edit

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Table 11.11 Buttons QCID Setup: View, Control Data Dialog Box (Continued)

Buttons Description

Select the Continue button to open the QCID Setup:

Edit dialog box to edit Control Data, QC Limits, and
Westgard Rules
Control Data page, Control Type: Whole Blood

Control Data page,

Control Type:
Commercial

Edit

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Table 11.11 Buttons QCID Setup: View, Control Data Dialog Box (Continued)

Buttons Description

NOTE: Background and RETC_Background QC Limits

cannot be edited
QC Limits page, QCID: RETC_Background

QC Limits page,
QCID:
Background

Opens the QCID Setup: Basics dialog box to create a

Create
new QCID file. See Subsection: QCID File Setup

Active only if the QCID file does not contain any

Delete
records

Close Closes the dialog box

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Moving Average View

.

Moving Average View, X-B page

Moving Average
View, X-B page
displaying Levey-
Jennings graphs

When F5Moving Average is selected from QC View to display the Moving

Average Programs: X-B, WBC, RBC/PLT, and RETC, the following function
keys are available for all tab views.
Table 11.12 Function Keys QC Moving Average View

Function key ... What it does ... Comments

F1Print Prints records in the It is suggested to customize

Moving Average view: and remove headings in the
all or selected records WBC and RBC tab view in
order for the print feature to
apply. See Subsection:
Printing Moving Average
Programs Information.

F8Levey- Displays the Moving Function keys change in this

Jennings Average Program view.
Levey-Jennings view of
the selected tab

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Table 11.12 Function Keys QC Moving Average View

F8 Closed Batch Displays the Moving Function keys change in this

Data Average Program view.
Closed Batch Data view
of the selected tab

Quality Control Software Setup

QCID File Setup
Control
QC Limits
Westgard

Commercial

PROCEDURE: CREATING A COMMERCIAL QUALITY CONTROL ID (QCID)

1. Select Setup from the menu bar and QCID Setup from the pull-down menu.
The QCID Status: View dialog box opens (default view displays QCID:
Background).

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Table 11.13 Field QCID Setup: View Dialog Box

Field Description

QCID Quality Control ID

Type of control used: Commercial, Whole Blood,

Control Type
Background

Test Selection CBC, CBC+NOC, etc.

Param Set Select 1 through 8 from the pull-down menu

Comments Optional operator-entered comment

Table 11.14 Buttons QCID Setup: View Dialog Box

Buttons Description

Edit Opens the QCID Setup: Basics dialog box

Create Opens the QCID Setup: Basics dialog box

Delete Active only if the QCID file does not contain any records

Close Closes the dialog box

2. Select Create and the QCID Setup: Basics dialog box opens.

Table 11.15 Field QCID Setup: Basics Dialog Box

Field Description

New QCID New QCID

Control Type Select from the pull-down menu: Commercial

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Table 11.16 Buttons QCID Setup: Basics Dialog Box

Buttons Description

Continue Opens the QCID Setup: Create New dialog box

Cancel Closes the dialog box

3. Enter the new Quality Control ID or scan the bar code (if one is present) in
the New QCID field. Select the control type from the pull-down menu in the
control field.
NOTE: If entering the QCID using a keyboard, ensure that the first
character is a tilda, ~.
4. To upload control assay values from the disk:
a. Confirm that the control name, lot number and expiration date on the disk
label are correct for the assay values to be loaded.
b. Insert the floppy disk into the drive.
c. Click the Browse button and navigate to the floppy disk drive.
d. Select the file - Low, Normal, or High.
e. Select Open or OK to close the Browser
f. Proceed to the next step.
IMPORTANT: The values on the control disk are manufacturers limits
and are not intended to be used as 2SD or 3SD ranges for your laboratory.

NOTE: To create a QCID without using an assay disk, deselect the

checkbox Upload from commercial assay disk and proceed to
step 5.
5. Click Continue and the QCID Setup: Create New dialog box opens with
the Control Data tab as the default.

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Bulletin message displays

until the QC Limits Standard
Deviation is set at 2SD or
3SD

Table 11.17 Field QCID Setup: Create New, Control Data Dialog Box

Field Description

QCID Assigned QCID

Control Type Indicates the type of control selected in the Basics dialog
box: Commercial

Lot number Enter lot number from the assay sheet

Expiration Date Enter a valid expiration date from the tube

Test Section Type of test selected from pull-down menu: CBC + NOC
or RETIC

Param Set Set from 1 through 8, from pull-down menu

Control Brand Select from the pull-down menu, N/A or select a product

Level Select from the pull-down menu, one of the following: I, II,
III, Low, High, Normal

Comments: Optional operator-entered comments

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Table 11.18 Buttons QCID Setup: Create New, Control Data Dialog Box

Buttons Description

If the Reset button is selected (before the OK button is

selected), any changes made to the information in the
Reset
QCID setup will reset back to its original content when the
dialog box was first opened to edit.

Selecting before all the info is entered gives a message

Becomes active once all the text is entered
OK
Once all text is entered, selecting OK ends the Create
New process and changes are made through Edit

Returns to QCID Setup: View without saving any

Cancel
information entered

6. Select the QC Limits tab and the QC Limits page opens.

7. Enter or confirm assay values:
a. If assay values were uploaded from a disk use the control assay sheet to
confirm the values displayed on the screen are correct for the appropriate
level.

Remove the disk and store it in a safe location. Discard the disk when the
lot has expired.
b. If an assay disk was not used, enter the control assay values using the
control assay sheet.
.

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Table 11.19 Field QCID Setup: Create New, QC Limits Dialog Box

Field Description

QCID Quality Control ID

N/A, not applying a standard deviation

Standard
NOTE: 2SD or 3SD must be selected to enable the
Deviation N/A
Westgard rules

Displays the parameter-specific means, limits, and units

Limits [+/-]
set up for the QCID file

Table 11.20 Buttons QCID Setup: Create New, QC Limits Dialog Box

Buttons Description

Opens the Update Details dialog box to update means,

Update Means/
limits, or both means and limits from existing QCID
Limits (+/-)
specimens, QCID file, or retrieve from file

Not available during create or edit. Only available in

Print
QCID Setup: View.

If the Reset button is selected (before the OK button is

selected), any changes made to the information in the
Reset
QCID setup will reset back to it's original content when
the dialog box was first opened to edit.

Accepts the data and any changes and returns to the

OK
QCID Setup: View dialog box

Cancel Returns to the QCID Setup: View dialog box

c. To update existing means and/or limits, select Update Mean/Limits

(+/-) and the Update Details dialog box opens.

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Table 11.21 Field Means and Limits [+/-] Update Details Dialog Box

Field Description

Select Means, Limits [+/-], or both Means and Limits

What to update
[+/-] radio button

Select N/A, not applying a standard deviation, or

Standard Deviation
2SD, or 3SD

Select updates using existing QCID specimens

Update by copying from an existing QCID. Select
from the pull-down menu.
Updates by uploading assay disk information to the
Source QCID file. See the following procedure: Retrieving
From File
NOTE: Control lot and Expiration Dates are listed on
the Control Assay Disk label. DISCARD disk when lot
has expired.

Table 11.22 Buttons Update Details Dialog Box

Buttons Description

OK Updates from selected source

Cancel Closes the dialog box

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PROCEDURE: RETRIEVING FROM FILE

Automated load of assay values from disk.
a. Select Retrieve from file and the Update Details dialog box opens a
Browse field.

b. Confirm that the control name, lot number and expiration date on the disk
label are correct for the assay values to be loaded.
c. Insert the floppy disk into the drive.
d. Click the Browse button and navigate to the floppy disk drive.
e. Select the file -- Low, Normal, or High.
f. Select Open or OK to close the Browser.
g. Proceed to the next step.
IMPORTANT: The values on the control disk are manufacturer's limits and
are not intended to be used as 2SD or 3SD ranges for your laboratory.

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8. Click OK and the QC Limits dialog tab opens.

NOTE: At the bottom of the dialog box: ! Means and/or limits (+/-) have
been updated.
9. Using the control assay sheet, confirm that the assay values displayed on
screen are correct for the appropriate level.
10. Remove the disk and store it in a safe place in case it is needed to reload data
for this control lot.
NOTE: Control Lot and Expiration Dates re listed on the Control Assay
Disk label. DISCARD disk when lot has expired.

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Table 11.23 Field QCID Setup: Create New, Westgard Dialog Box

Field Description

QCID Quality Control ID

Rule Westgard
Description
# Term

1 1 sub 2S Value outside 2SD

2 1 sub 3S Value outside 3SD

3 2 sub 2S Two consecutive values outside the same

2SD
Westgard Rules 4 R sub 4S The range between two consecutive values
is greater than 4SD

5 2 of 3 sub 2S Two of three consecutive values outside the

same 2SD

6 4 sub 1S Four consecutive values outside the same

1SD

7 10x Ten consecutive values on the same side of

the mean

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Table 11.24 Buttons QCID Setup: Create New, Westgard Dialog Box

Buttons Description

If the Reset button is selected (before the OK button

is selected), any changes made to the Westgard Rule
Reset
selections will reset back to it's original content when
the dialog box was first opened to edit.

OK Returns to QCID Setup: View dialog box

Cancel Returns to QCID Setup: View dialog box

11. Select the Rule or Rules, if any, and click OK. The QCID Setup: View
dialog box opens, reflecting the newly created QCID information.

Whole Blood

PROCEDURE: CREATING A WHOLE BLOOD QUALITY CONTROL (QCID)

1. Select Setup from the menu bar and QCID Setup from the pull-down menu.
The QCID Setup: View dialog box opens.

Whole Blood

Whole Blood

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Table 11.25 Field QCID Setup: View Dialog Box

Field Description

QCID Field Quality Control ID selected from the pull-down menu

Select from the pull-down menu: Commercial, Whole

Control Type
Blood, Background

Test Selection Type of test to be run, selected from the pull-down menu

Param Set Select from the pull-down menu from 1 through 8

Comments Optional operator-entered comment

Table 11.26 Buttons QCID Setup: View Dialog Box

Buttons Description

Edit Opens the QCID Setup: Basics dialog box

Create Opens the QCID Setup: Basics dialog box

Delete Active if the QCID file does not contain any records

Close Closes the dialog box

2. Select Create and the QCID Setup: Basics dialog box opens.

Table 11.27 Field QCID Setup: Basics Dialog Box

Field Description

New QCID Quality Control ID for new QCID file

Control Type Select from the pull-down menu: Whole Blood

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Table 11.28 Buttons QCID Setup: Basics Dialog Box

Buttons Description

Continue Advances to the QCID Setup: Create New dialog box

Cancel Closes the dialog box

3. Enter a name, or scan the bar code, if one is present, in the New QCID field
and select Whole Blood from the pull-down menu in the Control Type field.
4. Select Continue and the QCID Setup: Create New dialog box appears.
NOTE: The new QCID and Control Type are listed.

WBQCID

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Table 11.29 Field Dialog Box

Field Description

Original Spec Enter the whole blood original specimen ID number

Draw Date/Time Enter the date and time of the blood draw. Select the
check box to activate the field and enter the
information. To set the dates and time do one of the
following:
Type the information in
Use the pull-down menu to set the information

Test Selection Select the type of test from the pull-down menu:
CBC,CBC+NOC, etc.

Param Set Select from pull-down menu, from 1 through 8

Comments Optional operator-entered comment

5. Select the QC Limits tab and the QC Limits tab opens.

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Table 11.30 Field QCID Setup: Create New, QC Limits Dialog Box

Field Description

QCID Quality Control ID

N/A, not applying a standard deviation

Standard
NOTE: 2SD or 3SD must be selected to enable the
Deviation N/A
Westgard Rules

Displays the parameter-specific means, limits, and units

Limits [+/-]
set up for the QCID file

6. Select Update Mean/Limits (+/-) and the Update Details dialog box opens.

Table 11.31 Field Means and Limits [+/-] Update Details Dialog Box

Field Description

Select Means, Limits [+/-], or both Means and Limits

What to update
[+/-] radio button

Select N/A, not applying a standard deviation, or

Standard Deviation
2SD, or 3SD

Select updates using existing QCID specimens

Source Update by copying from an existing QCID. Select
from the pull-down menu.

