cd ruby operator manual 08h5602
TRANSCRIPT
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Operators Manual
List Number 08H56-02
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CELL-DYN Ruby System Operators Manual i9140559ESeptember 2013
Revision Status
Document ControlNumbers
RevisionDate
Section(s)Revised
Pages Revised,Added or Deleted
LN08H56-01A/
LN08H56-02
9212934A (TEXT)
9159955A (CD ROM)
May 2006 9140559A
Revision and Status Log
Initial release; all sections
new.
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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9140554ATroubleshooting and
Diagnostics
9140555A
Quality Control
9140556A
Reticulocyte Package
9140561AAppendices
9140562AIndex
LN08H56-03A/
LN08H56-02B9212934B (TEXT)
9159955B (CD ROM)
August
2006
9140559B
Revision and Status Log
9140540BForeword
9140541B
Master Table of Contents
9140542B
List of Figures
9140545B
Use or Function
9140549BOperating Instructions
9140552B
Hazards
9140553B
Service and Maintenance
9140561BAppendices
LN08H56-03B/
LN08H56-02C
9212934C (TEXT)
9159955C (CD ROM)
July 2008 9140559C
Revision and Status Log
9140540CForeword
9140541C
Master Table of Contents
9140542C
List of Figures
9140543BList of Tables
Document Control
Numbers
Revision
Date
Section(s)
Revised
Pages Revised,
Added or Deleted
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9140544BSystemDocumentation
9140545C
Use or Function
9140546B
Installation Procedures and
Special Requirements
9140547B
Principles of Operation
9140548B
Performance Characteristicsand Specifications
9140549C
Operating Instructions
9140550B
Calibration Procedures
9140551B
Operational Precautions and
Limitations
9140552C
Hazards9140553C
Service and Maintenance
9140554B
Troubleshooting and
Diagnostics
9140555B
Quality Control
9140556B
Reticulocyte Package
9140561CAppendices
9140562BIndex
Document Control
Numbers
Revision
Date
Section(s)
Revised
Pages Revised,
Added or Deleted
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LN08H56-03D/LN08H56-02E
9212934D (TEXT)
9159955F (CD ROM)
December2008
9140559DRevision and Status Log
9140540DForeword
9140541D
Master Table of Contents
9140542D
List of Figures
9140543CList of Tables
9140545DUse or Function
9140546C
Installation Procedures and
Special Requirements
9140547C
Principles of Operation
9140548C
Performance Characteristics
and Specifications
9140549DOperating Instructions
9140550C
Calibration Procedures
9140551C
Operational Precautions and
Limitations
9140552D
Hazards
9140553D
Service and Maintenance9140554C
Troubleshooting and
Diagnostics
9140555C
Quality Control
9140556C
Reticulocyte Package
Document Control
Numbers
Revision
Date
Section(s)
Revised
Pages Revised,
Added or Deleted
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9140561DAppendices
9140562CIndex
LN08H56-03F/
LN08H56-02F
9212934E (TEXT)
9159955G (CD ROM)
September
2013
9140559E
Revision and Status Log
ALL
9140540EForeword ALL
9140541E
Master Table of Contents
ALL
9140542E
List of Figures
ALL
9140543DList of Tables ALL
9140544CSystem
Documentation
ALL
9140545E
Use or Function
ALL
9140546D
Installation Procedures and
Special Requirements
ALL
9140547D
Principles of Operation
ALL
9140548D
Performance Characteristics
and Specifications
ALL
9140549E
Operating Instructions
ALL
9140550D
Calibration Procedures
ALL
9140551D
Operational Precautions and
Limitations
ALL
9140552E
Hazards
ALL
9140553E
Service and Maintenance
ALL
9140554D
Troubleshooting and
Diagnostics
ALL
Document ControlNumbers
RevisionDate
Section(s)Revised
Pages Revised,Added or Deleted
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9140555DQuality Control
ALL
9140556D
Reticulocyte Package
ALL
9140561EAppendices ALL
9140562DIndex ALL
Document Control
Numbers
Revision
Date
Section(s)
Revised
Pages Revised,
Added or Deleted
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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
ControlNumber
RevisionDate
SoftwareVersion
Revision
Incorporatedby
DateIncorporated
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NOTES
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CELL-DYN Ruby System Operators Manual i9140540ESeptember 2013
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 ServiceIf 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 DivisionCustomer 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 (2008 and 2013). All rights are reserved.
