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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

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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

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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

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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


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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.

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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.

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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.

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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.

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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

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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

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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

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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

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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

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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

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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

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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List of Figures

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

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


9140543AMay 2006
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

CELL-DYN RubyTM System Operators Manual 1


9140544AMay 2006
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

2 CELL-DYN RubyTM System Operators Manual


9140544AMay 2006
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


9140544AMay 2006
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


9140544AMay 2006
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

CELL-DYN RubyTM System Operators Manual 5


9140544AMay 2006
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


9140544AMay 2006
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.

CELL-DYN RubyTM System Operators Manual 7


9140544AMay 2006
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


9140544AMay 2006
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


9140544AMay 2006
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


9140544AMay 2006
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


9140544AMay 2006
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


9140544AMay 2006
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


9140545BAugust 2006
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.

1-2 CELL-DYN RubyTM System Operators Manual


9140545BAugust 2006
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


9140545BAugust 2006
Use or Function
Overview Section 1

NOTES

1-4 CELL-DYN RubyTM System Operators Manual


9140545BAugust 2006
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.

CELL-DYN RubyTM System Operators Manual 1-5


9140545BAugust 2006
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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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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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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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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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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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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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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Use or Function
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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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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Section 1 Use or Function

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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Section 1 Use or Function

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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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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Section 1 Use or Function

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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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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Section 1 Use or Function

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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Section 1 Use or Function

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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Section 1 Use or Function

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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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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Section 1 Use or Function

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 Procedures and Special Requirements
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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Section 2 Installation Procedures and Special Requirements

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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Section 2 Installation Procedures and Special Requirements

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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Section 2 Installation Procedures and Special Requirements

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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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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Installation Procedures and Special Requirements
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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Section 2 Installation Procedures and Special Requirements

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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Section 2 Installation Procedures and Special Requirements

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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Section 2 Installation Procedures and Special Requirements

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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Section 2 Installation Procedures and Special Requirements

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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Section 2 Installation Procedures and Special Requirements

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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Installation Procedures and Special Requirements
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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Section 2 Installation Procedures and Special Requirements

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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Section 2 Installation Procedures and Special Requirements

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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Section 2 Installation Procedures and Special Requirements

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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Installation Procedures and Special Requirements
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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Section 2 Installation Procedures and Special Requirements

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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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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Principles of Operation
Sample Analysis Cycle Overview Section 3

Hemoglobin Analysis
1. The Diluent/Sheath Syringe injects 1.7 mL of diluent through the Shear
Valve where the 12 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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Section 3 Principles of Operation

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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Principles of Operation
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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Principles of Operation
Flow Cytometry Section 3

WBC Measurement
Overview
The Optical Channel is used for the determination of WBC data. During sample
aspiration, 20 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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Section 3 Principles of Operation

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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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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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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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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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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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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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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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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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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Section 3 Principles of Operation

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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Section 3 Principles of Operation

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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Principles of Operation
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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Section 3 Principles of Operation

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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Principles of Operation
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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Section 3 Principles of Operation

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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Principles of Operation
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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Performance Characteristics and Specifications
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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Performance Characteristics and Specifications
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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Section 4 Performance Characteristics and Specifications

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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Performance Characteristics and Specifications
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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Performance Characteristics and Specifications
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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Section 4 Performance Characteristics and Specifications

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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Operating Instructions
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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Operating Instructions
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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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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Operating Instructions
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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Operating Instructions
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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Operating Instructions
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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Operating Instructions
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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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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Section 5 Post-Analysis Processing Datalog View

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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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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Section 6 Calibration Procedures

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 Procedures
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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Section 6 Calibration Procedures

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
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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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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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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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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Calibration Procedures Section 6

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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Calibration Procedures Section 6

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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Calibration Procedures Section 6

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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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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Calibration Procedures Section 6

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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Calibration Procedures
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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Calibration Procedures
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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Calibration Procedures
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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Operational Precautions and Limitations
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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Hazards
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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Hazards
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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Service and Maintenance
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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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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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