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Table 11.32 Buttons Update Details Dialog Box

Buttons Description

OK Confirms the change

Cancel Returns to the QCID Setup: View dialog box

7. Click OK and the QC Limits dialog tab opens.

NOTE: At the bottom of the dialog box: ! Means and/or limits (+/-) have
been updated.
8. Select the Westgard tab and Westgard dialog tab opens.

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Table 11.33 Field QCID Setup: Create New, Westgard Dialog Box

Field Description

QCID Quality Control ID

Rule Westgard
Description
# Term

1 1 sub 2S Value outside 2SD

2 1 sub 3S Value outside 3SD

3 2 sub 2S Two consecutive values outside the same

2SD
Westgard Rules 4 R sub 4S The range between two consecutive values
is greater than 4SD

5 2 of 3 sub 2S Two of three consecutive values outside the

same 2SD

6 4 sub 1S Four consecutive values outside the same

1SD

7 10x Ten consecutive values on the same side of

the mean

Table 11.34 Buttons QCID Setup: Create New, Westgard Dialog Box

Buttons Description

Reset Resets to data existing when dialog box opened

OK Returns to QCID Setup: View dialog box

Cancel Returns to QCID Setup: View dialog box

9. Select the Rule or Rules, if any, and click OK. The QCID Setup: View
dialog box opens, reflecting the newly created QCID information.

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QC Download ID Setup
The QC Download ID File Setup information is used to enter Laboratory
Identification information for the QCID file. This information is necessary for
participants in the CELL-DYN eQC Program. Laboratory Identification must be
entered before QC data can be transferred to the floppy disk.

PROCEDURE: QC DOWNLOAD ID SETUP

1. Select Setup from the menu bar and Administrative Setup from the pull-
down menu.
2. Select QC Download ID File Setup and the QC Download ID File Setup
dialog box opens.

Table 11.35 Field QC Download ID File Setup Dialog Box

Field Description

Serial Number Set at the factory

Name Select a name

Address 1 Laboratory address

Address 2 Laboratory address

Town/City Town or city in which laboratory is located

State State in which laboratory is located

Zip Code Zip code

Country Country

Attention Name of contact person

Phone Phone number of contact person

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Table 11.36 Buttons QC Download ID File Setup Dialog Box

Buttons Description

OK Accepts the information and closes the dialog box

Cancel Closes dialog box without saving information

3. Click OK and the QC Download ID File Setup dialog box closes.

Moving Average Acceptance Setup

Once enabled, the Moving Average Programs operate automatically and require
minimal direct operator action. The QC Status region provides information about
which programs are active and whether batches are in or out.

Turning Moving Average Programs On and Off

Moving Average Program monitoring can be turned on or off as desired. Abbott
recommends that the Moving Average Programs be used initially with the default
settings for acceptance limits and action limits until a laboratory can establish its
own values.

PROCEDURE: TURNING MOVING AVERAGE PROGRAMS ON AND OFF

1. Select Moving Average Acceptance Setup... from the pull down menu
under Setup on the menu bar. The Moving Average Acceptance Setup
dialog box opens.

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Table 11.37 Field Moving Average Acceptance Setup Dialog Box

Field Description

Groups X-B, WBC, RBC, RETC

Monitor Moving Average Select or deselect to monitor, or not monitor,

On/Off moving averages for the view selected

Table 11.38 Buttons Moving Average Acceptance Setup Dialog Box

Buttons Description

Resets the parameter lower/upper limits, target

Default values, and action limits to factory settings for the
selected view

OK Accepts changes and closes dialog box

Cancel Closes dialog box without saving information

2. Select or deselect the Monitor Moving Average On/Off checkbox for each
tab view.
3. Select OK to save the changes, and the dialog box closes.

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Customize Moving Average View

PROCEDURE: CUSTOMIZE MOVING AVERAGE VIEW

1. Select Setup from the menu bar and Customize Moving Average View...
from the pull-down menu. The Customize Moving Average View dialog
box opens.
.

IMPORTANT: Selecting the button returns ALL settings on

EACH tab page of the dialog box to the default settings.

Table 11.39 Field Customized Moving Average View Dialog Box

Field Description

X-B, WBC, RBC/PLT, RETC:

Groups
Each is a separate page view

Available Columns Determined for each page using the arrows

Selected Columns Determined for each page using the arrows

Add Heading

Remove Heading

Move column heading to the left

Move column heading to the right

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2. Select the page to customize X-B, WBC, RBC, or RETC.

3. Remove or add a column to the selected page:

PROCEDURE: TO ADD A COLUMN TO A PAGE

a. Select the column header from Available Columns field.
b. Select the right arrow and the column header moves to the Selected
Columns field.

PROCEDURE: TO REMOVE A COLUMN FROM A PAGE

a. Select the column header from the Selected Columns field.
b. Select the left arrow and the column header moves to the Available
Columns field.

PROCEDURE: TO CHANGE THE ORDER OF THE COLUMNS

a. Select the column header in the Selected Columns field.
b. Select an arrow use the up arrow to move the column to the left in the
display view, or the down arrow to move the column to the right in the
display view.
4. Select one of the buttons.
Table 11.40 Buttons Customize Moving Average View Dialog Box

Buttons Description

Resets the column configuration to factory settings

Default
for the view selected

OK Accepts the changes and closes the dialog box

Cancel Closes the dialog box

Performing a QC Run
Always mix and handle commercial control materials according to the directions
given on the package insert. Proper mixing is essential for accurate results.

PROCEDURE: TO PERFORM A QC RUN IN OPEN MODE

1. From the Next Open Tube Entry (NOTE) region using the mouse, click on
the QCID icon to display the QCID Lookup list of QCID files and select the
QCID Specimen ID you would like to run. The QCID Specimen ID selected
will automatically fill the NOTE region fields with the QCID, Specimen
Type, and Test Selection.
2. Remove the cap from a well-mixed control specimen tube and place the open
tube under the Open Mode Probe. Raise the tube so that the end of the probe
is deeply immersed in the specimen.
3. Press the Touch Plate to activate aspiration.

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4. When you hear the audible beep, the well-mixed control has been aspirated
from the tube. Remove the specimen tube and replace the cap while the Wash
Block moves down to rinse the probe.
NOTE: Review any messages that may appear in the System Messages
region during the run cycle. Refer to Section 10: Troubleshooting
and Diagnostics and repeat the run if necessary.
5. Verify that control results are within your laboratorys acceptable limits.
6. If the control results fall within acceptable limits, review the data for shifts or
trends and then begin to process patient specimens.
NOTE: If one or more result falls outside the laboratorys acceptable limits,
review Section 10: Troubleshooting and Diagnostics. If the
problem persists, contact your Country Service and Support
Center. Do not process patient specimens.

Rejecting/Accepting Specimens
Specimens can be rejected or accepted as needed. For example, one or more runs
can contain results that you do not wish to use in determining the QCID file mean.
1. To reject a QC specimen, proceed as follows:
2. From the QC View, highlight the specimen record from the log.
3. Select F8 QCID L-J Plots, then select F8 QCID Data.
4. From the QCID data view, highlight the specimen record and select F5
Reject to reject the specimen record from the QCID file data statistics. The
rejected record will be marked with R. Rejecting a specimen record does
not remove the record from QCID file.
NOTE: Selecting F5 Accept will include the specimen record in the
QCID file data statistics.

Edit QC Specimens
QC specimen runs cannot be manually deleted from QCID files. They can,
however, be edited to move from one QCID file to another. (For example, if the
Operator ran the incorrect level of control for the QC Specimen ID selected in the
Open Mode.) The QC specimen run can be moved to the correct QCID file.

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PROCEDURE: TO EDIT A QC SPECIMEN RUN

1. From the QC View, highlight the specimen record from the log.

2. Select F8 QCID L-J Plots and the Levey-Jennings format is displayed for
the selected specimen.

3. Select F8 QCID Data and the QCID Data View opens.

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4. From the QCID data view, highlight the specimen record and select F4 Edit
to open the QCID Edit dialog box.

5. Select the new QCID from the drop down list, enter an (optional) comment
in the Comment field, and select the OK button to close the dialog box.

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NOTES

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Evaluating and Investigating Commercial

and Patient Control Results

The QC Status region and the System Messages region show the general status of
quality control programs and can provide an early indication of potential problems.
If one or more of the Westgard Rules has been violated, a warning message is
displayed in the System Messages region and the Rule Alert field in the QC
Status region will indicate Yes. Moving Average Program monitoring can be
turned on or off as desired. If one or more of the closed batch data sets for each
Moving Average Program is out-of-limit, the Moving Average Program will
indicate OUT next to the program parameter title in the QC Status region. The
Operator should investigate to determine whether any intervention or corrective
action is needed.

If there is a problem, the operator should attempt to attribute the cause to the
control material, procedural error, reagents, or System operation. The operator can
do the following:
Review all information in the QCID File(s) involved
Open the QCID Setup dialog box for the QCID File(s) and check that the
means and limits are within acceptable limits according to the package insert
or the laboratorys historical ranges
Review the Reagent, Maintenance, and System Logs to see if reagent
changes, maintenance procedures, or other events could be the cause or could
have contributed to the problem

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Evaluating and Investigating Commercial and Patient Control Results Section 11

Review the Moving Average Programs and Datalog to see if the patient
samples exhibit a similar shift or trend
Review the Calibration Log for records of recent calibration and any specific
comments and remarks
Examine the System setup settings to ensure that the operating conditions and
setups are correct
For additional guidance in isolating problems with data, refer to Section 10:
Troubleshooting and Diagnostics.

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Analyzing QCID File Results

Levey-Jennings Graphs

Levey-Jennings graphs are a visual method of viewing quality control result data
for all parameters over time. These graphs allow the Operator to examine the
relationship of control result values to the established means and acceptable limits,
and to look for shifts and trends in results. All specimens in the QCID file will be
graphed. There are six customizable parameter tabs on the Levey-Jennings view.
The graph label will include the parameter being graphed and Westgard Rule
warnings for that parameter. Scale values on the left side of the graph indicate:
Solid black line is the mean
Dotted orange line is the 2SD
upper and lower limits
Solid red line is the 3SD upper
and lower limits
CAUTION: QC limits are assumed to be at 2SD for Westgard Rule
analysis and for Levey-Jennings graphs. It is crucial to ascertain that the QC
file range entered in the QCID Setup, QC Limits tab represents 2SD for
the laboratory for each parameter before interpreting Levey-Jennings
graphs and Westgard Rules.

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Analyzing QCID File Results Section 11

Values in the QCID file which are outside of the graph range will appear above the
solid red line
NOTE: Results from rejected specimens will not appear on the graph.

Westgard Rule Analysis

To allow for analysis of CELL-DYN Ruby System quality control results, a rule
exists to test control results against control limits to determine whether the
instrument shows acceptable accuracy and precision. The limits are derived from
the mean and standard deviation of control measurements when instrument
performance is stable and acceptable. The most common rule used in hematology
quality control is the mean 2SD. Ninety-five percent of control results should fall
within 2SD.
Quality control results detect random or systematic error. Random error may be
defined as an increase in the SD (loss of precision). Systematic error may be
defined as a shift in the mean value (loss of accuracy). A multi-rule quality control
procedure combines several control rules to improve the detection of both types of
error.
Westgard recommended a multi-rule approach to evaluating quality control
results.2 This approach has long been used in the chemistry laboratory.3 A set of
modified Westgard Rules can be selected to monitor quality control results on the
CELL-DYN Ruby System.

Westgard Rules for the CELL-DYN Ruby

The modified Westgard Rules (Westgards nomenclature is given in parentheses)
available on the CELL-DYN Ruby are:
Rule 1 (1 sub 2S) Value outside 2SD.
Rule 2 (1 sub 3S) Value outside 3SD.
Rule 3 (2 sub 2S) Two consecutive values outside the same 2SD.
Rule 4 (R sub 4S) The range between two consecutive values is greater than 4SD.
Rule 5 (2 of 3 sub 2S) Two of three consecutive values outside the same 2SD.
Rule 6 (4 sub 1S) Four consecutive values outside same 1SD.
Rule 7 (10x) Ten consecutive values on the same side of the mean.
The rules may be used singly or in combination, depending on Operator preference,
and are configurable for each QCID.
Selections are made in the QCID Setup, Westgard tab. See also
Subsection: QCID File Setup.
When a rule is selected (turned ON), a plus sign is displayed to the right of the
parameter. A minus sign is displayed if a rule is not selected (turned OFF). Rule
violations for a parameter are recorded above the Levey-Jennings graph for that
parameter. Whenever a rule is violated, the number of the rule will be displayed to
the right of the parameter in place of the plus sign.