The software and manual were developed solely for use with the CELL-DYN Ruby
and for in vitrodiagnostic applications as specified in the operating instructions.
The information and related graphics published herein (the Information) are thesole 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.
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Each person assumes full responsibility and all risks arising from use of the
Information. The Information is presented as isand may include technical
inaccuracies or typographical errors. Abbott Laboratories reserves the right to
make additions, deletions, or modifications to the Information at any time withoutany 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 actualpatient 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 thismedia 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 incorporatingsuch 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 Accessoriesare 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 (2007). 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 duringnormal 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 theapplicable 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
Trademark Statements
CELL-DYN Sapphire, CELL-DYN Ruby, eQC, MAPSS, CELL-DYN and
CELL-DYN HemCal are trademarks of Abbott Laboratories in various
jurisdictions.
All other trademarks are the property of their respective owners.
All Abbott Laboratories product names and trademarks are owned by or licensed
to Abbott Laboratories, its subsidiaries or affiliates. No use of any Abbotttrademark, trade name, trade dress, or product name may be made without the prior
written authorization of Abbott Laboratories, except to identify the product or
services of Abbott Laboratories. All other trademarks, brands, product names, and
trade names are the property of their respective companies. All rights reserved.
Except as permitted above, no license or right, express or implied, is granted to any
person under any patent, trademark, or other proprietary right of Abbott
Laboratories.
In Vitro Diagnostic Directive 98/79/EC
Legal Manufacturer Abbott Laboratories
Abbott Park, IL 60064, USA
Authorized Representative ABBOTT
Max-Planck-Ring 265205 Wiesbaden
Germany
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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
InputPressure 1
Application Software Pressure 2
Busy Pressure 3
Fault Ready
Filter 1 or 2 Reservoir
Frequency Revision
HGB Flow Cell Serial Number
Line Voltage Set-Up Disk
Maximum Power Shear Valve
Mixing ChamberStand By
Model Number Trap
OFF Vacuum 1 or 2
ON Vent
Operating System Waste
Peristaltic Pump Waste Sensor
Power
AC INPUT PRESS 1
APPLICATION SOFTWARE PRESS 2
BUSY PRESS 3
FAULT READY
FILTER 1/2 RESERVOIR
FREQUENCY REV
HGB
FLOW CELLSN
LINE VOLTAGE SET-UP DISK
MAX POWER SHEAR VALVE
MIXING
CHAMBER
MODEL TRAP
VAC 1/2
VENT
OPERATING SYSTEM WASTE
PERISTALTIC PUMP WASTE SENSOR
POWER
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Reagent related
Cyanide-Free Hemoglobin/Nuclear Optical Count Lyse Reagent
Diluent Reagent
Diluent/Sheath Reagent
Enzymatic Cleaner Concentrate
Use by
Hemoglobin
Hemoglobin Lyse
Batch Code
Red Blood Cell
Sheath Reagent
Temperature Limitation (Example shows Store at 28C)
White Blood Cell
WBC Lyse Reagent
CN-FREE HGB/NOC LYSE
DILUENT
DILUENT/SHEATH
ENZYMATIC CLEANER CONCENTRATE
HGB
HGB LYSE
LOT
RBC
SHEATH
8
WBC
WBC LYSE
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Calibrator/Control related
Assay Value
Calibrator
Calibrator
Control
Control Assay Files
Control, Level I, II, or III or Level L, N, or H
Control, Tri-Level
Danger: Respiratory Sensitizer
Mean Range
Mean Value
Parameter
Catalogue number
Reticulocyte Control
System
ASSAY VALUE
CAL
CALIBRATOR
CONTROL
CONTROL ASSAY FILES
CONTROL I/II/III or L/N/H
CONTROL L|N|H
DANGER: SENSITIZER
MEAN RANGE
MEAN VALUE
PARAMETER
REF
RETIC CONTROL
SYSTEM
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Miscellaneous
Authorized Representative in the European Community
Biological risks
Caution, consult accompanying documents
(Note: for Instrument reagents)
Caution, risk of danger / Caution, consult accompanying documents
(Note: for Instruments)
CE-mark
Consult Instructions for Use
Date of Manufacture
In VitroDiagnostic Medical Device
Catalogue Number
Separate collection for electrical and electronic equipment waste perDirective 2002/96/EC in the European Union
Separate Collection of spent batteries per Directive 2006/66/EC in the
European Union.