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CAUTION: QC limits are assumed to be at 2SD for Westgard Rule

analysis and for Levey-Jennings graphs. It is crucial to ascertain that the QC
file range entered in the QCID Setup, QC Limits tab view represents the
laboratorys 2SD range for each parameter before interpreting Levey-
Jennings graphs and Westgard Rules.

The rule violations listed above the graphs represent the modified Westgard Rule
status of the most recent control sample processed.
CAUTION: Do not use the values for mean range provided on the control
assay sheet in conjunction with Westgard Rules. Before using Westgard
Rule with commercial controls, establish the SD for each parameter on your
instrument and update QC limits based on these SDs.

Rule Violations
Only the directly measured parameters need to be monitored with multiple rules.4
In Laboratory Quality Management, Cembrowski and Carey suggest a protocol for
using the Westgard Rules in hematology. The following is a synopsis of that
protocol.
Because all three levels of control are typically used to monitor a hematology
analyzer, it is reasonable to consider all three at the same time. In other words,
check for rule violations across the three levels, not just within a particular level. If
the same rule is violated 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 one particular level of control. Therefore, if
a result exceeds 3SD, run another vial of that control. If the problem persists, then
additional investigation is required.
Check to see if the 2 of 3 sub 2S or R sub 4S rules have been violated for any level
or across levels. If the problem is confined to one level of control, check for a 2 sub
2S rule violation for that level. Again, if the violations are confined to one level of
control, use another vial and possibly another lot. Verify and follow all storage,
mixing, and handling instructions provided in the control package insert. Check
expiration dates and data entry. Check to be sure that the control is run into the
correct file, and the means and limits have been entered correctly for the particular
lot number in use.
If a combination of rules has been violated across three levels, determine whether
the violations indicate a loss of precision or a loss of accuracy, and troubleshoot
accordingly. Do not process patient specimens. If necessary, contact your Country
Service and Support Center.
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.

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Analyzing QCID File Results Section 11

NOTES

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Section 11 Quality Control

Moving Average Programs

Overview
The Moving Average programs on the CELL-DYN Ruby automatically and
continuously monitor instrument performance. This allows identification of
potential problems and more efficient troubleshooting. The programs track the
results of various parameters in the patient population analyzed on the System. On
the CELL-DYN Ruby, the Moving Average Programs and their associated
parameters and measurements include the following:
X-B Program: MCV, MCH, MCHC
WBC Program: WBC, %N, %L, %M, %E, %B and population statistics
(mean) for neutrophils and lymphocytes
RBC/PLT Program: RBC, RDW, HGB, HCT, MCH, MCHC, MCV, PLT, and
population statistics (mean) for linear RBC, PLT, and RBC
RETC Program: %R and population statistics (mean) for RETC
Any combination of Moving Average Programs can be active. The settings for each
Moving Average Program can be controlled independently of the other Moving
Average Programs.
Population statistics are also used by Abbott field personnel to evaluate fluidics or
other system problems, and are explained in Subsection: Principles of Moving
Average Analysis within this section.

How Moving Average Programs Work

On the CELL-DYN Ruby, Moving Average Programs calculate means for each
parameter in batches of 20 samples. Each program can be customized to display
from 20 to 120 batches and allows a wide acceptance range for data results. The
software includes a moving average statistical formula that smooths and trims data
to minimize the weight of outliers and calculates a mean for each parameter. The
calculated mean for each new batch is compared to the target value and its action
limits. If the mean for a batch falls outside the action limits, the QC Status region
is updated to indicate that the batch is OUT1. If the means for the last two
calculated batches of data for an individual Moving Average Program fall outside
the acceptance limits, the QC Status region is updated to indicate that the batch is
OUT2. For guidance, refer to Subsection: Investigating Moving Average Data
Problems within this section.

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Principles of Moving Average Analysis

Moving average analysis for hematology originated with X-B analysis, an
automated means of monitoring performance by using the known stability of the
red cell indices (MCV, MCH, MCHC). X-B stands for XB, which is the symbol for
the mean and used in calculating moving averages of the RBC indices with an
algorithm developed by Dr. Brian Bull. The CELL-DYN X-B Program uses similar
algorithms to monitor System performance by tracking the red cell indices from
patient data analyzed on the System.
On the CELL-DYN Ruby, this approach is extended by applying algorithms
similar to those of Dr. Bull for Moving Average Program analysis of other RBC/
PLT parameters (RBC, RDW, HGB, HCT, PLT), WBC, and %R parameters. This
approach is also extended to certain measured values called population statistics,
which consist of means of channel data for optical measurements.
Results for other RBC/PLT parameters, WBC, and %R parameters have a wide
range of absolute and percentage values. However, despite significant variation in
these parameters, the optical measurement population statistics for WBC, PLT, and
%R remain relatively constant from specimen to specimen. The population
statistics are therefore sensitive to changes in the Systems optical measurement
process and can be used in Moving Average Program analysis.
Moving Average Programs on the CELL-DYN Ruby use the following three
categories of numerical settings:
Upper and lower acceptance limits that determine which patient results are
used in a batch. These limits are set widely to exclude only grossly abnormal
specimens.
The target value, which is the expected mean of the parameter results, is
analogous to the assay value for a commercial control. Target values are
derived from the patient population analyzed on the System.
The action limit, which is the acceptable limit of variation around the target
value of the mean for a batch, expressed as a percentage.
NOTE: Abbott recommends that the Moving Average Programs be used
initially with the default settings for acceptance limits and action
limits until a laboratory can establish its own values. Target values
and action limits can be adjusted according to the guidelines
described in the following subsections.

Guidelines for Setting Up X-B Moving Average Program Analysis

It is recommended that the CELL-DYN Ruby be operated with the X-B program
turned on.
The default acceptance limits have been set so that at least 95% of patient results
are used in the X-B Program calculation. In the event that a laboratory has a highly
specialized patient population, the limits can be adjusted. For details about
adjusting acceptance limits, refer to Subsection: Moving Average Acceptance
Setup.

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A study5 by Dr. Bull collected data from 1767 patients and yielded the following
mean values for the red cell indices:
MCV = 89.9 fL
MCH = 30.5 pg
MCHC = 33.9 g/dL
These values confirmed other data that Dr. Bull published in an earlier study6 and
are used in the CELL-DYN Ruby as the default target values for beginning X-B
analysis.
The default action limit for the red cell indices is set at 30%.
Each laboratory should confirm the default values and, if necessary, establish its
own target values for the RBC indices. The action limits can be set to 5% during
the study period and tightened to 3% when the target values are confirmed. Refer
to Subsection: Establishing the Target Value immediately following.
A suggested protocol and guidelines for interpreting data based on X-B analysis
can be found in Chapter 1 of Laboratory Hematology, An Account of Laboratory
Techniques, edited by I. Chanarin7.

Establishing the Target Value

1. Calibrate the System.
2. Ensure that the calibration is stable and control results are acceptable during
data collection.
3. Collect data from at least 20 batches of 20 specimens each for a minimum
total of 400 specimens. Specimens should represent your laboratorys typical
population.
4. To understand how to use CELL-DYN Ruby software to view Moving
Average Program data, review Moving Average Program Operation later in
this section. Using the F8 - Closed Batch Data view in the QC Moving
Average view, examine the batch means. View the Levey-Jennings graphs of
the batches and determine whether the results are acceptable for MCV, MCH,
and MCHC.
5. When the results are determined to be acceptable, manually average the mean
values for 20 batches, enter these averages as the target values, and set the
action limits to 3% for all parameters. For instructions on how to change the
target values and action limits, refer to Subsection: Moving Average
Acceptance Setup.
6. Evaluate data from a minimum of 400 additional specimens to ensure that
entered target values are appropriate.
Laboratories seeing specialized patient populations, e.g. pediatric hospitals or
tumor centers, may need to verify these values due to abnormal patient
populations. Target values may be verified by evaluating approximately 400
samples and comparing the X-B means for those samples to the entered target
values. This can be done as follows:

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1. Collect data from at least 400 patients. (The 1.5% is one-half the allowable +
3% action limit.) If the CVs are greater than 1.5%, an additional 400 samples
should be evaluated.
2. If the CVs calculated in step 1 are less than 1.5%, enter the mean as the
Confirmed Target Value.

Guidelines for Interpreting X-B Moving Average Program Analysis

When X-B results are out of control, data should be reviewed for shifts and trends
in the results.
Shifts in results are usually caused by a non-random batch of 20 specimens such as
those from dialysis or pediatric units. Multiple repeats of the same abnormal
specimen within a given batch of 20 may also cause a non-random population in
that batch. Shifts caused by non-random data will usually be corrected in the next
batch of 20 as long as those data are random.
Shifts may also be caused by a change in reagent container or a lot number change.
If containers or lot numbers recently changed, try another container and see if the
problem persists.
Calibration changes may also cause a shift in results. If a shift cannot be explained
as described above, run commercial controls or run a patient selected from a
previous batch when X-B results were in control. If values are within acceptable
limits, a calibration shift is not the cause of the problem.
Trends in X-B results are usually caused by instrument problems. A recent
component change may also cause a trend in results. Use the following table to
determine the directly measured parameter(s) involved, and troubleshoot
accordingly. If a problem is not readily identified, perform routine maintenance
and repeat the commercial and patient controls to see if results are acceptable.
Since two of the RBC indices are calculated parameters, their inter-relationships
can be used to assist in troubleshooting. The following table uses the mathematical
relationships between the indices to aid in determining which directly measured
parameter(s) are involved when X-B is out of control. When the directly measured
parameter(s) are identified, refer to Section 10: Troubleshooting and Diagnostics
for troubleshooting assistance with these parameters.
Table 11.41 Troubleshooting X-B RBC
If the MCV If the RBC If the HGB

X-B is is is is is is Index
Pattern increased decreased increased decreased increased decreased Derivation

MCV High Low N/A N/A N/A N/A MCV

will be

MCH N/A N/A Low High High Low HGB/RBC

will be

MCHC Low High Low High High Low HGB/HCT

will be

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Guidelines for Setting Up and Interpreting Other Moving Average

Programs
Use the default acceptance limits for parameters in the other Moving Average
Programs (WBC, RBC/PLT, and RETC). Adjust the limits only after long-
term monitoring indicates that this is warranted.
Use the preceding steps to establish the target values for the other Moving
Average Programs. If necessary, action limits can be widened from default
settings during the study period. Using the default action limits for the
neutrophil and lymphocyte optical populations is strongly recommended.
It is recommended that these additional moving average programs be turned
on during routine operation, allowing data to be collected for use in
troubleshooting.
Because 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 Ruby System uses data obtained from the MAPSS technology used
for the WBC Differential measurement.
Five main subpopulations of WBC, which can vary widely in absolute number and
percentage values, are identified by the CELL-DYN Ruby 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 instruments
optical measurement process, can be monitored by the instrument and used to
monitor the WBC Differential parameters in much the same way that the RBC
indices are used to monitor the RBC parameters.
The CELL-DYN Ruby 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.
Each laboratory should establish its own target value for the X-B WBC parameters.
It is suggested that the process be started by using the default (preset) values
displayed in the following table. The action limits in the table may be used or
widened during the initial analysis. Reenter the default action limits shown in the
following table when the Target Values are confirmed. The values for the action
limits may be widened depending on the specimen population analyzed by the
laboratory. The values for the Lower/Upper Acceptance Limits may also be used
or widened depending on the specimen population analyzed by the laboratory.

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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 Moving Average Program WBC tab view. Refer to
Subsection: Printing Moving Average Programs Information. Calculate the
mean, standard deviation (SD), and coefficient of variation (CV) for each
parameter. The CV for LYM 0 , LYM 10 , NEU 0 , and NEU 10 should be
<2.5%. The CV for NEU 90 , NEU 90 depolarized, and NEU-EOS should be
<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 5% for LYM 0 , LYM 10 , NEU 0 ,
and NEU 10 , and to 10% for NEU 90 , NEU 90 depolarized, and NEU-EOS.
NOTE: Laboratories analyzing specialized patient populations (as described
above) may need to widen the action limits slightly to accommodate
results from these abnormal patients.
If the CV for each index is more than the limits described above, evaluate another
400 specimens and repeat the calculations.
When an acceptable target value has been entered, evaluate data from an additional
400 specimens to confirm the entered values.

Default (Preset) X-B WBC Values

Table 11.42 X-B WBC ValuesDefault

Acceptance
Parameter Target Value Action Limit
Limits

LYM 0 20100 64 20%

LYM 10 20130 72 20%

NEU 0 100210 158 20%

NEU 10 90210 171 20%

NEU 90 40160 121 20%

NEU 90 DEP 070 21 20%

NEU-EOS 040 22 30%

Interpreting X-B WBC Results

A suggested protocol and guidelines for interpreting X-B data can be found in
Chapter 1 of Laboratory Hematology, An Account of Laboratory Techniques,
edited by I. Chanarin.7

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Moving Average Program Operation

Once enabled, the Moving Average Programs operate automatically and require
minimal, if any, direct operator action. The QC Status region provides information
about which programs are active and whether batches are in or out.

One Batch Out

A single batch out is indicated as OUT1 (in orange). This occurs when only the
most recent closed batch is out and the current batch is still not calculated (fewer
than 20 specimens processed), or when the previous closed batch is in and the
current calculated batch (20 specimens processed) is out.

Two Batches Out

If a second batch goes out, this is indicated as OUT2 (in red). This occurs when the
previous closed batch is out and the current calculated batch (20 specimens
processed) is also out. For information on investigating Moving Average data
problems, refer to Subsection: Investigating Moving Average Data Problems
within this section.

Data Collection Process

Data for Moving Average Programs are automatically collected. If the monitoring
Moving Average Programs are selected to OFF, the QC Status region will display
dashes next to the parameter titles. When the monitoring Moving Average
Programs are selected to ON, the data is managed as follows:
As each specimen is processed, the System checks to see which Moving Average
Programs are on, and whether the specimen meets the acceptance criteria. For
example, specimens that triggered System Faults are not accepted into the X-B
Moving Average program files. Results for accepted samples become part of the
current batch for active Moving Average Programs.
20 specimens are used to calculate statistics for the closed batch.
NOTE: The number of specimens in the current batch displays in the QC Status
region; however, the Moving Average Program view only displays closed
batch statistics. The status of the last closed batch displays in the QC
Status region. If the batch status has been OUT2, it remains OUT2 until
the next closed batch results are calculated.
Each Moving Average Program has a number of parameter column headings for
viewing numerical data and information for basic data management functions.
Each parameter column heading is also displayed in the form of Levey-Jennings
graphs.

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Moving Average Programs Section 11

Investigating Moving Average Data Problems

Use the following guidelines to determine the causes for Moving Average Program
batch data being out, and to take preliminary action.

Investigating One Batch Out

1. A high proportion of non-randomized specimens can be considered a cause
of the closed batch going out. If results for closed batches are abnormal in the
same direction, all high results or all low results, the samples can be
considered the cause of the batch going out.
2. If such specimens are present, document the situation and continue to process
specimens.
3. If there are no such specimens, consider the batch out event as a warning.
Check controls, monitor results, and follow your laboratorys procedures.

Investigating Two Batches Out

Follow your laboratorys procedures. If your laboratory has no specific procedures,
try the following:
1. Run both commercial and patient controls. Select one or more patient
controls with results obtained during a time when the Moving Average
Program batch was in. If control results fall within acceptance limits but have
shifted, follow your laboratorys procedures.
2. If you suspect that there are no specimen-related reasons for the closed batch
to be out, check the control results, and check the Reagent, Maintenance,
Calibration, and System Logs for events that could have led to closed batch
results falling outside the action limits.
For information about how to view these logs, refer to Section 9: Service and
Maintenance, Subsection: Service and Maintenance Software.
If the control results also fall outside the limits, begin troubleshooting,
document the source of the problem, and take corrective action. For further
information, refer to Section 10: Troubleshooting and Diagnostics.

Printing Moving Average Programs Information

Moving Average Program reports can be printed for closed batches for each
Moving Average Program, along with Levey-Jennings graphs. The printout
contains the last closed batch Moving Average Acceptance Setup information and
may not match the current Moving Average Acceptance Setup dialog box if the
setup was changed since the last batch closed.
NOTE: For the WBC and RBC/PLT moving average program printing, use File,
Print Setup to change paper orientation to Landscape and File, Print
Preview to make sure the printout meets your labs expectations before
selecting F1 Print. Use Setup, Customize Moving Average View to
customize the parameter column headings you want to print.

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Customizing Moving Average Programs

Moving Average Programs on the CELL-DYN Ruby have been carefully designed
to meet the needs of most laboratories and should require minimal customization.
However, each program can be customized independently if necessary. Abbott
recommends using the factory settings for the initial 25 batches. For an explanation
of the factory settings and for information about adjusting the means, refer to
Subsection: Principles of Moving Average Analysis within this section. For
complete customization procedures, refer to Subsection: Moving Average
Acceptance Setup.

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NOTES

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References

1. Cembrowski GS, Carey RN. Laboratory quality management, p. 189.

2. Westgard JO et al. A multi-rule Shewhart chart for quality control in clinical
chemistry. Clin Chem 1981; 27:3:493501.
3. Cembrowski GS, et al. Use of a multirule control chart for the quality control
of PT and APTT analyses. Lab Med June 1989; 418421.
4. Cembrowski GS, Carey RN. Laboratory quality management. P. 190.
5. Bull BS, Jones AR, Gibson M, Twedt D. A method for the independent
assessment of the accuracy of hematology whole blood calibrators. AJCP
(accepted for publication), 1992.
6. Bull BS, Korpman RA. Intralaboratory quality control using patients data.
In: Cavill I, ed. Quality Control. Edinburgh: Churchill Livingstone 1982,
121150.
7. Chanarin I, ed. Laboratory hematology, an account of laboratory techniques.
Edinburgh: Churchill Livingstone, 1989:37.

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References Section 11

NOTES

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 Section 12 Reticulocyte Package

Section 12 Reticulocyte Package

Overview

The Reticulocyte Package software enables the operator of the CELL-DYN Ruby
System to analyze a whole blood specimen for reticulocytes. The Reticulocyte
specimen is prepared by the operator using reticulocyte reagent to produce a
diluted, stained sample. Reticulocyte specimens can be run as batches, or they can
be run on a STAT basis.
The Reticulocyte Package is enabled by selecting the Retic test selection in the
Next Open Tube Entry (NOTE) region and acknowledging the message to run the
reticulocyte method startup script. Reticulocyte processing and specimen
demographic orders can be added to the CELL-DYN Ruby manually or
automatically via the Laboratory Information System (LIS). See Section 5:
Operating Instructions, Subsection: Pending Orders in Open Mode. The
Reticulocyte Package is disabled by selecting either of the test selections: CBC,
CBC + NOC, CBC + RRBC in the Next Open Tube Entry (NOTE) region and
acknowledging the message to run the reticulocyte method cleanup script.
NOTE: The cleanup script takes approximately three minutes to return the
Analyzer Status to Ready state.
When the prepared reticulocyte specimen is run on the CELL-DYN Ruby, results
are measured as reticulocyte percent (%R). The reticulocyte absolute value
(RETC) is automatically calculated when the RBC concentration is entered using
the F12 RBC Source function key.
Reticulocyte results are stored chronologically in the Datalog view. Reticulocyte
Quality Control ID (QCID) File Setup, control material processing in the Open
Mode, control results analysis and file data management, Westgard rules, Levey-
Jennings graphs, and Moving Average Programs can all be displayed in QC View.
For more information on the Datalog view and QC View see Section 5: Operating
Instructions, Post-Analysis Processing Datalog View and Section 11: Quality
Control.
This section contains the following subsections:
Principles of Operation
Setup Guidelines
Retic Test Selection
Enabling Reticulocyte Processing
Disabling Reticulocyte Processing
Routine Operation

Reticulocyte Specimens
Quality Control
Maintenance and Troubleshooting

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Principles of Operation Section 12

Principles of Operation

The Reticulocyte Package software is designed to configure the instrument to

process stained, diluted specimens. When the System is enabled to run the RETIC
test selection, the instrument automatically selects the appropriate configuration
file and adjusts the instrument settings to the values in this file. This configuration
is retained until the System is disabled by selecting a non-reticulocyte test selection
and executing the reticulocyte method cleanup script.
Reticulocytes are defined by the Clinical Laboratory and Standards Institute
(CLSI) as transitional red cells, between nucleated red cells and the so-called
mature erythrocytes1. In contrast to mature RBC, reticulocytes contain ribosomal
RNA. This RNA can be seen with certain supravital, cationic dyes that
simultaneously stain and precipitate the polyanion to form a network or reticulum.
The CELL-DYN Ruby System reticulocyte method uses the thiazine dye New
Methylene Blue N. The reticulocyte assay is performed in the WOC channel of the
instrument. Sample preparation is performed manually by dispensing 20 L of
blood into a tube of CELL-DYN Reticulocyte Reagent. At room temperature,
staining of reticulum is complete within approximately 15 minutes. The stained
sample is aspirated in the Open Mode. After the stained sample is aspirated, it is
diluted approximately 50-fold with WBC Lyse Reagent. Once diluted with WBC
Lyse, the RBC sphere due to the influence of the nonionic detergent incorporated
into the staining solution. Sphering is necessary to eliminate optical orientational
noise that would otherwise be introduced into the scatter measurements. The usual
lytic action of the WBC Lyse is prevented by electrolytes contained in the staining
solution and the lack of the usual incubation period used in this channel during
WBC analysis. In addition, the high New Methylene Blue concentration in the
staining reagent exerts a stabilizing effect on RBC.
During data acquisition, 0 degree, 10 degree, and 90 degree scatter are collected for
up to 30,000 events. The 0 degree threshold is set high enough to exclude most
platelets. Histogram data are used to differentiate reticulocytes from mature RBC,
platelet clumps, and nucleated cells. Reticulocytes have 10 degree scatter that are
similar to the scatter for mature RBC, but differ from them by exhibiting greater 90
degree scatter. Reticulocytes are reported in percent (%R). The instrument will
automatically calculate the Reticulocyte Absolute value if an RBC concentration is
entered using the F12 RBC Source function key.

RUN VIEW
When the reticulocyte results fall outside patient limit sets, the result is displayed
in color on the screen to alert the operator. Results displayed in yellow are below
the limit, results displayed in purple are above the limit, and these flagged results
are underlined on the printed report. Patient results that exceed the linearity
specifications will be suppressed and (>>>>) will be displayed and printed.

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Patient Run View Chartable Page

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Principles of Operation Section 12

Patient Run View Graphs Page

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Datalog RETC Tab View

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Principles of Operation Section 12

NOTES

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Setup Guidelines

The CELL-DYN Ruby System software is configured to automatically analyze the

prepared reticulocyte specimen in the Open Mode when the Analyzer Status
indicates Ready state and RETIC is displayed in the <Test Selection> field of the
Open Tube Next Entry (NOTE) region. Datalog and QC View are customizable
for the display of the reticulocyte results.
NOTE: The single specimen run views (parameter sets) for reticulocyte results are
not customizable; however, the customized printed report can be
configured to include printing the graphs or not.
To customize units and patient limit sets for %R and RETC parameters, see Section
2: Installation Procedures and Special Requirements,
Subsection: System Customization. Refer to Section 5: Operating Instructions,
Subsection: Setup Guidelines for the tasks involved to configure the CELL-DYN
Ruby to your laboratorys requirements.

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Setup Guidelines Section 12

NOTES

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RETIC Test Selection

Specimen analysis is performed in the Open Mode.

NOTE: To ensure optimal flagging, the CBC must have been run within 8 hours
prior to the Retic run on the same analyzer using the same specimen.
NOTE: Specimen IDs must match exactly and are case sensitive.
Retic Test Selection

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RETIC Test Selection Section 12

Enabling Reticulocyte Processing

Procedure: Selecting RETIC test selection to enable Reticulocyte
method
1. Verify the Analyzer Status indicates Ready state and Open mode, select the
RETIC test selection in the NOTE region to open the message dialog box.

2. Select OK to run the Reticulocyte Method Startup Script and enable

reticulocyte processing.
The software to analyze reticulocytes is now enabled on the
CELL-DYN Ruby System.

Disable Reticulocyte Processing

Procedure: Selecting a non-RETIC test selection to disable
Reticulocyte method
1. Verify the Analyzer Status indicates Ready state and Open mode, select the
CBC test selection in the NOTE region to open the message dialog box.