Manufacturer
EC REP
IVD
REF
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Instrument Labeling
The following labels are affixed to the CELL-DYN Ruby.
Analyzer Rear Panel
Figure 1: Class 1 Laser Product Label
Figure 2: CELL-DYN Ruby US Patent Label
Figure 3: CE Mark and Legal Manufacturer
PN 9230702C
CLASS 1 LASER PRODUCT/Lasergert der Klasse 1/Produit laser de classe 1/Lser declase 1/Prodotto laser di classe 1/Produto laser da classe 1/Klasse 1-laserprodukt/Klass 1 laserprodukt/ 1
The following U.S. Patents are relevant to the CELL-DYN Ruby or its
components. There are other such patents and patent applications in theUnited States and worldwide.
5,017,497 5,378,633 5,510,267 5,733,784
PN: 9231334A
9221334A indd 1 6 24 2005 9:16:12 AM
ABBOTTMax-Planck-Ring 265205 WiesbadenGermany+49-6122-580
ABBOTT LABORATORIESAbbott Park, IL 60064 USA
PN 9230751
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Figure 4: CE Label
Figure 5: ETL Certification Label
Analyzer Right Flow Panel
Figure 6: Analyzer Serial Number Labels
PN 9231514A
EC REPABBOTTMax-Planck-Ring 265205 WiesbadenGermany+49-6122-580
Abbott
Diagnostics Division
ABBOTT LABORATORIES
Diagnostics Division
Abbott Park, IL 60064 USA
9221514A indd 1 1 16 2008 12:16:45 PM
ABBOTT DIAGNOSTICS DIVISIONAbbott Laboratories
Abbott Park IL, 60064, USA
DATE OF MANUFACTURE
REVREF
SN
MODEL
PN 9230308 REV J
THIS PRODUCT COMPLIES WITH FDAPERFORMANCE STANDARDS FOR LASER
PRODUCTS EXCEPT FOR DEVIATIONSPURSUANT TO LASER NOTICE NO. 50,
DATED JULY 26, 2001.
MODEL
PN 9230308 REV K
PRODUCT COMPLIES WITH FDA PERFORMANCESTANDARDS FOR LASER PRODUCTS EXCEPTFOR DEVIATIONS PURSUANT TO LASER NOTICE
NO. 50, DATED JULY 26, 2001.
Manufactured for Abbott LaboratoriesAbbott Park, IL 60064 USA
Product of Singapore
SN
REF REV
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Analyzer Left Flow Panel
Figure 7: CELL-DYN Ruby Service Technical Service Bulletin Record Label
Figure 8: Laser Warning Label
Analyzer Front and Rear
Figure 9: Biohazard
CAUTION Class 3B laser light when open. Avoidexposure to beam.VORSICHT Bei offener Abdeckung Laserstrahlung derKlasse 3B. Nicht direkt in den Laserstrahl blicken.ATTENTION Rayon laser de classe 3B si ouvert. Evitertoute exposition au faisceau laser.PRECAUCIN: Haz de lser de clase 3B. Evite laexposicin al lser cuando el analizador est abierto.ATTENZIONE:fascio laser di classe 3B se aperto. Evitarelesposizione al raggio.ATENO Quando aberto, emite luz laser da classe3B. Evitar a exposio ao raio laser.VIGTIGT:Klasse 3B-laserlys ved bning. Undgeksponering for strlen.VIKTIGT:Klass 3B laserljus nr luckan r ppen. Undvikexponering fr strlen. 3 .
.UPOZORNN:Po oteven krytu nebezpe ozenlaserem tdy 3B. Vyvarujte se kontaktu s paprskem.