2. Select OK to run the Reticulocyte Method Cleanup Script and disable

reticulocyte processing.
When the Reticulocyte method is disabled, the instrument automatically runs a
wash cycle and returns the Analyzer Status to the Ready state.
CAUTION: If the instrument has been idle for four hours in the RETIC
test selection, it enters the STANDBY state without running a cleaning
cycle. If this happens, perform an Auto-Clean cycle before using the
instrument again.

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Routine Operation

Overview
This section contains information and procedures that are recommended for the
routine operation of the Reticulocyte Package for the CELL-DYN Ruby System.
This section contains the following subsections:
Reticulocyte Specimens
Specimen Requirements
Interfering Substances
Running Specimens
RETC_Background Counts
Quality Control
Specimen Preparation
Patient Specimens

Reticulocyte Specimens
This subsection discusses routine operation of the Reticulocyte Package.
Guidelines and procedures are provided for running RETC_Background counts,
quality control, and patient specimens. Proper start-up procedures should be
performed prior to processing patient specimens. The Reticulocyte Package is only
available for use in the Open Mode.
For RETC_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.
RETC_Background counts should be performed, at a minimum, each day that
reticulocyte specimens are run or as required according to the laboratorys protocol
and with each new lot of reagent.
Always mix and handle commercial control materials according to the directions
given on the package insert. Proper mixing is essential for accurate results. Patient
reticulocyte controls should be run and handled according to the laboratorys
protocol. Quality control checks should be performed, at a minimum, each day that
reticulocyte specimens are run or as required according to the laboratorys protocol.
The operator enters the reticulocyte specimen ID to be run (Patient, QCID, or
RETC_Background) into the Specimen ID QCID field of the Next Open Tube
Entry (NOTE) region. If the specimen ID is matched to a record in the Orders
view, the System will display there is a match and the specimen demographics from
the pending order will be used in the Next Open Tube Entry (Detailed) dialog
box. See the following graphic example. When the reticulocyte sample is
completed and the Analyzer Status indicates Ready, the operator can then enter a
new specimen ID for the next specimen to run. Specific instructions for each
specimen type are given later in this section.

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Routine Operation Section 12

RETIC Test Selection Pending Orders Match View

Specimen Requirements
A fresh non-hemolyzed, whole blood specimen collection in K2EDTA is the
specimen of choice for Reticulocyte analysis on the CELL-DYN Ruby System.
Specimens may be run up to 8 hours after collection time when stored at room
temperature.
NOTE: Studies have shown that reticulocytes continue to mature at room
temperature. Increased flagging can occur when using specimens more
than 8 hours old.
If a delay in analysis is anticipated, specimens may be processed up to 72 hours if
stored at refrigerated temperature.
Refrigerated samples must be brought to room temperature before mixing; this
avoids damaging any fragile cells.
For the Absolute Reticulocyte calculation, it is recommended that the RBC
concentration used must be selected from the same specimen that will be used for
the Reticulocyte count and preferably run on the same analyzer.

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F11 RBC Source

When the F11 - RBC Source key is used to locate the RBC count, the system alerts
the operator when a valid result is not found. If a specimen is more than 8 hours old
and the CBC was processed more than 8 hours prior to performing the Reticulocyte
analysis, manual entry of the RBC value is an option. The System will alert the
Operator if the manual entry of the RBC value exceeds the software limit. See the
following two graphic examples. If the RBC value is not entered, only the %R
value will be obtained.

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Routine Operation Section 12

Interfering Substances
The CELL-DYN Ruby 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 Ruby reticulocyte count. Consequently, these specimens
should be flagged by the instrument. Refer to Maintenance and Troubleshooting,
Operational Messages and Data Flagging within this chapter for a complete
description of the Reticulocyte flags.
The information in the following table, based on CLSI Document H44-A21,
indicates substances that are known or potential interference. The
CELL-DYN Ruby Reticulocyte procedure is designed to minimize some common
interference, including high WBC counts and NRBC.
Table 12.1 Known or Potential Interferents

Cellular Elements Cellular Inclusions Miscellaneous

Platelet clumps Howell-Jolly bodies Abnormal red cells

Basophilic stippling Heinz bodies Paraproteins
Giant platelets Pappenheimer bodies Cold agglutinins
Leukocytes and Parasites (malaria, Platelet/erythrocyte
leukocyte fragments babesia) coincidence
Nucleated erythrocytes Hemolysis

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Specimen Preparation
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.

WARNING: Potential Biohazard. Consider all clinical specimens,

calibrators, and controls that contain human blood or serum as potentially
infectious. Wear gloves, labcoats, and safety glasses and follow other
biosafety practices as specified in the OSHA Bloodborne Pathogen Rule
(29 CFR Part 1910.1030) or other equivalent biosafety procedures.

Procedure: Specimen Preparation

1. The Reticulocyte Package is available for use only in the Open 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 L of the whole blood specimen into each labeled tube of
reticulocyte reagent.
6. Incubate the stained Reticulocyte specimens on a rotator or in a rack, after
fully inverting the stained specimens 5 times. Incubation must be performed
according to the reagent package insert.
NOTE: The stained Reticulocyte specimens must incubate for at least 15
minutes but no more than 2 hours prior to processing on the
CELL-DYN Ruby System.
This timing will allow the Reticulocyte specimens to be processed for STAT
requests. Reticulocyte specimens can also be grouped and run in batches, provided
that the 2-hour maximum incubation time limit is not exceeded.

Running Specimens

RETC_Background Counts
The reticulocyte background (RETC_Background) count should be included in the
daily start-up procedures to check for particulate matter in the reticulocyte reagent
and the CELL-DYN Ruby System. The RETC_Background count is determined
from the total counts that occur in the reticulocyte scatter area on the 10/90
scatterplot.
NOTE: Confirm that the RETC_Backgound count is within acceptable limits
before running controls or patient specimens.

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Routine Operation Section 12

Procedure: RETC_Background Count

1. Select a tube from the current lot of reticulocyte reagent that will be used for
the days testing.
2. Label the tube RETC_Background and record the current date on the tube.
3. Select the RETIC test selection in the Next Open Tube Entry (NOTE)
region, then select the Ok button to run the Reticulocyte Method Startup
script.
4. Verify that the Analyzer Status indicates Ready state, and select
RETC_Background from Specimen ID QCID drop down menu in the Next
Open Tube Entry (NOTE) region.
5. Open the tube labeled RETC_Background and immerse the Open Sample
Aspiration Probe in the reagent.
6. Press the Touch Plate located behind the probe to start the cycle. The BUSY
indicator light will be illuminated in yellow on the Analyzer Status Indicator
Panel. The Analyzer Status region will display messages indicating the
various stages of the cycle.
7. Remove the tube when the beep sounds. The Wash Block will move down the
probe and clean it.

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8. When the cycle is complete, the Wash Block moves back to the top of the
probe and the Ready state will display in the Analyzer Status region.
9. The Run View and Datalog, RETC tab view displays the
RETC_Background (RBGD) count results.
10. Verify that the RETC_Background count is within the acceptable limit of less
than or equal to 100 counts.
NOTE: Results that are outside the acceptable range are displayed in
purple.
11. If the RETC_Background count is unacceptable, repeat it. If the repeated
count is still unacceptable, follow the directions for troubleshooting
RETC_Background count problems given in Maintenance and
Troubleshooting later in this section.

Quality Control
Quality control checks should be performed, at a minimum, each day that
reticulocyte specimens are run or as required according to the laboratorys
protocol. Always mix and handle commercial control materials according to the
directions given in the package insert. Proper mixing is essential for accurate
results. Patient reticulocyte controls should be run and handled according to the
laboratorys protocol. See Section 11: Quality Control, Subsection: QCID File
Setup, for details on customizing the Quality Control ID (QCID) files.

Procedure: Quality Control

1. Always mix and handle commercial control materials according to the
directions given on the package insert. See Subsection: Quality Control
Guide, Mixing and Handling, later in this section.
2. Verify that the reticulocyte reagent vial is not expired before use. Store the
stock reagent in the dark at room temperature.
3. Label one tube of reticulocyte reagent for each level of control material.
4. Pipette 20 L of the control material into each labeled tube of reticulocyte
reagent.
5. Incubate the prepared control specimens for 15 minutes, on the rotator or in
a rack, after fully inverting the stained specimens 5 times. Incubation is
performed at room temperature according to the reagent package insert.
NOTE: The stained control specimens may incubate for up to 30 minutes
maximum prior to processing on the CELL-DYN Ruby System.
6. Verify that the RETIC test selection is displayed in the Next Open Tube
Entry (NOTE) region. For instructions on enabling the Reticulocyte
Package, refer to Subsection: Enabling Reticulocyte Processing.
7. Enter the reticulocyte QCID in the Specimen ID QCID field of the NOTE
region or select the QCID Lookup icon to display the list of available
reticulocyte QCID files to choose from.
8. Open the well-mixed, prepared control specimen tube and immerse the Open
Probe in the sample.

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Routine Operation Section 12

9. Press the Touch Plate located behind the probe to start the cycle. The BUSY
indicator light on the Analyzer Status Indicator Panel will be illuminated in
yellow. The Analyzer Status region will display messages indicating the
various stages of the cycle.
10. Remove the tube when the beep sounds. The Wash Block moves down the
probe and cleans it.
11. When the cycle is completed, the Wash Block moves back to the top of the
probe. Wait for the Ready state to display in the Analyzer Status region.
12. Repeat steps 7 through 11 for all prepared control specimens.
13. Verify that the control results are acceptable.
NOTE: Out-of-range results are displayed in color. Data invalidating alerts,
such as Fragile RBC, are not valid when running commercial
controls.
14. 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 Subsection: Maintenance and Troubleshooting.
15. When the control results are acceptable, patient samples may be analyzed.

Patient Specimens
A fresh non-hemolyzed, whole blood specimen collection in K2EDTA is the
specimen of choice for Reticulocyte analysis on the CELL-DYN Ruby System.
Specimens may be run up to 8 hours after collection time when stored at room
temperature.

Procedure: Running Patient Specimens

1. The prepared dilution(s) of the patient reticulocyte sample(s) can be run after
the control and RETC_Background count results have met the laboratorys
criteria.
2. Wand or enter the Specimen ID in the Specimen ID QCID field of the
region. If a specimen ID match is found in the Pending Orders, the specimen
demographics from the order are sent to the Next Open Tube Entry
(Detailed) dialog box. If there is no match found, the operator can select the
More Spec Info button to enter specimen demographics.
3. The patient demographic data can be added or edited in this dialog box before
the specimen is run, or using F4 Edit from the Datalog after the reticulocyte
run is complete.
4. Select F12 RBC Source to open the RBC Source Selection for
Reticulocyte Absolute dialog box.

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5. Choose the RBC source and select the OK button.

If the Specimen ID displayed is more than 8 hours old or none is found, the
RBC value can be entered by the operator.
6. Open the well-mixed, prepared reticulocyte specimen tube and immerse the
Open Probe in the sample.
7. Press the Touch Plate located behind the probe to start the cycle. The BUSY
indicator light on the Analyzer Status Indicator Panel will be illuminated in
yellow. The Analyzer Status region will display messages indicating the
various stages of the cycle.
8. Remove the specimen tube when the beep sounds. The Wash Block moves
down the probe and cleans it.
9. When the rinse cycle is complete, the Wash Block moves up the probe. Wait
for the Ready state to display in the Analyzer Status region.
10. The results of the reticulocyte run are displayed on the Run View and
Datalog, RETC tab views.
11. If automatic report printing has been specified, a report is printed according
to the graphs and limits report options selected in the Customize Printed
Report dialog box. If automatic report printing has not been specified, a
report may be printed by pressing F1 Print. Repeat this procedure for each
subsequent reticulocyte specimen.

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Routine Operation Section 12

NOTES

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Quality Control Guide

The CELL-DYN Ruby System offers several quality control options to monitor
and validate instrument performance while running the Reticulocyte Package. The
options are:
QCID Files Quality Control ID (QCID) file statistical and
graphical analysis of the data in each file to
calculate the mean, standard deviation, and
coefficient of variation
Westgard Rules A multi-rule system applied to the data in
each of the QC files
Moving Average Programs Monitors population statistics to detect
changes in the Systems optical measurement
process
Each of these options is discussed in detail in Section 11: Quality Control.
All QC data should be reviewed according to your laboratorys protocol.

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Quality Control Guide Section 12

Whole Blood Quality Control Run View Chartable Page

Control Material
See Appendix A: Parts and Accessories for the list of available controls for use
on the CELL-DYN Ruby. These controls should be run:
After daily start-up procedures are completed
After a reagent lot number change
After maintenance, component replacement, or a field service action
After a software change
Following calibration
According to your laboratorys quality control program
According to regulatory requirements
NOTE: Data invalidating alerts, such as Fragile RBC or ERL, are not valid
when running commercial controls.

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Mixing and Handling

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.

Reagent
Use Reticulocyte Reagent manufactured only by Abbott Laboratories. 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.

Quality Control Specimens

Always mix and handle commercial control material according to the directions
given in the package insert. Pay particular attention to the following:
Store the CELL-DYN controls in the refrigerator at 2 8 C. Store in a
suitable location in the refrigerator, away from the door if it is opened
frequently.
Carefully warm the CELL-DYN controls prior to mixing, according to the
directions given in the package insert. Proper mixing is essential for accurate
results.
Mix the CELL-DYN control vials gently by hand to thoroughly resuspend
the control material. Do not use automatic mixers to resuspend the control
material.
Check the open-vial stability dating given on the package insert and do not
use the products longer than is recommended or results may be
compromised.

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Quality Control Guide Section 12

NOTES

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Maintenance and Troubleshooting

Overview
This section provides instructions for identifying, troubleshooting, and correcting
instrument system information messages and conditions in the Reticulocyte
Package. These instrument conditions may be found in Section 10:
Troubleshooting and Diagnostics.
This section is divided into the following subsections:
Maintenance
General Guidelines for Reticulocyte Troubleshooting
Operational Messages and Data Flagging
Dispersional Data Alerts
Instrument Alert Messages
Alert Messages with Suppressed Reticulocyte Results
Data Invalidating Alerts
High RETC_Background Counts
NOTE: For a list of interfering substances, refer to Subsection: Interfering
Substances.

General Guidelines for Reticulocyte Troubleshooting

Reticulocyte troubleshooting should include an initial check of the following
items:
Reagent storage conditions and expiration. (Refer to the Reticulocyte
Reagent package insert for details).
Sample preparation technique including pipetting, mixing, and incubation.
(Refer to Subsection: Specimen Preparation.)

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Maintenance and Troubleshooting Section 12

Operational Messages and Data Flagging

Dispersional Data Alerts
The result of each run (patient, control, or RETC_Background) is reviewed within
the appropriate limits as entered by the operator or taken from the instruments
preset limits. If a result for a parameter exceeds these limits, they are flagged on
the screen and on the printed report. Dispersional Data Alerts are displayed or
printed as follows:
Screen Display:
Result(s) below lower limits shown in yellow
Result(s) above upper limits shown in purple
Analytical Measurement Range Exceeded: Result displayed as >>>> (See
Table 4.13)
Printed Report: Result(s) outside limits underlined
when printed

Instrument Alert Messages

Instrument System Information Messages are displayed when the instrument
detects an inappropriate condition during specimen processing. When necessary,
data is suppressed. When these messages occur, follow the instructions given and
take the appropriate corrective action. When the problem is corrected, repeat the
specimen.

Instrument Alert Messages with Suppressed Reticulocyte Results

Suppression of Reticulocyte results occurs when the sample run data acquisition
process exceeds normal parameters. When the Reticulocyte results are suppressed,
one of the following three alerts will be displayed in the lower left-hand quadrant
of the Run View and on the graphics printout under the heading ALERTS.

Table 12.2 Instrument Alert Messages

Alert Probable Cause Corrective Action

Flow Error Air bubble 1 Run a RETC_Background count to cycle air

Alert occurs when the Hardware malfunction through the system.
average count rate rapidly 2 Rerun the Reticulocyte specimen.
increases during the 3 If alert still occurs, refer to Section 10:
Reticulocyte count cycle. Troubleshooting and Diagnostics,
Subsection: Troubleshooting Tips and
Techniques

>>>> The Reticulocyte Verify Reticulocyte results by an alternate

percentage exceeds method.
the analytical
measurement linear
range.

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Data Invalidating Alerts

The Reticulocyte results are not suppressed for the Data Invalidating Alerts. The
alert message appears in the lower left-hand quadrant of the Run View and on the
graphics printout under the heading ALERTS.

Table 12.3 Data Invalidating Alerts

Alert Probable Cause Corrective Action

Fragile RBC Air bubble 1 Run a RETC_Background count to cycle

NOTE: Alert occurs when Staining a fragile RBC the system. Rerun the Reticulocyte
the average count specimen too long in the specimen.
rate rapidly reticulocyte reagent 2 Prepare another dilution verifying proper
decreases during Fragile RBC specimen preparation as discussed in
the Reticulocyte Subsection: Specimen Preparation.
Run the dilution after adequate incubation
count cycle.
as indicated in the Reagent package
insert.
3 Verify Reticulocyte results by an alternate
method.

Excessive RBC Loss (ERL) Specimen staining time 1 Prepare another dilution verifying proper
too long in the specimen preparation as discussed in
reticulocyte reagent Subsection: Specimen Preparation,
Rapid degeneration of and run after adequate incubation as
RBC indicated in the Reagent package insert.
High concentration of 2 Rerun the specimen.
platelets, platelet 3 If the flag persists, verify the reticulocyte
aggregates, or other results by an alternative method.
interfering substances
Microcytic RBC
Improper instrument
settings

Too Few Events Inadequate whole blood Prepare another dilution verifying proper
Alert occurs when fewer than sample mixing specimen preparation as discussed in
3000 events are counted Improper pipetting Subsection: Specimen Preparation within
during the Reticulocyte count Blood not stained this chapter.
cycle. Cold Agglutinin Verify Reticulocyte results by an alternate
method.

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Maintenance and Troubleshooting Section 12

High RETC_Background Counts

NOTE: The RETC_Background count should be less than or equal to 100 counts.
1. If the RETC_Background count is high, repeat the run.
2. If the results are still unacceptable, open a new tube of reticulocyte reagent
and repeat the RETC_Background count.
3. If the RETC_Background count is still unacceptable, run a tube from a new
lot of reticulocyte reagent if available.
4. If the results are still unacceptable, press the Touch Plate to cycle air through
the system.
5. If the results are still unacceptable, exit the Reticulocyte Package and
perform a routine background check. If these results are acceptable, repeat
the RETC_Background count and if the RETC_Background count is still
high, perform Extended Auto-Clean procedure (see Section 9: Service and
Maintenance, Subsection: 6008 Extended Auto-Clean.)
6. If the routine background count is unacceptable, see Section 10:
Troubleshooting and Diagnostics, Subsection: Troubleshooting Tips and
Techniques.

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References

1. NCCLS. Methods for Reticulocyte Counting (Automated Blood Cell

Counters, Flow Cytometry, and Supravital Dyes); Approved Guideline.
NCCLS document H44-A2 (ISBN 1-56238-527-5). NCCLS, 940 West
Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898, 2004.
2. NCCLS. Method Comparison and Bias Estimation Using Patient Samples;
Approved Guideline. NCCLS document EP9-A (ISBN 1-56238-472-4)
NCCLS, 940 West Valley Road, Suite 1400, Wayne, PA 19087-1898, 2002.
3. NCCLS. Evaluation of the Linearity of Quantitative Analytical Measurement
Procedures: A Statistical Approach; Approved Guideline. NCCLS document
EP6-A (ISBN 1-56238-498-8) NCCLS, 940 West Valley Road, Suite 1400,
Wayne, PA 19087-1898, 2003.
4. International Committee for Standardization in Haematology (ICSH). The
Assignment of Values to Fresh Blood Used for Calibrating Automated Cell
Counters. Clinical and Laboratory Hematology 1988; 10:203-212.
5. Clinical Applications of Flow Cytometry. ASCP National Meeting. Spring
1990.
6. Shapiro, Howard. Practical Flow Cytometry. New York: LISS. 1985.
7. US Department of Labor, Occupational Safety and Health Administration,
29 CFR Part 1910.1030, Occupational Exposure to Bloodborne Pathogens.
8. World Health Organization. Laboratory Biosafety Manual. Geneva: World
Health Organization, 1993.
9. Clinical and Laboratory Standards Institute (CLSI). Protection of Laboratory
Workers from Occupationally Acquired Infections; Approved Guideline
Third Edition. CLSI document M29-A3 (ISBN 1-56238-567-4). CLSI, 940
West Valley Road, Suite 1400, Wayne, PA 19087-1898, 2005.

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References Section 12

NOTES

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 Appendix A Parts and Accessories

Appendix A Parts and Accessories

Appendix A - CELL-DYN Ruby Parts

and Accessories

List numbers are unique identifiers that are used when ordering products. The list
number and quantity provided in Appendix: A Parts and Accessories are intended
for guidance only and are subject to change. Contact your Abbott representative for
the most current information regarding list numbers.
Table A.1 CELL-DYN Ruby Hardware List Numbers

List Number Includes Name Comments

08H67-01 1 CELL-DYN Ruby Analyzer

07H40-01 1 Bar Code Reader, Hand-Held, Includes Hand-Held Bar Code

Trigger Activated Reader Users Guide

05H00-02 1 Display, Flat Panel 17 inch

08H14-01 1 Keyboard Standard - (Flex style),

English

07H96-01 1 Keyboard Standard, English

09H41-01 1 Mouse Pointing Device

08H07-01 1 Printer, Graphics (color laser with 110 VAC

USB port connector)

08H07-02 1 Printer, Graphics (color laser with 220 VAC (Sourced locally)
USB port connector)

08H78-05 1 Printer, Graphics (Color deskjet 100-240 VAC

with USB port connector)

Item included in Accessories kit.

CELL-DYN RubyTM System Operators Manual A-1

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Parts and Accessories
Appendix A

Table A.2 CELL-DYN Ruby Accessories Kit (List Number 09H04-01)

Part/List
Quantity Name Description
Number

5406753 1 Allen Wr, Hex, Short L, 3/32 For maintenance

8952087701* 1 Cable, Data Station (HSSL) For communication between Data

Module Computer and Analyzer

09H00-01 1 Cable, (printer), 10' USB A/B

8240051601* 2 Cable, Power, 6'7" For Analyzer

06H92-01 1 pkg Diluent/Sheath Filter (Pkg of 6) Millipore filter for Diluent/Sheath

pathway

N/A 1 Mixing and Handling Inserts

09H06-01 1 Needle, SL Closed Mode Needle, for use with

CELL-DYN Ruby

03B96-02 1 Paper (printer)

21704-01 1 Plug, Dummy Waste For disabling waster sensor when

waste is routed to external drain

03H96-01 1 pkg Ring, Pull Solenoids Ring for Pulling Solenoid Valves

92532-01 1 Serial Loop-Back Device (RS232) For testing the Laboratory

Information System (LIS)

3106545 1 Tubing (120" roll) Tygon Tubing (1/4" ID, 3/8" OD)

09H38-02 1 Tubing, Reagent WBC Lyse Includes reagent container cap,

and sinker (4.0 L container)

92376-01 1 pkg Tubing set, Transfer Pump Package of one Transfer Pump
Tubing Assembly

09H41-01 1 Mouse, Digital USB Optical Mouse

07H40-01 1 Bar Code Reader, Handheld,

Trigger Activated

08H43-01 1 Tubing, Diluent/Sheath Includes reagent container cap, and

sinker (20L container)

08H44-01 1 Tubing, HB Lyse Includes reagent container cap, and

sinker (4L container)

02H96-01 1 Tubing, Waste Outlet Includes reagent container cap and

sensor

* Orderable by Abbott Personnel only.