PN 9230701F
PN 9231477A
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CELL-DYN Ruby System Operators Manual Master Table of Contents-19140541ESeptember 2013
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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xAnalyzer Right Flow Panel. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xi
Analyzer Left Flow Panel. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xii
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 . . . . . . . . . . . . . . . . . . . 1-5Test 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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Analyzer Flow Panels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-14
Analyzer Internal Assemblies. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-17
Analyzer Rear . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-19
Data Module Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-22Flat Panel Display with Touch Screen . . . . . . . . . . . . . . . . . . . . . . 1-24
Keyboard. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-25
Mouse Input Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-27
Hand-Held Bar Code Reader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-28
Printers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-29
System Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-31
Analyzer Operating Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-31
Data Station Operating Software . . . . . . . . . . . . . . . . . . . . . . . . . . 1-31
Screen Navigation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-32
Screen Layout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-32Title Bar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-33
Menu Bar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-33
Tool Bar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-35
Status Bar and System Messages Region . . . . . . . . . . . . . . . . . 1-38
NOTE Region (Next Open Tube Entry) . . . . . . . . . . . . . . . . . . 1-40
Function Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-42
CELL-DYN Ruby Reagents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-43
CELL-DYN Diluent/Sheath . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-43
CELL-DYN CN-Free HGB/NOC Lyse . . . . . . . . . . . . . . . . . . . . . 1-43
CELL-DYN WBC Lyse . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-44
CELL-DYN Reticulocyte Reagent . . . . . . . . . . . . . . . . . . . . . . . . . 1-44
Controls, Calibrator, and Standard Reference Particles . . . . . . . . . . . . . . . 1-45
Controls. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-45
Calibrators. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-45
Standard Reference Particles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-45
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
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Setup Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7
Patient Sample Setup... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9
Patient Sample Setup, Limits Tab View. . . . . . . . . . . . . . . . . . 2-10
Demographics Tab View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11Customize Limit Sets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11
Demographic Tab View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-21
Unit Sets Selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-23
Unit Format Selections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-23
Customize Run View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-24
Chartable Page . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-25
Lab Page . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-27
Graphs Page . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-29
Customize Data View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-30
Datalog, QC View, and Groups View . . . . . . . . . . . . . . . . . . . 2-30Customize Moving Average View . . . . . . . . . . . . . . . . . . . . . . . 2-32
Customize Printed Report. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-33
Customize Report Header. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-34
Auto Print Chartable Page Report . . . . . . . . . . . . . . . . . . . . . . 2-35
Other Printed Report Options . . . . . . . . . . . . . . . . . . . . . . . . . . 2-36
QCID Setup. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-37
Moving Average Acceptance Setup... . . . . . . . . . . . . . . . . . . . . . . 2-37
Administrative Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-37
Operators. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-38
User Interface Preferences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-50
Tool Tip Display Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-51
QCID Daily Cleanup Time. . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-51
Date/Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-52
Instrument ID Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-54
Bar Code Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-56
Orders Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-58
Automatic Order Cleanup. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-58
No Bar Code Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-59
LIS Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-61
LIS Configuration Tab View . . . . . . . . . . . . . . . . . . . . . . . . . . 2-64
LIS Tests Tab View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-65QC Download ID File Setup. . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-65
Flag Setting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-66
Logs Auto Backup Setup... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-67
Rule Setup... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-68
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Principles of Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
Sample Aspiration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1Sample Analysis Cycle Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
Sample Aspiration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
Sample Segments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
RBC/PLT Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7Detection 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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-15Nuclear 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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-21
MCH . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-21
MCHC. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-21
RDW. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-21
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Nominal Aspiration Volume. . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5
Recommended Anticoagulants . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5
Specimen Tube Dimensions (Closed Mode) . . . . . . . . . . . . . . . 4-5
Recommended Specimen Collection Tubes (Closed Mode) . . . 4-6Recommended 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
CBC Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-12
Imprecision (Reproducibility). . . . . . . . . . . . . . . . . . . . . . . . . . 4-13Analytical 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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-15Signing On and Off. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-15
Running Background Counts . . . . . . . . . . . . . . . . . . . . . . . . . . 5-15
Preparing and Handling Specimens . . . . . . . . . . . . . . . . . . . . . . . . 5-16
Anticoagulant . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-16
Specimen Stability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-17
Specimen Collection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-17
Interfering Substances. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-17
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Specimen Mixing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-17
Running Specimens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-18
Specimen Identification Methods . . . . . . . . . . . . . . . . . . . . . . . 5-18
Introduction to the Orders View . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-20Default Patient Test Selection Processing Conditions . . . . . . . 5-21
Pending Orders (Match Specimen ID or Match Rxx Tyy). . . . 5-22
Pending Order Entries from the LIS. . . . . . . . . . . . . . . . . . . . . 5-22
Processing with the Orders View . . . . . . . . . . . . . . . . . . . . . . . 5-22
Create Manual Orders. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-25
Printing a Pending Orders Log . . . . . . . . . . . . . . . . . . . . . . . . . 5-27
Orders Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-28
Open Mode Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-30
Closed Mode Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-31
Post-Analysis Processing Datalog View . . . . . . . . . . . . . . . . . . . . . . . . . 5-33Alerts and Indicators. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-33
Out of Range. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-33
System Messages and Fault Conditions . . . . . . . . . . . . . . . . . . 5-33
Run View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-34
Chartable Page . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-35
Lab Page . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-35
Graphs Page . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-36
Datalog View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-36
Backing up and Restoring System Data . . . . . . . . . . . . . . . . . . 5-40
Creating an Electronic Monthly Archive on the
CELL-DYN Ruby. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-43
Advanced Data Management Groups View . . . . . . . . . . . . . . . . . . . . . . 5-47
Creating Orders From the Group View . . . . . . . . . . . . . . . . . . . . . 5-48
Deleting Records From the Group View . . . . . . . . . . . . . . . . . . . . 5-48
Advanced Data Management Rules Based Annotations . . . . . . . . . . . . . 5-51
Creating Rules and Annotations . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-53
Creating Rules. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-53
Creating Annotations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-53
Procedure: Creating Annotations . . . . . . . . . . . . . . . . . . . . . . . 5-59
Enabling/Disabling Rules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-60
Rule Validation (within software) . . . . . . . . . . . . . . . . . . . . . . . . . 5-66Evaluating Rules During Run Time . . . . . . . . . . . . . . . . . . . . . . . . 5-70
Displaying Annotations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-71
Printing the Rules Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-74
Printing a Group of Specimens with Annotations . . . . . . . . . . 5-75
Importing /Exporting Rules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-76
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Calibration Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
When to Calibrate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3Calibration Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5
General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5
Auto-Calibration Wizard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5
Calibration Bias 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. . . . . . . . . . . . 6-7Requirements 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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-17Quick Precision Check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-18
Calibration Log. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-20
Auto-Calibration Wizard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-22
Manual Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-22
Calibration Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-25
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-25
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
Running the Calibration Bias Wizard. . . . . . . . . . . . . . . . . . . . . . . 6-65
Manual Calibration Method . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-72
Manual Calibration Dialog Box . . . . . . . . . . . . . . . . . . . . . . . . 6-72
Manual Calibration Primary Mode - Open. . . . . . . . . . . . . . . . 6-73
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Post-Calibration Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-77