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Appendix A Parts and Accessories

Table A.3 CELL-DYN Ruby Optional Accessories

Part/List
Quantity Name Description
Number

07H67-02 5 Cap (large), Reagent line tubing For the 3.8 and 20L containers

99650-01 1 Labels, Tube ID Bar Code, 1 roll Tube ID Bar Code Labels (1000
labels per roll)

99652-01 1 Labels, Bar Code, Q-Labels QC Bar Code Labels (numbered 1-

20), in Code 39 (without check digit)

01H59-01 1 Labels, Bar Code, Q-Labels QC Bar Code Labels (numbered

1-25), in Code 39 (with check digit)

09H31-02 1 Labels, Bar Code, Background Background Bar Code Labels

06H62-01 1 Labels, CELL-DYN Rack Bar Bar Code Labels for Sample Loader
Code, set of 100 Racks (#s 0-99)

08H06-02* 1 Rack, Sample Loader Single Standard Sample Loader

Rack

06H64-01 1 CELL-DYN Shear Valve Center Ceramic Center Section for

Section CELL-DYN Blood Shear Valve

02H82-02 1 Syringe, 10 mL For dispensing Diluent/Sheath

reagent

28561-01 1 Syringe, 2.5 mL For dispensing WBC Lyse or HGB

Lyse reagent

28560-01 1 Syringe, 500 L For injecting diluted sample into

optical flow cell

99644-01 1 Enzymatic Cleaner

03B96-02 500/pkg 8 1/2 x 11 Printer Paper

08H06-01* 1 Kit Rack, Autoloader Set of 10, Standard Autoloader

Racks

04H87-01** 1 Set Racks, Sample Loader Set of 5, Sample Loader Racks

09H32-01 1 Open Mode Probe Probe for Open Mode

* Same as CELL-DYN Sapphire Rack.

**Same as CELL-DYN 3200 Rack.

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Parts and Accessories
Appendix A

Table A.4 CELL-DYN Ruby Support Documentation List Numbers

List Number Quantity Name Description

08H56-04 1 Manual, Customer Training, Printed version

CELL-DYN Ruby

08H56-03 1 Manual, Online Operators, CD-ROM

CELL-DYN Ruby

08H56-02 1 Manual, Operators, Printed version

CELL-DYN Ruby

09H05-01 1 Specification, Laboratory Interface, Specification for communications

CELL-DYN Ruby between the CELL-DYN Ruby and a
Laboratory Interface System (LIS)

Table A.5 CELL-DYN Calibrator and Controls for use on CELL-DYN Ruby

List Number Quantity Name Description

08H57-01 1 kit Calibrator, CELL-DYN HemCal 2, 3-mL tubes with pierceable cap,
Plus insert, and assay sheets

08H58-01 1 kit Control, CELL-DYN 29 Plus (with 12, 3-mL tubes (4 tubes each of low,
Retic), full-pack (tri-level) normal, and high control) with
pierceable caps, insert, and assay
sheets

08H58-02 1 kit Control, CELL-DYN 29 Plus 6, 3-mL tubes (2 tubes each of low,
(with Retic), half-pack (tri-level) normal, and high control) with
pierceable caps, insert, and assay
sheets

99120-01 1 kit Calibrator, CELL-DYN 22 2.5-mL tubes, insert, and assay

sheet

93111-01 1 kit Control, CELL-DYN 22 (tri-level) 2.5-mL tubes, insert, and assay
sheet

08H62-01 1 kit Control, Retic Plus 3.0-mL tubes, levels I and II,
pierceable caps, insert, and assay
sheet

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Appendix A Parts and Accessories

Table A.6 CELL-DYN Reagents for use on CELL-DYN Ruby

Case Weight
List Number Quantity Name Single Container Size
QTY/ Case

08H52-01 1 Reagent, WBC Lyse 3.8 L cubitainer 4.03 .01 kg

1/case

01H73-01 1 Reagent, Diluent/Sheath 20-L cubitainer 21.9 0.5 kg

1/case

03H80-02 1 Reagent, CN free HGB/ 3.8 L cubitainer 4.03 .01 kg

NOC Lyse 1/case

03H40-01 1 Reagent, Reticulocyte 5.0 mL tubes, each Kit of 100

tube containing 3.7 mL
of reagent

CELL-DYN RubyTM System Operators Manual A-5

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Parts and Accessories
Appendix A

NOTES

A-6 CELL-DYN RubyTM System Operators Manual

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ppendix B Potential Causes of Spurious Results

Appendix B Potential Causes of Spurious Results

Appendix B Reference

Potential Causes of Spurious Results

This table provides a detailed list of potential causes of spurious results
with automated hematology analyzers.
NOTE: Some of the causes listed may not interfere with the
CELL-DYN Ruby parameters. Refer to Section 7: Operational
Precautions and Limitations, Subsection: Interfering Substances
and Conditions , for the list substances and conditions that can affect
the CELL-DYN Ruby parameters.
Table B.1: Potential Causes of Spurious Results with Automated Cell Counters

Parameter Causes of Spurious Increase Causes of Spurious Decrease

White Cell Count Cryoglobulin, cryofibrinogen Clotting

(WBC) Heparin Smudge cells
Monoclonal proteins Uremia plus immunosuppressants
Nucleated red cells
Platelet clumping
Unlysed red cells

Red Cell Count Cryoglobulin, cryofibrinogen Cold agglutinins

(RBC) Giant platelets Clotted specimen (microclot)
Elevated white cell count Hemolysis (in vitro)
(> 30,000/L) Polycythemia (increased RBC coincidence)
Microcytic red cells

Hemoglobin (HGB) Carboxyhemoglobin (> 10%) Clotted specimen (microclot)

Cryoglobulin, cryofibrinogen
Hemolysis (in vivo)
Elevated white cell count
(> 30,000/L)
Hyperbilirubinemia, severe Lipemia
Abnormal plasma proteins

Hematocrit (Packed Hyponatremia Excess EDTA

Cell Volume - Manual Plasma trapping Hemolysis (in vitro)
Method) Hypernatremia

Mean Cell Volume Autoagglutination Cryoglobulin, cryofibrinogen

High white cell count (> 50,000/L) Giant platelets
Hyperglycemia Hemolysis (in vitro)
Reduced red cell deformability Microcytic red cells
Swollen red cells

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Potential Causes of Spurious Results
Appendix B Reference Appendix B

Table B.1: Potential Causes of Spurious Results with Automated Cell Counters (Continued)

Parameter Causes of Spurious Increase Causes of Spurious Decrease

Mean Cell High white cell count (> 50,000/L) Spuriously low hemoglobin
Hemoglobin Spuriously high hemoglobin Spuriously high red cell count
Spuriously low red cell count

Mean Cell Autoagglutination High white cell count (> 50,000/L)

Hemoglobin Clotting Spuriously low hemoglobin
Concentration Hemolysis (in vivo and in vitro) Spuriously high red cell count
Spuriously high hemoglobin
Spuriously low hematocrit

Platelets (PLT) Cryoglobulin, cryofibrinogen Clotting

Hemolysis (in vivo and in vitro) Giant platelets
Microcytic red cells Heparin
Red cell inclusions Platelet clumping
White cell fragments Platelet satellitosis

SOURCE:
Cornbleet, J. Spurious Results from Automated Hematology Cell Counters. Laboratory Medicine, 1983.
August 14: 509-514.

B-2 CELL-DYN RubyTM System Operators Manual

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Index

Index

A B
Access Rights 2-9, 2-44, 2-45, 2-46 Background
Analysis Counts, on demand 5-16
Closed Mode 5-28 High Retic 12-28
Enzymatic Cleaner 9-30 RETC_Background 12-15
Open Mode 5-27 Troubleshooting 10-5
Specimen Analysis Tasks 5-13 Bar Code
Task 5-11 characters 4-8
Analyzer 1-7 codes: Code 39, Code 128, CODABAR,
Analyzer failed to prime 10-14, 10-78 Interleaved 2 of 5, and ISBT
Anticoagulants 4-5 formats 1-12
Heparin ID 5-15, 5-21
Anticoagulants match 5-21
Sodium Citrate 7-6 match by bar code label specimen ID 5-18
Recommended 4-5 part numbers A-3
As-Needed Service and Maintenance 9-4 Pending Orders 5-19
Aspiration 1-15, 8-11 placement 5-18, 5-28, 9-17
Bar Code 5-17 reader 1-6, 1-12, 1-21, 1-22, 1-27
cleaning 9-33, 9-36, 9-58, 9-71 setup 2-9, 2-41, 2-56
Closed 3-1, 5-13 Specimen Identification 1-5, 4-8, 5-18
disposal 8-11 Bar Code Labels See also Bar Codes
Enzymatic Cleaner 9-16, 9-30 Placement 4-9
Incomplete 5-30, 10-7, 10-10, 10-16 Bar Code Reader Window 9-31
Normal Volume 4-5 cleaning 9-31
Open 3-1, 5-13 dialog box 6051 9-32
Open Tube Mode Aspiration Probe (Open Bar Code Symbol Dimensions & Label
Mode Probe) 1-9 Requirements 4-7
Open Tube Mode Aspiration Probe Bar Codes See also Bar Code Labels
(with Wash Block) 1-12, 8-11 Symbologies
Sample 3-1, 6-1 Codabar 4-7
Sampling error 5-30, 10-7 Code 128 4-7
Tower 10-39, 10-48, 10-49, 10-77 Code 39 4-7
Vent needles 8-11 Interleaved 2 of 5 4-7
Aspiration Volume Specification 4-5 Bar Codes See also Bar Code Labels
Assistance, Telephone 1-i, 10-1 Symbologies
ATYPDEP 2-9, 2-65, 3-36 Codabar 4-8
Auto Background counts 5-8, 5-15, 7-3, 9-16, Code 128 4-8
10-5 Code 39 4-8
Auto-Calibration Wizard 5-21, 6-22 Interleaved 2 of 5 4-8
Autoloader
Specimen tube dimensions 7-6, 10-19

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 Index

C Pending Order 5-18, 5-21

Storing data 5-26
Calibration Overview 6-1 Diluent/Sheath 1-16, 1-41
Calibration overview 6-1 Filter 9-27
Calibration Procedures Syringe 1-14, 1-16
Overview 6-1 Dilution Ratios 3-3, 3-4
Change Demographics 5-26 Dilution ratios 3-4
Clearance Requirements 4-4 Dimensions
Closed Mode Analysis 5-28 Physical Specifications 4-3
Code 128 1-12, 4-7 Disclaimer
Collection Tubes Instrument 1-ii
Dimensions (Closed Mode) 4-5 Result Interpretation 7-8
Handling 7-6 Dispersional Data Alerts 12-26
Minimum Volume 4-6, 7-6
Recommended Anticoagulants 4-5
Components 1-7 E
Computer 1-21 Edit 11-27
Customer Service 1-i Enzymatic Cleaner 9-16
Event Log 9-10
D
Data Flagging 3-1, 3-19, 3-22, 3-33, 12-26 F
HGB 3-23 F10LIS Function Key
Patient Specimen type 3-33 F10 2-61
Platelet 3-21 Fault Condition
RBC 3-21 Analyzer 9-53
Reticulocyte 12-26 Fault Conditions 3-27
RGB 3-23 Analyzer 9-54, 9-55, 9-56, 9-57
WBC 3-19 System Messages 10-3
Data Invalidating Alerts 3-31, 12-18, 12-22, Flagging
12-27 Interfering Substances 7-8
Datalog View 1-33, 2-8, 2-29, 5-19, 5-24, Flagging Messages 3-27, 10-3
5-29, 5-32, 5-34 Flags - Suspect Parameter 3-32
CBC+NOC test 3-5 Fragile WBCs and Resistant RBCs 3-5
Customize data view 2-30 Instrument generated 3-1
Operator ID 5-14 Messages 3-29
operator ID 5-15 Floppy Disk Drive 1-10
Results 3-6, 3-15 Flow Cell Assembly 1-18
tests 3-5 Flow Error 3-31, 5-29, 12-26
Datalog View Displays 5-18 Troubleshooting 10-7
Decontamination 8-8, 9-65 Formats, Bar Codes, See Symbologies, Bar
Spill Clean-Up 8-7 Codes 4-7
Demographics 5-13 Fragile WBCs 3-5
Change 5-26 Front Panel 1-8, 1-10
Edit 5-34 Function keys
NOTE 1-39, 12-17 F1 5-19