Backing Up Calibration Factors . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-77
General Concepts and Guidelines. . . . . . . . . . . . . . . . . . . . . . . 6-77
Backup Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-77Manual Calibration Worksheets . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-80
Worksheet 1 Open Mode Calibration - New Factors . . . . . 6-81
Worksheet 2 Open Mode Factor % Difference . . . . . . . . . . 6-82
Worksheet 3 Open Mode Calibration Range Criteria . . . . . 6-83
Worksheet 4 Calibration Verification . . . . . . . . . . . . . . . . . 6-84
References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-85
Operational Precautions and Limitations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
General Requirements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2Precautions 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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1Operator 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
Disposing of Batteries. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-8
Decontamination Procedure Requirements . . . . . . . . . . . . . . . . 8-8
Electrical Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-8
Mechanical Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-10
Physical Hazards. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-12
References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-13
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Quality Control. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-1
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-1
When to Run QC. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-2QC 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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-10Quality Control Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-13
Using QC View. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-14
Main QC View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-14
Scrolling Through the QC View. . . . . . . . . . . . . . . . . . . . . . . 11-15
View QC Spec . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-20
QCID L-J Plots . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-22
QCID Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-23
Download QCID Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-27
View QC Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-28
Moving Average View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-34Moving Average Levey Jennings View. . . . . . . . . . . . . . . . . . . 11-36
Quality Control Software Setup . . . . . . . . . . . . . . . . . . . . . . . . . . 11-39
QCID File Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-39
QC Download ID Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-59
Moving Average Acceptance Setup . . . . . . . . . . . . . . . . . . . . 11-60
Performing a QC Run . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-64
Rejecting/Accepting Specimens . . . . . . . . . . . . . . . . . . . . . . . 11-64
Edit QC Specimens. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-65
Moving QCID Specimen Runs from One QCID File to Another 11-67
Evaluating and Investigating Commercial and Patient Control Results. . 11-69
Analyzing QCID File Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-71
Levey-Jennings Graphs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-71
Westgard Rule Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-72
Westgard Rules for the CELL-DYN Ruby. . . . . . . . . . . . . . . . . . 11-72
Rule Violations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-73
Moving Average Programs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-75
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-75
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How Moving Average Programs Work . . . . . . . . . . . . . . . . . . . . 11-75
Principles of Moving Average Analysis. . . . . . . . . . . . . . . . . . . . 11-76
Guidelines for Setting Up X-B Moving Average
Program Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-76Establishing the Target Value. . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-77
Guidelines for Interpreting X-B Moving Average
Program Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-78
Guidelines for Setting Up and Interpreting Other Moving Average
Programs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-79
Moving Average Program Operation . . . . . . . . . . . . . . . . . . . . . . 11-81
Data Collection Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-81
Investigating Moving Average Data Problems. . . . . . . . . . . . . . . 11-82
Investigating One Batch Out. . . . . . . . . . . . . . . . . . . . . . . . . . 11-82
Investigating Two Batches Out. . . . . . . . . . . . . . . . . . . . . . . . 11-82Printing Moving Average Programs Information. . . . . . . . . . . . . 11-82
Customizing Moving Average Programs . . . . . . . . . . . . . . . . . . . 11-83
References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-85
Reticulocyte Package . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-1
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-1
Principles of Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-3
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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-23Maintenance 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 B . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-1
Appendix B Reference. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-1
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Index-1
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List of Tables
List of Tables
Use or FunctionTable 1.1 Status Indicator LEDs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9
Table 1.2 Reagent Inlet Connectors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-20
Table 1.3 Keyboard Keys and Their Functions on the CELL-DYN Ruby. . . 1-26
Table 1.4 Mouse Actions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-27
Table 1.5 Printing Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-29
Table 1.6 Menu Bar Commands . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-33
Table 1.7 Tool Bar Button Navigation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-35
Table 1.8 Status Bar Function Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-40
Table 1.9 Tab Descriptions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-42
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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-22
Table 2.4 To Select the Default Patient Test Selection . . . . . . . . . . . . . . . . . 2-22
Table 2.5 Procedure to Change the Unit Sets Selection . . . . . . . . . . . . . . . . . 2-23
Table 2.6 Procedure to Customize Parameter Set - Chartable Page . . . . . . . . 2-25
Table 2.7 Customize the Run View - Lab Page . . . . . . . . . . . . . . . . . . . . . . . 2-27
Table 2.8 Procedure to Customize the Run View - Graphs Page . . . . . . . . . . 2-29
Table 2.9 Procedure to Customize Tab Titles and Column Headingsin Data View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-31
Table 2.10 Procedure to Add/Delete Tab Pages in Data View. . . . . . . . . . . . . 2-32
Table 2.11 To Customize the Printed Report Header . . . . . . . . . . . . . . . . . . . . 2-34
Table 2.12 Procedure to Auto Print Chartable Page Report . . . . . . . . . . . . . . . 2-35
Table 2.13 Procedure to Print Using Other Printed Report Options. . . . . . . . . 2-36
Table 2.14 Operator ID and Access Levels . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-38
Table 2.15 Procedure to Add an Operator . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-40
Table 2.16 Add Operator Dialog Box. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-41
Table 2.17 Procedure to Remove an Operator . . . . . . . . . . . . . . . . . . . . . . . . . 2-42
Table 2.18 Procedure to Edit Operator Information . . . . . . . . . . . . . . . . . . . . . 2-43Table 2.19 Edit Operator Dialog Box. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-44
Table 2.20 Procedure for Editing Permission Access Rights for Laboratory
Levels I and II . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-46
Table 2.21 Procedure for Setting Up Second Sign Ons . . . . . . . . . . . . . . . . . . 2-48
Table 2.22 Changing the Tool Tip Display Time. . . . . . . . . . . . . . . . . . . . . . . 2-51
Table 2.23 Procedure to Set Up Bar Code Including Symbology Setups . . . . 2-56
Table 2.24 Procedure to Change Automatic Order Cleanup . . . . . . . . . . . . . . 2-59
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List of Tables
Table 2.25 Procedure to Change Use Rack and Tube Matching . . . . . . . . . . . 2-60
Table 2.26 Setting Up Auto-Transmission and Manual Transmission. . . . . . . 2-62
Table 2.27 Flag Setting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-66
Table 2.28 Logs Auto Backup Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-67
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 theCELL-DYN Ruby . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-8
Table 4.9 Background Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11
Table 4.10 Carryover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-12
Table 4.11 Reticulocyte Carryover. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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
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List of Tables
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
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 . . . . . . . . . . . . . . 9-4Table 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. . . . . . . . . . . . . . . . . . . . . . . . . 11-20
Table 11.4 Function Keys QCID File Levey-Jennings View . . . . . . . . . . 11-22
Table 11.5 Function Keys QCID Data Dialog Box . . . . . . . . . . . . . . . . . . 11-24
Table 11.6 Field QC Download Dialog Box . . . . . . . . . . . . . . . . . . . . . . . 11-28Table 11.7 Buttons QC Download Dialog Box . . . . . . . . . . . . . . . . . . . . . 11-28
Table 11.8 Fields QCID Setup: View, Control Data Dialog Box . . . . . . . 11-30
Table 11.9 Fields QCID Setup: View, QC Limits Dialog Box . . . . . . . . . 11-30
Table 11.10 Fields QCID Setup: View, Westgard Dialog Box. . . . . . . . . . 11-31
Table 11.11 Buttons QCID Setup: View, Control Data Dialog Box. . . . . . 11-31
Table 11.12 Function Keys QC Moving Average View . . . . . . . . . . . . . . . 11-35
Table 11.13 Function Keys-Levey Jennings View. . . . . . . . . . . . . . . . . . . . . . 11-36
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List of Tables
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-2Table 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
Potential Causes of Spurious Results
Table B.1 Potential Causes of Spurious Results with Automated
Cell Counters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-1
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Section 3 Principles
of Operation
Refer to this section for an explanation of:
Scientific and technical principles
Types of system measurements
Data analysis and parameter reporting conventions
System Initiated Messages (SIMs) and Data Flags
Section 4PerformanceCharacteristics and
Specifications
Refer to this section for details such as:
Dimensions of the instrument
Power requirements
Environmental specifications
Operational specifications
Bar Code specifications
Performance specifications and performance characteristics
Section 5 OperatingInstructions
Use this section to learn how to perform:
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 CalibrationProcedures
Use this section to learn:
When to calibrate
Pre-Calibration procedures
Calibration procedures
Post-Calibration procedures
Section 7 OperationalPrecautions andLimitations
Refer to this section to understand the precautions, limitations, andrequirements associated with:
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
Maintenance
Refer to this section for:
Descriptions of all maintenance procedures
Recommended schedules for service and maintenance
Instructions for performing scheduled and as-needed maintenanceprocedures
Step-by-step instructions for replacing components
Table 1: Online Operators Manual Organization (Continued)
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Table 4: Online HTML Operators Manual Search Navigation
Actions Steps Reference
Using thetable ofcontents
1. Select the Contents tab on thenavigation pane to provide a visual tableof contents of the operators manual(See graphic to the right).