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Index

F12 5-8 Specimen 5-18

F9 1-38 Bar Code Specifications 4-7
Troubleshooting 10-2
G Incomplete aspiration 5-30, 10-7, 10-10, 10-16
Incubate 12-15
Groups View 1-34, 2-8, 5-24, 5-39, 5-40 Incubation time limit 12-15
Customizing view 2-8 Installation 2-3
Delete 5-40 Site Requirements 2-1, 2-3
F6 - Create Order 5-23 Instrument and Data Invalidating Alerts 3-31
Manually deleting records 5-40 Instrument Disclaimer 1-ii
Reorder 5-24, 5-34 Intended Use 1-2
Guidelines for Specimen Collection 4-6, 7-6 Interfering Substances 3-20, 5-17, 7-8, 12-14,
12-25, B-1
H Reticulocytes 12-11, 12-14
Spurious B-1
Hazards Suspect population flags 3-32
Biological 8-5 Interfering Substances and Conditions 7-8,
Chemical 8-7 12-14
Electrical 8-8 Interruption
Icons, Safety 8-2 Procedure, Sample loader 5-9
Mechanical 8-9
Physical 8-11
Safety Icons 8-2 L
HCT calculation 3-20 Labels
Heat Output Specifications 4-4 Instrument 1-x
Heaters, Reagent HGB 1-15 Laser Caution 8-3
Heaters, Reagent WOC 1-15 Light scatter 1-42
Helium 3-8 Limits
helium 3-8 Action 2-8
Helium Neon Laser 3-10, 3-19 Background counts 5-4, 6-12, 12-15
Help, Telephone 1-i Customize 2-11
Hemoglobin 1-42 Lower and Upper 2-8
Hemoglobin Analysis 3-6 Means 2-8
HGB Flow Cell 1-15 Patient Sample Setup 2-7, 2-10, 3-32
High Background Counts 10-5 QC 2-8, 2-38, 11-26
High Retic Background 12-25, 12-28 Reports 2-8, 2-34, 2-38
Histograms - WBC 3-17 LIS
HSSL Connector 1-22 pending order entries 5-21
Humidity Specification 4-4 LIS Setup 2-9, 2-61
hydrodynamic focusing 3-9 Accessing the LIS Setup dialog box 2-61
Logs
I Calibration 9-9
Event 9-10
Icon, Safety 8-2 Maintenance 9-8
Identification Reagent Log 9-13
Bar code reader 1-27 Set Point 9-11
QC Download ID File Setup 11-48

CELL-DYN RubyTM System Operators Manual Index-3

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 Index

M Operational Specifications 4-5

Operator ID
Main Power Cord 1-14 running background counts 5-15
Main Power Switch 1-18 signing on and off 5-15
Maintenance Operators 2-9, 2-37
Maintenance log 1-35 Access levels 2-37
non-scheduled 9-75 Adding 2-40
Scheduled 1-40, 9-4 Edit operator info 2-43
Maintenance Log 1-40, 9-8 Editing permission rights 2-44
Maintenance View 9-6 Factory set limits 2-11
MCH calculation 3-21 Removing 2-41
MCHC calculation 3-21 Second Sign On 2-47
MCV calculation 3-20 Set permissions 2-44
Minimum Volume 4-6 Optical Bench Assembly 3-8
Mixing Station 1-12, 5-17 Optical Flow Cell 3-9
Moving Average 1-34, 2-8, 11-30 Orders 1-33
Acceptance Setup 11-49 Orders Setup 2-9, 2-58, 2-59, 5-21, 5-22, 5-23
Moving Average Acceptance Setup 11-49 Bar code mismatch 10-24
MPV calculation 3-22 QCID mismatch 10-24
Orders View 1-5, 1-33, 5-19, 5-21, 5-22, 5-23,
N 5-40
Closed 3-1
New Methylene Blue N 12-2 Pending Orders 5-19
Noise Level Specifications 4-4 Orders View Customization
Nominal Aspiration Volume 4-5 default match criteria 5-19
Normally Closed Valves 1-14, 1-15, 5-5, 9-64 Default Patient Test Selection 5-19
Tubing 9-67
NOTE Region 1-38, 5-23
Nuclear Optical Count 3-5 P
Parameter Set 2-7, 2-24, 2-25
O Parts and Accessories A-1, B-1
Patent Statement 1-ii
Online PDF Documentation Patient Test Selection 5-20
Access Pending Orders
Stand Alone Computer 2-14 Closed Mode 5-18
Open 5-13 Open Mode 5-23
Open Mode analysis 5-27 originating from 5-21
Open Tube Mode Aspiration Probe (Open Mode Performance Specifications 4-11
Probe) 1-9 Peristaltic Pump 1-vi, 1-14, 9-15
Open Tube Mode Aspiration Probe (with Wash Sample transfer 1-14, 8-10
block) 1-12 Tubing 9-20, 9-21
Open Tube Mode Aspiration Tube Probe 1-11 Wheel 9-20
Operating Environment Requirements 4-4 Permission 2-9, 2-44
Operational Messages 3-27 Editing rights 2-45
Interfering Substances and Conditions 3-16,
Laboratory I and II 2-37, 2-38
5-17, 7-8, 12-14, 12-27 PLT 1-15, 1-16

Index-4 CELL-DYN RubyTM System Operators Manual

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Index

PLT calculation 3-22 Quality Control Guide 12-21

PLT Messages 3-40 Quality Control Methods 11-3, 12-21
Power Quality Control Specimens 11-3, 12-23
Off 5-6 Quick Precision Check 6-18
On 5-3, 9-69
Specifications 4-3 R
Preparation for Shipment 8-8, 9-59
Preparing and Handling Controls 7-4 Rack and Tube position 5-25
Preparing and Handling Specimens 7-6 Rack and Tube Setup 2-9, 2-58, 2-59, 5-18,
Preparing to run specimens 5-14 5-21, 5-22, 5-23, 5-24, 5-25, 10-24
Prime 9-7 RBC 1-15
Prime finished 10-10 RBC Count 3-20
Priming 5-3, 5-8, 9-59 RBC Messages 3-39
2099 Analyzer failed to prime 10-78 RBC/PLT Analysis 3-6
analyzer 9-53, 10-3, 10-14 RDW calculation 3-21
fatal fault 10-3 Reagent 7-4, 8-7
Prime finished - auto bkg to follow 10-10 Reagent Heaters
Printing HGB 1-15
Summary report of Pending Orders 5-19 WOC 1-15, 3-4
Procedure Reagent Log 1-35, 5-15, 9-13
Background Count 12-16 Reagent System 1-41
Quality Control 12-17 Reagents Heaters HGB 1-15
Reagents Heaters WOC 1-15
Reagents View 9-13
Q Current Reagents Tab 9-12
QC Limits 2-8, 11-26 Reagents Log tab 9-13
edit 11-27 Reagents View function keys 9-13
Setup 11-25 Reagents, CELL-DYN Ruby
tab 11-35 Hazards 8-7
QC View 1-34, 2-8, 11-10, 11-13, 11-20, Storage and Handling 7-4
11-21, 11-53 Recommended Anticoagulants 4-5
Bar and Buttons 11-16 Refrigerated
column headings 11-14 specimen stability 5-16
Customize 2-29 Refrigerator
customize 12-7 stored items 5-16
Editing a QC specimen run 11-54 Relocation of System 2-5, 8-8
Function keys 11-16, 11-18, 11-20, 11-30 Relocation 8-8
Main 11-14 Report Header 2-8, 2-32, 2-33
Moving average 11-30, 12-1 Requirements
Operator ID 5-15 Waste Disposal 4-4, 8-7
QC Data 11-48 Resistant RBCs 3-5
QC Info tab 11-15 RETIC Test Selection 12-9
QCID L-J Plots 11-20 Reticulocyte Package 12-2
Tab views 11-14 Reticulocyte Reagent 12-15, 12-23
View QC Spec 11-17 Reticulocytes 12-2
QC Views 11-9 Retrieve from file 2-8, 11-38

CELL-DYN RubyTM System Operators Manual Index-5

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 Index

Run Specimen Site Requirements 4-4, 7-2

required procedures 5-14 Special Protocols 9-7, 9-50, 9-52
Run Specimens 12-15 prime the analyzer 9-53
preparing to 5-14 Specifications
Run View 5-11, 5-30 Aspiration Volume 4-5
Background Counts 5-15 Clearance Requirements 4-4
Chartable Page 5-31 Collection Tubes Dimensions (Closed
Review results 5-27, 5-28 Mode) 4-5
Environmental 4-4
S Heat Output 4-4
Humidity 4-4
Safety Noise Level 4-4
Icons 8-2 Operational 4-5
Sample Performance 4-11
Volume See Aspiration Volume 4-5 Physical 4-3
Sample Analysis Cycle 3-3 Power 4-3
Sample Aspiration 3-1 Temperature 4-4
sample aspiration modes 3-1 Throughput 4-5
Sample Feed Nozzle 1-18 Waste Disposal Requirements 4-4, 7-2
Sample Loader 1-5 Specimen
Bar Code Reader 1-12 Handling 7-6
Components 1-11 Specimen Identification 7-4
interruption procedures 5-9 Invalid 4-8, 5-18
mixing 5-17 No ID 5-18
Specimen Rack 1-13 Specimen Preparation 12-15, 12-18
Specimen Tube Dimensions 4-6, 7-6 Specimen Requirements 12-11, 12-12
Tray 9-16 Specimen tube dimensions 7-6
Sample Loader Components 1-11 Specimen Tube, Minimum Volume in 4-6
Sample Loader Rack 1-13, 5-28 Specimens, preparing and handling 7-6
Sample Metering Syringe 3-10 Analysis 5-1, 5-8, 5-13
Sample Segments 3-3 collection 5-16
Sample Transfer Pump 3-10 handling 5-14, 7-6
SBar Codes See also Bar Code Labels mixing 5-17
Symbology 4-7 preparing 7-6
Schedule, Service and Maintenance 9-3 preparing to run 5-14, 12-11
Screen Navigation 1-30, 11-15 requirements 5-16
SD (Standard Deviation) 11-7 task 5-13
Second Sign On 2-47 Specimens, running
Service and Maintenance ID methods 5-18
As-Needed 9-4 rack and tube 2-58
Nonscheduled 9-4 Spill Clean-Up 8-7
Scheduled 9-4 Spinner Assembly 1-12
Service and Maintenance Schedule 9-3 Standby procedure
Setup Demographics 5-13 manually 9-7
Setup Guidelines 5-11, 12-7 Status conditions 3-27
Sheath Reservoir 1-16, 3-10 Suspect Parameter Flags 3-32

Index-6 CELL-DYN RubyTM System Operators Manual

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Index

Population 3-32 U
Symbologies, Bar Code 4-7, 4-8
Syringes - HGB Lyse 1-16 Ultrasonic Sensor 3-1
Syringes - Sample Metering 1-16 Unpacking and Inspection Guidelines 2-4
Syringes - WBC Lyse 1-16
System Connection and Start Up Guidelines 2-5 V
System Information Messages, SIMS 10-4,
Views
10-16
Datalog 1-33, 1-40, 2-8, 2-29
System Messages 10-3, 10-10
Maintenance 9-6
System Priming 5-8
Orders 5-19
System Relocation and Shipping Guidelines 8-8
QC View 1-34, 1-40, 2-8, 11-9, 11-13
System View
Reagents 9-12
Calibration Log 9-9
Run 5-28
Event Log 9-10
System 9-9
Set Point Log 9-11
Volumes
Minimum Volume in Specimen Tube 4-6
T Nominal Aspiration Volume 4-5
Technical Assistance 1-i
Telephone Support 1-i W
Temperature Specification 4-4
Warranty Statement for USA Customers Only 1-
Throughput Specifications 4-5
iv
Trademark Statements 1-v
Waste 1-15
Transfer Pump 9-64
Waste Disposal Requirements 2-4, 4-4, 8-7
Tubing 9-20
Troubleshooting 10-1 Waste disposal requirements 4-4
WBC 1-42
tube dimensions 10-19
Tube WBC Analysis 3-4
WBC Lyse 1-42
Tube Racks and Related Components 4-6
WBC Messages 3-39
Tubes
WBC Mixing Chamber 1-14, 1-15, 1-16, 1-42,
Sample Loader 1-5
3-4, 3-10
Tube Dimensions 4-5
Westgard Rules 1-37, 2-8, 2-36, 5-1, 10-18,
Tube Racks and Related Components 7-6
11-1, 11-3, 11-9, 11-11, 11-25, 11-26,
Tubes Dimensions 7-6
11-27, 11-36, 11-40, 11-41, 11-45, 11-47,
troubleshooting 10-39
11-57, 11-60, 11-61, 12-1, 12-21
Tubes Sensor Assembly 1-12

CELL-DYN RubyTM System Operators Manual Index-7

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 Index

NOTES

Index-8 CELL-DYN RubyTM System Operators Manual

9140562AMay 2006