2. Select the box icons and page icons toview subsections.
NOTE: The box icons expand andcollapse correspondingsubsections as they are selected.
3. Click on the desired topic to select thattopic. The topic page displays in thetopic pane (right side of window).
Scrollingthrough thecontent
1. Select the Contents tab on thenavigation pane (see graphic to theright), and then select a topic title. Thetopic content displays in the topic pane.
2. Drag the scroll bar on the right side ofthe topical pane to display subsequentcontent within the section.
3. Repeat step 2 as often as desired.
Pagingbetweensections
1. Select the Contents tab on thenavigation pane and select a topic title.The desired topic then displays in thetopic pane.
2. Select a left or right section arrow(located in the upper right-hand corner ofthe topic pane) to move betweensections of the manual (see graphic tothe right).
NOTE: Section arrows are also
visible at the bottom of the topicpane when viewing the end of asection.
2
1
1A
1
2
1
12
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Using theindex
1. Select the Index tab on the navigationpane (see graphic to the right).
2. Type in a keyword to find all referencesto the keyword within the manual. Or,click on any topic in the Index.
The topic content displays in the topic pane.
Using theSearchbutton
1. Select the Search button (see graphic tothe right).
2. Type a keyword (or phrase) in the fieldindicated and select List Topics
3. Review the topics displayed in theresults pane and double-click on a topicfor further review. This topic is thendisplayed in the topic pane.
4. To search for new content, type anotherkeyword (or phrase) in the field indicatedand select List Topics.
Table 4: Online HTML Operators Manual Search Navigation (Continued)
Actions Steps Reference
1
2
1
2
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Printed documentation
The printed version of the CELL-DYN Ruby Operators Manual contains complete
instructions for using and maintaining the CELL-DYN Ruby system. You will findit a valuable aid and an essential reference as you learn to use the system.
Printed documentationtopics 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 andLog
Refer to this section for the Revision Status and History of theCELL-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
Contents
Refer to the Table of Contents for a list of all:
Sections Subsections
List of Figures
List of Tables
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System
Documentation
Refer to this section for:
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 orFunction
Refer to this section for a brief description of the CELL-DYN Ruby, such as:
Intended use
Specimen processing sequence
Main hardware components
Basic features of the system software
Reagents, Controls, Calibrator, and Standard Reference Particles
Section 2 InstallationProcedures andSpecial Requirements
Refer to this section for:
Information on site requirements for installation
System installation and start-up guidelines
System software customization and procedural guidelines
System relocation and shipping guidelines
Section 3 Principlesof Operation
Refer to this section for an explanation of:
Scientific and technical principles
Types of system measurements
Data analysis and parameter reporting conventions
System Initiated Messages (SIMs) and Data Flags
Section 4PerformanceCharacteristics andSpecifications
Refer to this section for details such as:
Dimensions of the instrument
Power requirements
Environmental specifications
Operational specifications
Bar Code specifications
Performance specifications and performance characteristics
Section 5 OperatingInstructions
Use this section to learn how to perform:
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 CalibrationProcedures
Use this section to learn:
When to calibrate
Pre-Calibration procedures
Calibration procedures
Post-Calibration procedures
Table 5: Online Operators Manual Organization (Continued)
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Section 7 Operational
Precautions andLimitations
Refer to this section to understand the precautions, limitations, andrequirements associated with:
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 andMaintenance
Refer to this section for:
Descriptions of all maintenance procedures
Recommended schedules for service and maintenance
Instructions for performing scheduled and as-needed maintenanceprocedures
Step-by-step instructions for replacing components
Section 10Troubleshooting andDiagnostics
Refer to this section for:
Troubleshooting basics and procedures
Information on probable causes and corrective actions for observedproblems, System Initiated Messages (SIMs), and Data-Related problems
Section 11 QualityControl
Refer to this section for:
Internal and external quality control programs
Principles and procedures for running quality control using commercialcontrol material and whole blood patient controls
Procedures to customize system quality control files
Quality control data management
Section 12
Reticulocyte Package
This section is a self-contained module that describes how the Reticulo